Moderna

Cardiovascular symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-06 blood pressure increased Developed a severe headache within 2-3 hours of receiving vaccine. Took 2 Tylenol. Headache abated b... Read more
Developed a severe headache within 2-3 hours of receiving vaccine. Took 2 Tylenol. Headache abated but did not resolve. Within the next 2-3 hours felt tingling in my left upper lip. It grew worse and headache worsened. Lip felt like it was swelling but no change was seen. Then left side of face began to ache. Took 2 more Tylenol. Texted my primary care physician who recommended Benadryl in case it was an allergic reaction. Took Benadryl about 4:30 or 5:00. Left work and went home. Had severe headache. Took my blood pressure. It was 185/68. Had some old Propanolol 10 mg from 2 years earlier and took one and a Prednisone 10mg. By 9:00 pm still felt bad with facial pain and tingling. BP decreased to 148/89. Took another Benadryl and went to bed. Face ant lip better in the morning. Arm sore for 2 days. Developed body and joint aches for the past 2-3 days. Slowly resolving.
76 2021-01-08 heart rate increased, blood glucose increased Pt c/o having 'weird feeling/not feeling good' and increase heart rate about 7-8 minutes after recei... Read more
Pt c/o having 'weird feeling/not feeling good' and increase heart rate about 7-8 minutes after receiving vaccine. Pt denied any shortness of breath at the time, no swelling of face, BBS clear and equal with equal rise and fall of the chest wall, alert and oriented X 4, able to speak in complete sentences. Progressed to report 'lips feeling like they are swelling approximately 18 minutes after the vaccine was administered. 911 was activated. Epinephrine 0.3 mg IM via epi autoinjector was administered to left thigh. Pt still c/o feeling that her lips were swelling 8 minutes after first dose of Epinephrine; therefore, another dose of 0.3 mg Epinephrine IM via epi autoinjector was administered to left thigh. Diphenhydramine 25 mg IV was administered 2 minutes after second dose of Epinephrine. IV fluids administered as well, while awaiting arrive of EMS. EMS arrived on scene approximately 30 minutes after called. Blood glucose was 120 mg/dl approximately 25 minutes after vaccine administration. Pt report feeling better after the 2nd dose of Epinephrine and Diphendydramine and 500 ml of Normal saline IV. Pt was transported via EMS to the ER for further evaluation and treatment.
76 2021-01-11 hypotension, loss of consciousness Patient on evening of vaccine administration had low blood pressure, vomited, and had episode of los... Read more
Patient on evening of vaccine administration had low blood pressure, vomited, and had episode of loss of consciousness. Occurred in patient's home and spouse contact 911 after trying to communicate with her. EMS noted patient's blood low and transported to ER facility. Patient expresses she felt fine in ER and requested to discharge. No other issues after this episode and has follow-up appointment with physician given concomitant medical conditions.
76 2021-01-13 excessive bleeding Within about 2 days a round red sore appeared on my left arm just below my elbow. Each day it becam... Read more
Within about 2 days a round red sore appeared on my left arm just below my elbow. Each day it became more sore and inflamed. Within one week it became filled with puss, erupted, bled and now seems to be filling with puss again. Now, within the last 2-3 days the injection site has suddenly developed a large red patch of mildly itchy irritation surrounding the site, with one or two other small patches starting to appear nearby. During the last few days I have also notice a dull pain coming and going in my left arm. Using my cell phone, I have taken photos of the sore in 3 stages and of the red injection area. Those photos could be submitted to my doctor or this office, via text, if helpful.
76 2021-01-17 palpitations Palpitations at night time lasting 4 hours.
76 2021-01-18 heart rate increased temp 101.4 axillary , nausea ,without emesis HR 108 . weakness fatigue
76 2021-01-19 blood pressure increased Patient said she felt the meds going into her system after the vaccine was given and she became dizz... Read more
Patient said she felt the meds going into her system after the vaccine was given and she became dizzy. Her vital signs were taken over a course of 30 minutes and her blood pressure kept getting higher and higher to 210/140/ Pulse 55 and O2 sat was 99%. Dr. was called and she recommended pt be taken to the ER by the ambulance. The ambulance was called but the pt ended up leaving in the car with her son. I called both Medical Center and Hospital but pt had not been admitted to the ER this afternoon.
76 2021-01-19 fibrin d dimer increased, blood glucose increased Employee received vaccine on 12/29/2020, was diagnosed with COVID-19 on 1/12/2021, had ED visit, rec... Read more
Employee received vaccine on 12/29/2020, was diagnosed with COVID-19 on 1/12/2021, had ED visit, received the Bamlanivimab infusion, returned to the ED on 1/16/2021, was admitted with dehydration, currently remains inpatient receiving Remdesivir infusion.
76 2021-01-21 chest pain PATIENT RECEIVED 1ST DOSE OF MODERNA AT 9:10 AM. AT 940 SHE REPORTED TO THE MONITOR THAT SHE HAD A ... Read more
PATIENT RECEIVED 1ST DOSE OF MODERNA AT 9:10 AM. AT 940 SHE REPORTED TO THE MONITOR THAT SHE HAD A TINY SHARP PAIN TO LEFT SIDE OF CHEST THAT CAME AND LEFT QUICKLY. SHE STATES THIS PAIN HAPPENED 4 TIMES DURING HER MONITORING TIME. SHE STATES SHE HAS THIS TIME PAIN FROM TIME TO TIME. SHE STATES NO MORE PAIN AFTER THOSE 4 EPISODES.
76 2021-01-21 chest pain Generalized weakness, nausea, chest pain.
76 2021-01-21 loss of consciousness Pt well until approximately 2:55am when she passed out in bathroom according to her husband. Pt was ... Read more
Pt well until approximately 2:55am when she passed out in bathroom according to her husband. Pt was diaphoretic. Denied dyspnea, chest pain, fever, redness, or difficulty breathing. Patient: Age: 76 Years Additional information for Item 18: Date/Time: 01/22/21 03:19 Time of my initial contact with patient: 0319 Mode of Arrival: Ambulance Private Medical Doctor: Triage Narrative: Pt. bib medics from home after near syncopal event in bathroom, lowered herself ot the ground, no LOC/trauma. BP on medic arrival was 86/50 HR in 50s, improved to 100/68 w/ lying down and 250ml bolus. Received 1st covid vax today, has felt weak w/ diarrhea since then. Denies pain, skin pale/w/d, AxOx3, resp e/u. Chief Complaint: Syncope/Near syncope History of Present Illness: This is a 76-year-old female with history of CAD status post remote PCI, previous CVA on Plavix, hysterectomy, migraines who presents ER today for a syncopal event. Patient was given her first dose of Covid vaccine earlier today, per patient's primary doctor found in prior to arrival she had been very hesitant because she was concerned for triggering migraines, this was clear with her neurologist that she was pretreated with Benadryl, she states that she initially felt fine after vaccine administration, she states however later in the evening she developed 4 episodes of loose watery bowel movements and crampy abdominal pain, she states she was feeling tired and so she laid down to go to bed, she states that she woke up feeling as if she had to have another diarrheal episode, she reports that when she stood up and went to the bathroom she was not feeling well, she reports feeling very lightheaded while on the toilet and trying to have a bowel movement, she attempted to stand up however felt acutely lightheaded, she states that she sat back down the toilet and slumped down and woke up on the ground. She denies any pain other than her abdominal pain and a sensation that she has had further bowel movements. Per EMS patient was noted to be hypotensive on arrival 86/50 with heart rate in the 50s, this improved with laying flat on the gurney and given a 250 cc bolus. Patient has been seen in the past for syncopal events with postural changing. She denies any new medication changes, she states that she had been drinking water throughout the day but has had a poor appetite no dysuria frequency urgency no headache head injury neck pain back pain new numbness tingling or weakness in arms or legs no difficulty with speech Problem List & Past Medical/Surgical History: CAD (coronary artery disease) Dysuria Hysterectomy Migraine Potential stroke Stent Family History: No related illness Social History: The patient does not smoke tobacco or abuse alcohol. Allergies: Imitrex morphine (Nausea) shellfish traMADol Medications: Available Med List Reviewed Review of Systems: All other systems reviewed and are negative except per HPI Physical Exam: Vital Signs BP: 151/93 mmHg Temp (Oral): 36.4 DegC ( 97.5 DegF) HR: 73 bpm Resp: 18 br/min SpO2: 97 % GENERAL: Patient appears well developed, well nourished. HEENT: Normocephalic and atraumatic. EOMI. No scleral icterus. Airway is patent NECK: Supple Trachea is midline. No midline tenderness full range of motion without pain or discomfort RESP: Lungs are clear to auscultation bilaterally. No wheezing, rhonchi, rales CARDIOVASCULAR: Regular rate and rhythm 2+ radial and DP pulses symmetric bilaterally GASTROINTESTINAL: Abdomen is soft, mild diffuse tenderness and nondistended. No rebound, no guarding. No pulsatile mass appreciated. BACK: No CVA or spinal midline tenderness to palpation MUSCULOSKELETAL: No clubbing, cyanosis, or edema. No calf tenderness to palpation. SKIN: Warm and dry. No external evidence of trauma NEURO: The patient is alert and oriented x3, not confused. Speech not slurred. Normal facial symmetry. No subjective facial numbness. No vision changes. EOMI. Upper and lower extremitites with 5/5 strength globally. Normal sensation noted over all extremities. No subjective dizziness. Finger-to-nose testing normal. Normal gait. PSYCHIATRIC: Alert and appropriate. Test Results: Labs Results 01/22/21 03:38 134 L 102 9 109 4.2 23 0.6 01/22/21 03:38 12.9 9.6 355 37.8 01/22/21 05:20 Cardiac Studies Troponin-HS <2.0 01/22/21 03:38 Hematology WBC 9.6 HGB 12.9 HCT 37.8 PLT 355 MCV 94 RBC 4.03 MCH 32 MCHC 34.2 RDW 13.1 MPV 6.1 L Neutrophils 55 Lymphocytes 34 Monocytes 8 Eosinophils 2 Basophils 1 Neut Absolute 5.2 Lymph Absolute 3.3 Mono Absolute 0.8 Eos Absolute 0.2 Baso Absolute 0.1 Cardiac Studies Troponin-HS <2.0 Chemistry Calcium Lvl 8.1 L Anion Gap 9 Sodium Lvl 134 L Potassium Lvl 4.2 Chloride 102 CO2 23 Glucose Lvl 109 BUN 9 Creatinine 0.6 Alk Phos 75 ALT 13 AST 15 Bili Total 0.4 Total Protein 5.8 L Albumin Lvl 3.5 LAB >60 LAB >60 01/22/21 03:17 Chemistry Gluc POC 106 Gluc POC 106 (01/22/21 03:17) Diagnostic Results Preliminary CT head reveals no acute intracranial abnormality Preliminary CT abdomen pelvis revealed no acute intracranial abnormality other than hiatal hernia Chest x-ray is negative for acute pulmonary pathology EKG Results EKG obtained at 0323 interpreted by me reveals normal sinus rhythm, patient has diffuse T wave flattening which appears similar to previous no STEMI, no ectopy no heart block no WPW Brugada prolonged QTC Emergency Department Course and Procedures: Medications, IV's and Blood Products Ordered Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses Other Orders Nursing to Initiate Saline lock Insertion Careset (Stat) Oxygen Therapy (Titrate for SaO2 > 95%) Reexamination/Reevaluation: Critical Care Note The high probability of sudden, clinically significant deterioration in the patient's condition required the highest level of my preparedness to intervene urgently. Critical care was necessary to treat or prevent imminent or life-threatening deterioration of the following conditions: cardiac failure, circulatory failure, CNS failure or compromise, dehydration, hepatic failure, endocrine crisis, metabolic crisis, renal failure, sepsis, respiratory failure, shock, toxidrome and trauma. I provided critical care services requiring my management in the following manner: chart data review, documentation time, medication orders and management, re-evaluations, vital signs assessments and reviewing monitor data, and ordering and reviewing lab tests. Aggregate Critical care time was 30 minutes. My time did not include minutes spent treating any other patient simultaneously or on activities that did not directly contribute to the patient's treatment. It did not include time spent performing other reported procedures. Medical Decision Making: This is a 76-year-old female who presented ER today for evaluation of syncope. Patient was reportedly mildly hypotensive which improved with IV fluids. I suspect that patient had dehydration given 4 episodes of large watery stools. Patient had no recent antibiotic use and has no C. difficile risk factors, suspect this may be related to her Covid vaccine, she had no evidence to suggest anaphylactic shock, patient felt better after IV fluid bolus was able to ambulate around the emergency department without lightheadedness or near syncope. She had troponins x2 which were negative, her EKG was nonischemic and there was no evidence of ectopy or arrhythmia. Patient did have syncope and fell onto her side, she denies discrete head injury although patient is anticoagulated, CT head was obtained to rule out intracranial hemorrhage given the syncopal event. Patient CT abd/pelvix was negative for obvious cause of patient's abdominal tenderness may be related to her diarrheal illness patient will be prescribed Bentyl. She will call her primary care doctor in the morning to arrange close follow-up. She understands need for aggressive oral hydration at home. She will have low threshold to return should she develop lightheadedness syncope chest pain shortness of breath palpitations worsening abdominal pain bloody or dark stools any new or concerning symptoms. The patient presented to the emergency department with potentially life or limb-threatening symptoms. After my history, examination, and workup have decided that the patient is stable. My impression is that they are safe to go home at this time. I have reviewed ED return precautions with the patient. They understand to return if they are concerned for any reason. They will follow-up with their PCP in 1-2 days. Impression: Syncope, hypotension–improved, dehydration Plan: Discharge Follow Up Within: 1-2 days Comments: Please call your doctor in the morning to arrange follow-up with your primary care doctor in the next 24 hours. Please stay well-hydrated and eat regular meals. Please take Bentyl as needed for abdominal cramping with diarrhea. Please return to the ER if you develop worsening abdominal pain, feelings of lightheadedness passing out any new or concerning symptoms. Patient Education Syncope, Easy-to-Read Diarrhea, Adult Discharge Meds dicyclomine 10 mg 1 cap, PO, QID, 20 cap Referral for suspected pre-hypertension or hypertension was given. Please note: Unless specifically stated, all procedures mentioned, tests done and medications given were performed/interpreted by the emergency physician, or were under the direct supervision of the emergency physician. This ED Note was completed using voice-recognition transcription and may contain inadvertent errors. Additional information for Item 9:
76 2021-01-22 blood pressure increased, heart rate increased, palpitations Moderna COVID-19 vaccine EUA Headache, nausea, heart palpations, rapid heart beat, elevated blood pr... Read more
Moderna COVID-19 vaccine EUA Headache, nausea, heart palpations, rapid heart beat, elevated blood pressure Trip to ER Heart was not impaired
76 2021-01-23 chest discomfort, palpitations strong headache , brain fog, chills, nausea, heavy chest, heart palpitations,dizziness hot red spot... Read more
strong headache , brain fog, chills, nausea, heavy chest, heart palpitations,dizziness hot red spot 3 inches on arm
76 2021-01-25 loss of consciousness temporary loss of consciousness few second every few minutes; clammy skin, color improved once supin... Read more
temporary loss of consciousness few second every few minutes; clammy skin, color improved once supine with legs elevated
76 2021-01-25 loss of consciousness temporary loss of consciousness/ clammy
76 2021-01-26 blood pressure increased initially with redness and itching on chest and neck, elevated BP to 190/100, but otherwise normal 0... Read more
initially with redness and itching on chest and neck, elevated BP to 190/100, but otherwise normal 02 , HR, RR. Symptoms developed within 20 ish minutes of receiving vaccine. Hives developed on neck and near ear, then patient reported perioral sensations. Patient was non-verbal and communicating using texting so communication was challenging. Patient was initially given benadryl, but with the additional perioral sensations Epi was given. Patient transported to ER via rapid response team where additional benadryl and steriods were given.
76 2021-01-26 hypertension shot 2:30 pm slept woke up got coffee, sat down felt dizzy sweating weak nausea high blood pressur... Read more
shot 2:30 pm slept woke up got coffee, sat down felt dizzy sweating weak nausea high blood pressure 172/113
76 2021-01-26 oxygen saturation decreased 1/9/21 At 3:50 am started with nausea, weakness, and complaints of body aches. Required more assista... Read more
1/9/21 At 3:50 am started with nausea, weakness, and complaints of body aches. Required more assistance with ADL's than previous. @ 4:28 am: complaints of SOB, O2 sats 85% on room air. Required supplement O2, with tremors noted. PRN Zofran administered for nausea. 7:42 am noted with fever, decreased O2 sats, Tylenol administered for fever. Fever continue to climb despite Tylenol, supplemental O2 increased to 4L, rapid covid test negative, new orders to start Rocephin IM x 3 days and stat Xray which showed pneumonia. Temperature continues to remain elevated- O2 status continues to decline. Sent to ER 1/9/2021 @ 4:53 pm via ambulance. Admitted to Hospital with ABT tx for pneumonia and UTI. Respiratory status continued to decline- pulmonology consulted- Placed in ICU 1/13/21 and started on steroids. Required BiPap and was eventually weaned to supplemental O2. Multiple Covid tests- all negative. GI complaints addressed with GI consult- unremarkable. Started on PPI and Linzess. Eventually was placed on telemetry floor, closely monitored by pulmonology, and was cleared for discharge on 1/19/2021 back to nursing home.
76 2021-01-26 fainting Pt states she got her second Moderna COVID19 vaccine in her LUE yesterday 1/26/21. She developed a ... Read more
Pt states she got her second Moderna COVID19 vaccine in her LUE yesterday 1/26/21. She developed a low grade fever and nausea last night. Today, 1/27/21, around 0800, pt states that she fainted, fell on her left side and injured her L elbow. She states that her husband found her and said it appeared as if she was having a "mini seizure". Husband states pts fainting/seizure episode lasted for 15-20 seconds. Pt states that her L elbow pain was 7/10, but is currently 2/10 and she is now experiencing some tingling in her L third and fourth fingers. Pt denies any hx of a seizure and is currently able to get up and walk around. Pt speaking in full and coherent sentences while on call. Pt advised by triage RN and PCP to go to ER for an evaluation
76 2021-01-27 fainting Case was observed for standard 15 minutes. Was released, then fainting heading out to her car to lea... Read more
Case was observed for standard 15 minutes. Was released, then fainting heading out to her car to leave.
76 2021-01-28 blood pressure increased Flushed after 20 minutes blood pressure spiked to 205/105. Waited additional half hour went home. ... Read more
Flushed after 20 minutes blood pressure spiked to 205/105. Waited additional half hour went home. Blood pressure at home 225/125 called doctor who sent me to ER Remained at the hospital 5 hours and was released with pressure 187/80 Went to the hospital Jan 24 with pressure 205/95 released 4 hours later Pressure still out of control Jan 29 Never had pressure so high normally on meds 110/60
76 2021-01-28 chest pain 1/28/21 vaccine received; couple mins after receiving numbing, tingling in arms, flush feeling, stab... Read more
1/28/21 vaccine received; couple mins after receiving numbing, tingling in arms, flush feeling, stabbing pain in chest area/back for about an hour, arm sore, lightheaded. PT has had to take Tylenol as needed
76 2021-01-28 heart rate increased Patient started to experience increased heart rate, tingling of the tongue (possibly swelling) patie... Read more
Patient started to experience increased heart rate, tingling of the tongue (possibly swelling) patient just said it felt weird, feeling flushed or feeling hot, back of neck seemed warm. Shot was given 12pm (noon) 15 minutes later patient started to experience these symptoms. Blood pressure was checked initially (147/78).
76 2021-01-28 palpitations, chest discomfort 9 DAYS AFTER VACCINATION ITCHING, HIVES ON BACK AND ARMS; ARM HEAVY; TONGUE HEAVY; DIZZY, HEART POUN... Read more
9 DAYS AFTER VACCINATION ITCHING, HIVES ON BACK AND ARMS; ARM HEAVY; TONGUE HEAVY; DIZZY, HEART POUNDING; CHEST TIGHTNESS ED visit 01/21 --given Decadron and Benadryl IV for allergic reaction Urgent Care visit 01/25 for chest tightness
76 2021-01-29 blood pressure increased Patient With numbness and tingling of her lips, tongue, palate. Increased BP Clammy sweating
76 2021-01-29 chest discomfort Began to have slight wheezing and coughing on Wed afternoon, the day after getting the shot. Thursd... Read more
Began to have slight wheezing and coughing on Wed afternoon, the day after getting the shot. Thursday wheezing and coughing increased and woke me up during the night several times. Cough was productive with clear sputum. Friday felt very tired all day and coughing and wheezing increased substantially, producing shortness of breath upon any exertion, like going up and down the stairs. Very tired. Began to think I'd have to go to see the Dr. because wheezing was significant with every breath. Cough was racking, increasing through the day into the evening. At 10 p.m. I began to wonder if I'd make it through the night without calling the rescue squad. Couldn't take a deep breath or speak a whole sentence with out a coughing jag. Then, suddenly about 11:30, it just ceased. The tightness in my chest went away, the coughing with every inhalation stopped and I could take a deep breath. It was a bit stunning. Because I had pulmonary embollisms about ten years ago, my lungs have been a weak spot in my body with bronchitis occurring frequently. I hadn't seen reports of this side effect of the vaccine, so I thought I'd report it. This morning, Saturday four days after the shot, I am breathing much better, not coughing, and do not have any wheezing.
76 2021-01-29 chest pain Lower back pain radiating around to the rib cage. Went to ER and had ultrasound, cat scan, blood w... Read more
Lower back pain radiating around to the rib cage. Went to ER and had ultrasound, cat scan, blood work, urine culture. All scans negative awaiting results of urine and blood work. Possible uti but not sure. Prescribed Keflex
76 2021-01-29 heart rate increased Very high heart rate for several hours, chills, pressure on forehead
76 2021-02-02 cerebrovascular accident According to the staff at the Hospital, the patient was treated in their emergency room for a stroke... Read more
According to the staff at the Hospital, the patient was treated in their emergency room for a stroke this morning at approximately 730AM
76 2021-02-03 chest pain Patient had already been observed for 15 minutes and left the facility. Patient stated while on her ... Read more
Patient had already been observed for 15 minutes and left the facility. Patient stated while on her way home her and her husband were discussing side effects when she started to feel SOB, dizziness, and slight chest pain so they returned to the clinic. Full set of vitals was taken. Doctor evaluated patient. Patient started feeling better after drinking some water. Second set of vitals taken and patient discharged to go home with husband 1215pm.
76 2021-02-03 loss of consciousness Evening of vaccine patient felt chills that lasted through out the night. Patient got up Sunday mor... Read more
Evening of vaccine patient felt chills that lasted through out the night. Patient got up Sunday morning and passed out, fell to floor. Patient reports that once she woke up it was about 15 mins before she could get off the floor. All day Sunday felt very fatigued and rested. Then felt "foggy" on Monday.
76 2021-02-03 palpitations Tuesday after my injection I started getting nauseous, my right arm was very red and swollen along t... Read more
Tuesday after my injection I started getting nauseous, my right arm was very red and swollen along the injection site and overflowed into my upper arm. These symptoms lasted 7 days. When I went to bed on Tuesday night, I woke up early in the morning with palpitations, very nauseated, and light headed. The palpitations lasted about 2 hours, light headedness about 30 minutes. I had no further palpitations or light headedness after this.
76 2021-02-03 fainting Patient states two hours following vaccine injection, she experienced dizziness, feeling faint and a... Read more
Patient states two hours following vaccine injection, she experienced dizziness, feeling faint and an erratic heart (40-83 beats per minute) Breathing was fine, oxygen saturation was at 98. These symptoms lasted for about 2 hours.
76 2021-02-04 blood glucose increased, heart rate increased, atrial fibrillation Afib; Feeling uncomfortable; Blood sugar was around 150, which is higher than her normal levels; A s... Read more
Afib; Feeling uncomfortable; Blood sugar was around 150, which is higher than her normal levels; A spontaneous report was received from a consumer who is 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation, feeling uncomfortable, and increased blood sugar. The patient's medical history included diabetes and atrial fibrillation. Concomitant medications were not reported. On 02 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 025LZ0A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient experienced heart beating very fast and feeling uncomfortable; it lasted for a few hours. She stated it was atrial fibrillation, she had a diagnosis of this, and it only lasted a few hours. The patient also stated that her blood glucose was 150, which was higher than normal. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, increased blood sugar, was considered not resolved. The outcome of the events, atrial fibrillation and feeling uncomfortable, was considered resolved.; Reporter's Comments: This case concerns a 76 year-old female patient with a significant medical history of atrial fibrillation and diabetes, who experienced a serious unexpected event of Atrial fibrillation and non-serious unexpected events of Discomfort and Blood glucose increased. The events occurred one day (same day) after first dose of mRNA-1273, lot # 025LZ0A. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's medical history of atrial fibrillation and diabetes were considered strong confounders.
76 2021-02-05 palpitations About 9:00 pm in the evening I first noticed an unusual racing of the heart while watching televisio... Read more
About 9:00 pm in the evening I first noticed an unusual racing of the heart while watching television. It subsided and I proceeded to bed. About 10:30 while in bed and reading it occurred again and continued for a few minutes. It continued to wake me a couple of times in the night before stopping about 4:00 am. No further occurrence so have not sought medical assistance.
76 2021-02-07 heart rate irregular, blood pressure increased, heart rate increased rapid and irregular heartbeat, 132 bpm...blood pressure rose to 151/101 lasted several hours... i to... Read more
rapid and irregular heartbeat, 132 bpm...blood pressure rose to 151/101 lasted several hours... i took half of a metotropol 12.5mg laid down and hour later heart rate decreased
76 2021-02-10 chest discomfort Patient presented with bright, flushed face; nausea; chest pressure; medic on-scene performed EKG; p... Read more
Patient presented with bright, flushed face; nausea; chest pressure; medic on-scene performed EKG; patient refused transport
76 2021-02-11 cerebrovascular accident Unknown onset of altered mental status. Last time known well was day of vaccination 2/3/2021. Found ... Read more
Unknown onset of altered mental status. Last time known well was day of vaccination 2/3/2021. Found altered on 2/9/2021. Working diagnosis is encephalopathy: MRI unrevealing. CVA vs other etiology
76 2021-02-11 chest discomfort Patient with COPD here to receive her 1st dose of Moderna COVID vaccine. Patient was feeling well p... Read more
Patient with COPD here to receive her 1st dose of Moderna COVID vaccine. Patient was feeling well prior and her husband states she has not had any breathing issues for 2 months. Approximately 10 minutes after receiving her immunization, she developed a dry, tight cough but lung sounds were initially clear. Over the next 10 minutes she progressed to audible wheezing. She took 3 puffs of her home albuterol inhaler. Oxygen saturation was 99% but patient reported no improvement with her inhaler. Acute bronchospasm secondary to vaccine administration Patient was given albuterol 2.5 mg via nebulizer along with 25 mg Benadryl. Following the nebulizer treatment, lung sounds were once again clear, audible wheezing was gone, and patient was feeling back to baseline. She was given 125 mg Solumedrol to prevent relapse of symptoms. Advised use of nebulizer every 4 hours as needed today if cough or wheezing returns. As for her second dose, we discussed pretreating with Benadryl 25 mg and an albuterol nebulizer treatment prior to arriving. I would recommend she be monitored for 30 minutes when she receives it as well and be ready with Solumedrol and Epinephrine in the event she has issues. Husband and patient encouraged to call back if worsening issues today.
76 2021-02-11 fainting, cardiac arrest Received first 1/15/2021 with no adverse reaction. Received 2nd dose 2/9 @ 0846 with no adverse rea... Read more
Received first 1/15/2021 with no adverse reaction. Received 2nd dose 2/9 @ 0846 with no adverse reaction or report of feeling ill. Traveled to store and arrived approx. 2 hours after receiving vaccine. Daughter stated patient felt well and had to go to the restroom to have BM. Collapsed in bathroom. Transported by ambulance to Hospital @ 1439 in cardiac arrest. Was in PEA and went in v fib back to PEA. Resuscitation efforts initiated and patient expired with time noted at hospital records at 15:11.
76 2021-02-12 chest pain I still have redness, bruising and the area is warm to the touch at the injection site. I am having... Read more
I still have redness, bruising and the area is warm to the touch at the injection site. I am having pain in the underarm and going into the chest area. Have not been treated ... I did tell the people who are doing the texting about the results of the shot. I have not seen anyone about the problem. Since I had not received any text referencing the problem I assumed it was standard.
76 2021-02-13 dilation of blood vessels About about an hour after shot, (given in left arm) I had what felt like a jab pain the area inside ... Read more
About about an hour after shot, (given in left arm) I had what felt like a jab pain the area inside my left wrist. It was a sharp pain like being stung. Thus happened for two days, woke me up at night. I took a picture of my left wrist on Feb 11 and my right, both in the same minute. The structure and size of vein enlarged on the left side, as well as the color of skin. The right side was normal. As of today, the difference in the veins is still there, yet the jabbing pain has stopped.
76 2021-02-14 fast heart rate 2/10: fatigue, fever, decreased appetite. Tylenol 2/11: mental status wax/wane, lethargic 2/13 @ 090... Read more
2/10: fatigue, fever, decreased appetite. Tylenol 2/11: mental status wax/wane, lethargic 2/13 @ 0900: unresponsive to sternal rub, increased WOB, tachycardic, febrile D5 1/2 NS IV bolus, Rocephin Transferred to Hospital 2/13
76 2021-02-15 blood pressure decreased, blood pressure increased NO fever at all during this time or shortness of breath. Pain in the arm at injection site up into ... Read more
NO fever at all during this time or shortness of breath. Pain in the arm at injection site up into neck and top of head. (48 hours) Tylenol for pain. About 3pm Saturday 2/6: Concerning spike of blood pressure 154/92-resulted in urgent care visit. Covid test taken as precaution by MD. Mom not "feeling well" 0630 Sunday 2/7: BP spike to 166/109, Blurry vision, dizziness. EMS called to assess at home. followed up by ER visit. all tests resulted negative. BP dropped to 120/72. On discharge BP up to 162/92. Lisinopril prescribed for HBP. 1 dose given. Monday 2/8: Vomiting and diarrhea, lightheaded. EMS called for assessment, BP drop 100/70. Hydration, rest. Moderate/Severe fatigue and aches (6-7 days) Mild lethargy. (24-36 hrs)
76 2021-02-17 chest pain Symptoms of a bowel obstruction; Chest burning; Vomiting sensation; A spontaneous report was receive... Read more
Symptoms of a bowel obstruction; Chest burning; Vomiting sensation; A spontaneous report was received from a consumer, concerning herself, a 76-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation. The patient's medical history was not provided. Concomitant medications reported included telmisartan, nebivolol hydrochloride, ezetimibe, valaciclovir, buspirone and alprazolam. On 21 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 [lot number 011L20A] intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, following the administration of vaccine, the patient experienced a burning sensation in the chest, vomiting sensation and symptoms of a bowel obstruction. These side effects were worsened until the patient was admitted for bowel obstruction relief. Additionally, event symptoms of a bowel obstruction was considered life threatening. Treatment for the event included bowel obstruction removal. No side effects were existing at the time of this report. The second dose of mRNA-1273 was delayed in response to the events. The outcome of the events symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation were considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
76 2021-02-17 chest pain Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot Chest pains New l... Read more
Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot Chest pains New left axillary Adenopsthy -CT scan 2/11/21
76 2021-02-19 blood pressure increased While pt was sitting in observation for about 15 minutes she reported feeling excessive nasal conges... Read more
While pt was sitting in observation for about 15 minutes she reported feeling excessive nasal congestion. EMS was on site, Pt's BP was 224/112, came down to 203/108. Pt reported nasal congestion seemed to be getting better. Pt denied headache, dizziness, visual changes, chest pain, sob, swelling, tingling. Pt reports she usually has normal BP. Pt did not want to go to the hospital. She signed a refusal for transport to the hospital with EMS. Pt was advised to call her doctor when she got home. Pt was advised on ED precautions and when to call 911. Pt verbalized understanding.
76 2021-02-20 fainting Syncope 18 hours post injection, Feb 13 left eye irritation with tearing, Feb 14 mild case of Bell's... Read more
Syncope 18 hours post injection, Feb 13 left eye irritation with tearing, Feb 14 mild case of Bell's Palsey right side of face, along with headache, herpes on left corner of mouth, fatigue and ?Epstein-Barr. I was exposed to the virus by my hairdresser on 2-11-21 and she developed symptoms and tested positive 4 days later
76 2021-02-22 skin turning blue, oxygen saturation decreased Slight fever, loss of strength, headache, extreme difficulty breathing. Oxygen, steriods, antibiot... Read more
Slight fever, loss of strength, headache, extreme difficulty breathing. Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home. No accute pathology but hyperinflated WBC was 19. Sent home with oxygen
76 2021-02-23 blood pressure increased, chest discomfort shortness of breath, chest tightness, elevated blood pressure. Was sent to urgent care for further e... Read more
shortness of breath, chest tightness, elevated blood pressure. Was sent to urgent care for further evaluation and treatment
76 2021-02-23 chest pain Chest pain, fever, chills, headache all these lasted a day and a half. Took lots of Tylenol After th... Read more
Chest pain, fever, chills, headache all these lasted a day and a half. Took lots of Tylenol After the second day pain around chest and neck have subsided. 3rd day still have headache.
76 2021-02-24 chest discomfort 2/23/2021, 6:30 PM facial flushing, 10:30 PM diminished. 2/24/2021, 3 am awakened from restful slee... Read more
2/23/2021, 6:30 PM facial flushing, 10:30 PM diminished. 2/24/2021, 3 am awakened from restful sleep, sinus congestion progressed to bronchial congestion to chest tightness to difficulty breathing, throat tightening sensation, tongue tingling progressed to thickened sensation, slight difficulty swallowing water. Symptoms occurred over the course of 1.5 hrs. 4:45 am symptoms spontaneously ended. 5:00 am symptoms no longer present, body fatigue, restful sleep.
76 2021-02-24 heart rate increased, hypotension I woke up Friday 2/12 morning very dizzy. The dizziness subsided. Later Friday afternoon, I had seve... Read more
I woke up Friday 2/12 morning very dizzy. The dizziness subsided. Later Friday afternoon, I had severe dizziness and was vomiting when I got up. I went to Clinic Saturday 2/13, for being unbalanced and weak, but not so dizzy. Sunday 2/14 I was extremely weak with low blood pressure and fast heart rate. Monday 2/15, in the morning, my left arm started hurting, swelling, was feverish, red, itchy and I had a rash at the injection site. I went to my doctor on 2/19 and he stated that maybe I should not get the 2nd vaccine shot. He stated that he was not certain that everything that happened was a result of the vaccine, but that he couldn't say that it wasn't.
76 2021-02-25 blood pressure increased Patient presented to the ER ON 2/25/21 with symptoms of elevated blood pressure, severe lymph node s... Read more
Patient presented to the ER ON 2/25/21 with symptoms of elevated blood pressure, severe lymph node swelling in her left axillary region and on her left shoulder. It was determined she also had cellulitis of the left shoulder. She was started on antibiotics.
76 2021-02-25 blood pressure increased 30 minutes after shot, nose congestion and blood pressure rose to 225/100.
76 2021-02-25 chest discomfort patient complained of some slight chest discomfort 2 minutes after receiving vaccination. patient wa... Read more
patient complained of some slight chest discomfort 2 minutes after receiving vaccination. patient was examined and monitored to include physical exam, vital sign check and ECG all of which were normal. patient was kept in the office for monitoring for 60 minutes and symptoms had subsided. she left the office without any evidence of distress and reported she felt better. She was also advised to seek medical attention if symptoms returned/persisted or worsened. injection site viewed and no signs of reaction.
76 2021-02-25 pulmonary embolism The patient had bilateral Pulmonary Embolisms on February 8th. recommended we report this and any ma... Read more
The patient had bilateral Pulmonary Embolisms on February 8th. recommended we report this and any major incident a patient might have within 1 month of administering the vaccination.
76 2021-02-26 chest discomfort Pt reports mild chest tightness
76 2021-02-26 heart rate increased 02/25/21: Slightly accelerated heart rate; sore arm, tender nodule above left clavicle. 12/26/21: s... Read more
02/25/21: Slightly accelerated heart rate; sore arm, tender nodule above left clavicle. 12/26/21: severe chills, heart face and head, stiff neck, general weakness, sore arm. Severe symptoms lasted approximately four hours but continue to a lesser degree for several more hours. Throughout the day, weakness, feeling cold, sore arm and nodule is still there and still tender.
76 2021-02-27 cerebrovascular accident Began walking on treadmill at 5:30 a.m. and left foot felt heavy and dragging, L hand tingling, and ... Read more
Began walking on treadmill at 5:30 a.m. and left foot felt heavy and dragging, L hand tingling, and facial/neck numbness. Arrived at hospital at 8:15. Vitals, EKG, CT scan, and MRI conducted. MRI showed an acute mild stroke on R side of brain. Over-night stay was recommended. Echocardiogram was performed the following day and nothing was abnormal. I am now on a heart monitor for 30 days. Upon departure of hospital the symptoms in L leg and arm have nearly resolved but face is still numb/decreased sensation. Plan to contact PCP tomorrow.
76 2021-02-27 low blood oxigenation Patient has known lymphoma but was on break from chemotherapy. No known lung disease. She developed ... Read more
Patient has known lymphoma but was on break from chemotherapy. No known lung disease. She developed a very large left pleural effusion and became markedly hypoxia need chest tube drainage. Multiple fluid cultures were negative for infection and fluid sent twice for cytology and flow cytometry were negative for tumor cells. She was too ?sick? for thoracoscopy. Over the next 7 days the symptoms resolved and the effusion has not returned which speaks against this being from the lymphoma. She had symptoms the night of the vaccine but did not become critically ill for about 36 hours as the effusion was developing. Her oncologist and I both believe this was related to the vaccine and will not give the second dose.
76 2021-02-27 loss of consciousness, blood glucose increased Almost exactly 24 hours after 2nd shot, my mom was getting her hair done and she started breathing h... Read more
Almost exactly 24 hours after 2nd shot, my mom was getting her hair done and she started breathing hard. Hairstylist removed her mask and she then passed out. Called 911. They observed my mom sweating, her lips and hands were swollen, she was slack jawed, pale and clammy. After several minutes she came out of it. Was given a piece of candy thinking it was a sugar low, but her sugar was high 285 @9:00am. Her color was still pale and she was still incoherent. While still on with 911, she became more lucid and said she was feeling better, so ambulance was canceled. I drove her home and checked her sugar @11:00 - 295 and BP 125/55 pulse 75. She stayed with me for the rest of Saturday. Her sugar was still high Saturday evening and Sunday morning. Upon checking her blood sugar log, her sugar had gone up for a week following the first shot.
76 2021-02-27 loss of consciousness 24 hours after vaccination felt instant dizziness and nausea and fell against the wall. Crawled to ... Read more
24 hours after vaccination felt instant dizziness and nausea and fell against the wall. Crawled to the bed and collapsed. Stayed in bed with head flat for 2 days. Had to be helped to the bathroom. No walking capabilities. Gradually started coming out of it on the third day, still not able to have head up while trying to eat and drink. 4th day better in the morning with head up and walking. Seemingly gone by evening. Horrible episode.
76 2021-02-28 heart rate increased, chest discomfort, blood pressure increased, atrial fibrillation Periodic pressure and tightness across chest and diaphragm especially on day of vaccination and fol... Read more
Periodic pressure and tightness across chest and diaphragm especially on day of vaccination and following 2 days. Rapid heart beat followed by afib that was not terminated with normal medications. Dizziness and shortness of breath. Hospitalized with atrial fibrillation with rapid ventricular response. It resolved after getting two injections of a medication called diltiazem in the emergency department, after which I was monitored overnight in the hospital. Underwent stress test and echocardiogram - results normal. On the day I write this (March 1) continue to have shorter periods of rise in blood pressure and heart rate, diaphragm tightness, insomnia and lethargy.
76 2021-02-28 pallor Dizziness, Nausea/vomiting, palor,
76 2021-03-01 blood pressure increased Afternoon on the day of vaccination patient felt a little weak and c/o mild pain at the injection si... Read more
Afternoon on the day of vaccination patient felt a little weak and c/o mild pain at the injection site. Next morning after around 11 am patient started to vomit almost a lot, her fever went up to around 38.5C auxiliary, she reported extreme weakness and shakiness, her blood pressure also increased to 160s/high 90s, she complained of extreme shortness of breath. Elevated BP could be related to the fact that she was vomiting so much, she had hard time taking her scheduled medications, included BP medications. This lasted for 3 days. Patient was taking Ondasentron and that was only reliving nausea for 2 to 3 hours. She was taking Tylenol to bring her fever down. 650 mg Tylenol was only lowering temp to about 37.8. For about 72 hours she was complaining of extreme generalized pain and weakness and had very hard time getting up to go the bathroom. She started to fill a little better on March 27, 2021. Shortness of breath disappeared in the morning. Temperature fell to 37.1C. She stopped vomiting and was able to eat. Generalized weakness and shakiness persisted till March 2, 2021. At the moment of submitting this report, patient is still reporting that she does not feel that she is "100% back to normal"
76 2021-03-01 chest discomfort Tiredness that night and the next morning i felt like i had not slept and continued over 5 days. i ... Read more
Tiredness that night and the next morning i felt like i had not slept and continued over 5 days. i was so sleepy. legs were very shaky and i was very nervous inside. I had shortness of breath and i still have it. I road a bike 4 to 6 miles every day and now i cant. i had chills and body pain, i feel like i had the flu. dizziness, just just random spouts of sleepiness and it would last for about an 1 hr and half. My muscle in my chest just tightens and is hard as a rock. and then it goes away.
76 2021-03-01 palpitations First: Vaccine was not given at Center. It was a drive-up at Drive Thru. Adverse general side ... Read more
First: Vaccine was not given at Center. It was a drive-up at Drive Thru. Adverse general side effects that lasted from 3:00 a.m. 02/27/2021 through 03/01/2021: fatigue, headache, muscle pain, joint pain, chills, nausea, heart palpitations, loss of appetite. Considerably more pain than with Fibromyalgia, shaking chills even though wrapped in a quilt, more heart palpitations than usual.
76 2021-03-02 hypertension Severe pain in my head. Blood pressure went up high. blurred vision. Continues today.
76 2021-03-03 blood pressure increased Dizzy, difficulty walking due to loss of balance. Husband drove me to clinic where my blood pressure... Read more
Dizzy, difficulty walking due to loss of balance. Husband drove me to clinic where my blood pressure was above 214. Dr advised immediate trip to ER possible TIA. At ER in Hospital I was greeted by a nurse at the curb with a wheelchair. .
76 2021-03-03 cerebrovascular accident acute CVA, thrombolysed with TPA, with residual hand weakness
76 2021-03-03 chest discomfort Pt. got lightheaded, and felt tingly all over about 10 minutes after shot (12:10). About 10 minutes... Read more
Pt. got lightheaded, and felt tingly all over about 10 minutes after shot (12:10). About 10 minutes (12:20) letter started feeling "Chest tightening". She denied not shortness of breath, and no other symptoms. About 2 minutes after that all symptoms were resolved. She denied BP check, & EMS. Reports when she got home felt yucky & whoozy but was still able to do chores. Around 9:00 pm started feeling short of breath and real tight chest. She put vicks vapor rub on chest and in nose and about 20-30 minutes felt a little better. She was able to sleep her normal amount. She reports she is back to her baseline this morning.
76 2021-03-03 hypertension one day after receiving vaccine got chills and fever and didn't feel good for a week. Did not take t... Read more
one day after receiving vaccine got chills and fever and didn't feel good for a week. Did not take temperature. Doctor told her not to get second shot due to many allergies. Has had worse headaches than usual for a week and blood pressure was high precipitating trip to doctor 187/101.
76 2021-03-03 palpitations, heart rate increased, fast heart rate Rapid heart rate and palpitations. Resting heart rate increase. Week after vaccination threw up. ... Read more
Rapid heart rate and palpitations. Resting heart rate increase. Week after vaccination threw up. 2 weeks after vaccination I was admitted to hospital with Tachycardia and hypokalemia for three days. Since then I am still experiencing high tee resting heart rate.
76 2021-03-03 fainting hot sweats passing out dry mouth gasping for breath extreme energy loss (couldn't stand up)
76 2021-03-03 ventricular tachycardia, low blood oxigenation Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She... Read more
Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
76 2021-03-04 chest pain, blood pressure increased 6 days after first dose, developed pain behind R ear, down R neck, into R upper chest, elevated BP a... Read more
6 days after first dose, developed pain behind R ear, down R neck, into R upper chest, elevated BP at 4:05 pm on 03/01/21. Admitted to ER for workup. Remained in Hospital for 25 hours. All coronary tests negative. Tested positive for Covid-19 in ER
76 2021-03-05 chest pain Aside from the expected sore right arm, I developed painful welling of underarm glands (right side) ... Read more
Aside from the expected sore right arm, I developed painful welling of underarm glands (right side) which I've NEVER had before even as a child; also developed itching and some redness and swelling at injection site,. These occurred in late afternoon on 3/5/2021 - a day after 2nd Moderna vaccine injection. I also developed a low fever for part of the same afternoon (3/5) into early eve. I also had some ache in center chest (gone now) which I never had before (angina?). It is now 3/6/2021 and I still have swollen underarm glands (right arm), right arm soreness at injection site, and some itching there as well. But no fever just now. I'm VERY CONCERNED the swollen glands will not go away in time for my aortic valve replacement surgery on 3/15/2021.
76 2021-03-07 hypertension During post vaccination observation period, reported feeling flushed & was hypertensive 220/90, no h... Read more
During post vaccination observation period, reported feeling flushed & was hypertensive 220/90, no hives, facial swelling or difficulty breathing. Pt did not take her antihypertensive for 2 days. Transferred to ED, 1 dose of antihypertensive med (Toprol XL) given and discharged to home.
76 2021-03-08 hypotension Hypotension and development of colitis
76 2021-03-09 heart rate decreased, blood glucose increased sx APPROXIMATELY 20-30MINS AFTER: Facility nurse reported feeling light headed, heart rate was 44 bp... Read more
sx APPROXIMATELY 20-30MINS AFTER: Facility nurse reported feeling light headed, heart rate was 44 bpm, feeling cloudy, fatigued
76 2021-03-10 chest pain Intense pain on both sides of my torso lasting 3 days, headache, zapped all energy.
76 2021-03-10 loss of consciousness Same day vaccine second dose given March 4. Between 15 minutes reaction was dizziness, difficulty br... Read more
Same day vaccine second dose given March 4. Between 15 minutes reaction was dizziness, difficulty breathing. Went into adverse reaction. Did not wake up - moved to ER
76 2021-03-16 blood pressure decreased My blood pressure fell to 60/40, could not stand, light headed but did not pass out. It took all da... Read more
My blood pressure fell to 60/40, could not stand, light headed but did not pass out. It took all day for my g blood pressure to return slowly to normal. slight fever between 100 and 101, not over 100.7
76 2021-03-16 blood pressure increased Patient had her BP increased and light headed after vaccine 158/70 HR:86. Patient stated that she ha... Read more
Patient had her BP increased and light headed after vaccine 158/70 HR:86. Patient stated that she had her kitchen stove had caught fire this morning and she was upset about it. Nurse ask if patient about history of anxiety and she stated yes. So she stayed another 15 minutes in the observation area to make sure everything was ok. Nurse rechecked BP 156/75 HR:80. Patient felt better after 5 minutes of first symptoms. Nurse advice patient to seek medical attention if symptoms gets worst. Patient had no pain or general discomfort or dizziness or light headedness increased HR.
76 2021-03-16 chest discomfort Fatigue, lost appetite, congestion, bronchial congestion, chest tightness, throat tightness, difficu... Read more
Fatigue, lost appetite, congestion, bronchial congestion, chest tightness, throat tightness, difficulty breathing, tingling/thickness of tongue
76 2021-03-18 blood pressure increased Parkinson's got worse; blood pressure went high; A spontaneous report was received from a consumer c... Read more
Parkinson's got worse; blood pressure went high; A spontaneous report was received from a consumer concerning a 76 years old, female patient who developed worsened Parkinson's Disease and increase blood pressure. The patient's medical history included surgery to remove bowel obstruction and Parkinson's Disease. Concomitant product use was not provided by the reporter. On 5 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 5 Feb 2021 the patient's blood pressure went high and Parkinson's got worse. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events, Parkinson's got worse and blood pressure went high, was unknown/ not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
76 2021-03-18 nosebleed severe nosebleed. fever 100.1, Had to go to the emergency room and they cauterized.
76 2021-03-20 ischemic chest pain 1st day - Nothing. 2nd day - Extreme Fatigue, Rash and Itching on Chest, Sharp Pains in Heart, Sor... Read more
1st day - Nothing. 2nd day - Extreme Fatigue, Rash and Itching on Chest, Sharp Pains in Heart, Sore Throat (It's now 5 days and still having periodic sharp pains in heart and throat still hurts)
76 2021-03-21 chest pain She received vaccine at 1140 am. At 1200pm, she c/o dizziness upon standing and intermittent chest ... Read more
She received vaccine at 1140 am. At 1200pm, she c/o dizziness upon standing and intermittent chest pain. She stated that she had not eaten today. Crackers and water given. Chest pain worsened. Dr evaluated pt. 911 called. EKG done;no acute changes noted. She was taken to the ER by fire department.
76 2021-03-21 hypertension Patient was in the office on 3/19/21 for her first dose of Moderna COVID vaccine. 15 minutes after a... Read more
Patient was in the office on 3/19/21 for her first dose of Moderna COVID vaccine. 15 minutes after administration of vaccine, patient expressed she was feeling hypertensive and her hands were feeling cold. Patient was taken to an exam room for evaluation with assistance of language interpreter and RN. BP of 220/120 with symptoms of headache and blurry vision. No chest pain. No signs of anaphylaxis. Patient stated she was feeling slightly better after 3 minutes. Repeat vitals of BP 180/94, pulse 80, RR 32, O2 sat 98%. Patient did take BP meds as prescribed. Plan to go to the ED was communicated to patient and her brother in law to which they agreed. Patient requested that her brother-in-law drive her to the ED instead of activated EMS. Report was called to the hospital ED recieving provider by myself with diagnosis of hypertensive emergency.
76 2021-03-22 chest discomfort The evening of the first shot on February 5, I had a strong headache, muscle aches and was extremel... Read more
The evening of the first shot on February 5, I had a strong headache, muscle aches and was extremely tired for the next two days. I had brain fog for the next 2 weeks. Tylenol and Advil mostly relieved physical discomfort. I had the second shot March 16. The next day I had a severe headache, no energy, achy body, chills and fever and on the second day after the shot my temperature was 101.4 - 101.8. Tylenol and Advil relieved the symptoms. Today, one week after the second shot I developed a pungent chemical taste in my mouth and a similar sense of smell. The tip of my tongue is tingling, and while I can breathe in deeply, my chest feels heavy, like I'm not getting enough oxygen.
76 2021-03-23 heart attack Sister reports that she was fine, the day before I took her to the dentist. Sister on 5/3/2021 calle... Read more
Sister reports that she was fine, the day before I took her to the dentist. Sister on 5/3/2021 called her and did not answer, so she goes to the nursing home where she resides. She finds her sister cold in the apartment's furniture. Massive heart attack
76 2021-03-23 fainting POLIURIA, WEEKNESS, FAINTING.
76 2021-03-23 low platelet count plates went from normal to 3000; A spontaneous report was received from a consumer concerning a 76-y... Read more
plates went from normal to 3000; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having platelets went from normal to 3000 (Thrombocytopenia-unspecified). The patient's medical history, as provided by the reporter, included leukemia. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030O20A) intramuscularly for prophylaxis of COVID-19 infection. On 07 Feb 2021, the patient had an infusion of obinutuzumab for leukemia because her platelets went from normal to 3000. She was at the hospital for three days. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, platelets went from normal to 3000 was unknown.; Reporter's Comments: This case concerns a 76-year-old female who was hospitalized for infusion of obinutuzumab for leukemia because of a medically significant and serious unexpected event of thrombocytopenia. Event onset occurred 22 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
76 2021-03-24 heart failure They proceed to take the round and at that moment they realize that she was not breathing, she was a... Read more
They proceed to take the round and at that moment they realize that she was not breathing, she was already compromised . He dies of heart failure.
76 2021-03-24 pulmonary embolism bilateral pulmonary emboli
76 2021-03-25 blood pressure increased, troponin increased Troponin over 4000; Blood pressure over 300; Flushing beet red/erythema; Feeling groggy; Difficulty ... Read more
Troponin over 4000; Blood pressure over 300; Flushing beet red/erythema; Feeling groggy; Difficulty with cognition; Arm swelling; feeling hot/overheating; A spontaneous report was received from a consumer who is a 76-year-old, female patient who experienced blood pressure over 300 (blood pressure increased), troponin over 4,000 (troponin increased), flushing beet red (flushing), overheating (body temperature increased), grogginess (somnolence), difficulty with her cognition (cognitive impairment) and arm was swollen (peripheral swelling). The patient's medical history included breast cancer in the right breast. Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medication and once weekly Fosamax with calcium and vitamin D. On 10-MAR-2021, the patient received a dose of mRNA-1273 (Batch number: 026A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Mar 2021, immediately following the vaccination, the patient reported she experienced overheating, became beet red and her blood pressure was over 300. An ambulance took her to the emergency room. She had her troponin levels checked which were over 4000 that lead to a hospital admission and required a unspecified catherization. The patient was discharged home on unspecified date. She reported still feeling groggy and having difficulty with her cognition but it was improving throughout the day. The patient also reported her arm was still swollen, but improving. Treatment for the event included diphenhydramine and other unspecified medications and treatments. Action taken with mRNA-1273 in response to the events was unknown. The events, blood pressure over 300 and troponin over 4,000, were considered recovering. The events, flushing beet red, overheating, and grogginess were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
76 2021-03-25 hypertension I am allergic shellfish, the nurse ask me if I was allergic and I told her shellfish only. She gave ... Read more
I am allergic shellfish, the nurse ask me if I was allergic and I told her shellfish only. She gave me the shot anyway, that night I had chills, fever, and diarrhea. The next day I was ok but the following day I noticed my memory started to decline. It got worse where I develop a speech problem and my blood pressure was high. I also noticed that I had an unexpected limp. I went to urgent care and they performed a CT scan of my brain to see if I had a stroke. The results were negative. I wasn't getting better so they wanted me to go straight to the hospital to get an MRI. The hospital performed the MRI with contrast dye to get images of my brain (stroke). Results are neg,
76 2021-03-26 fibrin d dimer increased, pulmonary embolism 02/20/2021Shortness of breath on climbing 15-20 stairs, 02/24/2021/D-dimer test very high, 02/24/20... Read more
02/20/2021Shortness of breath on climbing 15-20 stairs, 02/24/2021/D-dimer test very high, 02/24/2021Admitted to hospital. CT Angiogram showed blood clots in lungs. Administered IV Hyperin. scans of legs-no blood clots, Scan of heart and arteries. 02/26/2021Released with perscription of Eliquis. 03/04/21 Blood test by Hematologist Normal; 03/08/21 CT Scan of body-Normal-no tumors/cancer detected
76 2021-03-27 heart rate irregular Exhaustion (still sleep several hours during the day), low grade fever, chills, involuntary body jer... Read more
Exhaustion (still sleep several hours during the day), low grade fever, chills, involuntary body jerks, headache, irregular heart beat, joint pain, muscle pain, itchy area under the shot, swelling of upper arm, red rash under shot-4"X6", continued "brain fog"
76 2021-03-28 fainting, fibrin d dimer increased, troponin increased Presented at PCP's office for progressive shortness of breath for the past few days. During visit p... Read more
Presented at PCP's office for progressive shortness of breath for the past few days. During visit patient had a syncopal episode regained consciousness then lost pulse for which she received 4 minutes of resuscitative care with chest compressions. She did regain a pulse after about 4 minutes of chest compressions. During that time emergency room physician said he saw a slow narrow complex rhythm. No reports of ventricular arrhythmias. Troponin and d-dimer were elevated. Heparin was started in the ED. During stay she was started on warfarin and bridging with heparin.
76 2021-03-29 deep vein blood clot, pulmonary embolism, oxygen saturation decreased Pt is a previously healthy 76 year old woman who received her covid vaccine 2 wks ago. She received ... Read more
Pt is a previously healthy 76 year old woman who received her covid vaccine 2 wks ago. She received Moderna vaccine on 3/8/21. On 3/16/21 She developed symptoms of fatigue, chills, body aches, decreased exercise tolerance. 3/19/21 exercised at YMCA as she does regularly. She was not able to do her usual level of activity and was only able to exercise low level for 10 minutes. Yesterday was very sob and after washing 2 windows had to lay down and rest. In my office the nurse rooming the pt noted the pt to be very winded and sob just ambulating from waiting room to the exam room. Pox was down to 89% and took a while to come up to 94%. Transferred to Hospital ED. DiagnosedDiagnosis: Acute hypoxic respiratory failure secondary to massive Pulmonary Emboli, DVT without known precipitating factors. pt without previous history of clotting disorder, no known neoplasm, no recent travel or sedentary period. unprovoked DVT with MASSIVE PE. patient did not have previous pulmonary disease. Additional information for Item 19: studies: PO Chest Final Result Stable chest. No new opacities are identified in this patient with known extensive bilateral pulmonary embolus. US Venous Duplex Lower Extremity Bilateral Final Result 1. Acute DVT involving the right popliteal and posterior tibial veins. 2. No acute DVT involving the left lower extremity. CT PE Protocol WITHOUT legs Final Result 1. Positive exam: Large-volume central pulmonary emboli seen in both main pulmonary arteries with extension bilaterally into all lobes. Dilated right heart chambers suggesting acute right heart strain. 2. Peripheral groundglass opacities in the right upper lobe may represent small area of pulmonary hemorrhage or developing infarct. Red Level 1 findings were entered into the system. | Actionable Findings system for documentation and communications on 3/22/2021 4:31 PM, Message ID 191499. 3. Pulmonary nodules in the right lower lobe measure up to 4 mm maximally. See below consensus guidelines. TTE - INTERPRETATION SUMMARY: Left ventricle is normal in size. There is normal left ventricular systolic function. The quantitative LVEF based on modified Simpson's method is 62%. There is asymmetric septal hypertrophy with maximal wall thickness of 1.3 cm. There is mild (grade I) diastolic dysfunction with normal left atrial pressure. Right ventricle is normal in size. There is normal right ventricular systolic function. No previous echocardiogram in Froedtert Health system for comparison.
76 2021-03-29 loss of consciousness The next morning, severe headache, vomiting, chills, sweating, passed out hit my head and now have a... Read more
The next morning, severe headache, vomiting, chills, sweating, passed out hit my head and now have a black eye and cheek bone swallon. extemely tired, light headed nausea .
76 2021-03-30 heart flutter Heart fluttering and weakness; Weakness; Eyes glazed over; Her eyes are bothering her, still feel we... Read more
Heart fluttering and weakness; Weakness; Eyes glazed over; Her eyes are bothering her, still feel weak; Head in a fog; Light headed; A spontaneous report was received from consumer concerning a 76 years old female who experienced heart fluttering (cardiac flutter) and weakness(asthenia), eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort), head in a fog (feeling abnormal), and light headed (dizziness). The consumer's medical history was not provided. No relevant concomitant medications were reported. On 02 FEB 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that on 03 FEB 2021 her eyes seemed glazed over, her head felt like it was in fog, and she had feelings of experienced heart fluttering and weakness. She stated that weakness was also associated with the heart fluttering. The symptoms resolved in about a week, other than her eyes which still feel weak, and bothering her enough. Treatment information included Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome for the events of eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort) was considered as not recovered. The events of heart fluttering (cardiac flutter) and weakness(asthenia), head in a fog (feeling abnormal), and light headed (dizziness) were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
76 2021-03-30 palpitations, lightheadedness brain fog; itchy spot; headache; Little bit nauseous; feels tired; chills; Felt like almost passed a... Read more
brain fog; itchy spot; headache; Little bit nauseous; feels tired; chills; Felt like almost passed away; Fast heart palpitations; Slept all next day more than usual; pain in her left jaw; diarrhea; A spontaneous report was received from a Consumer herself concerning as a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart palpitations, bad headache, felt like she almost passed away, slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired and brain fog. The patient's historical conditions were mentioned as High blood pressure and cholesterol. No relevant concomitant medications were reported. On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient experienced fast heart palpitations, bad headache, felt like she almost passed away which was a serious condition and considered as medically significant. Slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired. On an unknown date patient experienced brain fog. On 01 mar 2021, blood pressure was raised to 199/120, cardiac stress test as normal and low pulse rate. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The headache, tired and brain fog was ongoing and for other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
76 2021-03-31 transient ischaemic attack Sore arm; Transient ischemic attack, symptoms of tia; A spontaneous report was received from a consu... Read more
Sore arm; Transient ischemic attack, symptoms of tia; A spontaneous report was received from a consumer concerning a 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of transient ischaemic attack (TIA), transient ischemic attack/transient ischaemic attack and sore arm/pain in extremity. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date patient had sore arm like from a flu vaccine. On 24 Jan 2021, the patient went to emergency room thinking patient had a TIA (transient ischemic attack). TIA was not detected at that time but found one later which is considered as medically significant event. Patient had all the symptoms of TIA to the point where patient could not talk, right leg was numb, and eyes went grey. It is unknown whether the patient had history of TIA. The patient had a brain scan, heart tests, and an MRI whose results were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
76 2021-04-01 heart failure Respiratory distress, led to heart failure, and ultimately death of patient
76 2021-04-01 heart rate increased 8 days after receiving the vaccine I developed shortness of breath & rapid hard heartbeat. Symptoms ... Read more
8 days after receiving the vaccine I developed shortness of breath & rapid hard heartbeat. Symptoms have lessened but are not totally gone. Hoping it doesn't happen again after my 2nd shot.
76 2021-04-01 palpitations, low blood oxigenation Oxygen drop; Shingles on her forehead; Heart Racing; Aches/pain; Rash; Sore arm; Nausea; Fever; This... Read more
Oxygen drop; Shingles on her forehead; Heart Racing; Aches/pain; Rash; Sore arm; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Oxygen drop) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HYPOXIA (Oxygen drop) (seriousness criterion hospitalization), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever). The patient was hospitalized on 20-Feb-2021 due to HYPOXIA. At the time of the report, HYPOXIA (Oxygen drop), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
76 2021-04-03 chest pain shaking chills -severe X 15 hours, then intermittantly- day 1; Rt side crushing chest pain, Lt side ... Read more
shaking chills -severe X 15 hours, then intermittantly- day 1; Rt side crushing chest pain, Lt side extreme squeezing & twisting sensation of heart; intense bone pain in areas that were injured 15 years prior- neck, posterior thorax, sacral area- all on right side only- day 2; awoke day 3 drenched, extreme diaphoreses- loss of 4 lbs; others less intense- loss appetite & thirst, Rt side only parietal and also occipital headache; tired & weak. Ended in 7 days.
76 2021-04-04 low blood oxigenation, blood pressure increased, heart rate increased feeling shaky, dizzy and not right; Blood pressure was 172/101 at 6am, now is improving at 159/94, b... Read more
feeling shaky, dizzy and not right; Blood pressure was 172/101 at 6am, now is improving at 159/94, but heir normal blood pressure; body aches; feeling shaky; fever; headaches; oxygen was not as good as usual, at 95% (usually between 97-99%); elevated heart rate of 110ppm and climbing, for 3 days; A spontaneous report was received from a Healthcare Professional and a consumer concerning a 76 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Heart rate increased, Hypoxia, Dizziness, Blood pressure increased, Pyrexia, Pain and Headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient experienced elevated heart rate of 110ppm and climbing for 3 days, felt they were having a heart attack, oxygen was not as good as usual, at 95 percent (usually between 97 to 99). On 4 Feb 2021, the patient experienced the events feeling shaky, dizzy and not right, blood pressure was 172,101, now was improving at 159, 94, headache, fever and body aches. The Hypoxia was considered medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 2 Feb 2021 the outcome of elevated heart rate was resolved and for blood pressure was recovering. On an unknown date the outcome of other event was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with PMH of COVID-19 who had a serious unexpected event of hypoxia and nonserious unexpected blood pressure increased, heart rate increased, dizziness, nervousness, and expected pyrexia, headache. Event onset on Day 4 after first dose mRNA-1273. Main event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
76 2021-04-05 blood pressure increased 8 pm my blood pressure when up 201-107 89 pulse. I took 25 mg losartan. 8:40 pm blood pressure 165... Read more
8 pm my blood pressure when up 201-107 89 pulse. I took 25 mg losartan. 8:40 pm blood pressure 165-98 77p.
76 2021-04-05 chest pain, hypertension The day after the vaccine I started to feel nauseated, Chest pain, lower abdominal pain and back pai... Read more
The day after the vaccine I started to feel nauseated, Chest pain, lower abdominal pain and back pain. My blood pressure was a little high. The following day I was feeling a little better, but the chest pain was worrisome. I went to Urgent care and they said my EKG was not normal. I was taken to the hospital which was also the vaccine site. I was treated in the ER and they ruled out a heart issue with a complete workup. I was admitted for an unexplained bowel obstruction and remained in the hospital for four days. I got the second dose of the vaccine and I did not have any significant problems. I may have Covid-19 in the spring of 2020.
76 2021-04-06 pallor Patient's husband alerted pharmacy staff that patient was having difficulty breathing with bright re... Read more
Patient's husband alerted pharmacy staff that patient was having difficulty breathing with bright red pallor roughly 5 minutes following her second dose. She was slightly hyperventilating, had pain radiating from her neck superior to her ears and anterior down her back. She described the pain as "shooting" and moving downward. She was able to take deep breaths and converse with no issues so epinephrine was not administered. Paramedics were called to the scene to assess her condition. She was able to stand, showed no signs of dizziness or change in mental status, and her pallor began returning to baseline. EMS took her BP and oxygenation, she declined transport to a hospital and remained at the pharmacy for an extra 30 minutes.
76 2021-04-06 fainting passed out; she fell down; bruised her lower back; her back is killing her; she felt cold inside; re... Read more
passed out; she fell down; bruised her lower back; her back is killing her; she felt cold inside; really hot while in bed; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (passed out) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), FALL (she fell down), CONTUSION (bruised her lower back), BACK PAIN (her back is killing her), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed). On 26-Mar-2021, SYNCOPE (passed out), FALL (she fell down), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed) had resolved. At the time of the report, CONTUSION (bruised her lower back) and BACK PAIN (her back is killing her) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive. Concomitant medications taken by the patient were not provided. Treatment activities was done with paracetamol, ibuprofen, a shot and pill. This case was linked to MOD21-064155 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
76 2021-04-09 heart attack RECEIVED VACCINE ON 2/5/21 AND WAS FOUND DEAD MORNING OF 2/7/21. SHE HAD NO SIDE EFFECTS OTHER THAN... Read more
RECEIVED VACCINE ON 2/5/21 AND WAS FOUND DEAD MORNING OF 2/7/21. SHE HAD NO SIDE EFFECTS OTHER THAN SLIGHTLY SORE ARM UP TO THAT POINT. ED MD FELT SHE HAD SIGNIFICANT CARDIAC HISTORY AND LIKELY HAD MI. MEDICAL EXAMINER DID NOT ORDER AN AUTOPSY AND SHE WAS CREMATED. I FELT THAT I SHOULD JUST REPORT IT SINCE IT WAS SO CLOSE TO RECIVING THE VACCINE.
76 2021-04-11 chest pain Chest and back pain, legs weak since COVID shot 10 days prior; Feet feel like "pins and needles". Lo... Read more
Chest and back pain, legs weak since COVID shot 10 days prior; Feet feel like "pins and needles". Lower extremity weakness and paresthesia's and low back pain which now extend to her hands. Unsteady gait. No urinary or vowel incontinence. No similar reports from other vaccinations
76 2021-04-11 nosebleed 28 hours after receiving Moderna dose 2 patient had a "gusher of a nose bleed" and has had a total o... Read more
28 hours after receiving Moderna dose 2 patient had a "gusher of a nose bleed" and has had a total of 5 since then. She states she never has nose bleeds.
76 2021-04-11 fibrin d dimer increased, cerebrovascular accident, transient ischaemic attack 3/18/21 admitted via ER for Transient cerebral ischemia (left sided weakness/paralysis primarily le... Read more
3/18/21 admitted via ER for Transient cerebral ischemia (left sided weakness/paralysis primarily left arm)- discharged 3/19/21 3/19/21 Acute Stroke (progression of symptoms, involving left arm and leg/foot drop)- transported via ambulance to ER and admitted again, then transferred to inpatient rehab ~3/23/21 and discharged to home 3/31/21
76 2021-04-11 heart rate increased Swelling at vaccination site spreading to full upper arm from shoulder to elbow. Slight hacking coug... Read more
Swelling at vaccination site spreading to full upper arm from shoulder to elbow. Slight hacking cough, rapid heartbeat, miscellaneous pangs around body, earaches, edginess, swollen feet and face. Started about 4/06/21 and beginning to subside around 04/11/21
76 2021-04-12 blood pressure increased Kidneys not working properly; Elevated Blood pressure 170/? mmHg; Feeling of being Wiped-Out; Creati... Read more
Kidneys not working properly; Elevated Blood pressure 170/? mmHg; Feeling of being Wiped-Out; Creatinine Clearance Levels went up to 2.2 mg/dl; This spontaneous case was reported by a health care professional and describes the occurrence of RENAL IMPAIRMENT (Kidneys not working properly) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension and Kidney function abnormal. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RENAL IMPAIRMENT (Kidneys not working properly) (seriousness criterion medically significant), BLOOD PRESSURE INCREASED (Elevated Blood pressure 170/? mmHg) and MALAISE (Feeling of being Wiped-Out). On an unknown date, the patient experienced BLOOD CREATININE INCREASED (Creatinine Clearance Levels went up to 2.2 mg/dl). At the time of the report, RENAL IMPAIRMENT (Kidneys not working properly) and BLOOD CREATININE INCREASED (Creatinine Clearance Levels went up to 2.2 mg/dl) had not resolved and BLOOD PRESSURE INCREASED (Elevated Blood pressure 170/? mmHg) and MALAISE (Feeling of being Wiped-Out) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (100/70-140/90 mmHg): 170/?? mmHg 170/??. On an unknown date, Creatinine renal clearance increased (0.6-1.1 mg/dl): 2.2 mg/dl 2.2 mg/dl. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications not reported. Treatment was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
76 2021-04-12 pulmonary embolism On 3/11, patient complained of shortness of breath with ambulation. She was sent to the ED and diagn... Read more
On 3/11, patient complained of shortness of breath with ambulation. She was sent to the ED and diagnosed with pulmonary embolism. Negative for DVT.
76 2021-04-13 heart failure Issues with her heart pushing fluid; Cellulitis collecting fluid; Missed 2nd Dose due to hospitaliza... Read more
Issues with her heart pushing fluid; Cellulitis collecting fluid; Missed 2nd Dose due to hospitalization; Did not feeling well; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Nausea; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis collecting fluid) and CARDIAC FAILURE (Issues with her heart pushing fluid) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac catheterization. Concurrent medical conditions included Cellulitis. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced CELLULITIS (Cellulitis collecting fluid) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CARDIAC FAILURE (Issues with her heart pushing fluid) (seriousness criteria hospitalization and medically significant), PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea). The patient was hospitalized on 23-Mar-2021 due to CARDIAC FAILURE and CELLULITIS. At the time of the report, CELLULITIS (Cellulitis collecting fluid), CARDIAC FAILURE (Issues with her heart pushing fluid), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. patient missed second dose of vaccination due to hospitalization. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.
76 2021-04-13 chest discomfort Administered 2nd dose of Moderna Covid19 vaccination in L deltoid muscle. Approx. 10 minutes later, ... Read more
Administered 2nd dose of Moderna Covid19 vaccination in L deltoid muscle. Approx. 10 minutes later, client reported that she felt heaviness in her chest and that her head hurt badly. Notified EMS that were on-scene of client's condition.
76 2021-04-13 nosebleed I went to bed on 2/28/21 with fever (as high as 101.7), chills, and a sinus headache. The headache w... Read more
I went to bed on 2/28/21 with fever (as high as 101.7), chills, and a sinus headache. The headache was highly unusual for me. Sometime during the night I had a bilateral nose bleed. I didn't discover the nosebleed until the next morning. It was slight, easily controlled with pressure. It didn't recur thereafter. During a routine checkup not long after, my internist thought this was significant. He asked and I reported no other evidence of abnormal bleeding. He counseled me to consult him before taking any additional COVID-19 booster.
76 2021-04-13 heart rate increased Provided Moderna COVID-19 Vaccine EUA. Adverse Reactions are as follows: Elevated heart rate, Shor... Read more
Provided Moderna COVID-19 Vaccine EUA. Adverse Reactions are as follows: Elevated heart rate, Shortness of Breath, Severe Pain throughout entire body, Extremely Cold and Uncontrollable Shaking of her Body through the night and over the next two days. (The shaking would come in waves over the three days). Fever. Fatigue that lasted a few days. Diarrhea, Lost Appetit. Swelled/Sore Arm. Diarrhea, Fatigue and little apatite is still an issue as of today 4/14/2021. All symptoms are identical to when my mother had the virus in 2020. She is not getting the 2nd shot as a result; too risky for her health.
76 2021-04-13 pulmonary embolism, heart attack On 4/13 patient's daughter in law called public health department to report that patient was found b... Read more
On 4/13 patient's daughter in law called public health department to report that patient was found by EMS on 3/12/21. They believe patient had passed away over night. No autopsy was done. Family member reported that EMS believed the cause to be heart attack or pulmonary embolism.
76 2021-04-13 blood clot Two blood clots in right lung two days after second vaccine. I was hospitalized and I am now on oxyg... Read more
Two blood clots in right lung two days after second vaccine. I was hospitalized and I am now on oxygen 24/7 and I?m taking blood thinner Eliquis.
76 2021-04-15 chest pain Starting feeling bad about 4 hours after vaccination. By the next day (4/11) had difficulty breathin... Read more
Starting feeling bad about 4 hours after vaccination. By the next day (4/11) had difficulty breathing, nausea, severe bladder pain, stabbing pain in stomach, epigastric pain, chest pain, and alternating between severe chills and feeling hot. By 4/12 most of this had subsided and she was experiencing weakness and fatigue, in addition to loss of appetite. This resolved over the next few days.
76 2021-04-16 cerebrovascular accident, transient ischaemic attack Initially had headache, sore arm, chills, but on 4/1/21 had to go to ER with a stroke, and then on 4... Read more
Initially had headache, sore arm, chills, but on 4/1/21 had to go to ER with a stroke, and then on 4/5/21 had a TIA
76 2021-04-16 loss of consciousness 12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,... Read more
12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures .
76 2021-04-17 deep vein blood clot pain in right lower extremity few hours after first and second vaccine. pain then returned and was ... Read more
pain in right lower extremity few hours after first and second vaccine. pain then returned and was diagnosed with Right lower extremity DVT
76 2021-04-18 cerebrovascular accident Blood Clot in Lung, diagnosed March 27, 2021
76 2021-04-20 chest discomfort chest tightness; tingling; stomach pain; big red lump at injection site; vacination site swelling; T... Read more
chest tightness; tingling; stomach pain; big red lump at injection site; vacination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Polyethylene glycol.). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling). On 19-Mar-2021, CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Electrocardiogram: normal normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
76 2021-04-20 chest pain patient had covid shot given to her at drive up. she states immediately she started having a headach... Read more
patient had covid shot given to her at drive up. she states immediately she started having a headache, labored breathing, tongue swelling and burning in her chest along with being flushed. the physician on site gave her benadryl and epinephrine, and she was then driven to another ED where she was given IV steroids. she states the vaccine adverse event was not reported by any of the facilities that took care of her that day. she also has had flu like symptoms since she got her shot and she is still recovering.
76 2021-04-22 palpitations On March 5, 2021 I went to an emergency room because I fell and fractured my arm and I was in a Bige... Read more
On March 5, 2021 I went to an emergency room because I fell and fractured my arm and I was in a Bigeminal Heart Rhythm. I followed up with my Cardiologist in which they did an echocardiagram and placed a holter monitor on me to monitor my heart rate and rhythm. They are currently trying to get this rhythm back to normal with medications. I have NEVER been in a rhythm like this until after I received the vaccine.
76 2021-04-22 transient ischaemic attack Transient ischemic attack; This spontaneous case was reported by a health care professional (subsequ... Read more
Transient ischemic attack; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criterion hospitalization). The patient was hospitalized from 15-Apr-2021 to 16-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
76 2021-04-23 deep vein blood clot they did ultrasound and found a blood clot in her right leg behind the knee; This spontaneous case w... Read more
they did ultrasound and found a blood clot in her right leg behind the knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included LIRAGLUTIDE (VICTOZA) and INSULIN GLARGINE (TOUJEO) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Ultrasound scan: found a blood clot in her right leg behind the kne (abnormal) found a blood clot in her right leg behind the knee. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included xarelto 15mg. Concomitant medication included BP medicine. Her right leg started swelling and turned red a week ago(10Apr2021). She went to the doctor on 12Apr2021 and they did ultrasound and found a blood clot in her right leg behind the knee (12Apr2021). She is scheduled to get 2nd dose on 22Apr2021. She never had blood clot before so wanted to report it. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
76 2021-04-25 chest pain, pulmonary embolism Patient received her 2nd dose of the Moderna Covid-19 vaccine on 4/20/2021 at 0935. On 4/25/2021, pa... Read more
Patient received her 2nd dose of the Moderna Covid-19 vaccine on 4/20/2021 at 0935. On 4/25/2021, patient presented to the ER with SOB and mild CP that began after she walked a 1/2 mile to her nephew's home. Pt was diagnosed with bilateral PEs and admitted to the hospital for treatment. At this time patient is stable, improving , and remains admitted to the hospital.
76 2021-04-28 chest discomfort Within approximately 30 minutes post vaccination, the patient returned to the pharmacy stating her t... Read more
Within approximately 30 minutes post vaccination, the patient returned to the pharmacy stating her tongue was tingling and her chest felt very tight. She did not appear to be in any distress. Despite this we had epinephrine at the ready. At this time she offered that her last flu vaccine caused this kind of response but this time it was worse. When asked why she did not share this initially, she said, " i didnt see a place on the sheet for it". Over the next 30 minutes her tongue tingling resolved, however her chest remained tight. Her tongue tingling then recurred, at this time I suggested she needed a more appropriate setting to be monitored. The patient agreed, we called 911 and EMTS transferred her to the local hospital. At the time of transfer, the patient appeared stable without visible symptoms.
76 2021-04-28 fainting, pulmonary embolism Patient rec'd Moderna COVID vaccines 1/30/21 and 2/27/21. On 4/3 she presented to the emergency dep... Read more
Patient rec'd Moderna COVID vaccines 1/30/21 and 2/27/21. On 4/3 she presented to the emergency department following a syncopal episode. Prior to syncopal episode she had a 2 week history of dry, nonproductive cough, left side rib pain (Pain rating 8/10). She was admitted and treated for PE and possible pneumonia. She was discharged 4/5 on warfarin anticoagulation. She had follow up appointments with PCP and hematology and will likely be on anticoagulation for unprovoked PE x 6 months.
76 2021-04-29 deep vein blood clot L leg swollen, red, warm
76 2021-04-30 heart rate increased Had a spike in blood pressure (194/100); Increased heart rate; Toe injury/Minor bruising; Trouble sl... Read more
Had a spike in blood pressure (194/100); Increased heart rate; Toe injury/Minor bruising; Trouble sleeping; Sleeping pattern has changed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Insomnia. Concurrent medical conditions included White coat hypertension. Concomitant products included CALCIUM for Calcium supplementation, MELATONIN for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)) (seriousness criterion medically significant), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed). At the time of the report, HYPERTENSIVE CRISIS (Had a spike in blood pressure (194/100)), HEART RATE INCREASED (Increased heart rate), LIMB INJURY (Toe injury/Minor bruising), INSOMNIA (Trouble sleeping) and SLEEP DISORDER (Sleeping pattern has changed) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 194/100 (High) High. Two weeks after receiving the vaccine the patient had trouble sleeping and sleeping pattern was changed. The patient reported that she had a spike in blood pressure (194/100) and increased heart rate when she went for doctor's appointment. She has white coat syndrome. The patient was prescribed Ativan 1-2 times a week as needed (after sleeping pattern changed). The patient consumed a cup of wine to help her fall asleep. On 06-Apr-2021 or 07-Apr-2021, the patient had a toe injury which caused minor bruising and sleep problems started around that time. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
76 2021-04-30 pulmonary embolism clot in her lungs; This spontaneous case was reported by a non-health professional and describes the... Read more
clot in her lungs; This spontaneous case was reported by a non-health professional and describes the occurrence of PULMONARY EMBOLISM (clot in her lungs) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PULMONARY EMBOLISM (clot in her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (clot in her lungs) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pulmonary embolism, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-075030 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pulmonary embolism, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075030:Patient's brother in law case; cross linked case
76 2021-04-30 fainting Fainting; frequent urination; MODERNA toes/dots on her foot which still persist; itchiness; Dehydrat... Read more
Fainting; frequent urination; MODERNA toes/dots on her foot which still persist; itchiness; Dehydration; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by the reporter. Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLOMIDE HYDROCHLORIDE), TIMOLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), POLLAKIURIA (frequent urination), VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist), PRURITUS (itchiness), DEHYDRATION (Dehydration) and PYREXIA (Fever). At the time of the report, SYNCOPE (Fainting), POLLAKIURIA (frequent urination), DEHYDRATION (Dehydration) and PYREXIA (Fever) outcome was unknown, VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist) had not resolved and PRURITUS (itchiness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment medications were not reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-089293 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-089293:Husband case
76 2021-04-30 blood clot I got blood clots. I do not know if they were related to the vaccine or not. I was on Eliquis and to... Read more
I got blood clots. I do not know if they were related to the vaccine or not. I was on Eliquis and took it as prescribed. I was put on another blood thinner.
76 2021-05-02 fainting Pt received dose #1 Moderna COVID vaccine 1/19/21 @ LPH Vaccine clinic. Overnight some nausea, malai... Read more
Pt received dose #1 Moderna COVID vaccine 1/19/21 @ LPH Vaccine clinic. Overnight some nausea, malaise. 1/20/21 experienced a syncopal episode at home and BIBA to PVH ED. Vomiting, incontinence in route. Workup negative, given IVF and zofran, discharged. Per ED provider "Likely vasovagal syncope. Possibly related to reaction to vaccine. No worrisome findings in the evaluation today."
76 2021-05-05 chest pain shoulder blades with pain number 2 and head number 6; jaw pain; chest pain, chest was hurting; very ... Read more
shoulder blades with pain number 2 and head number 6; jaw pain; chest pain, chest was hurting; very bad feeling in the head, back of the throat and lips.; it has been over 42 days since she receive the first dose; very bad feeling in the head, back of the throat and lips.; shoulder blades with pain number 2 and head number 6; headache; very fatigue; felt drained; funny feeling that she doesn't know how to describe it in her lips; shortness of breath; lips were swollen; feeling like anxiety; barley walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain, chest was hurting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), DYSPNOEA (shortness of breath), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained), FATIGUE (very fatigue) and HEADACHE (headache). On an unknown date, the patient experienced CHEST PAIN (chest pain, chest was hurting) (seriousness criterion life threatening), OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.) and HEADACHE (shoulder blades with pain number 2 and head number 6). On 22-Feb-2021, CHEST PAIN (chest pain, chest was hurting), ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained) and HEADACHE (headache) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), DYSPNOEA (shortness of breath), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.), FATIGUE (very fatigue) and HEADACHE (shoulder blades with pain number 2 and head number 6) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment include Benadryl and Tylenol.. Event Start date and stop date updated. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Event start date and stop date updated for events On 28-Apr-2021: Significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
76 2021-05-05 heart attack, fainting On 5/6, the patient reports she was hospitalized on 4/14 after experiencing myocardial infarction, s... Read more
On 5/6, the patient reports she was hospitalized on 4/14 after experiencing myocardial infarction, syncope, and fall resulting in the patient hitting her head
76 2021-05-06 cerebrovascular accident I had my first vaccine in February and got along fine. My second shot was in March and the first th... Read more
I had my first vaccine in February and got along fine. My second shot was in March and the first thing I noticed was the shot hurt so bad, and I am not a whiner. The second day my arm hurt so bad i couldn't even lift it and could not use it for almost a week. The second day after the vaccine, I had a massive headache. The third day was Sunday and I was so sick with body aches, fatigue, the arm, and headache I couldn't go to church. For days and days I would wake up thinking I was better but by noon.I was a mess. A church friend mentioned she thought I had Covid bc my symptoms were so much like hers when she had the virus. Both my daughter and stepdaughter noticed how I was struggling with my speech, which has
76 2021-05-07 cerebrovascular accident This 76 year old female received the Moderna Covid shot on 1/30/21 and went to the ED on 2/26 /... Read more
This 76 year old female received the Moderna Covid shot on 1/30/21 and went to the ED on 2/26 /21 and was admitted on2/26 /21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident)
76 2021-05-08 heart attack FAMILY REPORTS MYOCARDIAL INFARCTION
76 2021-05-09 stroke Stroke-like symptoms Other cerebral infarction due to occlusion or stenosis of small artery
76 2021-05-10 cerebrovascular accident R29.90 - Stroke-like symptom CEREBROVASCULAR ACCIDENT
76 2021-05-10 blood clot, fibrin d dimer increased on post vaccine day #9 pt developed light bruising r antecubital [vaccine was l deltoid] and knots. ... Read more
on post vaccine day #9 pt developed light bruising r antecubital [vaccine was l deltoid] and knots. she has had ongoing mild nontraumatic bruising here and sq nodular lesions ? clot. pt also has had generalized malaise and some mild shortness of breath with this and has generally felt sick.
76 2021-05-12 low blood oxigenation, heart rate increased O2 levels where they'd be mid 90s and would walk a little and go down to 79%; weakness; shaking; sho... Read more
O2 levels where they'd be mid 90s and would walk a little and go down to 79%; weakness; shaking; shortness of breath; unable to get out bed; heart rate would go into the 100s with minimal exertion; myalgia in neck and shoulder; chills; 103F fever; This spontaneous case was reported by a physician and describes the occurrence of HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (had COVID19 at the end of October) in October 2020, Fever (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020, Myalgia (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020 and Appetite lost (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020.Concurrent medical conditions included Hypertension (for which she takes a small dose of an antihypertensive medication). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) (seriousness criterion medically significant), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever). At the time of the report, HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiogram: negative (Negative) Negative. In 2021, COVID-19: negative (Negative) Negative. In 2021, Cardiac stress test: negative (Negative) Negative. In 2021, Electrocardiogram ambulatory: negative (Negative) Negative.NThe action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included ANTIHYPERTENSIVES for Hypertension.BHer neck and shoulder pain persisted so she used Lidoderm topical and muscle relaxers which seemed to help as well as resting. Her doctor also advised she go to physical therapy to help.NBased on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.NThis case was linked to MOD-2021-103020 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.
76 2021-05-16 chest pain A few days before she had trouble breathing, wheezing and then she got the vaccine and it got worse... Read more
A few days before she had trouble breathing, wheezing and then she got the vaccine and it got worse. Also had pains in her legs and chest. She gets weak and would have to lay down a walk and when she goes up and down the steps had to huff and puff, which she had not have this type of trouble in the past. She went to her cardiologist who took blood work, and he also did a chest x-ray. She then went to her PCP last week, who said he would check with her cardiologist and see the results of his tests. She is also a little light headed, but the breathing and wheezing is what is most bothersome.
76 2021-05-20 low platelet count Death Thrombocytopenia Subdural bleeding HEADACHE DIZZINESS
76 2021-05-21 chest discomfort This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMAT... Read more
This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dairy intolerance, Drug allergy (allergic to Compazine), Hay fever since 1976, Osteopenia since 2000, Tinnitus since 2016 and Osteoarthritis since 1990. Concomitant products included MACROGOL 400 (BLINK TEARS) for Dry eye, VITAMINS NOS (MULTIPLE VITAMIN) for Multi-vitamin maintenance, VITAMIN D3, PROBIOTICS NOS, FISH OIL and HOMOCYSTEINE THIOLACTONE HYDROCHLORIDE for Routine health maintenance, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2020 to an unknown date and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Sinusitis, MAGNESIUM CITRATE for an unknown indication, GLUCOSAMINE & CHONDORITIN. On 22-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs). On 21-Apr-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (tightness in the chest). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) and ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs) had not resolved and CHEST DISCOMFORT (tightness in the chest) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Additional concomitant medication taken at the start of the events included OsteoThera 4 times per day. On 27-Jan-2021, the patient experienced intense pain in the joints and muscles of the legs. She applied ice as treatment. Over the next 2-3 weeks pain moved to other joints and muscles with varied intensity; fatigue and weakness noted. Overtime it became very difficult for the patient to stand up from a seated position, walk, turn over when lying down, or bend over to sit down. On 09-Feb-2021 additional daily supplements were started: Pea Protein, Calcium D-Glucarate, Digestive Enzymes (Digest Gold), GI Motility Complex, Glutagenics Powder, Sun Fiber. The patient sought medical attention from her Primary Care Provider (PCP). The patient's ESR and CRP were elevated, indicative of an inflammatory condition. The patient was referred to Rheumatology. While she waited 5 weeks for the appointment, she experienced tightness in the chest and continued loss of function. She eventually went to the Emergency Room (ER) and 1 lab result was slightly elevated, indicative of Lyme disease. The ER doctor administered ketorolac and iodixanol and the patient started treatment with doxycycline. On 21-Apr-2021, doxycycline was stopped as additional lab tests for Lyme disease were normal. The patient was diagnosed with Polymyalgia Rheumatica and started treatment with Prednisone 15 mg daily (gradual tapering off was planned), heat, light stretching, and exercise to regain leg movement. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Additional initial received on 12-May-2021. Concomitant medication added; event added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
76 2021-05-23 pulmonary embolism Admitted to facility for bilateral pulmonary embolism after bronchitis for 3 weeks
76 2021-05-25 loss of consciousness When I woke up I felt my legs wouldn't hold me up. I passed out in the bathroom. Finally managed to ... Read more
When I woke up I felt my legs wouldn't hold me up. I passed out in the bathroom. Finally managed to get up and walk with the aid of a walker. I have no more memory of that day. Except for meals and bathroom use I remained lying down all day. I was very nauseous and severely weak, light-headed, and had brain fog, Except for the nausea I felt that way for 10 days. On the 10th day I felt able to stand long enough to take a shower.
76 2021-05-27 pulmonary embolism, low blood oxigenation PATIENT DEVELOPED HYPOXIA, PNEUMONIA, PLEURAL EFFUSION AND LEFT LUNG PULMONARY EMBOLI PATIENT WAS T... Read more
PATIENT DEVELOPED HYPOXIA, PNEUMONIA, PLEURAL EFFUSION AND LEFT LUNG PULMONARY EMBOLI PATIENT WAS TREATED WITH ANTIBIOTICS, OXYGEN ANDF STARTED ON HEPARIN DRIP, WHICH WAS D/C AND PATIENT WAS STARTED ON LOVENOX PRIOR TO D/C. PATIENT ALSO NOTED TO HAVE PULMONARY NODULES ON IMAGING AND ARRANGMENTS MADE TO F/U OUTPATIENT FOR BIOPSY.
76 2021-05-31 loss of consciousness Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom; Left foot was broke... Read more
Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom; Left foot was broken; Had fallen on her foot, fell; Mild aches; Bed was soaked with diarrhea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Bed was soaked with diarrhea after second dose). 02-Apr-2021, the patient experienced MYALGIA (Mild aches). On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) (seriousness criterion medically significant) and FOOT FRACTURE (Left foot was broken). 19-Apr-2021, the patient experienced FALL (Had fallen on her foot, fell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom), FOOT FRACTURE (Left foot was broken), DIARRHOEA (Bed was soaked with diarrhea after second dose), FALL (Had fallen on her foot, fell) and MYALGIA (Mild aches) outcome was unknown. Concomitant product use was unknown. The patient reported that the day after her second shot, she woke up and her bed was soaked with diarrhea. She has no memory of this, but on 19Apr2021, she woke up on the floor in the bathroom. She stated that she had fallen on her foot, and her left foot was broken. She also reported she had mild aches on 02Apr2021. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-162182 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
76 2021-06-02 heart attack Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB. She was diagnose... Read more
Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB. She was diagnosed with myocardial Infarction in the ER with SOB adverse effect of the vaccine. She has no prior cardiac history
76 2021-06-03 atrial fibrillation, blood pressure increased Very strong a-fib attack, blood pressure spiked. From 3/19 on shortness of breath when walking and p... Read more
Very strong a-fib attack, blood pressure spiked. From 3/19 on shortness of breath when walking and pressure in head and blood pressure rise. Heart ultrasound 3/26 ok. Stress test with ultrasound 4/30 ok. Bloodwork, chest x-ray 6/4 ok. Drs. don?t know what?s going on. ER said people coming in with problems from the vaccines.
76 2021-06-07 palpitations, hypertension 1036 C/O Heart racing. BP 218/111, HR 118, resp 18, sats 97%. Reports Hx of HTN took BP meds this am... Read more
1036 C/O Heart racing. BP 218/111, HR 118, resp 18, sats 97%. Reports Hx of HTN took BP meds this am. AAOX4 DENIES DIZZINESS. Client daughter present. 1045 BP 198/104, HR 96, resp 16, sat 97%. 12 lead EKG done reg rhythm. 1100 BP 176/95, HR 85, sats 97%, Resp 16 11:15 BP 171/90, HR 80, sats 98%. C/O feeling tired requesting to go to the ER states her blood pressure has never been that high before. 11:19 Left with her daughter. Client daughter states she will take her to the ER. First vaccine.
76 2021-06-08 fluid around the heart On April 18 I developed a headache and fever (101), fatigue, tightness/pressure in my throat/esophag... Read more
On April 18 I developed a headache and fever (101), fatigue, tightness/pressure in my throat/esophagus. Continued through April 20, when I called my GI physician to describe symptoms. Doctor recommended going to Urgent Care to be tested for COVID 19. Within an hour or two I went for the test, which was negative. The attending doctor then ordered EKG, blood tests, and CT scan to see what was going on. Found high white blood cell count and Pericardial Effusion. Sent me to hospital, where I was admitted and spent 6 days. The diagnosis was that the Pericardial Effusion was caused by inflammation, not infection, and I was started on a combination of drugs to eliminate the fluid. I was released on April 26 with only trace fluid around my heart.
76 2021-06-09 atrial fibrillation, chest pain Patient presented to the ED and was subsequently hospitalized for atypical chest pain, abnormal stre... Read more
Patient presented to the ED and was subsequently hospitalized for atypical chest pain, abnormal stress test, atrial fibrillation within 6 weeks of receiving COVID vaccination.
76 2021-06-14 hypotension, heart rate increased on 6/10/21, case experienced low blood pressure and increased heart rate. Tested positive for Covid-... Read more
on 6/10/21, case experienced low blood pressure and increased heart rate. Tested positive for Covid-19 on 6/11/21. Case first visited emergency room at local Hospital due to low blood pressure, increased heart rate. Hospitalized 6/11/21 to 6/13/21. Fatigue, Shortness of Breath, and Cough also developed. Cough still persists as of 6/15/21
76 2021-06-23 heart attack Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/2... Read more
Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.
76 2021-06-25 atrial fibrillation Developed Atrial Fibrillation (24 hours) four days after 2nd immunization. One previous episode o... Read more
Developed Atrial Fibrillation (24 hours) four days after 2nd immunization. One previous episode of this arrhythmia was2.5 years previously. On 6/8/2021, I had a cardiac ablation for the arrhythmia which began in February
76 2021-06-28 low platelet count Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000; This spontaneous ca... Read more
Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Platelet count: 71000 (Inconclusive) Inconclusive. On 06-Apr-2021, Platelet count: 112000 (Inconclusive) Inconclusive. On 12-Apr-2021, Platelet count: 169000 (Inconclusive) Inconclusive. No concomitant medications were provided. No treatment medications were mentioned. This case concerns a 76-year-old female with a serious unexpected event of thrombocytopenia. Event latency 36 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of thrombocytopenia. Event latency 36 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
76 2021-07-01 pulmonary embolism Submassive PE
76 2021-07-07 heart attack I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
76 2021-07-08 fibrin d dimer increased, chest pain leukocytosis--March May--pneumonia July--nausea, headache, SOB, CP, elevated D-Dimer.
76 2021-07-13 blood pressure increased Blood pressure rose and stayed high, treated with Benazapril (40mg) once a day and Amlodipine (5 mg... Read more
Blood pressure rose and stayed high, treated with Benazapril (40mg) once a day and Amlodipine (5 mg) once a day. Now stable.
76 2021-07-15 cerebrovascular accident March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital... Read more
March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital could not even change clothes , went to Dr. , then ER. they did MRI, and found out she had a stroke on right side of brain. but right side was showing weakness. Week and half later weakness in right hand. 2nd MRI left side stroke on brain, inflammation on spinal cord, short term rehab. They found UTI after going back to ER. Son got call from The 2nd ER doctor and said she was diagnosed with neuromyelitis optica very rare disease. They said she had transverse myelitis (May, 14 2021) Returned to rehab then found out she had high white blood cell count , On May 16, 2021 readmitted to hospital and did not return to Rehab until June 18 2021 . Then returned and is still in on July 2, 2021. (Inflammation of gallbladder, 4th diagnose of Shower strokes, diabetes, On July 12, 2021 in hospital was diagnosed with Covid 19 and is still in hospital
76 2021-07-16 cerebrovascular accident My Mom suffered a series of debilitating strokes in the early morning hours of 04/09/2021 after rece... Read more
My Mom suffered a series of debilitating strokes in the early morning hours of 04/09/2021 after receiving the second dose of the Moderna vaccine on 04/08/2021.
76 2021-07-19 heart attack Patient tested positive for Covid 7/19/21. Hospitalized with COVID, pneumonia, NSTEMI
76 2021-07-20 increased heart rate A few hours after receiving 2nd Covid vaccine patient began feeling nauseated then started vomiting.... Read more
A few hours after receiving 2nd Covid vaccine patient began feeling nauseated then started vomiting. She denies blood in the emesis. She also endorses feeling "chilled to the bone." Triage temp is 103.1. Patient denies chest pain, shortness of breath, cough, numbness, tingling, falls, headache, abdominal pain, diarrhea, constipation, changes in diet, recent travel. No dysuria, hematuria, rashes, bruising or bleeding. She states she has had at least 6 or 7 episodes of emesis and is on her fourth emesis bag in the ER. She states she feels very dehydrated and week. I was informed that the patient was admitted and was under the care of a hospitalist who I could not reach.
76 2021-07-25 atrial fibrillation, heart flutter, fast heart rate Tachycardia, Afib, Pounding, Flutter (Heart) Short of Breath, runnier nose, Weak & Shaky, no Apatite... Read more
Tachycardia, Afib, Pounding, Flutter (Heart) Short of Breath, runnier nose, Weak & Shaky, no Apatite.
76 2021-07-26 blood clot Very heavy postmenopausal bleeding including large clots began evening of 3/12/21; ended 3/22/21. ... Read more
Very heavy postmenopausal bleeding including large clots began evening of 3/12/21; ended 3/22/21. Bleeding occasionally heavy for entire time. No other symptoms.
76 2021-07-28 lightheadedness Recurrent AvWD; Acquired hemophilia A; Admitted for Blood loss anemia; On day 7, she developed persi... Read more
Recurrent AvWD; Acquired hemophilia A; Admitted for Blood loss anemia; On day 7, she developed persistently melanotic stool; After dose 2, On day 4 she developed large ecchymoses covering most of her upper extremities; On day 15 she presented to the emergency department with presyncope; This case was reported in a literature article and describes the occurrence of ACQUIRED VON WILLEBRAND'S DISEASE (Recurrent AvWD), ACQUIRED HAEMOPHILIA (Acquired hemophilia A), BLOOD LOSS ANAEMIA (Admitted for Blood loss anemia) and MELAENA (On day 7, she developed persistently melanotic stool) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: The patient's past medical history included Ecchymoses (multiple episodes of large, upper extremity), Paraesophageal hiatal hernia and Nissen fundoplication (status post recent uncomplicated). Concurrent medical conditions included Asthma and Raynaud's phenomenon. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACQUIRED VON WILLEBRAND'S DISEASE (Recurrent AvWD) (seriousness criteria hospitalization and medically significant), ACQUIRED HAEMOPHILIA (Acquired hemophilia A) (seriousness criteria hospitalization and medically significant), BLOOD LOSS ANAEMIA (Admitted for Blood loss anemia) (seriousness criteria hospitalization and medically significant), MELAENA (On day 7, she developed persistently melanotic stool) (seriousness criterion medically significant), ECCHYMOSIS (After dose 2, On day 4 she developed large ecchymoses covering most of her upper extremities) and PRESYNCOPE (On day 15 she presented to the emergency department with presyncope). The patient was hospitalized for 28 days due to ACQUIRED HAEMOPHILIA, ACQUIRED VON WILLEBRAND'S DISEASE and BLOOD LOSS ANAEMIA. The patient was treated with METHYLPREDNISOLONE for Adverse event, at a dose of 125 milligram every six hours; METHYLPREDNISOLONE for Adverse event, at a dose of 125 milligram twice a day; PREDNISONE for Adverse event, at a dose of 50 milligram twice a day and PREDNISONE for Adverse event, at a dose of 50 milligram once a day. At the time of the report, ACQUIRED VON WILLEBRAND'S DISEASE (Recurrent AvWD), ACQUIRED HAEMOPHILIA (Acquired hemophilia A), BLOOD LOSS ANAEMIA (Admitted for Blood loss anemia), MELAENA (On day 7, she developed persistently melanotic stool), ECCHYMOSIS (After dose 2, On day 4 she developed large ecchymoses covering most of her upper extremities) and PRESYNCOPE (On day 15 she presented to the emergency department with presyncope) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Activated partial thromboplastin time: 122 Second (High) 122 s; mildly prolonged. In 2021, Anti factor VIII antibody test: high (High) High; uptrending and less than 3 (Inconclusive) less than 3 percent. In 2021, Coagulation time: prolonged (Inconclusive) abnormalities illustrates a durable immune response and highlights the utility of corticosteroids in eliminating an autoantibody inhibitor. In 2021, Electrophoresis protein: monoclonal protein was not detected (Inconclusive) Monoclonal protein was not detected. In 2021, International normalised ratio: 1.5 (Inconclusive) 1.5. In 2021, Platelet aggregation test: abnormal (abnormal) abnormal ristocetin. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Von Willebrand's factor activity test: abnormal (abnormal) showed a normal pattern and distribution of bands, consistent with a quantitative vWF deficiency, high (High) High; uptrending, 5 (Inconclusive) 5 percent and less than 3 percent (Inconclusive) less than 3 percent. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACQUIRED VON WILLEBRAND'S DISEASE (Recurrent AvWD), ACQUIRED HAEMOPHILIA (Acquired hemophilia A), BLOOD LOSS ANAEMIA (Admitted for Blood loss anemia), MELAENA (On day 7, she developed persistently melanotic stool), ECCHYMOSIS (After dose 2, On day 4 she developed large ecchymoses covering most of her upper extremities) and PRESYNCOPE (On day 15 she presented to the emergency department with presyncope) to be possibly related. Concomitant medications were not provided by the reporter. The patient was diagnosed with recurrent Acquired Von Willebrand's disease (AvWD) and acquired hemophilia A, presumed to be due to an antibody directed against the Factor (FVIII)/von Willebrand factor (vWF) complex. After dose 2 on days 17 to 19, vWF/FVIII replacement therapy was provided with Humate-P 2290 International unit (U) every 12 hours x 4 doses.Reduction of factor inhibitors was achieved using IV immunoglobulin (IVIg) and corticosteroids as follows: IVIg1g/kg on days 18 and19. On an unknown date lab test included were A factor VIII inhibitor was detected and quantified as 11.2 Bethesda units (BUs) also on days 19 and 26, levels were 1.6 BUs and 0.5 BUs respectively. It was thought to had triggered a flare of an underlying autoimmune- or complement-mediated hematologic condition.The rapid normalization of FVIII and vWF activity after administration of Intravenous immunoglobulin (IVIg) was suggestive of an IgG antibody-mediated process against endogenous and exogenous FVIII/vWF complex. This case was linked to MOD-2021-263889, MOD-2021-263965 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. A literature review case.
77 2021-01-10 palpitations Within about 10 minutes experienced heart thumping and light headedness. Felt overall as though I w... Read more
Within about 10 minutes experienced heart thumping and light headedness. Felt overall as though I was hyperventilating, but breathing was normal. By that evening, I was feeling "not right". By the next morning, started chilling, temp was elevated, over all "sick" feeling. Experienced that until the next afternoon. Arm was very sore (still is, but better). Please note that I had Covid starting November 8, was very ill 2 weeks and continued feeling extreme weakness and fatigue for several weeks after.
77 2021-01-11 blood glucose increased Dizziness/light headed (almost passed out) Vomiting Diarrhea Exhaustion (slept for 5 hrs) High blood... Read more
Dizziness/light headed (almost passed out) Vomiting Diarrhea Exhaustion (slept for 5 hrs) High blood sugar (300)
77 2021-01-16 fast heart rate Tachycardia (160 to 180 beats per minute), shortness of breath, lightheadedness. Onset 2.5 hours af... Read more
Tachycardia (160 to 180 beats per minute), shortness of breath, lightheadedness. Onset 2.5 hours after vaccine. Treated with diltiazem CR 120 mg. Resolved 6 hours after onset.
77 2021-01-18 chest discomfort DIZZY AND CHEST TIGHTNESS
77 2021-01-18 chest discomfort Tightness in chest with wheeze and cough, especially in evening on 1/16/21. These symptoms are slowl... Read more
Tightness in chest with wheeze and cough, especially in evening on 1/16/21. These symptoms are slowly going away.
77 2021-01-19 oxygen saturation decreased dry cough, chills, sweating, fatigue, headache, pulse ox lower than normal
77 2021-01-21 atrial fibrillation Moderna COVID-19 Vaccine EUA -Patient to emergency room 1/10/21 with debilitating atrial fibrillatio... Read more
Moderna COVID-19 Vaccine EUA -Patient to emergency room 1/10/21 with debilitating atrial fibrillation easily treated with Cardizem and Mg.. discharged to home within 2 hrs. with heart rate in the 90s BPM. -HR soon stabilized to HR 100-110 BPM flutter treated 1/21/21 with cardioversion at Hospital Outpatient Surgery. Discharged to home with heart rate in to 60s BPM sinus rhythm but irregular. Pulse Ox 94-97. Continues to present
77 2021-01-21 heart rate increased 20 minutes after injection my heart started beating rapidly and then it went into Atrial Fibulation.... Read more
20 minutes after injection my heart started beating rapidly and then it went into Atrial Fibulation. This irregular rhythm lasted for about 45 minutes and then converted back to sinus rhythm.
77 2021-01-21 heart rate increased chills, fever (more than 24 hours, 100.5-101.5F, ) body pain, weakness, fast pulse Feel very sick. N... Read more
chills, fever (more than 24 hours, 100.5-101.5F, ) body pain, weakness, fast pulse Feel very sick. No treatment.
77 2021-01-21 palpitations, heart flutter, fast heart rate, heart rate increased Pt received dose #1 Moderna COVID vaccine 12/28/20 @ Clinic. About 3 hours after had 30 minutes of r... Read more
Pt received dose #1 Moderna COVID vaccine 12/28/20 @ Clinic. About 3 hours after had 30 minutes of rapid heart rate, and fluttering. Laid down, went to sleep, and it resolved. She didn't seek emergency care. Did not have chest pain or shortness of breath. Continued to have palpitations occasionally, fatigue, tachycardia. Presented to PCP on 1/7/21 for symptoms and was transferred to ED for additional cardiac workup and treatment after capturing SVT on EKG. Also diaphoretic, dizzy, nauseous, SOB with palpitations. Given IV metoprolol in ED with conversion to NSR. Per ED "Suspect that the vaccine may have been her trigger." Able to discharge without escalation of care. Entered for tracking.
77 2021-01-24 hypotension About 10 minutes after receiving the vaccine, I was sitting in a well organized waiting area I start... Read more
About 10 minutes after receiving the vaccine, I was sitting in a well organized waiting area I started feeling flames in my throat. My throat was literally on fire. I raised my hand as I was instructed to do. I asked for water, they brought me a bottle water, I started to drink it. My throat was having a difficult time swallowing. They brought me over to nursing area. I went into this area and the nurses were there. They made me take my mask off, they took my blood pressure was way lower then normal (110/30). Then they gave me 50MG Benadryl. They called EMS and I refused to go. I had to wait at the clinic until the Benadryl took effect. The "flame" feeling began to lessen. When I got home I took another dose of Benadryl. The "flame" feeling went away but then I was left with a sore throat for the rest of the night and the following morning. It felt like there was an actual fire in my throat that the Benadryl put out but then it felt as if the after effects of a burn in my throat. I do have a call in to my primary care provider and still waiting for a call back.
77 2021-01-27 chest discomfort On day of shot, after I got home, I had tingling in my mouth, dizziness, and slight tightness in my ... Read more
On day of shot, after I got home, I had tingling in my mouth, dizziness, and slight tightness in my chest. The next day (1/27) I woke with chills and fever ranging from 99 to 102.4 degrees. And a severe headache., also very tired....Stayed in bed most of the day. On 1/28 I broke out in hives on my chest and stomach. Also have very sore muscles, especially in my legs, and shortness of breath.
77 2021-01-28 transient ischaemic attack Had Covid vaccine Friday morning, Saturday morning at breakfast started shaking, couldn't talk. Ca... Read more
Had Covid vaccine Friday morning, Saturday morning at breakfast started shaking, couldn't talk. Called 911 and treated for TIA. Received blood thinners, had CT scan . MRI, and echo gram on heart. Released from hospital Monday morning, no after effects.
77 2021-01-31 skin turning blue Patient arrived at shot table in TCPH w/c, short of breath. Taken straight back to private observati... Read more
Patient arrived at shot table in TCPH w/c, short of breath. Taken straight back to private observation from shot table. EMT on site in attendance. Upon assessment; patient having suprasternal, substernal, intercostal retractions. Patient on home O2 at 2 L/M per NC. Per EMT auscultation patient has inspiratory and expiratory wheezing. Patient has a loose congested cough. Pt's nail beds dusky, no blanching. Hands are cold. Unable to initially obtain O2 sat reading. Patient does not have inhalers with her. Pt. can't recall names of meds. 9:30 BP 132/62; HR 68 strong and regular per palpation. RR 30. 9:40 O2 sat 82% after hands warmed. Patient increased her own O2 to 3 L/m . EMS activated 9:45 O2 sat 84% with 3 L/m per NC. Still having deep retractions. 9:50 EMS arrived along with FWFD. Patient alert/oriented x 4, still labored breathing. Patient denies feeling badly. Med star team evaluating. 0957 O2 97% on 3 l/m per nc. HR 72; BP 104/58; ETCO2 41 1007 O2 97% on 3 L/m per NC; ETCO2 43; HR 112; BP 96/56. EMS recommends transport. Patient refused. Pt. states she will go home and take her own nebulizer treatment. Patient called brother for ride Patient left AMA, patient remains A/O x 4, taken via w/c to brother's car for transport home.
77 2021-01-31 palpitations, heart rate irregular At 4:15 am, 1/30/2021 (8 hours after received dose 1 of Moderna, I was awakened with a very strong h... Read more
At 4:15 am, 1/30/2021 (8 hours after received dose 1 of Moderna, I was awakened with a very strong heart beat in my chest, fast and irregular heart rate, I had no arm, back, or jaw pain. Within 40 mins., the pounding heart sensation subsided yet the fast, irregular heart beat continued. I finally fell asleep again around 5:00 am that morning and awoke at 9:30 am. At that time my pulse rate was still fast and irregular yet not strong. On Oct. 31 in the morning, my pulse rate was back to normal at 60 bpm and regular.
77 2021-01-31 fainting My arm was a little sore and a little achy first day. Next morning, Body aches and chills all day lo... Read more
My arm was a little sore and a little achy first day. Next morning, Body aches and chills all day long, had a funny taste in my mouth, no apatite as afternoon progressed developed diarrhea, nausea, was sitting on the toilet and fainted. Woke up and got up and went straight to bed and slept the entire night and got up the next morning, I was just tired and weak feeling, kind of dozing on and off. the next day Saturday i was feeling much better, and then Sunday i was perfectly fine.
77 2021-02-01 hypertension I awoke on 1/23/2021 (Saturday) morning to find my face and especially my lips swollen. Contacted d... Read more
I awoke on 1/23/2021 (Saturday) morning to find my face and especially my lips swollen. Contacted doctor's office for the on-call; he strongly suggested I visit the ER. Was kept there for 2-3 hours for observation. Was considered "hypertensive," routine blood work done (CBC, metabolic panel) all of which were normal. Was given Prednisone and ZyrTec. After no change in my condition, was discharged with instruction to contact primary physician and continue to take Prednisone and ZyrTec for the next four more days. The reason for the facial and lip swelling could not be determined......It was indicated that the swelling could be one of several things including an allergic reaction to something topical like a lip balm (I used a Blistix application before bed), a reaction to one of my medication (BP med-Olmesartan, which they told me to discontinue) or less likely a reaction to the COVID vaccine.
77 2021-02-02 chest discomfort Sudden onset in the evening of Feb 1 (17 days after initial dose)--chills, fever, headache, muscle a... Read more
Sudden onset in the evening of Feb 1 (17 days after initial dose)--chills, fever, headache, muscle ache, discomfort in upper chest and jaw. Temperature 100.1 which is about three degrees above my normal temp. Night sweats. Following day, malaise, headache, and discomfort when inhaling a full breath. Night sweats again. Today, much better. Able to breath fully without discomfort, not muscle aches or headache, but tired feeling.
77 2021-02-02 pulmonary embolism, deep vein blood clot Left deltoid IM injection on 1/26/21 Left upper extremity swelling on 1/28/21 Presented to clinic on... Read more
Left deltoid IM injection on 1/26/21 Left upper extremity swelling on 1/28/21 Presented to clinic on 2/2/21 and was found to have an acute LUE DVT and an acute PE on CTA chest
77 2021-02-03 palpitations Moderna COVID-19 Vaccine EUA. At home, about an hour after getting the vaccine had extreme blood pre... Read more
Moderna COVID-19 Vaccine EUA. At home, about an hour after getting the vaccine had extreme blood pressure spike, dizziness, heart palpations, ear ringing, dry mouth, weakness and trembly, visual aura with eyes closed of red ball in field of vision, some pain at temple as if migraine tho I only have had migraines in first trimesters of pregnancy, adolescence and at time of diagnosis of hyperthyroidism. Have had blood pressure brief spikes in past (possible tyramine sensitivity) but this persisted rather than momentary. Live alone and was at home so called Ambulance. Took over 12 minutes for ER to come after called when symptoms did not quickly resolve. Was still having symptoms though blood pressure had dropped to
77 2021-02-03 transient ischaemic attack, hypertension Ischemic attack; Severe high blood pressure; A spontaneous report was received from a consumer conce... Read more
Ischemic attack; Severe high blood pressure; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe high blood pressure (BP) and ischemic attack. The patient's medical history included diabetes. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, bupropion hydrochloride, gabapentin, ibuprofen, estradiol and metformin. On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient was taken by ambulance to the hospital with severe high BP. During her hospital stay the patient's BP readings were 190s/109. The patient was diagnosed with ischemic attack. On 14 Jan 2021, the patient was discharged from the hospital. Her BP readings since then have been 179/85. On 19 Jan 2021, the patient's BP reading was 145/80. Treatment for the event included lisinopril. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, severe high BP and ischemic attack, was considered unknown.; Reporter's Comments: This case concerns a 77-year-old female patient with medical history of diabetes who experienced the serious unlisted events of Hypertension and Transient ischaemic attack that required hospitalization. The events occurred approximately four days after receiving their first of two planned doses of mRNA-1273 (Lot number: 027L20A), Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's elderly age and history of diabetes are considered risk factors for the occurrence of the events.
77 2021-02-04 cerebrovascular accident, stroke unknown if it was moderna or pfizer. Vaccine administered elsewhere so details are not known to me.... Read more
unknown if it was moderna or pfizer. Vaccine administered elsewhere so details are not known to me. Pt received vaccine on Friday and was admitted to hospital Sunday 1/17 with CVA, right sided weakness.
77 2021-02-05 heart rate increased rapid heart beat followed by loss of breath. Couldn't get breath. Slight nausea called the nurse and... Read more
rapid heart beat followed by loss of breath. Couldn't get breath. Slight nausea called the nurse and she called 911. Then started in my intestines with numerous BMs that progressed to diarrhea . Breathing subsided back to normal within a half hour but the intestines continued through the next day.
77 2021-02-06 heart rate increased As outlined earlier
77 2021-02-07 blood glucose increased Patient received second dose of Moderna COVID vaccine on 2/4/21 at 9:00am. Patient took blood sugar ... Read more
Patient received second dose of Moderna COVID vaccine on 2/4/21 at 9:00am. Patient took blood sugar on 2/5/21 at 9:00am and blood sugar was elevated at 219. Patient reports normal blood sugar is around 110. Patient reports having a headache, chills, and muscle aches that night of administration. Patient continued to have a headache 24 hours after vaccine so she took her blood sugar and it was elevated. Client reports taking normal dose of glipuride (1mg) and farxgia to lower blood sugar. Patient retook blood sugar 3.5 hours later, 181. Patient retook blood sugar 4 hours after that and it was 161. Client reports her blood sugar is still currently evaluated and is taking her additional dose of glipuride.
77 2021-02-07 hypertension Extreme fatigue. Hypertension delivery into a rash, continued itching over all the body!
77 2021-02-09 blood pressure increased Elevated Blood Pressure 168/84 ,Low Grade fever 99.3, Chills, and headache
77 2021-02-10 chest pain, heart rate increased I developed on my arm under the injection site a lump the size of a half-dollar. I became dizzy and ... Read more
I developed on my arm under the injection site a lump the size of a half-dollar. I became dizzy and weak. then my back started to hurt. I got a very fast heartbeat. I slept for a long while. I also had chest pain.
77 2021-02-10 pallor After patient was watched for 15 mins she was discharge with her son. Just prior to leaving the buil... Read more
After patient was watched for 15 mins she was discharge with her son. Just prior to leaving the building she became pale, nauseated and started dry heaving. VS remained stable although she appeared tired. 20mg of pepcid given by mouth, 50mg of benadryl and 125mg of solumedrol given IM. Patient was then transferred to the ED via wheel chair for further monitoring and evaluation.
77 2021-02-10 fainting, nosebleed I was sleeping, then woke up and my whole body felt numb. I got up to go to the bathroom and fainte... Read more
I was sleeping, then woke up and my whole body felt numb. I got up to go to the bathroom and fainted. I fell on the floor and got a bloody nose, cut lip and cut and bump on my head. I had stiff neck for a week afterward.
77 2021-02-11 cardiac arrest Developed vomiting, seizure and cardiac arrest, V Fib
77 2021-02-14 chest discomfort Current: COVID arm- small patch around injection site became red on day 8, Feb.11. It is not Feb.15,... Read more
Current: COVID arm- small patch around injection site became red on day 8, Feb.11. It is not Feb.15, and the red itchy patch has grown to 2 1/2 " by 2 1/2". For the first 2-3 days, I had headaches, chills, extreme fatigue and had difficulty breathing. I had chest pressure the first day.
77 2021-02-14 chest pain Pt developed chest pain (EKG shows she is back in AFIB), upper abdominal pain, jaundice (labs pendin... Read more
Pt developed chest pain (EKG shows she is back in AFIB), upper abdominal pain, jaundice (labs pending), and possibly enlarged liver and spleen (feel enlarged on exam, US ordered). Symptoms began about 28 hours after administration.
77 2021-02-14 heart rate increased The evening of the vaccine started with fast heart beat, was unable to get to sleep as her heart was... Read more
The evening of the vaccine started with fast heart beat, was unable to get to sleep as her heart was beating fast and she was breathing fast. She has a sore arm with a slight redness. They lasted over night and then resolved. All these symptoms have resolved.
77 2021-02-15 fast heart rate mild tachycardia
77 2021-02-16 chest discomfort Pt. began to have tightness in the chest and throat. Pt. refused epipen. After further observatio... Read more
Pt. began to have tightness in the chest and throat. Pt. refused epipen. After further observation, I called 911. Outcome unknown
77 2021-02-16 chest pain, chest discomfort Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additi... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Unknown if patient experienced adverse effects 2-13 or 2-14, patient called facility 2-15 reporting body aches and chest pressure and was told by facility to seek medical attention, she passed later that day
77 2021-02-17 nosebleed Date and time of vaccination: (list both if they received both shots): 1-16-21 @ 12:00pm Modern... Read more
Date and time of vaccination: (list both if they received both shots): 1-16-21 @ 12:00pm Moderna LOT # 013620A 2-13-21 @ 12:00pm Moderna LOT # 029K20A Date and time adverse event started: 2/13/21 fatigue, chills, cough with phlegm and a HA, 2-15-21 at approx 0800AM had a slight nose bleed, Tuesday 2/16/21 had a nose bleed along with 1 episode of loose stool, 2/17 2 episodes of loose stool.
77 2021-02-18 fainting Pt. recieved 1st dose of Moderna vaccine on 3 Feb and presented to the ED with syncopy on 4 Feb. Pa... Read more
Pt. recieved 1st dose of Moderna vaccine on 3 Feb and presented to the ED with syncopy on 4 Feb. Patient was discharged on 7 Feb. Home course unknown
77 2021-02-21 blood pressure increased Four days after the 2nd dose, my blood pressure became elevated to 140/80. I went to the Emergency R... Read more
Four days after the 2nd dose, my blood pressure became elevated to 140/80. I went to the Emergency Room where the following tests were performed: BMP, CBC with Differential, Flu/RSV//Covid PCR, Troponin Ohr (initial), Urinalysis reflex Microscopy/Culture, CT HEAD BRAIN WITHOUT CONTRAST. Findings: No evidence of intra- or esttraaxial hemorrhage, mass effect, midline shift, hydrocephalus or acute transcortial infarct, No acute intracranial pathology. Cardiac silhouette and pulmonary vesselas are within normal range. No infiltrate, pleural effusion or pneumothorax. Impression: No acute disease. There were no other event occurences in my life to generate anxiety. Also General muscle
77 2021-02-23 atrial fibrillation Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possibl... Read more
Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possible gout from recent Lasix initiation or reactive arthritis from COVID vaccine received at pharmacy. Admitted to Hospital on 2/23/2021 with diffuse body aches, joint pains, weakness and episode of afib/RVR. Remains hospitalized on 2/24/2021
77 2021-02-23 haemoglobin decreased, oxygen saturation decreased Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standin... Read more
Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standing or walking; Sore arm; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, sore arm, oxygen level at 82 when walking, and hemoglobin went from 8.8 to 8.2. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number:039K20A) for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced soreness in arm immediately after receiving the shot. The soreness resolved few days later. On 29 Jan 2021, Lab work done due to her being anemic and on perpetual oxygen therapy. Her hemoglobin level went down from 8.8 to 8.2 and her oxygen level was 82 on exertion. On 31 Jan 2021, the patient started experiencing shortness of breath. Patient stated that her saturation level was at 82 percent whenever she is standing up or walking and she runs out of breath. When she sits down, the level of the oxygen will go up. She said she is not sure if her medical condition is getting worse or if this is vaccine related Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, shortness of breath, sore arm, oxygen level at 82 percent when walking, and hemoglobin went from 8.8 to 8.2 were unknown.; Reporter's Comments: Based on the information from the source document that the patient is an anemic patient on perpetual oxygen, the events of oxygen saturation decreased, hemoglobin decreased and dyspnea on exertion is assessed as unlikely related to mRNA-1273. The event of pain in extremity is possibly related. Further information has been requested.
77 2021-02-24 atrial fibrillation episodes of atrial fibrillation were triggered after each dose of the vaccine, both times requiring ... Read more
episodes of atrial fibrillation were triggered after each dose of the vaccine, both times requiring cardioversion
77 2021-02-24 chest discomfort, blood pressure increased A 77 year old female who presents with patient states went to see PCP today for six-month labs and w... Read more
A 77 year old female who presents with patient states went to see PCP today for six-month labs and was noted to have elevated BP. Patient's has never been diagnosed with hypertension. She states after going home she got a headache and dizzy since she recheck her blood pressure and noted that it was 190/106. Patient denies any chest pain or shortness of breath and says that her headache is resolved. 2039 BP 145/78, PT FEELS FINE. EXPLAINED TO PT WILL CHECK A SECOND TROPONIN WITH ABNORMAL EKG AND ELEVATED BP. PT VERBALIZED UNDERSTANDING. SECOND TROPONIN NEGATIVE WILL START PT ON ATENOLOL 25 MG DAILY AND DISCHARGE TO FOLLOW UP WITH PCP.
77 2021-02-24 loss of consciousness Passed out; A spontaneous report was received from a consumer concerning a 77-year old female patie... Read more
Passed out; A spontaneous report was received from a consumer concerning a 77-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient passed out. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273. Batch number not provided on an unknown date. On 09 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273: LOT 041L20A. intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, She got up this morning and passed out while standing at the kitchen island for 2-3 minutes. She wants to know if she should be checked out. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
77 2021-02-24 palpitations, heart rate increased On February 15 when I got up I had rapid, pounding heartbeat, felt exhausted, and had panic attacks
77 2021-02-24 lightheadedness vasovagal episode then perfuse sweating, then shaking chills
77 2021-02-25 cerebrovascular accident, fast heart rate, atrial fibrillation, blood clot, heart attack 5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she s... Read more
5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she saw a provider in an office for eval of abdominal pain and diarrhea and sent home. On 02/15/2021 she presented to a local ED with continuing symptoms, transferred to Medical Center. She is currently an inpatient there with a diagnosis of multiple blood clots in abdomen and brain and antiphospholipid syndrome.
77 2021-02-25 chest pain PRURITIS, CHILLS, CHEST PAIN
77 2021-02-25 hypertension, blood pressure fluctuation, palpitations Dizziness, feeling palpitation, cold. BP 172/80 (HR 100). Thirty minutes later, BP 132/71 (pulse 63... Read more
Dizziness, feeling palpitation, cold. BP 172/80 (HR 100). Thirty minutes later, BP 132/71 (pulse 63). Water given.
77 2021-02-25 hypertension struggle breathing and body shakes snd high blood pressure
77 2021-02-25 hypotension Pt received dose #2 Moderna COVID vaccine 2/1/21 @ clinic. 2/4/21 @ 1645 presents to ED for workup... Read more
Pt received dose #2 Moderna COVID vaccine 2/1/21 @ clinic. 2/4/21 @ 1645 presents to ED for workup of hypotension, headache. Also reporting back pain, fatigue, shortness of breath. Given IVF and able to discharge home without escalation of care
77 2021-02-27 cerebral haemorrhage Cerebral hemorrhage acute. Loss of speech. Agitation and confsion.
77 2021-02-27 chest pain, troponin increased, heart attack, low blood oxigenation, cardiac failure congestive The patient had her second Moderna shot on Feb 17, 2021. At 3 am the next morning she reported to th... Read more
The patient had her second Moderna shot on Feb 17, 2021. At 3 am the next morning she reported to the ED c/o being "fluish" and short of breath. She was found to be hypoxic to the upper 80's on RA, and a CXR was consistent with CHF. She stated she had some off and on chest pain for the last few weeks, especially with exertion. Ultimately it was found that she had an elevated troponin and was felt to have had an MI. She underwent cardiac cath and a stent was placed in a 95% ostial right coronary stenosis. Although she was reported as having had a "hyperimmune" response to the vaccine, I can only say for certain she had flash pulmonary edema due to cardiac ischemia that was due to a stenosis in her RCA that had been there for quite some time, but possibly just happened to become critical right after her second COVID vaccine. It would be hard to blame the vaccine, but it is also impossible I guess to absolve it from any role in her MI.
77 2021-02-27 lightheadedness Pt c/o nearsyncope shortly after vaccination. no loc. no vertigo. hx afib that is rate controlled... Read more
Pt c/o nearsyncope shortly after vaccination. no loc. no vertigo. hx afib that is rate controlled w/o meds. sx pr to assessment. BP and blood glucose wnl. HR=75-80 irreg irreg. 12-LEAD: AFIB RATE:78 NO ST/T CHANGES. PT REMAINS ASYMPTOMATIC AFTER 30MIN monitoring. pt and daughter declined transport to hospital for further eval. ems refusal signed
77 2021-02-28 nosebleed 2 days after vaccination I noticed that I had a blood red bruise just under my left eye, close to no... Read more
2 days after vaccination I noticed that I had a blood red bruise just under my left eye, close to nostril; I noticed blood in left nostril on 3rd day, and that evening noticed that I had redness in corner of my left eye with a red spot in very corner, which led me to reporting it here. I have not yet had contact with my doctor, but plan to call him and/or ophthalmologist tomorrow, Monday.
77 2021-02-28 fluid around the heart, cardiac arrhythmia Patient developed sudden SOB 1 week after she received #1 COVID vaccine on 1/28/2021 w/o associated... Read more
Patient developed sudden SOB 1 week after she received #1 COVID vaccine on 1/28/2021 w/o associated chest pain/palpitation/cough. Her SOB was significant enough for her to seek Urgent evaluation on 2/8 then ED evaluation on 2/11 then again on 2/20/2021. she continues to have SOB/DOE even now. She also has dizziness intermittently. she had chills initially but no fever until she had transient fever for less than 12 hours 2.5 weeks later likely associated w/ unrelated problem( UTI). so far no causes found regarding her SOB after numerous tests( see below for tests).
77 2021-02-28 fainting Feeling cold despite warm room and clothing starting about 10 hours after injection. Uncontrollable ... Read more
Feeling cold despite warm room and clothing starting about 10 hours after injection. Uncontrollable shivering starting about 12 hours after injection and lasting an hour, nausea, headache, weakness, passed out when I got out of bed the next morning, exhaustion and diarrhea lasting two days.
77 2021-03-01 chest pain Moderna COVID- 19 Vaccine EUA: Six days after receiving vaccine patient reported tongue and lip swel... Read more
Moderna COVID- 19 Vaccine EUA: Six days after receiving vaccine patient reported tongue and lip swelling starting soon after vaccination. Patient did not take diphenhydramine. During clinic visit seven days after vaccination patient reported chest burning, alternating hot/cold sensation, fever, facial erythema, and sensitivity to smell. No swelling or erythema noted on physical exam: findings include malaise/fatigue, tinnitus, constipation, back pain, nervousness, and insomnia. Vital signs all within normal ranges. Patient discharged home from clinic stable with prescription for hydroxyzine.
77 2021-03-03 blood pressure increased, heart rate increased Shivers, Weak Legs, increased heart rate and blood pressure, fever (103). After 30-45 minutes of get... Read more
Shivers, Weak Legs, increased heart rate and blood pressure, fever (103). After 30-45 minutes of getting vaccinated, patient got reaction, had to call 911 and transferred to urgent care
77 2021-03-03 cerebrovascular accident Massive stroke causing Left hemiplegia
77 2021-03-03 chest pain 2-24 hours post injection - inject site soreness, chills, flu-like symptoms 24-33-symptoms diminishe... Read more
2-24 hours post injection - inject site soreness, chills, flu-like symptoms 24-33-symptoms diminished-only site soreness 40 thru 96 hours - EVENT - repeat of increased site soreness, flu-like symptoms, achiness w/ radiating pain (various locations) esp thorasic muscles
77 2021-03-04 chest discomfort Approximately 10 minutes after second dose injection client experienced weakness in both arms and li... Read more
Approximately 10 minutes after second dose injection client experienced weakness in both arms and light headed in the 30 minute monitoring lot. The EMT on site was summoned to car: B/P 189/86, HR 80, SPo2 100%. Client reported to EMT, tingling hands, and chest pressure. No respiratory symptoms reported. Client was transferred to local hospital to monitor for symptom. No medications were administered in ambulance nor at the hospital ER per client report
77 2021-03-04 heart rate decreased I had no reaction to the first shot , except sore arm for one day. After the 2nd shot, the next day... Read more
I had no reaction to the first shot , except sore arm for one day. After the 2nd shot, the next day I developed a high fever (103) and chills. I called urgent care that evening to see how to bring the fever down. They told me that was my body building antibodies. The fever "broke" later that night. I never have gotten rid of the chills. I did not see a doctor for this reaction. During this time, not exactly sure of the dates, the cardiologist started me on a new medicine - Verapamil. I thought the chills might be from the medicine. She reduced the dosage due to low heart rate, and I'm still taking the medicine. I now have a rash on my side and on my left thigh, which is blotchy, red, and itchy. I do not know if these reactions are from the medicine or from the vaccine, but I suspect it is the Moderna vaccine. The chills are mostly centered in my legs. They are not letting up. I have not seen my doctor about the rash yet. I have had the rash for a couple of weeks, trying to get rid of it myself.
77 2021-03-05 chest pain Moderna COVID-19 Vaccine EUA Freezing cold, headache, arm swollen & hurt, fever, dizzy, Memory loss,... Read more
Moderna COVID-19 Vaccine EUA Freezing cold, headache, arm swollen & hurt, fever, dizzy, Memory loss, chest pain, fatigue. No treatment. These symptoms lasted 4 days. (not all at once)
77 2021-03-05 hypertension Patient used the restroom. After washing her hands and walking without assist, patient stated she fe... Read more
Patient used the restroom. After washing her hands and walking without assist, patient stated she felt like her blood pressure was really high - "like when I had a reaction to another medication." Patient was seated, VS taken Temp 98.3, O2 Sat 96%, patient was encouraged to hydrate given a water bottle. EMT arrived immediately on scene and took over. Vital sign monitored. After few minutes, patient felt better and was discharged with a companion. Patient advised to seek medical consult as needed. VS at departure B/P 120/90, HR 86, O2 Sat 96%.
77 2021-03-07 chest pain Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, f... Read more
Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21; used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.
77 2021-03-07 palpitations, palpitations, heart rate increased, lightheadedness, cardiac arrhythmia lightheadedness/presyncope, palpitations, racing heart, premature ventricular contractions with bige... Read more
lightheadedness/presyncope, palpitations, racing heart, premature ventricular contractions with bigeminy, atrial tachycardia, fever 101, chills, myalgias, arthralgias, headache, right arm pain
77 2021-03-08 chest pain, hypertension High fever of 102, dizziness, headache, pain in left side of jaw, neck , chest. Nausea, weakness, se... Read more
High fever of 102, dizziness, headache, pain in left side of jaw, neck , chest. Nausea, weakness, seizure.,( Never seized before) left eye burning high blood pressure. Symptoms started in bed while asleep 12 hrs after 2 nd vacccine
77 2021-03-10 palpitations Patient was waiting for appoximately 15 minutes past the Moderna COVID-19 vaccine (approx 1715), she... Read more
Patient was waiting for appoximately 15 minutes past the Moderna COVID-19 vaccine (approx 1715), she indicated she was feeling her heart racing and was not feeling so well
77 2021-03-11 heart attack patient status started to decline within a few hours of receiving her covid vaccine she was weak, de... Read more
patient status started to decline within a few hours of receiving her covid vaccine she was weak, developed increased shortness of breath and went to the emergency room were she was diagnosed with STEMI and within 2 days expired.
77 2021-03-13 cerebral haemorrhage Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coheren... Read more
Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm.
77 2021-03-14 heart attack Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte ab... Read more
Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia
77 2021-03-14 cardiac failure congestive, platelet count decreased, haemoglobin decreased "Moderna COVID-19 Vaccine EUA" Hospitalized CHF Exacerbation and abdominal pain, inc... Read more
"Moderna COVID-19 Vaccine EUA" Hospitalized CHF Exacerbation and abdominal pain, increased swelling,
77 2021-03-14 deep vein blood clot, pulmonary embolism Ache in back of left leg. Thought it was a muscle strain from working in yard. Did not go away so ... Read more
Ache in back of left leg. Thought it was a muscle strain from working in yard. Did not go away so went to Clinic February 2nd, 2021. They asked me my symptoms and then sent me for a Sonagram and discovered a DVT and later a Pulmonary Embolism in my right lower lung. I am now on Eliquis.
77 2021-03-15 blood glucose increased 13 min post vaccine pt became unresponsive to verbal and uncomfortable stimuli. Pt slumping in chai... Read more
13 min post vaccine pt became unresponsive to verbal and uncomfortable stimuli. Pt slumping in chair with right side facial drooping . Pt began to respond in approx 3 minutes with confusion and not recalling events of prior 3 min. Pt with max assist placed in wheelchair and paramedics called. RR. Low teens B/P 150/88 Per family pt had same episode yesterday
77 2021-03-15 chest discomfort 2nd Moderna 11:09 c/o "chest rush" & Headache Hx anxiety, depression, HTN, fibromyalgia Meds:Norvase... Read more
2nd Moderna 11:09 c/o "chest rush" & Headache Hx anxiety, depression, HTN, fibromyalgia Meds:Norvase, celebrex, Citalopram,Gabapentin,HCTZ,Lorzapem,Cozaar,K, Prevachol,Zanaflex Assess: denies CP, nausea, vomiting, dizziness. rt deltoid benign. vital signs 11:09 BP190/72,HR 70 reg resp 14 O2 sat 97%. brought pt to recovery area to monitor. 11:13 BP 190/72, HR 69, Resp 12, O2 sat 97%. Med Eval Doctor called to see pt. Continued to monitor pt vital signs. No other complaints of other symptoms 11:25 BP 198/74 HR 80 Pt Primary was called made appt to see pt 3:30. 1 hr recovery. 12 pm bp 184/70, hr pt stated feels fine. Dr ok'd pt to leave advised if any issues arise to go to urgent care or hospital.
77 2021-03-15 loss of consciousness Patient states that she experienced pain in her left arm within hours of the injection; she went to ... Read more
Patient states that she experienced pain in her left arm within hours of the injection; she went to bed that evening with increased arm pain and generalized body aches; patient denies taking any pain meds or any type of treatment for the pain. Patient states she slept well but 'knew her arm was in pain. The morning of 02/23/2021 patient awoke as usual but said she was still in extreme pain and felt her vertigo beginning. She did not take any of her vertigo medication. The last memory she has at home that morning was walking into the bathroom. her next memory was being in a helicopter. Patient reports that when she lost consciousness in the bathroom, she fell and sustained a head trauma. her husband called an ambulance that transported her to Medical Center; she was then air lifted to Hospital. Patient states she spent 10 days in ICU to treat an intracranial bleed. She is now in a rehab facility and expects to be there for 2 weeks before being discharged to home.
77 2021-03-15 pulmonary embolism Patient developed pulmonary embolisms 2 days after receiving the vaccination.
77 2021-03-15 fainting, blood clot in the brain, cerebrovascular accident I had quite an adverse reaction to the second MODERNA vaccine. That afternoon and evening I develop... Read more
I had quite an adverse reaction to the second MODERNA vaccine. That afternoon and evening I developed symptoms. I was experiencing chills, fever, body aches, headache, sore throat, shaking and nausea. As the week went on, my reaction became worse. I was sweating profusely and had shortness of breath accompanied with burning pain on the top of my hands and feet and a rash. On Friday morning, 5 days after the vaccine, I collapsed and had a stroke. I was rushed to hospital and was admitted. It was confirmed that I had a stroke. through a Cat Scan and MRI. On Saturday, I had another stroke. This time I was transferred to hospital. I had a huge blood clot on the left side of my brain which has effected my speech and walking. My entire life has been effected and changed. I had a plethora of tests done, MRI, CAT SCAN, EKG, BLOOD WORK etc. I also have to have speech therapy, physical therapy and occupation therapy. I spent about weeks in the hospital. The doctors think it is a possibility that the 2 Moderna vaccine caused my two strokes. What can be done about this? I will have problems for the rest of my life.
77 2021-03-16 fast heart rate, blood pressure increased Rapid heart beat during night at 109 (resting normally 70). Blood pressure elevated to 180/83. Too... Read more
Rapid heart beat during night at 109 (resting normally 70). Blood pressure elevated to 180/83. Took 2 Tylenol tabs, layed flat with feet elevated. Blood pressure dropped to 144/70 heart beat 91. Blood sugars consistantly over 200 (normally low at night) and within range during the day.
77 2021-03-18 atrial fibrillation A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; ... Read more
A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine. On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. Lab details was not provided by the reporter. Treatment for the events included rubbing gel. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
77 2021-03-18 hypertension, heart rate increased After receiving her second vaccine shot, while in the observation area approximately 20 minutes afte... Read more
After receiving her second vaccine shot, while in the observation area approximately 20 minutes after recieving the shot, patient became light headed and dizzy. Firefighter / EMT assessed vitals and reported that pt had high blood pressure and a rapid pulse. Chief / Paramedic spoke with pt also. Based upon her continued symptoms and no resolution of the dizzy feeling, an ambulance was summoned and pt was moved to a less crowded location for further observation. She walked with assistance to the kitchen in the fire station due to her dizziness. Lt. completed patient assessment while FF gathered vitals. EMS personnel recorded that pt had no medical history, no medications, and was allergic to penicillin. Patient continued to feel cold and light headed. Ambulance arrived and patient care was transferred to the medics. Medics then transported the female to hospital.
77 2021-03-20 loss of consciousness, fainting 2-3 WEEKs after receiving vaccine...pain in right foot (rheumatoid arthritis) sore and weak all ove... Read more
2-3 WEEKs after receiving vaccine...pain in right foot (rheumatoid arthritis) sore and weak all over, tired-lethargic on 3/19- woke up, sat at edge of bed to text daughter, got up walking to bathroom, got dizzy and collapsed = passed out. Got up and again collapsed passed out =don't remember it happening .... Went to ER for fall and analysis as to what , why, etc. I would be having this acute autoimmune reaction... blood work etc. you can contact the LWRM and Dr for details.
77 2021-03-20 fainting 19 days after the first shot I fainted and injured left ankle and bump on left forehead, 13 days af... Read more
19 days after the first shot I fainted and injured left ankle and bump on left forehead, 13 days after the second shot I fainted and injured my left ribs and bump on right forehead . I have not fainted before in 77 years.
77 2021-03-22 blood pressure increased, transient ischaemic attack Painful R Deltoid x 2 days, followed by chills, fever, diarrhea evening of day 3. Malaise day4. T... Read more
Painful R Deltoid x 2 days, followed by chills, fever, diarrhea evening of day 3. Malaise day4. Tight feeling (semi headache) from then on (probably related to Increased BP) culminating in BP of 202/102 and TIA day 10. Taken to ED. CT scan performed-no bleeding. Physicians assumed TIA caused heightened BP. Not so. BP decreasing graduallly, today, day 13 now around 135/80 (still elevated for me). semi-H/A resoluved.
77 2021-03-22 blood pressure increased The day following the 2nd dose of Moderna Covid-19 vaccination extreme pain in the side began, on 3/... Read more
The day following the 2nd dose of Moderna Covid-19 vaccination extreme pain in the side began, on 3/11/2021 patient saw PCP regarding pain nothing was determined however BP was elevated and losartan dose was increased. Hypertensive urgency requiring hospitalization occurred on March 19 2021 clonidine was prescribed to control BP and is being taken to date however BP is still erratic.
77 2021-03-22 cerebrovascular accident 12 days following vaccine, stroke occurred.
77 2021-03-23 blood glucose increased 3/24/21 ER: 77 y.o. female who presents with suprapubic abdominal discomfort. Patient reports a 2 d... Read more
3/24/21 ER: 77 y.o. female who presents with suprapubic abdominal discomfort. Patient reports a 2 day history of increasing cramping and pressure in the suprapubic area. Patient reports she felt this way when she had urinary tract infections. However, patient denies any current urinary frequency, dysuria, hematuria, or urgency. Patient does report some minor dribbling which she states is common for her. Patient denies any fevers but does report an occasional chill. Patient does report pain across her low back. Patient denies any nausea, vomiting, constipation, diarrhea, melena, hematochezia. Patient does have an extensive abdominal surgical history including colon resection, cholecystectomy, appendectomy, and hysterectomy
77 2021-03-23 cerebrovascular accident 2/22/21- Resident began falling multiple time and reporting loss of feeling in her Rt leg. Sent to E... Read more
2/22/21- Resident began falling multiple time and reporting loss of feeling in her Rt leg. Sent to ER. Diagnosis with multiple acute CVA and Rt sided hemiplegia
77 2021-03-23 loss of consciousness, pallor Pt became mostly unconscious/unresponsive for approximately 24 hours after vaccine and very pale. H... Read more
Pt became mostly unconscious/unresponsive for approximately 24 hours after vaccine and very pale. Hospice nurse called to facility. Pt vital signs stable and pt on hospice, so family did not elect to go to hospital. Pt did eventually start arousing the next day but was lethargic . Pt started eating and drinking normally after approximately 2 days.
77 2021-03-24 cerebrovascular accident Symptoms like a stroke; Slurring her words; Became uncoordinated; Not feeling 100%; Very nauseous; L... Read more
Symptoms like a stroke; Slurring her words; Became uncoordinated; Not feeling 100%; Very nauseous; Little headache; Tired for a few days; A spontaneous report was received from a consumer concerning a 77-year-old female patient who experienced slurring her words (dysarthria), became uncoordinated (coordination) abnormal and had symptoms like a stroke (cerebrovascular) accident, felt very nauseous (Nausea) and not feeling 100% (Malaise). The patient's medical history was not provided. Relevant concomitant medications reported included Baby Aspirin and Vitamins NOS for unknown indication. On 10 Mar 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: 048AZIA) intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient began slurring their words, became uncoordinated and had symptoms like a stroke. The patient was also very nauseous and went to the emergency room. The event, symptoms like a stroke was considered medically significant. On, the same day, the patient was discharged. The patient still was not feeling 100% still. No Treatment information were provided. Action taken with mRNA-1273 in response to the event(s) was Not applicable. On an unknown date, the outcome of the event, was slurring their words, became uncoordinated and had symptoms like a stroke, felt very nauseous and not feeling 100% resolved on 11MAR2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-03-24 heart rate increased Extreme dizziness the day after, weakness, fatigue. Symptoms of rapid heartbeat, fatigue and weak... Read more
Extreme dizziness the day after, weakness, fatigue. Symptoms of rapid heartbeat, fatigue and weakness have continued - this is day 15 of the effects. Some days better than others.
77 2021-03-25 palpitations, heart attack Pt explained that she was sleeping and her cat woke her up, she said her heart was pounding and it w... Read more
Pt explained that she was sleeping and her cat woke her up, she said her heart was pounding and it wouldn't stop so she drove herself to the hospital thinking it was an anxiety attack. Upon arrival pt was examined and told it was likely a myocardial infarction and transferred to another hospital for higher level of care per pt.
77 2021-03-30 cerebrovascular accident, chest pain Patient admitted to the hospital with a CVA with right sided weakness and chest pain. Chest pain rad... Read more
Patient admitted to the hospital with a CVA with right sided weakness and chest pain. Chest pain radiated to her right arm and had significant shortness of breath. Symptoms started one week prior to seeking emergency care.
77 2021-03-31 hypertension, heart rate increased High blood pressure spike 186/81; Rapid heart rate; Difficulty breathing; I had a visual aura I saw ... Read more
High blood pressure spike 186/81; Rapid heart rate; Difficulty breathing; I had a visual aura I saw a big red ball with my eyes closed; Arm soreness; trembly; dry mouth; weak; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. The patient's medical history was not provided. Concomitant medications reported were Lotrel 5/10mg for drug use for unknown indication. On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) high blood pressure spike 186 81, rapid heart rate, difficulty breathing, a visual aura I saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), high blood pressure spike 186 81, rapid heart rate, difficulty breathing, i had a visual aura i saw a big red ball with my eyes closed, arm soreness, weak, trembly, dry mouth was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
77 2021-03-31 hypertension 30 MINUTES AFTER THE SHOT MY FACE BECAME NUMB, MY TONGUE BECAME HARD AND THE TOP OF THE TONGUE FELT ... Read more
30 MINUTES AFTER THE SHOT MY FACE BECAME NUMB, MY TONGUE BECAME HARD AND THE TOP OF THE TONGUE FELT LIKE THERE WERE LITTLE SWORDS, MY BREATHNG BECAME A LITTLED LABORED. WHEN I GOT OUR OF MY CAR AND WAS ALKING INTO Y HOME I FELT VERY WEAK. I WAS VERY AFRAID! I CALLED 911, EMT'S DID MY VITALS, BLOOD PRESSURE HIGH, OXYGEN 95 WHICH IS NOT Y NORM(99). AFTER MUCH DISCUSSION THEY WERE WORRIED I WAS HAVING A STROKE, THE AMBULANCE TOOK ME TO THE HOSPITAL. DID CAT SCAN. BLOOD TESTS. WATCHED ME. I WAS THERE ALL DAY. SENT HOME AT ABOUT 5:30PM HOSPITAL.
77 2021-03-31 hypertension extremely high blood pressure; entire body filled with heat during high blood pressure episodes; Sor... Read more
extremely high blood pressure; entire body filled with heat during high blood pressure episodes; Sore arm; itch all over body; feels terrible; can't eat anything but ice chips; Headache; A spontaneous report was received from a consumer concerning a 77-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headache, itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes. The patient's medical history was not provided. No relevant concomitant medications were reported. Additional suspected products included Prolia. On Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number not provided) intramuscularly for prophylaxis of COVID-19 infection. Patient received Prolia injection 2 weeks after 2nd dose of Moderna's COVID-19 vaccination. Patient side effects reported since Prolia injection are itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes. Patient has been hospitalized twice over the past 2 weeks. Treatment for the events included steroids and amlodipine. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcomes of the events were considered not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the Prolia injection received by the patient, which is known to cause these side effects.
77 2021-03-31 low blood oxigenation Patient presented to the ER via ambulance on 3/22/21 with a 5-6 day history of increasing shortness ... Read more
Patient presented to the ER via ambulance on 3/22/21 with a 5-6 day history of increasing shortness of breath. Patient is on home oxygen 2 L prior to admit. Patient hypoxic at home by EMS was 88% on 2L
77 2021-03-31 pulmonary embolism A spontaneous report was received from a consumer who is also the 77-year-old, female patient who re... Read more
A spontaneous report was received from a consumer who is also the 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clots in lung/pulmonary embolism. The patient's medical history was not provided. No concomitant product use was reported. On 10 Feb 2021, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient was admitted to hospital with blood clots in lung. Patient was put on blood thinner. On 26-Feb-2021, the patient was discharged from hospital. Treatment medication included unspecified blood thinners. Action taken with mRNA-1273 was unknown. The outcome of the event, blood clots in lung/pulmonary embolism, was reported as resolved on 26-FEB-2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
77 2021-04-01 cerebrovascular accident As I was driving at 70 mph along the highway 4 days after I had my second dose of the COVID-19 vacci... Read more
As I was driving at 70 mph along the highway 4 days after I had my second dose of the COVID-19 vaccine, suddenly I went blind in my right eye. I was blind in that eye for about 10 minutes. We drove right away to my eye doctor, who sent me to the ER. The hospital is Stroke Certified. They admitted me and did a stroke workup. I was in the hospital for 1 day (24 hours) which included overnight. The treating HCP concluded that I had experienced an ocular stroke. Since it was exactly 4 days after my second dose of the Moderna COVID-19 vaccine, it most likely was caused by that vaccine.
77 2021-04-01 hypertension Vaccinated at 1pm 10minutes post vaccine epigastric tightness & lightheadedness that improved with g... Read more
Vaccinated at 1pm 10minutes post vaccine epigastric tightness & lightheadedness that improved with getting up and walking. Declined ED when encouraged during post vaccination observation. She left the clinic on her own after 30 minutes . She did go to ED at 1435 EKG with normal sinus rhythm, hypertensive, admitted for observation r/t hypertension, oral medication change and discharged to home the next day..
77 2021-04-01 loss of consciousness first shot a month earlier - sore arm, gland swollen in armpit, very cold & headache. 2nd shot - so... Read more
first shot a month earlier - sore arm, gland swollen in armpit, very cold & headache. 2nd shot - sore arm, sore back of neck from headache (muscles seemed frozen for days), really cold from 8pm to 4am with debilitating headache. left side of body was without coordination, hip, knee, ankle didn't work. Went sideways with all joints when walking. 03/18/2021 - passed out in bathroom due to pain. Hit door frame and had large lump on forehead. Bowel mess to clean up. 03/21/2021 - didn't dress, still wobbly stomache upset, neck sore, dizzyness, ate squash and beans. 04/01/2021 - still have stomache upset and though day temperature is over 70 degrees, am very cold, tired as soon as do just one thing. continues
77 2021-04-01 palpitations Awakened @ 1:00 am with heart palpitations and headache. Called nurse hotline and described symptom... Read more
Awakened @ 1:00 am with heart palpitations and headache. Called nurse hotline and described symptoms...nurse asked many questions and advised me to go to emergency room to be evaluated. Emergency room performed ECG, blood work and results were negative for any other problems...also administered Ibuprofen. After Visit Summary was printed @ 8:42 am and I was released from Emergency Room.
77 2021-04-02 blood pressure increased The following started the morning after the shot: Achy, no desire for food, felt like I had a b... Read more
The following started the morning after the shot: Achy, no desire for food, felt like I had a bad case of the flu, very tired and wanted to sleep all the time. The second day was the same, except that my Blood Pressure went up, and remains up. It currently( Day 3) registers at 153/99, with a pulse of 101.
77 2021-04-02 cerebrovascular accident Began having ever increasing visual /ocular migraines with very slight headache after first injectio... Read more
Began having ever increasing visual /ocular migraines with very slight headache after first injection on February 1, 2021. After second injection, March 1, 2021 began having very frequent visual migraines and light headaches and went to emergency room. 7 days later I had an occipital stroke and was hospitalized for several days. I am slowly recovering. Symptoms were only visual but quite severe for a short time.
77 2021-04-05 palpitations, fast heart rate Rapid Heart Beat; Heart rate pounding for hours; Full Body aches; Nausea; Headache; Fever; Chills; A... Read more
Rapid Heart Beat; Heart rate pounding for hours; Full Body aches; Nausea; Headache; Fever; Chills; A spontaneous report was received from other concerning 77-year-old female patient who developed Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever. The patient's medical history included Cardiac issues in 2016 and 2018. Concomitant medication included Motoporal for heart issues. The patient received their first of two planned doses of mRNA-1273 (Batch number:001AZ10 ) on 26/2/2021 Intramuscularly and suppose to have second dose on 26/3/2021, for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient took the shot and experienced fever, chills, full body aches, nausea and headaches. The patient also had very fast heart rate that was pounding for hours, she had the fast heart rate for 24 to 30 hours. The patient also said that she had Covid in Dec 2020 and Jan 2021 for 6 weeks with the same symptoms. The patient was supposed to have her second dose on 26 Mar 2021. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever were resolved on 28 Feb 2021.; Reporter's Comments: This case concerns a 77 Y/O F with a serious unexpected event of tachycardia, and nonserious unexpected palpitations, and expected pyrexia, chills, headache, pain, and nausea. Event onset the same days as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
77 2021-04-05 blood clot Blood clot that caused total vision loss in right eye. It occurred on 04/03/2021. Was treated by oph... Read more
Blood clot that caused total vision loss in right eye. It occurred on 04/03/2021. Was treated by ophthalmologist at eye Center, and at Hospital,
77 2021-04-06 chest discomfort, palpitations 03/30/2021 @ vaccine drive though safe room site-pt received 2nd dose Moderna vaccine in left deltoi... Read more
03/30/2021 @ vaccine drive though safe room site-pt received 2nd dose Moderna vaccine in left deltoid. Approx. 5 minutes after vaccination @ 10:15am, pt reported tightness in throat, chest pressure heart and palpitations. EMT assessed pt obtained v/s -b/p 144/78, P 64 o2sat 96% Pt was observed for 15 minutes after given Benadryl25mg po nurse Pt stated that she felt " a little better" left side. Pt stated she had a history of hypothyroidism and A-Fib
77 2021-04-07 cerebrovascular accident, atrial fibrillation small stroke; heart went to into a-fib; light and dark spots; hurting badly at injection site; This ... Read more
small stroke; heart went to into a-fib; light and dark spots; hurting badly at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation since an unknown date. Concurrent medical conditions included Drug allergy (Eliquis). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ATRIAL FIBRILLATION (heart went to into a-fib) (seriousness criteria hospitalization and medically significant) and VACCINATION SITE PAIN (hurting badly at injection site). On 07-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (small stroke) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (light and dark spots). The patient was hospitalized for 4 days due to ATRIAL FIBRILLATION and CEREBROVASCULAR ACCIDENT. At the time of the report, ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) outcome was unknown, VISUAL IMPAIRMENT (light and dark spots) had resolved and VACCINATION SITE PAIN (hurting badly at injection site) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. This case was linked to US-MODERNATX, INC.-MOD-2021-060976 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-060976:MOD-2021-060528 (Wife case)
77 2021-04-09 loss of consciousness Following the vaccine, my day progressed normally. Started feeling a bit tired and dizzy in the ev... Read more
Following the vaccine, my day progressed normally. Started feeling a bit tired and dizzy in the evening. Next morning, upon rising became very dizzy. Sat in my chair and promptly passed out. Eyes rolled to back of head. Husband could not rouse me for several minutes. Following that experience, became very tired. Returned to bed. Was dizzy, fever of 100.2, headache for a few days. Minor arm pain.
77 2021-04-09 oxygen saturation decreased Owner emailed the following message on 03/23/2021, "Patient was feeling not good after the vaccinati... Read more
Owner emailed the following message on 03/23/2021, "Patient was feeling not good after the vaccinations and we call 911. She refused to go to hospital . Today she did do good and we call 911 and they took her because her oxygen dropped down . As of now she passed away"
77 2021-04-10 hypotension, heart rate increased, atrial fibrillation Patient was seen at healthcare clinic 3/5/21 for complaints of abdominal pain and diarrhea x 1 week,... Read more
Patient was seen at healthcare clinic 3/5/21 for complaints of abdominal pain and diarrhea x 1 week, no fevers. Admitted to the hospital for IV fluids and Zofran. Lab work shows elevated WBC and patient was given x1 dose of Metronidazole IV and discharged to home with appointment to f/u at healthcare clinic 3/6/21. On 3/6/21 patient was not improved and was sent back to hospital for IV fluids. Lab worked showed further elevated WBC, CRP and PCT so CT abdomen was done and found to have inflammation throughout the colonic wall. She is then admitted to for further evaluation and antibiotic treatment. Patient remained afebrile and WBC, CRP and PCT all trended downward. During hospital course she was also treated for hypokalemia due to diarrhea. She was started on Budesonide for colitis and was discharged on 3/11/21. On 3/25/21 patient is again seen at healthcare clinic for N/V/D with dehydration and is sent to hospital for IV fluids. Lab is again elevated and patient improves and is sent home with instructions for f/u at healthcare clinic on 3/26/21. On 3/26/21 patient is then admitted to hospital for N/V/D with dehydration and fatigue with headache. CT again shows pancolitis. On 3/26 patient then experiences A.FIB with RVR and is stable but as the day progresses becomes unstable with elevated heart rate and low BP. Due to patient?s unstable condition she is flown to another hospital for increased level of care.
77 2021-04-11 low blood oxigenation Presented to emergency department with increased fatigue, body aches, fever, chills, and difficulty ... Read more
Presented to emergency department with increased fatigue, body aches, fever, chills, and difficulty breathing and was found to be COVID-19 positive. Was treated with supplemental oxygen and dexamethasone and was discharged. Patient presented to the ED again following low pulse ox readings at home in the high 60s. Patient was found to by hypoxic and was admitted for further management. Patient is still currently admitted.
77 2021-04-12 blood pressure decreased, fainting put on 30 pounds of water weight; Fainted; blood pressure dropped so low that she fainted; Moderna C... Read more
put on 30 pounds of water weight; Fainted; blood pressure dropped so low that she fainted; Moderna COVID-19 Vaccine reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included MACITENTAN for Primary pulmonary hypertension, WARFARIN, TADALAFIL and DILTIAZEM for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction). The patient was hospitalized on sometime in February 2021 due to SYNCOPE. At the time of the report, VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On an unspecified date in Feb-2021, the patient reported that she became very ill and hospitalized for 12 days after receiving the Moderna vaccination. She reported that her blood pressure dropped so low that she fainted. She also had had put on 30 pounds of water weight, which she is trying to get off. She reported that her doctor was aware of the hospitalization. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-04-12 blood pressure increased dizziness and concern for elevated blood pressure reading. This afternoon at around 12:00, the patie... Read more
dizziness and concern for elevated blood pressure reading. This afternoon at around 12:00, the patient received her second dose of the Moderna COVID-19 vaccine at the clinic. She had no apparent complications with her first dose of the COVID vaccine. However, about 10 minutes post second vaccination, she suddenly began to feel dizzy, described as lightheadedness, with associated nausea, all of which were rated a 4/10 in severity. Staff there took her blood pressure, which was noted to be elevated, reportedly at 220/104. EMS was activated, and en route to the ED, the patient was given Zofran by paramedics. Currently the patient no longer has nausea and has not had any vomiting. She does have chills, but no measured fever.
77 2021-04-12 cerebral haemorrhage Within hours patient began studdering, slurring and became unable to form a sentence. She had diffic... Read more
Within hours patient began studdering, slurring and became unable to form a sentence. She had difficulty doing regular tasks such as drive a car., she was tired and went to bed early. The next morning she complained of a headache, pain in her right arm at the insertion site, and could not walk without holding on to walls, speaking was difficult the same as above. She went to the ER by 1 pm where they found that she was having a double brain bleed. With a cat scan with contrast. They send her to a near by hospital with a Neurosurgeon on staff, Medical Center. They administer Vitamin K and Platelets and monitored her. At the first Hospital. She is presently being admitted to a Rehabilitation unit. She continued with difficulty with speaking, difficulty with simple tasks such as using the phone and the nurse reported that she is weaker today than yesterday.
77 2021-04-12 cerebrovascular accident Stroke, nausea, numbness, dizziness, fatigue,
77 2021-04-12 chest pain explosive loose bowel movements with burning anus for two weeks (burning elemenations continue still... Read more
explosive loose bowel movements with burning anus for two weeks (burning elemenations continue still); head ache on top of head - several days; puffy face; Brief Chest pain on 4/4/21 with fatigue following for several hours and balance problems. pain in left plantar fascia and discomfort in right Siatic nerve area and upper thigh 4/13 Cough - productive; patient is mostly recovered from adverse reactions with exception of burning bowel movements
77 2021-04-14 blood glucose increased, low blood oxigenation, oxygen saturation decreased, fast heart rate Patient received the vaccine on 2/8/21. There was a continued gradual weight loss and decrease of a... Read more
Patient received the vaccine on 2/8/21. There was a continued gradual weight loss and decrease of appetite after vaccine. On 3/2, patient had unknown reason for elevated blood sugar of 303. On 3/4, patient had oxygen of 78% on room air, Pulse 127, RR 22, BS 158. Oxygen started. Lethargic, hypoxic, tachycardia. Transfer to hospital. Patient readmitted on 3/12/21 with community acquired pneumonia, bacteria in urine acute kidney injury. Treated with antibiotics and hydration.
77 2021-04-14 low blood oxigenation, fibrin d dimer increased PATIENT PRESENTED TO ER WITH COMPLAINT OF DIARRHEA SIN AM OF 4/14/21. ER WORKUP WAS UNREMARKABLE EXC... Read more
PATIENT PRESENTED TO ER WITH COMPLAINT OF DIARRHEA SIN AM OF 4/14/21. ER WORKUP WAS UNREMARKABLE EXCEPT PT WAS HYPOXIC. HOSPATILIST CONSULTED AND PATIENT WAS ADMITTED FOR OBSERVATION DUE TO HYPOXIA
77 2021-04-15 platelet count decreased FEVER, Wheezing, Shortness of Breath DX Fever, unspecified fever cause R50.9 Pulmonary infiltrate R... Read more
FEVER, Wheezing, Shortness of Breath DX Fever, unspecified fever cause R50.9 Pulmonary infiltrate R91.8 New Prescriptions DOXYCYCLINE HYCLATE (VIBRAMYCIN) 100 MG CAPSULE Take 1 capsule by mouth 2 (two) times daily for 10 days.
77 2021-04-15 blood clot, nosebleed Body aches night of injection. Extreme bloody nose with clots on 3rd day after injection. Swollen an... Read more
Body aches night of injection. Extreme bloody nose with clots on 3rd day after injection. Swollen and very itchy right wrist 3rd day after injection. Was able to stop bloody nose after 1 hour, did not need medical help. Have not experienced a bloody nose in over 50 years so this was quite unusual.
77 2021-04-15 troponin increased, heart failure, fibrin d dimer increased on 4/15 pt. presents to local ED with c/o SOB. Husband poor hx. but reports that pt. was not taking ... Read more
on 4/15 pt. presents to local ED with c/o SOB. Husband poor hx. but reports that pt. was not taking medications as prescribed. Documentation from MD in ED uncertain if pt. taking her amiodarone, torsemide and elquis. Noted to have O2 sats on RA of 81%. Pt. was in respiratory distress upon arrival to ER. Pt. was transferred to higher level of care, another Hospital on 4/15/2021 placed on Bipap.
77 2021-04-16 fainting Morning after injection, I sat down at the breakfast table and said to my husband" I can see you, b... Read more
Morning after injection, I sat down at the breakfast table and said to my husband" I can see you, but everything else out the windows (there is a bank of windows surrounding table) is completely grey....I can't see trees or house next door." The next I knew he was peeling me off the floor after I completely fainted and fell off my chair. No injury other than small bruises and head bump. He got me back to bed and doctor was not needed.
77 2021-04-17 platelet count decreased, low platelet count Patient developed thrombocytopenia with a platelet count of 13,000, found on routine blood test on ... Read more
Patient developed thrombocytopenia with a platelet count of 13,000, found on routine blood test on 3/10/2021. Patient asymptomatic with no bleeding.
77 2021-04-18 ischemic chest pain, cardiac failure congestive, atrial fibrillation, heart rate irregular Congestive heart failure (Stage 2); occasional angina during acitivty; more fatigue; irregular heart... Read more
Congestive heart failure (Stage 2); occasional angina during acitivty; more fatigue; irregular heartbeat after cardioversion; Atrial fibrillation and 2 ER visits, 2 days in a row; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)), ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) and ANGINA PECTORIS (occasional angina during acitivty) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Mercury sensitivity (itching, tearing; reacted once), Shellfish allergy (rash) and Hypertrophic cardiomyopathy. Concomitant products included AMIODARONE from 06-Feb-2021 to an unknown date for Atrial fibrillation, METOPROLOL SUCCINATE (TOPROL XL) and RIVAROXABAN (XARELTO) for an unknown indication. On 05-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) (seriousness criterion medically significant). On 06-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat after cardioversion). On 14-Feb-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ANGINA PECTORIS (occasional angina during acitivty) (seriousness criterion medically significant) and FATIGUE (more fatigue). The patient was hospitalized from 14-Feb-2021 to 16-Feb-2021 due to CARDIAC FAILURE CONGESTIVE. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)) and ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) had resolved and ANGINA PECTORIS (occasional angina during acitivty), HEART RATE IRREGULAR (irregular heartbeat after cardioversion) and FATIGUE (more fatigue) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) to be possibly related. No further causality assessments were provided for CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)), ANGINA PECTORIS (occasional angina during acitivty), HEART RATE IRREGULAR (irregular heartbeat after cardioversion) and FATIGUE (more fatigue). The patient was treated with cardioversion on 06-FEB-2021 and IV Lasix. Very limited information regarding these events has been provided at this time. The CHF was attributed to the use of the amiodarone for aggravated atrial fibrillation. No further follow-up information is expected. This case was linked to MOD-2021-006529 (E2B Linked Report). This case was linked to MOD-2021-006529 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. The CHF was attributed to the use of the amiodarone for aggravated atrial fibrillation. No further follow-up information is expected. MOD-2021-006529:Same patient, 1st dose
77 2021-04-19 atrial fibrillation Patient states that she started having trouble feeling tired, having difficulty concentrating/making... Read more
Patient states that she started having trouble feeling tired, having difficulty concentrating/making decisions, vision problems, and dizziness/lightheadedness after the first vaccine dose on 1/26/21. She was not very clear on timeframe of onset of individual symptoms. She received her second dose on 2/26/21. She was diagnosed with A-fib during the time between her 2 doses. She did not notify pharmacy where vaccine was administered of her suspected side effects until 4/20/21. Patient states she has seen several of her healthcare providers to see if they could find any reason for her to be experiencing these things other than the vaccine but she says they haven't found anything.
77 2021-04-20 stroke, cerebrovascular accident 04/11/21 stroke event --unable to speak and not consistent with actions, CT 04/11/21 L MCA infarct n... Read more
04/11/21 stroke event --unable to speak and not consistent with actions, CT 04/11/21 L MCA infarct no midline shift
77 2021-04-20 cerebrovascular accident The patient's husband stated she woke up after receiving her second dose of the Moderna shot & she ... Read more
The patient's husband stated she woke up after receiving her second dose of the Moderna shot & she couldn't move her fingers on left hand. Also, she says her arm was very weak, She called her doctor which preceded to tell her to go to the hospital. The patient arrived at hospital & was admitted for 2 days. Upon her discharge the doctors told her they believe she had a minor stroke. She starts rehab next week. I tried to reach out to patient several times about retrieving her current medication list but there was no answer.
77 2021-04-20 chest pain, chest discomfort Client started to c/o symptoms approximately 10 minutes after vaccination. She c/o numbness in her ... Read more
Client started to c/o symptoms approximately 10 minutes after vaccination. She c/o numbness in her fingers, feet, and lips. Stated that she had heaviness in her chest and a pain that shot from her chest to her back lasting only a few seconds. She c/o dizziness. Client reported her BS was 140 this AM, B/P was 136/82, pulse regular and steady. EMS called to evaluate the client at 0930. EMS checked her BS which was 324, and her B/P was increasing. Client was transported to the hospital for further evaluation.
77 2021-04-21 low blood oxigenation Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis nee... Read more
Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9.
77 2021-04-21 blood clot Reports she was exhausted and weak for a few days after the shot. on 4/20 she went to the ER to rece... Read more
Reports she was exhausted and weak for a few days after the shot. on 4/20 she went to the ER to receive treatment for a blood clot in her right leg. Reports she had been having trouble with her leg for 5 days before going to the ER. She has started taking Xarelto. She went for treatment. She was not admitted.
77 2021-04-23 blood glucose increased vomiting, B/P- 151/98, P-62, blood sugar- 149
77 2021-04-23 fast heart rate, atrial fibrillation Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrat... Read more
Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, The patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.
77 2021-04-25 cerebrovascular accident Case noted with increasing difficulty walking and writing. Once case noted with difficulty speaking... Read more
Case noted with increasing difficulty walking and writing. Once case noted with difficulty speaking s/o transported to hospital. Hospital dx CVA. Case now resides at LTC permanently.
77 2021-04-28 cardiac failure congestive Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and A... Read more
Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis.
77 2021-05-02 chest pain "Patient reports fatigue, subjective fever, redness in the cheeks, sensitivity to smell and swollen ... Read more
"Patient reports fatigue, subjective fever, redness in the cheeks, sensitivity to smell and swollen lips since pt received the moderna vaccine on 2/11/21. She also states she has burning in the chest. pt feels like she is very hot and then very cold. PCP found patient to be back at baseline now.
77 2021-05-02 coughing up blood March 8th thru March 29 swollen ankle and left calf. Treated by patient with compression socks. Seem... Read more
March 8th thru March 29 swollen ankle and left calf. Treated by patient with compression socks. Seemed to relive swelling April 13th Emergency Room at hospital, after extreme shortness of breath + coughing up blood at home. Admitted to hospital
77 2021-05-03 heart rate decreased Coudn't breath. Called 911. Was taken to hospital. She stayed Hospitalized for 2days.
77 2021-05-04 arrhythmia arrhythmia nervosa; Ankles swollen; Areas on both legs that were bright red/swollen/tender; Areas on... Read more
arrhythmia nervosa; Ankles swollen; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia nervosa) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (arrhythmia nervosa) (seriousness criterion medically significant), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender). At the time of the report, ARRHYTHMIA (arrhythmia nervosa), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender) had not resolved. No concomitant medications provided. Treatment included doxycycline and prednisone. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-05-04 cerebrovascular accident presented to local ED lethargic, disoriented and unable to provide clear history on evening of 5/1/2... Read more
presented to local ED lethargic, disoriented and unable to provide clear history on evening of 5/1/21 with severe frontal headache and increasing lethargy throughout the day. Admitted to hospital with suspected subacute stroke. Overnight developed LT sided weakness and RT gaze. Transferred to another healthcare facility on 5/3/21 with suspected seizure / encephalitis.
77 2021-05-04 hypertension Dizziness, High blood pressure
77 2021-05-05 heart attack, chest discomfort Patient presented to the ED on 3/15/21 and was subsequently hospitalized with NSTEMI. She also prese... Read more
Patient presented to the ED on 3/15/21 and was subsequently hospitalized with NSTEMI. She also presented to the ED on 4/14/21 with chest heaviness.
77 2021-05-06 lightheadedness, chest pain 5/6/21 Presented to ED by EMS with SOB and CP, near syncope, N&V
77 2021-05-07 heart flutter, fast heart rate, palpitations 30 minutes of rapid heart rate and fluttering; shortness of breath; supraventricular tachycardia; Di... Read more
30 minutes of rapid heart rate and fluttering; shortness of breath; supraventricular tachycardia; Dizzy; diaphoretic; Palpitations; Fatigue; nauseous; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), DIZZINESS (Dizzy), HYPERHIDROSIS (diaphoretic), PALPITATIONS (Palpitations), FATIGUE (Fatigue) and NAUSEA (nauseous). On 21-Dec-2020, CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) had resolved. At the time of the report, DYSPNOEA (shortness of breath), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), DIZZINESS (Dizzy), HYPERHIDROSIS (diaphoretic), PALPITATIONS (Palpitations), FATIGUE (Fatigue) and NAUSEA (nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Electrocardiogram: abnormal (abnormal) supraventricular tachycardia. On 21-Dec-2020, Heart rate: increased (High) increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. About 3 hours after receiving vaccine, patient had 30 minutes of rapid heart rate, and fluttering. She laid down, went to sleep, and it resolved. She didn't seek emergency care. Did not have chest pain or shortness of breath. Continued to have palpitations occasionally, fatigue, tachycardia. She presented to primary care professional on 07 Jan 2021 for symptoms and was transferred to for additional cardiac workup and treatment after capturing supraventricular tachycardia (SVT) on electrocardiogram (EKG). Also diaphoretic, dizzy, nauseous, shortness of breath with palpitations. She was given IV metoprolol in ED with conversion to normal sinus rhythm (NSR). They suspect that the vaccine may have been her trigger. She was able to discharge without escalation of care. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-05-07 heart rate irregular, palpitations, palpitations palpitations; irregular heartbeat; light headed; Upon receiving at first I felt weird; felt like my ... Read more
palpitations; irregular heartbeat; light headed; Upon receiving at first I felt weird; felt like my heart was skipping beats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Contrast media allergy and Drug allergy. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ROPINIROLE, ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN CALCIUM (ATORVASTIN), FAMOTIDINE, LORATADINE and PANTOPRAZOLE MAGNESIUM (PANTOPRAX) for an unknown indication. On 04-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization), DIZZINESS (light headed), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats). On 13-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat). The patient was hospitalized on 19-Feb-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (palpitations), HEART RATE IRREGULAR (irregular heartbeat), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats) outcome was unknown and DIZZINESS (light headed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 13-Feb-2021, Heart rate: irregular (abnormal) Irregular. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. About 9 days later she experienced irregular heartbeat. She was seen by a physician and treated with Metoprolol. Upon receiving at first she felt weird, light headed and that night she starting heart palpitations. It felt like her heart was skipping beats. She called doctor and had an electrocardiogram (EKG), and then she went home. The heart palpitations continued to get worse and she went back to doctor and was admitted in the hospital on 19-Feb-2021. She was continually working with her doctor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: added patient contact details (address, email ID, phone number), patient demographics (height, weight, race), added patient's allergies, concomitant drugs and events (palpitation, weird feeling, dizziness, heartbeats skipped); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-05-08 fainting Driving my car on route 50 in morning of the 6th, felt fine after getting up showering and getting r... Read more
Driving my car on route 50 in morning of the 6th, felt fine after getting up showering and getting ready for work. About 10 miles to my destination I felt naueous and completed fainted at the wheel. I then hit a guard rail on the right and I can only assume I pulled the wheel to the left and hit the guard rail there. I was very lucky I did't hit another car or I wasn't hit myself by another car. This road is very busy all the time. I then got myself together and pulled off to a place where I could evaluate my situation. Someone came to my aid as I tried to remove myself from the drivers side door, which was dented in. The called 911 and I was taken to the hospital. The did a number of tests and I was told that I was fine. I have had no re-occurrences and have no history of fainting. I did about 15,000 of damage to my car.
77 2021-05-10 chest pain Sore throat and COVID exposure Pneumonia due to COVID-19 virus Chest pain
77 2021-05-10 nosebleed Foggy brain, dizziness, fatigue, weakness, loss of appetite, depression, nosebleeds. diarrhea, groin... Read more
Foggy brain, dizziness, fatigue, weakness, loss of appetite, depression, nosebleeds. diarrhea, groin pain (left & right), Sciatica (left & right) headaches, head pain,
77 2021-05-11 increased heart rate, blood glucose increased, blood pressure decreased 1020: Patient was complaining of dizziness. When transporting patient to stretcher she was having we... Read more
1020: Patient was complaining of dizziness. When transporting patient to stretcher she was having weakness and shaking. Onsite NP and EMT assessed patient immediately. First BG reading read low, second reading read 29. Patient was immediately given a breakfast bar. Vitals were taken. BP 171/96, HR 116, 02 98%. EKG showed sinus tach. Patient stated she had not eaten this morning and she is a diabetic. Fire rescue was called. 1035: Second set of vitals were taken BG 89, BP 177/96, HR 120, O2 98%. 1045: Fire rescue arrived, assessed patient. BG was 179. Patient refused to be transported to the hospital. 1100:, Patient agreed to no further medical intervention on our end.
77 2021-05-13 chest pain, heart failure right side chest pain and mild heart failure with bilateral pleural effusion and increased SOB- seen... Read more
right side chest pain and mild heart failure with bilateral pleural effusion and increased SOB- seen in hospital ER twice in 24 hours
77 2021-05-13 ejection fraction decreased, fast heart rate (Information gained secondhand from patient's close friend as patient was intubated and sedated at t... Read more
(Information gained secondhand from patient's close friend as patient was intubated and sedated at the time that potential relationship between events and vaccine administration recognized). 77 yo F with no known significant PMH (was independent in ADLs, active, line-danced twice/week) who developed nausea, headache, fatigue on first day after first dose of Moderna vaccine. Friend reports that patient complained of "just not feeling right" following vaccine administration. Complained of poor sleep, poor appetite, dyspepsia and began complaining of lower extremity swelling in the weeks following vaccine administration. Was no longer able to line-dance, etc. Was fatigued. Her friends became concerned and encouraged her to seek medical attention, patient reported that she had was prescribed "water pill" and told to "lay off salt,". Friends later found out that she had lied about doctor's visit and was self-medicating with over the counter "water pills" for all of the water weight she was gaining. Eventually developed worsening shortness of breath. Admitted to hospital on 5/4 with shortness of breath and worsening abdominal pain. Found to have systolic heart failure (EF 20-30%) and was in SVT. Also diagnosed with UTI and SMV thrombus. Grossly anasarcic on exam. Treated for heart failure with diuretic and for her UTI with antibiotics, was started on Heparin drip for SMV thrombus. Underwent left heart catheterization at OSH that was negative for significant CAD. Developed worsening septic shock and was transferred to our hospital for higher level of care. Unfortunately had ongoing decline, found to be fungemic. Eventually succumbed to her septic shock, passed away on 5/14/21. Patient had second dose of vaccine on 3/18/21 according to vaccine card in her purse. Friend states that because of symptoms she developed after first dose of vaccine, she was fearful of getting second dose. Friends insist that she was well before the vaccine---knee pain was limiting factor for her activity level, never shortness of breath. Of note, several friends tested positive for COVID on 2/11/21, the week prior to patient receiving her vaccine. Patient tested negative and reportedly got tested at frequent intervals and was always negative.
77 2021-05-14 chest discomfort, chest pain 05/07/2021 from 12:30 am - 6:30 am experienced painful crushing viselike pressure on left torso area... Read more
05/07/2021 from 12:30 am - 6:30 am experienced painful crushing viselike pressure on left torso area behind left breast down to left waist in front and back lasting for several hours making it impossible to sleep. 0/5/15/2021 from 3:30 am - 6:30 am again experienced this pain but not as crushing making it impossible to sleep. Pain also occurred in right upper arm and shoulder area at that time. Due to uncertain origin of this pain, I am seeing cardiologist and having Left Diagnostic Breast Mammogram and ultrasound on 05/17/2021, followed by Covid Test on 05/19/2021 and Stress Test on 05/21/2021.
77 2021-05-20 fainting multiple syncopal episodes the day after receiving vaccine, resulting in tibial/fibular fracture and... Read more
multiple syncopal episodes the day after receiving vaccine, resulting in tibial/fibular fracture and hospitalization
77 2021-05-23 haemoglobin decreased, low blood platelet count, platelet count decreased Patient reports 3 weeks prior to presentation to our hospital bruising and petechial rash as well as... Read more
Patient reports 3 weeks prior to presentation to our hospital bruising and petechial rash as well as gum bleeding. At time of presentation she was found to have platelets <5K, normal hemoglobin and WBC . Diagnosed with ITP and started on treatment
77 2021-05-25 fainting, haemoglobin decreased, anaemia, low platelet count, low blood pressure Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to ho... Read more
Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to hospitalization 3/17-8/21. Benadryl, loratadine, famotidine, cephalexin for UTI. 2nd Moderna shot 3/27/21. 4/2 Office visit dizzy, weak, headaches, nausea, loss of appetite since 2nd vaccine Na 127. 4/16 Office visit for Headache, neck pain. 4/25 ED visit for dizziness. MRI head NL, labs mild hyponatremia. Given meclizine. 4/27-8 Hospitalization for dizziness, orthostasis, URI symptoms. OC43 Coronavirus, orthostasis. Alb 2.7 Globulin 5. New cervical and axillary Lymph adenopathy. 5/8/21 admitted to hospital w/ new diagnosis of lymphoma (pathologic diagnosis Nodal peripheral T cell lymphoma w/ follicular helper phenotype. Large axillary lymphadenopathy, thrombocytopenia, elevated total protein, acute kidney injury, anemia. 5/15/21 patient passed away from acute hypoxic respiratory failure in the setting of new lymphoma diagnosis.
77 2021-05-26 chest pain Difficulty breathing and pain in the chest.
77 2021-05-29 transient ischaemic attack TIA at home. Taken by ambulance to ER. Had MRI and blood work. Self-resolved in a few hours.
77 2021-05-31 chest pain Client admitted to St Luke's for chest pain, SOB, and aortic stenosis requiring oxygen.
77 2021-05-31 heart rate irregular, increased heart rate, transient ischaemic attack, atrial fibrillation Patient started having stroke like symptoms at approximately 1145am on May 30th. Pt was having dif... Read more
Patient started having stroke like symptoms at approximately 1145am on May 30th. Pt was having difficulty dressing and generalized feeling of being paralyzed for a brief moment or two. Pt was also having trouble getting out her words/thoughts. Pt never had loss of function of her limbs, No weakness, No facial droop, No loss of bowel or bladder control. Once in ER at Hospital, pt was found to have irregular heart rhythm e on EKG (Sinus Tachycardia with possible AFib with rate in the 100's up to 130's) - CT Scan of Head was negative for bleed or acute ischemia. By 8pm the same day the pt had improvement of speech and getting out words/thoughts better and by the next day at 10am sounded back to normal self and still with no other neurological deficits. During that next day we learned that the patient had been to her Primary Care Dr on 5/24/2021 for routine visit when they did an EKG in the office and pt was thought to have an "irregular Heart rhythm" and referred to see a cardiologist. During course of hospital stay the patient was treated with heart rhythm medications and Eliquis for Diagnosis of Afib/TIA.
77 2021-06-01 cerebrovascular accident I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) E87.1 - Hypo-osmolality and ... Read more
I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) E87.1 - Hypo-osmolality and hyponatremia R29.810 - Facial weakness
77 2021-06-14 cerebrovascular accident massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBR... Read more
massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (massive stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient did not have allergies to medications, food, or other products. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
77 2021-06-15 cerebrovascular accident Massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBR... Read more
Massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
77 2021-06-17 chest discomfort 5/23/chest discomfort. Hiked pain going uphill. went to Clinic care. They did ekg -negaitve. Dx me... Read more
5/23/chest discomfort. Hiked pain going uphill. went to Clinic care. They did ekg -negaitve. Dx me as Costa Chondritis and rx prednisone 6 -1st day to 1- 6th day Pain abated somewhat at first by 6th day could not sleep from the pain. Admitted into hospital 5/31 for stress test 5/31. Negative discharged. Returned 6/4 admitted second time in hospital. Placed on iv antbiotics . 5/7 83 cc removed from cardiac sack and 6/6 6oocc removed from left lung sack. Pain abated. all lab tests negative no cause found for this strange event. I am a daily workout person. I do hike and yoga and taichi.
77 2021-06-17 loss of consciousness Fainted; Diarrhoea; Feels weak; bone pain from falling; Vomiting; This spontaneous case was reported... Read more
Fainted; Diarrhoea; Feels weak; bone pain from falling; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fainted) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fainted) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-Mar-2021, LOSS OF CONSCIOUSNESS (Fainted), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting) had resolved. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 was not applicable. Company Comment: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
77 2021-06-19 hypertension I had my 2nd Moderna Vaccine on March 12th approx. 1 day later I started having a headache that cont... Read more
I had my 2nd Moderna Vaccine on March 12th approx. 1 day later I started having a headache that continued to become worse nto realizing it was my blood pressure (BP) running high . On March 19th I took my BP at home & it was
77 2021-06-20 deep vein blood clot Deep Vein Thrombosis (DVT) diagnosed at Hospital
77 2021-06-20 hypertension DIZZINESS, HIGH BLOOD PRESSURE (213/108)
77 2021-06-20 heart attack, oxygen saturation decreased On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleurit... Read more
On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.
77 2021-06-21 nosebleed 2 separate nose bleeds. Patient stated she had to go to the ER during the second nose bleed, because... Read more
2 separate nose bleeds. Patient stated she had to go to the ER during the second nose bleed, because she couldn't get it to stop bleeding after an hour.
77 2021-06-22 atrial fibrillation I developed a rash from my shoulder to my elbow. I had a fever for 24 hours, weakness in the legs, n... Read more
I developed a rash from my shoulder to my elbow. I had a fever for 24 hours, weakness in the legs, nauseated, went into AFIB. Went to hospital.
77 2021-06-28 coughing up blood She was coughing blood clots and I took her to the ER and she was diagnosed with blood clots in her ... Read more
She was coughing blood clots and I took her to the ER and she was diagnosed with blood clots in her lungs.
77 2021-06-29 cerebrovascular accident, cerebral haemorrhage Stroke due to intracerebral hemorrhage Cerebrovascular accident (CVA), unspecified mechanism
77 2021-06-29 ejection fraction decreased Possible myocarditis. Patient experiencing profound non-ischemic cardiomyopathy and acute CHF, witho... Read more
Possible myocarditis. Patient experiencing profound non-ischemic cardiomyopathy and acute CHF, without obvious other cause on preliminary investigation. Sx of fatigue, dyspnea, exercise intolerance, myalgia began 24 hours after vaccination. Myalgias resolved but CHF progressed until Dx 6/29/21. Previously an active runner.
77 2021-06-30 palpitations, loss of consciousness Shortness of breath; loose bowels, cannot eat fiber; Bled a bit; Spasm in Neck; Temperature of 100.3... Read more
Shortness of breath; loose bowels, cannot eat fiber; Bled a bit; Spasm in Neck; Temperature of 100.3; Chills very severe; Headache; Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones; Injection really hurt; Nausea; Knocked out from going up stairs and getting up chair now; Pain in tendons in her arm/ sore arm; Pain in ribs; Pain in all her bones; Rapid heartbeat/Palpitation Continues; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Patient had arthritis attack prior to vaccination.). On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now) (seriousness criterion medically significant), TENDON PAIN (Pain in tendons in her arm/ sore arm), MUSCULOSKELETAL CHEST PAIN (Pain in ribs), BONE PAIN (Pain in all her bones), PALPITATIONS (Rapid heartbeat/Palpitation Continues), VACCINATION SITE HAEMORRHAGE (Bled a bit), PYREXIA (Temperature of 100.3), CHILLS (Chills very severe), HEADACHE (Headache), ARTHRALGIA (Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones) and VACCINATION SITE PAIN (Injection really hurt). 03-Apr-2021, the patient experienced MUSCLE SPASMS (Spasm in Neck) and NAUSEA (Nausea). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). an unknown date, the patient experienced DIARRHOEA (loose bowels, cannot eat fiber). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Headache, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. On 05-Apr-2021, CHILLS (Chills very severe) had resolved. On 25-Apr-2021, TENDON PAIN (Pain in tendons in her arm/ sore arm), MUSCLE SPASMS (Spasm in Neck), PYREXIA (Temperature of 100.3) and NAUSEA (Nausea) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now), MUSCULOSKELETAL CHEST PAIN (Pain in ribs), BONE PAIN (Pain in all her bones), DYSPNOEA (Shortness of breath), VACCINATION SITE HAEMORRHAGE (Bled a bit), HEADACHE (Headache), ARTHRALGIA (Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones) and VACCINATION SITE PAIN (Injection really hurt) outcome was unknown and PALPITATIONS (Rapid heartbeat/Palpitation Continues) and DIARRHOEA (loose bowels, cannot eat fiber) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Body temperature: 100.3 (High) Temperature 100.3 Degree. On 01-Jun-2021, Cardiac monitoring: inconculsive (Inconclusive) Patient Wears a heart monitor.. On 16-Jun-2021, Antibody test: negative (Negative) Patient was reported to have no antibodies at all. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's Date of Birth was reported to be 1944. Chills were reported to be very severe and she could not get warm even with a heater on. Patient was reported to have had a cardiogram done after consultation with physician. No concomitant medications were reported. Patient also reported that she could not eat fiber. Patient still has heart palpitation and wears Heart monitor. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up was received on 17-JUN-2021. Lab data- antibody test was added. Additional event- diarrhea was added.. Event- Loss of consciousness was updated. Case was upgraded to serious- medically significant. Outcome of events- arthralgia, palpitations were updated. On 21-Jun-2021: Secondary reporter information was added. Added medical history Arthritis.Lab data-Cardiac monitoring was added. Added newevents spasm in neck and Nausea. Added stop date for sore arm/pain in tendon in her arm event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-07-02 fainting left knee warmth; left knee swelling; woke up/collapsed after trying to get out of bed; felt fluish;... Read more
left knee warmth; left knee swelling; woke up/collapsed after trying to get out of bed; felt fluish; felt weak/got weaken as day went on; fall; could not walk; joint infection; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (woke up/collapsed after trying to get out of bed), GAIT INABILITY (could not walk), INFLUENZA LIKE ILLNESS (felt fluish), JOINT WARMTH (left knee warmth), JOINT SWELLING (left knee swelling), ASTHENIA (felt weak/got weaken as day went on), FALL (fall) and ARTHRITIS INFECTIVE (joint infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Knee replacement (LEFT) in 2013. Previously administered products included for Hives: Amoxicillin. Past adverse reactions to the above products included Rash with Amoxicillin. Concurrent medical conditions included Tobacco user (30 TO 40 CIGARETTE STICKS A DAY) since 1962, Drug allergy (AMOXICILLIN-RASH AND HIVES), Abstains from alcohol, Diabetes, Blood pressure high, High cholesterol, Water retention and Rheumatoid arthritis. Concomitant products included LISINOPRIL for Blood pressure high, INSULIN GLARGINE (LANTUS) and INSULIN ASPART (NOVOLOG) for Diabetes, SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE for Water retention and Blood pressure high, AMOXICILLIN for an unknown indication. In September 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg. On 10-May-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg. In February 2021, the patient experienced FALL (fall) (seriousness criteria hospitalization and medically significant). On 22-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt fluish) (seriousness criteria hospitalization and medically significant) and ASTHENIA (felt weak/got weaken as day went on) (seriousness criteria hospitalization and medically significant). On 23-Feb-2021, the patient experienced SYNCOPE (woke up/collapsed after trying to get out of bed) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (could not walk) (seriousness criteria hospitalization and medically significant). On 25-Feb-2021, the patient experienced JOINT WARMTH (left knee warmth) (seriousness criteria hospitalization and medically significant) and JOINT SWELLING (left knee swelling) (seriousness criteria hospitalization and medically significant). On 17-Mar-2021, the patient experienced ARTHRITIS INFECTIVE (joint infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Feb-2021 to 25-Feb-2021 due to GAIT INABILITY. The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 1 dosage form. In February 2021, SYNCOPE (woke up/collapsed after trying to get out of bed), JOINT WARMTH (left knee warmth) and FALL (fall) had resolved. In April 2021, GAIT INABILITY (could not walk) and JOINT SWELLING (left knee swelling) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt fluish) had not resolved and ASTHENIA (felt weak/got weaken as day went on) and ARTHRITIS INFECTIVE (joint infection) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Laboratory test: left knee infection (abnormal) Left Knee Infection. On an unknown date, Culture: unspecified (Inconclusive) unspecified. On an unknown date, Laboratory test: showed no stroke (normal) Showed no stroke and unrecalled results (Inconclusive) Unrecalled results. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included un-specified intravenous fluids and unspecified intravenous medications during her hospital stay. Patient stated that On 23 Mar 2021, she had a Left knee replacement surgery due to the infection of the Stryker knee. Laboratory test include fluid sample test which results in Left Knee Infection on 17-mar-2021. Patient stated that her metal knee was replaced with a plastic knee patient went to rehabilitation on 02-apr-2021 and was discharged from rehabilitation care on 16-apr-2021. Patient stated that she was admitted for three days on 23 Feb 2021.On 02 Apr 2021, she was discharged from hospital. It was reported that the patient had a culture test and unspecified laboratory test on an unknown date; results were not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's medical condition and co-administered drugs may be considered as a alternative explanation for the reported events. This case was linked to MOD-2021-234196 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's medical condition and co-administered drugs may be considered as a alternative explanation for the reported events.
77 2021-07-02 fainting Swelling of L knee; infection of the stryker knee/ left kneee replacement surgery; Joint infection; ... Read more
Swelling of L knee; infection of the stryker knee/ left kneee replacement surgery; Joint infection; joint warmth; Orthostatic collapse; weak; Flu-like symptoms; fall; unable to walk; This spontaneous case was reported by a physician and describes the occurrence of ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery), SYNCOPE (Orthostatic collapse), ARTHRITIS INFECTIVE (Joint infection), ASTHENIA (weak), GAIT INABILITY (unable to walk), INFLUENZA LIKE ILLNESS (Flu-like symptoms), JOINT WARMTH (joint warmth), JOINT SWELLING (Swelling of L knee) and FALL (fall) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A2114) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. The patient's past medical history included Knee replacement (left knee replacement.) in 2013. Concurrent medical conditions included Tobacco user (TOBACCO USER:30 TO 40 CIGARETTE STICKS A DAY) since 1962, Allergy to antibiotic (AMOXICILLIN DRUG ALLERGY MANIFESTED BY RASHES/HIVES), Abstains from alcohol, Diabetes, High cholesterol, Water retention and Blood pressure high. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN ASPART (NOVOLOG) for Diabetes, SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE for Hypertension and Water retention. In September 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. On 10-May-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. In February 2021, the patient experienced FALL (fall) (seriousness criterion hospitalization). On 22-Feb-2021, the patient experienced ASTHENIA (weak) (seriousness criterion hospitalization) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) (seriousness criterion hospitalization). On 23-Feb-2021, the patient experienced SYNCOPE (Orthostatic collapse) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (unable to walk) (seriousness criterion hospitalization). On 25-Feb-2021, the patient experienced JOINT WARMTH (joint warmth) (seriousness criterion hospitalization). On 17-Mar-2021, the patient experienced ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery) (seriousness criteria hospitalization and medically significant) and ARTHRITIS INFECTIVE (Joint infection) (seriousness criteria hospitalization and medically significant). On 25-Apr-2021, the patient experienced JOINT SWELLING (Swelling of L knee) (seriousness criterion hospitalization). The patient was hospitalized from 23-Feb-2021 to 25-Feb-2021 due to GAIT INABILITY. The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) at an unspecified dose and frequency. In February 2021, SYNCOPE (Orthostatic collapse), JOINT WARMTH (joint warmth) and FALL (fall) had resolved. In April 2021, GAIT INABILITY (unable to walk) and JOINT SWELLING (Swelling of L knee) had resolved. At the time of the report, ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery), ARTHRITIS INFECTIVE (Joint infection) and ASTHENIA (weak) was resolving and INFLUENZA LIKE ILLNESS (Flu-like symptoms) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body fluid analysis: left knee infection (abnormal) Left Knee Infection. On an unknown date, Laboratory test: showed no stroke (normal) Showed no stroke. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included un-specified intravenous fluids and unspecified intravenous medications during her hospital stay. Patient stated that On 23 Mar 2021, she had a Left knee replacement surgery due to the infection of the Stryker knee. Laboratory test include fluid sample test which results in Left Knee Infection on 17-mar-2021. patient stated that her metal knee was replaced with a plastic knee patient went to rehabilitation on 02-apr-2021 and was discharged from rehabilitation care on 16-apr-2021.Patient stated that She was admitted for three days on 23 Feb 2021.On 02 Apr 2021, she was discharged from hospital. On an unknown date, it was reported that the patient had an unspecified laboratory test; results were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may remain as confounding factors. This case was linked to MOD-2021-234158 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.However, multiple underlying co-morbidities may remain as confounding factors.
77 2021-07-07 platelet count decreased, haemoglobin decreased 7/8/21 0430: Resident sitting on floor in room. Staff assisted back up, resident noted to have fev... Read more
7/8/21 0430: Resident sitting on floor in room. Staff assisted back up, resident noted to have fever of 103 degrees. Shaking movements of extremities, weakness in legs, and confusion noted. Resident sent to local ER. Ct of head showed no acute process, CXR showed no acute process, and urinalysis did not indicate a UTI. Resident returned to facility after about 2 hours in the emergency room. At time of return was coherent and no longer confused.
77 2021-07-08 blood pressure increased, cerebral haemorrhage Approximately April 16 (2 weeks after second shot) Left leg went out from under me unexpectledly. F... Read more
Approximately April 16 (2 weeks after second shot) Left leg went out from under me unexpectledly. Few days later happened again but continued to be weaker and Blood pressure increased to 207/140 while I was out shopping. Drove myself to hospital ER and they admitted me. from 04/26 to 04/29. On 04/29 they did MRI brain scan and determined that I had suffered a right quadron brain bleed which left me left side leg weakness and balance issues. Sent me home on 04/29 and told me see primary Dr. right away.. They ordered in home therapy for a few weeks and in 2 weeks I start outpatient therapy . Since this 3 of my Dr's agreed to have a Heart loop monitor inserted in my chest which I agreed to. Staples come out next week.
77 2021-07-08 fainting, atrial fibrillation, excessive bleeding, platelet count decreased Patient received Moderna COVID-19 vaccine Dose #1 on 3/15 and Dose #2 on 4/12, unsure where patient ... Read more
Patient received Moderna COVID-19 vaccine Dose #1 on 3/15 and Dose #2 on 4/12, unsure where patient received vaccine. Admitted to hospital for syncopal episode at a store on 7/8. The ED provider note does mention that the patient reports increased weakness and fatigue over the last month with heart rates in the 40-50s. She had bleeding head laceration on admission. New Afib noted this admission. Platelets low on admission (9) with no prior CBC's in the chart. Three units of platelets were ordered to be transfused. Low platelets are an incidental finding.
77 2021-07-09 hypertension High blood pressure - it's over 200. I called the doctor and went in- they told me to go to ER at ho... Read more
High blood pressure - it's over 200. I called the doctor and went in- they told me to go to ER at hospital in area. ER gave me a Tylenol and three pills and didn't tell me what they were. He told me at the time that he believed it was caused by the Prolia shot. So they sent me home. It went down that day and I slept but it didn't go back down good, just below 200. But the rest of the week is what going up again. I called the doctor and went in and they told me to go to ER again. The second time, they didn't give me anything and sent me home. Now it's gradually going down. It was 179 over something not too long ago. It went up to 231 in the hospital when they checked it. I had a headache but I thought it was allergies but I'm beginning to think it was from the blood pressure. I have taken medicine for blood pressure but it has stayed medicine but now after the vaccine and the Prolia shot (I had had cancer) it isn't. My arthritis has been feeling worse and now I found out that I have carpal tunnel and I'm going to a doctor for that one. They are a new doctor for that. Yesterday, when I took my blood pressure it was down and I'm not jerking as bad.
77 2021-07-11 cardiac arrest Patient unknowingly received 4 doses of covid vaccine and had a cardiac arrest on 7/12/21
77 2021-07-11 cardiac failure congestive Moderna COVID 19 vaccine EUA Admitted inpatient for CHF exacerbation
77 2021-07-12 loss of consciousness Got out of bed, took 3-4 steps, got very dizzy or passed out. Family member stopped by, found me on... Read more
Got out of bed, took 3-4 steps, got very dizzy or passed out. Family member stopped by, found me on floor, and called 911. Paramedics transported me to the hospital where I remained until 4-03-2021. Many tests, transferred to specialist hospital.
77 2021-07-15 lightheadedness Nine days after receiving first Moderna shot I broke out with rash on injection site. That evening... Read more
Nine days after receiving first Moderna shot I broke out with rash on injection site. That evening I experienced extreme abdominal, back, underarm pain and bloating. It was enough to double over and almost pass out. Pain has continued on still. I called my gastroenterologist a few days after. We had a telehealth call. I?ve had ultrasounds, endoscopys, mris, ct scans, blood work. No diagnosis as yet. I have malnutrition and extreme weight loss.
77 2021-07-17 fast heart rate, hypertension didn't get the second dose; Blood pressure High; Heart beat raised up to 110 bpm; Throat raspy; Thr... Read more
didn't get the second dose; Blood pressure High; Heart beat raised up to 110 bpm; Throat raspy; Throat dry; Knees swollen,knuckles swollen; Knees red, knuckles red, face red; Knees hot, knuckles hot; A little bit of fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure High) (seriousness criterion medically significant), TACHYCARDIA (Heart beat raised up to 110 bpm) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat raspy) (seriousness criterion medically significant), DRY THROAT (Throat dry) (seriousness criterion medically significant), JOINT SWELLING (Knees swollen,knuckles swollen) (seriousness criterion medically significant), ERYTHEMA (Knees red, knuckles red, face red) (seriousness criterion medically significant), FEELING HOT (Knees hot, knuckles hot) (seriousness criterion medically significant), PYREXIA (A little bit of fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't get the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form; ALPRAZOLAM (XANAX) for Adverse event, at a dose of 1 dosage form and AMLODIPINE for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't get the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 210/110 mmhg (High) Blood pressure went up very high. On 04-Feb-2021, Heart rate: 110 bpm (High) Heart beat was raised all day. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Patient went to the Emergency Room and diagnosed for allergic reaction. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
77 2021-07-19 blood glucose increased Elevated liver enzymes and elevated glucose
77 2021-07-27 loss of consciousness Her ALT was 101,JUL2021 her ALT (83); AST was 70,and AST (66) rose again; she has no memory of falli... Read more
Her ALT was 101,JUL2021 her ALT (83); AST was 70,and AST (66) rose again; she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off; she has been having is a backache on her right side above her waist possibly by her kidney; had an unusual need of staying alert and trying not to fall asleep while texting because her texts; unusual need of staying alert and trying not to fall asleep while texting; On 30APR2021, she experienced the shaking again from her hips to her shoulders; it was my body shaking,her body was shaking again at night but not as violently as the1st time.; had an occasion to be awakened at night,the following night, I had an awakening again; tremor; passed out after turning on television; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out after turning on television) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history is provided by the reporter. Concomitant products included Vitamin B, Vitamin C, COLECALCIFEROL (VITAMIN D3), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]) for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out after turning on television) (seriousness criterion medically significant). On 27-Apr-2021, the patient experienced TREMOR (tremor). On 28-Apr-2021, the patient experienced SLEEP DISORDER (had an occasion to be awakened at night,the following night, I had an awakening again). On 29-Apr-2021, the patient experienced TREMOR (it was my body shaking,her body was shaking again at night but not as violently as the1st time.). On 30-Apr-2021, the patient experienced TREMOR (On 30APR2021, she experienced the shaking again from her hips to her shoulders). On an unknown date, the patient experienced ALANINE AMINOTRANSFERASE INCREASED (Her ALT was 101,JUL2021 her ALT (83)), ASPARTATE AMINOTRANSFERASE INCREASED (AST was 70,and AST (66) rose again), MEMORY IMPAIRMENT (she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off), BACK PAIN (she has been having is a backache on her right side above her waist possibly by her kidney), SOMNOLENCE (had an unusual need of staying alert and trying not to fall asleep while texting because her texts) and FEELING ABNORMAL (unusual need of staying alert and trying not to fall asleep while texting). At the time of the report, LOSS OF CONSCIOUSNESS (passed out after turning on television), SLEEP DISORDER (had an occasion to be awakened at night,the following night, I had an awakening again), ALANINE AMINOTRANSFERASE INCREASED (Her ALT was 101,JUL2021 her ALT (83)), ASPARTATE AMINOTRANSFERASE INCREASED (AST was 70,and AST (66) rose again), MEMORY IMPAIRMENT (she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off), BACK PAIN (she has been having is a backache on her right side above her waist possibly by her kidney), SOMNOLENCE (had an unusual need of staying alert and trying not to fall asleep while texting because her texts), FEELING ABNORMAL (unusual need of staying alert and trying not to fall asleep while texting), TREMOR (tremor), TREMOR (it was my body shaking,her body was shaking again at night but not as violently as the1st time.) and TREMOR (On 30APR2021, she experienced the shaking again from her hips to her shoulders) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment drug was provided by the reporter. On 28APR2021, she was able to sleep well through the night. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-262809 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow Up appended. On 22-Jul-2021: non-significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-07-28 excessive bleeding Superficial bleeding left leg; Numbness in l. arm; This spontaneous case was reported by a consumer ... Read more
Superficial bleeding left leg; Numbness in l. arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Superficial bleeding left leg) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis (gradual improvement) since 1996 and Hypertension (stable) since 2018. Concomitant products included METOPROLOL from 2018 to an unknown date for Hypertension, METHOTREXATE from 1996 to an unknown date and HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) from 1996 to an unknown date for Rheumatoid arthritis. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness in l. arm). On 16-Jun-2021, the patient experienced HAEMORRHAGE (Superficial bleeding left leg) (seriousness criterion medically significant). On 05-Jul-2021, HYPOAESTHESIA (Numbness in l. arm) had resolved. At the time of the report, HAEMORRHAGE (Superficial bleeding left leg) had resolved with sequelae. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: elevated (High) Elevated. In 2021, Ultrasound scan: normal (normal) Normal. The patient reported that signs of bleeding were still present .Ten days later bleeding in left leg, area 4 in. x 8 in. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-163325 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
78 2021-01-13 heart rate increased EXTREME LETHERGY, NAUSEA, FATIGUE, WEAKNESS, ELEVATED TEMP, ELEVATED HEARTRATE, SENT TO THE HOSPITAL... Read more
EXTREME LETHERGY, NAUSEA, FATIGUE, WEAKNESS, ELEVATED TEMP, ELEVATED HEARTRATE, SENT TO THE HOSPITAL FOR EVALUATION, FLUIDS ADMINISTERED AND MONITORED, THEN RETURNED TO FACILITY
78 2021-01-14 chest discomfort, blood pressure increased 15 minutes after Moderna COVID vaccine patient experienced dizziness, slight chest tightness, and nu... Read more
15 minutes after Moderna COVID vaccine patient experienced dizziness, slight chest tightness, and numbness to her lower lip. She was given benadryl 25 mg. Her dizziness, chest tightness, and lip numbness resolved. She did have elevated blood pressure reading at 1200 was 130/90 1230 was 180/82 it took 2 hours of resting to get her blood pressure down to 152/82
78 2021-01-17 palpitations Dizziness, vomiting, rapid heartbeat, chills, temperature 96.4
78 2021-01-18 heart rate increased, heart rate decreased, blood pressure fluctuation I DON'T KNOW if this was a reaction to vaccine: I felt "weird" for a few seconds, so I decided to ta... Read more
I DON'T KNOW if this was a reaction to vaccine: I felt "weird" for a few seconds, so I decided to take my blood pressure and heart rate. HR 185, BP 90/57. I continued to monitor and over next 90 minutes my HR went to 165 then 175, back to 165, and my BP got as low as 57/37 and everything in between that low and 90/57. After about 90 minutes both HR and BP stabelized to 112/90. I have never had any heart issues. I have felt fine since then.
78 2021-01-20 chest pain, blood pressure increased Pt. received the COVID 19 vaccine on 1-15-21. On 1-21-2021 the pt. called to report that on the Satu... Read more
Pt. received the COVID 19 vaccine on 1-15-21. On 1-21-2021 the pt. called to report that on the Saturday following her vaccine she had chest pain, pain in her jaw, chills, fever, her BP went up, and grinding of her teeth for just that one day and then it went away.
78 2021-01-20 chest pain, blood pressure increased Pt. received the COVID 19 vaccine on 1-15-21. On 1-21-2021 the pt. called to report that on the Satu... Read more
Pt. received the COVID 19 vaccine on 1-15-21. On 1-21-2021 the pt. called to report that on the Saturday after her vaccine 1-16-21 she had chest pain, chills, fever, her blood pressure went up, jaw pain, and grinding of her teeth that lasted for one day.
78 2021-01-20 palpitations, blood pressure increased PATIENT COMPLAINED OF PALPITATIONS AND SOME DIZZINESS THAT STARTED ABOUT 10MINS AFTER ARRIVING TO OB... Read more
PATIENT COMPLAINED OF PALPITATIONS AND SOME DIZZINESS THAT STARTED ABOUT 10MINS AFTER ARRIVING TO OBSERVATION AREA. NO OTHER SYMPTOMS REPORTED AT THAT TIME . PATENT DID REPORT A HISTORY OF HYPERTENSION. INITIAL BLOOD PRESSURE WAS 178/103, PULSE 68, O2 SAT 97%. PATIENT GIVEN WATER AND DRANK THE ENTIRE BOTTLE. AFTER ABOUT 5 MINS REPORTED THAT PALPITATIONS HAD RESOLVED. BLOOD PRESSURE REMAINED SLIGHTY ELEVATED 166/99, PULSE=67. PATIENT REPORTED THAT SHE RUNS O N THE HIGH SIDE TOWARDS THE AFTERNOON. FINAL BP WAS 170/110. PATIENT REPORTING THAT SHE FEELS WELL ENOUGH TO GO HOME AND WILL FOLLOW UP WITH HER PHYSICIAN AFTER SHE RECHECKS BP AT HOME. PATIENT ESCORTED HOME ACCOMPANIED BY HER SISTER IN LAW.
78 2021-01-24 hypertension pt received the moderna COVID-19 vaccine. Approximately 10 minutes later she experienced dizziness a... Read more
pt received the moderna COVID-19 vaccine. Approximately 10 minutes later she experienced dizziness and lightheadness and weakness. She was evaluated in urgent care, found to have severe hypertension 230/120 (no h/o htn). Hypertension remained present for 2 hours and troponin returned indeterminate. She was transferred to ED for further evaluation and management. See note for details of care.
78 2021-01-25 palpitations patient reports on 1/25/2021 - Within 2 hours after returning home from receiving vaccine she had a ... Read more
patient reports on 1/25/2021 - Within 2 hours after returning home from receiving vaccine she had a severe headache and fever, unknown exact temp, nausea and vomiting. Fever stopped on 1/20/21 per patient. She reports her eyes seemed blurry for several days, like haziness. States she felt like her heart was racing for a few days beginning on 1/18/21. She did have a routine doctors apt on 1/22/21 and her physician completed bloodwork, unsure of labs or results. Her physician said that she should report her symptoms after the vaccine. She also had swelling and redness to her left upper arm all the way down to her elbow area after the vaccine.
78 2021-01-28 blood glucose increased Patient presented with vomiting symptoms, fever, general weakness, high blood sugar, and loss of app... Read more
Patient presented with vomiting symptoms, fever, general weakness, high blood sugar, and loss of appetite. COVID19-IgG and IgM test were ordered and both were positive. PCR testing was also performed, with positive result. Case was consulted with the Infectious Disease clinician, who also recommended treatment with Bamlanivimab. Patient has not shared that he had recently traveled 7 days prior and that her grandchildren had also tested positive for COVID-19.
78 2021-01-31 body temperature decreased The first day felt fine, the next day when she got up in the morning she didn't feel well, but felt ... Read more
The first day felt fine, the next day when she got up in the morning she didn't feel well, but felt well enough to put a roast in the crockpot. Felt then headache, aching in all joints and muscles with achiness. Felt it in her heart, short of breath. The following day felt worse, just wanted to sleep, freezing cold and her temp was low, she could not get warm, and went back to bed and stayed there. She could not eat much, drank water. The following day after that felt a little bit better. She feels about the same she did yesterday, heaviness of her legs especially her knees, weakness and fatigue. Had a pressure like headache in the top of her head and back of her head, right side of her face. The 2nd day the pain was up her neck on the right side, it hurt bad. All her joints are hurting, she does have arthritis. Also having back pain. The 2nd day took Tylenol a couple of days, and took 1/2 pill of Hydrocodone, which causes liver/stomach pain. Not in the pain in the muscles now just a heaviness in her legs and shaky. Called her doctor who did not have much information and informed to call us.
78 2021-02-01 chest discomfort PT STATED " MY CHEST FEELS LIKE ITS GETTING TIGHT AND MY TONGUE FEELS LIKE ITS GETTING THICK"
78 2021-02-01 chest pain shortness of breath, chest pain
78 2021-02-02 atrial fibrillation pt states that after vax she had fatigue and loss of appetite. The next day pt woke up w/ no appeti... Read more
pt states that after vax she had fatigue and loss of appetite. The next day pt woke up w/ no appetite, dizzy, weak and felt like she needed to faint. She was experiencing angina type symptoms w/ short frequent episodes of AFIB. She went to bed and woke up around 11 PM on 1/31/2021 sweating and had a temp of 103. She took extra strength Tylenol and went back to bed. Next morning her temp 101.5. but had returned to normal during the day but had gone back up to 99 later that night. On 2/2/2021 states there was no temp but her arm is swollen, itchy and red with pain. She was able to eat and get hydrated. Pt is still dizzy and light headed at this point. On 2/3/2021 patient woke up feeling some better and able to focus but still has itchy, painful and pink arm that is hot to touch. She is going to call her PCP and Cardiologist today on 2/3/2021.
78 2021-02-02 chest discomfort Pt reported dizziness and was observed coughing and continuing to c/o of SOB. Pt reported chest tig... Read more
Pt reported dizziness and was observed coughing and continuing to c/o of SOB. Pt reported chest tightness and throat tightness.
78 2021-02-03 palpitations Patient complained of headache, lightheadedness and anxiety. Observation awake, alert and anxious. ... Read more
Patient complained of headache, lightheadedness and anxiety. Observation awake, alert and anxious. No wheezing. Initial blood pressure was 190/100 pulse 92 . Lungs clear. After 5 minutes of observation symptoms unchanged. 170/90 pulse 90 . Extra systoles on pulse palpation. Administered 12.5 mgs Benadryl p.o.. No change in symptoms, no further improvement in blood pressure and pulse. Patient remained anxious, lives alone, transported patient to emergency room.
78 2021-02-04 loss of consciousness I did not feel particularly lightheaded or dizzy, but I passed out in my kitchen while preparing bre... Read more
I did not feel particularly lightheaded or dizzy, but I passed out in my kitchen while preparing breakfast at approximately 7:30 AM on the morning following my vaccination
78 2021-02-07 blood pressure decreased, heart rate irregular, heart rate increased It was my heartbeat that was irregular and my pulse was higher than normal (between 92 and 105) and ... Read more
It was my heartbeat that was irregular and my pulse was higher than normal (between 92 and 105) and my blood sugar was running higher than normal (157 one day, then two normal days, 132, 149, then 132 again today). Blood pressure was lower 100/70 (blood pressure is normally 125 over 70).
78 2021-02-07 chest pain Extreme weakness, chills, mild fever, body & joint aches, headache, coughing, one episode of ch... Read more
Extreme weakness, chills, mild fever, body & joint aches, headache, coughing, one episode of chest pain! Trying to recover by resting and staying in. I will be contacting the my doctor, just as soon as I finish this inquiry!
78 2021-02-08 chest discomfort 3 days after the injection I experienced a heavy chest and shortness of breathe on exertion. This ha... Read more
3 days after the injection I experienced a heavy chest and shortness of breathe on exertion. This happened after receiving each shot.
78 2021-02-08 pallor, blood pressure increased Pt experienced dizziness and became pale, blood pressure was found to be elevated to 175/84 @1340. P... Read more
Pt experienced dizziness and became pale, blood pressure was found to be elevated to 175/84 @1340. Previous dose of COVID vaccine had created a similar response but she had just adjusted medications and attributed it to that. In this case she had taken all her medications. Took rx medication for high BP while being monitored but BP increased to 201/104. Her PCP was notified and she took a second dose of her BP medication. By 1500 her BP had improved to 155/89 and she was no longer dizzy. Taken home with instructions to follow up with PCP if symptoms return or worsen.
78 2021-02-10 excessive bleeding Feb 8 states she had a cold. Feb 9 added stomach ache and nausea. Feb 9 visited urgent care facilit... Read more
Feb 8 states she had a cold. Feb 9 added stomach ache and nausea. Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine. Told to go home and rest. Feb 10 at 9:00 am found dead on the floor in pool of blood and aspirated. Excessive blood in toilet, pooled on floor and hallway rug.
78 2021-02-11 chest discomfort SHE EXPERIENCE TIGHTNESS IN HER CHEST AND LIGHTHEADEDNESS 10 MINUTES AFTER VACCINATION. OUR ONSITE E... Read more
SHE EXPERIENCE TIGHTNESS IN HER CHEST AND LIGHTHEADEDNESS 10 MINUTES AFTER VACCINATION. OUR ONSITE EMS WAS REQUESTED. NO VITALS PATIENT REFUSED SAID SHE WAS FEELING BETTER. STATED SHE TOOK HER MEDICATION THIS MORNNG AND DID NOT EAT BREAKFAST BEFORE HAND. PATIENT HAD A B-12 INJECTION 3 DAYS PRIOR TO VACCINE AND FLU VACCINE APPROXIMATLY 2 WEEKS BEFORE. NO RECORD OF FLU VACCINE IN MICR. HER SYPTOMS RESOLVED AND PATIENT WAS RELEASED TO GO HOME.
78 2021-02-11 heart rate increased TINGLING IN TONGUE & GUMS ADVANCED TO BURNING & NUMBNESS- TONGUE FEELING OF THICKNESS WITH RAPID HEA... Read more
TINGLING IN TONGUE & GUMS ADVANCED TO BURNING & NUMBNESS- TONGUE FEELING OF THICKNESS WITH RAPID HEART RATE. TREATED WITH BENADRYL & PREDNISONE 20MG 1 DAILY FOR 5 DAYS STILL FEEL AFFECTS 02/05/2021
78 2021-02-11 palpitations, atrial fibrillation My heart started racing and then I went into a fib until Sunday February 7. No other reactions.
78 2021-02-11 palpitations, chest pain Dizziness/lightheaded Palpitations Mild chest pain
78 2021-02-11 fast heart rate, pulmonary embolism, pallor, haemoglobin decreased HISTORY OF PRESENT ILLNESS: Pleasant 78-year-old female with history of lung cancer with remote part... Read more
HISTORY OF PRESENT ILLNESS: Pleasant 78-year-old female with history of lung cancer with remote partial pneumonectomy, some element of COPD and chronic respiratory failure on home oxygen therapy. She presents with worsening shortness of breath, which started rather abruptly the day prior to presentation. On arrival to the ED she was mildly tachypneic and slightly tachycardic and appeared to be in mild respiratory distress. Her O2 had been titrated to 4 L/m nasal cannula in order to sustain SaO2 values in the 90% or above range. Patient also noted to have pallor. No hematemesis, melena, hematochezia, abdominal pain, fever, cough or known exposure to COVID. Patient reports having received her first COVID vaccination just over one 1 week ago. A hypochromic microcytic anemia, progressive, was noted with a hemoglobin of 7.4 g/dL. Patient reported that she was up-to-date on EGD and colonoscopy within the past year without findings of acute pathology or bleeding. A CTA of the chest was conducted with findings of bilateral pulmonary emboli. She denies lower extremity swelling, pain or tenderness. Patient placed in observation in order to provide palliative blood replacement therapy and commence with anticoagulation for venous thromboembolism. DISCHARGE SUMMARY/OBSERVATION COURSE: Uneventful observation course for this pleasant 78-year-old female who presented with somewhat sudden worsening of her chronic shortness of breath and was found to have CTA evidence of bilateral pulmonary emboli. This in the setting of a progressive iron deficiency anemia without evidence of active clinical gastrointestinal bleeding. The patient received 2 units of packed red blood cells in a palliative fashion for her presenting hemoglobin of 7.4 g/dL. Posttransfusion hemoglobin was 10.1 g/dL. Concurrently, she was placed on weight-based low molecular weight heparin for full anticoagulation. I examined the patient on the morning of February 12 and found her to be nondistressed. Her SaO2 value was 96% on 4 L/m nasal cannula O2. Recall that her baseline flow rate historically had been 2 L/m his cannula. Etiology of the patient's thromboembolism uncertain. She had no clinical findings of unilateral or bilateral lower extremity swelling or tenderness. Patient noted to be a survivor of both breast and lung cancers but without known evidence of active persistent malignancy. Of interest, she had received a COVID-19 vaccine just over one week prior to presentation. I contacted pharmacy in this regard and encouraged him to report possible adverse event via VAERS. I recommended a course of rivaroxaban and provided a prescription with a VTE dosing schedule. Patient was advised to followup with Dr in 10 days. M.D., Hospital Medicine MD Feb 12, 2021 08:40
78 2021-02-14 chest discomfort Patient received Moderna COVID 19 vaccine EUA. Patient reported to nurse that she was "feeling weird... Read more
Patient received Moderna COVID 19 vaccine EUA. Patient reported to nurse that she was "feeling weird" along with chest tightness at 10:30 am. Patient placed on non-rebreather and oxygen a 100% wide open. Vitals taken every minutes. EMS called at 10:36 am. Patient declined EMS. Patient monitored for one hours. Patient left clinic with her daughter.
78 2021-02-14 loss of consciousness 30 Hours after the shot without any warning or ill effects, I suddenly collapsed from my chair at th... Read more
30 Hours after the shot without any warning or ill effects, I suddenly collapsed from my chair at the dining room table. Fell on the floor unconscious and ended up in the Emergency room with a broken nose ,concussion, and no memory of the episode. Hospital did a CAT scan which did not show indication of a stroke but did verify concussion and broken nose. Later saw personal physician and heart monitor was placed on my body, and echo cardiogram scheduled. Echo cardiogram did not indicate any blockage. Results from heart monitor not available at this time. I am a perfectly healthy individual - walk 3-4 miles every day, swim, play golf, eat a keto diet and have never had an episode like this. An hour before it oc Apple watch 6 texted a message that read: "are you okay or should we call 911". I was perfectly fine and just thought the message was a fluke - replied I am fine. An hour later the episode occured. I am not used to taking vaccines - no flu shots, no shingles shots - only keep up my tetanus. The only vaccine I have had recently was in 2009 - yellow fever shot so I could travel to. I have never had a reaction like the one after the Moderna vaccine.
78 2021-02-15 body temperature decreased extreme temperature drop; extreme fatigue; headache; joint pain; right side of face and ear painful;... Read more
extreme temperature drop; extreme fatigue; headache; joint pain; right side of face and ear painful; Next day - drenched, trouble controlling temperature, headache & joint pain and nausea
78 2021-02-15 fainting, chest discomfort Day after injection-Chills, headache, nausea, body aches, diarrhea, dizziness, fainting, temperature... Read more
Day after injection-Chills, headache, nausea, body aches, diarrhea, dizziness, fainting, temperature. 2nd - 3rd day- headache, fatigue, slight temperature, tightness in chest
78 2021-02-16 heart rate increased I had my first dose on 1/11 I had dizziness and rapid heartbeat and light Flu-like symptoms On2/8 I... Read more
I had my first dose on 1/11 I had dizziness and rapid heartbeat and light Flu-like symptoms On2/8 I had my second dose and the injection site got very sore. I experienced flu like symptoms of achiness, fever, chills. I also had diarrhea and I felt like my intestines were on fire. my arm turned red and was incredibly itchy
78 2021-02-16 pallor Dizzy, seeing white, world disappears, feel faint, broke out into sweat, face is ghostly white. Epis... Read more
Dizzy, seeing white, world disappears, feel faint, broke out into sweat, face is ghostly white. Episode lasted about 10 to 15 minutes. Went to bed, slept, This happened at 2pm on February 1. Felt all right after sleeping. Talked with my doctor on Feb. 2 and started taking electrolytes. Have been okay.
78 2021-02-17 hypertension I had Soreness on the arm the same day of vaccination, redness, achy in the muscle area on my arm. I... Read more
I had Soreness on the arm the same day of vaccination, redness, achy in the muscle area on my arm. I think the injection was administrated to high in my arm. The within the next 24-48 hours I had a headache and was tired. About the 4th-5th day I had tingling, prickly feeling across right shoulder, down both arms down to my fingers and down my legs down to my toes. This lasted about 5-10 minutes. Then on the 16th it happened again but this time it was my whole body the torso area and my limbs. I also had weakness, I felt like I needed to hold onto to someone to be able to stand. I had an unstable feeling while standing. The headache has occurred on and off since time of vaccination about 4-5 times. I went doctor on Tuesday 2/16/2021, I did not see my doctor this time I see a different it was a lady doctor. She wasn't aware of this being one of the side effects and just to monitor myself and return if the symptoms worsen. She thought it was safe to get the 2nd dose. I have a virtual visit scheduled with Dr. on 2/23/2023
78 2021-02-17 bleeding on surface of brain ON 2/14/21 PATIENT WAS FOUND BY FAMILY CONFUSED, DIAPHORETIC, VOMITING, TAKEN TO E.D, CT SCAN REVEAL... Read more
ON 2/14/21 PATIENT WAS FOUND BY FAMILY CONFUSED, DIAPHORETIC, VOMITING, TAKEN TO E.D, CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE, PT INTUBATED IN ICU PER DAUGHTER FOUND have 2 ANEURYSMS.
78 2021-02-18 blood pressure increased Pt began to complain of feeling dizzy. Initial BP was 130/80. Pt then began to complain of double vi... Read more
Pt began to complain of feeling dizzy. Initial BP was 130/80. Pt then began to complain of double vision and her head feeling "tight". BP at that time was 160/77. EMS called due to increasing BP, double vision and headache. BP when EMS arrived was systolic BP of 180. Pt also complained of nausea. EMS did not transport patient to ED per daughters request to wait at clinic under observation for 30 min in the quiet and then will go home. Pt observed for 30 min and all symptoms resolved within 30 min. Pt taken home by private care.
78 2021-02-20 transient ischaemic attack Massive headache for 24 hours following the 2nd dose Mini stroke (TIA)
78 2021-02-20 troponin increased, heart attack was given maternal vaccine, developed acute heart failure, and NSTEMI then next day
78 2021-02-21 heart rate irregular, palpitations Approximately 10 minutes after receiving the Moderna vaccine patient started complaining of heart ra... Read more
Approximately 10 minutes after receiving the Moderna vaccine patient started complaining of heart racing. After assessing the patient her heart rate was 117 and irregular, her bp was 172/100. We advised the patient to go to the emergency room for evaluation, she refused transport by ambulance but agreed for her friend to bring her.
78 2021-02-23 blood pressure increased, heart rate increased Had increased heart beat on the second day and elevated blood pressure for three days following gett... Read more
Had increased heart beat on the second day and elevated blood pressure for three days following getting the shot
78 2021-02-23 chest pain 15 minutes after vaccination, Patient complained of non-radiating chest pain and "stomach discomfo... Read more
15 minutes after vaccination, Patient complained of non-radiating chest pain and "stomach discomfort." States chest pain 3-4 out of 10. Vital signs stable. Denies nausea or pain in other areas. States "a little" short of breath. Unable to determine pulse ox related to client nail polish. 911 was called, paramedics recommended client go for hospital evaluation, client refused. Client walked out with her husband. She was encouraged multiple times to go for evaluation, and to call her doctor to report symptoms.
78 2021-02-25 cardiac failure congestive, troponin increased, oxygen saturation decreased Admitted to hospital for acute on chronic respiratory failure following covid vaccination. (patient... Read more
Admitted to hospital for acute on chronic respiratory failure following covid vaccination. (patient significantly fatigued, slept most of the day after vaccine, not on BIPAP as needed) HISTORY OF PRESENT ILLNESS: patient is a 78 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease, obstructive sleep apnea, and persistent atrial fibrillation who presents today with general malaise. She received her 2nd COVID-19 vaccination yesterday and complained of fatigue, body aches, and general malaise all day. Later in the evening she noticed that her blood oxygen level was low. She denies having any more shortness of breath abnormal. She has had no vomiting, headache, or chest pain. On arrival she was noted to be febrile and required 6 L supplemental oxygen via nasal cannula. She usually uses 2 L nasal cannula at baseline, occasionally increasing it to 3 or 4 with exertion. She also had elevated troponin levels and noted leukocytosis. There was radiographic evidence of congestive heart failure. On exam, she is tired and wants to go to sleep. She is still requiring 4 L of oxygen via nasal cannula. Her daughter is at bedside. Plans are discussed for admission and she is agreeable. ASSESSMENT / PLAN: * Acute on chronic hypoxemic respiratory failure (HCC) Assessment & Plan Admit to medicine- hypoxic requiring 6 L nasal cannula, utilizes 2 L nasal cannula baseline Hypoxia appears to be secondary to robust immune response to COVID-19 vaccination Increased hypoxia, fever, leukocytosis, elevated troponin, radiographic evidence of congestive heart failure Will repeat troponin level in the morning, daily chemistry and blood count, will treat congestive heart failure as below CHF (congestive heart failure) (HCC) Assessment & Plan Transesophageal echocardiogram from October 2020 noted preserved left ejection fraction, and had no evidence for diastolic dysfunction Radiographic evidence of congestive heart failure, normal BNP, elevated troponin with an increase of 18 at the 2 hour mark, will recheck in the morning As this is her 2nd hospitalization since that echo with hypoxia and concern for CHF, will obtain repeat echocardiogram Received 80 mg IV Lasix in the emergency department, will continue 40 mg IV Lasix 2 times a day Daily weights, 2 L fluid restriction Patient was admitted with acute on chronic hypoxic respiratory failure. I think this is due to acute on chronic diastolic congestive heart failure that was brought on after she was sleeping most of the day without her BiPAP. She says she got her COVID-19 booster shot and felt so tired she slept all day. She did not think she needed her BiPAP during the day even if she was sleeping. She has not had a recent sleep study. Patient is diuresing and will likely be able to discharge tomorrow.
78 2021-02-25 cerebrovascular accident The medical facility did not treat patient as her primary care, but were informed that she passed aw... Read more
The medical facility did not treat patient as her primary care, but were informed that she passed away on 15 February 2021 of a stroke. I do not have further information on the medical aspect of this as we were not her treating provider but did administer the vaccine on 12 February.
78 2021-02-25 hypertension, chest pain in the middle of the night my toes turned beat red/purplish color and numb and cold started to form ... Read more
in the middle of the night my toes turned beat red/purplish color and numb and cold started to form blisters took almost a week to get over it still have rough spots where the blisters were. Went to the dr. took my blood pressure and it was high. went for several test at the Cardiologist my blood pressure was still high and i was also having some discomfort and chest pain
78 2021-02-26 blood pressure increased 10 minutes after injection sudden increase in bp to 17 8/90, swelling of tongue and nasal passages, ... Read more
10 minutes after injection sudden increase in bp to 17 8/90, swelling of tongue and nasal passages, fever 3 degrees higher.
78 2021-02-26 fluid around the heart, inflammation of the pericardium The patient developed back pain one month after the first injection on February 24 she was diagnosed... Read more
The patient developed back pain one month after the first injection on February 24 she was diagnosed with pericardial effusion?s and 750 mL was drained from the pericardium. The work up is on going but it seems to be Pericarditis which occurred after the vaccination
78 2021-02-28 blood pressure increased Patient started to feel flush in the face. She also reported a headache. She was seen by the EMS on... Read more
Patient started to feel flush in the face. She also reported a headache. She was seen by the EMS on the premises today and they obtained vital signs. Patient had elevated blood pressure but reports this is normal. After being evaluated for 30 minutes her blood pressure did improve and she reports feeling better. Nurse assisted patient to the car. Patient ambulated well to her car with no symptoms noted of change.
78 2021-03-03 blood pressure decreased When I got the vaccine it hurt so much that I jumped. It felt like it burned for like 3min. The next... Read more
When I got the vaccine it hurt so much that I jumped. It felt like it burned for like 3min. The next day I had shortness of breath & I fainted the next thing I seen when I woke up was the paramedics taking me in to the ambulance to do an EKG. Everything was good except my blood pressure dropped. I was not taken to the hospital.
78 2021-03-03 hypotension, platelet count decreased Pt had received dose 1 of COVID vaccine on 12/22/20. On 01/01/21 pt presented to the emergency depa... Read more
Pt had received dose 1 of COVID vaccine on 12/22/20. On 01/01/21 pt presented to the emergency department for intractable nausea, vomiting, cough, and non bloody diarrhea. Pt had tested positive for COVID 19 on 12/30/2020. Pt was spiking high fevers and was hypotensive. Pt was admitted to the hospital from 1/01-1/06 and treated with dexamethasone, remdesivir, and convalescent plasma.
78 2021-03-03 pallor right after receiving covid vaccine-19 second dose , pt started having audible wheezes, can only spe... Read more
right after receiving covid vaccine-19 second dose , pt started having audible wheezes, can only speak 1-2 sentences, grasping for air, cold clammy perspiration, pale. Pt states she has asthma and wheezing before she came in but worse after the covid vaccine dose. pt vital signs taken . Pt restless and asking for an injection to help her breath, Sats 96% RA. Pt had 2 puffs of albuterol and with slight relief. Pt was taken to Urgent care in stable condition ( same building) for an evaluation.
78 2021-03-03 palpitations After 2 days pt experienced difficulty of breathing, dizziness, coughing, racing heart, palpitation,... Read more
After 2 days pt experienced difficulty of breathing, dizziness, coughing, racing heart, palpitation, has a pacemaker, headache, was treated with Prednisone tablets
78 2021-03-04 fast heart rate Patient had COVID-19 with pneumonia at the end of December 2020 and recovered. Received vaccine in ... Read more
Patient had COVID-19 with pneumonia at the end of December 2020 and recovered. Received vaccine in mid February and 2nd dose of vaccine on March 3rd. Presented to the emergency department on the night of March 4th from correctional facility where she is incarcerated because of fever over 103 and lethargy/confusion and tachycardia of 115.
78 2021-03-05 heart rate increased, blood pressure decreased Dizziness; initial BP 186/89 (pulse 50). F/u BP 178/64 (pulse 54).
78 2021-03-07 haemoglobin decreased, troponin increased 2/3/21 ER to Hospital admit for global weakness.
78 2021-03-08 chest pain, chest discomfort Patient states two hours post vaccination, she had chest pain, describes "pushing or sitting on my c... Read more
Patient states two hours post vaccination, she had chest pain, describes "pushing or sitting on my chest" for approximately 30 to 40 minutes subsiding slowly. Then, fell "instantly asleep" for two hours. States abnormal for her. PCP notified.
78 2021-03-09 pulmonary embolism, deep vein blood clot, nosebleed, fainting Called nurse line 4 days after 2nd Moderna vaccine, SOB, fainting, can't eat, dry cough, nose bleeds... Read more
Called nurse line 4 days after 2nd Moderna vaccine, SOB, fainting, can't eat, dry cough, nose bleeds since shot. Advised to go to ED, patient refused as she feels a bit better today. Called again the following day with same symptoms - again advised to go to ED and quarantine for flu/covid-like symptoms. Patient agreed to come to ED, found to have bilateral PEs and RLE DVTs. Covid/flu negative. LUE red/swollen at injection site - no cellulitis. Admitted overnight and d/c'd home the following day.
78 2021-03-10 cerebral haemorrhage, excessive bleeding, loss of consciousness fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT sca... Read more
fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.
78 2021-03-11 heart rate increased 3/4 very sore arm. 3/6 arm soreness gone. 3/7 at 2:30am awoke with rapid heart rate. Continued to mi... Read more
3/4 very sore arm. 3/6 arm soreness gone. 3/7 at 2:30am awoke with rapid heart rate. Continued to mid morning and developed chills, fatigue, slight fever, no appetite. By days end felt much better. However the very next day 3/8 woke up feeling fine but by days end lower abdomen painful. Pain continued into 3/9. I called my family Dr and went over systems on phone. Diagnoses, bout of Diverticulitis. Which I have had before. The times before required antibiotic etal, not this time. I writing this today 3/12 to say feeling much better. I?m on a light diet and this seems to have helped this time.
78 2021-03-13 atrial fibrillation, heart rate irregular, heart rate increased 2 days later, at night, I began an episode of rapid and irregular heartbeats. I was taken to hospit... Read more
2 days later, at night, I began an episode of rapid and irregular heartbeats. I was taken to hospital where atrial; fibrillation was diagnosed, After about 12 hours it converted to regular sinus rhythm. I was kept under observation for another 24 hours and then released. I have had several episodes since then.
78 2021-03-13 fainting Didn't feel well around 4:45 p.m. Laid down to rest, went to bed early. The next morning I was di... Read more
Didn't feel well around 4:45 p.m. Laid down to rest, went to bed early. The next morning I was dizzy didn't do much. Late afternoon I decided to go out and get my mail. Reached down to pick up a solar light on the ground and just went face down in an icy snowdrift. A neighbor came to my rescue the police and fire came, eventually I went by ambulance to the hospital to be examined.
78 2021-03-13 fainting Patient fainted 1 hour and 15 minutes after receiving 2nd Moderna vaccine. Paramedics were called b... Read more
Patient fainted 1 hour and 15 minutes after receiving 2nd Moderna vaccine. Paramedics were called but patient felt well enough to go home instead of going to the hospital.
78 2021-03-14 fibrin d dimer increased, hypertension Admitted to hospital 3/13 with encephalopathy for monitoring. Discharged 3/14. At the beginning of... Read more
Admitted to hospital 3/13 with encephalopathy for monitoring. Discharged 3/14. At the beginning of ED visit, Patient did not know her daughter's name. She was unable to lift her legs at home when daughter tried to help patient to dress. At ED patient was given Tylenol and fluid. Patient now recognizes her daughter and was able to get up to the bathroom with only minor assistance. During encounter, patient is awake and able to follow directions. Patient is not oriented to time, though she know she is in the hospital. Patient states that she had COVID this morning and that is the reason why she was in the hospital. Daughter at bedside helped history. Patient received 2nd Moderna COVID 19 vaccination yesterday. Daughter called but patient did not respond at noon. daughter went over to see the patient. Patient could not finish the sentence to questions. Patient could not get her dressed up by herself. Patient went to bathroom for urination but she wiped the toilet, and folded the towel. But she did not do what she was there for. Also she could not life her legs to get helped to get dressed to come to the hospital. Now patient is able to shuffle to the toilet. Now she is able to answer her name and birthday. But still patient looks confused and not her baseline. Patient has difficulty remembering her medications. Patient does remember her children's name and home address. Patient lives alone at home and daughter wishes patient to be monitored as she has not recovered completely. Hospital Course/Treatment Rendered 78/F, CC : altered mental status PMHx Endometrioid adenocarcinoma stage IA, grade 2, status post hysterectomy and BSO on 04/06/2015. Diabetes type 2. HTN. HLD. Altered mental status, Encephalopathy, metabolic, likely related to COVID 19 vaccination. Neuro status as well as hemodynamics been monitored. Fall precaution. PT/OT was consulted for home safety evaluation as patient lives alone. Neurology, Dr. was consulted. Patient refused lumber puncture in ED. CT chest - no pneumonia or Pulmonary embolism. UA - ketone positive and dehydrated but no UTI. In the morning of 3/14/2021, patient has improved and mental status back to baseline. PT deemed patient able to go home safe. Uncontrolled hypertension at ED. Gentle hydration as patient has dehydration(urine specific gravity 1.026) and continue antihypertensives such as losartan. SBP 145-165mmHg, Asymptomatic. Will continue home medication. High D-dimer. CTA chest - excluded DVT. Venous duplex US of Both Lower extremity in AM done and no evidence of DVT. Type 2 Diabetes Mellitus. continue to monitor blood glucose and continue glipizide. controlled with blood glucose 188-135.
78 2021-03-14 hypertension Patient began to experience headaches. Familiar with high blood pressure symptoms, she took her bloo... Read more
Patient began to experience headaches. Familiar with high blood pressure symptoms, she took her blood pressure, it was extremely high (220). She called the doctor, doctor prescribed her a second blood pressure pill. A couple of days after second pill, blood pressure remained high. Patient was admitted to the hospital where she stayed overnight to be administered blood pressure medication intravenously.
78 2021-03-14 loss of consciousness Unconsciousness; Feeling discomfort within a few minutes after the vaccination; A spontaneous report... Read more
Unconsciousness; Feeling discomfort within a few minutes after the vaccination; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced of feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the event, patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death. Treatment information for event unconsciousness included resuscitate via cardiopulmonary resuscitation with no success. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event unconsciousness was fatal and patient died.; Reporter's Comments: This is a case of death of a 78-year-old, female patient who experienced within a few minutes of product use who experienced feeling of discomfort and became unconscious and subsequently expired. Based on the current available information, a strong temporal association between the product use and onset of the events, a causal relationship with the events cannot be excluded. However, critical details such as the patient's medical history and actual cause of death is lacking.; Reported Cause(s) of Death: Unknown cause of death
78 2021-03-14 fainting Injection hit blood vessel, bleeding, dark blue bruise. Intense Swelling down arm to elbow, deep ... Read more
Injection hit blood vessel, bleeding, dark blue bruise. Intense Swelling down arm to elbow, deep redness and itching Friday 3-12-21 to today?s date 3-15-21 continues. 3-13-21 fainted after shower, 3-14-21 some dizziness during day. No dizziness as of 3-15-21. Swelling down some, Itching continues.
78 2021-03-14 blood clot blood clot in left forearm; Sore arm; A spontaneous report was received from a consumer concerning a... Read more
blood clot in left forearm; Sore arm; A spontaneous report was received from a consumer concerning a78, year, old, female patient who developed a blood clot in the left forearm. The patient's medical history included hypertension, hiigh cholesterol and hypothyroidism. On 19-JAN-2021 the patient had two stents placed in her heart. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate (One 5 milligram AM and PM) and apxaban (One 5 milligram AM and PM) and Asprin. On 10-FEB-2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient had a sore arm for about a day after the vaccination. Six days later the left arm was red and swollen, inside forearm four inches down below the elbow it was stinging, slightly swollen, just to a soft touch she felt lumps of swelling. The patient went to the emergency room and had blood work and an ultrasound. The emergency room doctor told her that she had a blood clot in the left forearm four inches down below the elbow. The lab test done at the emergency were blood work and ultrasound. Treatment for the event included changing her current medication to one clopidogrel bisulfate 5 milligrams AM and PM and apxaban two tablets of 5 milligrams AM and PM and to discontinue the Asprin for one week. There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and is scheduled to get her second vaccination 10-MAR-2021. The outcome of the events were considered as unknown. Follow up: No follow up information received.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
78 2021-03-17 chest pain patient presented to emergency department with chief complaint of SOB, b/l rash on arms, neck, and ... Read more
patient presented to emergency department with chief complaint of SOB, b/l rash on arms, neck, and chest, as well as chills. Patient admitted to observation status with diagnosis of precordial chest pain.
78 2021-03-17 pulmonary embolism, chest pain Patient was awakened at 0400 on 3/18/2021, with shortness of breath and her entire right side hurtin... Read more
Patient was awakened at 0400 on 3/18/2021, with shortness of breath and her entire right side hurting. Pain was in the lower right chest, right upper abdominal quadrant and right flank pain. Presented to the ED. CT of chest /abdomen showed pulmonary embolus in the right lower lung. Patient is being treated with Eliquis and was sent home from the ED on 3/18.
78 2021-03-17 fainting ALLERGIC REACTION Syncope and collapse
78 2021-03-18 palpitations, heart flutter pt states that about 30 minutes after getting the vax her heart started racing and fluttering so she... Read more
pt states that about 30 minutes after getting the vax her heart started racing and fluttering so she took her bayer aspirin and went to bed. This lasted about 30 minutes total. Next day she had a headache and sore arm. She no longer has any symptoms. Pt wanted to make a note of her size since she only 4'11" and weighs 97 lbs and doesnt do well taking any medication.
78 2021-03-21 hypertension Patient reported a welt and itching on day 2, then very high blood pressure about 3 days after whi... Read more
Patient reported a welt and itching on day 2, then very high blood pressure about 3 days after which she went to the ER to get evaluated and nothing determined to be for certain related and she was sent home . about a week after shot , she developed Covid Arm (rash and itching on arm and neck) and also had nausea.
78 2021-03-22 blood pressure fluctuation, heart rate abnormal very cold the night after shot. very tired the next day. a few days later had blood pressure and hea... Read more
very cold the night after shot. very tired the next day. a few days later had blood pressure and heart rate fluctuating. sore red swollen arm. md says infected.
78 2021-03-23 hypertension HTN, Dizziness
78 2021-03-24 hypertension 25 minutes after administrating the 2nd moderna vaccine. , patient started complain of tongue swel... Read more
25 minutes after administrating the 2nd moderna vaccine. , patient started complain of tongue swelling . BP 183/101 , Pulse 81. symptom wasn't getting worse . Called 911. they evaluate patient. Bp was still high, There are no signs of anaphylaxis. Recommend to go to hospital for follow up . Patient stayed in the pharmacy for 20 minutes after 911 left and felt good and left home.
78 2021-03-25 blood pressure fluctuation About 10 mintues after the vaccination while the patiet was waiting the 15 minute obvservation time,... Read more
About 10 mintues after the vaccination while the patiet was waiting the 15 minute obvservation time, she complained about feeling nausea, and tingling and numbness running down her left arm. ( The left upper arm recieved the IM shot). Patient stated she was feeeling anxiety and was afraid her blood pressue was increasing. She took a read on the automated personal health station and got a reading of 178/99. Pulse 78 10mins later I took a reading using a hand held blood pressure reader and got 175/98 pulse 74, 10min later next reading was 176/89 pulse 68. At this time I called for EMS to come and evaluate the patient and her symptoms. About 10 minutes after the last reading the EMS tech took reading of 174/73 pulse unknown. After their assetment of the patient and talking with the her daughter the patient refuse transport to the ER and was taken home by her daughter
78 2021-03-25 cerebrovascular accident Sent to ER on 3/25/21 for stroke-like symptoms. Found to have had a stroke with test results
78 2021-03-25 cerebrovascular accident Stroke following administration; A spontaneous report was received from a consumer concerning a 78 y... Read more
Stroke following administration; A spontaneous report was received from a consumer concerning a 78 year old ,female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a stroke/cerebrovascular accident. The patient's medical history was reported as previous stroke two years ago. Concomitant medications taken by the patient included losartan, glipizide, lintas, metformin, blood thinners, hydrochlorothiazide. On 26 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient experienced a stroke which needed emergency treatment. She received treatment for this condition and was back at home at the time of reporting and at that point she had no other side effects. Treatment activities for event was received but not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, stroke was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age along with prior history of stroke are considered significant risk factors.
78 2021-03-26 hypertension Lightheaded, dizzy hypertensive 208/103 Sent to the emergency room for further evaluation
78 2021-03-28 blood glucose increased complaints of generalized weakness. Patient states she was sitting at home when she developed sudde... Read more
complaints of generalized weakness. Patient states she was sitting at home when she developed sudden weakness throughout her body. She states she walked to the bathroom and felt as though she was going to fall down. She reports feeling sweaty as if she was having a hot flash. She states her symptoms lasted approximately 45 minutes and resolved after arriving to the ER. She denies feeling dizzy, lightheaded, no visual disturbances, paresthesia or headache. She denies any chest pain or shortness of breath. No recent fever, cough or chills.
78 2021-03-28 chest pain Chills, pain in legs, back, neck, teeth, headache, chest pain, site pain, weakness, fatigue
78 2021-03-29 loss of consciousness Patient had 2nd dose of Moderna vaccine and within her 15 minute waiting period she became lethargic... Read more
Patient had 2nd dose of Moderna vaccine and within her 15 minute waiting period she became lethargic and had a decreased level of consciousness. She was lowered to the floor where she then vomited. She was placed in the recovery position and 911 was called. She was then transported vis EMS to the ER.
78 2021-03-30 chest pain Heart pain immediately after the shot which lasted ~6 hours (9:15 am to ~4 pm). Nex day, 3/24/2021,... Read more
Heart pain immediately after the shot which lasted ~6 hours (9:15 am to ~4 pm). Nex day, 3/24/2021, right arm pain and red spots on the chest.
78 2021-03-30 deep vein blood clot Patient states she received first COVID vaccination approximately one week ago (not a great historia... Read more
Patient states she received first COVID vaccination approximately one week ago (not a great historian); she tells me about 4 days later she became shorth of breath that progressively worsened - especially with exertion. She went to ER and was sent home on steroids and antibiotics. Shortness of breath became worsened so she presented back to ER and CTA was performed. There is no evidence of PE but patient has what looks to be a chronic DVT of left subclavian vein extending up to IJ junction. I do not believe this is for sure vaccine related but felt it was important to report it anyway. She cannot tell me why she takes warfarin at home but I do assume it is for this known chronic DVT. Unsure of Vaccine brand name. Most vaccines in this area have been Moderna.
78 2021-03-30 loss of consciousness I ended up passing out while driving home, hitting a fence and totaling out my car. For about 4 days... Read more
I ended up passing out while driving home, hitting a fence and totaling out my car. For about 4 days after was very depressed and would randomly start to cry multiple times during the day.
78 2021-03-31 loss of consciousness passed out; feeling strange; started sweating; sore arm; A spontaneous report was received from a co... Read more
passed out; feeling strange; started sweating; sore arm; A spontaneous report was received from a consumer concerning a 78-year-old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and tender right arm, feeling strange, started sweating and passed out. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On 16-MAR-2021 the patient received their second dose of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On 16-MAR-2021 patient had a sore and tender right arm. On 19-MAR-2021, she started feeling strange, started sweating and passed out. The adverse event of passed out was assessed as medically significant. Action taken with mRNA-1273 in response to the events was not applicable. Outcome of the events of sore and tender right arm, feeling strange, started sweating and passed out was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
78 2021-04-01 anaemia 29 days after patient's second Moderna dose, she had sudden onset significant pain where she couldn'... Read more
29 days after patient's second Moderna dose, she had sudden onset significant pain where she couldn't stand or walk, her left leg became swollen twice it's size, and blue. She went to the ER with no treatment. About 5-6 hours after discharged she returned with her leg turning purple and uncontrollable pain. She was diagnosed with venous thromboembolis and transferred to a larger facility where she underwent lytic therapy and venous angioplasty. She is having to go for venous stenting in the next two weeks. She continues to have pain in her leg, chronic fatigue and weakness, as well as being lightheaded with a stable BP (no orthostasis). She has been diagnosed with anemia since vaccination and is being worked up for that.
78 2021-04-01 skin turning blue, heart rate decreased, blood pressure increased Last night around 10 pm she achey, muscle and joint pain, and then a headache and then chills, lips ... Read more
Last night around 10 pm she achey, muscle and joint pain, and then a headache and then chills, lips bluish, but not SOB, blood pressure 185/78 usually it's lower like 120 or 130, pulse ox 85 low. Suggested to go to ER or call 911 She called her DR.
78 2021-04-02 low blood oxigenation, haemoglobin decreased, anaemia April 3rd:Anemia, hgb 3.7 Recieved blood transfusion. Hypoxic: oxygen saturations mid 80's when pres... Read more
April 3rd:Anemia, hgb 3.7 Recieved blood transfusion. Hypoxic: oxygen saturations mid 80's when presenting to ER. Put on Nasal cannula. Being admitted to Hospital
78 2021-04-04 blood pressure increased Pt stated she was unable to walk and had dizziness. She had to be assisted to chair. BP was 170/6... Read more
Pt stated she was unable to walk and had dizziness. She had to be assisted to chair. BP was 170/60 and a pulse was 60 bpm. Pt stated that she was breathing but felt unable to take a deep breath. Pt stated that she had problems opening eyes and leaving them open. also reported headache . Pt reported chilling and was having tremors possibly related to being cold.
78 2021-04-04 loss of consciousness, fainting DIZZINES, LOST COUNSIOUSNESS, DESMAYO
78 2021-04-05 pulmonary embolism, chest pain Received Covid vaccine on 4/2 and then starting 4/3 starting experiencing nocturnal chest pain. Fou... Read more
Received Covid vaccine on 4/2 and then starting 4/3 starting experiencing nocturnal chest pain. Found to have bilateral pulmonary embolism on evening of 4/5.
78 2021-04-07 blood clot Moderna EUA Pt started having left leg pain, discoloration (blue-purple) and swelling on 3/9/2021. P... Read more
Moderna EUA Pt started having left leg pain, discoloration (blue-purple) and swelling on 3/9/2021. Pt went to the hospital and was later called to come back to the hospital because she had a blood clot. Pt was sent to clinic and had a procedure by to remove clots. Pt states that the clot was "2/3 size of thigh." Pt states that she is scheduled to have a second procedure in May to remove blockages from iliacs.
78 2021-04-08 heart rate increased, palpitations Pounding heart, elevated heart rate. Visit to ER Hospital admit A-fib diagnosis Prescribed Cardiz... Read more
Pounding heart, elevated heart rate. Visit to ER Hospital admit A-fib diagnosis Prescribed Cardizam cd 120mg daily
78 2021-04-08 oxygen saturation decreased The day following the injection, the patient experienced fever, chills, fatigue, aches. She began w... Read more
The day following the injection, the patient experienced fever, chills, fatigue, aches. She began wheezing significantly and had tremors. Oxygen levels dropped to 82-84% which persisted following two albuterol nebulizer treatments. She was taken to the emergency department and was admitted for 2 days for oxygen and steroid treatment.
78 2021-04-12 atrial fibrillation, palpitations, chest discomfort is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; coul... Read more
is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; could not walk; dizzy; Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long; headache; nausea but did not throw up; have never ache and hurt as bad as they started hurting; sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis and Cardioversion (Had 2 cardioversions). Concurrent medical conditions included Atrial fibrillation. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long), HEADACHE (headache) and NAUSEA (nausea but did not throw up). On 29-Jan-2021, the patient experienced ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) (seriousness criterion medically significant), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way). On 28-Jan-2021, PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long) and NAUSEA (nausea but did not throw up) had resolved. On 29-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 80 (High) 80. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included paracetamol. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
78 2021-04-14 heart attack patient hospitalized for stemi about 1 month after second dose
78 2021-04-14 heart failure Death - no symptoms, signs or treatment provided
78 2021-04-15 blood pressure increased, chest pain Headache, pain in chest, increased blood pressure, systolic reading increased to 210 day of vaccinat... Read more
Headache, pain in chest, increased blood pressure, systolic reading increased to 210 day of vaccination (unsure of diastolic reading). Today blood pressure 155/107. Patient went to healthcare facility on 4/12/21. was prescribed ASA, Xanax 0.25mg and Norvasc 2.5mg. Headache and chest pain resolved. Patient takes log of blood pressure readings daily. 4/16/21 Follow up: Patient stated as of this morning her BP is 140/109 , chest pain has subsided but she feels its related to gas, headache has also subsided. Advised her to continue with the meds she is taking and also advised her that she can take a gas-x otc to help to relieve some of the bloating and gas feeling she has. Will follow up on Monday 4/19/21.
78 2021-04-15 chest pain 10 minutes after receiving the vaccination she started having chest pain, Sweating, numbness and ti... Read more
10 minutes after receiving the vaccination she started having chest pain, Sweating, numbness and tingling throughout entire body, headache. She started getting wheezing. She developed a rash on arms and legs. She went to the ER on 4/5/2021. She was discharged home with albuterol. Her shortness of breath got progressively worse and she was advised to return to the ER. She went back on 04/08/2021. She was given toradol and discharged home. Followed up with primary care on 4/15/20, still having shortness of breath, but improved from the last ER visit. She has significant exertional dyspnea. Her exercise capacity has reduced from 3-4 blocks, to barely able to make it across her house without stopping.
78 2021-04-15 deep vein blood clot, fast heart rate Extensive DVT(blood clots) involving both legs-- initially with tachycardia dyspnea. Now on 10a meds... Read more
Extensive DVT(blood clots) involving both legs-- initially with tachycardia dyspnea. Now on 10a meds. Likely to have disability or permanent damage. History of post-op DVT with PEs following sholder surgery, subsequent placement of IVC filter.
78 2021-04-15 nosebleed Heavy nosebleeds-- 10 minutes, heavy blood loss. Daily since day of second shot
78 2021-04-15 palpitations Tiredness in leg; in a wheelchair after second dose of vaccine; Swelling; Heart racing; Out of breat... Read more
Tiredness in leg; in a wheelchair after second dose of vaccine; Swelling; Heart racing; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Tiredness in leg) and GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction (no reported medical history). On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Tiredness in leg) (seriousness criterion disability), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) (seriousness criterion disability), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath). At the time of the report, MUSCULAR WEAKNESS (Tiredness in leg), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No relevant concomitant medications were reported. The patient was treated with prednisone and Percocet (oxycodone/paracetamol).; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
78 2021-04-15 blood clot Blood clot; Left leg pain; Discoloration (blue-purple); Swelling; This spontaneous case was reported... Read more
Blood clot; Left leg pain; Discoloration (blue-purple); Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination. The patient's past medical history included Clot blood in 2010. Concurrent medical conditions included Drug allergy (Dalaudid, Ambien and Demerol) and Hypertension. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE (AMARYL), ACETYLCARNITINE HYDROCHLORIDE (NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]), COLECALCIFEROL (CALTRATE VITAMIN D DAILY), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and VITAMIN D NOS for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain) (seriousness criterion hospitalization), SKIN DISCOLOURATION (Discoloration (blue-purple)) (seriousness criterion hospitalization) and SWELLING (Swelling) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was sent to hospital to remove clots. The patient stated that the clot was 2/3 size of thigh. The patient scheduled to have a second procedure in May to remove blockages from iliac. Action taken with mRNA-1273 was not applicable. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.
78 2021-04-16 atrial fibrillation Next day 04/01/21 patient hallucinated that there were spiders on the wall, a-fib went crazy, short... Read more
Next day 04/01/21 patient hallucinated that there were spiders on the wall, a-fib went crazy, shortness of breath, sweating, vomiting.
78 2021-04-17 heart attack, blood clot Blood clot leading to heart attack
78 2021-04-18 atrial fibrillation on 9th started with a sore throat.running nose,coughing, by the 12th throat was so sore could hardly... Read more
on 9th started with a sore throat.running nose,coughing, by the 12th throat was so sore could hardly swallow. Went to urgent care .Was treated for just a sore throat. Wed 14th in the evening I went into a-fib and ambulance called and taken to hospital. They tried two different meds to get me back to normal sinus rhythm..They sent me home that evening the 15th.Today I`m starting to feel better.
78 2021-04-21 low blood platelet count, fast heart rate, haemoglobin decreased, platelet count decreased, hypotension Unsure of cause/effect. Patient developed idiopathic thrombocytopenic purpura with platelets of 400... Read more
Unsure of cause/effect. Patient developed idiopathic thrombocytopenic purpura with platelets of 4000 from normal the month prior. With most recent different events being the COVID-19 vaccination and starting prolia twice yearly for osteoporosis. She developed purpura on left arm starting on 4/18 which enlarged and coalesced throughout the week. She then developed oozing from known wound and purpura on chest. Entire left arm developed diffuse bruising and swelling by 4/22. Left side of face also with spontaneous bruising. Developed mucosal bleeding of mouth and throat on 4/22. Presented tachycardic and mildly hypotensive.
78 2021-04-22 heart rate increased an hour and a half after shot, rapid heart beat 101 hard to breathe like just after doing yard work,... Read more
an hour and a half after shot, rapid heart beat 101 hard to breathe like just after doing yard work, Took several slow breaths drank lots of water and rested. By 8 pm was back to normal.
78 2021-04-24 blood clot I had tender areas on the inside of my left leg starting about mid or late March in the upper thigh ... Read more
I had tender areas on the inside of my left leg starting about mid or late March in the upper thigh region and some aching in the inner aspect of the calf portion of the leg. This became worse over the Easter weekend and I went to clinic on April 6, 2021. I had a superficial blood clot just above the knee on the inner aspect of my left leg. After that appointment the redness and soreness and very hard feeling of the veins extended up my leg 8 to 10 inches. I did not have a blood clots in the deep veins. I have had some varicose vein?s and surgery for such about five years ago. The clinic did not say the clot was due to the vaccine but I had no injuries, no recent surgeries and nothing unusual that would have caused the clot other than the vaccine
78 2021-04-26 cerebrovascular accident Stroke
78 2021-04-26 heart attack Heart Attack 2 days after 2nd dose of moderna vaccine - followed by death
78 2021-04-26 fainting vomiting, diarrhea, n/v, metallic taste in mouth, syncope, weakness, anorexia, abdominal cramping Dr... Read more
vomiting, diarrhea, n/v, metallic taste in mouth, syncope, weakness, anorexia, abdominal cramping Drinking warm ginger-ale, dried cheerios, sips of water with some relief. Recommended Mylanta to help soothe stomach. 4/23-symptoms lasted 1 week; feels improved. Still fatigues easily.
78 2021-04-30 blood pressure increased CONFUSION, HALLUCINATIONS, FEVER (103), INCREASED BLOOD PRESSURE, CHILLS
78 2021-04-30 cerebrovascular accident Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal... Read more
Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot; Woke up shaking; Eyesight effected; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seizure. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot) (seriousness criteria hospitalization prolonged, disability and life threatening), TREMOR (Woke up shaking) (seriousness criterion hospitalization prolonged) and VISUAL IMPAIRMENT (Eyesight effected) (seriousness criterion hospitalization prolonged). The patient was hospitalized on sometime in March 2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) outcome was unknown. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Products known to have been used by the patient, within two weeks prior to the event, included seizure medication. Treatment for the event included intensive care and stroke unit. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this event has been provided at this time. Further information has been requested.
78 2021-04-30 heart attack, chest discomfort Initially she experienced fever, fatigue, aches, chills. Then later, several days of tightening che... Read more
Initially she experienced fever, fatigue, aches, chills. Then later, several days of tightening chest leading up to heart attack (20 days post vaccine). Doctor expressed surprise by heart attack. Not sure if there's a connection, but thought I'd submit.
78 2021-05-01 atrial fibrillation Transient Global Amnesia on 3/14/21: when my husband got up I was already up. i was asking questio... Read more
Transient Global Amnesia on 3/14/21: when my husband got up I was already up. i was asking questions about where things were that I should have known. I came back to myself and was then ok, Because I was concerned by the strangeness of the incident i went to my doctor the next day. He sent me for tests and told me to follow up with cardiologist. which i did. t
78 2021-05-06 atrial fibrillation Autoimmune encephalitis vs Listeria infection - 78 yo F with encephalitis. Second Moderna vaccine on... Read more
Autoimmune encephalitis vs Listeria infection - 78 yo F with encephalitis. Second Moderna vaccine on 3/6/2021, admitted on 3/31/2021. 4/18 IM Progress NOTE states: #Limbic encephalitis, improving. Treating for Listeria given inflammatory findings in addition to lymphocytic CSF and few gram-positive cocci on stain. CSF paraneoplastic antibodies are negative therefore anticipating that the serum antibodies will also come back negative Depressed flat affect consistent with limbic inflammation -improving Repeat MRI 4/14 shows improvement Ampicillin, tentative plan for 4 to 8 week course for possible listeriosis Gentamicin, completed 1 week course 4/15. Continues on Keppra 4/20 Neurology Progress NOTE: Impression - Meningoencephalitis, presumed to be secondary to listeria. 4/27 ID progress NOTE : Patient found to have limbic encephalitis and possible infectious cerebritis. CSF exam, was performed after about 2.5 days of antibiotics due to patient anticoagulation, showed 27 white blood cells, 96% lymphocytes; protein 146, glucose 69. Meningitis encephalitis PCR panel negative. Gram stain with rare intracellular GPC's, culture negative. Per micro lab, 2 different techs each visualized 2 different fields with an intracellular GPC. Clinical picture was thought compatible with Listeria (which is a bacillus, but could be mistaken for a coccus). Completed 10 days of empiric vancomycin and ceftriaxone on 4/10. was on ampicillin CNS dosing, plus gentamicin for synergy started 4/9, now off of gentamicin. Ampicillin changed to meropenem due to drug eruptions. Continued slow clinical improvement; repeat MRI brain 4/13 showed radiographic improvement. Noted to have negative coccidioides serology but not titre came back at 1:8, repeat titre negative. Repeat LP shows similar findings with 28 WBCs, with lymphocytic predominant, slightly low glucose and elevated protein. Awaiting Coccidioides CSF and fungal cultures. Continue fluconazole 400 mg daily, renally adjusted. No evidence of QTc prolongation. Continue to monitor rash. No evidence of DRESS, TENS or SJS. Patient has eosinophiluria. Continue current plan of care. Diagnosis: -Limbic encephalitis -Positive coccidioides titre of 1:8 -Possible infectious cerebritis -Rash and pruritus - improving. -Breast cancer in remission s/p mastectomy, radiation, chemotherapy -Atrial fibrillation with RVR -AKI with eosinophiluria Discharged on 4/27/21
78 2021-05-07 low platelet count This 77 year old female received the Moderna Covid shot on 2/18 /21 and went to the ED on 3/16/2... Read more
This 77 year old female received the Moderna Covid shot on 2/18 /21 and went to the ED on 3/16/21 and was admitted on 3/16/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
78 2021-05-09 chest pain Pt states about 2 weeks after taking the vax she had back pain, pain in her left arm and stabbing ch... Read more
Pt states about 2 weeks after taking the vax she had back pain, pain in her left arm and stabbing chest pain. On 4/23/21 she went to ER. They did multiple test but could not find anything wrong. Pt developed red blotches on her left breast. She had a FU apt w/ Cardiologist Dr. on 4/28/21. She was diagnosed w/ Shingles. He referred her to see a Primary Care doctor but she does not have one at this time. She will visit an Urgent Care since she is still in pain and has a severe rash.
78 2021-05-10 loss of consciousness If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Di... Read more
If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (all cillins), Drug allergy (ibuprofen (MOTRIN)), Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM)), Allergic to cats and Asthma. Concomitant products included DILTIAZEM, LISINOPRIL and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) (seriousness criterion medically significant) and DYSPNOEA (After 2 weeks, she had shortness of breath). At the time of the report, LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) had resolved and DYSPNOEA (After 2 weeks, she had shortness of breath), DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received her first dose of Moderna COVID-19 vaccine on 20-APR-2021. After two weeks, she had shortness of breath and "if she walks little bit then she felt she passed out." The patient's health care provider did some test (unspecified) and everything came out normal, her lungs are clear and her oxygen level is normal. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
78 2021-05-10 pulmonary embolism Pulmonary embolism
78 2021-05-11 heart flutter She had labored breathing in her chest and rib cage hurt for 36 hours post vaccination. She also had... Read more
She had labored breathing in her chest and rib cage hurt for 36 hours post vaccination. She also had a urinary tract infection at the time and felt her heart flutter. In the past, she reported a history of reaction to any vaccine, including polio.
78 2021-05-11 enlargement of the heart Acute respiratory failure with hypoxia (HCC) (Primary Dx); Shortness of breath; Tachypnea; Pneumo... Read more
Acute respiratory failure with hypoxia (HCC) (Primary Dx); Shortness of breath; Tachypnea; Pneumonia due to COVID-19 virus Office Visit 3/4/2021 Internal Medicine Internal Medicine Cough +2 more Dx Shortness of Breath ? Cough Reason for Visit Progress Notes (Physician) ? ? Internal Medicine ? ? Encounter Date: 3/4/2021 ? ? Signed Expand AllCollapse All Assessment/Plan Diagnoses and all orders for this visit: Cough - X-ray chest 2 views; Future - B-type natriuretic peptide; Future - CBC and differential; Future Iron deficiency anemia, unspecified iron deficiency anemia type - CBC and differential; Future - Iron + Transferrin + % Saturation; Future Shortness of breath - B-type natriuretic peptide; Future
78 2021-05-11 chest pain PAin in chest area Began on right breast and under arm. Moved to left breast and under arm also. ... Read more
PAin in chest area Began on right breast and under arm. Moved to left breast and under arm also. All skin around painful. Hurts all the time unless very involved with an activity. Acedimen helps somewhat Have clear mammogram and chest X-ray. Taking prescribed Meloxicam - noticed no difference.
78 2021-05-11 deep vein blood clot Deep vein thrombosis occurring 12 days after 2nd vaccine. No previous DVT in lifetime.
78 2021-05-11 low platelet count Developed profound leukocytosis with WBC 173,000 and elevated LDH following first dose. Increased hy... Read more
Developed profound leukocytosis with WBC 173,000 and elevated LDH following first dose. Increased hydrea (already on for CNL). Developed transfusion dependent thrombocytopenia
78 2021-05-14 heart attack, cerebrovascular accident, transient ischaemic attack, blood clot My mom, got her first Moderna shot on Feb. 4th, 2021 and developed trombosis in the legs about a wee... Read more
My mom, got her first Moderna shot on Feb. 4th, 2021 and developed trombosis in the legs about a week later. She went to the doctor, who at first didn't want to see her and told her to elevate her leg. Pt. had a scheduled eye appointment on Feb. 12th with an other doctor and when she asked if she had any other issues, pt. showed her her leg. The eye doctor immediately told her to go to urgent care. When she did she received blood thinners and started injections in her stomach for 5 days. Feb. 18th pt. suffered a mini stroke and went to the hospital emergency room. She was transferred over to another facility in the afternoon and kept overnight. She had a phone appointment with the Dr. on Feb. 24th and on the 26th she received a heart monitor to wear for 2 weeks. She also had a check up about her leg, which was still swollen. On March 4, pt. received her second Moderna shot and she was feverish and very tired for days and weeks after. By March 18th her condition didn't improve at all and in fact she was felling really bad over night, so on March 19th she was admitted again to the hospital. She was monitored and kept over night, but during the early morning she suffered a stroke and a heart attack and passed way the next day.
78 2021-05-16 loss of consciousness She got her vaccine, and felt fine. She came home and did what she had to do and when she went to b... Read more
She got her vaccine, and felt fine. She came home and did what she had to do and when she went to bed she felt fine. When she woke up yesterday she sat on the edge of the bed for a minute and then passed out and woke up on the floor. She called the manager of the apartments and asked if she would come and help her get up. She helped her and felt that she should call the paramedics, which she did, and they came out and checked her out and she was okay. Later in the day the dizziness hit her again and she passed out again. She finally managed to get to her phone again, she was not able to get up, and she called 9-1-1 and they came out and got her in the chair, but did not take her to the hospital. She has not passed out anymore but she feels very dizzy and woozy and does not move fast. She also had some nausea, but that is pretty much gone. She has not called her doctor as it was over the weekend.
78 2021-05-19 blood pressure increased Pt c/o headache, muscle weakness, anxiety, flushing/sweating. Pt indicates that they have a hx of a... Read more
Pt c/o headache, muscle weakness, anxiety, flushing/sweating. Pt indicates that they have a hx of adverse rxn reported w/ first vaccine dose but no VAERS was submitted by clinic staff at that time. Clinical review cleared patient for second dose. Pt assisted to bed. Abnormal vitals. BP 251/91 (133), HR 82, RR 21 -- > 237/84 (120), 70, 17. Pt denies hx of HTN, NKA. Physician advised patient to go to urgent care d/t elevated BP; pt verbalized understanding. After 5 mins pt denies and HA, verbalizes feeling calm, muscle weakness resolved. Pt ambulating w/o c/o dizziness. Patient taken to Urgent Care/ER by private car.
78 2021-05-19 heart rate increased, low blood pressure significant dropped in her systolic pressure; Feel like her heart is racing; This spontaneous case w... Read more
significant dropped in her systolic pressure; Feel like her heart is racing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (HYDROCHLOROTHIAZIDE WITH TRIAMTERENE) for Blood pressure management. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) (seriousness criterion hospitalization) and HEART RATE INCREASED (Feel like her heart is racing). The patient was hospitalized from 26-Apr-2021 to 28-Apr-2021 due to ORTHOSTATIC HYPOTENSION. At the time of the report, ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) and HEART RATE INCREASED (Feel like her heart is racing) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: decreased (Low) decreased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 was not applicable. On 26-Apr-2021, it was reported that the patient was admitted to the hospital for the adverse event and was discharged on 28-Apr-2021. On 03-May-2021, the patient was re-admitted to the hospital and treatment provided included intra-venous fluids (IV fluids). It was also reported that concomitant medications, hydrochlorothiazide and triamterene were stopped. This case was linked to MOD-2021-116530 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
78 2021-05-23 atrial fibrillation Pt admitted to hospital from 5/21 to 5/22 discharged home, dehydration, atrial fibrillation, malaise... Read more
Pt admitted to hospital from 5/21 to 5/22 discharged home, dehydration, atrial fibrillation, malaise, had second moderna covid vaccine 5/21, became ill 5/22 woke up with low grade fever, generalized weakness, malaise, no appetite, lightheaded, fall to ground stricking righ cheek, no LOC, baselilne memory losse, confusion improved, better on 5/22 morning, no need for follow up clinic visit. Can't get to fill in hospital information to unshade to fill in
78 2021-05-23 heart flutter Patient reports approx 48 hours after 2nd dose of Moderna COVID 19 vaccine nausea/vomiting, fatigu... Read more
Patient reports approx 48 hours after 2nd dose of Moderna COVID 19 vaccine nausea/vomiting, fatigue, headache. Pt has had ongoing symptoms of extreme fatigue, headache, feels like her heart "flutters". Pt began experiencing intermittent shortness of breath which began approx 2-3 weeks ago. Pt reports seen by Primary 3-5 times since 2nd vaccine and concerns. Pt reports had routine bloodwork, and everything has come back normal. Pt reports has been seen by endocrinologist for evaluation and all testing and bloodwork has also been normal
78 2021-05-23 nosebleed, hypotension, low blood oxigenation, anaemia, atrial fibrillation Infection and hospitalization. 2/13/2021 admission with discharge on 2/22/2021. Worsening SOB and ep... Read more
Infection and hospitalization. 2/13/2021 admission with discharge on 2/22/2021. Worsening SOB and epistaxis upon admission requiring intubation and admission to ICU. Extubated on 2/17/2021. Dx during visit include hypoxia, sepsis, hypotension, anemia, aspiration into airway, creatinine elevation, epistaxis, atrial fibrillation, essential hypertension, diastolic heart failure
78 2021-05-25 cardiac failure congestive, haemoglobin decreased Moderna COVID-19 Vaccine EUA: three days after vaccination patient presents to clinic reporting coug... Read more
Moderna COVID-19 Vaccine EUA: three days after vaccination patient presents to clinic reporting cough, chills, and over one month worsening of dyspnea on exertion, lower extremity edema, and orthopnea. Patient immediately transferred to hospital, diagnosed with acute on chronic volume overload and acute diastolic heart failure exacerbation, diuresed, and discharged to home medically stable. On outpatient follow-up patient is improved clinically.
78 2021-05-25 oxygen saturation decreased During vital sign inspection, patient presented low saturation, and was taken to the Hospital.
78 2021-05-26 atrial fibrillation, blood pressure fluctuation This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes th... Read more
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DESLORATADINE for Allergy, ASA and APIXABAN (ELIQUIS) for Anticoagulant therapy, LOSARTAN and METOPROLOL for Blood pressure, FUROSEMIDE for Diuretic effect, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for Dry eye, FLECAINIDE from 14-May-2021 to an unknown date and CLONIDINE for Heart disorder. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).) (seriousness criterion medically significant), HUNGER (Unusual hungry feeling) and BLOOD PRESSURE FLUCTUATION (Fluctuations of Blood Pressure readings). On 15-May-2021, the patient experienced VACCINATION SITE WARMTH (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE ERYTHEMA (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE RASH (Rash in the circle) and VACCINATION SITE SWELLING (Circle 4 inches below the injection site, size of a golf ball). At the time of the report, ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).), HUNGER (Unusual hungry feeling), BLOOD PRESSURE FLUCTUATION (Fluctuations of Blood Pressure readings), VACCINATION SITE WARMTH (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE ERYTHEMA (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE RASH (Rash in the circle) and VACCINATION SITE SWELLING (Circle 4 inches below the injection site, size of a golf ball) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Blood pressure measurement: 104/54 (Inconclusive) At 6:50am, 97/62 (Inconclusive) At 11:40am, 110/62 (Inconclusive) At 2:50pm, 142/89 (Inconclusive) At 8:45pm and 119/69 (Inconclusive) At 10pm. On 12-May-2021, Heart rate: 74 (Inconclusive) At 6:50am, 73 (Inconclusive) At 11:40am, 62 (Inconclusive) At 2:50pm, 109 (Inconclusive) At 8:45pm, 103 (Inconclusive) At 10pm and 97 (Inconclusive) At 2:50pm. On 13-May-2021, Blood pressure measurement: 110/87 (Inconclusive) At 7:12am and 117/76 (Inconclusive) At 8:06am. On 13-May-2021, Heart rate: 104 (Inconclusive) At 7:12am and 101 (Inconclusive) At 8:06am. On 14-May-2021, Blood pressure measurement: 116/80 (Inconclusive) At 7:32am, 129/78 (Inconclusive) At 1:02pm and 169/97 (Inconclusive) At 8:32pm. On 14-May-2021, Heart rate: 99 (Inconclusive) At 7:32am, 102 (Inconclusive) At 1:02pm and 107 (Inconclusive) At 8:32pm. On 15-May-2021, Blood pressure measurement: 140/83 (Inconclusive) At 7:03am, 147/88 (Inconclusive) At 9:19am, 146/96 (Inconclusive) At 4:55pm, 161/95 (Inconclusive) At 8:20pm and 112/83 (Inconclusive) At 10:00pm. On 15-May-2021, Heart rate: 78 (Inconclusive) At 7:03am, 104 (Inconclusive) At 9:19am, 108 (Inconclusive) At 4:55pm, 109 (Inconclusive) At 8:20pm and 95 (Inconclusive) At 10:00pm. On 16-May-2021, Blood pressure measurement: 136/75 (Inconclusive) At 7:03am, 101/67 (Inconclusive) At 9:12am, 101/62 (Inconclusive) At 2:03pm and 127/75 (Inconclusive) At 10:00pm. On 16-May-2021, Heart rate: 101 (Inconclusive) At 7:03am, 104 (Inconclusive) At 9:12am, 90 (Inconclusive) At 2:03pm and 70 (Inconclusive) At 10:00pm. On 17-May-2021, Blood pressure measurement: 139/86 (Inconclusive) At 7:03am. On 17-May-2021, Heart rate: 73 (Inconclusive) At 7:03am. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Very limited information regarding the event atrial fibrillation has been provided at this time. For the other events a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the event atrial fibrillation has been provided at this time. For the other events a causal relationship cannot be excluded. Further information has been requested.
78 2021-05-26 atrial fibrillation, heart rate irregular presented for a well exam and was noted to have an irregular heart rate. She was in atrial fibrilla... Read more
presented for a well exam and was noted to have an irregular heart rate. She was in atrial fibrillation with rapid ventricular response. now on beta blocker, digoxin and eliquis.
78 2021-05-26 blood glucose increased Device connection fit issue; stomach pain; nausea; Infected sebaceous cyst; postoperative pain; bloo... Read more
Device connection fit issue; stomach pain; nausea; Infected sebaceous cyst; postoperative pain; blood sugar increased; This spontaneous case was reported by a consumer and describes the occurrence of INFECTED DERMAL CYST (Infected sebaceous cyst) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and DULAGLUTIDE (TRULICITY) for Blood sugar increased. The patient's past medical history included Thyroidectomy NOS in 1976, Total hip replacement in 2019, Hysterectomy, Gallbladder removal and Bladder repair. Previously administered products included for Plaque psoriasis: Aclovate, Clobetasol and Tacrolimus; for Product used for unknown indication: phenobarbital, Neosporin, Cardura, Vasotec, amlodipine, diovan, isoptin, Metformin, Carafate, januvia, CARDIZEM [DILTIAZEM] and ZITROMAX. Concurrent medical conditions included Sebaceous cyst since 2020, Denture wearer, Non-tobacco user, Abstains from alcohol, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Shellfish allergy. Concomitant products included METOPROLOL and NITRIC OXIDE for Blood pressure high, ACARBOSE and GLIMEPIRIDE for Diabetes, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Macular degeneration, AMOXICILLIN for Prophylaxis, METHOTREXATE SODIUM (METHOTREXAT [METHOTREXATE SODIUM]) for Rheumatoid arthritis, FOLIC ACID and VITAMIN D3 for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder. On 30-Oct-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In February 2021, the patient started DULAGLUTIDE (TRULICITY) (Subcutaneous) 40 milligram. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In February 2021, the patient experienced PROCEDURAL PAIN (postoperative pain) and BLOOD GLUCOSE INCREASED (blood sugar increased). On 23-Feb-2021, the patient experienced INFECTED DERMAL CYST (Infected sebaceous cyst) (seriousness criterion medically significant). In March 2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Device connection fit issue). The patient was treated with INSULIN GLARGINE (TOUJEO) on 26-Apr-2021 for Blood sugar abnormal, at an unspecified dose and frequency; GINGER ROOT [ZINGIBER OFFICINALE RHIZOME] for Nausea and Stomach pain, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CORTISONE at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and CLINDAMYCIN at an unspecified dose and frequency. On 15-Mar-2021, INFECTED DERMAL CYST (Infected sebaceous cyst) had resolved. In April 2021, ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea) had resolved. At the time of the report, PROCEDURAL PAIN (postoperative pain), DEVICE CONNECTION ISSUE (Device connection fit issue) and BLOOD GLUCOSE INCREASED (blood sugar increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Pathology test: benign (Inconclusive) Benign sebaceous cyst. On an unknown date, Blood test: trouble with blood sugar (Inconclusive) trouble with blood sugar. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included a surgery for the removal of sebaceous cyst infection on patient's right breast in the dermatologist clinic on 15 Mar 2021. Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273. This case was linked to MOD-2021-131000 (Patient Link).; Sender's Comments: Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.
78 2021-05-26 loss of consciousness, cerebrovascular accident Passed out; Does not want to get 2nd dose; Head was hurting; Mini stroke; Speech difficulties; This ... Read more
Passed out; Does not want to get 2nd dose; Head was hurting; Mini stroke; Speech difficulties; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and CEREBROVASCULAR ACCIDENT (Mini stroke) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was reported. Concomitant products included LOSARTAN, LEVOCETIRIZINE, TEMAZEPAM, ATORVASTATIN CALCIUM (LIPITOR), BISOPROLOL and BUSPIRONE for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On 01-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Mini stroke) (seriousness criteria hospitalization and medically significant), SPEECH DISORDER (Speech difficulties) and HEADACHE (Head was hurting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Does not want to get 2nd dose). The patient was hospitalized from 01-Apr-2021 to 04-Apr-2021 due to CEREBROVASCULAR ACCIDENT and LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CEREBROVASCULAR ACCIDENT (Mini stroke), SPEECH DISORDER (Speech difficulties) and HEADACHE (Head was hurting) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Does not want to get 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included generic Plavix and blood thinner. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
78 2021-05-29 cerebrovascular accident, hypertension I happened to counsel patient's husband about his prescription 2 days ago and hear that his wife die... Read more
I happened to counsel patient's husband about his prescription 2 days ago and hear that his wife died of stroke approximately a month after the second dose of Moderna vaccine. I could not ask him further about exact date when she was admitted at the hospital because he was sick. I am not sure whether moderna vaccine caused her stroke, or not. Her husband said his wife had high blood pressure. They got Moderna vaccine on the same date. Her husband thought her high blood pressure caused the stroke. I don't have any info about her medical progress at the hospital.
78 2021-05-31 blood pressure increased Numbness/tingling in left arm and hand. No other symptoms. Baseline BP is elevated at home & BP elev... Read more
Numbness/tingling in left arm and hand. No other symptoms. Baseline BP is elevated at home & BP elevated here, asymptomatic. Neurological exam benign. No fever, no swelling, respiratory exam benign. Stable s/s on exit from clinic
78 2021-06-02 hypertension Systemic: Headache-Medium, Systemic: Hypertension-Mild, Additional Details: said her head started hu... Read more
Systemic: Headache-Medium, Systemic: Hypertension-Mild, Additional Details: said her head started hurting her from behind. her bp was 140/77 heart rade 77. told her to take tylenol and her regular meds. if her headache persists or gets worse to go to the er. her son has a bp cuff and will check her bp
78 2021-06-06 loss of consciousness I had just woken up and I was making my coffee and I passed out and I found myself sitting in my kit... Read more
I had just woken up and I was making my coffee and I passed out and I found myself sitting in my kitchen floor which is granite, which is very hard, I really hurt myself so I called my primary care and she said to go to the ER and I waited for a couple of days until I finally went. On the ER they only did the CT scans. I have been to many doctors after that and they did a bunch of CTs, MRI, x-rays, echocardiogram, EKG. The diagnosis was that I fractured my sacrum and had acute strains of the muscles in the pelvis. I am still being treated for the muscle sprains.
78 2021-06-07 palpitations I felt fine after my vaccination until about midnight. I felt weak, and generally sick - horrible. I... Read more
I felt fine after my vaccination until about midnight. I felt weak, and generally sick - horrible. I felt like I had a fever and I felt like my heart was still thumping too hard. I felt nauseas and generally all over sick as a dog, weak as a kitten. And I was afraid as well, because it was midnight and I live alone. I thought about going to the ER due to my condition. I took my BP and it was 120/68 which is normal. I took my temperature and it was 96.7 and then I did my blood oxygen and it was 96 with a heart rate of 66 so all of my little at home tests were normal. I was no longer afraid. I took two baby aspirin and I drank a lot of water and I went to sleep. I did not feel good in the morning but due to my vitals being okay, I began to stop worrying. Around noon the day after my vaccine, I felt OK. I contacted my DR the next day and they called me back and I was fine at that point so said nevermind.
78 2021-06-13 heart attack, troponin increased, chest pain Had chest pain and came into ED, found to have NSTEMI went to cardiac cath, no stent needed at this ... Read more
Had chest pain and came into ED, found to have NSTEMI went to cardiac cath, no stent needed at this time. given aspirin 81 mg daily for life and plavix 75 mg daily for 1 year discharged home
78 2021-06-14 palpitations, cardiac failure congestive Heart palpitation, congestive heart failure, Dsypnea
78 2021-06-15 loss of consciousness Passed out; Felt very sick for 12 hrs; Body was shaking; Chills so bad; This spontaneous case was re... Read more
Passed out; Felt very sick for 12 hrs; Body was shaking; Chills so bad; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ILLNESS (Felt very sick for 12 hrs), TREMOR (Body was shaking) and CHILLS (Chills so bad). On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On 25-Feb-2021, ILLNESS (Felt very sick for 12 hrs), TREMOR (Body was shaking) and CHILLS (Chills so bad) had resolved. On 26-Feb-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. Concomitant medication and treatment information were not reported. Patient did not experienced any side effects after the first dose of vaccination. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
78 2021-06-15 blood clot Patient developed blood clots in her legs, heart, and lungs within 48 hours after receiving her seco... Read more
Patient developed blood clots in her legs, heart, and lungs within 48 hours after receiving her second dose of the Moderna vaccine. She was subsequently treated with Eliquis (apixaban).
78 2021-06-16 atrial fibrillation I experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and ... Read more
I experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and Lymphocytic Leukemia.
78 2021-06-16 pulmonary embolism Pulmonary Embolism
78 2021-06-17 anaemia tireness, no appetite, finds it difficult to converse These symptoms have gradually gotten worse sin... Read more
tireness, no appetite, finds it difficult to converse These symptoms have gradually gotten worse since the second vaccination. She has been to ER and Prompt care.
78 2021-06-27 cardiac failure congestive Patient admitted for AKI and CHF
78 2021-06-28 heart attack I21.4 - Non-ST elevation (NSTEMI) myocardial infarction
78 2021-06-29 cerebrovascular accident, atrial fibrillation, cerebral haemorrhage broken foot; Fall; Unevaluable event; Atrial fibrillation; Fall; Cerebral bleeding; Stroke; This spo... Read more
broken foot; Fall; Unevaluable event; Atrial fibrillation; Fall; Cerebral bleeding; Stroke; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), the first episode of FALL (Fall), FOOT FRACTURE (broken foot), the second episode of FALL (Fall) and UNEVALUABLE EVENT (Unevaluable event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Depression, Bladder disorder, Cholesterol, Abstains from alcohol and Non-smoker. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (DITROPAN) for Bladder disorder, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METOPROLOL for Heart disorder, MIRTAZAPINE (REMERON) for Unevaluable reaction. In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of FALL (Fall) (seriousness criteria hospitalization and disability). In February 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant) and UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). On 08-Jun-2021, the patient experienced FOOT FRACTURE (broken foot) (seriousness criteria hospitalization and disability) and the second episode of FALL (Fall) (seriousness criteria hospitalization and disability). The patient was hospitalized from 15-Feb-2021 to 18-Feb-2021 due to ATRIAL FIBRILLATION, CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT and FALL. On 08-Jun-2021, last episode of FALL (Fall) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), FOOT FRACTURE (broken foot) and UNEVALUABLE EVENT (Unevaluable event) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging head: confirmed brain is bleeding (abnormal) Confirmed brain is bleeding. On 10-Mar-2021, Electrocardiogram: confirmed atrial fibrillation (abnormal) Confirmed Atrial fibrillation. On 08-Jun-2021, X-ray limb: confirmed broken foot (abnormal) Confirmed broken foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was sent to urgent care because the patient fell again and it was determined that her left foot was broken where a boot cast was put on her left leg and was advised to have bed rest and had the left leg elevated. The patient was waiting for brain bleeding to heal. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
78 2021-07-04 hypertension, loss of consciousness Severe heart issues resulting in fall, loss of consciousness and a laceration to head. Brain hematom... Read more
Severe heart issues resulting in fall, loss of consciousness and a laceration to head. Brain hematoma which is effecting eye function. HIGH blood pressure, pulmonary concerns, thyroid module. Tests and treatment plans still in development. Patient did have a pacemaker inserted. Multiple CAT scans, blood draws, x-rays have been preformed and 1 biopsy on the calendar.
78 2021-07-05 chest discomfort Tested POSITIVE for COVID-19 on Friday, July 2, 2021. Was held a tele-med appointment over the phon... Read more
Tested POSITIVE for COVID-19 on Friday, July 2, 2021. Was held a tele-med appointment over the phone. Referred me as a candidate to receive a monoclonal antibody infusion which I had on July 5, 2021. My symptoms are deep cough, tightness in my chest, sore throat, slight headache, tiredness and loss of taste.
78 2021-07-10 chest discomfort developed anxiety; Chest tightness/chest congestion; shortness of breath; it felt like she had asthm... Read more
developed anxiety; Chest tightness/chest congestion; shortness of breath; it felt like she had asthma; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ASTHMA (it felt like she had asthma), ANXIETY (developed anxiety) and CHEST DISCOMFORT (Chest tightness/chest congestion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (atropine- high fever and vomiting) since 1952. Concomitant products included GEMFIBROZIL and AMLODIPINE for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), ASTHMA (it felt like she had asthma) (seriousness criterion hospitalization) and CHEST DISCOMFORT (Chest tightness/chest congestion) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANXIETY (developed anxiety) (seriousness criterion hospitalization). The patient was hospitalized on 10-Mar-2021 due to ANXIETY, ASTHMA, CHEST DISCOMFORT and DYSPNOEA. The patient was treated with GUAIFENESIN (MUCINEX) for Asthma and Dyspnoea, at an unspecified dose and frequency; LORAZEPAM at a dose of 1 dosage form; SALBUTAMOL SULFATE (VENTOLIN RESPIRATOR) for Asthma, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLOVENT HFA) on 04-May-2021 for Asthma, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), ASTHMA (it felt like she had asthma), ANXIETY (developed anxiety) and CHEST DISCOMFORT (Chest tightness/chest congestion) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Fibrin D dimer: normal (normal) normal. On an unknown date, Troponin: negative (Negative) negative. Patient height was 5 inches. Action taken with mRNA-1273 in response to the events were not applicable Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD21-032955 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow Up information was received on 01-Jul-2021 Patient demographics updated. patient medical history updated. Concomitant medications provided. Treatment medication was provided Start date for the events updated. Case is upgraded to serious and seriousness criteria included hospitalization. Outcome of the events updated ( from unknown to not resolved).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
78 2021-07-11 anaemia Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dyin... Read more
Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna
78 2021-07-19 blood pressure decreased BP DROP 78/53 HR 36-37 WENT TO ER CARE 11:30 PM TIL 10:00 AM WAS TOLD HAD A STROKE TRANSFERRED TO ER... Read more
BP DROP 78/53 HR 36-37 WENT TO ER CARE 11:30 PM TIL 10:00 AM WAS TOLD HAD A STROKE TRANSFERRED TO ER 12 NOON TIL 7:30 PM DOCTOR TOLD HER NO STROKE RELEASED NEXT DAY BP REBOUND TO 170/101 HR 73 STILL RUNNING HIGH 7/20/2021 TOLD TO CHECK WITH CARDIOLOGIST
78 2021-07-19 hypotension Intermittent low blood pressure (diastolic of 50 or under) for approximately 3 months after 2nd Mod... Read more
Intermittent low blood pressure (diastolic of 50 or under) for approximately 3 months after 2nd Moderna vaccine .(incident on 5/17/21 where bp was 70/30 and was taken to ER and hospitalized overnight until bp stable for several hours. Several other tests (bloodwork) also performed to be sure there were no other adverse health conditions.
78 2021-07-22 cerebral haemorrhage, cerebrovascular accident Major Stroke with bleed to brain. Medical providers were unable to determine the cause. I reported ... Read more
Major Stroke with bleed to brain. Medical providers were unable to determine the cause. I reported the vaccine given the week before the event three times to the Emergency room team, the Hospitalist and to the Rehab Unit.
78 2021-07-27 fibrin d dimer increased - stye on left eye - uncontrollable diarrhea - diagnosed with lymphocytic colitis - shortness of bre... Read more
- stye on left eye - uncontrollable diarrhea - diagnosed with lymphocytic colitis - shortness of breath - blood in urine - hematuria
78 2021-07-28 heart attack I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
78 2021-07-28 cerebrovascular accident I63.9 - Completed stroke (CMS/HCC)
79 2021-01-01 blood pressure increased Vomiting, not feeling good, malaise, muscle pain, +fever, vomiting 99-100-99; incr BP 184/79, 136/76... Read more
Vomiting, not feeling good, malaise, muscle pain, +fever, vomiting 99-100-99; incr BP 184/79, 136/76, 157/82 feeling better after 24 hours. Given Tylenol. Had refused medications while feeling ill after vaccination, medications taken next day with no problem.
79 2021-01-01 chest discomfort This vaccine was administered on 12/23/2020. On 12/30/2020 I experienced intermittent headaches (wa... Read more
This vaccine was administered on 12/23/2020. On 12/30/2020 I experienced intermittent headaches (waking me during the night), very heavy pressure between the breasts, fatigue and extreme redness, swelling, itching at injection site. I went to emergency clinic on 1/1/2021. The performed blood work, EKG, Chest X -Ray, took vital signs and all were normal. All symptoms have disappeared as of today, 1/2/2021, except the redness and extreme tenderness at injection site.
79 2021-01-12 haemoglobin decreased The patient presented to hospital on 1/6/2021 with a primary complaint of Fatigue (pt had covid vacc... Read more
The patient presented to hospital on 1/6/2021 with a primary complaint of Fatigue (pt had covid vaccine yesterday. Now displaying increased weakness, blood in urine, increased confusion and urinated on herself today. Fever of 101.9 ) 79-year-old female presents to the emergency room with fatigue. The patient states yesterday she had the Moderna COVID-19 The patient states today she had a temperature 101.8° prior to arrival. Her son noted that she was having episodes of urinary frequency and also that she was profoundly weak and fatigued. They denied falling or hitting her head. The patient also states she been having nausea vomiting with diarrhea.
79 2021-01-13 heart rate decreased EXTREME LETHERGY, ELEVATED HEARTRATE, ELEVATED FEVER, NAUSEA, FATIGUE
79 2021-01-18 fainting Two days after her shot, she was sitting down working on her computer paying bills. She became nause... Read more
Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.
79 2021-01-18 dilation of blood vessels on 1/13/21 after the shot and stayed at rest area for 15 minutes, as we went outside , walking to th... Read more
on 1/13/21 after the shot and stayed at rest area for 15 minutes, as we went outside , walking to the parking lot, I noticed a distinctive stinging pain on back of my right hand below thumb, I saw puff veins and a quarter-size lump that was very painful. I took Tylenol and put on my arm-wrist wrap wrapping overnight, it started to get warm and red the next two day. I called my primary physician on Monday 1/18/21 and have a victual visit for 15minutes at 3PM. It is getting better as of now on 1/19/21.
79 2021-01-23 hypertension Day of injection arm a little sore. Next day (Friday) felt perfectly fine and spent the day at home ... Read more
Day of injection arm a little sore. Next day (Friday) felt perfectly fine and spent the day at home doing usual house cleaning and laundry. Felt fine in the evening and Saturday morning was extremely fatigued, loss of equilibrium, and elevated blood pressure. This condition remained for a few days and on Tuesday my pressure was somewhat down and I saw my doctor. He suggested that since I was doing a little better had NO other symptoms such as fever or chills or muscle aches I would be better in time. It was a rough week feeling so unlike my self but I pushed through. I see the doctor again on Tuesday the 26th. I have never had any reaction to any other vaccine such as flu or shingles vaccine at any time. I am an active woman who exercises and walks to the beach near my home frequently every week. I am anxious about the second dose of the vaccine. I have an appointment on Thursday, February 4th. Hopefully all my strength will have returned by then. I feel like I'm still only 80% back to normal. I have spoken to a young woman who called me back. I would like very much to speak with a medical person who can give me some feedback on my response to the vaccine. That would be reassuring that I am not alone with these side effects. Thank you.
79 2021-01-23 oxygen saturation decreased Patient obtained initial dose of Moderna vaccine on Thurday, Jan 14. No adverse effects reported dur... Read more
Patient obtained initial dose of Moderna vaccine on Thurday, Jan 14. No adverse effects reported during initial 15 minute post vaccine waiting period. Saturday morning (Jan 16), patient developed severe cough, labored breathing, and fever. Additionally patient mental status changed suddenly, became non-communicative (unable to speak, but would scream if she was touched). O2 status was irregular, dropping to 78. Sunday morning, EMT and then hospice was hospice called. Monday morning, after hospice emergency kit was initiated, patient passed away.
79 2021-01-24 hypertension Headache, nausea, fever, chills,body ache, high blood pressure
79 2021-01-24 loss of consciousness Passed out; Felt weak; Sweaty; Could not walk; Arm still sore at the left arm injection site; A spon... Read more
Passed out; Felt weak; Sweaty; Could not walk; Arm still sore at the left arm injection site; A spontaneous report was received from a consumer, who was an 80-year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out, felt weak, sweaty, couldn't walk, and arm still sore at the left arm injection site. The patient's medical history was not provided. Concomitant product use was not reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient woke up real sweaty at 3 am. She got up and went to the bathroom and passed out. The patient reported that she fell on the commode then got to the floor because she felt weak and could not walk. Once she regained her strength, she returned to bed. On 07 Jan 2021, the patient reported that her arm was still sore at the injection site and continued to feel weak. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events, passed out, sweaty, and couldn't walk were considered resolved on 06 Jan 2021. The outcome of the events, felt weak and arm still sore at the left arm injection site, were considered not resolved.; Reporter's Comments: This case concerns an 80-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Loss of consciousness, the non-serious listed event of Injection site pain, and the non-serious unlisted events of Asthenia, Hyperhidrosis, and Gait disturbance. Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
79 2021-01-25 blood pressure increased Patient reports 1 day after vaccination, blood pressure rose to 210/120 and patient had to be rushed... Read more
Patient reports 1 day after vaccination, blood pressure rose to 210/120 and patient had to be rushed to ER. Patient was treated in ER and followed up with PCP. PCP advised Patient not to have second dose of Covid-19 vaccination.
79 2021-01-25 loss of consciousness, cerebral haemorrhage After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient st... Read more
After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient struck head and received a concussion, broken nose, brain bleed, tear in the lip and damage to 6th cranial nerve in right eye. Patient has double vision now.
79 2021-01-25 palpitations Patient called over nurse and stated she felt like her heart was racing. Vitals taken and pulse 64-... Read more
Patient called over nurse and stated she felt like her heart was racing. Vitals taken and pulse 64-72 and regular. Patient states she is feeling very emotional and she states she thinks this is anxiety. Patient reassured and monitored until 2 :20. All symptoms resolved and patient states she felt fine prior to discharge
79 2021-01-25 pulmonary embolism, fibrin d dimer increased Acute onset of SOB presented to ED and diagnosed with a pulmonary embolism. Tested positive for SAR... Read more
Acute onset of SOB presented to ED and diagnosed with a pulmonary embolism. Tested positive for SARS-Co-V-2 on 01/25/21 using NAT.
79 2021-01-27 blood glucose increased Extreme fatigue/weakness Muscle aches Blood glucose levels over 300
79 2021-01-27 haemoglobin decreased 1/2/21: Redness/warmth/in duration observed to right arm injection site. c/o pain to right arm 1/3/2... Read more
1/2/21: Redness/warmth/in duration observed to right arm injection site. c/o pain to right arm 1/3/21: Redness/induration improving. Warm to touch with mild complaints of pain Resolved with no further action
79 2021-01-27 haemoglobin decreased 1/2/21: redness, warmth, induration observed to right arm injection site. c/o pain to arm. CBC w/dif... Read more
1/2/21: redness, warmth, induration observed to right arm injection site. c/o pain to arm. CBC w/diff ordered to be drawn 1/4/21 1/3/21: Redness/induration improving. remains warm to touch and mild c/o pain Resolved
79 2021-01-28 palpitations, hypotension, fast heart rate a few minutes following the injection patient reporting a feeling of heart racing and appeared to be... Read more
a few minutes following the injection patient reporting a feeling of heart racing and appeared to be sweaty. Vitals showed that patient was tachycardic and hypotensive. EMS was called. 2 doses of 0.5 mg EPI was given IM 5 minutes apart along with 100 MG of Benadryl.
79 2021-01-29 palpitations Swollen tongue, chest palpitations, SOB
79 2021-01-31 chest discomfort Jan 24 - shortness in breathe, back and lungs hurt with deep breathe and pressure in chest lasted ... Read more
Jan 24 - shortness in breathe, back and lungs hurt with deep breathe and pressure in chest lasted 2 1/2 days. Jan 28- large red rash on arm itchy , sill red . Also having light headiness and pressure in chest and short of breath at time
79 2021-02-01 chest pain On 1/28/2021, starting having severe pain in chest/lungs and especially a quarter size area above ri... Read more
On 1/28/2021, starting having severe pain in chest/lungs and especially a quarter size area above rib cage located on top of right breast next to breast bone. This area was especially painful when pressure applied. No shortness of breath. Symptoms lasted for about 10 hours and subsided somewhat on 1/29/2021. Severe pain symptoms returned early morning on 1/30/2021 and resulted in my going to the ER at the local hospital around 10:00 a.m. An EKG , CT scan, and blood tests determined no heart attack or other life threatening conditions and I was released from the hospital around 4:00 p.m., still experiencing pain without a cause being determined. Pain and painful area were no longer present on 1/31/2021.
79 2021-02-01 low blood oxigenation Vaccination date: 1/30/21. Nausea, vomiting & abdominal pain started 1/31/21, day after vaccination.... Read more
Vaccination date: 1/30/21. Nausea, vomiting & abdominal pain started 1/31/21, day after vaccination. Presented to emergency room 2/1/21. found to be hypoxic 85% (pt. had not been on supplemental 02). chest x-ray showed some patchy opacities likely COVID-19 induced fibrosis (per MD progress notes)
79 2021-02-02 chest discomfort Immediately had visual disturbance: couldn't focus clearly. And felt tingly-sensation all across che... Read more
Immediately had visual disturbance: couldn't focus clearly. And felt tingly-sensation all across chest, deep inside, very uncomfortable and scary, and couldn't get a deep breath. Visual problem lasted about 1 hr.; chest/lung feeling lasted about 5-8 mins., tightness in chest lasted about 10-15 mins. Later in afternoon had pain/edema at injection site, left shoulder joint pain. As of today, 2/3, it's minimal.
79 2021-02-02 oxygen saturation decreased, chest discomfort Tightness in chest, easily short of breath with lower oxygen levels. Oxygen level when vaccine admin... Read more
Tightness in chest, easily short of breath with lower oxygen levels. Oxygen level when vaccine administered was 97. Following few days concerning so bought pulse/ox monitor Thursday 1/28. Oxygen readings ranging 92-94 from 1/28 onward. Second side effect noted evening of 1/24: bright red as if sunburned throat and center of upper chest and puffy. as of 2/3/21 red color and puffiness diminished.
79 2021-02-04 blood pressure increased swelling, redness, tenderness at site of shot. Red face and warm forehead, no thermometer to check... Read more
swelling, redness, tenderness at site of shot. Red face and warm forehead, no thermometer to check but believe slightly elevated temp. Later, circa 9AM, face redness and warm disappeared. Otherwise feels good.
79 2021-02-04 cerebrovascular accident Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nys... Read more
Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nystagmus; Throat swelling; Dizziness with vertigo; Dizziness with vertigo; A spontaneous report was received from a nurse concerning a 79-year-old, white, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. The patient's medical history, as provided by the reporter included anemia, overactive bladder, fibroid cystic disease, allergy to fluoroquinolone, ciprofloxacin, povidone iodine, morphine and adhesive tape. The concomitant medications reported included atorvastatin, calcium, colecalciferol, metoprolol succinate, pramipexole hcl and prasugrel hcl for unspecified indications. On 07 Jan 2021, 11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced stroke like symptoms, couldn't speak, shortness of breath and throat swelling. It was reported that the patient was hospitalized for acute stroke. On an unknown date, while still being hospitalized, the patient developed, dizziness with nystagmus and dizziness with vertigo. The lab findings included, magnetic resonance imaging (MRI) and computed tomography (CT) scans as negative for acute findings, electrocardiography (EKG), complete blood count (CBC), X-ray and chemistries were reported as within normal limits. The patient remained hospitalized for 2.5 days while the symptoms improved. On 09 Jan 2021, the patient was discharged. On 20 Jan 2021, the reporter stated that the patient felt weak and tired without other symptoms. It was also noted that the patient's discharge summary stated the patient's symptoms may be worse following a second dose of mRNA-1273 vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. were considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 79-year-old, white, female patient with medical history of anemia, overactive bladder, fibroid cystic disease, who experienced the serious, unexpected event of stroke, Aphasia, dyspnea and non-serious, unexpected events of , dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness. The events of stroke, Aphasia, Dyspnea and pharyngeal swelling occurred 11 hours after the first dose of mRNA-1273 (Lot number: 025J20-2A) administration and the events of dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness occurred on an unknown date while the patient was still hospitalized. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
79 2021-02-08 heart rate increased Reports feeling elevated heart rate post vaccination; Medical monitoring x 30 minutes; Vitals asses... Read more
Reports feeling elevated heart rate post vaccination; Medical monitoring x 30 minutes; Vitals assessed BP 120/60 HR 96 02 sat 98%. rest "Feels better" after rest. Released to home, advised to f/up as needed with PMD.
79 2021-02-09 heart rate irregular Pt received dose #2 Moderna COVID vaccine 1/26/21 @ Vaccine Clinic. Pt presented to PVH ED 1/29/21 @... Read more
Pt received dose #2 Moderna COVID vaccine 1/26/21 @ Vaccine Clinic. Pt presented to PVH ED 1/29/21 @ 0732 for workup. "Patient states that she got her Covid vaccine 3 days ago, had 1 day of myalgias, flulike symptoms, yesterday she felt much better however she felt that her heart was beating irregularly and she was feeling anxious. This persisted through the night. She denies any chest pain, shortness of breath. Patient is scheduled for follow-up with her cardiologist later next week." Afib, tachycardia, palpitations. Rhythm self converted. Given NS bolus and discharged home without further escalation of care. Entered by PSS for tracking.
79 2021-02-11 blood glucose increased (1) fatigue beginning at 7pm, (2) from 2am until about 2pm the next day: headache, body aches (arms,... Read more
(1) fatigue beginning at 7pm, (2) from 2am until about 2pm the next day: headache, body aches (arms, legs, back, neck), chills, fever 101°, heavy fatigue, sleeplessness, (3) high blood glucose levels all the next day. (4) At this time injection arm still sore, somewhat lightheaded,.
79 2021-02-11 chest discomfort guy put the needle in and the man pushed when he put the needle in and i think he hit the bone and i... Read more
guy put the needle in and the man pushed when he put the needle in and i think he hit the bone and i cant lift my arm today., I don't have fever but i have chills, and body aches, i have tightness in my chest.
79 2021-02-14 blood glucose increased, oxygen saturation decreased Here, brought in by EMS with complaints of having body aches, headaches, some cough, and generally n... Read more
Here, brought in by EMS with complaints of having body aches, headaches, some cough, and generally not well since she got her second Covid Vaccine. She states that she has not been taking any tylenol because she did not have any. Denies nausea and vomiting and denies any dysuria. Her friend that is a retired nurse came over to check on her and gave her 1g of Tylenol 70 minutes ago. EMS stated her temperature was 106.7 on scene, but she is 98.4 here. She has no other focal complaints, just has felt bad since the second Covid Vaccine. Her oxygen saturation on admit to the ER was 84%.
79 2021-02-14 oxygen saturation decreased 2/10: fatigue 2/12 @ 1900: SOB, wheeze, rhonchi, decreased SpO2. Tylenol, 2L NC applied, duoneb, IM ... Read more
2/10: fatigue 2/12 @ 1900: SOB, wheeze, rhonchi, decreased SpO2. Tylenol, 2L NC applied, duoneb, IM Solumedrol, ST CXR, mucinex 2/12 @ 22:00 SpO2 70's, transfer to Hospital via EMS @ 22:30
79 2021-02-14 transient ischaemic attack On Monday February 8 , i was hospitalized for TIA.
79 2021-02-15 cerebral haemorrhage, loss of consciousness Blacked out; fell down the stairs; concussion; damaged or severed 6th cranial nerve to right eye; br... Read more
Blacked out; fell down the stairs; concussion; damaged or severed 6th cranial nerve to right eye; brain bleed; split lip; A spontaneous report was received from a consumer concerning a 79-years-old, female patient who received Moderna's COVID-19 Vaccine, and who blacked out, fell down the stairs, brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The patient's medical history included diabetes, two unspecified high blood pressure medications and naproxen sodium. Products known to have been used by the patient, within two weeks prior to the event, included Sitagliptin and blood pressure medication. On 21 Jan 2021, approximately one and half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient "blacked out" while walking downstairs after one in and half hours of receiving vaccination. Patient was hospitalized from 21 Jan 2021 until 22 Jan 2021. Patient has a brain bleed and a concussion, damaged 6th cranial nerve to right eye, and split her lip which need stitches. Treatment for the event included Tylenol as needed. Action taken with mRNA-1273 in response to the events was withdrawn. The events blacked out and fell down the stairs was resolved on 21 Jan 2021. The outcome of the events brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip was unknown.; Reporter's Comments: This case concerns a 79 year old female patient with medical history of diabetes, two unspecified high blood pressure medications and naproxen sodium, who experienced serious unexpected events of fall, cerebral hemorrhage, loss of consciousness, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The event occurred approximately one and half hours after first dose of the study medication administration. Treatment included Tylenol as needed. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the subject's underlying medical condition could remain a confounder.
79 2021-02-15 chest discomfort A few hours later, my head and bones and muscled started hurting. I was hurting really badly when I ... Read more
A few hours later, my head and bones and muscled started hurting. I was hurting really badly when I woke up this morning. I had a little nausea and my hips felt like they were going to collapse. I started coughing and developed a fever. The muscle pain is very bad. my chest area is very uncomfortable. ( its not over my heart, its higher up) I took Tylenol that seems to be helping the muscle pain a little.
79 2021-02-15 heart rate increased COVID-19 Vaccine EUA-FDA/CDC Vaccine Adverse Event; Onset: 3:30 pm Headache, fatigue, dizziness, jo... Read more
COVID-19 Vaccine EUA-FDA/CDC Vaccine Adverse Event; Onset: 3:30 pm Headache, fatigue, dizziness, joint pain, muscle pain, chills, rapid heart, some GI distress. Duration: 28 hrs. Tylenol 500 mg. kept it under control.
79 2021-02-18 hypotension 9:05 AM on 2/10/21 - Fever of 101.3F with lethargy; emesis x1 followed by Respiratory distress (O... Read more
9:05 AM on 2/10/21 - Fever of 101.3F with lethargy; emesis x1 followed by Respiratory distress (O2 sat 90% room air, RR 40); HR 115 regular rhythm; decreased breath sounds with rales upper lobes and no breath sounds at base; tranferred via EMS to local hospital ER where received 2L fluids and admitted to care of hospitalist service with primary diagnosis of "adverse effect of COVID-19 vaccination and possible pneumonia." Presenting hypotension improved with fluid bolus and Zosyn IV was started empirically.
79 2021-02-18 loss of consciousness laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have... Read more
laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain); horrible pain on left side (side of the injection); awful pain on left leg; could not raise leg; congestion in head, like a sinus infection; tiredness/fatigue; Headache; Chills; A spontaneous report was received from a consumer, a 79-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, tiredness/fatigue, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection. The patient's medical history was not provided. Her allergies included sulfa, mycin, meloxicam and glycopyrrolate. Concomitant medications included blood pressure medication (name not reported). On 28 Jan 2021, approximately one day prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 028L20A) on the left side (anatomical location not reported) for prophylaxis of COVID-19 infection. On 28 Jan 2021, on the night of the vaccination, the patient woke up with a horrible pain one her left side (side of the injection), headache, chills, fatigue/tiredness, an awful pain on her leg, and congestion in her head, like a sinus infection. She got up thinking that walking would make the pain on her leg go away, but it did not. When the patient tried to go back to bed, she could not raise her leg so she laid on the floor and she did not know if she passed out on the floor or fell asleep (she thought she could not have fallen asleep with such pain). When the patient woke up, she could move her leg normally. Treatment information was not provided. Action taken in response to the events was unknown. The events, laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection were considered resolved on 29 Jan 2021. The event, fatigue/tiredness was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 79 year old female subject, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# 028L20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
79 2021-02-19 hypertension, oxygen saturation decreased 2nd dose lot #042L20A. Had not reaction the 1st shot. 2nd shot (Tuesday) within few hours was cold... Read more
2nd dose lot #042L20A. Had not reaction the 1st shot. 2nd shot (Tuesday) within few hours was cold and tired. Next morning (Wednesday) temp which is normally 96.9 was 100 in am and 102 in pm. Was extremely exhausted. Oxygen sat which is normally 99 was running around 92. Next morning (Thursday) temp 99.9 and was exhausted all day. I can not say if aches was from COVID as I am always somewhat achy. Friday woke up feeling great but with a few hours started to feel strange - took blood pressure and was 102/56 in am. Later in afternoon was at 136/90. Oxygen sat back to 99 all day. Blood pressure been running high since.
79 2021-02-21 chest discomfort Immediately nose started running, backdrip, hoarseness. After I left with my daughter, cough, mucou... Read more
Immediately nose started running, backdrip, hoarseness. After I left with my daughter, cough, mucous in chest, hoarseness, heaviness in chest, tickle in chest Have been on Benadryl and Nasacort since. Today is the 6 th day and I still need Benadryl every four hours Need a spray for chest. Have used albuterol. Tomorrow I will speak to the doctor
79 2021-02-21 low blood oxigenation Hypoxic; Tested positive for COVID; A spontaneous report was received from a physician concerning a ... Read more
Hypoxic; Tested positive for COVID; A spontaneous report was received from a physician concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic and tested positive for COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, approximately 1 day prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient started showing symptoms of COVID and she tested positive for the virus that same day. She received Regeneron antibody infusion. On 16 Jan 2021 (day 4), the patient became hypoxic and was admitted to the hospital for 2 days. The patient was discharged not needing oxygen. She was greatly improved on Day 7. Treatment provided included Regeneron antibody infusion. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events hypoxia and COVID-19 was unknown.; Reporter's Comments: The patient had COVID symptoms one day after mRNA-1273 vaccine administration. The events were consistent with increased risk of respiratory complications associated with viral infection in pandemic set up. Based on test results the events are assessed as unlikely related to mRNA-1273.
79 2021-02-21 oxygen saturation decreased Short of Breath, Spo2 74%
79 2021-02-22 cerebrovascular accident Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations). In... Read more
Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations). In ER 1/2/2021-CT of head(WNL), MRI (saw lesion and physician thought she had a stroke). Neurologist consult on 1/3 and felt it was not a stroke and unsure the reason of dizziness.. 1/3 no arm or leg weakness. Order to see a cardiologist d/t residual dizziness and advised against 2nd moderna covid 19 vaccine.
79 2021-02-22 heart rate increased Severe chills, 100.9 temp, elevated heartrate (88 bpm) began around 9 PM, lasted 2 1/2 hours. Used ... Read more
Severe chills, 100.9 temp, elevated heartrate (88 bpm) began around 9 PM, lasted 2 1/2 hours. Used heated blankets to help convulsive chills . Took one Extra Strength Tylenol. Fever gradually lessened, returning to normal 48 hours after the injection.
79 2021-02-22 heart rate irregular, cardiac arrhythmia, heart rate increased Day 1 Rapid heart rate, Fatigue, chills, slight temp, Slept off and on 24 hrs thru Day 2 Day 3... Read more
Day 1 Rapid heart rate, Fatigue, chills, slight temp, Slept off and on 24 hrs thru Day 2 Day 3 Red rash over both arm pitts, below breasts, upper thighs, Rapid heart pulse, irregular pulse, called and visited Cardiology Clinic for Ekg confirmed PVCs Day 4 Light headed, dizziness affecting gait, forced lying down , general brain fog, rash continued, shortness of breath, rapid heart rate, went to ER, saw nurse for Ekg, blood work, blood pressure, Tylenol 100mg 3x a day Day 5
79 2021-02-22 loss of consciousness Grandson reported that she passed out while getting dressed for the day and that her arm was extreme... Read more
Grandson reported that she passed out while getting dressed for the day and that her arm was extremely sore and painfully. At the time of event it was reported that her BP was WML and she had not eaten since the night before. She is not a diabetic.
79 2021-02-24 heart rate decreased, fainting Pt felt "off" some minutes after receiving vaccine. reported to staff and fainted upon standing. ea... Read more
Pt felt "off" some minutes after receiving vaccine. reported to staff and fainted upon standing. eased her to floor and elevated legs. regained consciousness immediately. called 911. heart rate low blood pressure normal. clammy before faint quickly regained color. EMS took over and transported pt to hospital
79 2021-02-25 cerebrovascular accident left sided weakness; Stroke like symptoms; Slurred speech; Pneumonia; spontaneous report received f... Read more
left sided weakness; Stroke like symptoms; Slurred speech; Pneumonia; spontaneous report received from a Consumer concerning, 79-year-old female patient who received the first dose of Moderna COVID-19 vaccine and woke up the next morning not feeling well. /PT: [Not Feeling Well]. The patient's medical history included COPD, hypertension and hyperlipidemia. Patient allergies included sleep medications. Patient's concomitant included Gabapentin, Simvastatin, Advair, Spiriva and Proventil. On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in left arm (Batch #: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter called on behalf of her mother. Patient daughter stated that her mother received the Moderna COVID-19 vaccine on 04FEB2021 and on 05Feb2021 her mother woke up and wasn't feeling well. She stated her mother had weakness on her left side. The daughter stated that ambulance took her mother to hospital. The daughter stated that her mother had stroke like symptoms. The daughter stated her mother had difficulty speaking and slurred speech. The daughter stated the doctor Called it "Neglect for sensation". The daughter stated her mother was treated like she had a stroke. The daughter stated that the doctor gave her mother a "Clot buster" treatment and it started to normalize. The daughter stated the MRI was negative. She daughter that her mother was still hospitalized and now has pneumonia. Wanted to know if this has been previously reported. Treatment that was given in the hospital was a "Clot Buster" Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Hemiparesis, dysarthria, and pneumonia were consistent with increased risk of cerebrovascular accidents related to high blood pressure confounded by elderly age of patient. Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
79 2021-02-25 coughing up blood, blood vessels inflammation vasculitis; coughing up blood; really bad head cold; dizzy; Started gettting sick; A spontaneous rep... Read more
vasculitis; coughing up blood; really bad head cold; dizzy; Started gettting sick; A spontaneous report received from a Consumer concerning, 79-year-old, female patient who received dose of Moderna COVID-19 vaccine experienced Vasculitis. The patient's medical history included Afib. Patient's concomitant included Eliquis. On 04FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter reports her mother who is 79-year-old female with no underlining health issues other than Afib, which she takes blood thinners for has been in ICU since 10FEB2021. Patient daughter stated that she was told her mother has vasculitis as a result of the Moderna Covid-19 vaccine. Patient daughter stated that her mother started getting sick on 06Feb2021. She stated her mother started coughing up blood on Sunday 07FEB2021. She stated her mother also had a bad head cold and was dizzy. Patient daughter stated that her mother has some genetic predisposition and the Moderna COVID-19 vaccine triggered it. Patient daughter stated that her mother doctor advised her not to receive the 2nd dose of the Moderna COVID-19 vaccine. Patient treatment included Chemotherapy Infusion (Rituxan) and Blood Transfusion. Action taken with mRNA-1273 in response to the event was withdrawn. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
79 2021-02-25 heart rate decreased Patient received vaccine and proceeded to waiting area. She began to feel "off" and reported. She ... Read more
Patient received vaccine and proceeded to waiting area. She began to feel "off" and reported. She did not improve and staff assisted her to rise and she collapsed and was eased to floor and legs elevated and 911 was called. She did not lose consciousness. She was clammy and then color improved; low pulse; normal BP. No problems breathing and no rash. EMS arrived and transported her to hospital. We later learned she was being transported back and doing fine
79 2021-02-25 lightheadedness 2 episodes in which she wanted to pass out; Ache; Flu like symptoms; Fever; A spontaneous report was... Read more
2 episodes in which she wanted to pass out; Ache; Flu like symptoms; Fever; A spontaneous report was received from a consumer, concerning herself, a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, flu like symptoms and 2 episodes in which she wanted to pass out. The patient's medical history was not provided. Concomitant product use was not provided. On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# 007M20A]) intramuscularly for prophylaxis of COVID-19 infection. On 08-Feb-2021, the patient reported that about 1 to 2 hours after receiving the vaccine, the patient reported that she "wanted to pass out" when she went grocery shopping. The patient also had fever, aches and flu-like symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events of fever, aches, flu like symptoms and "2 episodes in which she wanted to pass out", were considered resolved on an unspecified date in Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
79 2021-02-27 cerebrovascular accident stroke spent 3 days in ICU and saw a neurologist
79 2021-02-27 fainting fever, syncope after vaccine
79 2021-02-28 palpitations Moderna COVID-19 Vaccine EUA Swelling on hands, arms and feet---How likely am I to have swelling wit... Read more
Moderna COVID-19 Vaccine EUA Swelling on hands, arms and feet---How likely am I to have swelling with the second shot?? Many, many strong heart palpitations fatigue!! Body aches Low stamina Chills Sore arm Occasional headache
79 2021-02-28 platelet count decreased, haemoglobin decreased Patient was diagnosed with acute leukemia within 6 weeks of receiving first and 2 week of receiving... Read more
Patient was diagnosed with acute leukemia within 6 weeks of receiving first and 2 week of receiving second Covid Vaccine. I do NOT think vaccine caused the leukemia, but am reporting it in view of timing of her having received the vaccine and being diagnosed.
79 2021-03-01 hypotension Patient became weak and lightheaded after receiving vaccination. Pt states she ahs had some problems... Read more
Patient became weak and lightheaded after receiving vaccination. Pt states she ahs had some problems with low blood pressure lately. Observed patient for 30 minutes after which she felt better and left on her own.
79 2021-03-01 loss of consciousness After awakening at 11p.m., 1a.m. , and 3:00a.m. , I was off balance and found myself on the bathr... Read more
After awakening at 11p.m., 1a.m. , and 3:00a.m. , I was off balance and found myself on the bathroom floor. I must have passed out but don't remember how. I had no injuries that I could see. I lay there for a while. I carefully got up and crawled back into my bed. I lay there until about 6:00 a.m. I again carefully arose, and I felt OK.
79 2021-03-02 cardiac arrest Anaphylaxis Patient "went into cardiac arrest", was taken to ER. Physician stated this was a reacti... Read more
Anaphylaxis Patient "went into cardiac arrest", was taken to ER. Physician stated this was a reaction from the vaccine.
79 2021-03-02 hypertension Severe Headache on February 5th and nausea, headache, and the feeling that I would faint if I stood ... Read more
Severe Headache on February 5th and nausea, headache, and the feeling that I would faint if I stood on the 6th. I checked my BP and it was 128/70. My blood sugar was 80. The symptoms passed by the 7th of February (my 80th birthday).
79 2021-03-03 cerebrovascular accident, blood clot Initial flulike symptoms with fever Tues -Friday. Had a right side stroke 6 AM Saturday morning . R... Read more
Initial flulike symptoms with fever Tues -Friday. Had a right side stroke 6 AM Saturday morning . Rushed to hospital and had a procedure involving a catheter through the body to the clot in the brain. Came out of that with a weekend left side and was medicated through Sunday night. At 10:30 PM Sunday night had a second stroke on the right side. Did not wake from that. Now I?m not expected to survive.
79 2021-03-03 palpitations, fast heart rate tachycardia, palpitations lasting all morning; 2 extra doses of metoprolol
79 2021-03-03 palpitations, fast heart rate tachycardia, papitations lasting 3-4 hours, took extra 25 mg metoprolol
79 2021-03-04 blood glucose increased Patient received second dose of Moderna Covid vaccine at 0930 on 3/4/21 and presented to ED at 1800 ... Read more
Patient received second dose of Moderna Covid vaccine at 0930 on 3/4/21 and presented to ED at 1800 on 3/4/2021 with complaint of weakness and not being able to get out of recliner. Patient was admitted to hospital under observation stay. The following meds were started: pantoprazole 40 mg IVP once and normal saline at 100 mL/hr (ran for 7.5 hours = 750 mL). Patient returned back to her baseline by approximately 1400 on 3/4/21.
79 2021-03-04 cardiac arrest Pt. had a cardiac arrest and expired on 2/20/21.
79 2021-03-05 arrhythmia Patient had long cardiac pauses and had to get a pacemaker. Symptoms started two days after the vacc... Read more
Patient had long cardiac pauses and had to get a pacemaker. Symptoms started two days after the vaccination
79 2021-03-07 atrial fibrillation, heart rate increased A-fib; Rapid heart beat; A spontaneous report was received from a consumer concerning a 79 year old,... Read more
A-fib; Rapid heart beat; A spontaneous report was received from a consumer concerning a 79 year old, female patient who experienced rapid heartbeat and atrial fibrillation (A-fib). The patient's medical history included hypertension and renal disease. Concomitant product used were losartan potassium ,levothyroxine, fluorseminde ,levotiroxine, multivitamin, zinc , vitamin for knee joint movement, vit D3 , alpha lipoic acid, rosuvastatin calcium , elequis, milatonin , probtotic 10. On 27 JAN 2021, approximately 30 minutes prior to the onset of the symptoms, the patient received her first of two planned doses of mrna-1273, batch number was not provided, intramuscularly in an unknown injection site for the prophylaxis of COVID-19 infection. On 27th JAN 2021, after receiving the vaccine she experienced rapid heartbeat and she reached out to the pharmacy where she took the vaccine. From there the pharmacist called 911. On 27th JAN 2021 she was hospitalized, and the hospitalization prolonged for four days and discharged on 31 JAN 2021. Treatment for the event included Eliquis 5 milligrams (mg) and Metoprolol Succinate ER 25mg. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events rapid heart beat and A-fib were unknown.; Reporter's Comments: This case concerns a 79-year-old female, with medical history of hypertension, who was hospitalized with serious unexpected events of atrial fibrillation and heart rate increased. The events occurred the same day as the first dose of mRNA-1273 and were treated with Eliquis and Metoprolol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
79 2021-03-08 chest pain Patient came with husband to Vaccine clinic today 3/5 for 2nd dose of vaccine. Did well during and i... Read more
Patient came with husband to Vaccine clinic today 3/5 for 2nd dose of vaccine. Did well during and immediately after vaccine. Husband states patient has c/o severe chest pressure and pain for several weeks but has refused to come to ER for evaluation. Today, after getting vaccine dose and going to local bank, patient was in passenger side of truck when chest pain started again. Husband begged patient to let him take her to the ER but she said no, I?m fine and I don?t want to go. She then went unresponsive. At a stop light, he was next to a couple of cops who he was able to wave down and proceed to escort them in to ER. Upon arrival to the ER, patient was unresponsive and pulseless. CPR was initiated, 1 defib, and 1mg of epi was given. Return of pulse was obtained, but husband asked for no life support and only comfort measures. Patient was admitted for comfort measures. I do NOT think this was related to her vaccine, but rather the unfortunately end to a sub-acute chest pain patient that declined multiple urgings to seek care. Patient then expired on 3/5/21 at 2037.
79 2021-03-08 loss of consciousness Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Jo... Read more
Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Joint pain; Nausea without vomiting; Low grade fever; A bit of an ache in injection arm; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, passed out, and a bit of an ache in her injection arm. The patient's medical history was not provided. No concomitant medications were reported. On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20a) intramuscularly for prophylaxis of COVID-19 infection. On 19-Feb-2021, the patient received the vaccine around noon and by the evening she could tell things were going downhill. She went to bed early, and throughout the night the injection site was painful, she was fatigued, she had muscle pain, joint pain, nausea without vomiting, and a low grade fever. The patient got up at night to go to the bathroom and got dizzy and passed out. She said she was passed our for barely a minute and when she came too she laid there for a bit before she went back to bed with her husband's help. All day on Saturday 20-Feb-2021 the patient was in bed but by that evening she was able to get up and walk out of the bedroom. On Sunday night 21-Feb-2021, she was able walk up stairs without huffing and puffing and felt much better. The patient states they have recovered from it all except sometimes when doing yoga, they can feel a bit of an ache in the injection arm. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, and passed out, were considered recovered/resolved. The outcome of the event, ache in injection arm, was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected event of loss of consciousness along with NS unexpected dizziness, feeling abnormal, pain in extremity, and NS expected fever, fatigue, myalgia, arthralgia, nausea, vaccination site pain. Event onset the same day as second dose mRNA-1273. Events resolved except arm pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
79 2021-03-09 nosebleed Following the vaccine she was at the grocery store around 5:00 PM, her granddaughter asked her why h... Read more
Following the vaccine she was at the grocery store around 5:00 PM, her granddaughter asked her why her mask was red, and she noticed that she had a dripping nose bleed, and left and by the time she got home it was done. Then, 2/21/21, she had another nose bleed, was at a pizza place in the car, and felt like she had to spit and it was blood and had a smaller nose bleed that did not last night. The next one 2/26/21, was in the store and had a dripping nose bleed again, took a while to get it stopped, but by the time she left the store she was fine. Then Saturday 2/27/21, she kept getting up in the night and had nose bleeds off and on, and managed through the night and the morning. She went to the ER in the morning on 2/28/21, and her nose was packed with dissolving packing and gave her a prescription for 3 pills to take to prevent her from getting an infection. During the night Sunday night she had a very bad night and went to the ER again on 3/1/21 at around 5:00 AM. They then packed her nose with a balloon and then got the first prescription filled that she took. On Wednesday she went back to the ER and they removed the balloon and now has been fine. Her Coumadin has been up and down during this period of time. Her INR reading was 4.5 on 2/28/21, and subsequently has gone down to where it is quite low. No issues with the injection site. She has never had nosebleeds prior to the vaccine. In October/November she had a procedure she had a hernia repair and had a COVID test and since then she has had a tinge on tissue, but not a nose bleed. These were mainly on the right until she had the profuse one, and then it was both nostrils as well as coming out of her mouth. Has an appointment with the ENT on 3/18/21.
79 2021-03-09 hypertension Dizziness. BP 179/97 (pulse 83), 175/96 (pulse 81). O2 sats 98%. Offered water and snack, but patien... Read more
Dizziness. BP 179/97 (pulse 83), 175/96 (pulse 81). O2 sats 98%. Offered water and snack, but patient refused.
79 2021-03-10 blood pressure decreased I notice mild weasing after about 10 minutes but used my Albuterol Sulfate HFA Inhaler. Weasing w... Read more
I notice mild weasing after about 10 minutes but used my Albuterol Sulfate HFA Inhaler. Weasing went away. I did feel fine until I got severe chills about 6 PM. Chills remained for several hours. Went to bed with heavy covers. Woke up about 2 AM with stomach not feeling well. Was dizzy walking into kitchen getting a Sprite. Set in recliner with heavy covers. Took my blood pressure at 5AM & it had dropped to 104 /44 which was apparently why I was so dizzy. I then took a Tylenol and felt fine after 9AM. I still feel fine but wanted to report my extremely low blood pressure which usually is 135/65 in mornings. I' m thankful for the vaccine.
79 2021-03-10 chest discomfort Day after receiving vaccine patient noted tightness in chest and difficulty breathing. Went to loca... Read more
Day after receiving vaccine patient noted tightness in chest and difficulty breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to Hospital, 02/12/21 and discharged 02/13/21. Patient states stress test, echo, and CT with contrast, and xrays all normal. She states hospital did not know what caused her symptoms and could not tell her if this was caused by vaccine. She followed up with her PCP on 02/15 and was told that by her xray it looked like she might have had the starting of something like bronchitis. Administered antibiotic shot and steroid shot and RX inhaler. Moderna COVID-19 vaccine EUA.
79 2021-03-10 chest discomfort Tightness in chest about 3 to 4 hours after the vaccine felt very much like an allergic reaction tha... Read more
Tightness in chest about 3 to 4 hours after the vaccine felt very much like an allergic reaction that I?ve had before
79 2021-03-10 heart rate increased 10 minutes after injection, heart rate escalated to 125 BPM. Since second injection, heart rate, de... Read more
10 minutes after injection, heart rate escalated to 125 BPM. Since second injection, heart rate, despite medication, has consistently been high (95--110 BPM) and BP has been slightly elevated.
79 2021-03-11 atrial fibrillation Pt became encephalopathic, developed afib, and urinary retention. Admitted to the hospital for 2 we... Read more
Pt became encephalopathic, developed afib, and urinary retention. Admitted to the hospital for 2 week stay until encephalopathy resolved. Afib broke spontaneously. Required foley catheter placement.
79 2021-03-11 cardiac failure congestive Developed fever and chills around 6pm on day of vaccination. Severe febrile reaction. Developed resp... Read more
Developed fever and chills around 6pm on day of vaccination. Severe febrile reaction. Developed respiratory distress and became unresponsive. Transported to ED where O2 sat'n on room air was 45%. Intubated and transferred to ICU. Extubated on 2/24/21 and transferred to telemetry floor with nasal cannula. Ultimately stable on room air. Treated for pulmonary edema, cardiogenic shock and acute on chronic CHF. Resolved and back to baseline by 3/4 when she was discharged.
79 2021-03-11 chest pain, blood pressure increased 2nd dose of vaccine rec'd Tuesday afternoon, there was hurting between breast bone, felt really weak... Read more
2nd dose of vaccine rec'd Tuesday afternoon, there was hurting between breast bone, felt really weak, aching, BP went up, and didn't feel well.
79 2021-03-11 chest pain Was napping the day after receiving the vaccine and woke up about 3:00 pm to severe chest pain on th... Read more
Was napping the day after receiving the vaccine and woke up about 3:00 pm to severe chest pain on the right side radiating deep into the shoulder blade. It would last about 5 - 10 min., stop for the same amount of time, then start up again.... on & off until close to 11:00 pm. Since someone else I know had the same thing happen the day after her shot, I assumed I had the same symptom, tho' it was very frightening. A week later after going to bed on Friday night, I woke at 2:00 a.m. to the same pain only this time on my left side. Thinking I could be having a heart attack, I went to the hospital where I was admitted after having a series of tests. I was there for 2 days during which time I also began to have un-controllable diarrhea. Altho' they could find nothing wrong with my heart, after scans, x-rays, a stress test, numerous blood tests etc., they cannot say positively whether or not it was from the Covid vaccine. I tho't it best to report this in case others have similar events. I had the MODERNA vaccine
79 2021-03-11 loss of consciousness I became progressively more sleepy the afternoon after the vaccination, as expected. I did get up a... Read more
I became progressively more sleepy the afternoon after the vaccination, as expected. I did get up and make dinner, then went to bed at 9:15 p.m. on March 8th and slept until 9:15 a.m. March 9th. I felt unstable walking into the bathroom to urinate, and even more unstable waking into the kitchen to take my meds. I passed out and woke up on the floor. I was weak but managed to pull myself up holding on to the kitchen range. I headed for the living room sofa and passed out again, waking up on the floor by the sofa. I'm guessing I was unconscious about 2 minutes each time, but don't really know. I lay down on the sofa and called a neighbor. He thought I should call 911, and they came and drove me to ER . They did an EKG, chest x-ray, and CAT scan of my brain, and drew blood. All results were normal. I returned home that same day (March 9) and had little energy, and ate lightly. When I was getting in bed about 10:30 p.m. I let my head drop on the pillow and the room started to whirl around me for about six seconds. Sometimes when I roll over in bed during the night there is a pause before it feels like the room gives one spin. My scalp is very tender in the large area where I hit it twice when passing out. I'm taking it easy again today, but do feel a little stronger. I am normally exceptionally healthy for my age, and work , traveling to destinations to research and photograph my articles. Both the travel and article take stamina, and I thrive on the work.
79 2021-03-11 palpitations, chest discomfort, blood pressure increased, chest pain Elevated BP, shortness of breath, tightness of the chest/chest pain, palpations, dizziness 11 days a... Read more
Elevated BP, shortness of breath, tightness of the chest/chest pain, palpations, dizziness 11 days after the vaccine. Continued daily for four consecutive days onset.
79 2021-03-11 troponin increased, heart attack 5. Brief History and Hospital Course: Patient is a/an 79 y.o. female with a past history significan... Read more
5. Brief History and Hospital Course: Patient is a/an 79 y.o. female with a past history significant for HTN, HLD, and DM who presented to facility on 3/9/2021 with complaints of severe 8/10 right jaw pain lasting 3 minutes. EKG with new left BBB and troponin mildly elevated 8-17-35-26. She was seen by Cardiology and determined to have NSTEMI and taken for cardiac cath with drug eluting stent placed to LAD. Echo was also ordered with evidence of murmur. Cavity size is normal. Wall thickness is normal. Systolic function is normal. The estimated ejection fraction is 55%. Dyssynchronous interventricular septal motion, likely related to conduction abnormality/bundle branch block. Grade I diastolic dysfunction. Annulus is severely calcified. Severely calcified and restricted opening of posterior mitral leaflet. Mild mitral valve stenosis at the max. She remained stable post stent placement. She remained on dual antiplatelet therapy
79 2021-03-13 cerebrovascular accident Son reports the day after the vaccination, the patient had a stroke while waiting in the pre-op area... Read more
Son reports the day after the vaccination, the patient had a stroke while waiting in the pre-op area for a trigger finger surgery. Patient had not been asked about pending surgeries or other medications on day of vaccination. Son reports patient stopped taking blood thinning medication 2 days earlier because of surgery. According to son, patient's symptoms have resolved and patient did return for second dose on 2/26/2021.
79 2021-03-13 chest pain, pulmonary embolism shortness of breath, pain in chest increasingly more severe as time went on. Noticed shortness of br... Read more
shortness of breath, pain in chest increasingly more severe as time went on. Noticed shortness of breath about 12 days after the vaccine was given. I am a 2 mile a day walker and very healthy. It was below freezing and I attributed the shortness of breath to weather. I went to an ER on March 8, 2021 after realizing symptoms were worse. I was admitted with Pulmonary embolism in both lungs and pneumonia in both lungs. The hospitalist could not give me a reason why this happened. He encouraged me to report this incident. You would need to contact him for tests and such. I am a patient. I live where medical help is limited. The vaccine was administered at a clinic but the ER I went to was a different system.
79 2021-03-15 cerebrovascular accident Acute stroke. Left facial droop with dysarthria. Admitted to the hospital and received tPA.
79 2021-03-17 hypotension It started with a headache, and then i was shaky(but that went away) tired,chills, fever 101.6, bloo... Read more
It started with a headache, and then i was shaky(but that went away) tired,chills, fever 101.6, blood pressure was really low (I typically have high blood pressure). Major loss of appetite. Vomited twice. Runny nose. Forgetfulness.
79 2021-03-18 cerebral haemorrhage Patient had chills and low fever (99.4) 8 hours after vaccine. Patient went to bed early (8 PM). P... Read more
Patient had chills and low fever (99.4) 8 hours after vaccine. Patient went to bed early (8 PM). Patient awoke about 2 AM on 03/09/2021, walked through a dark hallway, and fell down a flight of steps. Injuries include 17 fractures (5 vertebrae, 9 ribs, 1 clavicle, 1 area of lower rear skull, and nose), collapsed lung, brain bleed, and cognition issues. This may be a sleep walking or hallucination issue. Patient has no previous history of sleep walking or hallucinations.
79 2021-03-18 blood clot I HAD HEADACHES, CHILLS, DIARRHEA, ACHES AND TIREDNESS BUT MY BIGGEST CONCERN IS THE FACT THAT I WOU... Read more
I HAD HEADACHES, CHILLS, DIARRHEA, ACHES AND TIREDNESS BUT MY BIGGEST CONCERN IS THE FACT THAT I WOUND UP IN THE HOSPITAL ON FEB 8 WITH BLOOD CLOTS DOWN MY ENTIRE RIGHT LEG AND IN MY LUNGS. I NEED TO KNOW IF THE MODERNA CAUSED THESE OR MADE THEM WORSE. I HAD NO IDEA I HAD BLOOD CLOTS BUT MY FOOT, LEG WERE SWOLLEN AND I ACHED FROM MY HIP DOWN THAT LEG. I ACTUALLY THOUGHT IT WAS SIADACA.
79 2021-03-21 heart rate abnormal Heart rate affected - going from 57 to 118 with little or no activity, O2 levels ranging from 77 - 9... Read more
Heart rate affected - going from 57 to 118 with little or no activity, O2 levels ranging from 77 - 98 (after a few minutes of long slow deep breaths when level is low), BP 3 days after injection was 90/60 - had 2 nurses advise not to take cardevilol that evening. (in fact that same day -Sunday- at 4 am, my cat woke me up doing hard chest "paws", realized horrible headache, checked O2 level was 80 . Can tell when O2 level drops - feel lightheaded, sometimes to the point of touching walls, touching backs of chairs when walking to feel secure, Have kept a record for most of the time for first week after 2nd injection, last few days only occasionaly written down information. 319/2021 approx 4:45 pm O2 was 92 HR was 118. On 3/20/21 felt lightheaded, O2 level 73 HR 52 approx 4;25 had walked approx 150 steps to mailbox and back, at 6:09 pm O2 was 93, HR 58, 3/21/2021 8:30 am O2 97, HR 100;. 3/22/2021 12:58 O2 74, HR 52. Today at 8:41 am O2 95, HR 103.
79 2021-03-21 pallor, haemoglobin decreased, anaemia, low blood oxigenation, hypotension Pt. presented to ER on 3/19/2021. Family reports that pt. received her Covid vaccination on 3/17/202... Read more
Pt. presented to ER on 3/19/2021. Family reports that pt. received her Covid vaccination on 3/17/2021. Since then her stomach started hurting and pt. is lethargic. Pt. did not open eyes when asked questions and was quite pale. Son reports increased confusion last day or two. Pt. reports that she started feeling ill immediately after receiving the injection. Complains of generalized weakness and fatigue. Denies dizziness or lightheaded. C/o abd. pain. Denies nausea, vomiting, but admits to diarrhea. Denies fevers, cough congestion. She is alert to place and name, but unsure of date at time seen in ER. When seen in ER she was afebrile, but hypoxic and hypotensive. Initial saturations were in mid 80's, but dropped to low 60's. With a non-rebreather mask she maintained at 90%. BP 60's systolic but with fluids increased to 90's . No rectal bleed or hematemeis. Diagnosis of septic shock, anemia, elevated LFT's, pneumonia, and UTI.
79 2021-03-23 chest discomfort cardiovascular event; Tightness in chest; Difficulty Breathing; Bronchitis; A Spontaneous report wa... Read more
cardiovascular event; Tightness in chest; Difficulty Breathing; Bronchitis; A Spontaneous report was received from a health care professional concerning a 79 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cardiovascular symptom, Chest discomfort, Dyspnea, Bronchitis. The patient's medical history as provided by the reporter included Neuropathy of feet, elevated Cholesterol, Osteoarthritis, Aortic aneurysm. Concomitant medication included Levothyroxine sodium, Sumatriptan, Rosuvastatin, Piroxicam and Vitamin D On 11 Feb 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: MOD012M20A ) intramuscularly in the right arm for prophylaxis of covid 19 infection. On 12 Feb 2021, the patient had tightness in chest and difficulty in breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to hospital on 12 Feb 2021 and discharged on 13 Feb 2021. She had stress test, echo, CT and x-rays all were normal. She followed up with her PCP on 15 Feb 2021 and was told that she might have starting of something like bronchitis. The events caused hospitalization and was serious. Treatment included antibiotics and steroid shot and prescribed inhaler. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, Cardiovascular symptom, Chest discomfort, Dyspnea, considered recovered on 13 Feb 2021 and outcome of the event Bronchitis considered recovered on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
79 2021-03-23 chest pain, chest discomfort 79 year old Female received the 1st dose of the Moderna COVID-19 Vaccine Lot# 030A21A on 03/12/2021... Read more
79 year old Female received the 1st dose of the Moderna COVID-19 Vaccine Lot# 030A21A on 03/12/2021 @ 09:40. Pt was placed in observation for 30 minutes and then released. On the drive home pt felt tightness in the chest, chest pain, roof of mouth was swelling and burning, severe itching on the arm, (shortness of breath was experienced while walking to the car), and immediately drove to ED. Pt was admitted to the ED 03/12/2021 @ 11:00 and was discharged 03/12/2021 @ 12:30. Pt was given Prednisone, Benedryl, Pepcid, Potassium, and Clonidine in the ED. Upon discharge, pt was advised by the ED to come back if symptoms come back/worsen, make an appointment with primary doctor, and was given a prescription for Prednisone and Atarax (hydroxyzine) 25mg. Morning of 03/13/2021 pt reported throat was narrowing, dificulty swallowing, lips feeling tingly, and shortness of breath when normally walking down the hall. Pt went to ED , was admitted 03/13/2021 @ 12:00 and discharged same day 03/13/2021 @ 17:00. Pt takes Amlodipine 5mg qd, Levothyroxine 25mcg qd, Losartan 50mg bid, Furosemide 40mg qd, Diltiazem 120 mg qd, Tizanidine 2mg qhs, Anatrozole 1mg qd, Venlofaxine ER 37.5mg qd, Clonidine 0.1mg (PRN when SBP > 170), K 20 mEq, Folic Acid, B12, Homocysteine Factor, IBU (PRN for discomfort), and Cetirizine. Pt is diagnosed with osteoarthritis, obstructive sleep apnea, degenerative joint disease, degenerative dsic disease, scoliosis, hypertension, cardiac arrhythmia, hypothyroidism, breast cancer remission (5 years of remission on the left breast and 4 years of remission on the right breast). Pt is allergic to Sulfa drugs, Nitrofurantoin (Macrobid), and Prempro. Pt made an appointment with the primary doctor for 04/01/2021 and the cardiologist appointment is scheduled for 04/22/2021. Pt was advised to call cardiologist and move the appointment to the next availability, consult primary doctor and cardiologist to see if it is advised to received the second dose and abide by their recommendation, and immediately go to the ED for for any symptoms/side-effects. SPI was consulted and Dr was notified.
79 2021-03-24 cerebrovascular accident Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report wa... Read more
Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers, lost speech, lost eyesight. The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided. On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection. On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak. Patient went to hospital and treatment activities for events was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine. Critical details such as the onset date of the event is lacking. Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.
79 2021-03-24 haemoglobin decreased, platelet count decreased, very slow heart rate To er for eval of seizure activity at hospital . Nurse reported that seizure activity lasted 1.5 m... Read more
To er for eval of seizure activity at hospital . Nurse reported that seizure activity lasted 1.5 min and took approx. 30 minutes for her to start " coming around" to her self. Patient was bradycardic en route to hospital. er hpi: "79 y.o. female who presents with seizure activity. Patient is brought to the ER via EMS from nursing home with new onset seizure. Nursing home staff reports patient had tonic-clonic seizure which lasted approximately 1 min. Patient was apneic. Patient is slightly postictal but no urinary incontinence. Patient has no known history of seizure disorder. Patient is resident of nursing home and is a DNR comfort care. Patient with underlying dementia. In speaking with patient she denies any current headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, fevers, or chills. She is alert only to name." Inpatient admission to hospital 3/24/21 dx acute hepatic encephalopathy, new onset seizure without head trauma
79 2021-03-24 fast heart rate the evening of the vaccine started having tongue swelling, difficulty breathing, itching, and tachyc... Read more
the evening of the vaccine started having tongue swelling, difficulty breathing, itching, and tachycardia. lasted 3 days
79 2021-03-24 transient ischaemic attack Pt suffered a TIA. She had right sided weakness and difficulty speaking. She was taken to the ER, CT... Read more
Pt suffered a TIA. She had right sided weakness and difficulty speaking. She was taken to the ER, CT waa preformed and no abnormalities were detected. The symptoms resolved in 24 hours.
79 2021-03-25 hypertension I detected high blood pressure while at an eye doctor"s office--He had me verify it at my primary ca... Read more
I detected high blood pressure while at an eye doctor"s office--He had me verify it at my primary care physicians office same day. I have never had high blood pressure--always normal or even a little low.
79 2021-03-25 blood clot Blood clots in both legs; Cramps and spasms on her right and left legs; Painful nodules under both a... Read more
Blood clots in both legs; Cramps and spasms on her right and left legs; Painful nodules under both arms and shoulders; Itching down to her toes and left side of the body; Injection site itching; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cramps and spasms on her right and left legs, injection site itching, itching down to her toes and left side of the body/pruritus, painful nodules under both arms and shoulders/nodules and blood clot in both legs/Thrombosis. Medical history was not reported. Concomitant medications included losartan, cetirizine hydrochloride and pantoprazole. On 30 Jan 2021, the patient received her first planned dose of mRNA-1273 (batch number: 007MZ0A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, she had her second planned dose of mRNA-1273 (batch number: 01021A) intramuscularly on left arm. Soon, she developed itching at injection site down to her toes and left side of the body. She developed painful nodules on shoulders as well as both under arms and it was mentioned that the one on left side was severe. On 09 Mar 2021, she began experiencing cramps and spasms on her right and left legs. She was diagnosed with blood clots in both legs while in the emergency room (ER). She was treated with hydroxyzine and apixaban. The event blood clot in both legs was considered to be medically significant. The action taken with mRNA-1273 in response to the events injection site itching, itching down to her toes and left side of the body, painful nodules under both arms and shoulders and blood clot in both legs was unknown. The outcome of the events Cramps and spasms on her right and left legs, injection site itching, itching down to her toes and left side of the body and blood clot in both legs was unknown whereas painful nodules under both arms were still sore but better.. The reporter did not provide any causal relationship between mRNA-1273 and the events injection site itching, itching down to her toes and left side of the body, painful nodules under both arms and shoulders and blood clot in both legs.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
79 2021-03-28 chest discomfort Difficulty swallowing, swollen lips - benadryl Subsequently - Diarrhea, migraines and chest discomf... Read more
Difficulty swallowing, swollen lips - benadryl Subsequently - Diarrhea, migraines and chest discomfort.
79 2021-03-28 heart rate increased Rapid heart rates of about 200 for 3 times this past week, two times lasting about 20 minutes, yeste... Read more
Rapid heart rates of about 200 for 3 times this past week, two times lasting about 20 minutes, yesterday lasting three hours. My husband has experienced fatigue, low fever, weakness starting 5 days after second shot, also.
79 2021-03-28 loss of consciousness, blood pressure increased Severe vomiting, blood pressure spiked at172/157 pulse rate 148, then severe hot flushing sensation ... Read more
Severe vomiting, blood pressure spiked at172/157 pulse rate 148, then severe hot flushing sensation ending in being soaking wet and clammy feeling, dizziness and feeling like I was passing out. Sat down on toilet, called my daughter and all I could say was help, I think I'm passing out. She found me passed out on the toilet , got me to wake up but not coherent. She called 911 and I was checked and taken to emergency room with diagnosis of dehydration caused by the vomiting.
79 2021-03-28 fainting, pulmonary embolism, loss of consciousness, hypotension, cerebrovascular accident Received vaccine on 01/26/2021 and unknowingly experienced event. Early morning of 01/28/2021 had f... Read more
Received vaccine on 01/26/2021 and unknowingly experienced event. Early morning of 01/28/2021 had fainting spell and thought it was caused by low blood pressure. Felt fine for remainder of day. On evening of 01/29/2021 I started having strange symptoms. Could not concentrate, vision impaired and couldn?t figure out what evening meds I needed to take. Decided to go? to hospital on 01/30/2021. Getting ready, I passed out and husband called emergency services. Husband learned later in the day that I had a stroke. Doctors i;nfo?rmed that had blood clots in heart and lungs. Doctors advi;se not to get second vaccine shot.
79 2021-03-30 chest pain Pt presented w/crushing chest pain, diaphoresis, and SOB. Unlikely from vaccination, but entering V... Read more
Pt presented w/crushing chest pain, diaphoresis, and SOB. Unlikely from vaccination, but entering VAERS for "Serious adverse event requiring hospitalization" 39 days COVID vaccination
79 2021-03-30 palpitations, heart rate irregular, palpitations Slight feeling of light headedness. By 9:30 pm pounding heart beat, a few skipped beats with an irre... Read more
Slight feeling of light headedness. By 9:30 pm pounding heart beat, a few skipped beats with an irregular pattern. I could feel my heart beat at the tips of my fingers when I touched something. This lasted for slightly over two hours.
79 2021-03-31 arrhythmia, atrial fibrillation Patient admitted to local hospital for new onset atrial fibrillation/flutter with rapid ventricular ... Read more
Patient admitted to local hospital for new onset atrial fibrillation/flutter with rapid ventricular response. Patient last known well at time of vaccination (no reported complications with 1st vaccination). After 24 hrs, began feeling fatigued, with general malaise, and fever. Presented to hospital ED 4 days after vaccination and found to be in new onset afib/flutter. Required admission and introduction of diltiazem and metoprolol for rate control and started on rivaroxaban for anticoagulation
79 2021-03-31 heart rate increased, blood pressure increased I had Moderna COVID-19 vaccine EUA. Somewhere between one and two weeks following my first injecti... Read more
I had Moderna COVID-19 vaccine EUA. Somewhere between one and two weeks following my first injection, I experienced rapid heartbeat and increased blood pressure. I saw my doctor and he referred me to the hospital ER for further testing. All lab work was WNL.
79 2021-03-31 palpitations Immediately after injection Lips tingled and swelled. difficulty swallowing, On day after: two days ... Read more
Immediately after injection Lips tingled and swelled. difficulty swallowing, On day after: two days of intense headaches, followed by two days of flu-like symptoms and 99.0 fever and heart palpitations, and for the next two weeks intense frequent diarrhea and continuing heart palpitations, which continue to current date.
79 2021-04-04 blood pressure decreased Patient received the above Friday p.m., woke up Saturday with 101.7 temp. Had all day, finally broke... Read more
Patient received the above Friday p.m., woke up Saturday with 101.7 temp. Had all day, finally broke during the night. Sunday & Monday still feel out of sorts. Temp normal but blood pressure on lower side. Reports today still feel unwell; injection site slightly warm, feeling light-headed, slightly nauseous, headache, again lower BP. Took 2 Tylenol @ 4pm.
79 2021-04-04 chest discomfort feels like she is still not okay; choking on the mucus; 7 minutes after first dose immediate allergi... Read more
feels like she is still not okay; choking on the mucus; 7 minutes after first dose immediate allergic reaction; mucus in her nose,terrible back drip; Tickle in her chest,tickle in her throat; heaviness in her chest; hoarseness; cough; lost her voice; described her symptoms as bronchitis like; described her symptoms as laryngitis; felt like she had an entire respiratory infection; A spontaneous report was received from a consumer concerning a 79-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 7 minutes after first dose immediate allergic reaction(hypersensitivity), mucus in her nose and terrible back drip(secretion discharge), tickle in her chest and tickle in her throat(general discomfort), heaviness in her chest(chest discomfort) choking on the mucus(choking), hoarseness(Dysphonia), cough, lost her voice(aphonia), described her symptoms as bronchitis like(bronchitis), described her symptoms as laryngitis(laryngitis), felt like she had an entire respiratory infection,(respiratory infection) feels like she is still not okay(feeling abnormal). The patient's medical history was not provided. Concomitant medications reported were Claritin, Vit D, Calcium Pills, Mirtazapine, antidepressants, multivitamins for drug use for unknown indication. On 16 Feb 2021, approximately 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004MZ0A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the event(s) 7 minutes after first dose immediate allergic reaction , mucus in her nose , terrible back drip , tickle in her chest, tickle in her throat , heaviness in her chest ,choking on the mucus, hoarseness, cough , lost her voice ,described her symptoms as bronchitis like, described her symptoms as laryngitis, felt like she had an entire respiratory infection . Event choking on the mucus was considered medically significant. On 24 Feb 2021, the patient experienced the event(s) feels like she is still not okay. Treatment details included Robitussin and Honey, she has taken Tylenol for symptoms with only 20% relief. Her doctor states that if she does not, improve he will give her prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), 7 minutes after first dose immediate allergic reaction, mucus in her nose,terrible back drip, tickle in her chest, tickle in her throat, heaviness in her chest, choking on the mucus, hoarseness, cough, lost her voice, described her symptoms as bronchitis like, described her symptoms a laryngitis, felt like she had an entire respiratory infection, feels like she is still not okay was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected choking and NS unexpected hypersensitivity, rhinorrhea, discomfort, chest discomfort, dysphonia, cough, aphonia, bronchitis, laryngitis, respiratory tract infection, feeling abnormal. Event onset 7 minutes after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
79 2021-04-04 loss of consciousness The day after the vaccine I was tired, sleepy and "groggy". I went to the toilet and passed out aft... Read more
The day after the vaccine I was tired, sleepy and "groggy". I went to the toilet and passed out after standing up and turning toward the sink to wash my hands. My husband (retired internist) heard a thump and found me on the floor. It took him calling my name 10 times before I woke up. My pulse was strong and heartbeat regular. I don't remember being dizzy or lightheaded, only remember going to the toilet and then waking up and wondering why I was lying on the bathroom rug. I would very much like to know if other people have passed out the day after getting the vaccine.
79 2021-04-04 palpitations Heart palpitations, dizziness
79 2021-04-06 chest discomfort 3/21/2021 Husband , reported that wife attended the Covid clinic 2/13/2021 and received #1 covid vac... Read more
3/21/2021 Husband , reported that wife attended the Covid clinic 2/13/2021 and received #1 covid vaccine about 11:30 AM Soon after she complained of Discomfort at site on right arm with area from shoulder to elbow swollen extremely tight, red, and had rash by evening. Generalized side effects of nausea and weakness with the inability to ambulate unassisted. She did have Covid #2 3/13/2021 with somewhat similar response but not as severe.
79 2021-04-06 nosebleed, hypertension Moderna COVID-19 Vaccine EUA. On early morning of 04/02/2021 arm became very discolored (mostly bri... Read more
Moderna COVID-19 Vaccine EUA. On early morning of 04/02/2021 arm became very discolored (mostly bright red/scarlet color) between elbow and just below vaccination injection site. Through the course of the weekend arm became worse but the initial pain changed to irritation/itching primarily. On 04/05/2021 at 6 a.m. upon wakening arm was still vividly discolored but my blood pressure reading first thing was high (197/99 with a 90 pulse) which is very unusual for me now. Not only that but I also experience at same time a nose bleed. Since other than assuming in general that the arm discoloration connected somehow to the vaccination I had no idea if the spike in BP also connected and the nose bleed (since I rarely have any nose bleeds) I went to the ER - which is a small county hospitals about 3 miles from my home. I did not attempt to take a Clonidine at home before going there as I wanted them to see if there was a connection between these 3 issues. Upon arrival my blood pressure was taken again and it was the same high numbers as at home not long before. The ER doctor on duty that morning unfortunately didn't seem to know what might be wrong with my arm and so she focused on bringing down my blood pressure by instructing a nurse to give me a Clonidine. Within about a half hour when my BP had returned to normal they dismissed me to go home without any actual information as to whether the 3 issues were connected of not and without obviously having a clue as to what the situation was with my arm. During the course of the day my daughter did some research on the internet and determined that it must be 'COVID Arm' that I was suffering from. First thing the next morning (04/03/21) I called my GP doctor's office to try to get an appointment but unfortunately he was fully booked and so instead I called the the local Health Department and spoke with one of the nurses who works in their COVID Vaccination program. On telling her of my experiences she confirmed that it sounded very much like COVID Arm.
79 2021-04-06 blood clot The patient started to feel swelling, redness on the interior of upper right leg.It was a swollen v... Read more
The patient started to feel swelling, redness on the interior of upper right leg.It was a swollen vein. She went to the physician on 2-15-2021. She was diagnosed with having a blood clot and had to have it removed. She is wearing compression stockings now 24/7.
79 2021-04-12 fainting head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzie... Read more
head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzied; irritated; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (head injury/head trauma) and SYNCOPE (syncope/passed out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma. Concomitant products included CLONAZEPAM (KLONOPIN) for Glaucoma. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HEAD INJURY (head injury/head trauma) (seriousness criterion hospitalization), SYNCOPE (syncope/passed out) (seriousness criterion medically significant), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied) and IRRITABILITY (irritated). On 25-Mar-2021, the patient experienced EYE INFECTION (eye infection). The patient was hospitalized from 09-Mar-2021 to 11-Mar-2021 due to HEAD INJURY. At the time of the report, HEAD INJURY (head injury/head trauma), SYNCOPE (syncope/passed out), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied), IRRITABILITY (irritated) and EYE INFECTION (eye infection) outcome was unknown. No treatment medication was included. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-071179 (E2B Linked Report). This case was linked to MOD-2021-071179 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-071179:Case for first dose
79 2021-04-13 cardiac arrest Patient developed diarrhea within hour of receiving injection. She developed shortness of breath re... Read more
Patient developed diarrhea within hour of receiving injection. She developed shortness of breath requiring trip to ED approximately 12 hours later. She had cardiac arrest in ED.
79 2021-04-13 cerebrovascular accident Massive stroke, given tPA, severe reaction, had to be intubated for 3 days
79 2021-04-13 platelet count decreased, low blood platelet count Patient has history of ITP (Immune related thrombocytopenia) which recurred after receiving her 2nd ... Read more
Patient has history of ITP (Immune related thrombocytopenia) which recurred after receiving her 2nd dose
79 2021-04-13 blood clot, atrial fibrillation Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > ... Read more
Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21
79 2021-04-14 heart attack, low blood platelet count DRESS syndrome also with STEMI and shock 2 weeks in the CCU, also developed ITP. Derm biopsy still p... Read more
DRESS syndrome also with STEMI and shock 2 weeks in the CCU, also developed ITP. Derm biopsy still pending. resolved with IVIG and steroids
79 2021-04-14 cerebrovascular accident 4/13/2021 patient had a stroke
79 2021-04-14 fainting Patient presented to ER after a syncopal episode at home. She reports feeling lightheaded and fell ... Read more
Patient presented to ER after a syncopal episode at home. She reports feeling lightheaded and fell to the floor, she is uncertain how long she was unconscious, but when she came to, she called 9-1-1.
79 2021-04-17 atrial fibrillation, heart rate increased, heart rate decreased Fatigue; dizziness; light-headedness; repeated episodes of atrial fibrillation and vascillation betw... Read more
Fatigue; dizziness; light-headedness; repeated episodes of atrial fibrillation and vascillation between low and high heart rates (ranging between 42 and 130 BPM) These symptoms began 2 days after I received the 1st Moderna vaccine and lasted approx. 7 days. Though I was diagnosed with Afib 10 years ago, my prior experience with Affib was limited to 3-4 isolated episodes per year, lasting only 1-3 hours each. My past Afib experiences were never as long or as intense as this experience. It is not clear whether this worsening Afib experience simply coincided with my Covid vaccination or whether there may have been a causal relationship.
79 2021-04-17 atrial fibrillation Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate rangin... Read more
Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate ranging between 37 and 180; nausea; repeated sensation that I might pass out. These symptoms began on 2/23/21, 5 days after receiving the 2nd Moderna vaccine. Symptoms were similar to but more intense than symptoms experienced after my 1st Moderna vaccine. I was taken to the ER during the night of 02/24/2021 beause of intensification of symptoms. Symptoms continued intermittently until 03/23/202 when a cardiac ablation was performed at a Cardiovascular Center. I also experienced some post-op Afib in first 2 weeks following the procedure.
79 2021-04-17 cerebrovascular accident Had blood clots in my brain 4 days later resulting in a stroke
79 2021-04-18 enlargement of the heart 3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who p... Read more
3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also cites dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. At the present again, she just feels achy. There is no chest pain or shortness of breath. No abdominal pain or urinary symptoms. No rash. 3/26/21 admitted 80 y.o. female with a PMH notable for COPD, atrial fibrillation, hypertension, diabetes and obesity who presented on 3/26/2021 for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital from 03/21 through 3/26/2021. Hospital course - The patient is an 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also states dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the machine. Since admit, patient admitted to pain in her back. CT spine showed L1 compression fracture which appeared new. PT worked with patient and felt she should go to rehab for continued therapies.Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. 4/17 ER: 80 y.o. female who presents with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. 4/18/21 ER to admit: dx sepsis 80 y/o F with PMHx COPD with chronic CO2 retention and respiratory failure on 2L NC, OSA, non-compliant with CPAP, myoclonic jerks, essential tremor, type 2 DM, HTN, paroxysmal a.fib on eliquis, essential tremor and recurrent falls with recent L1 compression fracture s/p brace placement, presented to ED on 4/18/2021 for shaking and AMS.
79 2021-04-20 oxygen saturation decreased Patients daughter states that about a week and a half after receiving the vaccine, patient started h... Read more
Patients daughter states that about a week and a half after receiving the vaccine, patient started having trouble catching her breath. On April 9th, she called the squad and they administered a breathing treatment. She showed improvement and was not transported. On April 19th, she went to hospital to be seen in the ER. She was kept in observation status and was discharged home on April 20th. She went home on prednisone of levofloxacin.
79 2021-04-20 blood clot Blood clots
79 2021-04-21 chest discomfort, blood clot Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her ches... Read more
Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her chest started really getting tight she was sweating really bad went to bed slept all day tried walking on Wednesday put a heating pad on her legs with muscle spasms called me at 5 AM to get her to the ER she couldn?t walk her leg swelled up really bad
79 2021-04-21 fainting After 4 hours of the vaccine dose, but within 6 hours; the patient experienced: patient reported let... Read more
After 4 hours of the vaccine dose, but within 6 hours; the patient experienced: patient reported lethargy, "blood spots" in the hand (possibly petechiae), itchiness all over body; bruises on arms; fever and chills; headache; muscle pain. Received the 1st dose vaccine on 3/1/21. Then, on 3/3/21, patient reported fainting, and hospitalized (duration of hospital stay was about 12 hours). After hospital discharge; patient reported that felt all symptoms were resolving.
79 2021-04-22 hypotension Extreme fatigue, chills, muscle pain in back, slight headache, fever, lack of appetite - for 3 days;... Read more
Extreme fatigue, chills, muscle pain in back, slight headache, fever, lack of appetite - for 3 days; then Diarrhea & bloating for 24 hrs; then prior symptoms gone but very weak & tired - for 4 days (the first day had low blood pressure); then general malaise for 1 week
79 2021-04-24 excessive bleeding Eight sessions of diarrhea which led to internal bleeding; fever of 102, and an inability to verbali... Read more
Eight sessions of diarrhea which led to internal bleeding; fever of 102, and an inability to verbalize thoughts with clarity without tremendous concentration.
79 2021-04-24 hypertension Presented to ED with hypertension, BP 198/71, HR 88, RR 20, SpO2 99%, hyponatremia (126) and hyperka... Read more
Presented to ED with hypertension, BP 198/71, HR 88, RR 20, SpO2 99%, hyponatremia (126) and hyperkalemia (5.6). She remained saturating adequately on room air and all inflammatory markers did not show evidence of active disease; thus, ID has recommended not to offer COVID therapeutic protocol
79 2021-04-25 atrial fibrillation Patient lost memory, had vomiting, and very tired, patient had incontinence. patient also went into ... Read more
Patient lost memory, had vomiting, and very tired, patient had incontinence. patient also went into afib.
79 2021-04-26 heart attack Patient presented to the ED on 2/4/21 with NSTEMI and was subsequently hospitalized. She also presen... Read more
Patient presented to the ED on 2/4/21 with NSTEMI and was subsequently hospitalized. She also presented to the ED and was subsequently hospitalized on 2/24/21. These visit were within 6 weeks of receiving COVID vaccination.
79 2021-04-26 chest pain 3 HOURS LATER AFTER VACCINE PATIENT EXPERIENCED: DIZZINESS, BACK AND CHEST PAIN, SHORTNESS OF BREATH... Read more
3 HOURS LATER AFTER VACCINE PATIENT EXPERIENCED: DIZZINESS, BACK AND CHEST PAIN, SHORTNESS OF BREATH, LEG AND STOMACH HIVES, INSOMNIA, AND VOMITING. CONTINUED FOR 3 DAYS. TODAY (ALMOST 2 WEEKS LATER SHE IS FULLY RECOVERED)
79 2021-04-27 brain sinus blood clot Bilateral dural sinus and jugular vein thromboses. Has viridans streptococcal bacteremia. Thromb... Read more
Bilateral dural sinus and jugular vein thromboses. Has viridans streptococcal bacteremia. Thrombosis may be infected. Patient also tested positive for SARS-CoV2 4/23/2021. Being treated with antibiotics, Eliquis. Not thrombocytopenic. HIT studies pending.
79 2021-04-27 chest discomfort patient felt chest pressure, heart raising, intense heat from toe to head in waves, dizziness (walki... Read more
patient felt chest pressure, heart raising, intense heat from toe to head in waves, dizziness (walking on clouds), red and swollen hands
79 2021-04-28 chest discomfort STILL WAITING, SUBSEQUENT EKG, OKAY NOW.. WILL BE HAVING FURTHER TESTING TO SEEK FURTHER INFO ON HE... Read more
STILL WAITING, SUBSEQUENT EKG, OKAY NOW.. WILL BE HAVING FURTHER TESTING TO SEEK FURTHER INFO ON HEART. PRESENTLY AM GOING THUR EXPECTED EFFECTS OF BACK TO SLEEP 14/16 HRS DAILY, SWOLLEN LYMPHS UNDER LEFT ARM ONLY, BACK HEAD PAIN WHEN RESTING, PAIN, PALMS HANDS, SAME PAIN, LEFT AREA ABOVE EAR, INTERMITTENT HEADPAIN DIFFERENT AREAS OF SKULL...
79 2021-04-29 lightheadedness Presyncope directly after injection. SIRVA directly after injection and prolonged. Fatigue, Chills,... Read more
Presyncope directly after injection. SIRVA directly after injection and prolonged. Fatigue, Chills, Muscle Aches in chest and back set in 4/30/21 at 12:00 pm.
79 2021-05-02 ischemic chest pain First night, low energy, upset stomach, brain fuzz. Next day, chills and fever, nausea, heart pain, ... Read more
First night, low energy, upset stomach, brain fuzz. Next day, chills and fever, nausea, heart pain, headache. 3rd day, same, but no heart pain. By 5th day all okay, except some cognitive issues (slower thinking, searching for words, poor memory) still with me on May 3, these are subtle changes, but it's obvious to me they began after this vaccine shot. SERIOUS REACTIONS BEGAN AFTER 2ND COVID SHOT ON 2/26/2021: Pain in neck, hips, head, down left leg. Diagnosed as inflammation and bursitis in left hip, which still remains in May and limits my life in the extreme.
79 2021-05-03 deep vein blood clot, pulmonary embolism Pt has DVT/PE 3 days post vaccination. Pt is being treated with Eliquis.
79 2021-05-03 hypertension Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting dia... Read more
Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia.
79 2021-05-03 ventricular tachycardia ventricular tachycardia: A ventricular high rate detection on 2/12/2021 at 2259 hrs. lasting 6 secon... Read more
ventricular tachycardia: A ventricular high rate detection on 2/12/2021 at 2259 hrs. lasting 6 seconds and 13 beats with max V rate 213 bpm; EGM appeared to show sudden onset and conclusion of V>A on remote device check 2/19/2021.
79 2021-05-04 blood pressure increased, chest pain, heart rate increased, atrial fibrillation Patient began with chest pain onset today while sitting in chair at home. Patient called ems and was... Read more
Patient began with chest pain onset today while sitting in chair at home. Patient called ems and was found to have HR of 193. Patient did 2 vagal maneuvers and hr dropped to 150. Patient reports decreased chest pain, denies cough or n/v. Patient on arrival has an initial HR of 132 and a BP 106/69. Temp 36.6 degrees Celsius. HR decreased to 100 with no intervention. 500mL of fluids given. Diltiazem was not given as HR decreased to 100 and BP was 98/62. Patient reports that she had her COVID19 vaccine yesterday followed by some arm pain and aches in her legs. Patient does have a history of Afib and is on diltiazem at home. Dx with Afib with RVR. Patient will be admitted to the hospital. Patient converted to NSR on her own.
79 2021-05-05 chest discomfort Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt... Read more
Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt like something was stuck in her throat and not feeling right for the past one week had the chills; legs weak, EKG showed ST segment elevation. Patient was transferred to hospital ED and admitted
79 2021-05-05 heart rate irregular, hypotension Sudden onset of irregular heartbeat, low Sudden increase in BP
79 2021-05-06 deep vein blood clot, pulmonary embolism very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder;... Read more
very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder; found two blood clots on lungs and two in legs; found two blood clots on lungs and two in legs; there was damaged to his wife's heart too; weighed165 pounds initially and then went down to 145; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) and CARDIAC DISORDER (there was damaged to his wife's heart too) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A2 or 078A2 and 028A2 or 078A2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing) (seriousness criterion hospitalization), ARTHRALGIA (pain in back of right shoulder) (seriousness criteria medically significant and life threatening), FATIGUE (very tired, slept all day) (seriousness criteria hospitalization, medically significant and life threatening), HYPERSOMNIA (slept all day) (seriousness criteria hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (there was damaged to his wife's heart too) (seriousness criterion hospitalization) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145). At the time of the report, DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs), CARDIAC DISORDER (there was damaged to his wife's heart too) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: two blood clots on lungs and two (abnormal) two blood clots on lungs and two in legs. On an unknown date, Weight: 145 (Low) weighed 165 pounds initially and then went down to 145. The patient was hospitalized for around four days. The patient size of clots as 10 cm and 9cm in the lungs. The reporter stated that Heparin was used in the hospital and after the discharge the patient was put on Eliquis for the next 6 months. The reporter reported that the patient weighed165 pounds initially and then went down to 145 afterwards. Action taken with the mRNA-1273 is considered as not applicable. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.
79 2021-05-06 deep vein blood clot Patient developed a DVT (deep vein thrombosus) in left leg which was diagnosed on 3/6/21.
79 2021-05-06 troponin increased Patient started to develop shortness of breath, worse with exertion after 2nd dose of Moderna. Not ... Read more
Patient started to develop shortness of breath, worse with exertion after 2nd dose of Moderna. Not relieved with inhalers or nebulizers at home. Shortness of breath was relieved by Oxygen provided to her by EMS. Low BNP, elevated Troponins without significant peak noted. Treated for COPD exacerbation, which may have been set off by 2nd dose of Moderna. Patient being treated with 7 day course of increased steroids and Doxycycline.
79 2021-05-07 cerebrovascular accident This 79 year old black female received the Moderna Covid shot on 1/30 /21 and went to the ED on... Read more
This 79 year old black female received the Moderna Covid shot on 1/30 /21 and went to the ED on 2/8/21 and was admitted on 2/9 /21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) (HCC) N17.9 - Acute kidney failure, unspecified
79 2021-05-11 cardio-respiratory arrest Cardio respiratory arrest. During rounds, patient was found without vital signs
79 2021-05-11 pulmonary embolism, anaemia Subsequential PE; Anemia; This spontaneous case was reported by a physician (subsequently medically ... Read more
Subsequential PE; Anemia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Subsequential PE) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis, Hypothyroidism, COPD, Asthma, Drug allergy (Sulfa), Drug allergy (Ceftin) and Drug allergy (Cefuroximine). Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, SALBUTAMOL (ALBUTEROL HFA), DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) and LEVOTHYROXINE for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ANAEMIA (Anemia). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Subsequential PE) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Subsequential PE) and ANAEMIA (Anemia) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-029848 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
79 2021-05-12 oxygen saturation decreased, low blood oxigenation ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Gen... Read more
ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient reports that she received her second COVID-19 vaccine approximately 1 week ago. Tolerated this without any particular symptoms. She has had 2 days of watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting earlier today. She is denying any particular abdominal pain. Does believe she felt her urine burning earlier today but has had no gross hematuria. Denies any flank pain. No ill contacts although her husband has been at home with a slight cough. Patient does have a cough presently but it is nonproductive. She is denying any particular chest pain or subjective shortness of breath. No rash or unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19. She had however received a second dose of COVID-19 a week before and was discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911. Upon EMS arrival patient was saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was eventually placed on 10 L oxygen support. She was noted to be in significant respiratory distress during speech. Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia. She had evidence of acute on chronic hypoxic respiratory failure as well. She was started on IV antibiotics, as well as remdesivir and Decadron at high dose. Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy. She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment. She did not respond to remdesivir or steroids or antibiotics. Post intubation, she also developed acute renal failure during the course of her admission. Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive. She received full medical treatment, including life support, with minimal improvement. Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia. She was proned, and was unable to sustain oxygen saturations when supine even for short period. Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again. They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy. Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection. She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5. New small left pleural fluid collection. 6. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Portable Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic Echo (tte) Complete Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D, Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is normal in size. Ejection Fraction 55% (normal range 50-70%). All wall segments showed normal motion. Mild concentric LVH. Trivial aortic regurgitation. No additional significant valvular abnormality. No prior study for comparison. Presentation and History: Indication: The patient presents for evaluation of arrhythmia. The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications. Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size. There is mildly increased left ventricular wall thickness. The left ventricular systolic function is normal. The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis. There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison. Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final electronically signed on 4/11/2021 5:10:04 PM with status of Final Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD
79 2021-05-19 chest pain My mom, patient was a health 79 year old women, only two health issues were COPD and moderate dement... Read more
My mom, patient was a health 79 year old women, only two health issues were COPD and moderate dementia. She had even gotten her annual labs done recently which came back all with in normal range, she as far as we knew did not have any issues with her heart. After her first vaccination in March she started to lose interest in things and didn't have energy to be as active as she was. After the second shot with in two days she started to report pain in chest and head and trouble breathing, She went to her PCP on 5/12 and he wanted her to go to a cardiologist, this referral was made but by the 16th she was in the ER due to extreme chest pain and trouble breathing, a stent was placed in her heart on 4/17/21 my mom's 80th birthday. with in 4 days she died. Her heart just deteriorated. i feel that if she didn't get this shot she would be alive today, she was healthy, now she is dead.
79 2021-05-19 transient ischaemic attack Transient ischemic attack; Bad urinary tract infection; Missed her second dose of vaccination; This ... Read more
Transient ischemic attack; Bad urinary tract infection; Missed her second dose of vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) and URINARY TRACT INFECTION (Bad urinary tract infection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg operation and Knee surgery NOS. Concurrent medical conditions included Anxiety, Fibromyalgia and Wheelchair user. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Bad urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Missed her second dose of vaccination). The patient was hospitalized on 26-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK and URINARY TRACT INFECTION. The patient was treated with Rehabilitation therapy (Sent to rehab for 2 weeks) for Transient ischaemic attack and Rehabilitation therapy (Sent to rehab for 2 weeks) for Urinary tract infection. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) and URINARY TRACT INFECTION (Bad urinary tract infection) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Missed her second dose of vaccination) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Magnetic resonance imaging: abnornal (abnormal) Confirmed TIA. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications or treatment information has been specified. The symptoms resembled having a mini stroke. The doctors did not state that the events happened due to the vaccine. The patient was sent to rehab for 2 weeks and consequently missed her second dose. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
79 2021-05-23 loss of consciousness Cleared pharmacist verification with no red flags. Administered in the shot booth in chair and info... Read more
Cleared pharmacist verification with no red flags. Administered in the shot booth in chair and informed patient to wait the designated 15 minutes. Patient seemed fine with no distress. Color normal. I came back into the pharmacy and seen patient doing well. Patient then a couple minutes later stood up and took a couple steps which put her out of my view. technician the asked if she was ok and the I could see the shot booth going sideways. Then I could see her fall. I then ran out the pharmacy to check and she landed in the chair sitting up right. she was still semi-conscious and I talked to her. I got a pulse and told the technician to call an ambulance. while trying to keep the lady awake she drifted unconscious but was breathing ok. Pulse was low but didn't lose. Had the help of a nurse at this time and ambulance arrived. Patient was awake by this point with drowziness and could talk.
79 2021-05-24 ventricular tachycardia orthostatic dizziness began one week after vaccine. eventually progressed into 2nd degree type 2 he... Read more
orthostatic dizziness began one week after vaccine. eventually progressed into 2nd degree type 2 heart block. Had v Tach. Got a pacemaker.
79 2021-05-25 transient ischaemic attack On 4/2/2021 resident experienced slurred speech, left sided weakness and overall decline. Facial dro... Read more
On 4/2/2021 resident experienced slurred speech, left sided weakness and overall decline. Facial drooping and neurological deficits resulting in diagnosis of TIA.
79 2021-06-02 enlargement of the heart Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental s... Read more
Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly. Mild bibasilar volume loss is again seen. Remaining lungs are clear. No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy. There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash. On 26-Mar-2021, patient presented for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice. Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m. Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may re; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may remain as confounding factors.
79 2021-06-05 nosebleed Patients daugter-in- law called and she said her mother in law had 2 hours nosebleed. She called aro... Read more
Patients daugter-in- law called and she said her mother in law had 2 hours nosebleed. She called around 11:00 am I asked any headache, confusion and dizzness. Daughter-in-law said none of that and she orinted to place and time she said yes. The nosebleed compltely stopped. I check back with daughter-in-law at 14:00 P.M she said she is doing fine. If she does not feel ok to go to ER.
79 2021-06-05 blood clot clot behind right knee, had ultra sound done, sent me o emergency room was given a pill of xarelto a... Read more
clot behind right knee, had ultra sound done, sent me o emergency room was given a pill of xarelto and prescription ans sent home, have to take pills for the next 31 days.
79 2021-06-07 blood pressure increased She got her vaccine, she felt very weak, woozy, tired, lethargic. Her blood pressure went up to 196... Read more
She got her vaccine, she felt very weak, woozy, tired, lethargic. Her blood pressure went up to 196/116 several days later. She was sick for 5 weeks. Her arm was a little achy, which was normal to her as she gets allergy shots which she has the same reaction to. She called her doctor who was out on leave and they told her to go to UC. She went to UC twice and the ER twice due to her BP and her weakness and dizziness. She was not able to drive due to these symptoms. They did increase her BP medication and he said that if it did not help then go to the ER. She went to the ER and was still feeling very weak, and they told her that it was from the vaccine as they have seen other people with the same reactions, and it can last up to 6 weeks. She said nobody knew what happened, she had CT scan of the head, EKG, blood work, chest x-ray and other tests. She went to the cardiologist who believed that she had the COVID virus, and he ordered an echocardiogram that was normal. She also had a LEXI-scan that was normal as well. The symptoms finally went away and is back to normal now and said that it was exactly 5 weeks later that she finally felt better and was not dizzy or woozy any longer. She felt as though she was going to die as she was so weak. She feels that it needs to be explained further that it is not FDA approved and that the elderly do not understand what EUA means.
79 2021-06-08 chest discomfort On 5/28/2021 pt started feeling light-headed, dizzy, chest heaviness, chills and her arm and legs we... Read more
On 5/28/2021 pt started feeling light-headed, dizzy, chest heaviness, chills and her arm and legs were burning. Her husband eventually called 911 and they told him it "sounded like a reaction to COVID vaccine" and "if she got worse they would send someone out". Pt stated these feelings lasted until about 0300 on 5/29/21 and after she fell asleep most things resolved expect the light-headedness. Pt reports she is still fatigued and has bouts of dizziness and lightheadedness and she has no energy. Pt was encouraged to call and report her symptoms to her primary provider and seek their guidance on when to receive her second injection.
79 2021-06-10 deep vein blood clot DVT
79 2021-06-14 deep vein blood clot Deep vein Thrombosis
79 2021-06-15 fainting Around 02/05/2021-02/06/2021 she started having a cough, upset stomach, and a fever. On 02/09/2021 w... Read more
Around 02/05/2021-02/06/2021 she started having a cough, upset stomach, and a fever. On 02/09/2021 we both got the Covid antibodies but they did not work for her. It ended up going into Covid pneumonia and she was treated for that and once she got over that she got bacterial pneumonia and we have been going through that since (still ongoing). She has seen specialists and had a hospital stay for 9 days. She has had all kinds of blood tests. She just had a test on 06/16/2021 to see if she has an immunity to Covid. She has had overall weakness and when we took her to hospital she fainted.
79 2021-06-16 oxygen saturation decreased Patient became short of breath about 5 days post covid vaccine. She presented to the office on 6/14... Read more
Patient became short of breath about 5 days post covid vaccine. She presented to the office on 6/14/2021 and was noted to be SOB with a SPO2 of 74% on room air. Patient SPO2 did increase with oxygen at 2l/nc to 92-94%. Patient was transferred to local ER for evaluation and there she was noted to have multiple blood clots in both lungs. Patient spent 3 days in the hospital and was discharged today.
79 2021-06-24 heart rate increased Within 5 minutes of receiving the injection, my heart rate increased to 125 BPM
79 2021-07-08 coughing up blood Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with ne... Read more
Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family
79 2021-07-19 deep vein blood clot, pulmonary embolism Skin itching, skin blisters, PE, DVT
79 2021-07-22 heart rate increased, atrial fibrillation patient developed weakness and onset of increased shortness of breath with rapid heartrate. She was ... Read more
patient developed weakness and onset of increased shortness of breath with rapid heartrate. She was taken to emergency room and found to have Atrial Fib. She had multiple episodes over 3 weeks and now hasn't had anymore since
79 2021-07-25 palpitations Heart palpitations, Pulse 99, BP 218/116. Was referred to a cardiologist.
80 2021-01-03 lightheadedness, blood pressure decreased Patient stood up and blood pressure dropped and started to faint and nursing staff was with her. Her... Read more
Patient stood up and blood pressure dropped and started to faint and nursing staff was with her. Her blood pressure was 85/45 and pulse of 60. Patient got nauseated and vomited. Nursing staff contacted MD and they decided to have her checked out at the ER.
80 2021-01-10 blood pressure increased Within an hour my blood pressure peaked and stayed that way for three hours. Normaly 140/ 80's and ... Read more
Within an hour my blood pressure peaked and stayed that way for three hours. Normaly 140/ 80's and went to 199/ 85
80 2021-01-12 chest pain Systemic: mild chest pain, vitals ok, bp ok, o2 ok, etc, shot site no heat/swelling/redness. history... Read more
Systemic: mild chest pain, vitals ok, bp ok, o2 ok, etc, shot site no heat/swelling/redness. history of panic attacks; symptoms lasted 0 days
80 2021-01-13 heart rate increased rapid heart rate starting when she got the shot, nausea and fever 99.8 around 5 pm. Symptoms gone b... Read more
rapid heart rate starting when she got the shot, nausea and fever 99.8 around 5 pm. Symptoms gone by about 10 pm. She took her heart medication as ordered and felt better by bedtime.
80 2021-01-18 blood pressure increased, palpitations Elevated blood pressure, heart palpitations
80 2021-01-19 loss of consciousness Patient was still within the 15 minute observation period. Patient starting saying she was hot. Bott... Read more
Patient was still within the 15 minute observation period. Patient starting saying she was hot. Bottle of water given to patient. Patient then passed out, attempted to talk to patient and performed sternal rub. Patient was lowered to floor with assistance to flat surface, rolled to side. Patient become alert. Rapid Response was called and patient was then taken to the Emergency Department.
80 2021-01-20 loss of consciousness At 7 pm arm began hurting, by 11 pm was vomiting then passed out, vomited 4 more times during the ni... Read more
At 7 pm arm began hurting, by 11 pm was vomiting then passed out, vomited 4 more times during the night and passed out each time very briefly, for a total of 5 times. Stopped by 6 a.m. Did not vomit or pass out any more after 6 a.m. Next day (1/19/21) stayed in bed and slept most of day, started eating again normally 1/20/21. Feels much more normal 1/21/20 other than sore arm.
80 2021-01-20 oxygen saturation decreased, hypertension HIGH BLOOD PRESSURE AND DROP IN O2 SAT
80 2021-01-20 fast heart rate developed an itchy rash about 11 hours after administration that remained isolated to chest, abdomen... Read more
developed an itchy rash about 11 hours after administration that remained isolated to chest, abdomen and arms in the office, she was slightly tachycardic 108
80 2021-01-23 cerebrovascular accident Pt received vaccine and within 72 hrs developed a stroke. Low platelet count. Endocarditis. Emboli t... Read more
Pt received vaccine and within 72 hrs developed a stroke. Low platelet count. Endocarditis. Emboli to liver, spleen, kidney.
80 2021-01-24 nosebleed Moderna COVID-19 Vaccine EUA My mother got a nose bleed around 9pm after taking her medications that... Read more
Moderna COVID-19 Vaccine EUA My mother got a nose bleed around 9pm after taking her medications that evening. The bleed was not significant and stoped fast. No medical help was sought.
80 2021-01-24 heart rate irregular, heart rate increased, atrial fibrillation irregular / rapid heartbeat; a-fib (irregularity) lasted about 30 minutes.
80 2021-01-25 blood glucose increased, loss of consciousness, loss of consciousness The patient received the Moderna Covid 19 vaccine on 1/19/21 and reported to the pharmacy that durin... Read more
The patient received the Moderna Covid 19 vaccine on 1/19/21 and reported to the pharmacy that during the night on 1/20/21, she passed out. She reported having a mild headache all day but no other problems. She was putting drops in her husband's eyes around 11pm and told him she needed to sit down that she was going to "pass out." Her husband said she did pass out and he called 911. He said she was unconscious maybe 3 or 4 minutes. She woke up alert and knew what had happened. The EMT's checked her out--said she had no temperature, blood pressure was ok, and blood sugar was 280. They told the couple they thought it was probably from the vaccine. They wanted to transport her to the ER to be "checked out" but the patient refused to go. She has not had any problems since the incident except some fatigue
80 2021-01-25 loss of consciousness Passed out the morning after receiving the vaccine without any dizziness or prior warning
80 2021-01-25 palpitations Heart palpitations at 2:am and then again at about 9: am the next day after the vaccination
80 2021-01-26 palpitations Pt came up to medical staff in observation room after waiting 15 minutes. Pt stated she felt heart p... Read more
Pt came up to medical staff in observation room after waiting 15 minutes. Pt stated she felt heart palpitations. This RN brought her and her son back to the resting area and started collecting information. Upon auscultation, pt's heart rate was 86. The first BP collected was 168/89. After talking to the pt, she stated she was "nervous". This RN guided her in some deep breathing, calming conversation, and gave her some water. After five minutes, this RN rechecked her vitals and her heart rate was 82 and blood pressure was 136/85. Pt stated she was feeling better. Her son stated she would rest at his house for a couple hours. This RN directed them to contact her PCP if she were to have further concerns.
80 2021-01-28 hypertension Client called 1/22/2021 to report that she woke around 3AM with severe stomach cramps and the start ... Read more
Client called 1/22/2021 to report that she woke around 3AM with severe stomach cramps and the start of flu symptoms "feeling yucky". Reported she took a Benadryl and went back to sleep. Said when she woke up the cramps were gone but now her B/P was elevated. Denies any other c/o.
80 2021-01-31 chest discomfort hours after vaccination arm soreness, stiffness in hands, two days after vaccination fatigue, breath... Read more
hours after vaccination arm soreness, stiffness in hands, two days after vaccination fatigue, breathing difficulty-feeling of tightness around rib cage, heart felt tight, headache, body aches, sinus trouble
80 2021-02-01 chest discomfort, fainting pt c/o chest tightness, hx of chest in last week, took 1 nitro glycerine , appeared to faint with he... Read more
pt c/o chest tightness, hx of chest in last week, took 1 nitro glycerine , appeared to faint with heavy breaths. 1505 bp 130/80, p76,o2sat 97% became diaphoretic nauseated , threw up ,became more alert 911 called O2 applied 1520 bp118/74 p61 o2sat 96% Ambulance arrived transport to ED
80 2021-02-03 chest pain 20 mins after vaccine became nauseated, light headed and chest pain, tightness in central to epigast... Read more
20 mins after vaccine became nauseated, light headed and chest pain, tightness in central to epigastric area. VS found she was Orthostatic - BP dropped to 99/55 while standing. Diabetic. Chest pain persisted. Sent to ED
80 2021-02-03 fainting Pt fainted, and fell forward out of her chair onto the floor during post vaccination observation.
80 2021-02-04 chest pain 80-year-old female with a history of atrial fibrillation and coronary artery disease, was obtaining ... Read more
80-year-old female with a history of atrial fibrillation and coronary artery disease, was obtaining her first dose of the Moderna COVID-19 vaccine today, and about 10 minutes afterwards began feeling warm and diaphoretic and developing left chest pains and nausea, at approximately 11 AM. This lasted about 5 minutes and then subsequently resolved. She then got up to leave and again began feeling the left chest pain, diaphoresis, and again lasting about 5 to 6 minutes and then subsequently resolving. She does state a history of anxiety but did take Xanax this morning preventatively. However, she states she has had similar pains in her chest over the past month. She states these are not necessarily associated with any exertion and seemed to be somewhat better after antacids. She notes she has not had anything to eat or drink this morning which is not unusual for her and her blood sugar was 117 this morning.
80 2021-02-04 fainting, hypotension, atrial fibrillation, lightheadedness Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes pat... Read more
Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes patient had a near syncopal episode. She felt lightheaded and shortly after had episode of nonbloody vomiting. Hypotensive 81/69 and started on levophed. Alert and orientated. Lungs clear, abdomen benign on admission. Patient had no reaction when received first dose of the vaccine. Patient developed worsening shortness of breath, tachypnea, Afib with RVR, hypotension and required intubation and multiple pressors.
80 2021-02-07 blood pressure increased Patient had increased BP, felt flush, sweaty, and shaky about 15 minutes after receiving the vaccine... Read more
Patient had increased BP, felt flush, sweaty, and shaky about 15 minutes after receiving the vaccine. Patient vitals taken every 10 minutes and monitored until she returned to her baseline. Patient also provided a water and snack. After about 20 minutes of additional observation the patient was fine and able to leave.
80 2021-02-07 cerebrovascular accident Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, te... Read more
Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself, she fell 3 times on Feb. 3, I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand. Feb. 4 she had the dry heaves all morning, she slept all afternoon. I called the doctors office @ 8:00am and again later @ 8:30am. He said he wanted her to have a CAT scan Medical Center. He said they would call
80 2021-02-07 chest pain Shaking with chills. Could not warm up. Nausea. Pain in chest. Temperature of 99.9, lasted about 7 h... Read more
Shaking with chills. Could not warm up. Nausea. Pain in chest. Temperature of 99.9, lasted about 7 hours and then I felt fine, but tired. The next day felt normal, except for arm being slightly sore. The worse part was the severe shaking from chills and nausea. I did take a Tylenol before going to bed.
80 2021-02-08 pallor Shortness of breath within 5 minutes and pale. Oxygen at 2l/min given. On room air at 1426. Patient ... Read more
Shortness of breath within 5 minutes and pale. Oxygen at 2l/min given. On room air at 1426. Patient is feeling well .
80 2021-02-16 chest pain Suddenly this morning, 13 days after receiving the first Covid Moderna vaccine - my arm is red and f... Read more
Suddenly this morning, 13 days after receiving the first Covid Moderna vaccine - my arm is red and feverish at injection site. In the meantime starting Sunday, Feb. 14th, I had pain in right chest and right upper back, that I contributed to making a wrong move and straining muscles. The back pain is better, but I still have it when I reach high , move wrong, or take a deep breath.
80 2021-02-16 fainting pt had syncopal episode 12 hours after receiving the vaccine with no dizziness, chest pain or warnin... Read more
pt had syncopal episode 12 hours after receiving the vaccine with no dizziness, chest pain or warning signs prior
80 2021-02-18 atrial fibrillation Went into Afib within 3 hours
80 2021-02-18 blood pressure fluctuation Reddening and burning of top of ears. Blood pressure became erratic. Going from dangerously low to... Read more
Reddening and burning of top of ears. Blood pressure became erratic. Going from dangerously low to dangerously high. lowest reading 80/50 highest reading 200/100. Still erratic
80 2021-02-19 heart rate increased, blood pressure increased, fainting Rapid heart, increases BP, fainting, heady feeling, nausea,
80 2021-02-19 fainting Got shot at 8:15am and got reaction at 9:45pm with violent chills-got into hot shower & got temp up ... Read more
Got shot at 8:15am and got reaction at 9:45pm with violent chills-got into hot shower & got temp up to 95 degrees; went to bed with several blankets; temp went up to 100 degrees about 11pm with stomach ache, horrible headache, & loose stool; lasted all night all next day; day 3 Saturday 4am got up to pee dizzy & faint & fell into glass closet doors then into wooden door then to floor & broke nose & bruised several other areas besides face. Now 11am still dizzy & sick to stomach & loose stool so called CDC but no help so took meds on hand. Zofran 4mg & Loperamide 2mg.
80 2021-02-20 fainting 10:30 pm same day/night -- extreme cold; dizziness; 4 fainting spells; head rush-inflamation extreme... Read more
10:30 pm same day/night -- extreme cold; dizziness; 4 fainting spells; head rush-inflamation extreme the next day and Saturday. I found myself looking up at the ceiling 4 times during the night after fainting dead away. Frightening as that has never happened to me before. It was the weekend; I was unable to reach any doctor for advice. Plus with a major snow storm we were snowed in and I couldn't get out. This was the sickest I've ever been in my life!
80 2021-02-21 fainting Chills, pain throughout body, fainting (30 hours after injection, general weakness for 40 hours
80 2021-02-22 blood pressure increased, palpitations "within 24 hours after the vaccine, my heart started racing and my blood pressure went up"
80 2021-02-23 blood pressure fluctuation pt stated that the day after the covid vax she had the dry heaves and body aches and pains. The sec... Read more
pt stated that the day after the covid vax she had the dry heaves and body aches and pains. The second day she shaking and jerking, couldn't hold on to anything. Her blood pressure was up and down that day. She said she felt like she was dying and then she vomiting where she bruised both elbows on the toilet bowl due to the jerking movement she was experiencing. She took a nap and woke up confused. She was hallucinating saying she felt like she went from a small box to a blue box to red box and didnt recognize her room. Her sitter said her eyes were glazed but was able to recognize her sitter at that time. Blood pressure dropped so the sitter then called EMTs where they checked her out. Vital signs were good but she declined to be transported to the hospital via ambulance. The third day she was feeling some better where she was able to eat and get a sponge bath. Fourth day she was better so was able to shower. She states she is better now with just a little soreness and redness around the injection site. Pt has contacted her PCP and spoke with the nurse about her symptoms.
80 2021-02-24 cerebrovascular accident My mother received her vaccine at 12:40 on 2/2. She waited longer than the fifteen minutes and she s... Read more
My mother received her vaccine at 12:40 on 2/2. She waited longer than the fifteen minutes and she seemed fine. We left the facility and on the way home, approximately 45 after she received the vaccine, she began slurring her words ands was confused. The slurring lasted for 2-3 minutes The confusion continued. I brought her the ER where she was immediately taken in for a CT Scan. She later had an MRI, and met with a Cardiologist. She later had an EEG at the request of a Neurologist. She spent three nights in the hospital. All tests showed no acute signs of stroke, etc.
80 2021-02-24 hypotension hypotension, diaphoresis, dyspnea
80 2021-02-24 fainting Faint; Hives up and down both of her arms; Felt warm; A spontaneous report was received from a healt... Read more
Faint; Hives up and down both of her arms; Felt warm; A spontaneous report was received from a healthcare professional, concerning a 80-year-old, female patient who was administered Moderna's COVID-19 vaccine and felt warm, faint and hives occurred afterwards up and down both of her arms. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042670A) intramuscularly, for prophylaxis of COVID-19 infection. On 19-Jan-2021, right after getting her vaccine patient felt warm and faint afterwards. Approximately, eight or nine days after the injection, patient had hives up and down both of her arms. Patient was concerned if it was a systemic allergic reaction and likeliness of another reaction in future with increased severity. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, felt warm, faint and hives occurred afterwards up and down both of her arms were considered unknown.; Reporter's Comments: This report concerns a 80--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 042670A , and felt warm, faint and hives occurred afterwards up and down both of her arms. Very limited information regarding this event has been provided at this time. Further information has been requested
80 2021-02-26 loss of consciousness Cold, loss of consciousness, vomiting that lasted 1 - 2 hours.
80 2021-02-27 atrial fibrillation, heart rate irregular atrial fibrillation as captured by smartphone (i can send PDF if desired) at 5:44pm ...irregular he... Read more
atrial fibrillation as captured by smartphone (i can send PDF if desired) at 5:44pm ...irregular heartbeat caused me to capture event on my phone, especially since I had a similar reaction to the first shot.
80 2021-02-27 heart rate irregular Irregular heartbeat for approximately 5-8 minutes. Light-headed during this time. Resolved on its o... Read more
Irregular heartbeat for approximately 5-8 minutes. Light-headed during this time. Resolved on its own eventually.
80 2021-03-01 cerebral haemorrhage My mother had a seizure on February 15th after recieving the moderna vaccine on February 11th within... Read more
My mother had a seizure on February 15th after recieving the moderna vaccine on February 11th within four days of the vaccine. Doctors at hospital. Staff cannot answer what caused the seizure though they found a 4mm bleed on her brain; believed unrelated to seizure; on an MRI. My mother has never had a seizure and noone in my family have had seizures. I don't know if it's related to the vaccine but felt it should be reported to you.
80 2021-03-01 palpitations Extreme loss of breath and racing hart
80 2021-03-02 loss of consciousness 02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then w... Read more
02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then woke up flat on back-no memory of falling , had to get up 2 more times in night, same thing happened, lost consciousness waking up flat on back both times as well. Slept the next day, headache similar to sinusitis, lost her appetite and swollen glands for 2 days. Today 2/26 appetite returning, scheduling MRI next week per primary care
80 2021-03-04 atrial fibrillation Patient complained of lightheadedness, dizziness, and fatigue the next morning. That afternoon she ... Read more
Patient complained of lightheadedness, dizziness, and fatigue the next morning. That afternoon she experienced Afib.
80 2021-03-04 hypotension Non severe anaphylaxis with low BP
80 2021-03-04 loss of consciousness Passed out; Felt tired; A spontaneous case report was received from a consumer concerning an 80 year... Read more
Passed out; Felt tired; A spontaneous case report was received from a consumer concerning an 80 years-old female patient who experienced passed out (MedDRA PT: loss of consciousness) and felt tired (MedDRA PT: fatigue) The patient's medical history included cancer. Concomitant product use included chemotherapy and other medications (not specified). The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on an unknown date. On 16 Feb 2021, approximately one day prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #011M20A) intramuscularly in an unspecified site for prophylaxis of COVID-19 infection. On 17 Feb 2021, one day after receiving the vaccination, the patient felt tired and passed out. The patient inquired if this was a normal side effect. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events passed out and felt tired is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
80 2021-03-05 heart rate irregular, loss of consciousness By afternoon I felt a little chilly and achy and took Tylenol. I woke at 2:00am the following morni... Read more
By afternoon I felt a little chilly and achy and took Tylenol. I woke at 2:00am the following morning to go to the restroom and my dog needed to go out. I felt light headed as soon as she was back in the house. I felt things going dark and I passed out in the hallway. I don't know how long I was out but when I came to, I felt like I couldn't move. I laid there for a while and finally crawled back to my bed. I was able to get back in bed. By then it was 3:00am. The next night I woke in the night and had an irregular heartbeat. I could not get back to sleep until it finally went away. For several days after the vaccination, I had very little energy.
80 2021-03-10 chest pain, pulmonary embolism Patient is a very pleasant 80 year old female with a history of hypertension and recent pelvic fract... Read more
Patient is a very pleasant 80 year old female with a history of hypertension and recent pelvic fracture approximately two months ago who presented to the emergency department reporting right sided chest pain. She states that her symptoms started on Sunday. She has pain with a deep breath and also with exhaling. She reports it is a sharp pain. She states that she has had no lower extremity edema or calf pain, however, she did have a shooting pain down her right leg recently. She denies any history of personal or family history of deep venous thrombosis or pulmonary embolus. She reports that she has not had any hemoptysis. She denies feeling short of breath. She denies abdominal pain, nausea, vomiting, or diarrhea. She states that she has not had any COVID exposures or known symptoms. She has received two COVID vaccine doses. She reports that she has not been sick and denies fever, chills, or cough. In the emergency department she was diagnosed with an acute pulmonary emboli in the right main pulmonary artery with extension into the segmental pulmonary arteries. There is concern for early pulmonary infarct. This has prompted admission to the hospital.
80 2021-03-10 haemoglobin decreased Developed diplopia 3 hours post vaccine
80 2021-03-10 hypertension, chest discomfort While in the observation room after receiving Moderna vaccination, member complained of chest tightn... Read more
While in the observation room after receiving Moderna vaccination, member complained of chest tightness; she denied difficulty breathing/shortness of breath, was alert and oriented and did not appear to be in respiratory distress (also no itching, hives, rashes, or other complaints at the time); manager on duty was also present. Blood pressure, heart rate, and oxygen saturation were 250/87, 76, and 100% (room air), respectively (4:55 pm). 911 was called (4:55 pm). Blood pressure was repeated at 5:00 pm (230/77) and 5:03 pm (221/159); oxygen saturation remained at 100%. At 5:04 pm, member started to complain of lightheadedness and EMS arrived at that time. Member was placed on the stretcher and transferred member to the Hospital. Note: Member has hypertension and stated she did not take her medication today.
80 2021-03-11 hypertension Heavy legs, numbness in arms, reported swelling of face, tingling of tongue. Hypertensive. Hx of a... Read more
Heavy legs, numbness in arms, reported swelling of face, tingling of tongue. Hypertensive. Hx of anxiety, HTN on Zanax. Only took 1/2 dose this morning. Patient taken to emergency room.
80 2021-03-12 fainting Nausea, fever, fainted, chills.
80 2021-03-14 cerebrovascular accident Large Stroke
80 2021-03-14 troponin increased, heart attack Patient presented to ED with AMS, GCS 8, elevated troponin within 48hrs of receiving vaccination. In... Read more
Patient presented to ED with AMS, GCS 8, elevated troponin within 48hrs of receiving vaccination. Initial dx NSTEMI
80 2021-03-15 cardiac failure congestive, atrial fibrillation, blood glucose increased, chest pain, inflammation of the pericardium Chest Pain Pt has been having flu like sxs the past few days and tonight was woken out of her sleep ... Read more
Chest Pain Pt has been having flu like sxs the past few days and tonight was woken out of her sleep by chest pain. (3/13/2021) pericarditis, atrial fibrillation, and CHF
80 2021-03-15 palpitations With in the 30 minutes after vaccine administration, became diaphoretic, racing heart, and shaky. Se... Read more
With in the 30 minutes after vaccine administration, became diaphoretic, racing heart, and shaky. Sent to ED for further evaluation
80 2021-03-15 blood clot PT WAS VACCINATED WITH SECOND MODERNA DOSE ON 02/16/2021 . DR CALLED ME TO INFORM OF PT ADVERSE EV... Read more
PT WAS VACCINATED WITH SECOND MODERNA DOSE ON 02/16/2021 . DR CALLED ME TO INFORM OF PT ADVERSE EVENT. PT PRESENTED TO DR WITH SWELLING IN LEFT LOWER LEG. DR ORDERED VENUS DOPLAR SHOWING A LARGE BLOOD CLOT FROM PT'S GROIN TO HER CALF MUSCLE. DUE TO NO PREVIOUS HX OF CLOTTING OR BLOOD DISORDERS NOR FAMILY HX AND PROXIMITY TO VACCINATION, DR BELIEVES VACCINE CAUSED THE CLOT. DR PLACED PATIENT ON ELIQUIS. DR WISHES TO BE CONTACTED IF FURTHER DETAIL IS NEEDED.
80 2021-03-16 cardiac failure congestive 03/15/2021: Presented to the emergency department with worsening lower extremity edema and dyspnea o... Read more
03/15/2021: Presented to the emergency department with worsening lower extremity edema and dyspnea on exertion. The patient was admitted for a congestive heart failure exacerbation for IV diuretics. Patient currently still admitted and now having lower GI bleeding on a heparin infusion.
80 2021-03-16 hypertension, blood pressure decreased, cardiac arrest After vaccine (2nd dose) on 3/04, patient resumed normal activities, running errands, etc. In the ev... Read more
After vaccine (2nd dose) on 3/04, patient resumed normal activities, running errands, etc. In the evening of 3/05, patient complained of extremely sore arms (not alleviated by painkillers) and nausea. Additionally, patient felt extremely cold. She went to bed early, at 7:00 pm, and was found dead the next morning 3/06 at 7:30 am. She had vomited. The coroner (not a medical examiner) declared cause of death as 1) cardiac arrest 2) hypertension and 3)hypercholesterolemia, based solely on medical records. There was no autopsy. Due to or despite medications, patient's blood pressure readings were typically low (last one 118/70), pulse normal (89), BMI 25.29, cholesterol levels normal (166/LDL 82), blood sugar 95.
80 2021-03-16 loss of consciousness A spontaneous report was received from a consumer concerning a 80-year-old, female patient who sudde... Read more
A spontaneous report was received from a consumer concerning a 80-year-old, female patient who suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), head fell forward and she was out for 20-30 seconds (loss of consciousness), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 01-FEB-2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 01-MAR-2021, the patient received her 2nd dose of the Moderna COVID-19 vaccine (Batch number: 023M20A) in her left (dominant) arm. On 02-MAR-2021, she experienced a side effect which was not listed in the sheet she was given. She wanted to call and report the side effect. She said that she was at the stove cooking and suddenly felt very weak and felt that her vision started to flip. She called for her husband to come over who seated her on a chair. After that she says she doesn't remember what happened, but her husband told her that her whole body was shaking, her head fell forward and she was out for 20-30 seconds. When she came back, she could hear a rushing sound coming out of her left ear. She was also drenched in perspiration. She felt very nauseated and cold the whole afternoon. On 03-MAR-2021 she felt better. She had a low grade fever of 99.4 degrees Fahrenheit. Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia) was considered recovered/resolved on an unknown date. The out come of the event, head fell forward and she was out for 20-30 seconds (loss of consciousness), was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
80 2021-03-17 increased heart rate Pt received her 2nd Moderna covid 19 vaccination on 3/10/2021 and the following day woke up severely... Read more
Pt received her 2nd Moderna covid 19 vaccination on 3/10/2021 and the following day woke up severely weak with chills, fever, vomiting and diarrhea and headache and was found on the floor by family at 2:30 pm. She reported she was so weak she lowered herself to the floor around 7:30and lie there till she was found in the afternoon. She was given IVF and admitted to the hospital for further work up and physical therapy.
80 2021-03-19 deep vein blood clot Blood clot in lower right leg
80 2021-03-21 blood pressure decreased BP dropped to 81/57 Pulse 65 Limbs completely limp Unable to arouse Lasted for about 5-6 hours
80 2021-03-22 pulmonary embolism Bilateral pulmonary emboli; A spontaneous report was received from a physician concerning an 80-yea... Read more
Bilateral pulmonary emboli; A spontaneous report was received from a physician concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced shortness of breath and oxygen level low. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received her first of two planned doses of mRNA-1273 (LOT: unknown) on 05-Feb-2021. On 05-Mar-2021, approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly for prophylaxis of COVID-19 infection. On 06-Mar-2021, the patient developed shortness of breath and her oxygen level was low. On 09-Mar-2021, she was diagnosed with bilateral pulmonary embolisms. No hospitalization was required. The reporter stated that the patient had no history of blood clots. Treatment for the event included apixaban. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
80 2021-03-23 hypertension The patient felt fine on 2/25 and 2/26. On the morning of the 27th, she woke up and was very light-... Read more
The patient felt fine on 2/25 and 2/26. On the morning of the 27th, she woke up and was very light-headed and worsened throughout the day. She checked her blood pressure which is normally around 110-130/60's and it was 170/68. She continued to check her blood pressure for the several days and it remained high for 3 days and she continued to feel light headed for 2.5 more days. Then the symptoms and the high blood pressure went away. She continued to take her regularly scheduled Lisinopril 10mg daily on each of these days as she normally did.
80 2021-03-24 cerebrovascular accident Was made aware on 3-25-21 that the pt. had been admitted to the hospital for a Stroke . Informed Dr.... Read more
Was made aware on 3-25-21 that the pt. had been admitted to the hospital for a Stroke . Informed Dr. of same. Per pt. daughter pt. was admitted to Hospital on 3-24-21.
80 2021-03-24 heart rate increased, heart rate irregular, hypertension Continuing Irregular and fast heartbeat with high blood pressure. 20 days non stop so far.
80 2021-03-25 cerebrovascular accident Looks like a stroke; She became unresponsive; A spontaneous report was received from a consumer conc... Read more
Looks like a stroke; She became unresponsive; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and she became unresponsive and it looked like a stroke. The patient's medical history was not provided. Concomitant medications reported included carvedilol, acetyl salicylic acid and an occasional injection for hives. The last injection for hives was administered a week and a half ago. On 10 Mar 2021 at 4pm, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, it was reported that the patient became unresponsive and she appeared to be having a stroke. The patient was taken to the emergency room where she underwent treatment. No other details were provided. Treatment information were not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken in response to the events was not applicable. The outcome of events, became unresponsive and it looked like a stroke, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
80 2021-03-26 heart attack My mom received her second covid shot at 10:05 AM on 3/26 and experienced no adverse symptoms. At ar... Read more
My mom received her second covid shot at 10:05 AM on 3/26 and experienced no adverse symptoms. At around 6 am the following day, on the morning of 3/27 she was found on the floor, and presumably suffered from a heart attack. After devastation to our family, we called her physician and he himself was also surprised. Although she is a type 2 diabetic with high blood pressure she has maintained great health and kept her conditions under control with her medications. This, unfortunately, seems too coincidental to not have been in some way or completely caused by the second dose of the shot.
80 2021-03-27 loss of consciousness, fainting The morning after the 2nd dose, I got up to make coffee. I had just started and felt a bit light-he... Read more
The morning after the 2nd dose, I got up to make coffee. I had just started and felt a bit light-headed. I was going to go sit down, but I passed out and fell onto the kitchen floor for a few seconds. I have never passed out before or felt such light-headedness. I went to lay down. I vomited a bit of liquid. I lay down and several hours later my husband drove me to the emergency room. After many tests they said I had suffered a Syncope and had a slight concussion.
80 2021-03-29 blood pressure fluctuation Exhaustion Erratic blood pressure spikes Switch from am active time to pm active Afternoon naps Sh... Read more
Exhaustion Erratic blood pressure spikes Switch from am active time to pm active Afternoon naps Shortened less active dog walks
80 2021-03-30 loss of consciousness Almost passed out; Vomiting; Heat on side of head; A spontaneous report was received from a consumer... Read more
Almost passed out; Vomiting; Heat on side of head; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost passed out/loss of consciousness, heat in head/feeling hot and vomiting. The patient's medical history was not provided. Concomitant medications included inhaler and statin. On 22 Feb 2021, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 031L20A) for prophylaxis of COVID-19 infection. On 22 Feb 2021, three hours later, the patient experienced heat on side of head and almost passed out a medically significant event. On 26 Feb 2021, the patient had heat in head again and did pass out and vomited. The patient was hospitalized when passed out and did tests and everything was ok. Treatment details included anti-nausea medication. Action taken with mRNA-1273 in response to the events was not reported. The outcomes of the events almost passed out, heat in head and vomiting was resolved on 27 Feb 2021.; Reporter's Comments: This case concerns an 80-year-old female who had a serious unexpected event of loss of consciousness along with NS events of unexpected feeling hot and expected vomiting. Event onset the same day as the first dose of mRNA-1273. Treatment with anti-nausea medication. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
80 2021-03-30 fainting Moderna COVID-19 Vaccine EUA Mod. severe muscle pain, esp across back/shoulders, incr, weakness, hea... Read more
Moderna COVID-19 Vaccine EUA Mod. severe muscle pain, esp across back/shoulders, incr, weakness, headache, pain at injection site, fatigue, nausea and dizziness. Retired early and got up during night with GI distress. Before getting back to bed passed out hitting my head and lower back on a metal door frame. I did not recall this but found myself back in bed partially dressed. Husband found a hallway Persian rug (heavy) displaced in AM. Slept until 3PM following day and awoke with lg. bump on head and pain in sacral area. Self treated with ice to painful areas plus Tylenol 500 mg. After 6 days with no relief saw orthopedist who took x-rays and diagnosed bruise to sacrum and post-concussive syndrome. Offered visit to neurologist which was declined as cognitive ability seemed intact, Treated with ice to sacrum 20 min. x 5 daily, Tylenol 1000 mg. and Aleve 1 q 12h x 5 days. Sx continued for 8 days requiring Tylenol, Aleve, iceand/or heat. Feeling less pain by Day 20 post vaccine.
80 2021-03-30 transient ischaemic attack mini stroke; still weak; A spontaneous report (United States) was received from a consumer concernin... Read more
mini stroke; still weak; A spontaneous report (United States) was received from a consumer concerning an 80 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event mini stroke/transient ischaemic attack and still weak/asthenia. The patient's medical history was not provided. The concomitant medications on use were also not provided. On 26 Feb 2021, approximately 17 days prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch number: 011A21A) through unknown route of administration for prophylaxis of COVID-19 infection. On 15 Mar 2021, patient experienced mini stroke. The patient was hospitalized on the same day till 17 Mar 2021.It was serious event which required hospitalization. Laboratory tests performed included ultrasounds, cat scan of the brain, MRI of brain, ultrasound of arteries, and chest x-ray. The findings of lab tests were not provided. The patient was given acetylsalicylic acid and an injection in the belly to prevent blood clots. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
80 2021-04-02 loss of consciousness Pt was exiting the building and became light headed and dizzy. Pt then passed out and was slowly rel... Read more
Pt was exiting the building and became light headed and dizzy. Pt then passed out and was slowly released to the ground. Pt did not hit her head and had no hx of fainting/dizziness spells. EMS were contacted and arrived on scene approximately 5 minutes later.
80 2021-04-06 deep vein blood clot DVT in R leg
80 2021-04-08 loss of consciousness No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had ... Read more
No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia. The patient's medical history was not provided. concomitant product used not provided by reporter. On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak). On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body). On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs). The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported. The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
80 2021-04-10 hypertension Dizzy, couldn?t do normal housework, breathless after little exertions, terrible headaches . After 1... Read more
Dizzy, couldn?t do normal housework, breathless after little exertions, terrible headaches . After 10 Days went to Yavapai Regional Medical Center ER and was admitted with high blood pressure 225/97.
80 2021-04-12 cerebrovascular accident She is high risk but she had a stroke within a couple of weeks of the Moderna vaccine. There's no wa... Read more
She is high risk but she had a stroke within a couple of weeks of the Moderna vaccine. There's no way to know if it is related but definitely something that needs to be tracked.
80 2021-04-12 chest pain could hardly breathe/hurts me to breath; Right side of chest hurt/pain on right side of the chest li... Read more
could hardly breathe/hurts me to breath; Right side of chest hurt/pain on right side of the chest like muscle pulled; two weeks ago had dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (two weeks ago had dysentery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus and Blood pressure high. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSENTERY (two weeks ago had dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled). At the time of the report, DYSENTERY (two weeks ago had dysentery), DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. At first she didn't feel bad but last night 31Mar2021, she could hardly breathe, right side of chest hurt, hurts me to breathe, pain on right side of chest like I pulled a muscle, two weeks ago had dysentery. Treatment included ointment. Patient didn't want to call doctor as her doctor would just tell her to go to the hospital. Doctor told her to get tested for COVID. Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely. Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273. Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.; Sender's Comments: Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely. Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273. Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.
80 2021-04-12 haemoglobin decreased, fibrin d dimer increased, pulmonary embolism Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several da... Read more
Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several days, along with light headedness. ED visit on 3/14 diagnosed with COPD flare advised to follow up with PCP. 3/22 follow up with PCP, discovered blood in stool sent to ED. Admitted on 3/22 with low hemoglobin and blood in stool. Endoscopy on 3/23 and coloscopy on 3/24. Source of bleed undetermined. Released on 3/23. 4/1 returned to ED as symptoms continued. D-dime blood test and CAT found blood clots in lower right lung. Prescribed Eloquis and released. Returned to ED on 4/5 admitted with low hemoglobin (7.1) bleeding, breathing difficulty. Endoscopy repeated on 4/6 not bleeding found. Released on 4/9.
80 2021-04-13 chest pain could hardly breathe; right side of chest hurt, like I pulled a muscle; dysentery; This spontaneous ... Read more
could hardly breathe; right side of chest hurt, like I pulled a muscle; dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (dysentery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood pressure high and Blood sugar abnormal. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSENTERY (dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe) and CHEST PAIN (right side of chest hurt, like I pulled a muscle). At the time of the report, DYSENTERY (dysentery), DYSPNOEA (could hardly breathe) and CHEST PAIN (right side of chest hurt, like I pulled a muscle) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medication and medication for sugars. Treatment of these events included unspecified ointment. Very limited information regarding the has been provided at this time for the event. Further information has been requested. The reported events were considered possibly related to mRNA-1273.; Sender's Comments: Very limited information regarding the has been provided at this time for the event. Further information has been requested.
80 2021-04-14 nosebleed Nose bleed at about 25 minutes after second Covid Vaccine. That is unusual for me to have a nose ... Read more
Nose bleed at about 25 minutes after second Covid Vaccine. That is unusual for me to have a nose bleed. It took about 30 minutes to stop flow. Stopped by Clinic and saw NP. There was no pain, just sudden blood flow.
80 2021-04-15 hypotension every afternoon she gets chills; blood pressure extremely low; pelvic fracture; Fell in her bedroom;... Read more
every afternoon she gets chills; blood pressure extremely low; pelvic fracture; Fell in her bedroom; legs felt very weak, like they were giving out; she was in lot of pain; sick with fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PELVIC FRACTURE (pelvic fracture) and FALL (Fell in her bedroom) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (sick with fever). On 27-Feb-2021, the patient experienced FALL (Fell in her bedroom) (seriousness criterion medically significant), MUSCULAR WEAKNESS (legs felt very weak, like they were giving out) and PAIN (she was in lot of pain). On 10-Mar-2021, the patient experienced PELVIC FRACTURE (pelvic fracture) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced HYPOTENSION (blood pressure extremely low). On an unknown date, the patient experienced CHILLS (every afternoon she gets chills). At the time of the report, PELVIC FRACTURE (pelvic fracture), FALL (Fell in her bedroom), MUSCULAR WEAKNESS (legs felt very weak, like they were giving out), HYPOTENSION (blood pressure extremely low), PAIN (she was in lot of pain), PYREXIA (sick with fever) and CHILLS (every afternoon she gets chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, X-ray: normal (normal) normal. On 10-Mar-2021, X-ray: abnormal (abnormal) pelvic fracture. On 09-Apr-2021, Blood pressure measurement: extremely low (Low) Extremely low. No relevant concomitant medications were reported. On 28-FEB-2021, patient went to emergency room and x-rays were normal. On 10-MAR-2021, she went to her orthopedist, and repeat x-rays showed pelvic fracture. Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided. This case concerns an 80-year-old female with serious unexpected events of pelvic fracture and fall, and nonserious unexpected hypotension, muscle weakness, pain, and expected pyrexia, chills. Event onset on Day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 80-year-old female with serious unexpected events of pelvic fracture and fall, and nonserious unexpected hypotension, muscle weakness, pain, and expected pyrexia, chills. Event onset on Day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
80 2021-04-15 pulmonary embolism, chest pain patient presented to ER with left sided chest pain. Chest x-ray and chest CT performed. Chest CT sho... Read more
patient presented to ER with left sided chest pain. Chest x-ray and chest CT performed. Chest CT showed linear embolism in lingular branch of left pulmonary artery. EKG showed right bundle branch block which was different than last EKG in 2019. Patient treated with Eliquis 10mg BID x 7 days, then 5mg BID x 3 months.
80 2021-04-18 atrial fibrillation Developed trigger finger right thumb and transient AFIB. Never had any heart iriblem before. I felt ... Read more
Developed trigger finger right thumb and transient AFIB. Never had any heart iriblem before. I felt it was post inflammatory. reaction. Treated myself with oralInoroohen. . Afib resolved after one hour, trigger thumb improved after 3 hours.
80 2021-04-19 haemoglobin decreased autoimmune hemolytic anemia; Evans Syndrome; Jaundice (presumed from hemolysis) weakness light-head... Read more
autoimmune hemolytic anemia; Evans Syndrome; Jaundice (presumed from hemolysis) weakness light-headedness Patient received first COVID-19 Moderna vaccination ~10-14 days prior to onset of hospitalization. Presented with weakness, malaise, jaundice. Lab tests revealed severe anemia that did not respond to transfusions (presumed due to ongoing hemolysis). Began treatment with corticosteroids (IV Solu-Medrol) and IV immunoglobulin to attempt to treat immune-mediated hemolysis.
80 2021-04-20 ischemic chest pain The day after the shot pain in her chest, "pain in her heart"; The day after the shot pain in her ch... Read more
The day after the shot pain in her chest, "pain in her heart"; The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CARVEDILOL, AMLODIPINE, ISOSORBIDE and METFORMIN for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") (seriousness criterion medically significant) and PAIN IN EXTREMITY (The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days). At the time of the report, ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") and PAIN IN EXTREMITY (The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient stated that these events occurred even before receiving the vaccine every once in a while. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
80 2021-04-22 cerebrovascular accident Resident had a stroke and seizures the next morning.
80 2021-04-22 hypertension Patient describes feeling anxious. HBP
80 2021-04-23 chest pain difficulty breathing; soreness after 1st dose left arm; Clot in Lung; chest pain; This spontaneous c... Read more
difficulty breathing; soreness after 1st dose left arm; Clot in Lung; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (Clot in Lung) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disorder. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PULMONARY THROMBOSIS (Clot in Lung) (seriousness criterion medically significant) and CHEST PAIN (chest pain). On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness after 1st dose left arm). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing). On 30-Mar-2021, VACCINATION SITE PAIN (soreness after 1st dose left arm) had resolved. At the time of the report, PULMONARY THROMBOSIS (Clot in Lung), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Echocardiogram: normal (normal) Normal. On an unknown date, Computerised tomogram: abnormal (abnormal) Blood clot in Lung. On an unknown date, Pulmonary function test: normal (normal) came back perfect. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 08-Mar-2021 patient had an echocardiogram (results are not provided). Concomitant medications are not reported. No Treatment for events is provided. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine This case was linked to MOD-2021-084017 (Patient Link).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine
80 2021-04-24 coughing up blood, pallor Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 da... Read more
Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 days after vaccine
80 2021-04-26 platelet count decreased, low platelet count Severe thrombocytopenia requiring hospitalization Subdural hematoma from low platelets Pt in excell... Read more
Severe thrombocytopenia requiring hospitalization Subdural hematoma from low platelets Pt in excellent state of health until about 2 weeks after vaccine. Pt started exhibiting spontaneous bruising and petechia without external causes of trauma. Days later patient started exhibiting signs of confusion and sluggishness and complaining of headache. On post vaccination day 21 patient taken to ER where platelets found to be 18 and CT scan showed a subdural hematoma. patient continues to be hospitalized and workup is underway to determine cause. My belief is the severe thrombocytopenia is related to the vaccine.
80 2021-04-27 blood clot Shortness of breath, fatigue, blood clots in right lung diagnosed in ER, Medical Center
80 2021-05-01 low blood platelet count, platelet count decreased Pt with long history of CLL, not on active treatment developed immune mediated thrombocytopenia Plat... Read more
Pt with long history of CLL, not on active treatment developed immune mediated thrombocytopenia Platelet count fell from 112 to 5k, did not respond to prednisone but improved with IVIG, event started on the day patient was due for her 2nd dose of the Moderna vaccine. It has been held.
80 2021-05-02 fibrin d dimer increased Received second dose of Covid-19 Moderna vaccine on 2/8/21. On 3/10/2021 she went to ophthalmologis... Read more
Received second dose of Covid-19 Moderna vaccine on 2/8/21. On 3/10/2021 she went to ophthalmologist for normal checkup. Did have her eyes dilated (Tropi-Phen). 3/14/21 started having what she thought was floaters in her left eye, has a history of floaters. Then 3/16/21 got worse with blurred vision in both eyes. 3/22/21 Retinal specialist diagnosis of panuveitis with significant vitritis and retinal vasculitis on angiogram. On 3/24/2021 she was started on 60 mg of prednisone daily along with Prednisolone acetate eye drops. Vision beginning to improve. Due to ADRs from steroids (SOB, insomnia, hyperglycemia, myopathy) , started on Humira 4/27/21 with goal to taper steroids. Patient has been unable to work due to vision issues.
80 2021-05-03 blood glucose increased, increased heart rate, hypotension, heart rate increased, deep vein blood clot, arrhythmia 80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric p... Read more
80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric pain, vomiting x1. In Er presented with elevated heart rate, EKG with sinus tachycardia, regular rythm. CXR with COPD changes. There are bibasilar infiltrates suspicious for pneumonitis in the appropriate clinical setting. PAtient admitted to unit for further treatment and workup. WBC 16.91 4/27/2021
80 2021-05-03 platelet count decreased, low platelet count Severe thrombocytopenia developing 1 week after 1st Moderna vaccine. Pt got first vaccine April 12 o... Read more
Severe thrombocytopenia developing 1 week after 1st Moderna vaccine. Pt got first vaccine April 12 or 14 (she can't remember which) and is due for her next May 10 or 12 (though she is not getting this dose per Hem/onc note). Plt down to 3K (from 258K on 3/29/21). This has required 2 hospitalizations with multiple transfusions, bone marrow bx, high levels O2. She is currently in the hospital and her oncologist noted on 5/4/21: "this is covid vaccine related until proven otherwise (she got her 1st Moderna shot one week before plts plummeted); would not get 2nd dose; should be reported to VAERS."
80 2021-05-04 blood pressure decreased, low blood platelet count, superficial blood clot, haemoglobin decreased, excessive bleeding, platelet count decreased March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary car... Read more
March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary care doctor, blood work shows significant drop in platelets March 9 - first visit with oncologist/haematologist & hospitalized March 9-19 - hospitalized for tests, treatment to increase platelets, & many blood panels. No official diagnosis, treat as ITP. Follow up visits with oncologist/haematologist to keep an eye on platelets as they increase. March 30-Apr 4 - ER visit due to swelling of ankles, feet, and left arm. Tests show superficial blood clot, fluid on lungs, and pneumonia. Oncologist said that "we have no official diagnosis", that she's being treated for ITP. April 6-14 - follow up visit to oncologist/haematologist show elevated kidney enzymes, then later liver enzymes, low sodium. April 14 - decision to move to short term rehab for regular PT and OT. Continued swelling (fluid in third spaces.) April 21 - visit to cardiologist to perform cardioversion, successful (during first week of hospital stay, heart rhythm med had to stop). April 23 - facility nurse discovered significantly low Hemoglobin and a blood transfusion was ordered. April 24 - returned to short term rehab facility. April 25 - discovered my mother on O2 and state of health was different, extremely weak and not moving, arm hurting badly. I insisted that her oncologist is contacted. Transported to ER. Discovered her blood work abnormal. After stabilizing her, rushed to the hospital ICU. April 26 - Discussed with her ICU doctor the history of what you have read above. He explained that the covid-19 vaccination has a tendency to affect three proteins specifically that clot and thin blood. I begged him to "get it out of her system." Her bleeding was significant and platelets dropped, again. Still has her mental facilities. Responding well to aggressive treatment: albumin transfusion, plateletpheresis, and CRRT. Pleural catheter to remove fluid from the lungs. Mention of Sepsis. April 27 - Lifted her head up today, opened her eyes, making doctors very happy. Her cardiologist and the ICU doctor both said they were "confused" and everything happening to my mom was "a mystery." Though going in to the evening, her nurse expressed to me that she's worried. The ICU oncologist called me at home in the evening. He asked me if she had been having a fever on a regular basis. He said he thought it could be TTP or a rare disease called HTH, but both results wouldn't be back for one week. He planned to consult with a doctor. He explained to me that the blood was attacking itself and "confused," and that her organs were shutting down. He indicated that the blood work wasn't indicating significant infection. He referenced how the vaccination has made her auto immune system "go crazy." April 28 - I get a call very early from the nurse that she has been fighting with my mother's blood pressure all night, trying to keep it elevated. She told me to come to the hospital, because she had taken a turn for the worse. I arrive to find my mother's eyes wide open, breathing shallow, and blood pressure steady, but drops without assistance from medication. She continues to have her mental facilities. She passed away, organs shutting down, and blood pressure dropped.
80 2021-05-05 blood pressure increased, loss of consciousness, heart rate increased Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and th... Read more
Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination
80 2021-05-06 transient ischaemic attack Transient ischaemic attack; Flickering lights; This spontaneous case was reported by a non-health pr... Read more
Transient ischaemic attack; Flickering lights; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criterion medically significant) and PHOTOPSIA (Flickering lights). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) and PHOTOPSIA (Flickering lights) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment medications are not provided. The patient was taken to the emergency room, where the patient was evaluated and released without an overnight stay. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
80 2021-05-11 atrial fibrillation atrial fibrillation; itching on right scapula, intense incredible itching, whole body itching; face ... Read more
atrial fibrillation; itching on right scapula, intense incredible itching, whole body itching; face was flushed; led to intense red marks; Scratching would make blood vessels burst underneath; swollen armpits; Chills; big rash all over body; low grade fever of 99.1F; Itching on left scapula; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Drug allergy (Augmentin and Demerol). Concurrent medical conditions included Allergy (banana and plantain). Concomitant products included AMLODIPINE, EZETIMIBE (ZETIA), ATORVASTATIN CALCIUM (LIPITOR), NEBIVOLOL HYDROCHLORIDE (BISTOLIC), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN 2000), CENTRUM SILVER +50 and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Itching on left scapula). On 31-Jan-2021, the patient experienced PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F). On 13-Feb-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized on 13-Feb-2021 due to ATRIAL FIBRILLATION. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), PRURITUS (Itching on left scapula), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included Diphenhydramine, Cetirizine, OTC Cortisone cream, Methylprednisolone. Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
80 2021-05-11 fainting, lightheadedness, loss of consciousness Patient received Moderna COVID-19 vaccine #1 on 02/09/2021. Patient received Moderna COVID-19 vacci... Read more
Patient received Moderna COVID-19 vaccine #1 on 02/09/2021. Patient received Moderna COVID-19 vaccine #2 on 03/09/2021. Patient admitted to hospital 03/10/2021 through 03/11/2021 due to syncope on 3/110/2021. Patient had gotten up out of bed to go to the bathroom, called out to her husband then had syncopal episode and fell to the floor. According to husband, she had loss of consciousness for 5 minutes. Per husband and EMS, she then had another syncopal episode after taking a few steps and then collapsed. No urinary incontinence. Syncope occurred day after receiving 2nd dose of COVID-19 vaccination. CT brain as well as CT cervical spine negative for acute abnormality or cervical fracture. Hemodynamically stable. Cardiac enzyme negative x 2. EKG negative for acute abnormality or arrhythmia but with baseline abnormalities. Suspicion was that symptom was due to vasovagal reaction to 2nd dose of COVID19 vaccine. Notably husband also reported that on 02/23/2021 patient was showering, and he then heard her calling out. He found her undressed and wet in the living room area confused. She did not know where she was. Patient also with history of TIA in 05/2020. patient with history of mild dementia.
80 2021-05-16 heart rate abnormal, loss of consciousness, heart failure, cardiac arrest Sudden death due to heart failure (patient without any underlying heart conditions or experiencing a... Read more
Sudden death due to heart failure (patient without any underlying heart conditions or experiencing any symptoms prior to death). Called 911 when family noticing patient being unconscious; 911 arrived detecting weak heart beats and took the patients to the nearest emergency room. Heart stopped beating when arriving at emergency room.
80 2021-05-18 fast heart rate The morning after the second vaccine, my pulse was over 150, I was short of breath, light headed and... Read more
The morning after the second vaccine, my pulse was over 150, I was short of breath, light headed and experienced nausea. This has persisted since with pulse more often in the 105 to 120 range, although it will go to the 150's at times. The feeling lasts anywhere to about five minutes to the entire day.
80 2021-05-20 nosebleed, palpitations Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of d... Read more
Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of desperation , crying episodes, sob
80 2021-05-20 fainting pt says she developed fever, was shivering, and was very weak and tired. She went to bed. She woke... Read more
pt says she developed fever, was shivering, and was very weak and tired. She went to bed. She woke up to use the restroom. Next thing she remembered was waking up on the bathroom floor. She didnt know where she was or what had happened. She was finally able to reach her son to come help her get up and get back into bed. She was extremely weak for a couple of days. She contacted her PCP and was told to file a VAERS report. She no longer has any symptoms.
80 2021-05-23 cerebrovascular accident Stroke despite being on anticoagulation. Patient ultimately discharge to hospice.
80 2021-05-26 chest discomfort Immediately after receiving her second Moderna vaccine, patient states that she felt a tightness in ... Read more
Immediately after receiving her second Moderna vaccine, patient states that she felt a tightness in her chest. No shortness of breath noted. She did not tell anyone at the clinic, but went home to rest. She states that immediately after vaccine, she began to have cough, chest congestion and tightness. Two days later, she went to PCP for evaluation. The Dr diagnosed her with pneumonia and prescribed treatment of antibiotics, steroids and albuterol. Per patient, she has gone back to see the Dr four times and been on treatments continuously. She was referred to Pulmonologist and was seen on 4/14/21. She states that the insignificant nodules that were previously in her lungs were more pronounced. She continues to have cough and chest congestion. No fever has been noted. She will follow up with pulmonologist in July 2021. Patient states that she feels like she still has pneumonia.
80 2021-05-26 hypotension Patient was referred to emergency department by primary care physician for concerns of sepsis. Patie... Read more
Patient was referred to emergency department by primary care physician for concerns of sepsis. Patient UA outpatient that showed a urinary tract infection and was experiencing hypotension. During screening for admission, was found to be COVID-19 positive. Patient was asymptomatic for COVID-19 infection at presentation and was only recieving supportive care. She does not require antiviral, steroid, or supplemental oxygen at time of writing. Patient is currently admitted at time of writing.
80 2021-05-26 pulmonary embolism, fibrin d dimer increased Pulmonary Embolism
80 2021-05-27 hypertension Had a Bad Headache for 2 Days took Tylenol. Muscle Aches had to take tramadol. Weak Legs blood pres... Read more
Had a Bad Headache for 2 Days took Tylenol. Muscle Aches had to take tramadol. Weak Legs blood pressure was high
80 2021-05-28 chest pain, loss of consciousness patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till ... Read more
patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now; passed out; chest burning; leg pain; severe pain on one side; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), CHEST PAIN (chest burning), PAIN IN EXTREMITY (leg pain) and PAIN (severe pain on one side). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now). On 02-Jan-2021, LOSS OF CONSCIOUSNESS (passed out), CHEST PAIN (chest burning), PAIN IN EXTREMITY (leg pain) and PAIN (severe pain on one side) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was provided. Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
80 2021-05-29 fast heart rate Received her second dose of Moderna Covid vaccine yesterday (5/23), subsequently this morning (5/24)... Read more
Received her second dose of Moderna Covid vaccine yesterday (5/23), subsequently this morning (5/24) noted to feel lethargic, dizzy, and had elevated temperature. She sought medical attention and in the ER was found to have temperature of 104°F, tachycardia, and elevated lactic acid. The patient has had no headache, change in vision, photophobia, neck stiffness, abdominal pain, cough. There is no report of sick contacts the patient resides with daughter-in-law and son. She received Rocephin empirically in the emergency room along with 30 mL/kg IV fluid bolus.
80 2021-06-01 fast heart rate The day after the shot, patient developed low-grade fever which lasted 3 days. For 3 days, the pati... Read more
The day after the shot, patient developed low-grade fever which lasted 3 days. For 3 days, the patient was lethargic and had no energy to perform normal household duties. On the 3rd day after the shot, patient developed tachycardia for several minutes, became feverish with a clammy sweat and had vertigo saying the room was spinning and said she felt like fainting. She could not recognize her son, asking him, "Who are you?" Patient lost site in her eyes which was recovered several minutes later. Patient felt better starting the 4th day.
80 2021-06-07 hypertension The following day I had a fever of 102 and was achy. In February, I developed a horrendous ringing i... Read more
The following day I had a fever of 102 and was achy. In February, I developed a horrendous ringing in my ear. I went to the doctor and my BP was high, but the ringing persisted even when it was regulated. I was sent to an ENT and was told that tinnitus is usually a nerve issue. Initially, I didn't think it had anything to do with the vaccine until my neighbor told me about her experience. She said that there isn't any treatment for it, so I'm still dealing with the ringing.
80 2021-06-09 chest pain, pulmonary embolism pulmonary embolism chest pain shortness of breath, blood thinner given patient sent home on o2 and b... Read more
pulmonary embolism chest pain shortness of breath, blood thinner given patient sent home on o2 and blood thinner still non o2.
80 2021-06-09 loss of consciousness On 04/01/2021 at about noon, I passed out and lost concsisness and hit my head on the floor. I had t... Read more
On 04/01/2021 at about noon, I passed out and lost concsisness and hit my head on the floor. I had to go to the ER in which I spent for hours. I had to get a CT scan and a EKG done which came back fine. My blood levels showed my sodium was low. I was also put on a heart monitor for a month.
80 2021-06-10 blood pressure increased Overlapping symptoms and treatment, so reports were combined. Dose 1 - The following Tuesday, I was... Read more
Overlapping symptoms and treatment, so reports were combined. Dose 1 - The following Tuesday, I was hospitalized with very bad dizzy spells. They did a CT Scan and couldn't find anything. They also performed a chest x-ray. I was there for two days and I was fine up until the second dose. Dose 2 - 03/11/21 - The following Wednesday, I started having the dizzy spells again. They wanted me to go in the following Tuesday, but had me to come in on Friday instead due to the severity of the spells. They told me to go to an ear specialist. On 3/30, I was given a hearing test and also tested to see if there were crystals in my head, which there were none. They suggested that I see a neurologist and I met with him on 4/27. On 5/27, he performed an EEG and some type of ear test where they put ear muffs on you and play high pitched sounds. On 6/3, I received my results and both were negative. After that, I was fine until 6/7. I woke up really dizzy and I had a severe headache, which I never have. I went to the ER and also discovered that my BP was elevated. They gave me the choice of staying there and seeing the neurologist the next day or going home and making an appt. I chose to go home. I was given Meclizine 25mg to take 3 times a day for dizziness. I saw the neurologist yesterday (6/10) and he suggested therapy to help with the dizziness. I was told to cut the meds in half and wait on my therapy, which begin on 6/22. I've also had a regular eye and dental appt and both said neither of those areas are the issue.
80 2021-06-13 chest pain, pulmonary embolism I had the vaccine on 01/16/2021 and then at the end of the month my husband got Covid and we both ha... Read more
I had the vaccine on 01/16/2021 and then at the end of the month my husband got Covid and we both had the vaccine already. Of course he gave it to me, so the 02/01/2021 he tested positive and then he had the antibody infusions and a couple of days later I tested positive and I had the infusions on 02/05/2021. About 2 weeks later I got very sick, back ache and chest pains so I went to the ER so I ended up with blood cots in my lungs. They did scans and tons of blood tests, heart scan, lung scans. I have been on blood thinners since them. After Covid and everything I had me second dose this past Friday. So far I am doing okay, I am feeling a little bit dizzy.
80 2021-06-15 chest pain She got her 2nd vaccine, they kept her 30 minutes as she had problems with the 1st one, her BP was o... Read more
She got her 2nd vaccine, they kept her 30 minutes as she had problems with the 1st one, her BP was okay and that she could drive home and was told to drink a lot of water. She went home and after every bottle of water she had 3-4 episodes of diarrhea and kept drinking water all day and after 3-4 she did not have any more diarrhea. She had some pain in her arm. She started having visions of chicken scratches/white lines across her eyebrows from the left to the right across her whole forehead. She always has this vision discrepancy all day long inside the house and outside when she goes and gets the mail. She first went to the eye doctor as she was having floaters, white lines visually appearing but have not had them for a long time, and these did not go away and they were not the usual floaters like she had before. They got her in the office immediately and that doctor said that he did not have an answer for her and he didn't find anything wrong with her eyes. She told him that she was worried about what happened after the vaccine. She went to her PCP and she ended up in the hospital as she has a problem with her left rotator cuff and needs surgery on that but is waiting for her leg to heal from total knee surgery. When she lays down at night she has chest pains, and didn't know what it was and was told that there is a nerve that runs down from the shoulder and crosses over to the heart and gives the feeling of chest pains. She had tests done and they did not give her any answers to what the pains were. She then went to her PCP again and told her about the vision issues and she didn't have an answer to her issues either. Her daughter suggested that perhaps her BP was an issue and she brought that to her attention and she told her to document it and to FU this week with her nurse to see that everything was working okay. She states that her BP has never been the same, she has never had a BP problem before. She takes it every morning between 9-10 AM. 131/86, 139/80, at 5:00 132/74, 148/88, 133/84, 139/92, yesterday was 137/83, today 132/84. She has been placed on BP medicine, Cardizem 30 mg.
80 2021-06-16 hypotension, fainting Renal conditions leading to hospital stay; Fainted due to low Blood Pressure; low Blood Pressure; Mi... Read more
Renal conditions leading to hospital stay; Fainted due to low Blood Pressure; low Blood Pressure; Missed Second dose Beyond day 36; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL DISORDER (Renal conditions leading to hospital stay), SYNCOPE (Fainted due to low Blood Pressure) and HYPOTENSION (low Blood Pressure) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Kidney disorder and Blood pressure abnormal. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (Renal conditions leading to hospital stay) (seriousness criterion hospitalization), SYNCOPE (Fainted due to low Blood Pressure) (seriousness criteria hospitalization and medically significant), HYPOTENSION (low Blood Pressure) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose Beyond day 36). At the time of the report, RENAL DISORDER (Renal conditions leading to hospital stay), SYNCOPE (Fainted due to low Blood Pressure) and HYPOTENSION (low Blood Pressure) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed Second dose Beyond day 36) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications included medications as blood thinners, for High Blood Pressure, Insulin and for renal conditions . Treatment information was not provided. Caller also mentioned that her grand mother fainted recently due to low blood pressure. Company comment:Causality for the event Missed Second dose is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events Renal disorder, Syncope and Hypotension, a causal relationship cannot be excluded.; Sender's Comments: Causality for the event Missed Second dose is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events Renal disorder, Syncope and Hypotension, a causal relationship cannot be excluded.
80 2021-06-20 cerebrovascular accident Acute CVA
80 2021-06-20 blood clot, inflammation of the heart muscle, deep vein blood clot, troponin increased Myocarditis in 2 days - diuretics, Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg i... Read more
Myocarditis in 2 days - diuretics, Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg in a few weeks Angiogram and Fascitomy, Ischemic gut weeks - comfort care orders, DVT in arm in weeks could have been due to PICC also - Elquis
80 2021-06-22 cardiac failure congestive, oxygen saturation decreased Two days after second injection we noticed swelling in ankles, which has not happened before. We cut... Read more
Two days after second injection we noticed swelling in ankles, which has not happened before. We cut back her fluid intake but the swelling persisted for two weeks. She was brought to see doctor (NP) on 17th of March which lead to no resolution. She was brought to ER on the 18th and admitted. After inpatient treatment she was released two days later and has had no subsequent issues.
80 2021-06-22 heart rate increased rapid pulse, x 24 hr mental disconnect issues, x 48hrs anxiety sleeplessness x 2wks
80 2021-06-22 loss of consciousness The patient reported that after receiving the second Moderna Covid-19 vaccination that she had a hea... Read more
The patient reported that after receiving the second Moderna Covid-19 vaccination that she had a headache for 3 days. Additionally, she has been experiencing a stiff neck, has been passing out, her toes have been turning blood red, and she feels like she has not been able to function during the past 3 months. She reported that she went to the hospital to have multiple tests ran, and no unusual lab values were noted. The patient went to the hospital due to the adverse effects she experienced from the vaccine. Upon speaking to the patient it was not noted how long the patient remained in the hospital.
80 2021-06-23 hypertension Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; ... Read more
Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; Dehydrated; Nauseous; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Constipation (Normally she is constipated). Concurrent medical conditions included Hypertension. On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) (seriousness criteria hospitalization and disability), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting). The patient was hospitalized on 19-May-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: 250/110 (High) High and 200/110 (High) High. Concomitantly the patient was receiving unspecified medication for hypertension . Reportedly, the patient was taken to the hospital on 19 May 2021. At the hospital, the patient's blood pressure was high and the doctors were not able to bring it down. Since the second vaccine, the patient's blood pressure has gotten much worse. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.
80 2021-07-01 heart attack myocardial infarction leading to death. Impossible to know causality, but completing this out of an... Read more
myocardial infarction leading to death. Impossible to know causality, but completing this out of an abundance of caution.
80 2021-07-05 heart rate increased Patient stated that 2-3 hours after taking the shot she got a rapid heart rate like her heart was g... Read more
Patient stated that 2-3 hours after taking the shot she got a rapid heart rate like her heart was going to beat out her body. Heart rate was 162. Patient stated that she took Aspirin with warm water. Patient stated that she had the same reaction with the flu Vaccine. Patient stated that the rapid heat beat lasted about a day.
80 2021-07-05 hypertension Blood Pressure over 200/My blood pressure was over 200; I became light headed; I had a reaction to m... Read more
Blood Pressure over 200/My blood pressure was over 200; I became light headed; I had a reaction to my second shot of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200), DIZZINESS (I became light headed) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200) (seriousness criteria hospitalization prolonged and life threatening), DIZZINESS (I became light headed) (seriousness criterion hospitalization prolonged) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) (seriousness criterion hospitalization prolonged). At the time of the report, HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200), DIZZINESS (I became light headed) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: increased (High) Blood pressure was over 200. No concomitant product information was provided. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Live follow up received contains new events light headed and vaccination complication.; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
80 2021-07-07 palpitations, chest discomfort, heart rate irregular, chest pain chest tightness; loss of appetite; irregular heart rate/palpitations; irregular heart rate/palpitati... Read more
chest tightness; loss of appetite; irregular heart rate/palpitations; irregular heart rate/palpitations; extreme PMS; Diarrhea; Fatigue; sleeping on and off all day; shakes; trouble moving and walking; terrible cramping like menstruation; bloated; had a painful stomach; pain moved to the chest area; body aches; chest pain; body pain; lung congestion; so much muscle pain - Muscle pain throughout the body was intense; sick; Muscle pain; fever; Nausea; Headache; chills; Fatigue/ extreme fatigue; shortness of breath; Weakness in her body, muscle and legs; Intense pain; Sore throat; Shaking; Diarrhea; Dizziness; severe stomach cramps - PMS type; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lung congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma since an unknown date, Bronchitis, Hives since an unknown date, Hypersensitivity reaction since an unknown date, Irritable bowel syndrome in 2000 and Reflux esophagitis. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Irritable bowel syndrome, Penicillin allergy (penicillin allergy), Drug allergy (arestin), Allergy to antibiotic (allergy to macrolides) and Allergy to antibiotic (ketolides used for red rashes). Concomitant products included ERYTHROMYCIN, DENOSUMAB (PROLIA), ARTHROBENE PLUS, VITAMIN D3 and DOXYCYCLINE HYCLATE for an unknown indication. On 07-Mar-2021 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), the first episode of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced ILLNESS (sick) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense). On 12-May-2021, the patient experienced PULMONARY CONGESTION (lung congestion) (seriousness criterion medically significant). On 24-May-2021, the patient experienced CHEST PAIN (chest pain) and PAIN (body pain). On 08-Jun-2021, the patient experienced MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL DISTENSION (bloated), ABDOMINAL PAIN UPPER (had a painful stomach), CHEST PAIN (pain moved to the chest area), TREMOR (shakes), HYPOKINESIA (trouble moving and walking) and MYALGIA (body aches). On 09-Jun-2021, the patient experienced HYPERSOMNIA (sleeping on and off all day), the second episode of DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations) and HEART RATE IRREGULAR (irregular heart rate/palpitations). The patient was treated with PARACETAMOL (TYLENOL) on 28-Mar-2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 08-Jun-2021 at a dose of 500 mg; ARNICA MONTANA (ARNICA 30C) at a dose of 2 Tablets; MAGNESIUM at a dose of 500 mg four times per day; LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing from 09-Jun-2021 for Diarrhea, at a dose of 2 mg as required and CHLORPHENAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (ALLERGY RELIEF MEDICINE) ongoing since an unknown date at a dose of 180 mg once a day. On 18-Mar-2021, DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), DIZZINESS (Dizziness), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache) had resolved, ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type) had not resolved. At the time of the report, PULMONARY CONGESTION (lung congestion), ILLNESS (sick), ABDOMINAL DISTENSION (bloated), CHEST PAIN (pain moved to the chest area), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest tightness), TREMOR (shakes), HYPOKINESIA (trouble moving and walking), HYPERSOMNIA (sleeping on and off all day), PAIN (body pain), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations), HEART RATE IRREGULAR (irregular heart rate/palpitations), FATIGUE (Fatigue), MYALGIA (body aches) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense) outcome was unknown and MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL PAIN UPPER (had a painful stomach) and the last episode of DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 193/75 mmhg (High) 193/75 mmHg. On 17-Mar-2021, Body temperature: 98.8 degree celsius (Inconclusive) 98.8 degree Celsius. On 17-Mar-2021, Heart rate: 60 breaths per minute (Low) 60 breaths per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took 2 papaya chewable tabs for stomach. The patient is taking allergy 10 -plus, refresh lubricant eye drops, refresh optive advanced eyedrops every 2-3 hours as needed for both eyes, trace mineral drops -8 drops(3-4 water bottles per day). Company Comment: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Concomitant medication Prolia, Treatment medication Arnica tablets were added. New events severe stomach cramps - PMS type, extreme fatigue, too sick, so much muscle pain - Muscle pain throughout the body was intense were added. On 10-May-2021: Reporter's FAX number was added. On 10-Jun-2021: Treatment medication Imodium and Magnesium were added. New events were added. On 23-Jun-2021: Outcome, FAX number updated On 01-Jul-2021: event added, lab data, medical history, con-med added; Sender's Comments: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested.
80 2021-07-11 loss of consciousness, hypertension really high blood pressure; could not get up; a reaction to the vaccine at the site of injection wit... Read more
really high blood pressure; could not get up; a reaction to the vaccine at the site of injection with a rash; Nauseous; Passed out; Light Headed/dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PRAMIPEXOLE HCL for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Light Headed/dizzy). On 28-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Light Headed/dizzy), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported Treatment information was not provided Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-248557 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
80 2021-07-12 lightheadedness, hypertension could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizzin... Read more
could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizziness; Pneumonia; nausea; had a temperature; sick for five days; vomited for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAMIPEXOLE for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), VACCINATION COMPLICATION (sick for five days), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), VOMITING (vomited for 3 days), NAUSEA (nausea) and PYREXIA (had a temperature). At the time of the report, PNEUMONIA (Pneumonia), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), NAUSEA (nausea) and PYREXIA (had a temperature) outcome was unknown and VACCINATION COMPLICATION (sick for five days) and VOMITING (vomited for 3 days) had resolved. It was reported that the blood pressure intervals were high mainly during the day time. The patient stated that prior to getting the vaccine, she was healthy and was baby sitting for 10 hours. The patient said she had to do stop doing that because she felt like she may drop her grandson since she felt like passed out. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-023313 (Patient Link).
80 2021-07-20 chest discomfort Difficulty breathing, blurred vision, pressure of chest, loss of voice
80 2021-07-20 ischaemic stroke, atrial fibrillation Ischemic Stroke, Hospitalization, Ambulance, arterial blood clot, loss of balance, atrial fibrillati... Read more
Ischemic Stroke, Hospitalization, Ambulance, arterial blood clot, loss of balance, atrial fibrillation , emergency room
80 2021-07-21 palpitations, fainting Syncope within 48 hr of vaccination and persisting lightheadedness, palpitations, then hypertensive ... Read more
Syncope within 48 hr of vaccination and persisting lightheadedness, palpitations, then hypertensive urgency
80 2021-07-23 heart rate irregular Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could n... Read more
Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (The patient stated she has a lot of allergies). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested. This case was linked to MOD-2021-035954 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.
81 2021-01-10 blood glucose increased Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted i... Read more
Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted increased confusion. Temp. 99.6 FBS 114. Resident had been provided tylenol just prior in shift for general discomfort (sore muscles) and low grade temp. On call for Dr notified of all and received order to send to ER.
81 2021-01-11 blood pressure increased Fever (101.4 F), lethargy, and no appetite elevate BP 133/113, P-129
81 2021-01-13 atrial fibrillation, heart rate irregular Systemic: Headache, Systemic: IRREGULAR HEARTBEAT (HAS HISTORY OF AFIB), COMPLAINED OF BEING HOT; sy... Read more
Systemic: Headache, Systemic: IRREGULAR HEARTBEAT (HAS HISTORY OF AFIB), COMPLAINED OF BEING HOT; symptoms lasted 0 days
81 2021-01-13 pallor After the vaccine was administered , she stared and said "I feel really tired." Then she looked at ... Read more
After the vaccine was administered , she stared and said "I feel really tired." Then she looked at this vaccinator and said "You better keep an eye on me." She continued to ask if she should feel tired, ask questions, speak coherently, move all extremities. BP 110/80. No respiratory distress noted. Skin dry. No diaphoresis. Color pale. Patient's daughter was present. She stated that her mother sometimes liked to seek attention. Patient taken to medical area for monitoring. Monitored by nursing staff for 30 minutes. symptoms resolved per patient and family member.
81 2021-01-20 chest pain Had very bad chest pains and hard to get my breath about 45 min after the shot and it lasted 30 mi ... Read more
Had very bad chest pains and hard to get my breath about 45 min after the shot and it lasted 30 mi or so. I feel ok now but do I still take the 2nd shot? Thanks
81 2021-01-25 chest discomfort Pt complained of feeling flushed and tightness in her chest. Pt face was visibly red and she began ... Read more
Pt complained of feeling flushed and tightness in her chest. Pt face was visibly red and she began to have blotches down her back. BP 170/84 at 1:30. Benadryl 50mg given IM at 1:40pm. 2 L of O2 via nasal cannula at 1:42pm. On call physician assessed pt at 1:42 at which time pt started complaining of nausea. BP 132/76 @ 1:45pm.
81 2021-01-25 heart rate irregular Patient was in 15 minutes observation after COVID vaccination when she started experiencing SOB at 4... Read more
Patient was in 15 minutes observation after COVID vaccination when she started experiencing SOB at 4:18 pm. Started with O2 treatment at 3 ml flow rate, notified site lead immediately. Under site lead supervision, attempted to take VS : HR 90 irregular, RR 40 irregular, unable to take BP due to equipment malfunction. No T due to no thermometer in observation room. Patient is diaphoretic states SOB, dizziness. Denies Chest pain. No N/V. At around 4:20 pm, one dose ( 0.3 ml) of epi-pen adult was administered left lateral thigh and called Emergency service ambulance per protocol. At 4:30 pm, EMS ambulance and police were arrived. Detailed patient care information was provided and handed over the care to the team. At 4:40 pm, patient left with emergency ambulance team.
81 2021-01-27 loss of consciousness night of injection chills lasted about an hr. this morning when i woke up i felt very weak and went ... Read more
night of injection chills lasted about an hr. this morning when i woke up i felt very weak and went to the bathroom and tried to sit down and i passed out.
81 2021-02-01 transient ischaemic attack TRANSIENT ISCHEMIC ATTACK= AFFECTED FACE, WITH PARESTHESIAS, BLURRY VISION, GENERAL WEAKNESS, WHICH ... Read more
TRANSIENT ISCHEMIC ATTACK= AFFECTED FACE, WITH PARESTHESIAS, BLURRY VISION, GENERAL WEAKNESS, WHICH RESOLVED IN A FEW MINUTES.
81 2021-02-03 palpitations Client called to report that she had the COVID vaccine yesterday morning, that she felt a little diz... Read more
Client called to report that she had the COVID vaccine yesterday morning, that she felt a little dizzy after, but she was okay and able to drive home. She stated that around 1pm yesterday that she got really dizzy so she took some medication that she had for dizziness, she had it for a previous fall d/t dizziness. She stated that the medication helped, but around 8pm yesterday her head felt like it was going to explode and her heart was racing, so she called her daughter and her daughter called the ambulance and she was taken to the ER. She said they ran a bunch of tests at the ER, including a CT scan, she is doing okay now, and is at home. She stated that she is calling because she does not want to get the 2nd dose of COVID vaccine because she does not want to go through that again. Client stated that she lives alone but her daughter checks on her frequently.
81 2021-02-04 atrial fibrillation, heart rate increased, blood pressure increased Two nights after injection, had terrifying nightmare, 3 nights a bad dream, nightmares, bad dreams w... Read more
Two nights after injection, had terrifying nightmare, 3 nights a bad dream, nightmares, bad dreams waking me up with a rapid heart beat and fast pressured breathing, and vivid dreams continued for approximately 10 -12 nights had 2 nights with vivid dreams. On 2/5/21, woke at about 4:50 am with rapid heart beat that changed into AFib and elevated blood pressure. Heart beat reached 151 bpm and subsided about 30 minutes after getting out of bed.
81 2021-02-06 blood pressure decreased, loss of consciousness, fainting patient said on 2.7.21 around 12 pm she got light headed and black out/fainted for a few minutes and... Read more
patient said on 2.7.21 around 12 pm she got light headed and black out/fainted for a few minutes and blood pressure dropped to 93/56, she felt like it could be vaccine related, no treatment, patient feeling better
81 2021-02-07 hypertension chills and hypertension. systolic bp 200s
81 2021-02-08 body temperature decreased Painful neck and shoulders, right arm, followed by chills. Also lightheadedness and slight dizziness... Read more
Painful neck and shoulders, right arm, followed by chills. Also lightheadedness and slight dizziness. Temp 90.1 degrees (at highest). Total lack of energy and appetite. Next day, lethargy and some diarrhea (not bad). side effects lasted from Feb. 7 evening to Feb. 8 evening. On Feb. 9, just some lightheadedness.
81 2021-02-08 hypertension, fast heart rate tachycardia, hypertension
81 2021-02-11 fainting Fever, chills, body aches, fatigue, fainting through first night. Body aches and fatigue next day an... Read more
Fever, chills, body aches, fatigue, fainting through first night. Body aches and fatigue next day and night. Still have some aching and fatigue on fri, second full day after vaccination
81 2021-02-14 blood pressure increased pt stated that she has had difficulty breathing at night, congestion, thickness in her throat, chill... Read more
pt stated that she has had difficulty breathing at night, congestion, thickness in her throat, chills, nausea, constant dizziness, has a rash around her neck, has fatigue and weakness. Pt also has had pain in her right knee the night of the vax. Pt just feels bad, raised blood pressure, has numbness in both hands and is very uncomfortable. Pt called her PCP and was told to her to take an extra HBP pill. Since pt is still having most of these symptoms she will call her PCP back for more medical advice.
81 2021-02-16 transient ischaemic attack 1-TRANSIENT ISCHEMIC ATTACK: PARESTHESIAS OF FACE, MORE MARKED AROUND CHEEKS AND MOUTH, FELT EYES DE... Read more
1-TRANSIENT ISCHEMIC ATTACK: PARESTHESIAS OF FACE, MORE MARKED AROUND CHEEKS AND MOUTH, FELT EYES DEVIATING TO RIGHT SIDE, BLURRED VISION, DIZZINESS, FEELING OF MAJOR DISTRESS 2-, MUSCLE SORENESS STARTED TO INCREASE AFTER ONE WEEK AND HAS CONTINUED TO INCREASE OVER TIME, BECOMING WORSE AT 4 WEEKS, AND LIMITING EXERCISE: CANNOT RAISE ARM, OR DO ANY MOVEMENT THAT REQUIRES MUSCLE FLEXION OR EXTENSION.
81 2021-02-19 hypertension, chest pain Five days after first shot, had chest pain, high BP and severe shortness of breath.
81 2021-02-21 heart rate irregular I had some shortness of breath. I had chills. 99.4 temp. I was nauseated but never vomited. irregula... Read more
I had some shortness of breath. I had chills. 99.4 temp. I was nauseated but never vomited. irregular heartbeat. very tired most of the day. 3 days later I broke out in a rash on my arm below the injection site and around my arm.
81 2021-02-21 fainting Nausea, vomiting, diarrhea, dizziness, fainting
81 2021-02-22 blood glucose increased Partial deafness, right ear, noted two days after the vaccine was administered. A ten-day course of... Read more
Partial deafness, right ear, noted two days after the vaccine was administered. A ten-day course of Prednisone begun, and hearing PARTIALLY returned two days later. Unknown if the inflammatory reaction expected of the Moderna vaccine caused the deafness. Also unknown if the the dosage of Prednisone reduced the effectiveness of the vaccine. (My history of Meniere's disease does cloud the issue, but I decided to report the inflammatory response to the vaccine as likely relevant.)
81 2021-02-22 loss of consciousness 12:01 am 2-18-21 pt. felt sick went to bathroom, passed out and lost control of bowel. Said she fel... Read more
12:01 am 2-18-21 pt. felt sick went to bathroom, passed out and lost control of bowel. Said she felt like she had the "flu".
81 2021-02-23 chest discomfort, chest pain Patient c/o feeling dizzy/lightheaded and her face was warm. Reported feeling anxious. Facial flush... Read more
Patient c/o feeling dizzy/lightheaded and her face was warm. Reported feeling anxious. Facial flushing noted. Patient taken to private room for further observation via w/c. Patient reports SOB and chest pressure 9/10 BP 204/85 hr 71 spo2 99%. Nitroglycerin 0.4 mg SL given. Pt continues to appear flushed, and c/o h/a and chest pressureEKG completed and handed to doctor at bedside. FM replaced with O2 2LNC. Patient's facial flushing, redness to upper extremities and tremors, has subsided notably and pt is reports feeling better. Continues to deny chest pain. Pt's affect improving and she is able to smile when she answers questions. BP 144/53 HR 88 Spo2 100%. Pt discharged via w/c with family in stable condition as per doctor. Patient aware allergy department will be following up on her reaction and she will be provided with further instructions regarding second dose of moderna covid vaccine.
81 2021-02-23 chest pain #1 Moderna 1/24/2021 1500 #2 Moderna 2/21/2021 1500 #1Moderna lot 029L208 #2Moderna lot 039K208 Side... Read more
#1 Moderna 1/24/2021 1500 #2 Moderna 2/21/2021 1500 #1Moderna lot 029L208 #2Moderna lot 039K208 Side effects started that day after, that include pain to abdomen, chest, pelvic area and chills, felt feverish did not check temp, headache, injection site pain. Did the adverse event start after the first or second vaccination? Side effects started after each vaccines the following day, she just now realized this today. Symptoms severity about the same compared to 1st shot. Symptoms started resolving after a week or so.
81 2021-02-24 pallor 8 days after vaccination pt noted a 1.5 - 2 in diameter pale red area with speckled dots around her ... Read more
8 days after vaccination pt noted a 1.5 - 2 in diameter pale red area with speckled dots around her injection site. 4 days later on 2/22/2021 area was larger at 2.5in x 3in area that was pale red with red dots dispersed around the injection site. Pt did take antihistamine on 2/21/2021 for headache and sinus. Reported very minor itch or irritation to the area but not pain, warmth or swelling. Pt saw her primary provider on 2/24/2021 due to area still present. No treatment course given per her primary provider. Pt reported on 2/25/2021 that the area was not a pale pink color and less noticeable but the size was the same. She feels it is starting to subside. No other s/s of reaction reported.
81 2021-02-26 loss of consciousness At 5:15 AM, the patient went to the bathroom and collapsed into unconsciousness upon trying to leave... Read more
At 5:15 AM, the patient went to the bathroom and collapsed into unconsciousness upon trying to leave. Eventually, she was moved into bed but was only semi-conscious the rest of the day.
81 2021-03-01 heart flutter within 2 min of sitting for observation period, pt reports heart was "fluttering". Lasted about 2 m... Read more
within 2 min of sitting for observation period, pt reports heart was "fluttering". Lasted about 2 min. Notified staff. BP was taken. 150/90. Fluttering had already resolved at that time. FYI-pt states she completed her Z-pack on 1/26/21-sinus infection. PCP aware of above; recommends 2nd dose be given in hospital setting.
81 2021-03-02 chest pain slow onset of fever, aches, chills, stiffness and pain in lower extremities and back (entire), pain ... Read more
slow onset of fever, aches, chills, stiffness and pain in lower extremities and back (entire), pain in center of chest, neck, head no trouble breathing, greast weakness, difficulty rising and standing -- best lying in bed under warm covers- Like the worst cases of flu or virus I've ever had.. Very thirsty
81 2021-03-03 cerebrovascular accident Had a stroke; A spontaneous report was received from a caregiver concerning an 81-years-old female p... Read more
Had a stroke; A spontaneous report was received from a caregiver concerning an 81-years-old female patient who received Moderna's Covid-19 vaccine and had a stroke. Patient's medical history included a mini stroke (5-6 years ago). Concomitant medication included blood thinners. On 02 Feb 2021 at 4:30 pm, ten days prior to onset of the event stroke, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot/batch: unknown) for prophylaxis of Covid-19 infection. On 11 Feb 2021, the patient had an event of stroke for which was hospitalized. The patient was on a lot of medications (not specified). Action taken with second dose of mRNA-1273 in response to the event was not recorded. The outcome of the event stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded. However, patient's elderly age and prior history of TIA are considered as risk factors.
81 2021-03-04 heart rate increased The next day, patient developed rapid heart rate and blood pressure.
81 2021-03-04 loss of consciousness, cardio-respiratory arrest The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burn... Read more
The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg. She had fatigue and myalgias. Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine. She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain. Ambulated in to ER. After her work up she was discharged home - she present back to the ER within 30 minutes. PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious. She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective
81 2021-03-07 hypertension During post vaccination observation period reported feeling hot and nauseous. Was hypertensive 214/1... Read more
During post vaccination observation period reported feeling hot and nauseous. Was hypertensive 214/102 and couldn't recall if she took her antihypertension medicine that day. BP decreased to 187/86, pt anxious and felt tingling sensation and tightness in face and gums. Transported to ED, no difficulty breathing, no facial swelling and no hives. Given diphenhydramine and d/c to home.
81 2021-03-09 palpitations, pallor Lightheaded, palpitations, very pale face and extremities, dizzy very tired, fatiguesd
81 2021-03-11 hypertension, chest pain She had no issues with the 1st dose in the series. She did not have any symptoms but acknowledged f... Read more
She had no issues with the 1st dose in the series. She did not have any symptoms but acknowledged feeling anxious about the side effects prior to arrival for vaccine. After the 2nd dose, she experienced chest pain, jaw pain, body numbness and tingling, and nausea. She did not have vomiting, shortness of breath, syncope, or headache. She was hypertensive on the cardiac monitor and EKG with T wave inversion in lead III, otherwise unremarkable. Heart rate stable, alert and oriented, cardiopulmonary exam benign. She was sent to the ER for further workup, but did not seem to have any allergic reaction to the vaccine. It is unknown what occurred at ER, as she either went to a separate health system or did not go at all.
81 2021-03-11 platelet count decreased, coughing up blood Patient is a 81 y.o. female who received the Moderna vaccine on Monday. On Tuesday she developed or... Read more
Patient is a 81 y.o. female who received the Moderna vaccine on Monday. On Tuesday she developed oral purpura and began spitting up blood. She developed some large hematomas. She was seen in clinic today and had a platelet count of 5k previously normal. Labs are still pending right now. No head ache or neuro changes. No obvious GI bleeding. No chest pain or shortness of breath.
81 2021-03-11 fainting early next morning got up to use bathroom, and collapsed on bathroom floor, went in and out of consc... Read more
early next morning got up to use bathroom, and collapsed on bathroom floor, went in and out of consciousness and was too weak/had no energy to pull herself up from the floor. Severe diarrhea all over floor and self. Was not found until Saturday afternoon, and was transported to the ER by ambulance. Remained in hospital Saturday evening until Monday afternoon. As of today, the following Friday the 12th, she is still weak and unsteady at times, where she was previously ambulating fine with adequate energy. Still feels like she has no strength.
81 2021-03-12 chest discomfort Dizziness, difficulty breathing, swelling of face, rash on thighs and low back, slight tightness of ... Read more
Dizziness, difficulty breathing, swelling of face, rash on thighs and low back, slight tightness of chest. Symptoms continued to get worse. After 45 minutes went to ER Vital signs taken + EKG, observation. After approximately 3 hours breathing, dizziness, swelling of face improved. Some rash remains.
81 2021-03-14 chest pain, very slow heart rate Bradycardia; Chest pain; Shortness of breath; Sinus bradycardia; Symptomatic sinus bradycardia
81 2021-03-17 loss of consciousness 1/13/21 Evening of vaccination pt experienced body aches. States she feels like she had the flu. R... Read more
1/13/21 Evening of vaccination pt experienced body aches. States she feels like she had the flu. Reports feeling better Friday, Sat and Sunday. Cough productive of green phlegm. Weakness and dizziness that kept her from getting off toilet. Fell or passed out upon return to bed.
81 2021-03-23 ischemic chest pain Pain in my heart; A spontaneous report was received from an 81 year-old female patient who received ... Read more
Pain in my heart; A spontaneous report was received from an 81 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in heart. The patient's medical history included heart problem and concomitant medications included Metoprolol. On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced pain in her heart and went to emergency care. The patient said the doctor asked for stress test but the patient could not walk on the treadmill so she was given a shot instead of walking. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event, pain in my heart, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
81 2021-03-23 pallor I felt really funny after the vaccine. I picked up my girls and we went to eat. They told me I was v... Read more
I felt really funny after the vaccine. I picked up my girls and we went to eat. They told me I was very quiet. When we were going home they told me I was swerving, all over the road and they told me to stop, they would drive, I said no, i don't trust anyone with my car. We got home, I remember changing into my nightgown and was texting someone and I suddenly I stopped. After that I was unresponsive. I would not answer anyone, they said I looked pale and stared into the air. They called my children and they came and emergency personnel was called. I was taken to a hospital and they transferred me to another hospital. I stayed there for 3-4 days. After going home it took me some days to be able to walk without assistance. I wanted to say I had covid in May (1st time) and September (2nd time) . I still do not have taste or smell back from the covid. I can only eat 3 or 4 bites and then I am done.
81 2021-03-24 heart failure, hypotension She was transferred to the hospital on 3/4/2021 due to low blood pressure, she understands that due ... Read more
She was transferred to the hospital on 3/4/2021 due to low blood pressure, she understands that due to heart failure. The death certification information is unknown.
81 2021-03-25 fainting Syncopal event. Dizziness per-post event x 2 days
81 2021-03-31 loss of consciousness passed out; Fall; knee got banged up pretty bad; Got dizzy; weak; A spontaneous report was received ... Read more
passed out; Fall; knee got banged up pretty bad; Got dizzy; weak; A spontaneous report was received from a consumer who was also an 81-year-old, female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out/ loss of consciousness, fall, knee got banged up pretty bad/ joint injury, dizzy/ dizziness, and weak/ asthenia. The patient's medical history included knee replacement, COVID-19 in Nov 2020, and pneumonia. Concomitant product use was not provided by the reporter. On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013h21a or 013E21a) intramuscularly for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient got dizzy. The patient was weak and passed out. She was sitting on toilet cover and was getting ready for a shower but the next thing she knew was that, she found herself laying in the shower stall. The patient did not know for how long she was passed out for. Treatment for the events included 2 Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of events, loss of consciousness, fall, joint injury, dizziness, and asthenia, were considered as unknown.; Reporter's Comments: Very limited information regarding these even/s has been provided at this time. Further information has been requested.
81 2021-04-01 heart flutter, palpitations A spontaneous report was received from a consumer concerning an 81 years old, female patient who exp... Read more
A spontaneous report was received from a consumer concerning an 81 years old, female patient who experienced headache, heart flutter and skip a beat/extra systoles. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 02 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient experienced headache, heart flutter and skip a beat. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events headache, heart flutter and skip a beat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-04-01 chest pain Besides my arm being sore, I had no issues. On the 23rd, I started having chest pains and worsened u... Read more
Besides my arm being sore, I had no issues. On the 23rd, I started having chest pains and worsened until I decided to go to the clinic. I was still having pain after they gave me some aspirin. I was taken to the hospital and admitted. They did a stress test and it was normal. I was sent home the next day and I was fine.
81 2021-04-04 low blood oxigenation 4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date... Read more
4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date per pt's daughter) 2/21/21 onset SOB/DOE, fever 2/24/21 Seen at Urgent Care: RML crackles and infiltrate on CXR, given azithromycin and Augmentin 2/27/21 Presented to ED with progression of SOB/DOE, fatigue, diarrhea. Hypoxemic requiring low-flow NC, B/L basilar crackles noted; started on CTX/azithro (2/27-3/3) for presumed CAP 3/08/21 Required HFNC; first seen by me personally: diffuse, distinct velcro crackles, lower > upper fields 3/12/21 Started on high-dose steroids without improvement; unable to wean from HFNC with progressively worsening hypoxemia; pt declined intubation. 03/22/21 Patient died in Palliative Care Unit Diagnosis: Interstitial lung disease of uncertain etiology, acute interstitial pneumonitis vs. undiagnosed connective tissue disease
81 2021-04-11 heart rate irregular Irregular heart beat after eating. Food/beverage sensitivities, like caffeine, wine, carbonation... Read more
Irregular heart beat after eating. Food/beverage sensitivities, like caffeine, wine, carbonation. Heartburn.
81 2021-04-12 arrhythmia, hypertension heart irregularities; high blood pressure; This spontaneous case was reported by a consumer and desc... Read more
heart irregularities; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (heart irregularities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported. ). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (heart irregularities) (seriousness criterion medically significant) and HYPERTENSION (high blood pressure). At the time of the report, ARRHYTHMIA (heart irregularities) and HYPERTENSION (high blood pressure) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-04-12 fainting fainting spells; Chills; Pain at site of the injection; itchiness at the site of the injection; rash... Read more
fainting spells; Chills; Pain at site of the injection; itchiness at the site of the injection; rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting spells) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection). On 02-Apr-2021, the patient experienced SYNCOPE (fainting spells) (seriousness criterion medically significant) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainting spells), CHILLS (Chills), VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment included Tylenol. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-04-13 pulmonary embolism Shortness of breath for about one week Saw DR who gave me referral to Community Radiology on April ... Read more
Shortness of breath for about one week Saw DR who gave me referral to Community Radiology on April 1st. Pulmonary Embolism Diagnosed. Went to Emergency at Hospital. They sent me home with rx for Eliquis.
81 2021-04-15 blood pressure increased nausea, elevated blood pressure, stiff neck, and stiff back, low grade temp
81 2021-04-15 hypertension, cardiac failure congestive Patient received Moderna Dose #1 on 1/11/2021. Later that day, her armpit had a swollen lymph node.... Read more
Patient received Moderna Dose #1 on 1/11/2021. Later that day, her armpit had a swollen lymph node. This was treated topically with clindamycin for hidrandenitis suppurative for about 2 weeks. Then patient received Moderna Dose #2 on 2/8/21. By 2/11/21, patient had some intermittent confusion noted. Vitals were mostly WNL. On 3/4, patient observed with SOB and restlessness. SPO2 was 86%, Temp 98.4, HR 59, BP 136/59. Oxygen started. Later on 3/4, patient had change in mental status, lethargy, SOB and SPO2 90% on PRN oxygen. Transferred to hospital. Patient was admitted to hospital on 3/4/21. She was readmitted to nursing home on 3/12/21. Discharge diagnosis included: altered mental status, acute expiratory failure, fever, atypical pneumonia, CHF exacerbation, HTN, DM, dementia, asthma/restrictive lung disease.
81 2021-04-16 cardiac arrest, cerebral haemorrhage 4/4/21 at 11:30 pm the patient started to make snoring-like sounds in her sleep and could not be wok... Read more
4/4/21 at 11:30 pm the patient started to make snoring-like sounds in her sleep and could not be woken up. 911 was called and in the hospital a CT scan identified extensive large right-sided intraparenchymal hemorrhage within the frontal, parietal and temporal regions, extending into the ventricular system. The patient was put on the ventilator and administered blood pressure medication. A-line was inserted to read blood pressure. 4/11/21 at 8:11 pm the patient passed away due to cardiac arrest
81 2021-04-16 fibrin d dimer increased, pulmonary embolism Patients First dose 01/13/2021 and second dose of Moderna Covid 19 vaccine was administered on Febru... Read more
Patients First dose 01/13/2021 and second dose of Moderna Covid 19 vaccine was administered on February 11th. Patient developed pulmonary embolism in both lungs and hospitalized February 25th. Patient later developed PCP Pneumonia and died March 23rd.
81 2021-04-16 troponin increased, blood glucose increased patient hospitalized secondary to fever, generalized weakness and myalgias and had a fall. she wa... Read more
patient hospitalized secondary to fever, generalized weakness and myalgias and had a fall. she was hospitalized for 2 days.
81 2021-04-19 blood vessels inflammation Patient is a 81-year-old woman who last Tuesday received her second vaccination shot in her left arm... Read more
Patient is a 81-year-old woman who last Tuesday received her second vaccination shot in her left arm. Several hours after the procedure she developed pain and discomfort in her left arm. The left arm discomfort gradually increased over the past 3 to 4 days and she began to experience symptoms of claudication in her left forearm and hand. She had a difficult time performing her daily tasks. The pain significantly worsened today to the point that she had constant pain in her hand and developed numbness in her fingers. She presented to the urgent care clinic and was subsequently transferred to the emergency room where CT angiogram demonstrates thrombus in her left brachial artery. She denies a history of heart palpitations. She has no history of hypercoagulable state. She has no history of blood clots or easy bleeding. She has no history of infection and denies fevers chills or night sweats. She has no significant history of peripheral vascular disease and can walk over a mile without difficulty. She denies symptoms of transient ischemic attacks. Left brachial ulnar and radial artery thrombectomy due to inflammation of the brachial artery and thrombus in the brachial artery extending into the origin of the radial and ulnar arteries done on 3/22/2021. Discharged on aspirin 81 mg daily and Lovenox. Has transitioned to Eliquis now. Complication of left arm wound dehiscence. Debrided by wound clinic on 4/9/2021. Taken for washout/wound closure on 4/13/2021. Continues to f/u in our clinic.
81 2021-04-21 blood pressure increased spike in blood pressure that lasted for 8 days
81 2021-04-22 chest pain Chest pain
81 2021-05-02 blood clot We noticed my mother's foot was swollen, after alerting her nurse practicioner they ordered a scan t... Read more
We noticed my mother's foot was swollen, after alerting her nurse practicioner they ordered a scan to be done on my mother. It confirmed that she had a blood clot between her groin and below her knee. They prescribed eloquis.
81 2021-05-06 anaemia Shortness of breath, severe anemia. I don't know if these symptoms were caused by the vaccine. These... Read more
Shortness of breath, severe anemia. I don't know if these symptoms were caused by the vaccine. These symptoms ocurred 5-6 weeks after the 2nd shot (on Feb.10,2021)
81 2021-05-11 fainting, deep vein blood clot Syncope leading to fall 24 hours post vaccine Deep venous thrombosis 2 weeks post vaccine
81 2021-05-14 loss of consciousness MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 da... Read more
MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 days Not only tired, but seemed to be passing out Neck ache--third day Fever/sweating for 4 days and nights Swollen, painful, numb and itchy left inside arm from pit to elbow Previous one--numb and swollen through 5 days
81 2021-05-15 cerebrovascular accident, blood clot, cerebral haemorrhage blood clot, stroke
81 2021-05-18 cerebral haemorrhage Per nursing notes: patient received Moderna vaccine #1 on 2/1/21. There is no mention of skin is... Read more
Per nursing notes: patient received Moderna vaccine #1 on 2/1/21. There is no mention of skin issues or rashes in notes until 2/25/21. Then there is an alert note indicating she has red spots all over skin. Skin intact on 2/28/21. Lotion was applied. No itching. On 3/8/21, she received Moderna #2. Hydrocortisone cream started on 3/8 for itchy skin. Eucerin and hydrocortisone used daily. On 3/27, Nystatin topical was added. On 3/30, per primary request, patient went to see Dermatologist. Triamcinolone cream started. On 4/2, reddish raised rash on neck and shoulders noted. On 4/15, she had a fall, hit head and transported to ER. Suffered a brain bleed and vertebra fracture. Upon readmission, itching rashes remained upper/lower extremities, back/front of body, with skin intact. Mention neurodermatitis in notes. On 4/26 ration noted all over hand and body with left hand swelling. Triamcinolone cream applied. On 4/27 rash on body worsening and clear fluid filled blisters noted on left hand, therefore Change in condition noted. 4/28 visit dermatologist. 4/28 blisters with clear fluid open and drained. Bacitracin applied. Red raised rash on her body slightly improved. 5/2 rashes on upper and lower body more raised, itching started. Several small blisters on leg, neck, right hand. Dermatologist appointment on 5/5 noted. 5/4 multiple blisters with clear fluid on upper and lower body, different sized. 5/6 prednisone oral taper started. Triamcinolone and mupirocin topical started. New diagnosis of bullies pemphigoid noted. Treatment in process.
81 2021-05-20 troponin increased, chest pain flu like sxms, acute exacerbation of copd/pneumonia starting 02/08/21, headache, chx pain all night ... Read more
flu like sxms, acute exacerbation of copd/pneumonia starting 02/08/21, headache, chx pain all night starting 02/13/21. Pt admitted to hospital 02/14/21. Performed lab work, elevated troponin level which continued to climb. Discovered two blockages and installed two stints to primary artery. Pt was discharged 02/16/21
81 2021-05-26 blood clot 4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVE... Read more
4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVENING OF NEXT DAY) ABOUT 40 MINUTES AFTER RECEIVING VACCINE. 4/29/21: EVER SINCE VACCINATION, EXPERIENCING EXCESSIVE THIRST. ONGOING 5/1/21: PATIENT DESCRIBED SYMPTOM AS SKULL BONE PAIN (TENDER SCALP WHEN TOUCHED) UNTIL 5/5/21 5/3/21: ONGLING BLADDER IRRITATION. NO BLOOD IN URINE, BUT SOME SPOTTING (~2TSP) ON PADDING 5/17/21 . NO BLOOD PRESENT SINCE 5/4/21 MORNING: LYMPH NODE SWOLLEN UNDER THE LEFT ARM (INJECTION WAS IN RIGHT ARM). SIZE OF A TENNIS BALL, VERY PAINFUL, AND PAIN RADIATED TO AROUND THE LEFT BREAST AREA. PAIN LASTED UNTIL THE AFTERNOON OF 5/6/21. 5/9/21: BLOOD CLOT IN LEFT LEG REACTIVATED IN THE MORNING, ACCOMPANIED BY EXTREME PAIN, SWELLING, WARM TO THE TOUCH. PAIN AND SWELLING HAS BEEN MINIMAL BEGINNING 5/24/21, AND HAS NOT BEEN AS WARM TO THE TOUCH AS IT HAS BEEN. TREATMENTS: TOOK IBUPROFEN AND TYLENOL AS NEEDED FOR PAIN. USED ARNICA GEL ON THE ARM AT THE INJECTION SITE + MASSAGE+ CONSTANT MOVEMENT FOR PAIN/STIFFNESS. USED ARNICA GEL ALSO ON LYMPH NODE UNDER LEFT ARM ELEVATED CLOTTED LEG AND STAYED ACTIVE TO OPTIMIZE BLOOD FLOW, USED LIGHTLY HEATED PAD TO EASE THE LEG PAIN
81 2021-05-28 palpitations Shortness of Breath and heart palpations on 1/27/21 at 4AM. another shortness of breath on 2/6/21 at... Read more
Shortness of Breath and heart palpations on 1/27/21 at 4AM. another shortness of breath on 2/6/21 at 9AM. Had follow up of stress test and wore a heart monitor. Both test showed heart dysfunction (stiff heart and doesn't relax). Have had no problems since 2/6/21
81 2021-06-07 low platelet count Admitted to acute care as inpatient with severe thrombocytopenia (1000) treated with Immunoglobulin
81 2021-06-13 nosebleed pt says she developed a rash and has progressively gotten worse since then. The rash is red, with l... Read more
pt says she developed a rash and has progressively gotten worse since then. The rash is red, with little pea shaped pimples that are burning and spreading all over her body. The skin is prickly and very sensitive. She still cannot think clearly and still has fatigue. Her legs are bothering her know as well. She saw PCP Dr on 2/19/21 and told to take Claritin which did not help. On 2/26/21 she saw Dermatologist PA. She was given a skin biopsy. She was diagnosed w/ spongiotic and interfaced dermatitis w/ rare eosinophils. She was prescribed triamcinolone. She has since developed nose bleeds that would come every couple of days then started happening daily. She has had blood test which white blood count cells were up, the doctor thinks the steroid cream may have caused this so she is no longer using it. She has been to the doctors several times due to the skin rash and nose bleeds and nothing the doctors have done for her has helped with her symptoms thus far. She goes back to the doctors in a couple of weeks for another biopsy. These has had these symptoms for months.
81 2021-06-14 fainting Ok I went to bed in the evening of the shot and it wasn't long before I was very uncomfortable and f... Read more
Ok I went to bed in the evening of the shot and it wasn't long before I was very uncomfortable and feeling aches all over. This went on all throughout the night and when I got up I was faint and nauseas a few times through the night. I did not sleep at all. And late morning/mid day I took something like an Advil/ibuprofen and some tums and felt better the next evening.
81 2021-06-16 nosebleed Symptoms Began on 1/29/2021. Shortness of breath which has still not gotten better.
81 2021-06-22 chest pain, blood clot Noted on previous page
81 2021-06-22 nosebleed Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off; This spont... Read more
Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028921A) for COVID-19 vaccination. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) (seriousness criterion hospitalization). The patient was hospitalized on 03-Apr-2021 due to EPISTAXIS. At the time of the report, EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Treatment included saline, humidifier and other treatments, not specified. Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
81 2021-06-28 blood clot Throbbing pain in leg right next to my shin bone; Kept me awake at night; Developed a small blood cl... Read more
Throbbing pain in leg right next to my shin bone; Kept me awake at night; Developed a small blood clot in the vein running along shin bone; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed a small blood clot in the vein running along shin bone) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Throbbing pain in leg right next to my shin bone), INSOMNIA (Kept me awake at night) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) (seriousness criterion medically significant). At the time of the report, PAIN (Throbbing pain in leg right next to my shin bone) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) had resolved and INSOMNIA (Kept me awake at night) outcome was unknown. No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-017541 (Patient Link).
81 2021-06-30 atrial fibrillation I had internal bleeding from ulcers in my stomach and small intestine and I had Afib. May 15th - I w... Read more
I had internal bleeding from ulcers in my stomach and small intestine and I had Afib. May 15th - I went to ER - I went to Hospital. I was transferred from there because they didn't have a GI doctor on staff - to Hospital.. I received blood transfusions 8 units of blood. Was put on several medications. Medications - I was put on Amiodaron and Dojoxin (that was stopped so I'm not taking it now - I didn't need it anymore); put on Ferrous Sulfate; Pantoprazole; - those were the new ones I was put on. Have almost recovered.
81 2021-07-09 deep vein blood clot, platelet count decreased, haemoglobin decreased, excessive bleeding, pulmonary embolism On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she de... Read more
On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.
81 2021-07-10 hypertension, transient ischaemic attack On April 5, 2021, developed uncontrollably high blood pressure, resulting in a TIA and 8-day hospi... Read more
On April 5, 2021, developed uncontrollably high blood pressure, resulting in a TIA and 8-day hospitalization -
81 2021-07-12 cerebrovascular accident minor stroke/a small stroke in the left parietal region of the brain, tiny but visible; Have to use ... Read more
minor stroke/a small stroke in the left parietal region of the brain, tiny but visible; Have to use a cane or a walker; right leg gave up; patient fell on the floor; difficulty with balance because of their right leg; difficulty with walking because of their right leg; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fall (Patient had a fall in November 2020 and broke their shoulder) in November 2020 and Broken hand (Patient had a fall in November 2020 and broke their shoulder) in November 2020. Concomitant products included FISH OIL, MAGNESIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FISH OIL (OMEGA XL), LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]), DILTIAZEM, LISINOPRIL and ROSUVASTATIN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible) (seriousness criteria hospitalization and medically significant), MUSCULAR WEAKNESS (right leg gave up), FALL (patient fell on the floor), BALANCE DISORDER (difficulty with balance because of their right leg) and GAIT DISTURBANCE (difficulty with walking because of their right leg). On an unknown date, the patient experienced WALKING AID USER (Have to use a cane or a walker). The patient was hospitalized from 28-Jan-2021 to 29-Jan-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for Adverse event, at a dose of UNK, qd. At the time of the report, CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible), MUSCULAR WEAKNESS (right leg gave up) and FALL (patient fell on the floor) outcome was unknown and BALANCE DISORDER (difficulty with balance because of their right leg), GAIT DISTURBANCE (difficulty with walking because of their right leg) and WALKING AID USER (Have to use a cane or a walker) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: small stroke in the left parietal region of the br (abnormal) Small stroke in the left parietal region of the brain, tiny but visible. Additional concomitant medications included vit-asid for macular degeneration. Company comment: This case concerns an 81-year-old female hospitalized with a serious unexpected event of cerebrovascular accident, and nonserious muscular weakness, fall, balance disorder, gait disturbance, and walking aid user. Event latency 18 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 81-year-old female hospitalized with a serious unexpected event of cerebrovascular accident, and nonserious muscular weakness, fall, balance disorder, gait disturbance, and walking aid user. Event latency 18 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
81 2021-07-26 troponin increased, low blood oxigenation, fibrin d dimer increased Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experie... Read more
Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experiencing nausea, vomiting, and diarrhea, as well as loss of taste and smell. She presented to the ED with these symptoms and fatigue. She was diagnosed with COVID pneumonia and dehydration and admitted to the COVID Unit. Problem list: -Severe Covid pneumonia with pulmonary infiltrates and new hypoxia. Symptom onset 7/11/2021 -Hypoxic respiratory failure secondary to above -mildly elevated troponin w/o chest pain -Nausea/vomiting/diarrhea, suspected to be secondary to coronavirus -Acute kidney insufficiency, suspect prerenal azotemia from volume depletion -History of hypertension, currently hypotensive -Weakness -new dx of DMII with steroid induced hyperglycemia Plan: -Continue inpatient level of care in the Covid unit -Dexamethasone (7/18/2021-) and completed remdesivir (7/17/2021-7/21), supplementary oxygen, Mucinex, albuterol, proning, is at the spirometry. CRP elevated at 19, D-dimer elevated at 1200 will trend CRP but currently not severely hypoxic enough to qualify for Tocilizumab. Troponin downtrended. TTE with right sided heart dyfxn, likely at least partially chronic as CTA does not show any evidence of pulmonary embolus. Would recommend repeat transthoracic echocardiogram after recovery from acute illness and consideration of right heart catheterization if right ventricle dysfunction appears to be persistent. -Sliding scale of insulin started given her history of borderline diabetes with the expectation of hyperglycemia on dexamethasone. 7.5. Continue lantus, medium dose SSI -Resume amlodipine. Continue holding ACE inhibitor given acute kidney insufficiency -Renal function improving, appreciate assistance -PT/OT consulted and rec -Acetaminophen and Zofran for symptomatic management
82 2021-01-06 chest pain PATIENT DEVELOPED PROGRESSIVE NEW DYSPNEA, DIFFERENT FROM HER BASELINE. SHE HAS BEEN HOSPITALIZED TW... Read more
PATIENT DEVELOPED PROGRESSIVE NEW DYSPNEA, DIFFERENT FROM HER BASELINE. SHE HAS BEEN HOSPITALIZED TWICE FOR PERSISTENT DYSPNEA AND CENTRALIZED CHEST PAIN, WHICH HAS OTHERWISE HAD NEGATIVE WORK UP.
82 2021-01-21 palpitations, pallor After about 10 mins i started to get headache, dizzy,. Got pale. Was put on cot. had heart palpitati... Read more
After about 10 mins i started to get headache, dizzy,. Got pale. Was put on cot. had heart palpitation felt cold and shaky. After about an hr and half i started to get back to normal. When i got up i started to walk funny. I was able to drive home. took Tylenol when i got home. ate a little soup. laid down and fell asleep. when i woke up a couple hrs later i still had a headache. took another tylenol.
82 2021-01-23 chest pain Pain upper rt. Lateral back, side, chest- unable to sleep because of pain-tender to touch-reflux wit... Read more
Pain upper rt. Lateral back, side, chest- unable to sleep because of pain-tender to touch-reflux with no relief from antacids
82 2021-01-23 chest pain mild fever (101-102), chills, intermittent chest pain (she said it was likely related to muscle cont... Read more
mild fever (101-102), chills, intermittent chest pain (she said it was likely related to muscle contractions due to chills), pulse ox 91-92, pulse 110, finger bone ache. the following morning, vomited water, diarrhea symptoms resolved over the next 2-3 days.
82 2021-01-23 hypertension Pt. stated "my head feels funny". Blood pressure was high. @ 9:58 am 188/90, @ 10:02 - 176/84. c... Read more
Pt. stated "my head feels funny". Blood pressure was high. @ 9:58 am 188/90, @ 10:02 - 176/84. consulted with APRN on call & was informed to monitor BP & observe pt. for 20 more minutes. AT 10:10, BP was 180/88, @ 10:20 - 190/98. Pt continued expressing head feeling funny & stated she had a mini stroke in February 2020. Nurse again consulted with APRN & was informed to offer to call an ambulance for pt. Patient initially refused ambulance, but eventually decided to accept. Ambulance was called & transported pt. to hospital at 10:45 am.
82 2021-01-25 fainting Fainted; A spontaneous report was received from a consumer, who was an 82-year old, female, patient ... Read more
Fainted; A spontaneous report was received from a consumer, who was an 82-year old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Jan 2021, approximately 6 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Jan 2021 at 19:30, the patient fainted. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, fainted, was unknown.; Reporter's Comments: This case concerns a 82 year old female patient who experienced a serious unexpected event of Syncope. The event occurred 6 hours after first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
82 2021-01-26 oxygen saturation decreased Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and... Read more
Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021. She felt poorly and did not know her son's name which was not normal. She went to ER on 1/24. She was assessed as not having fractures. She was going to be transferred to a skilled nursing facility. She was not having respiratory complaints. She was awaiting transfer when her O2 levels started dropping substantially. She declined aggressive intervention and she died within a few hours.
82 2021-01-28 oxygen saturation decreased Confusion, brain fog, loss of appetite, extreme muscle weakness with inability to stand by herself a... Read more
Confusion, brain fog, loss of appetite, extreme muscle weakness with inability to stand by herself and walk, intermittent dry cough, decreased oxygen level
82 2021-02-01 loss of consciousness passed out without warning around 10pm. woke up on floor. couldn't move right leg. slept on floor a... Read more
passed out without warning around 10pm. woke up on floor. couldn't move right leg. slept on floor all night.
82 2021-02-02 fainting Dizziness, severe headache, fainting
82 2021-02-03 chest pain 5 MINUTES AFTER PTS FIRST COVID VACCINE, SHE STARTED EXPERIENCING CHEST PAIN AND BURNING. PULSE SEE... Read more
5 MINUTES AFTER PTS FIRST COVID VACCINE, SHE STARTED EXPERIENCING CHEST PAIN AND BURNING. PULSE SEEMED NORMAL AS WELL AS BLOOD PRESSURE, BUT THE PAIN WHIC WAS 5 ON A SCALE OF 10 WAS NOT GOING AWAY. EMS WAS CALLED AND SHE WAS TAKEN TO LOCAL HOSPITAL FOR TREATMENT
82 2021-02-04 transient ischaemic attack Pt's son called and reported that pt had COVID vaccine on 1-25-21 and was taken to the hospital via ... Read more
Pt's son called and reported that pt had COVID vaccine on 1-25-21 and was taken to the hospital via EMS due to confusion and memory loss. Pt's son states that pt was diagnosed with "TIA" and stayed in the hospital x 3 days. Pt states that the physicians at facility was not sure if TIA was related to vaccine but encouraged him to report adverse event. Pt's son states that pt has short term memory loss and has since moved in with him after this event happened.
82 2021-02-05 heart rate increased Chills Headache Nausea Rapid Heart Beat
82 2021-02-05 loss of consciousness she was driving home from being vaccinated and said she blacked out and hit car in front of her ch... Read more
she was driving home from being vaccinated and said she blacked out and hit car in front of her checked by paramedics and released
82 2021-02-07 low blood pressure 3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R ... Read more
3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R face Bells Palsey
82 2021-02-08 chest pain, chest discomfort Patient complained of shortness of breath, chest pain, and chest tightness after about 1 minute foll... Read more
Patient complained of shortness of breath, chest pain, and chest tightness after about 1 minute following vaccine. She was given Epi 0.3, Benadryl 25mg, and Solumedrol 125mg. She was transported to ER and was released after symptom resolution and normal EKG at the Hospital.
82 2021-02-14 palpitations, heart rate irregular Patient stopped into the pharmacy 2/15/21 8am, and notified the pharmacist of her heart racing and e... Read more
Patient stopped into the pharmacy 2/15/21 8am, and notified the pharmacist of her heart racing and extensive arrhythmias that developed the night of the 1st vaccine dose. The symptoms lasted for a couple hours then subsided. She stated that her previous COVID infection may have precipitated her current arrhythmia problems. No other symptoms since that night
82 2021-02-15 cardiac failure congestive Patient had a sharp decline in her health following her second vaccine. Leg pain, lower ext claudica... Read more
Patient had a sharp decline in her health following her second vaccine. Leg pain, lower ext claudication, acute renal failure and acute congestive heart failure
82 2021-02-17 fainting Redness, swelling and pain @ injection site and syncopal episode resulting in injury to face.
82 2021-02-18 low blood oxigenation Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went... Read more
Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date). See following discharge summary from ED: 82 y.o. female who initially presented to the ED with complaint of generalized weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt. During her stay in the hospital, pt did test positive for Covid 19. She developed rapidly progressive respiratory failure, felt to be secondary to ARDS. There was also question of contributing pulmonary edema, however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately, she continued to suffer greatly with the BiPAP in place, and therefore made the decision to transition herself to comfort measures only after visitation from her family. Her other medical issues were supported as appropriate during her stay, with dextrose infusion for hypoglycemia and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine­ enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia.
82 2021-02-21 cerebrovascular accident, transient ischaemic attack Had vaccine on 2/15 , then on 2/16 evening had stroke like symptoms trying to turn the TV channel an... Read more
Had vaccine on 2/15 , then on 2/16 evening had stroke like symptoms trying to turn the TV channel and could not find numbers on remote. then her friend called and could not formulate words to her on the phone and could not say the words that she was thinking. Then she called her brother who is a doctor and he told her to go to Cardiologist and get in. She was talking normal by the time she talked to him. Adverse reaction was TIA. TIA symptoms lasted 5-10 minutes max per patient.
82 2021-02-21 heart rate increased, skin turning blue Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the... Read more
Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the next few days. I developed a swollen and itchy arm. I developed dark bags under my eyes that made me look like I had "black eyes". My fingers turned purple. my veins in my hands and feet enlarged and looked green to me. I feel fine, I just have these funny things happening. everything started to go away after about 3 days and are almost normal except for the veins. I felt fine. then 3 days later on 2/15 I felt like I was going to faint, I felt a rush of heat like a fever and nausea. I felt fine by the end of the day. I am sleeping a lot. I also have a strange feeling in my foot that comes and goes for a few seconds.
82 2021-02-23 fast heart rate right arm cellulitis. had to be hospitalized due to tachycardia, fever, clinical exam consistent wi... Read more
right arm cellulitis. had to be hospitalized due to tachycardia, fever, clinical exam consistent with cellulitis
82 2021-02-23 ventricular tachycardia, palpitations, atrial fibrillation, troponin increased headache, chills, fever, palpitations found to have NSVT, A Fib with RVR and hypomagnesemia
82 2021-02-24 chest discomfort Patient reported that during the first hour after vaccine she felt pain in her shoulders and back, a... Read more
Patient reported that during the first hour after vaccine she felt pain in her shoulders and back, and "intense chest tightening". She took a children's tylenol tab and put heat on her back and then rested and fell asleep for a period of time. SHe woke up to "pins and needles" feeling in her head and face that felt "intense" to her maybe 4-5 hours after vaccination. She continued to feel "discomfort, tightness in chest/back" for 2-3 days. SHe then stated around day 10 she had abdominal tightening, overwhelming nausea, and pressure in her stomach, but no diarrhea for about 6-7 days. She also states she had "bad reflux". Around Feb 14th-16th she started feeling a rash on both arms/neck/chest and then hives that were red/blotchy a few were raised and hard on thighs/hip/arms. She went to physician and was given Benadryl and Steroid cream. She then reports that on Feb 20th she had swollen lymph nodes under arm.
82 2021-02-25 blood pressure increased, heart rate increased RASH ON ARM AND ACROSS CHEST; GLANDS SWELLED A LITTLE; BURNING, ITCHING AND STINGING ARMS AND LEGS;... Read more
RASH ON ARM AND ACROSS CHEST; GLANDS SWELLED A LITTLE; BURNING, ITCHING AND STINGING ARMS AND LEGS; CONTINUED FOR 5 WEEKS AND STILL CONTINUES ALTHOUGH SUBSIDING. STOMACH MUSCLES HURT BUT NO NAUSEA. EXPECTED FATIGUE, DIZZINESS AND WEAKNESS BUT NOT CONCERNED ABOUT THAT. RAISED BLOOD PRESSURE AND PULSE RATE ON 2/3/2021. STILL EXPERIENCING VARIATIONS IN HEAT/COLD FEELINGS..MAY OR MAY NOT BE RELATED.
82 2021-02-26 nosebleed Chills, fever, headache, body aches, A couple of nosebleeds, and my arm hurt from the injection site... Read more
Chills, fever, headache, body aches, A couple of nosebleeds, and my arm hurt from the injection site down to the end of my fingers. Headache continued for four days and fever would come and go but usually at night. I did not receive treatment but I did let my cardiologist office know what was going on. When I continued with the headache, I contacted the internist?s office and I only had a TelMed visit with them. My nostrils had something like cold sores but then I started sneezing and realize there was infection also. Had a second TelMed visit with the PA who started me on an anabiotic Amoxicillian. The infection is clearing up in my sinuses but I am coughing a lot. Overall continue to feel very tired and weary
82 2021-02-28 pallor, heart rate increased Ten minutes after her vaccination, patient noticed her heart beating faster and she became pale.
82 2021-03-02 arrhythmia, hypertension, heart rate decreased I started having chills and loss of energy. The second day really felt very tired. When I took my ... Read more
I started having chills and loss of energy. The second day really felt very tired. When I took my blood pressure it was very high. Twice in the next few days I went to the ER with over 200 over 79 I saw my family doctor and they did a k g and said my heart was out of rhythm and they sent me to the cardiologist. I still feel light headed and blood pressure still high and heart rate low.
82 2021-03-02 atrial fibrillation, sinus rhythm So tired; No energy, very weak; Same night went into afib; A spontaneous report was received from a ... Read more
So tired; No energy, very weak; Same night went into afib; A spontaneous report was received from a 82 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced atrial fibrillation, so tired and no energy, very weak. Patient's medical history included atrial fibrillation. Relevant concomitant medications included prednisone and benadryl. On 28 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On the same day, patient experienced atrial fibrillation. On 29 JAN 2021, she was so tired and had no energy and was very weak which lasted for 6 days. She thought that this was due to prednisone and Benadryl prophylactically. On the same day, her sinus rhythm was found to be back to normal. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events atrial fibrillation was considered resolved on 29 JAN 2021 and the events so tired and no energy, very weak were considered resolved on 04 FEB 2021.; Reporter's Comments: This case concerns an 82 year old female patient, with medical history of paroxysmal atrial fibrillation (2016), who experienced a serious unexpected event of atrial fibrillation, among other non-serious events, after receiving first dose mRNA- 1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
82 2021-03-02 palpitations Disorientated; racing heart rate; fever of 101, had to call paramedics
82 2021-03-03 atrial fibrillation Atrial fibrillation; elevated diastolic blood pressure; A spontaneous report was received from a con... Read more
Atrial fibrillation; elevated diastolic blood pressure; A spontaneous report was received from a consumer, who is a 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sustained atrial fibrillation and elevated diastolic blood pressure. The patient's medical history or concomitant medications were not provided. On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (037M20A) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection. On 14-Feb-2021, the patient experienced the sustained atrial fibrillation and elevated diastolic blood pressure, which were considered medical significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event was unknown. The patient believe the events, sustained atrial fibrillation and elevated diastolic blood pressure, may be related to the vaccine. Consent given for Safety Division to follow up with her, if needed.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
82 2021-03-03 low blood oxigenation Pt was hospitalized due to positive COVID 19 and hypoxia from 2/2/21 and 2/5/21. Pt had a 4 day his... Read more
Pt was hospitalized due to positive COVID 19 and hypoxia from 2/2/21 and 2/5/21. Pt had a 4 day history of weakness, abdominal pain, and shortness of breath. Pt tested positive for COVID 19 and was hypoxic requiring hospitalization. Pt was treated with Remdesivir and Dexamethasone in hospital and weaned off oxygen at discharge. Py had CT of chest showing groundglass opacity. Pt had received her first Moderna COVID 19 vaccine previously on 1/26/21.
82 2021-03-07 fast heart rate, chest pain SOB, nausea, chills, chest pain, tachycardia. Went to ED.
82 2021-03-08 atrial fibrillation, heart rate increased first dose: at 60 hours after shot went into Atrial Fib. Heart Beat up to 150 plus. Had paramedic... Read more
first dose: at 60 hours after shot went into Atrial Fib. Heart Beat up to 150 plus. Had paramedics come. Took a Flecanide. They ran heart test and it doing okay. Delined hospital emergency room transpoort as heart beat came down. Had not had an AFIB event since I had been carioverted a year and a half previously. Second dose was 2/19/21 Same lot. At approximately 81 hours after shot haI d another fib EVENT. aLTHOUGH FOR 24 HOURS BEFORE HAD ERRACTIC and higher thannormal poulse. Highest was 110 beats . Tookm FlecNIDE.sINCE that time have had increased symptomology
82 2021-03-08 fainting On the first evening I had a fever and joint pains which resolves by the next morning, On 02/03/2021... Read more
On the first evening I had a fever and joint pains which resolves by the next morning, On 02/03/2021 I had diarrhea on awakening and about two hours later, after doing morning chores including carrying and lifting 4 gallons of water, I fainted,which included having another episode of diarrhea while I was out. I was seen by emergency medical personnel, had an EKG, and then my children, with whom I live, took me to see my primary care provider who ordered some basic blood tests: a CBC and panel. All blood tests were normal as well as the EKG, I assume. We think the faint was perhaps triggered by the diarrhea and exertion of chores in addition to the vaccine's effect . Since then I have had fatigue.
82 2021-03-09 hypertension Day 7 started feeling dizzy took blood pressure and was 188/80. Fever was 99.8. Achey body and heada... Read more
Day 7 started feeling dizzy took blood pressure and was 188/80. Fever was 99.8. Achey body and headache. After 3 days blood pressure went down and all was back to normal.
82 2021-03-10 cardiac arrest Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultim... Read more
Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultimately succumbed to cardiac arrest.
82 2021-03-11 fainting Flu like symptoms including but not limited to fever, aches, sweating, dizziness. Resulted in faint... Read more
Flu like symptoms including but not limited to fever, aches, sweating, dizziness. Resulted in fainting and falling, proceeded to faint multiple times - lost all bodily functions, eyes rolled in back of head multiple times and 911. Did get back to ability to get home but now repeats herself more than before and seemed to have lost some mental capacity till Wednesday March 10 / she now is better but scared to do anything on her own as fearing issues again
82 2021-03-14 fainting Lost control of muscles; ended up blacking out; could not move; could not talk; A spontaneous report... Read more
Lost control of muscles; ended up blacking out; could not move; could not talk; A spontaneous report was received from a Consumer concerning about a 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Paralysis, Syncope, Mobility decreased and Aphasia. The patient's medical history was provided as diabetes, dementia as current illness. Relevant concomitant medication was reported as blood thinner for blood clots. On 08 FEB 2021, prior to the onset of event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 10 FEB 2021, the patient experienced Paralysis, Syncope, Mobility decreased and Aphasia. Due to these events patient's required hospitalization and on oxygen. Laboratory details was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event's Paralysis, Syncope, Mobility decreased, and Aphasia was as unknown.; Reporter's Comments: The events were consistent with increased risk of cerebrovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
82 2021-03-17 cerebrovascular accident The patient reported feeling tired and diziness beginning February 20, 2021 and had a stroke later t... Read more
The patient reported feeling tired and diziness beginning February 20, 2021 and had a stroke later that day. She was treated in the hospital for 4 days and later released. She did not get her second dose.
82 2021-03-17 haemoglobin decreased x2 ER visits 2/7/21, 2/8/21 c/o n/v/d; X2 inpatient admissions for small bowel obstruction 2/8/21, 2... Read more
x2 ER visits 2/7/21, 2/8/21 c/o n/v/d; X2 inpatient admissions for small bowel obstruction 2/8/21, 2/16/21; admitted 3/18 swg bed for physical deconditioniong. 3/18/21 Swg Bed admission HPI: 82 y.o. female presents for direct admission to swing bed. Back in the middle of February the patient had a high-grade small-bowel obstruction ended up with laparotomy and lysis of adhesions. She was extremely deconditioned. She came to swing bed here and states here for about 2 weeks. She thought she was ready to go home and be successful at that time. Unfortunately, she has gotten home and found that she can barely take care of herself. She is extremely deconditioned. She thinks she just needs to be built up for another week or 2 and then could be very successful at home. She does have a friend that is helping her, but is worried about getting so weak that she end up hurting herself. I saw her yesterday in the office and thought that another swing bed stay a might be in order.
82 2021-03-18 heart rate increased, blood pressure decreased, blood pressure increased blood pressure was going real high, then go low; dehydration; diarrhea; blood pressure would drop to... Read more
blood pressure was going real high, then go low; dehydration; diarrhea; blood pressure would drop to 40; will go upto walking rate 95 to lower 100s; heart rate normally stays 60s - 70s (averages 66 for resting rate); heart rate going up now; A spontaneous report was received from a consumer who is a 82-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase, which led to hospitalization. The patient's medication history included diabetes and high blood pressure. Concomitant medications included amlodipine , irbesartan and pravastatin. On 21-Jan-2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 012L20A ) intramuscularly in the the left arm for prophylaxis of COVID-19 infection. The patient referred he had diarrhea prior to the administration of the vaccine. Following the vaccine administration, he continued having the diarrhea during 3 weeks that made him lost a lot of fluids. He attended to the ER several times for dehydration but in the last visit, he got admitted due to increased blood pressure, dehydration, increased heart rate and prior history of diabetes. Laboratory details included electrocardiogram, stress test. Treatment information included fluids,taken off metformin and metoprolol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
82 2021-03-21 heart failure Experiencing similar symptoms of those of heart failure; Feeling bad; Congestion; Coughing a lot; Ti... Read more
Experiencing similar symptoms of those of heart failure; Feeling bad; Congestion; Coughing a lot; Tired alot; A spontaneous report was received from a consumer concerning an 82-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced feeling bad/feeling abnormal, had similar symptoms of those of heart failure/cardiac failure, coughing a lot/cough ,congestion/nasal congestion and tired a lot/fatigue. The patient's medical history included heart failure and hypothyroidism. Concomitant medications reported included medication for heart failure and hypothyroidism. On 19-JAN-2021, approximately three weeks prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10-FEB-2021, the patient reported that three weeks after receiving the vaccine she started feeling bad, had similar symptoms of those of heart failure (which he has had), cough/coughing a lot, congestion and tired a lot. The event similar symptoms of those of heart failure is considered as medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events feeling bad, similar symptoms of those of heart failure, cough (coughing a lot),congestion and tired a lot, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
82 2021-03-21 chest discomfort As reported yesterday, temp keeps going up & down, while the itching in my left forearm has stopped,... Read more
As reported yesterday, temp keeps going up & down, while the itching in my left forearm has stopped, last night about 11:00 that part of my arm was burning altho there was no redness or itching. My face was burning as well. My temp was 100.1 & I took a Tylenol for that. No redness. I had a very bad headache that started about 6:00. I take Butalbital as needed & by 11:00 it was so bad I had taken 3, starting at 6:00. Today I feel a slight heaviness in my chest, & have no energy at all.
82 2021-03-21 heart rate increased Severe dizziness, vertigo, nausea, vomiting,headache, fast heartbeat, over period of two days. Occu... Read more
Severe dizziness, vertigo, nausea, vomiting,headache, fast heartbeat, over period of two days. Occurred on the 11th and 12th days after my second Moderna vaccination shot. Ressol,ved after two days
82 2021-03-23 blood clot 2 large Blood Clots in the lungs
82 2021-03-24 cerebrovascular accident stroke; affected right hand and right foot; woke up with affected sites; thought initially this was ... Read more
stroke; affected right hand and right foot; woke up with affected sites; thought initially this was stiffness side effect of vaccine; however it did not improve over a couple of days then went to ER
82 2021-03-24 heart rate increased rapid heart rate
82 2021-03-25 low blood oxigenation Pt received first Moderna COVID shot 2/25/2021. Pt developed acute on chronic respiratory failure wi... Read more
Pt received first Moderna COVID shot 2/25/2021. Pt developed acute on chronic respiratory failure with hypoxia, presented to local hospital ED on 3/25 and transferred to our facility for higher level of care. Currently in ICU with covid related hypoxia and pneumonia.
82 2021-03-27 fast heart rate Site: Pain at Injection Site-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial a... Read more
Site: Pain at Injection Site-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 6 hour after vaccine, patient was awoken from sleep with tingling sensation in tongue. Patient felt tachycardic and felt like body was going to break out into hives. Patient did not have rashes or itching but took benadryl anyway. All her symptoms went away roughly 30 minutes later.
82 2021-03-28 blood clot Superficial blood clot in the leg/area is sore to touch; A spontaneous report was received from a co... Read more
Superficial blood clot in the leg/area is sore to touch; A spontaneous report was received from a consumer (patient), concerning a 82-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced superficial blood clot in the leg/area is sore to touch (thrombosis). No medical history was reported. No concomitant medications were reported. On 19 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided), on 15 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a superficial blood clot in her leg (medically significant). She also reported that the area was sore to touch. The doctor prescribed medication to treat her problem, but they said to wait a week to see if it solved on its own before taking it. She was also applying ice pack on the affected area. No further information as reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. The event of superficial blood clot in the leg/area is sore to touch (thrombosis) was unresolved. The reporter did not provide assessment for the event of superficial blood clot in the leg/area is sore to touch (thrombosis).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
82 2021-03-28 blood clot Last Moderna vaccine March 3, 2021. On March 17 began not feeling well. Never felt this way. Then ... Read more
Last Moderna vaccine March 3, 2021. On March 17 began not feeling well. Never felt this way. Then on March 25 had severe low abdominal pain that sent her to ER.
82 2021-03-29 skin turning blue, chest pain, pulse abnormal Vaccine administered at 1816. Patient walked to the observation area and while in the observation ar... Read more
Vaccine administered at 1816. Patient walked to the observation area and while in the observation area, got up to use the restroom. Patient exited the restroom and said she needed assistance. She indicated to the observation nurse that "this ain't good" or "this ain't right". Patient reported seeing spots and having chest pain. The time was approximately 1830. She was assisted to the floor. Help was summoned and 911 called at approximately 1834. Upon being lowered to the floor patient was breathing, she was not cyanotic, her eyes were open and she was not responsive. The patient had a pulse. Sometime after 1830, but before 1835, the patient was observed to have seizure like activity as bilateral
82 2021-03-29 blood clot At 2AM on Saturday, March 13, 2021, I began passing blood into the toilet. That evening I went to th... Read more
At 2AM on Saturday, March 13, 2021, I began passing blood into the toilet. That evening I went to the Emergency Department and was admitted as an inpatient. I was treated there and discharged to home on Tuesday, March 16. Over the next two days I passed substantial amounts of coagulated blood. My diagnosis was colitis.
82 2021-03-30 loss of consciousness Found on unconscious on the floor, I have no memory of coming of bathroom; I felt weak and hot; I fe... Read more
Found on unconscious on the floor, I have no memory of coming of bathroom; I felt weak and hot; I felt shaking extremely cold; I felt weak and hot; I felt shaking extremely cold; Nausea; Headaches; Soreness to left arm; A spontaneous report was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was found on unconscious on the floor/loss of consciousness, hit me like a ton of bricks, soreness to left arm/pain in extremity/, I felt shaking extremely cold/feeling cold, I felt weak and hot/feeling hot; asthenia, I felt shaking extremely cold/tremor, nausea and headaches. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, vitamin D, calcium and senior vitamin not specified. The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 06 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, patient experienced sore arms which was resolved on 08 Feb 2021. On 06 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Mar 2021 the patient experienced headaches, nausea, felt shaking extremely cold, hot and weak, the patient was found unconscious, hitting patient with a ton of bricks and was taken to emergency room on an ambulance. Treatment for the event included hydration fluids, tylenol and aspirin. The action taken with the drug in response to the events was not applicable. The all events were recovered except tiredness which was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
82 2021-03-31 chest pain Severe auto immune flare--terrible unrelenting muscle aching all over body--profound weakness and fa... Read more
Severe auto immune flare--terrible unrelenting muscle aching all over body--profound weakness and fatigue necessitating bedrest for hours at a time. This has continued for 4 WEEKS and is just beginning to slightly let up. My immune system has been in the worst flare I have ever experienced in all the 20 years I have had auto- immune flares--it just cannot seem to down regulate itself and I have crippled up badly as a result. Every movement hurts--even my chest hurts every time I take a breath!
82 2021-03-31 skin turning blue A spontaneous report was received from a consumer concerning a 82-years-old, female patient who rec... Read more
A spontaneous report was received from a consumer concerning a 82-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on her legs/ urticaria, a very bad rash/ rash, blood was coming out in her stool/ hematochezia, ulcerative colitis/ colitis ulcerative, her lips swollen/ lip swelling, her face turned red and hot/ erythema, she feels her teeth burning/ oral discomfort, lips turned blue/ cyanosis, had a 98 °F temperature/pyrexia and had a lump on her back/ vaccination site mass. The patient's medical history as provided by the reporter included prior breast cancer. No relevant concomitant medications were reported. On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 011A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced hives on her legs and a very bad rash. She had to go back to the ER (emergency room) because blood was coming out in her stool, she had a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis, she had never had that before. On an unspecified date she had her lips swollen, her face turned red and hot and she feels her teeth burning. Her lips turned blue. The patient had a 98 ° F temperature and she had a lump on her back. The event ulcerative colitis and hematochezia were medically significant. Treatment for the events included Benadryl. Lab data included on an unspecified date, the patient had a 98 ° F temperature and underwent a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis on 27-FEB-2021. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, hives on her legs, a very bad rash, blood was coming out in her stool, ulcerative colitis, her lips swollen, her face turned red and hot, she feels her teeth burning, lips turned blue, had a 98 °F temperature and had a lump on her back was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
82 2021-04-01 cerebrovascular accident Resident showed signs of a stroke at 8:30am on 4/1/2021; transferred to hospital; 4/1/21 12:22 pm r... Read more
Resident showed signs of a stroke at 8:30am on 4/1/2021; transferred to hospital; 4/1/21 12:22 pm resident admitted to hospital with symptoms of stroke; UTI; and elevated cardiac enzymes
82 2021-04-05 loss of consciousness hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeli... Read more
hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeling the same symptoms as she did when she had covid; taste not the same; headache; Fatigue; mucsle aches; slight nausea; problem with a lymph node in that arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (hit her head and blacked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (also treated with 5 days of Remdesivir) in January 2021 and Lumpectomy. Concomitant products included NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS], ZINC, APIXABAN (ELIQUIS), CARVEDILOL, ATORVASTATIN and LETROZOLE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (hit her head and blacked out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm). At the time of the report, LOSS OF CONSCIOUSNESS (hit her head and blacked out), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: sensitive (Inconclusive) Sensitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included was acetaminophen for headache. The patient was hospitalized with coivd in January and had 5 days of Remdesivir. The patient also had problem with a lymph node in that arm. She had a Lumpectomy. They took at a lymph node in the left side of that armpit to see if it had spread. It was sensitive when she had a breast exam and was sent to get a mammogram. Got the breast exam last week in February. Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.
82 2021-04-07 platelet count decreased, haemoglobin decreased, low platelet count, anaemia Despite patient having long-standing history of ET, she had a completely normal CBC in August of 202... Read more
Despite patient having long-standing history of ET, she had a completely normal CBC in August of 2020 and was maintained on the same dose of hydrea for more than 10 years. She was found to have an abrupt drop in both hemoglobin (13->9g/dl) and platelets (300s-- >104) 2 days after her 2nd vaccine. Her hydrea dose was lowered and repeat blood work 1 month later demonstrated platelets of 64 and hemoglobin of 6.7. patient was admitted to the hospital and was transfused 2 units of blood. Bone marrow biopsy demonstrated 50% cellular marrow with grade three fibrosis consistent with Post-ET MF. No evidence of hemolysis, vitamin, or iron deficiency. Spleen not enlarged. Hydrea was stopped completely during admission. Today's blood work (4/8/2021) demonstrates continued thrombocytopenia and anemia - platelets of 54 and hemoglobin of 7.5.
82 2021-04-09 fibrin d dimer increased, blood clot Fatigue, achy all over, pain under right rib cage that hurt threw to my back. Went to med center and... Read more
Fatigue, achy all over, pain under right rib cage that hurt threw to my back. Went to med center and was seen by Dr. He was concerned so that he insisted that I go to the hospital to be admitted on Tuesday 4/6/21. Was admitted and blood work was done and ct abdomen and car which was negative. More lab work was done on 4/7/21 which showed a elevated d-diner. At that time a ultrasound of legs done which showed a clot in my right leg. Then a ct chest was scheduled and done 4/8/21 which showed a clot in my right lung.
82 2021-04-09 fainting Fainted and fell to ground, dry heaving for 30 min and chills,
82 2021-04-11 blood glucose increased Rash. On body. Cleavage Spike in blood sugar. 248
82 2021-04-12 palpitations, chest pain, atrial fibrillation On 1/27/21, after receiving Dose 1 , I had some chest pains, shortness of breath and a pulse rate ... Read more
On 1/27/21, after receiving Dose 1 , I had some chest pains, shortness of breath and a pulse rate as high as 190. I (foolishly) did not do anything but suffered through these symptoms at varying degrees of pain/discomfort for about an hour and a half. Recently on 4/9/21, I experienced these same symptoms. My heart felt like it was pounding out of my chest; pulse rate was up to 170 and BP was 190/86. I also had intermittent chest pains at different levels of severity. Called 911, ambulance took me to healthcare facility where I was advised that I had Atrial Fibrillation. I don't know if this is related to the Covid shots but I feel it should be documented. While I have had high blood pressure for years and I am an older adult, I have never had any heart problems, per se. I also know it would not be unusual for someone with my characteristics to develop- Atrisl Fibrillation, however, it is suspicious that this occurred only after the covid vaccines were administered. Pregnancy History; 1 child.
82 2021-04-13 anaemia Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal... Read more
Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal failure) Anemia
82 2021-04-13 heart failure Patient was admitted to the hospital for Heart Failure and was discharged; Readmitted to the hospita... Read more
Patient was admitted to the hospital for Heart Failure and was discharged; Readmitted to the hospital for second time for heart related complications; Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged) and CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse drug reaction (No reported medical history). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged) (seriousness criterion hospitalization), CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled). At the time of the report, CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged), CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Concomitant product use was not provided by the reporter. Limited information regarding the events of cardiac failure and cardiac disorder has been provided at this time and a causal relationship cannot be excluded. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the events of cardiac failure and cardiac disorder has been provided at this time and a causal relationship cannot be excluded. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error
82 2021-04-13 chest pain, inflammation of the pericardium, heart rate decreased, atrial fibrillation Started feeling weak next day after shot. As days went by I became increasingly short of breath. T... Read more
Started feeling weak next day after shot. As days went by I became increasingly short of breath. This continued for over 2 weeks and then started having chest pain. Went to ER and admitted with pericarditis. 2 days later I went into Atrial fib. The next day I had a cardioversion. Home the following day. One week at home not feeling well, I was readmitted with increased chest pain and shortness of breath. Pulse very low and needed a pacemaker which was inserted Easter Sunday. Home now and still not feeling well.
82 2021-04-13 deep vein blood clot, pulmonary embolism Patient presented to ED ~2months after 2nd Moderna vaccine with multiple subsegmental PEs as well as... Read more
Patient presented to ED ~2months after 2nd Moderna vaccine with multiple subsegmental PEs as well as small popliteal and calf vein thrombosis. Admitted for 2 days for anticoagulation then sent home on oral anticoagulation in stable condition. No history of thrombosis.
82 2021-04-17 blood clot Blood clot in left arm on 2/28/2021 (2 weeks after 2nd dose of Moderna). Diagnosed at Emergency Roo... Read more
Blood clot in left arm on 2/28/2021 (2 weeks after 2nd dose of Moderna). Diagnosed at Emergency Room.
82 2021-04-18 nosebleed She got her vaccine, she did not have any reactions other than the soreness of the arm when she touc... Read more
She got her vaccine, she did not have any reactions other than the soreness of the arm when she touched it. Then five days later she had a serious nose bleed like water gushing out of a faucet. She put her head back to stop the bleeding. She had 3 on 4/5/2021, then had 1 on 4/8/21, 2 on 4/10/21, 2 on 4/11/21, and then on 4/12/21 they finally lightened up and then on 4/13/21 she was okay and has had none since. The only that she did was put her neck back, squeeze her nose and then sat up. It was about an hour between intervals before the bleeding would stop. She called her ENT and when she called them she left her name and phone, but they have not called back yet.
82 2021-04-20 blood pressure fluctuation high blood pressure (230/120); L arm of vaccination site a circle around the area red and blooded; b... Read more
high blood pressure (230/120); L arm of vaccination site a circle around the area red and blooded; blood pressure high and down, but she has never had the blood; L arm of vaccination site warm to touch; L arm of vaccination site swollen; L arm of vaccination site a circle around the area red and blooded; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (high blood pressure (230/120)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure fluctuation (Patient reported is common for her to have high and low blood pressure.). On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSIVE CRISIS (high blood pressure (230/120)) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (L arm of vaccination site a circle around the area red and blooded), BLOOD PRESSURE FLUCTUATION (blood pressure high and down, but she has never had the blood), VACCINATION SITE WARMTH (L arm of vaccination site warm to touch), VACCINATION SITE SWELLING (L arm of vaccination site swollen) and VACCINATION SITE ERYTHEMA (L arm of vaccination site a circle around the area red and blooded). At the time of the report, HYPERTENSIVE CRISIS (high blood pressure (230/120)), VACCINATION SITE HAEMORRHAGE (L arm of vaccination site a circle around the area red and blooded), BLOOD PRESSURE FLUCTUATION (blood pressure high and down, but she has never had the blood), VACCINATION SITE WARMTH (L arm of vaccination site warm to touch), VACCINATION SITE SWELLING (L arm of vaccination site swollen) and VACCINATION SITE ERYTHEMA (L arm of vaccination site a circle around the area red and blooded) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: 230/120 (High) high. On 14-Apr-2021, Blood pressure measurement: 150/80 (High) down to 150/80. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported taking blood pressure medication. She also indicated that she takes other medications, but no names or indications were provided as patient has been taking them for many years and does not consider them related to the event. No additional treatment medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
82 2021-04-21 deep vein blood clot patient developed DVT to right lower extremity on the 4/19/21
82 2021-04-21 hypertension Two days after the 2nd dose, the patient presents the following symptoms: 75% oxigenation, 35% Puls,... Read more
Two days after the 2nd dose, the patient presents the following symptoms: 75% oxigenation, 35% Puls, 153 sugar, HBP 64/44 and vomiting.
82 2021-04-25 chest pain onset of severe L back pain, L arm pain and L chest pain very similar to previously experienced brac... Read more
onset of severe L back pain, L arm pain and L chest pain very similar to previously experienced brachial plexopathy
82 2021-04-25 nosebleed Dizziness, severe nose/throat bleed
82 2021-04-25 ischaemic stroke My mother suffered a massive stroke 40 days after receiving the 2nd dose of the cover 19 vaccine. Sh... Read more
My mother suffered a massive stroke 40 days after receiving the 2nd dose of the cover 19 vaccine. She fell sick the day after the injection and suffered with brain fog, memory issues, lethargy from that day forward. On day 36 after the 2nd dose she developed a debilitating stomach issue that cause explosive diarrhea that lasted 4 days/nights. This bout with stomach issues left her extremely weak and exhausted. On the 4th night of the diarrhea she got up in the middle of the night to go to the bathroom and couldn't lift herself off of the commode. It took two hours for her to call for help. Once admitted to the ER the stroke was confirmed. Because they could not pinpoint the first stroke symptom she was not eligible for the life saving blood thinning meds and suffered complete paralysis of her right side.
82 2021-04-26 brain sinus blood clot Moderna COVID-19 Vaccine EUA: one month after vaccination patient presents to emergency department r... Read more
Moderna COVID-19 Vaccine EUA: one month after vaccination patient presents to emergency department reporting worsening headache for three months. Diagnosed with dural venous sinus thrombosis, admitted to hospital, anticoagulated, and discharged to home stable with symptom resolution.
82 2021-04-28 cerebrovascular accident Stroke at the base of my head/neck. Affected my sight, gave me a migrane-type headache, and memory l... Read more
Stroke at the base of my head/neck. Affected my sight, gave me a migrane-type headache, and memory loss.
82 2021-04-28 cerebrovascular accident Stroke at the base of the head/neck - affecting sight and giving me a migrane-like headache Outcome ... Read more
Stroke at the base of the head/neck - affecting sight and giving me a migrane-like headache Outcome - Memory loss
82 2021-04-28 hypotension The patient was admitted for hospitalization on 4/28/2021 from a Unit with an ongoing COVID outbreak... Read more
The patient was admitted for hospitalization on 4/28/2021 from a Unit with an ongoing COVID outbreak. Patient presented with a fever and hypotensive. Patient also reports a UTI. Tested for COVID has a part of hospital admission guidelines. The test returned positive.
82 2021-04-29 blood pressure decreased Vitals of patient were taken in mornings after initial dose of vaccine. On the 12th day after said ... Read more
Vitals of patient were taken in mornings after initial dose of vaccine. On the 12th day after said inoculation patient blood pressure dropped from normal 139/63 to 100/54 for period of 2 - 3 days. Patient demonstrated no additional adverse symptoms, i.e., fever, joint pains, respirator distress, headaches, etc.
82 2021-04-29 fibrin d dimer increased, low blood oxigenation, oxygen saturation decreased Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen... Read more
Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.
82 2021-05-02 blood pressure increased On third day had extreme pain in abdomen (felt like huge air bubble) for 24 hours; Saw acupuncturist... Read more
On third day had extreme pain in abdomen (felt like huge air bubble) for 24 hours; Saw acupuncturist, which helped relieve it; then for 4 weeks was extremely fatigued....I am healthy and exercise regularly and I could not do anything like shop, cook, except briefly....less than 2 hours and then would need to lay down to recoup.....no energy at all...the stress and not knowing what was happening increased my blood pressure and my anxiety greatly. After 4 weeks, energy began to come back gradually over the next two weeks. Am now fine.
82 2021-05-07 cerebrovascular accident, stroke This 82 year old female received the Moderna Covid shot on 1/28/21 and went to the ED on 2/24/2... Read more
This 82 year old female received the Moderna Covid shot on 1/28/21 and went to the ED on 2/24/21 and was admitted on 2/24/21 with the following diagnoses listed below. CVA (cerebral vascular accident) Cerebral infarction, unspecified Facial weakness
82 2021-05-07 low platelet count This 82 year old female received the Moderna Covid shot on 2/17/21 and went to the ED on 2/25/21... Read more
This 82 year old female received the Moderna Covid shot on 2/17/21 and went to the ED on 2/25/21 and was admitted on 2/25/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
82 2021-05-10 cerebrovascular accident had all signs of a stroke (could have had a stroke); migraine headache; incoherent speech; This spon... Read more
had all signs of a stroke (could have had a stroke); migraine headache; incoherent speech; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was reported. Concomitant products included ATORVASTATIN for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) (seriousness criterion medically significant), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech). At the time of the report, CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech) outcome was unknown. Additional concomitant medication included an unspecified blood pressure medication. Treatment information was not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up/additional information included the reporters contact information (address) and the mention of had all signs of a stroke / could have had a stroke.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.
82 2021-05-12 heart attack I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute renal injury (CMS/HCC... Read more
I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute renal injury (CMS/HCC)
82 2021-05-12 blood pressure decreased, oxygen saturation decreased Low arterial pressure, low saturation pressure.
82 2021-05-13 fainting Moderna COVID-19 Vaccine EUA. Approximately 4 hours of extreme chills, followed by a heavy sweat. Re... Read more
Moderna COVID-19 Vaccine EUA. Approximately 4 hours of extreme chills, followed by a heavy sweat. Returned to "normal. Following morning, period of lightheadedness, followed by a brief fainting spell. Return to "normal" but experienced recurring vague headaches, treatable with double doses of aspirin for about a week afterwards. Nothing since.
82 2021-05-18 pulmonary embolism, blood pressure decreased, deep vein blood clot, platelet count decreased 3/25/2021 was at store when she felt weak, dizzy and nauseated. She had severe left lower pelvic pa... Read more
3/25/2021 was at store when she felt weak, dizzy and nauseated. She had severe left lower pelvic pain above her left hip. Heart rate was 40 and blood pressure was very low. Was taken to local ER. CT of chest revealed pulmonary embolism in the right lower lobe, left retro-peritoneal hemorrhage and large intramural thrombus in the inferior aspect of the IVC extending into the left common femoral vein and superficial femoral vein. Platelet count 147. After initial treatment in ER, she was transferred to another Hospital for hemorrhage and large thrombus. She was eventually released to rehab.
82 2021-05-19 blood clot Patient developed a cough a week or so after getting the vaccine. Unclear if clots were starting to ... Read more
Patient developed a cough a week or so after getting the vaccine. Unclear if clots were starting to develop at the same time.
82 2021-05-20 heart attack Symptom onset 4/12/21 (cough, diarrhea, feverish, nausea, chills, fatigue and abdominal pain). 4/14/... Read more
Symptom onset 4/12/21 (cough, diarrhea, feverish, nausea, chills, fatigue and abdominal pain). 4/14/21 PCR positive for COVID-19 virus. Admitted inpatient 4/14/2021.
82 2021-05-20 transient ischaemic attack TIA (transient ischemic attack); symptoms appeared a week prior to presentation to ED but subsided t... Read more
TIA (transient ischemic attack); symptoms appeared a week prior to presentation to ED but subsided then reappeared again so she came to ED and was admitted for observation. Under observation symptoms subsided again, except for a decreased sensation on the left arm and right foot. Patient is currently on stroke work up and was started on dual antiplatelet therapy with aspirin and plavix for 21 days.
82 2021-05-23 ischemic chest pain 2-27-21 Heart pain, transported to ER 2x in 2 days. Within 2 days, her Liver and Kidney function fai... Read more
2-27-21 Heart pain, transported to ER 2x in 2 days. Within 2 days, her Liver and Kidney function failed. and Acute Hypoxic Respiratory Failure and Cardiogenic Shock were listed as cause of death on 3-3-21
82 2021-05-23 chest discomfort Within 10 minutes of receiving the injection, the patient felt like her chest was expanding and was ... Read more
Within 10 minutes of receiving the injection, the patient felt like her chest was expanding and was going to explode. Waited 20 more minutes and finally had some relief from the chest pressure, but then was completely exhausted for 10 days, finally went to urgent care. Urgent care diagnosed her with an allergic reaction to the vaccine. Was told that 10% of the population with allergy-induced asthma have a reaction to the vaccine. Was prescribed a Medrol dose pack and was told to follow up with her primary care physician in 4 days. Due to the Scripps outage, the patient followed up in our office and was told that she would recover within a month's time.
82 2021-05-23 troponin increased, inflammation of the pericardium, inflammation of the heart muscle Patient was admitted to the hospital 2 weeks following first Moderna Vaccine for COVID. Diagnosed w... Read more
Patient was admitted to the hospital 2 weeks following first Moderna Vaccine for COVID. Diagnosed with pericarditis/myocarditis. No other clear preceeding illness or precipitant.
82 2021-05-24 blood clot blood clot was discovered in the left leg; excruciating pain in the left leg below the knee; area is... Read more
blood clot was discovered in the left leg; excruciating pain in the left leg below the knee; area is swollen; Area of the left leg below the knee is red; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot was discovered in the left leg) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (blood clot was discovered in the left leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red). At the time of the report, THROMBOSIS (blood clot was discovered in the left leg), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red) had not resolved. The patient's concomitant medication was not reported. The information regarding the patient's treatment medication was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-116642 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
82 2021-05-26 platelet count decreased Lung bleeding; Rash on her leg came back; Redness; Tenderness; Bruise; Purple extending bruise-like ... Read more
Lung bleeding; Rash on her leg came back; Redness; Tenderness; Bruise; Purple extending bruise-like rash on the left leg; Itching; Painful; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY HAEMORRHAGE (Lung bleeding) and RASH (Rash on her leg came back) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY HAEMORRHAGE (Lung bleeding) (seriousness criteria hospitalization prolonged and medically significant), RASH (Rash on her leg came back) (seriousness criterion hospitalization prolonged), ERYTHEMA (Redness), TENDERNESS (Tenderness), CONTUSION (Bruise), RASH (Purple extending bruise-like rash on the left leg), PRURITUS (Itching) and PAIN (Painful). The patient was hospitalized on sometime in 2021 due to PULMONARY HAEMORRHAGE and RASH. The patient was treated with Surgery (Grafted the vein from right under for the bypass.) for Pulmonary haemorrhage. At the time of the report, PULMONARY HAEMORRHAGE (Lung bleeding), RASH (Rash on her leg came back), ERYTHEMA (Redness), TENDERNESS (Tenderness), CONTUSION (Bruise), PRURITUS (Itching) and PAIN (Painful) outcome was unknown and RASH (Purple extending bruise-like rash on the left leg) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count decreased: 90-110 (Low) Platelets are trending on the lower side 90-110.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment for the event included blood transfusions. On an unknown date the patient experienced, ERYTHEMA (Redness), TENDERNESS (Tenderness), CONTUSION (Bruise), RASH (Purple extending bruise-like rash on the left leg), PRURITUS (Itching) and PAIN (Painful). On an unknown date she had major heart surgery since and experienced RASH (Rash on her leg came back) (seriousness criterion hospitalization prolonged) and PULMONARY HAEMORRHAGE (Lung bleeding) (seriousness criteria hospitalization prolonged and medically significant). The rash on her leg came back during the postop course. It was in the exact location. Unfortunately they grafted the vein from right under for the bypass. She was in ICU for the last 6 weeks with unknown etiology of lung bleeding. Based on the current available information and temporal association between the use of the product and the start date of the events Erythema, Tenderness, Contusion, Rash, Pruritus and Pain, a causal relationship cannot be excluded. As for the serious events Pulmonary Haemorrhage and Rash requiring hospitalization, very limited information regarding these events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received included laboratory investigations, new events, seriousness and treatment details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events Erythema, Tenderness, Contusion, Rash, Pruritus and Pain, a causal relationship cannot be excluded. As for the serious events Pulmonary Haemorrhage and Rash requiring hospitalization, very limited information regarding these events has been provided at this time. Further information has been requested.
82 2021-05-28 deep vein blood clot Pt was found by daughter 3/14/2021 weak, unable to stand and with swollen legs. Pt was taken to ER w... Read more
Pt was found by daughter 3/14/2021 weak, unable to stand and with swollen legs. Pt was taken to ER where she was found to have left leg DVT despite being on Eliquis 5 mg bid which she confirmed she was taken as prescribed
82 2021-06-01 cerebrovascular accident I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)
82 2021-06-03 heart rate increased, chest pain 1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days... Read more
1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days post Vax) 2. Baseball sized lump , iced, resolved (occured 2 days post Vax) 3. approximately 2 weeks post Vax - began difficulty breathing and chest pains, elevated heart rate. Went to clinic , was sent via ambulance to ER . Admitted with diagnosis of pneumonia, fluid retention /edema . Spent 6 days in the hospital. Was told by hospital staff to report to VAERS. Covid test was negative. 4. Today - 15 weeks post Vax, never recovered energy, has severe fatigue, weakness, unable to stand for long periods of time or walk more than a minute. Saw Dr. - look work showed severely elevated Ferritin levels 900+. Still battling and treating with home heath care 4 days a week / OT x2 and PT x2. Home bound. This is ALL since Vax #2....she was walking 30 minutes a day and completely self sufficient before this shot.
82 2021-06-07 blood glucose increased, pallor, oxygen saturation decreased, heart rate irregular, haemoglobin decreased, skin turning blue On 6/4/21 at 10:40, res became unresponsive with agonal/snoring respirations, no palpable pulse, but... Read more
On 6/4/21 at 10:40, res became unresponsive with agonal/snoring respirations, no palpable pulse, but audible apical pulse with irregular rhythm, general pallor nd cyanosis, cool and clammy skin. BP92/58 manual, R 4 initially sats low 90's. Accucheck 181. required heavy tactile sternal rub; Res vomited large amt of yellow/white vomitus and had large diarrhea episode. She became responsive after sternal rub but shortly thereafter became unresposnive again. MD notified with new orders for labs and head CT.
82 2021-06-07 nosebleed Headache for 2 days and nose bleed that lasted 25 minutes in left nostril. Nose bleed started the e... Read more
Headache for 2 days and nose bleed that lasted 25 minutes in left nostril. Nose bleed started the evening that vaccine was given. Patient had received Pfizer vaccine (one dose) on February first and then caught Covid-19 three weeks later. Her doctor at emergency room told her to start the series over again. She wanted to then get Moderna since she had such bad side effects with Pfizer brand.
82 2021-06-13 heart attack Reporting today because the doctor at the hospital told me that he didnot understand what caused my ... Read more
Reporting today because the doctor at the hospital told me that he didnot understand what caused my heart attack. When he did the heart cath there were no clogged arteries or evidence of hypertension.
82 2021-06-14 hypertension Debilitating headache and high Blood Pressure
82 2021-06-18 heart attack not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph no... Read more
not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved. Concomitant medications were not reported. Company Comment ; Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR) upgraded case to serious, new event added, action taken updated; new reporter added.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Massive heart attack
82 2021-06-20 atrial fibrillation Acute respiratory failure; atrial fibrillation
82 2021-06-20 heart attack Myocardial infarction
82 2021-06-20 fainting 82 year old woman admitted to the ICU for management of worsening acute hypoxic respiratory failure ... Read more
82 year old woman admitted to the ICU for management of worsening acute hypoxic respiratory failure secondary to severe COVID 19 pneumonia on 6/17/21. Patient was originally hospitalized for treatment of COVID 19 in the beginning of June 2021. She was discharged on 6/10/2021. She presented to the emergency room on 6/12/2021 for syncopal episode at home. Head CT was negative for any acute intracranial pathology. 12 lead EKG did not demonstrate any arrhythmias, nor any ST to T changes, and echocardiogram demonstrated EF=70% with no wall motion abnormalities. She was admitted to the hospitalist service continued work up for syncope.
82 2021-06-22 pulmonary embolism Within two weeks following second covid shot, my mother developed extreme pulmonary issues with lung... Read more
Within two weeks following second covid shot, my mother developed extreme pulmonary issues with lungs that presented a "ground glass" appearance. Shortly thereafter, she was diagnosed with interstitial lung disease despite having never been a smoker or exposed to asbestos. While her medical doctor does not believe there is a connection, in the 8-10 weeks following the initial event she is improving significantly. It took three hospital stays, a lung biopsy, a pulmonary embolism and lengthy time in the ICU but she is starting to improve to the point that she does not need oxygen. The level of improvement she is showing and the rate of improvement seems inconsistent with ILD.
82 2021-06-29 cerebral haemorrhage, loss of consciousness, cerebrovascular accident She had a non traumatic intracerebral hemorrhage; Never regained consciousness after the stroke/unre... Read more
She had a non traumatic intracerebral hemorrhage; Never regained consciousness after the stroke/unresponsiveness; Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) and CEREBROVASCULAR ACCIDENT (Stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Type 2 diabetes mellitus on 21-Jan-2021. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) (seriousness criteria death, hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 21-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medications include unspecified medications for diabetes and low pressure. Reporter further explained the event as non traumatic intracerebral hemorrhage. Patient was hospitalized for some days and died one or two days after coming back to home. The treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
82 2021-07-11 palpitations, arrhythmia Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitor... Read more
Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitoring device and it stated it might be afib and something else (she cannot remember the term); Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hypothyroidism. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep). At the time of the report, ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment medication included an unspecified cream for an unknown indication. A week after the 1st dose (??-Mar-2021), patient reportedly had red blotches on her arms, face, back, thigh and chest areas. She consulted with two doctors and was prescribed with an unspecified cream which did not help. The red blotches are still present - they are itchy and she cannot sleep. She also says that she has to explain to everyone she meets that they are not contagious. She has an appointment with her rheumatologist on the last week of September. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-248016 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
82 2021-07-28 atrial fibrillation on anticoagulation wtih xarelto for a fib started having rectal bleeding 1 wk after moderna #1 2/6/... Read more
on anticoagulation wtih xarelto for a fib started having rectal bleeding 1 wk after moderna #1 2/6/21 then again 1 wk after moderna #2 3/6/21. pt has continued to have intermittent bleeding since 2nd vaccine
83 2021-01-04 loss of consciousness "Patient with seizure this am during 1 assist transfer, resident passed out, lowered to shower chair... Read more
"Patient with seizure this am during 1 assist transfer, resident passed out, lowered to shower chair next resident with incontinent episode and was sent to Emergency Department emergently and currently under evaluation with possible admission. "
83 2021-01-10 hypotension Resident vomited several times throughout the night, started running a fever as high as 102.3, devel... Read more
Resident vomited several times throughout the night, started running a fever as high as 102.3, developed a cough, c/o dizziness and increased confusion. Went out EMS, BP was low, will be kept for obs at hospital.
83 2021-01-10 fainting FAINTING EPISODE CONFUSION
83 2021-01-13 blood clot Moderna COVID-19 Vaccine At 2 PM I went blind in my left eye. Went to emergency room at Hospital W... Read more
Moderna COVID-19 Vaccine At 2 PM I went blind in my left eye. Went to emergency room at Hospital Was told I have Blood clot in my eye causing the blindness and Ophthamologist says it will probably be permanent
83 2021-01-20 platelet count decreased At this time provider of this patient feels the only reasoning behind patient's low platelet count c... Read more
At this time provider of this patient feels the only reasoning behind patient's low platelet count could be in possible relation to COVID19 vaccine given 01/05/21. Patient is not having any other concerns and health status has not changed (besides platelet result) since before vaccine on 01/05/21. Patient was not given vaccine by our facility but by the pharmacy. At this point provider plans to advise patient does NOT get 2nd dose.
83 2021-01-24 atrial fibrillation Heart experienced atrial fibrillation.
83 2021-01-24 palpitations About 2 hours started to feel sick to her stomach. All of a sudden felt heart pounding and racing.... Read more
About 2 hours started to feel sick to her stomach. All of a sudden felt heart pounding and racing. Could hear her heart pounding and racing really fast. Laid down and after 45 minutes to an hour was still racing, so laid back down and when got up the 2nd time her heart was still beating fast but not as bad as when it first happened. Gradually the symptoms subsided. Not having problems now. Did not feel very good Saturday or Sunday, but today is feeling fine. The first day was the worst.
83 2021-01-24 fast heart rate She was admitted to the hospital on 1/24/21 with acute symptoms of fatigue, malaise and some increas... Read more
She was admitted to the hospital on 1/24/21 with acute symptoms of fatigue, malaise and some increased confusion. Patient also developed a junctional heart rhythm on night of admission.
83 2021-01-25 fainting Patient was observed for 15 minutes after the injection time. Patient left with her daughter to the ... Read more
Patient was observed for 15 minutes after the injection time. Patient left with her daughter to the car and while she was in the car she had a vasovagal syncope. This last for couple seconds. Vital signs were stable except for her pulse Ox at RA was 80%. The ambulance was called and the EMT kept patient on the ambulance monitoring her vital signs.
83 2021-01-26 cardio-respiratory arrest about 20+ hours after vaccination resident was having hard time breathing, 911 was called. Resident... Read more
about 20+ hours after vaccination resident was having hard time breathing, 911 was called. Resident coded multiple times at the facility after CPR she was taken to ICU. She coded again and was placed on life support. Due to her choice to not be on life support she passed on 11/26/2021.
83 2021-01-30 blood pressure increased Initially itching, painful burning hives and welts on both arms began about Jan 12-13. Began low... Read more
Initially itching, painful burning hives and welts on both arms began about Jan 12-13. Began low dose benedryl from 1/13 - 1/25. Second adverse event on Jan 25; began sudden onset of dizziness, weakness, nausea, vomiting and unusual blood pressure elevation. Went to ER @4 pm.. Released after 6 hours. Same occurrence next day, similar symptoms. Began to feel 'bad'; BP still elevated. Went to closest ER at 3 pm. Discharged after 5 hours with clonidine. Skipped a day, but could not resume normal activities. On Jan 29 returned to ER early afternoon, admitted for observation. Discharged ~6:30 pm on Jan 30. Currently only on higher dose of losinipryl. Rash bumps persist as 'red streaks', elevated BP and not feeling well. Streak is inner right arm above elbow. Rash streaks continue but are not bother some. Including morning of 1:30 after night in hospital. Rash usually appears after sleeping and early a.m. No medication. Still unable to resume normal activities. "feel terrible".
83 2021-02-01 hypotension PATIENT RECEIVED COVID-19 VACCINE AND WAS TAKEN BY WHEELCHAIR TO THE OBSERVATION AREA WHERE A PROVID... Read more
PATIENT RECEIVED COVID-19 VACCINE AND WAS TAKEN BY WHEELCHAIR TO THE OBSERVATION AREA WHERE A PROVIDER AND NURSE WERE OBSERVING FOR ANY ADVERSE REACTIONS. THE PATIENT WAS ADVISED TO WAIT 15 MINUTES BEFORE LEAVING THE FACILITY. THE PROVIDER NOTICED THE PATIENT LEANING FORWARD IN HER WHEEL CHAIR. SHE TRIED TO ENGAGE HER AND SHE WAS UNRESPONSIVE. SHE TRIED TO ALERT HER AND SHE WAS AGAIN UNRESPONSIVE. THE PROVIDER ADVISED NEARBY STAFF TO CALL 911 AND FOR THE NURSE TO BRING THE CRASH CART AND OXYGEN AS SHE ASSESSED THE PATIENT FOR A RADIAL PULSE. NO PULSE WAS PALPABLE. SHE THEN ASSESSED FOR A CAROTID PULSE AND NO PULSE WAS PALPABLE. ANOTHER PROVIDER ARRIVED AND THEY QUICKLY PUSHED THE PATIENT TO THE CLOSEST EXAM ROOM FOR FURTHER ASSESSMENT AND POSSIBLE CPR. VITAL SIGNS WERE BEING OTAINED WHICH REVEALED HYPOTENSIVE. BLOOD GLUCOSE TAKEN AND WAS WITHIN NORMAL LIMITS. AS THEY STARTED TO REMOVE HER CLOTHING TO PREPARE FOR RESUCCITATION SHE BECAME ALERT AND APPEARED ANGRY AND CONFUSED. SHE QUICKLY BECAME ALERT AND ORIENTED. EMT'S ARRIVED AND COLLECTED THE INFORMATION NEEDED TO TRANSPORT THE INDIVIDUAL TO THE NEAR BY EMERGNECY ROOM FOR FURHTER EVALUATION.
83 2021-02-02 atrial fibrillation Patient states Right neck pain, middle and down Right arm, not sharp, in the evening after shot. Afi... Read more
Patient states Right neck pain, middle and down Right arm, not sharp, in the evening after shot. Afib evening of 1-19-21, patient took nitro pill and called Dr.
83 2021-02-03 heart rate increased Rapid heart beat on and off for 3 days. Large hard swelling and redness at injection site continui... Read more
Rapid heart beat on and off for 3 days. Large hard swelling and redness at injection site continuing to persist (9th day).
83 2021-02-04 chest pain pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt wi... Read more
pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt within 5 minuted developed resp distress, sob, chest pain and crushing chest feeling along with lip tongue mouth tingling, difficulty swallowing, increasing anxiety and diaphoresis.
83 2021-02-04 hypertension Patient received vaccine and was in the monitoring center when she made staff aware of tingle in lip... Read more
Patient received vaccine and was in the monitoring center when she made staff aware of tingle in lips. Patient vitals were taken and stable with elevated blood pressure due to not taking morning medication. While documenting and staying with the patient stated that the tingle was moving into cheeks and throat. Per 25mg IM once given. Patient symptoms resolved within 15 mins. Vitals stables and discharged home.
83 2021-02-04 palpitations, blood pressure increased Filing this additional report because I neglected to report all of possible side effects. In additi... Read more
Filing this additional report because I neglected to report all of possible side effects. In addition to the fast and hard heartbeating for 20 minutes in the evening, I should tell you that I decided to take my Blood Pressure before retiring. I usually have low BP at about 125/68 or so. That night I took it and it was 182/160. I decided that HAD to be wrong so I took it immediately again and the next time it was 165/82. I decided that this must be anxiety and went to bed. My son suggested that I should report all this to you anyway.
83 2021-02-04 palpitations Sore arm directly after and all day. In evening, heart suddenly started pounding and beating at 85 ... Read more
Sore arm directly after and all day. In evening, heart suddenly started pounding and beating at 85 when typical resting pulse is 60. Can and does happen from time to time for a couple heart beats. Has all my life. This time did not stop for 20 or more minutes. I took an extra propranolol and it went back to normal in a few minutes. Not positive it was result of injection but thought I should mention.
83 2021-02-07 cardiac arrest, heart rate irregular, loss of consciousness Patient found down at home with agonal respirations and per EMS asystole, received 2 rounds of epi a... Read more
Patient found down at home with agonal respirations and per EMS asystole, received 2 rounds of epi at her house with return of spontaneous pulses, lost pulse again in route to ER and another round of epi was given, CPR in progress when arrived at hospital. Prior to this patient's husband states he heard her fall in the bathroom but did not immediately check on her as he states that this has happened before. He checked on her 10 min later and that's when he found her unconscious. Daughter called 911 and she began CPR. No previous complaints of headache, chest pain, back pain, fever or chills. Husband states patient was drinking that evening which is not unusual for her. Patient died at hospital.
83 2021-02-07 cerebrovascular accident Patient reported left arm numbness. Went to the hospital for full stroke evaluation all tests return... Read more
Patient reported left arm numbness. Went to the hospital for full stroke evaluation all tests returned negative. (CT scan, MRI, etc.). Patient was observed overnight and released from hospital with resolved symptoms and negative report of any stroke or mini-stroke. Patient has had follow-up appointments with PCP and Cardiologist. Received ok from PCP prior to second dose vaccination of COVID.
83 2021-02-07 lightheadedness Dizziness and near faint; unsteadiness; headache, three days after shot.
83 2021-02-07 lightheadedness Started with intense abdominal pain and need to evacuate/nearly fainted ... Read more
Started with intense abdominal pain and need to evacuate/nearly fainted Started to run a fever accompanied bu aching in joints, muscles, head. The fever has continued for two days (low grade 100.8 plus or minus No appetite for two days so far
83 2021-02-09 fast heart rate arm pain, fever, tachycardia, tachypnea
83 2021-02-10 blood pressure increased The next day after getting the vaccine, it went up to 189/85/74, I took her to the hospital emergenc... Read more
The next day after getting the vaccine, it went up to 189/85/74, I took her to the hospital emergency room and it went up to 207, I had already gave her losartan 100mg at 10:00 pm and Lopressor at 11:00 pm, all these days she has been with pressures of 164/76/66, 179/80/72, mostly a range of 150 to 164 systolic, before administering the vaccine she had been 8 months more or less with stable pressure of 126/58/76 .
83 2021-02-10 heart attack, chest pain 1/11 I had an EKG that was normal. after receiving the vaccine, my chest started hurting, both arms ... Read more
1/11 I had an EKG that was normal. after receiving the vaccine, my chest started hurting, both arms started hurting really bad. 30 hours later the arms stopped hurting but the chest was still hurting. back started hurting but went away but the chest still hurt. I went to Dr. 3 days after i started hurting and he did an EKG 1/25 and that evening the DR called and said "GO TO THE HOSPITAL YOU ARE HAVING A HEART ATTACK. CALL AN AMBULANCE." I took an ambulance to the hospital and had surgery and had 3 stints put in.
83 2021-02-15 chest pain Patient complained of severe chest pain radiating to back within 5 minutes of vaccination. Significa... Read more
Patient complained of severe chest pain radiating to back within 5 minutes of vaccination. Significant language barrier but patient grimacing and clutching chest. Pain described as burning by family member. Evaluation by EMS, vital signs stable, Oxygen given and transported to Hospital ED - disposition unknown.
83 2021-02-16 fast heart rate, heart rate increased, blood pressure increased Patient received the first dose of her covid vaccine by Moderna in her left arm at 1445. Lot number ... Read more
Patient received the first dose of her covid vaccine by Moderna in her left arm at 1445. Lot number 023M20A. Exp. 8-10-2021. Patient had no pain with injection. Tolerated well. Approximately 30 seconds to one minute after injection patient reported to nurse that her mouth and throat felt dry. This nurse asked the patient if she was feeling anything else different and if her throat felt itchy. Patient reported that her throat did feel a little itchy. This nurse called for assistance. RN obtained Dynamap to take patient vital signs. This nurse stayed by patient's side at all times. NP responded and was by patient's side throughout event. Patient now reporting feeling very hot. Ice pack applied to back of her neck. Initial vital signs 184/87, Map 123, HR 119. Patient tachypnic and tachycardic. Pulse ox WNL at 99%. Lung sounds clear. Radial pulse obtained, rapid. First responder called for with overhead page. Next vital signs 189/79.map of 113. HR 116. Patient still tachypnic and tachycardic with a pulse ox of 99%. Patient reports she is feeling dizzy and hot still. Able to answer questions and was oriented at all times. Dr and first responder team arrived at scene. Patient able to answer questions. Is still dizzy and not feeling well. Patient transferred safely to cart and strapped in with safety straps. All patient belongings placed on cart with her. Patient taken to ED for evaluation.
83 2021-02-17 chest pain Chest pains, vomiting, chills, aches, dizziness, swollen and red face and neck. Also hallucinating.
83 2021-02-17 oxygen saturation decreased 4 hours after receiving vaccine she had dyspnea, low oxygen saturation levels. EMS called and she wa... Read more
4 hours after receiving vaccine she had dyspnea, low oxygen saturation levels. EMS called and she was transported to local hospital, then air flighted to Clinic. She was diagnosed with COVID when she was admitted.
83 2021-02-17 low platelet count, platelet count decreased Patient noticed what appeared to be severe rash mostly on lower extremities (legs). It did not itch... Read more
Patient noticed what appeared to be severe rash mostly on lower extremities (legs). It did not itch and she is not sure the onset except that it appeared sometime after her Moderna vaccine (only had one shot). She ended up at Emergency Department per her doctor's orders and was diagnosed with thrombocytopenia (platelets 130). They also found stage three kidney failure. She was not aware of these conditions prior to vaccine although it sounds like there were prior labs suggesting some issues. She was advised to not get the second vaccine as it could potentially further lower platelets. Apparently, other pts have been in their hospital with severe platelet issue post second Moderna vaccine.
83 2021-02-18 heart rate increased, hypertension Vaccine was administered on 2/08/21. Pain at injection site that day. On 2/16/21, I started to deve... Read more
Vaccine was administered on 2/08/21. Pain at injection site that day. On 2/16/21, I started to develop hives on my upper stomach region. By the next morning (2/17/21), the hives turned into large, red, swollen welts and spread to other areas on my torso, under arms, and back of my neck. I went to an Urgent Care and was prescribed two antihistamines. By the next day (2/18/21), the welts spread even more.. I went to the Emergency Room. Both my heart rate and blood pressure were elevated. I was given an IV with a steroid. Upon discharge, I was prescribed a steroid to be taken for 6 days, continue with the nighttime antihistamine for 10 days and Allegra for 30 days.
83 2021-02-20 oxygen saturation decreased Approximately 2 hours after the vaccination was given patient experienced shortness of breath, cough... Read more
Approximately 2 hours after the vaccination was given patient experienced shortness of breath, coughing, and decreased 02 stats with a pulse oximeter. Caregiver applied oxygen supplementation which improved 02 stats. Vaccinating pharmacist and home health nurse were notified and returned to facility. When pharmacist arrived patient was eating lunch and appeared to be normal. No observable breathing problems or swelling. Local inject site appeared normal with no rash or swelling. Patient tolerated 1st dose well previously. Nurse and caregiver attempted to measure oxygen while pharmacist was there but could not obtain a reading. Observed patient for an additional half an hour with no observable issues.
83 2021-02-21 chest discomfort Within about 20 minutes, pt began to feel dizzy, had a headache and had tightness in chest. Her blo... Read more
Within about 20 minutes, pt began to feel dizzy, had a headache and had tightness in chest. Her blood pressure and pulse were normal. She had water and cold compress. I sat with her and her caretaker for another 15 minutes or so. The caretaker left to bring car around and we used wheelchair to help her to car. She never did pass out, and was feeling a little better. The caretaker was going to stay with her to keep a watch over her. Patient called a couple of hours later to let us know she was doing ok and had been lying down. She wasn't having the chest tightness anymore and her head felt better, but she had developed a rash across the chest.
83 2021-02-21 chest discomfort difficulty breathing, tightness in chest, dizziness, weakness, headache, rash-immediately after vacc... Read more
difficulty breathing, tightness in chest, dizziness, weakness, headache, rash-immediately after vaccination
83 2021-02-21 platelet count decreased, haemoglobin decreased jaundice->hemolytic anemia-> hemorrhagic shock->multi organ failure->death pt admitted to ICU 2/16 w... Read more
jaundice->hemolytic anemia-> hemorrhagic shock->multi organ failure->death pt admitted to ICU 2/16 with Hgb=3.4, treated with steroids, supportive care , pressors, pt died 2/20/21
83 2021-02-22 chest pain Develope a cough with chest pain
83 2021-02-24 cardiac arrest On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2... Read more
On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021, she was transferred to Rehabilitation Center for continued treatment. She spent 16 days there. She developed UTI and CDIF infections and was on/off oxygen. She started physical therapy. She was scheduled to be released to go home on January 27, 2021. On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine. On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative). Two days later, she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative. The only thing they could trace it to was an adverse reaction to the vaccine. After spending 11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly.
83 2021-02-25 oxygen saturation decreased, heart rate decreased Pt immediately began to cough after vaccine given and her O2 saturation dropped to 45%. Her HR dropp... Read more
Pt immediately began to cough after vaccine given and her O2 saturation dropped to 45%. Her HR dropped to 40-45 and she was given oxygen and epi-pen administered. Ambulance called during that time and she was taken to ED.
83 2021-02-28 fainting, hypertension, heart rate increased Evening of day of vaccination, had fever, chills high blood pressure and pulse. Lasted all night an... Read more
Evening of day of vaccination, had fever, chills high blood pressure and pulse. Lasted all night and next day started to get less until Friday morning. Feeling good that day and went to friends house for dinner. At end of dinner felt like going to throw up but instead I passed out for 1-2 minutes (have never passed out in my life!). Medics came and ran several tests but all was okay and I have had no trouble since.
83 2021-03-01 loss of consciousness Got the vaccine and was feeling tired, and her arm hurt, an all she wanted to do was lay in bed with... Read more
Got the vaccine and was feeling tired, and her arm hurt, an all she wanted to do was lay in bed with her heating pad. The following day she woke up with a headache, some nausea but nothing came up. She also had diarrhea and her arm was sore. She felt weak, and since she had COVID she has had shortness of breath. She stayed in the bed all day unless she had to as her arm felt like it was made of metal and was extremely tired. She was moving around upstairs and somewhere around 8:00 PM she went to the bathroom, was sweating profusely and wiping herself with tissue, and apparently turned out the light and apparently passed out as she woke up on the floor in the hallway and could not get up right away. She could not use the left arm, was able to get herself up with the help of the door to stand on her feet. She walked into her room and sat on the bed, and did not lay back down and greatful that she did not fall down the steps. She went back to bed, but in the morning she was terrified and her family heard her talking to the doctor on call who told her to go to the ER. In the ER they told her that she had syncope, seen by Dr. at Health Care. She was admitted at 11:11 AM on 2/27/21. She was given IV, had a CAT scan of her head, told her that it did not reveal any blood. After several hours they discharged her. She called her doctor and she has an appointment tomorrow morning. She is feeling tired, not sleeping well.
83 2021-03-02 blood pressure fluctuation Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizzi... Read more
Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizziness; Nausea; Vomited; Blood pressure fluctuation; Hives on inner arms; A spontaneous report was received from a consumer and physician concerning a 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt was going to die, general malaise, red streak on inner side of left arm, hives on inner arms, weakness, dizziness, blood pressure fluctuating, nausea and vomited. The patient's medical history included breast cancer, breast cancer surgery and hives. Concomitant product use was not provided. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 039K20A) (route of administration not specified) in the right arm for prophylaxis of COVID-19 infection. On 17 Jan 2021, 12 to 13 days after the vaccination, the patient developed hives on inner arms which would come and go, appearing in the morning and disappearing during daytime. Patient took Benadryl for it and applied cortisone cream. On 26 Jan 2021, after taking a walk, the patient experienced weakness, slight dizziness, and nausea. Patient was taken to the emergency room (ER) and vomited. The patient was sent home the same day but the patient's blood pressure was noted to be fluctuating. On 27 Jan 2021, the patient "felt that she was going to die" and had general malaise. The patient was brought to the ER of another hospital but again was sent home. On 29 Jan 2021, with the symptoms still ongoing and a red streak noted on the inner side of the left arm, the patient was admitted for observation at the second hospital. Laboratory details included Blood works and radiologic tests were done with normal results. The patient's blood pressure was stabilized but patient was still experiencing malaise and still had the on and off rash on both inner arms. Treatment information included Benadryl and Cortisone Cream for the indication hives. Action taken with mRNA-1273 in response to the events was not reported. The event, blood pressure fluctuation, was considered resolved/recovered on 01 Feb 2021. The outcome of the events, hives on inner arms, red streak on inner side of left arm, weakness, dizziness, nausea, vomited, felt was going to die and general malaise, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case concerns an 83-year-old female hospitalized with serious unexpected malaise, erythema, anxiety, and NS unexpected urticaria, asthenia, dizziness, BP fluctuation and NS expected nausea, vomiting. Event onset 23 days after the first dose of mRNA-1273. BP changes resolved, other events unknown. As above, a causal relationship cannot be excluded.
83 2021-03-04 blood glucose increased Raised Blood sugar for about 10 days and then is gradually lowering
83 2021-03-04 chest discomfort, pallor patient had severe headache, felt extremely tired, her face was very pale. she said she had some cer... Read more
patient had severe headache, felt extremely tired, her face was very pale. she said she had some cereal in the am and that she was a little tired even before the shot, gave her some orange juice. she said she is going to wait a little bit till she feels better. she get worse, her chest was heavy but she was still talking normally. called 911, EMS came and transported her to the hospital
83 2021-03-04 nosebleed 3/5/21 emergency roomHPI 83 y.o. female who presents with Complaints of nose bleed reports that sh... Read more
3/5/21 emergency roomHPI 83 y.o. female who presents with Complaints of nose bleed reports that she had a nose bleed this ongoing now for the past hour she could not stop at home and came for help she reports her symptoms are mild-to-moderate better with putting pressure on her nose worse without pressure denies any injury FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Hypertensive urgency I16.0 401.9 2. Epistaxis R04.0 784.7 2/22/21 Emergency room HPI 83 y.o. female who presents with SHORTNESS OF BREATH ONSET BEFORE ARRIVAL. EMS GAVE PT A DUONEB AND NOW SHE STATES SHE FEELS FINE. DAUGHTER STATES THAT PT HAD A YELLOW STOOL YESTERDAY. PT STATES THE SHORTNESS OF BREATH IS WORSE WITH LAYING FLAT. NO OTHER EXACERBATING FACTORS. FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Acute urinary tract infection N39.0 599.0 2. Shortness of breath R06.02 786.05
83 2021-03-06 fainting Systemic: Fainting / Unresponsive-Severe
83 2021-03-07 palpitations Day 1 No adverse affect. Day 2 about 7:15 pm suddenly pounding heart and panting to breath. Fitbi... Read more
Day 1 No adverse affect. Day 2 about 7:15 pm suddenly pounding heart and panting to breath. Fitbit showed HR of 134. Weak. Layed down. Took extra Propanolol. Stopped after 5-10 minutes. Scary. Took BP and it was 175/89. Felt warm while sleeping poorly. Got up and BP was 105/40. Temp was 99. Fell asleep. Felt poorly all day but fine on Day 3
83 2021-03-08 atrial fibrillation Diarrhea; A-afib; A spontaneous report was received from an 83-year-old female patient who received ... Read more
Diarrhea; A-afib; A spontaneous report was received from an 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea followed by exacerbation of her A-fib (atrial fibrillation). The patient's medical history included hypertrophic obstructive cardiomyopathy. Concomitant product use was not provided. On 25-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number 011M20A) for prophylaxis of COVID-19 infection. On 01-Feb-2021 (reported a week later), the patient experienced persistent diarrhea. She stated, "I believe it's affecting my heart" and that "she went into A-fib since having diarrhea." Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The events of diarrhea and atrial fibrillation were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
83 2021-03-08 lightheadedness Rigors and pre-syncope with fall and right hip fracture
83 2021-03-09 chest pain, arrhythmia, atrial fibrillation next day dyspnea chest pain-- ekg showed A-fib and st changes
83 2021-03-11 cerebrovascular accident Hours after receiving the 1st Moderna Vaccine patient realized left arm would not move at all and le... Read more
Hours after receiving the 1st Moderna Vaccine patient realized left arm would not move at all and left leg was weak and dragging. Called ambulance and was transported to Hospital. No other signs of a stroke, other than paralyzed left arm and weak leg. Initial scans did not show a stroke. Patient could talk fine, smile, etc. Ran tests in ER, then admitted patient. Treated with muscle relaxers given arm was bent and stiff and would not move. After admitted, the next day an MRI was performed and indicated a stroke in the part of the brain which affects the left side. Began treatment for stroke with blood thinners, etc. Patient moved to Rehab after 4 days in hospital. Remained in Rehab until Monday, March 15th then discharged with weakness in arm and leg remaining.
83 2021-03-12 loss of consciousness Patient had severe diarrhea within 30 minutes of getting the shot and passed out
83 2021-03-13 atrial fibrillation About 52 hours later I had chills, fever & diarrhea. Five days later I had an Atrial Fibrillation a... Read more
About 52 hours later I had chills, fever & diarrhea. Five days later I had an Atrial Fibrillation attack and ended up in the ER. Was given Metoprolol infusion plus 2 Metoprolol pills to get me back into normal rhythm. Was in ER about 5.5 hrs.
83 2021-03-14 chest pain, loss of consciousness knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spin... Read more
knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain. The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain. Treatment details included Tylenol and ibuprofen Action taken with mRNA-1273 in response to the events was not reported. At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
83 2021-03-14 chest pain Chills, temperature 103.6, nausea, chest pain, vomiting progressively (temperature went below normal... Read more
Chills, temperature 103.6, nausea, chest pain, vomiting progressively (temperature went below normal after vomiting) for 15 hours total. Left arm still red, swollen and hot.
83 2021-03-17 nosebleed Awoke at 8 a.m. on Thursday. 0311/2021, to find a lot of blood on gown, bedding, and face, coming fr... Read more
Awoke at 8 a.m. on Thursday. 0311/2021, to find a lot of blood on gown, bedding, and face, coming from left nostril constantly. I don't know how long it had been going on. Kept pressing nostril for about 30 minutes, bleeding didn't stop. I got an ice pack and pressed against nose for 20 minutes, did this off and on 3 times and bleeding finally slowed down and stopped at about 11:00 a.m. There have been no problems since. I have had very few nosebleeds due to dry air and they have been short and light. I have never had one like this. I don't know when it started during the night but ended about 11 a.m. There was a already a lot of blood by 8 a.m. My daughter thought such a rare event might be connected to the vaccine and that I should report it.
83 2021-03-17 heart rate increased patient came in for Moderna #2-reported she was hospitalized 2/14/2021-had GB removed-developed a st... Read more
patient came in for Moderna #2-reported she was hospitalized 2/14/2021-had GB removed-developed a stomach bleed which was cauterized-had a very fast heartrate that required IV medications to treat. States she is now on several new medications. Says she was hospitalized for 12 days.
83 2021-03-17 ischaemic stroke 5 days after vaccination patient admitted to hospital with acute ischemic stroke. she was "dragging"... Read more
5 days after vaccination patient admitted to hospital with acute ischemic stroke. she was "dragging" her left leg
83 2021-03-18 pulmonary embolism Pulmonary embolism starting March 1
83 2021-03-18 fainting faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday... Read more
faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday started to get itch and rash around the injection site; Was sick for days; joint pains; fatigue; headache; muscle pain; chills; sore arm; A spontaneous report was received from a consumer who was an 82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills, itch and rash around the injection site and faints when I get up. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03-Mar-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection. On 03-Mar-2021, the patient experienced the events sore arm. She reported that she was sick for days, suffered fatigue, headache, muscle and joint pain and chills. On 06-Mar-2021, she stated that her vaccination site started to itch and a rash developed around it and that she felt tired all day. On 07-Mar-2021, she reported that the redness and itchiness at the injection site was gone and that she felt better but still like when she had Covid in the past. Additionally, patient reported that she fainted when she got up (date unknown). Treatment included paracetamol 2 tablets on 06-Mar-2021 in the evening. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, itch and rash around the injection site, was considered recovered/resolved. The outcome of the events, sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills and faints when I get up, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
83 2021-03-19 hypertension High Blood Pressure after Vaccine
83 2021-03-20 arrhythmia Soreness of entire arm, shortness of breath, arrhythmia
83 2021-03-23 excessive bleeding Right arm full of blood; Fell while walking, over the right arm; Has to crawl, drag herself to the p... Read more
Right arm full of blood; Fell while walking, over the right arm; Has to crawl, drag herself to the phone; Joints still swollen; Muscles, legs, hip, and knees were steel; Arm sore; Elbow sore; A spontaneous report was received from a consumer who was an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right arm full of blood/ hemorrhage, fell while walking/ fall, has to crawl/ mobility decreased, joints swollen, muscles, legs, hip, and knees were steel/ musculoskeletal stiffness, arm sore/ pain in extremity, and elbow sore/ arthralgia. The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinners, blood pressure medications, and vitamins. On 4 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: Not provided) Intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient could not get up from bed. She stated her muscles, legs, hip and knees were steel. The patient stated she fell while walking, over her right arm- which resulted in the right arm sore and full of blood. The patient stated she had to crawl, drag herself and her joints still swollen, and elbow sore. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcomes of events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
83 2021-03-23 fast heart rate, chest pain Patient complains of nausea. This is nausea, without vomiting. This has been present for the past ... Read more
Patient complains of nausea. This is nausea, without vomiting. This has been present for the past 2 weeks. The frequency of episodes is several times daily. Associated symptoms include lightheadedness and weakness. Pt received her first Moderna COVID-19 vaccine on 3/11/21, she has been experiencing these symptoms since that date. ROS: CONSTITUTIONAL: Negative for chills, fatigue, fever, and weight change. CARDIOVASCULAR: Positive for tachycardia. RESPIRATORY: Positive for dyspnea and unusual chest pain. GASTROINTESTINAL: Positive for heartburn. MUSCULOSKELETAL: Positive for bilat leg pain. NEUROLOGICAL: Positive for weakness. PSYCHIATRIC: Positive for frustrated.
83 2021-03-25 cerebrovascular accident became dehydrated in spite of drinking water and started Pedialyte right before the stroke Admitted... Read more
became dehydrated in spite of drinking water and started Pedialyte right before the stroke Admitted into the hospital on March 19th late morning early afternoon. via ambulance to helicopter At hospital
83 2021-03-25 loss of consciousness felt groggy; sick to the stomach; passed out; felt very weak; cold sweat; shaky; A spontaneous repor... Read more
felt groggy; sick to the stomach; passed out; felt very weak; cold sweat; shaky; A spontaneous report was received from a consumer who was also an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out/loss of consciousness, felt very weak/asthenia, sick to the stomach/ nausea, cold sweat, shaky/ tremor, could not see straight/ blurred vision and felt groggy/ somnolence. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, calcium, tramadol and vitamin B complex. The patient received their first of two planned doses of mRNA-1273 (Batch number:02AL20A) on 29 Jan 2021. On 01 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, 10 hours after getting the 2nd dose, the patient felt very weak, sick to the stomach, cold sweat, shaky, could not see straight and she passed out. On 02 Mar 2021, the patient felt groggy. The patient stated that she did not take any medications for her symptoms. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, passed out, felt very weak, sick to the stomach, cold sweat, shaky and could not see straight, were considered resolved on 02 Mar 2021. The event felt groggy was considered resolved on 03 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
83 2021-03-25 blood clot Develop a blood clot on their left knee; Left leg kept swelling up; A spontaneous report was receive... Read more
Develop a blood clot on their left knee; Left leg kept swelling up; A spontaneous report was received from a physician concerning a 83-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a blood clot on her left knee and left leg kept swelling up. The patient's medical history included cholesterol unspecified. Products known to have been used by the patient, within two weeks prior to the event, included vitamin D and medications for cholesterol. On 26 Feb 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date after the vaccination patient developed blood clot on left leg, leg also kept swelling. Relevant treatment for the event included blood thinners and aspirin. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, blood clot on their left knee and left leg kept swelling up, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
83 2021-03-26 cerebrovascular accident, ischaemic stroke CVA - ischemic stroke of frontal lobe and parietal lobe
83 2021-03-31 blood pressure increased Blood pressure spiked; Dizzy spell; A spontaneous report was received from a consumer concerning an ... Read more
Blood pressure spiked; Dizzy spell; A spontaneous report was received from a consumer concerning an 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy spell and blood pressure spiked. The patient's medical history was not reported. No relevant concomitant medication were reported. On 16 Feb 2021, approximately one month and one day prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: C1215 ) in the left arm for prophylaxis of COVID-19 infection. On 16 Mar 2021, the patient experienced dizzy spell, blood pressure spiked to almost 200 to before second dose that was scheduled on the 16Mar2021 and the patient was hospitalized. No treatment information was provided. Action taken with mRNA-1273 in response to events was not reported. The outcome of the events dizzy spell and blood pressure spiked was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
83 2021-03-31 heart rate irregular Client came in accompanied at approx. 1150 for 2nd Moderna vaccine. Roughly 5 min post vaccine (1200... Read more
Client came in accompanied at approx. 1150 for 2nd Moderna vaccine. Roughly 5 min post vaccine (1200) clients asked for water so her mother could take meds. Client took her prescribed Norco and around 1205 began feeling very lethargic. Vitals were taken and were WNL with the exception of an irregular heartbeat as well as being significantly lethargic and unable to ambulate. At that time denied that client had a Hx of an abnormal heart rate and that this was not a normal occurrence for the client after taking her prescribed pain med. It was recommended that the client be seen at the clinic however the clinic was busy so opted to an ambulance ride to the ER as she was concerned about her ability to transfer to and from the vehicle.
83 2021-03-31 hypertension fatigue, arm soreness down to fingers, decreased appetite, head feeling "foggy" and high blood press... Read more
fatigue, arm soreness down to fingers, decreased appetite, head feeling "foggy" and high blood pressure
83 2021-04-03 blood pressure increased, heart attack, oxygen saturation decreased heart attack; Admitted to hospital 3Feb2021 oxygen satuation 77; BP elevated; fluid was drained from... Read more
heart attack; Admitted to hospital 3Feb2021 oxygen satuation 77; BP elevated; fluid was drained from her gall bladder and antibiotics were started; lot of fluid in her stomach / the fluid was drained from her gall bladder; 2nd dose of vaccine is overdue by 66 days; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diabetes mellitus, Hypertension, AFib, Congestive heart failure and Pacemaker complication. Concomitant products included AMIODARONE, AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], BUMETANIDE, BUSPIRONE, CYANOCOBALAMIN, APIXABAN (ELIQUIS), VITAMIN D2, ESCITALOPRAM OXALATE (LEXAPRO), GLIPIZIDE, LISINOPRIL, LOSARTAN POTASSIUM (COZAAR), LOSARTAN, MAGNESIUM OXIDE, METOPROLOL, PRAVASTATIN and SPIRONOLACTONE for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder) (seriousness criterion hospitalization), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (BP elevated) (seriousness criterion hospitalization) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) (seriousness criterion hospitalization). On 10-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days). At the time of the report, GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) was resolving and PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Blood pressure measurement: elevated (High) elevated. On 03-Feb-2021, Oxygen saturation: 77 (Low) low. On 10-Feb-2021, Catheterisation cardiac: abnormal (abnormal) a blockage was found. On 10-Feb-2021, Myocardial necrosis marker: elevated (High) elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included cholecystostomy and antibiotics for infection. The coronary artery blockage was deemed to be medically treated. Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of 66 days delay for mRNA-1273, lot # unknown. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of 66 days delay for mRNA-1273, lot # unknown. Further information has been requested.
83 2021-04-05 heart rate increased increased heart rate, hospitalized, received medications to lower heart rate then cardio version to ... Read more
increased heart rate, hospitalized, received medications to lower heart rate then cardio version to stabilize heart
83 2021-04-06 blood glucose increased, blood pressure increased (197/101) high blood pressure; Blood sugar was up to 196; Extreme dizziness; Could not get warm (chi... Read more
(197/101) high blood pressure; Blood sugar was up to 196; Extreme dizziness; Could not get warm (chills); Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ((197/101) high blood pressure) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ATENOLOL, LISINOPRIL, METFORMIN, SIMVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, ANASTROZOLE and AMLODIPINE for an unknown indication. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED ((197/101) high blood pressure) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), DIZZINESS (Extreme dizziness) and CHILLS (Could not get warm (chills)). On 26-Mar-2021, BLOOD PRESSURE INCREASED ((197/101) high blood pressure) and DIZZINESS (Extreme dizziness) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), PAIN IN EXTREMITY (Sore arm) and CHILLS (Could not get warm (chills)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: 196 (High) high. On 25-Mar-2021, Blood pressure measurement: 197/101 (High) High. On 26-Mar-2021, Blood glucose: 190 (High) high. On 26-Mar-2021, Blood pressure measurement: (normal) normal. No treatment was provided.; Sender's Comments: This case concerns an 83-year-old female with a serious unexpected event of increased blood pressure, and nonserious unexpected dizziness, pain in extremity, glucose increased and expected chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
83 2021-04-10 troponin increased It was just brought to our attention that this person went to the ER on 02/27/2021 and has elevated ... Read more
It was just brought to our attention that this person went to the ER on 02/27/2021 and has elevated troponins. then was transferred to another hospital. this person's family doctor contacted us and stated that the ER doctor said this was vaccine related.
83 2021-04-12 chest pain really sick; chest pains; will not take the second shot; pretty bad cold; This spontaneous case was ... Read more
really sick; chest pains; will not take the second shot; pretty bad cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (really sick) and CHEST PAIN (chest pains) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced NASOPHARYNGITIS (pretty bad cold). On an unknown date, the patient experienced MALAISE (really sick) (seriousness criterion hospitalization), CHEST PAIN (chest pains) (seriousness criterion hospitalization) and TREATMENT NONCOMPLIANCE (will not take the second shot). At the time of the report, MALAISE (really sick), CHEST PAIN (chest pains), TREATMENT NONCOMPLIANCE (will not take the second shot) and NASOPHARYNGITIS (pretty bad cold) outcome was unknown. Not provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's weight is 170 (units not reported). Whilst hospitalized, all laboratory tests (unspecified) were normal. Concomitant medication included unspecified medication for asthma. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
83 2021-04-12 palpitations partial loss of vision , starting 7 p.m. vaccine admin 10:45 am , 2 hours loss on vision and ongoing... Read more
partial loss of vision , starting 7 p.m. vaccine admin 10:45 am , 2 hours loss on vision and ongoing distorted vision ,blurriness, heart palpitations
83 2021-04-12 pulmonary embolism on 4/5/2021 patient started experiencing shortness of breath and pleuritic pain. Admitted to hospit... Read more
on 4/5/2021 patient started experiencing shortness of breath and pleuritic pain. Admitted to hospital 4/12 with bilateral PE's per diagnostic tests.
83 2021-04-15 heart attack Pt was admitted with COVID-19 pneumonia on 4/15 that has progressed to COVID ARDS, DKA, AKI on CKD, ... Read more
Pt was admitted with COVID-19 pneumonia on 4/15 that has progressed to COVID ARDS, DKA, AKI on CKD, NSTEMI
83 2021-04-15 very slow heart rate, enlargement of the heart, troponin increased, low blood oxigenation, fainting, hypotension Pt. c/o symptoms of fatigue and dizziness on 3/2. On 3/3 pt. presents to ER, afebrile, c/o fatigue, ... Read more
Pt. c/o symptoms of fatigue and dizziness on 3/2. On 3/3 pt. presents to ER, afebrile, c/o fatigue, feeling of being lightheaded, reports syncope and falling x's 2. Pt. according to MD documentation was in good health. Denies any recent illness. Pt. was found to be bradycardic, sick sinus syndrome, r/o MI. Pt. was transferred to higher level of care hospital on 3/3. Pt. had emergency pacemaker insertion. She became hypotensive and hypoxic post-op and was found to in lactic acidosis. Pt. expired on 3/3/21.
83 2021-04-16 cardiac arrest Approximately 1800, nursing staff reported patient had facial drooping and slurred speech. Patient v... Read more
Approximately 1800, nursing staff reported patient had facial drooping and slurred speech. Patient vitals were stable. Symptoms resolved. 2/1/2021 Resident observed in the bedroom, unresponsive. No heartbeat or lung sounds upon auscultation. Pupils mid-dilated and fixated, no reaction to light. Carotid pulses were not palpable. Pronounced dead at 1422 by nurse practitioner.
83 2021-04-18 blood clot, cerebrovascular accident Blood clot, stroke
83 2021-04-19 loss of consciousness Patient became altered and unresponsive to simple commands within 2 days of 2nd Moderna Covid-19 Vac... Read more
Patient became altered and unresponsive to simple commands within 2 days of 2nd Moderna Covid-19 Vaccine
83 2021-04-21 anaemia 1/5 vaccination. Dizziness / light headiness; getting weaker. PCM wanted to run blood work. 1/14 b... Read more
1/5 vaccination. Dizziness / light headiness; getting weaker. PCM wanted to run blood work. 1/14 blood panel / CBC. *1958 Hospital diagnosed me with '5th Leukemia'; anemic. **I do have records if would like me to provide.
83 2021-04-24 cerebrovascular accident Stroke, confusion, cognitive deficits. Went to ER on March 1, 2021. Diagnostics with stroke.
83 2021-04-26 loss of consciousness Five days after receiving the Covid-19 vaccine, patient suddenly began having trouble breathing. We ... Read more
Five days after receiving the Covid-19 vaccine, patient suddenly began having trouble breathing. We called 911 right away but, by the time EMS arrived, she was unconscious and didn't appear to be breathing. Patient was not sick at the time this occurred but she was hospitalized in December of 2019 and was diagnosed with pulmonary fibrosis and pulmonary hypertension which required her to go home with and continue on supplemental oxygen. However, she never experienced pulmonary distress after coming home and her SPO2 levels consistently ranged between 96 and 99% with supplemental oxygen. Patient's death was very sudden and unexpected.
83 2021-04-27 anaemia, low platelet count This 83 year old female received the vaccine on 2/26/21 and went to the ED on 4/22/21 and was admitt... Read more
This 83 year old female received the vaccine on 2/26/21 and went to the ED on 4/22/21 and was admitted with Thrombocytopenia, acute renal failure, fall with subdural hematoma, clavicle fracture, anemia, head injury, anascara, hyperkalemia and died on 4/27/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
83 2021-04-27 transient ischaemic attack TIA
83 2021-05-01 cerebrovascular accident, transient ischaemic attack Pt admit 4/8/21 2' suspected TIA or stroke vs seizure disorder. Encephalitis (MRI+) post-Moderna COV... Read more
Pt admit 4/8/21 2' suspected TIA or stroke vs seizure disorder. Encephalitis (MRI+) post-Moderna COVID-19 Vaccine 2nd dose 3/8/21. Started on IVIG x5 doses and prednisone, along with seizure meds for tx. Temporary pacemaker placed 4/13 (HR=32). Pt with improved mentation post-tx and sx. Discharged home stable 4/19.
83 2021-05-02 cerebrovascular accident Stroke occurred on 3/6/2021, seen in ED at healthcare facility. Transferred to another healthcare f... Read more
Stroke occurred on 3/6/2021, seen in ED at healthcare facility. Transferred to another healthcare facility. Right sided weakness/paralysis, altered mental status, dysphagia, slurred speech. Rehab at another healthcare facility. Now at home cared for by family.
83 2021-05-02 low blood oxigenation This is an 83 years old lady who was presented to the emergency department because of increasing dif... Read more
This is an 83 years old lady who was presented to the emergency department because of increasing difficulty breathing, coughing, generalized body ache, and weakness. She was diagnosed with COVID-19 on April 9, 2021. The patient chest x-ray showed ill-defined bilateral opacities. She was hypoxic on presentation. 1. Bilateral COVID-19 pneumonia. Present on admission. Associated with hypoxia. The patient was diagnosed with COVID-19 on April 9th but her initial symptoms started even earlier
83 2021-05-03 fast heart rate Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, t... Read more
Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy infiltrates. COVID test positive. Respiratory failure and COVID19 pneumonia. Patient referred to hospice.
83 2021-05-06 cerebrovascular accident Stroke lead to death
83 2021-05-06 nosebleed Non-stop nose bleed. Went to Emergency, admitted to hospital to stop bleeding. Got into my lungs, wh... Read more
Non-stop nose bleed. Went to Emergency, admitted to hospital to stop bleeding. Got into my lungs, which caused a cancerous thing on my lung. Treated with radiation for five days.
83 2021-05-08 chest discomfort, blood glucose increased Patient received the first dose of COVID vaccination at approximately 12:36pm on 5/9/2021 at approx... Read more
Patient received the first dose of COVID vaccination at approximately 12:36pm on 5/9/2021 at approximately 1:00pm on 5/9/2021 the patient's caregiver informed the Rph that patient was having tightness in chest and her arm was warm. The pharmacist called EMS. EMS took patients blood sugar, an ekg, and blood pressure. Patient was blood sugar was elevated but she refused to be taken to hospital.
83 2021-05-09 heart attack Hospital admission STEMI 5/4/21
83 2021-05-09 chest pain Severe L. arm pain and swelling, L. neck, L. face and head severe pain w/headache; chest pain w/m... Read more
Severe L. arm pain and swelling, L. neck, L. face and head severe pain w/headache; chest pain w/malaise and felt sick. Incapacitated for 5-6 days . Symptoms lasted for over a week
83 2021-05-11 blood pressure decreased, fainting, heart attack, hypotension, heart rate decreased, chest pain Pt suffered diarrhea for two days prior to collapsing . she could not move that morning to get out ... Read more
Pt suffered diarrhea for two days prior to collapsing . she could not move that morning to get out of bed and could barely talk. She mentioned chest pain and an ambulance was called. Following her vaccinations she was very confused and had fallen in the kitchen the Thursday (22nd) prior to her heart attack. They took her to ER noted she was in shock and had very low blood pressure enroute to hospital. Her pulse was very low. She was life flighted to the medical center. It was determined a blood clot had blocked a major artery into the right side of her heart and it was removed and a stent was placed. She remained at hospital 3 nights and was transferred to nursing home for recovery and therapy where she currently is being assessed for mental issues and is on 4 different heart medications to control blood pressure and prevent future heart attacks. There is not a family history of heart issues. Pt was very healthy in spite of being 83 years old.
83 2021-05-12 heart attack I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (... Read more
I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)
83 2021-05-21 lightheadedness Patient had a TIA event at home about 3.5 weeks after 1st Moderna shot, eventually diagnosed at hosp... Read more
Patient had a TIA event at home about 3.5 weeks after 1st Moderna shot, eventually diagnosed at hospital. Stayed overnight 2 nights at hospital. She was approved to get 2nd Moderna shot. She did so on 2/26/2021. About a month later, she suffered vasovagal episode at home. Not clear if these events are related but doctor suggested we report it.
83 2021-05-23 blood glucose increased Extreme fatigue, lightheadedness, shortness of breath. Initial onset was rather sudden on 4/29/21 a... Read more
Extreme fatigue, lightheadedness, shortness of breath. Initial onset was rather sudden on 4/29/21 and seen at urgent care without definitive dx and DC'd without treatment and somewhat improved. Health did not resume to normal and deteriorated again with same sx on 5/1/21; presented to UC again and transferred to main ED. Again, DC'd without definitive dx or tx ordered and marginally improved at the time of DC. Sx worsened again prompting another visit to the ED on 5/3/21 and again DC'd without definitive dx or tx.
83 2021-05-27 low blood platelet count, platelet count decreased Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue. We do not kn... Read more
Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue. We do not know why my platelate count dropped so low. I was not ill before I had the vaccine. I only know that after my reaction to the second Moderna Vaccine, I had side effects and never felt well after the vaccine. My bloodwork done for my Wellness Checkup showed low platelet and as time went by my white count went higher and higher above normal. Weekly bloodwork and testing of my blood showed that "something" caused my platelets to fight, thus dropping my count to a low of 21. What caused the platelets to attack? We will never know. Now, with all the study done by my Oncologist, I am beginning to heal. It all started after my Moderna Vaccine. Do you think that the vaccine may have caused my health issues?
83 2021-05-27 platelet count decreased, low blood platelet count Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue.
83 2021-05-30 hypertension, fast heart rate Tachycardia, Hypertension
83 2021-06-08 cerebrovascular accident A week after the injection hardly able to move arm. large red spot and appeared swollen. Dr. advise... Read more
A week after the injection hardly able to move arm. large red spot and appeared swollen. Dr. advised to give it time, then after several weeks of no improvement Dr. referred her to physical therapy. On 5-20-2021 before she could respond she suffered a stroke that has paralyzed her left side, can't walk, can't talk or eat on her own. Has a feeding tube and is currently in Rehab facility.
83 2021-06-08 cerebrovascular accident My aunt got her 2nd shot on 4/7. She was admitted to hospital 4/10 stroke. I am led to believe she s... Read more
My aunt got her 2nd shot on 4/7. She was admitted to hospital 4/10 stroke. I am led to believe she spent 2 days on her homes floor between those 2 dates. She has been in a nursing and rehab facility since April 20th and not getting much better. I am convinced that the shot could have put her where she is today. Her insurance ran out early may and this care is costing her money per day with no end in sight. She was an extremely independent woman who lived alone before this happened. Please contact me for more info . This warrants an investigation.
83 2021-06-08 blood clot Superficial blood clot; it was bigger after the first dose; Very painful to touch/arm was in pain; T... Read more
Superficial blood clot; it was bigger after the first dose; Very painful to touch/arm was in pain; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Superficial blood clot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain). At the time of the report, THROMBOSIS (Superficial blood clot), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
83 2021-06-21 cardiac arrest I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5... Read more
I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/14/21 after the completion of a full Moderna vaccine series (Dose 1 on 4/1 and Dose 2 on 4/29). The patient later died on 6/5/21 . Cause of Death is listed as cardiac arrest; hypoxic RF; Extensive PAD and ischemic leg/foot ulcers s/p bypass surgery. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)
83 2021-06-23 atrial fibrillation Death 4/7/2021 Causes of death listed on death certificate: 1) Acute respiratory failure 2) Chroni... Read more
Death 4/7/2021 Causes of death listed on death certificate: 1) Acute respiratory failure 2) Chronic kidney disease 3) Diabetes mellitus 4) Atrial fibrillation Other: COVID 19
83 2021-06-23 heart rate increased, chest pain Mom woke me up with her pulse at 134, 140, her BP about 160/90, she was out of breath, complained of... Read more
Mom woke me up with her pulse at 134, 140, her BP about 160/90, she was out of breath, complained of chest pain, refused going to the ER. I increased her Toprol b/c it had controlled her pulse when she developed A-fib in 2011. I was afraid to do it, so I increased it very little after I confirmed clinical protocol online, plus I know her condition well, but still I am not a physician. Very early in the morning with her cardiologist from home called me and told me to increase by half the Toprol dosage. He is her cardiologist when mom lives . It took almost a week to bring her pulse down to the 70's which is the ideal goal Dr. set. Her feet remained swollen for a few weeks. I am taking her to the clinic to see her cardiologists there as well on July 7th. PCP ordered two ekg's locally and her usual blood work-up for tikosyn (every 90 days). We go once a year because it was Doctor who stabilized her back in 2011 with tikosyn. I drove her from out of state then to the clinic. She had had an awful adverse response to multaq . It almost killed her. My brother was traveling abroad an took her to my home. I had her hospitalized to have her pulse stabilized and then arranged the clinic visit. Since then she has the yearly visits and her home cardiologist supervised her care. She is very lucky to have such amazing physicians. This year was a bit different because of online health care, but now that we are vaccinated we are driving in.
83 2021-06-23 hypertension Death 04/23/2021 Causes of death listed on death certificate: 1. hypoxic respiratory failure 2. co... Read more
Death 04/23/2021 Causes of death listed on death certificate: 1. hypoxic respiratory failure 2. covid 19 3. diabetes mellitus 4. hypertension
83 2021-06-23 palpitations, cardiac failure congestive Shortness of breath (very) and heart palpitations (many)... diagnosis of congestive heart failure fr... Read more
Shortness of breath (very) and heart palpitations (many)... diagnosis of congestive heart failure from a cardiologist
83 2021-06-24 pulmonary embolism URI signs and symptons began approx. 2-2-21 which did not respond to antibiotic, Predisone, inhale... Read more
URI signs and symptons began approx. 2-2-21 which did not respond to antibiotic, Predisone, inhaler, Nebulizer Tx. etc. After six office visits to PCP and severe shortness of breath Cat Scan was ordered on 3-09-2021 which revealed multiple Pulmonary Emboli in both lungs. Xarelto was perscribed.
83 2021-07-05 oxygen saturation decreased Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. T... Read more
Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. The following day the patient complained of SOB and the nursing staff found her O2 sat in the 50 so she was brought to the hospital. She was evaluated at the Hospital and discharged back to nursing facility the same day. Patients daughter brought patient back to facility from hospital. On 07/03 patient complained of congestion but "breathing better". On 07/04, patient stayed in bed all day. RN at facility administered tylenol and a soda and right after administration found the patient unresponsive. Nurse started CPR and 911 was called. EMS used defibrillator until the staff alerted EMS that patient was DNR. Patient passed away in room between 3-4pm.
83 2021-07-18 cerebrovascular accident Daughter called on 07/19/21 and stated patient had a CVA on 01/17/2021. Patient was transported to ... Read more
Daughter called on 07/19/21 and stated patient had a CVA on 01/17/2021. Patient was transported to Hospital and patient died on 01/23/2021.
83 2021-07-26 fibrin d dimer increased, pulmonary embolism SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE... Read more
SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE DAY FOLLOWING THIS PARTY, SHE STARTED TO COMPLAIN ABOUT SHORTNESS OF BREATH AND LEFT PLEURITIC PAIN., FEVER AND POOR PO INTAKE. SHE WAS ADMITTED TO THE HOSPITAL UNTIL JULY 7. SHE WAS DIAGNOSED WITH PNEUMONIA , SEPSIS AND MILD PLUERAL EFFUSION. HER D DIMER WAS ELEVATED AND SHE WAS TREATED WITH LOVENOX FOR SUSPECTED PULMONARY EMBOLISM. DUE TO HER POOR KIDNEY FUNCTION, SHE WAS UNABLE TO GET A CT SCAN WITH CONTRAST TO DETERMINE THE THE SEVERITY OF THIS CLOT. SHE HAS SINCE BEEN DISCHARGED HOME FROM HER REHAB DUE TO NOT BEING ABLE TO PARTICIPATE IN CARE, TO HOSPICE CARE.
84 2021-01-04 pallor has a rash that started in her feet, not spreading. Appears to be mottled, not raised. Blanching r... Read more
has a rash that started in her feet, not spreading. Appears to be mottled, not raised. Blanching rash. NO pain, not itching. Started later the day she got the vaccine. Maybe improving but they are unsure.
84 2021-01-13 chest pain Chest Pain, Nitro given and sent to ER for treatment and eval.
84 2021-01-31 cerebrovascular accident spoke with patient husband on Saturday 1/23 and he said that she had been in the hospital. that she ... Read more
spoke with patient husband on Saturday 1/23 and he said that she had been in the hospital. that she had had a stroke, the MD's at the hospital told him that it was not contributed to the vaccine and that they were unsure even if the stroke had occurred prior to the vaccine or after. spoke with him again on 1-29 and he stated that she had passed away on 1/25/21
84 2021-02-01 skin turning blue The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. Sh... Read more
The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. She was eating breakfast after at home and complained to a neighbor that her teeth hurt and she was nauseated after eating. In the afternoon, she felt dizzy and had diarrhea accompanied with blood. Close to 9 PM, her son went to check on her. The patient was found on the floor--she was unresponsive and had purple lips. Her son called an ambulance and started chest compressions. The patient passed away at the hospital. The doctor has ordered an autopsy, and the results are pending.
84 2021-02-03 heart rate increased PT feeling warm, flushed, accelerated pulse, shaking, No apparent distress Monitor for 30 minutes
84 2021-02-03 palpitations Patient reports shortness of breath ad her heart racing. EMS performed EKG which was abnormal - ST e... Read more
Patient reports shortness of breath ad her heart racing. EMS performed EKG which was abnormal - ST elevation. Patient was transported to ER. Daughter of patient reports that patient was at the ER 2 days prior due to blood pressure.
84 2021-02-03 inflammation of the pericardium, chest discomfort Pericarditis Tamponade. She went to the hospital with chest discomfort on the 25th and by the eveni... Read more
Pericarditis Tamponade. She went to the hospital with chest discomfort on the 25th and by the evening of the 26th had pericarditis to a degree that required a Pericardial Window emergency procedure. Prior to the vaccine, she was doing great with no issues. She was put on a ventilator and came through the procedure on the 27th. She was moved to rehab on February 1st, which is where she remains as of this submission.
84 2021-02-06 chest discomfort no treatments at present Insomnia, weakness, muscle aches all over, discomfort in left side of chest... Read more
no treatments at present Insomnia, weakness, muscle aches all over, discomfort in left side of chest, just did not feel well, all happened within 48 hours
84 2021-02-07 hypertension Patient reports high blood pressure daily since receiving vaccine for the past 2 weeks. No other cha... Read more
Patient reports high blood pressure daily since receiving vaccine for the past 2 weeks. No other changes to medications/diet/conditions.
84 2021-02-08 hypertension CONFUSED, HEADACHE, PRONOUNCED WEAKNESS--UNABLE TO STAND OR SIT PROPPED UP FOR 5 DAYS, LOW O2 SATURA... Read more
CONFUSED, HEADACHE, PRONOUNCED WEAKNESS--UNABLE TO STAND OR SIT PROPPED UP FOR 5 DAYS, LOW O2 SATURATION, HIGH BLOOD PRESSURE
84 2021-02-08 loss of consciousness, atrial fibrillation, heart rate irregular some bruising near my eye; area was a little tender; Afib started to act up; blacked out; Hit forehe... Read more
some bruising near my eye; area was a little tender; Afib started to act up; blacked out; Hit forehead on the door jamb; A spontaneous report was received from a consumer who was a 84-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced area was a little tender, Afib started to act up, blacked out, hit forehead on the door jamb and had some bruising near eye. The patient's medical history, as provided by the reporter, included atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 14 Jan 2021, after receiving the vaccine, the patient had no pain or soreness, but the area was a little tender if you pushed, and she waited one hour in the hospital afterwards. As the patient was getting ready to leave, she felt a little lightheaded. She was driven home, she ate lunch and then worked in the yard for a little bit. As she came inside, her Afib started to act up, she took an extra half of metoprolol, and had supper. She took half an alprazolam before going to bed. That night, as she got up to use the restroom, she had a strange feeling in her head like everything was going away. As she walked into the hallway, she blacked out and hit her forehead on the door jamb. Her forehead was all right but there was some bruising near her eye. She went back to bed and fell asleep. On 15 Jan 2021, when the patient woke up in the morning, her rate was still acting up. At about 9:30am to 10:00am, everything improved, and her heart felt normal. Everything seemed to resolve in approximately 25 hours. Treatment also included acetaminophen/diphenhydramine (no details when it was taken). She contacted her cardiologist since receiving the first dose of the vaccine. The cardiologist encouraged her to take the second dose of vaccine with diphenhydramine and have someone stay with her that night in case something happened again. Consent given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, Afib started to act up, blacked out and hit forehead on the door jamb, were resolved on 15 Jan 2021. The outcome of the events, area was a little tender and had some bruising near eye, were not provided.; Reporter's Comments: This case concerns a 84 year old female patient with medical history including atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. She experienced serious unexpected events of Atrial fibrillation and Loss of consciousness and NS unexpected events of Contusion, Head injery and Vaccination site pain. The events occurred after first dose of the study medication administration after she went back home. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, her medical history of heart condition and medication she took could remain a confounder.
84 2021-02-09 cerebrovascular accident Started on Jan 24 or 25-Extreme fatigue, sleeping til late in afternoon,, unable to get out of bed,,... Read more
Started on Jan 24 or 25-Extreme fatigue, sleeping til late in afternoon,, unable to get out of bed,, headache, just didn't feel right. Went to primary doctor office on 29th. Ran every blood test, ekg and chest xray-mostly normal except orthostatic hypertension. Told to increase fluids. Felt a little better over the next week then same symptoms again Feb 4 and 5th. Took to ER had a seizure and vomiting. CT showed a Stoke and am currently in hospital.
84 2021-02-15 haemoglobin decreased fell & hit head, +HA, lost vision left eye x 20mins, +weak
84 2021-02-16 heart attack My Mom received the COVID shot on Friday January 29th. On Friday Feb 5 one week later she suffered ... Read more
My Mom received the COVID shot on Friday January 29th. On Friday Feb 5 one week later she suffered a major heart attack and had to be rushed to the hospital. There has not been any heart conditions in her medical history her entire life. The family is wondering is the COVID shot had any thing to cause this and if there have been any other reported cases.
84 2021-02-17 fainting The morning after vaccination, she felt extremely and unusually fatigued. After getting up from bed... Read more
The morning after vaccination, she felt extremely and unusually fatigued. After getting up from bed and eating her usual breakfast, she was returning to her bedroom when she became dizzy and fainted, falling to the floor, hitting her head and suffering other effects, including rhabdomyolysis from being on the floor for a long time after the fall as she was unable to get up. She was transported to the ER and was admitted to the hospital for 3 days. She was treated with IV fluids, Tylenol and a short course of antibiotics. While hospitalized, she had a repeat of a rash/swelling at injection site that began about 48 hours after vaccination. The hospital treated the rash with some barrier cream and within 48, the redness, rash and swelling abated.
84 2021-02-18 heart rate increased, heart rate irregular Rapid and irregular heartbeat Taken to hospital emergency room Treated Remained 8 hours until heart ... Read more
Rapid and irregular heartbeat Taken to hospital emergency room Treated Remained 8 hours until heart stabilized
84 2021-02-23 chest pain Face swelling, chest pain, arms and legs swelling and aching, sore throat
84 2021-02-23 loss of consciousness, low blood pressure 11PM CHILLS,TEETH CHATTERING, BODY SHAKING, NAUSEA. APPROX 2-3 AM 2/18/21 ON WAY TO THE BATHROOM L... Read more
11PM CHILLS,TEETH CHATTERING, BODY SHAKING, NAUSEA. APPROX 2-3 AM 2/18/21 ON WAY TO THE BATHROOM LOSS OF CONSCIOUNESS-FELL HIT HEAD, PASSED OUT 2 X MORE. PARAMEDICS CALLED ADMITTED TO HOSPITAL EEG, CAT SCAN, NO FEVER, CHILLS 4-5AM SWEATING PROFUSLY, LOW BP, POSTURAL HYPOTENSION, DISCHARGE FRIDAY 2/19/2021 . SATURDAY 2/20/2021 HIGH BP > 170. BP CURRENTLY UNSTABLE HIGH AND LOW
84 2021-02-27 chest pain shortness of breath and n burning in center of chest. Like Lungs were hot. Call to Nurse Pract. rec... Read more
shortness of breath and n burning in center of chest. Like Lungs were hot. Call to Nurse Pract. recommended I go to Emergency room as could be heart attack. Went to Medical Center Emergency Dept as recommended. Took vitals and waited for additional tests. arrrived at Emergency Room of Medical CEnter
84 2021-02-28 hypertension, chest discomfort High blood pressure 2 1/4 hours after the injection, tightness of chest
84 2021-03-01 loss of consciousness The morning after vaccine was administered my mother woke up in the morning blacked out resulted in ... Read more
The morning after vaccine was administered my mother woke up in the morning blacked out resulted in a fall on her left arm that caused a fractured clavicle. The dizziness and vertigo continue through the day Along with chills and nausea throughout the day. My biggest concern was the dizziness which has never happened before. I took her to the emergency room which resulted in a diagnosis of a fractured and displaced clavicle . The dizziness was the most concerning part and they ruled out any cerebrovascular causes. A meclizine 25 mg was given and also prescribe for her when she was discharged. I am a registered pharmacist and is a healthcare provider I looked into the side effects listed. Vertigo and dizziness is not commonly communicated as a adverse effect. This is so concerning for the elderly patients regarding potential falls which can lead to fractures and be detrimental to their health.That?s exactly what happened to my mother
84 2021-03-02 fainting 02/20/2021 at 6:30am when getting up, dizziness, nausea, vomiting, fainted, fell and hurt back. 9:... Read more
02/20/2021 at 6:30am when getting up, dizziness, nausea, vomiting, fainted, fell and hurt back. 9:00am when getting up a second time, again - dizziness, nausea, fainting , falling and hitting head in bathroom. During day , hematoma over left eye, swelling, no Headache, no blurred vision, back pain increased. Treated with heat.
84 2021-03-02 transient ischaemic attack she had TIA (a mini stroke) on 2/15/2021 put in the hospital and got released the next day, doctor ... Read more
she had TIA (a mini stroke) on 2/15/2021 put in the hospital and got released the next day, doctor said is ok to get 2nd covid 19 shot.
84 2021-03-04 loss of consciousness 2:15 - Altered mental status, responsive to verbal, c/o and pain and "indigestion" 2:16 - Loss of co... Read more
2:15 - Altered mental status, responsive to verbal, c/o and pain and "indigestion" 2:16 - Loss of consciousness & urinary incontinence, EMS activated 2:17 - Transported via wheelchair to treatment room 2:20 - A&O x 3, EKG (Normal sinus rhythm) 2:25 - EMS on scene, Patient signed Against Medical Advise form. EMS released patient to friend to be transported home via POV
84 2021-03-07 loss of consciousness Passing out and falling; vomiting; Feeling strange; A spontaneous report ( was received from a consu... Read more
Passing out and falling; vomiting; Feeling strange; A spontaneous report ( was received from a consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of consciousness, vomiting, feeling abnormal. The patient's medical history included thyroid disorder and hypertension. Concomitant medications used by the patient were thyroid medication and blood pressure medication. On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced passing out and falling, vomiting and feeling strange. She was taken to the emergency room and was administered IV and had some tests done. The patient was not admitted. The event passing out and falling (loss of consciousness) was considered as medically significant . No Laboratory details were provided. Action taken with mRNA-1273 in response to the events was not reported. On 13 Feb 2021, the outcome of the events, loss of consciousness, vomiting, feeling abnormal were considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
84 2021-03-07 palpitations Hives, Palpitations
84 2021-03-08 pulmonary embolism Pulmonary embolism; tested positive for covid; A spontaneous report was received from a consumer con... Read more
Pulmonary embolism; tested positive for covid; A spontaneous report was received from a consumer concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary embolism, and tested for positive for Covid-19/COVID-19. The patient's medical history included arthritis, and high blood pressure. Concomitant medication history was not provided. On 26-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 12-Feb-21, she started experiencing shortness of breath and went to her local urgent care. They sent her to the emergency room where she was admitted and diagnosed with a Pulmonary Embolism. The patient was prescribed a blood thinner. While in the hospital, she tested positive for Covid-19 on 14-Feb-21. She was in the hospital from 12-Feb-21 to 22-Feb-21. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, pulmonary embolism were recovered. The outcome of the event, COVID-19 was recovering.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed to be unlikely related.
84 2021-03-08 fainting Patient entered lobby after 1st Moderna vaccine accommodated by daughter for monitoring. This nurse ... Read more
Patient entered lobby after 1st Moderna vaccine accommodated by daughter for monitoring. This nurse asked patient three times during monitoring if she felt fine. Patient responds yes each time. Once 15 minutes patient was released with daughter and walked to car with walker. At 1410 this nurse was called out to car to assess patient due to n/v. Vitals were obtained T-99.0, B/P 148/96, R-18 regular and at ease, P- 96, O2-96 at room air. Dr. consulted and this nurse was instructed to patient into office to be evaluated by provider. With stand by assist from 3 LPN's patient walked into building with walker. Once entering lobby patient fainted and was assisted slowly to ground with one nurse behind her and one on each side. Patient awoke 30 seconds later. Physician came to scene of accident, vitals were obtained B/P- 140/88, O2-97% at 3 L of oxygen, P-92, no Temp obtained, squad called and in route. On scene approx. 1420 squad arrived. Paramedics took over care at that point. This has been reported to CDC
84 2021-03-08 blood vessels inflammation 84 yo woman here to follow up from recent episode of vasculitis. She started getting a rash - star... Read more
84 yo woman here to follow up from recent episode of vasculitis. She started getting a rash - started 7 days after 2nd dose of vaccine At last visit, we did testing for vasculitis after the rash looked more vasculitic to me; ANCA testing was positive, as was ANA. - 17 days after 2nd vaccine She was given prednisone 20 mg taper over the last 8 days. She is feeling much better in terms of her rash and swelling. She is having surgery on the 29th for her BCC on the left eyelid. She is noticing blurred vision in both eyes since this all started and she is mentioning this to the eye doctor when she sees them. She says her head was fuzzy when this started and this is better but is still "fuzzy sometimes" Her renal function was normal. Her CBC was mildly elevated WBC but otherwise normal. She denies any breathing problems, blood in stools or blood in urine, or neurologic symptoms other than the fuzzy head.
84 2021-03-10 pallor, loss of consciousness Patient briefly lost consciousness and turned pale after immunization was administered. She quickly ... Read more
Patient briefly lost consciousness and turned pale after immunization was administered. She quickly recovered and stayed in the pharmacy for 30 minutes. She stated she felt fine with multiple probing questions.
84 2021-03-11 chest pain Patient had chest pain,non-cardiac . EMS was called vitals BP 164/88 100% O2 HR 68. Patient tre... Read more
Patient had chest pain,non-cardiac . EMS was called vitals BP 164/88 100% O2 HR 68. Patient treated and transported by the EMS to the hospital.
84 2021-03-14 atrial fibrillation pt states that 5 days after getting the vax she had brain fog and fatigue. She also developed a 6x4... Read more
pt states that 5 days after getting the vax she had brain fog and fatigue. She also developed a 6x4 red, hot, itchy hives arounds the injection site. She stated she had an AFIB event that started up this same day. She has had this before but has not been a problem until this day. Pt is using Goldbond itching cream and Benadryl. Pt will contact her PCP about the AFIB event. Pt still has some redness and itchiness of the arm. The brain fog and fatigue is gone but she still has some AFIB going on.
84 2021-03-14 loss of consciousness I passed out the next day and had to be taken to Bethesda East ER.
84 2021-03-18 heart rate irregular 03/02/21 the patient was visited by nurse. No signs of distress. Normal vitals. No GI concerns accor... Read more
03/02/21 the patient was visited by nurse. No signs of distress. Normal vitals. No GI concerns according to staff. Her appetite was her usual described as fair. She received her 2nd Moderna vaccination on 03/08/21. Within hour she because very ill according to facility staff. She began to vomit up to 5 times. Her stools because loose. She became more lethargic. She was started on compazine for the vomiting. Her oral intake was minimal. Her symptoms did not resolve and she was visited by the nurse again on 03/11/2021 where she was not very responsive. Her vitals included an irregular pulse and apnea noted in her breathing up to 15 seconds. She died on 03/12/21
84 2021-03-18 loss of consciousness, fainting, haemoglobin decreased 2/23/21 84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m... Read more
2/23/21 84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m.. Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member. Family member says she was out for about 10 min and then came around. The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath. Patient has not been eating or drinking because she has and lost some. Has some food after this episode but was brought in because of continued dizziness. 3/15/21 84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival. Patient states she has mobility issues and normally uses a walker but she did not. Patient is on home oxygen. Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke. She does have a pacemaker. Patient denies any other injuries..
84 2021-03-20 chest pain, fainting Received 2nd COVID vaccine 3/7/21. Suffered syncopal episode on 3/8/21 resulting in fall, hit head, ... Read more
Received 2nd COVID vaccine 3/7/21. Suffered syncopal episode on 3/8/21 resulting in fall, hit head, ambulance transfer to ER. Non-contrast CT head negative, discharged from ER. Another ER visit on 3/13/21 due to chest, shoulder and back pain, was found to have fractured ribs and discharged to care of child. Pt was taken to ER on 3/14/21 as woke up unable to ambulate without 2 person assist. CT chest revealed 3 fractured ribs, magnesium level low and replaced in ER. Pt was eventually admitted to the hospital, 2 night stay and transferred to an extended care facility where she remains. Pt is still unable to ambulate without 1-2 person assist, has suffered confusion and occasional hallucinations. Awaiting results of 2nd CT of head obtained on 3/18/21.
84 2021-03-20 low blood pressure Moderna Covid vaccine at 10:30 AM and by 8:30 PM she had chills, and difficulty staying awake. Went ... Read more
Moderna Covid vaccine at 10:30 AM and by 8:30 PM she had chills, and difficulty staying awake. Went to ER the next day. Admitted for 26 hours with orthostatic hypotension, due to COVID vaccine.
84 2021-03-28 hypotension, cardio-respiratory arrest During the last month she was losing weight, reflux due to having PEG, low blood pressure, lack of t... Read more
During the last month she was losing weight, reflux due to having PEG, low blood pressure, lack of tension. They notified relatives and hospice, she lost mobility, stopped urinating. Respiratory cardiac arrest and end-stage Alzheimer's certified
84 2021-03-30 atrial fibrillation Atrial Fibrillation acted up; Hot in my injection site arm; Itching in my injection site arm; Hives ... Read more
Atrial Fibrillation acted up; Hot in my injection site arm; Itching in my injection site arm; Hives in my injection site arm; Swelling in my injection site arm; Pain in my injection site arm; Red in my injection site arm; A spontaneous report was received from a consumer concerning herself, an 84-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation acted up/atrial fibrillation, hives/urticaria, pain/injection site pain, red/injection site erythema, itching/injection site pruritus, swelling/injection site swelling, hot sensation/injection site warmth. The patient's medical history was not reported. Relevant concomitant medications were included losartan, furosemide, warfarin, thyroid, diltiazem, carvedilol, lorazepam. On 05 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection and patient had no reactions to that vaccination. On 05 Mar 2021, prior to the onset of event, the patient received the second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced atrial fibrillation acted up which was considered medically significant and hives, pain, red, itching, swelling and hot sensation in the injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events atrial fibrillation acted up, hives, pain, red, itching, swelling and hot sensation in the injection site were unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
84 2021-03-30 chest pain, pulmonary embolism MODERNA COVID-19 Vaccine EUA Patient received first dose of Moderna COVID vaccine on 1/20/2021, pre... Read more
MODERNA COVID-19 Vaccine EUA Patient received first dose of Moderna COVID vaccine on 1/20/2021, presented to Emergency Department on 1/29/2021 with complaints of left-sided chest pain below her breast, with an onset 1/26/2021. In ED diagnosed with Pulmonary Emboli in lower branches of left lung, and a urinary tract infection. Pulmonary Embolism diagnosed with CTA of Chest. Patient treated with Apixiban 10 mg BID with anticipated duration of therapy for at least 6 months. Patient subsequently received second dose of Moderna COVID vaccine on 2/26/2021
84 2021-04-01 cerebrovascular accident Two days following second dose of Moderna, patient began having symptoms of CVA in the late evening.... Read more
Two days following second dose of Moderna, patient began having symptoms of CVA in the late evening. ER visit the following morning. Diagnosed wtih CVA.
84 2021-04-02 cerebrovascular accident My Mom had a stroke 3 weeks to the day she got her second shot
84 2021-04-04 cardiac failure congestive Patient fully recovered from natural SARS-COV-2 infection in early December 2020. Patient was doing... Read more
Patient fully recovered from natural SARS-COV-2 infection in early December 2020. Patient was doing quite well between mid December and mid January. Patient was hospitalized with congestive heart failure in late January 2021. Received first dose of Moderna COVID19 vaccine shortly before being discharged around February 1 (not sure of exact date). Patient was feeling well at that time. Patient became quite ill within 24 hours of Moderna COVID19 vaccine. Patient steadily worsened during February 2021. Was hospitalized in mid February (unsure of date) and diagnosed with kidney failure and liver disease. Congestive heart failure rapidly worsened and previously stable leukemia flared up. Patient was discharged from hospital February 19 and was placed in quarantine at Care Center. Patient was considered terminal and was to go into hospice care. Patient was administered second COVID19 vaccine on February 25, rapidly deteriorated, and died on March 1.
84 2021-04-04 loss of consciousness, ischaemic stroke On Saturday March 27,2021 the patient was fine on the actual day of second shot which she received a... Read more
On Saturday March 27,2021 the patient was fine on the actual day of second shot which she received at approximately 11:30am. The next day she had a fever of 102, chills, body aches, and severe headache. Tylenol was given with little relief. Symptoms persisted until Monday morning and she reported feeling ?much better.? On Tuesday 3-30-21 at about 3pm she passed out n was taken to an urgent care center where a CT scan of the head was done and was negative. She was discharged to home. The next morning she felt ok but as the day went on she developed facial drooping and slurred speech. She was taken back to the ER and admitted where she remains. An MRI confirmed an ischemic stroke on 4-1 -2021
84 2021-04-06 oxygen saturation decreased Patient's provider states patient experienced after her first Moderna vaccine, fever, her oxygen lev... Read more
Patient's provider states patient experienced after her first Moderna vaccine, fever, her oxygen levels went down, she sweated profusely, her eyes were rolling out, she was also congested and had gurgling sounds and started foaming at the mouth. Hospice care and Medical workers came through to help. X-rays were performed along CT scans of the brain and lungs at Hospital. X-rays of the chest showed ammonia and with lab work performed showed she also had an UTI infection. A Covid test was done which was negative. She was given Tylenol at Hospice Care. After her second dose she also went through the same symptoms but overall is doing well now and is stabilized.
84 2021-04-08 nosebleed Patient contacted me on 04/09/21 and said she has never had a nose bleed in her life. She received ... Read more
Patient contacted me on 04/09/21 and said she has never had a nose bleed in her life. She received the Moderna vaccine at 1:00 pm on 04/08/21 and had a nose bleed at 10:00 pm. She was able to get it stopped and then had another nose bleed on the morning of 04/09/21. She was able to also stop the second nose bleed. I ask her if she had a rash and she answered no.
84 2021-04-08 transient ischaemic attack the next day after vaccine I felt sick, then I had a TIA mini-stroke, I've recovered but I still hav... Read more
the next day after vaccine I felt sick, then I had a TIA mini-stroke, I've recovered but I still have memory loss, I forget everything now.
84 2021-04-09 fainting Pt experienced vasovagal syncope after 2nd dose of moderna vaccine today. After admininstration, pt ... Read more
Pt experienced vasovagal syncope after 2nd dose of moderna vaccine today. After admininstration, pt was able to walk and sit in chair in waiting area to begin 15 min waiting period. After 1 minute I overhear pt tell husband she is getting dizzy. I go over and talk to pt and she states she is getting very dizzy, but states no issues breathing. Pt closes eyes and begins to mutter responses. I lay her down on the floor and have someone call 911 and code white at the store. I raise the patients legs while pt lays flat on the floor, pt begins to be responsive and regains full consciousness. She sits up and begins sipping on a bottle of water. Paramedics show up and evaluate her vitals. Her daughter is called and pt is able to leave with daughter and husband to return home.
84 2021-04-10 pulmonary embolism Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and... Read more
Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clot in lung) and DYSPNOEA (Difficult breathing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Hypertension. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood clot in lung) (seriousness criteria hospitalization and medically significant) and PYREXIA (fever). At the time of the report, PULMONARY EMBOLISM (Blood clot in lung), DYSPNOEA (Difficult breathing) and PYREXIA (fever) outcome was unknown. Treatment details included Heparin, Xarelto. Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine
84 2021-04-12 cerebrovascular accident Right MCA ischemic stroke with full left hemiparesis, mostly resolved with tPa. Idiopathic. Negativ... Read more
Right MCA ischemic stroke with full left hemiparesis, mostly resolved with tPa. Idiopathic. Negative work up for coronary artery or carotid artery or intracerebral artery disease, arrhythmias, anatomic cardiac disease.
84 2021-04-12 chest discomfort arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,tee... Read more
arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,teeth hurt, tightmess in chest, felt like throat was closing up. That lasted for 4 hours, I took an asperin finally, and it started to subside,
84 2021-04-12 nosebleed pt states bloody noses began 2 days later-required follow up in hospital and has developed second bl... Read more
pt states bloody noses began 2 days later-required follow up in hospital and has developed second bloody nose since
84 2021-04-12 blood clot Pt was seen by me for full arm thrombosis and CNS thrombosis which occurred approximately 1 week fol... Read more
Pt was seen by me for full arm thrombosis and CNS thrombosis which occurred approximately 1 week following second vaccine
84 2021-04-13 nosebleed Patient had epistaxis the day following the first dose and again the day following the second dose
84 2021-04-14 deep vein blood clot Right lower extremity swelling/pain 4/13/21 Improved swelling of right lower extremity 4/14/21 Hepar... Read more
Right lower extremity swelling/pain 4/13/21 Improved swelling of right lower extremity 4/14/21 Heparin 1,000 unit/ml 5,592 units IV (80 units/kg x 69.9 kg) daily 4/12/21 Eliquis 10 mg po BID 4./14/21 to 4/20/21 Eliquis 5 mg po BID 4/21/21
84 2021-04-14 low blood platelet count, low platelet count D69.3 - Immune thrombocytopenic purpura D69.6 - Thrombocytopenia (CMS/HCC) D69.3 - Acute ITP (CMS/HC... Read more
D69.3 - Immune thrombocytopenic purpura D69.6 - Thrombocytopenia (CMS/HCC) D69.3 - Acute ITP (CMS/HCC)
84 2021-04-15 haemoglobin decreased, excessive bleeding hemoglobin levels were dropping – it was a 4 when it should be a 14; Body started bruising - starte... Read more
hemoglobin levels were dropping – it was a 4 when it should be a 14; Body started bruising - started on her legs and then spread to other locations; she was bleeding everywhere on her body; experienced a little bit of shortness of breath; got tired very easily; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Scoliosis and Sciatica. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily). On 03-Mar-2021, the patient experienced INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) (seriousness criteria hospitalization and medically significant). On 28-Mar-2021, the patient experienced HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14) (seriousness criterion hospitalization) and HAEMORRHAGE (she was bleeding everywhere on her body) (seriousness criterion medically significant). At the time of the report, HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) had not resolved and DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After a few days, her body started bruising. It started on her legs and then spread to other locations. On 28-Mar-2021, she went into the hospital because of the bruising that kept expanding. The doctor there said that her hemoglobin levels were dropping – it was a 4 when it should be a 14. They did a couple of transfusions and discharge her on 30-Mar-2021. On 02-Apr-2021, she had to go back to the hospital, she had bruising on her hands, feet, and arms. Doctor told them that it was that her blood was thinning and that she was bleeding everywhere on her body. She was still at the hospital. They also said that it looked like her body was fighting the treatments - producing antibodies against them. They gave her plasma and steroids. They also did every test possible, CT scans, and the doctors still dis not know what is causing it. Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-071592 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded.
84 2021-04-16 hypertension, heart rate increased We are not sure if these are related, to the vaccine but are reporting them anyway. Six hours after... Read more
We are not sure if these are related, to the vaccine but are reporting them anyway. Six hours after the vaccine, pt had a very rapid heartbeat that lasted an hour. Three days after the vaccine, patient had hours of extreme high blood pressure (190/100) but the pulse rate was normal.
84 2021-04-17 blood vessels inflammation My mother died in the hospital after being in the ICU for a week with severe breathing problems. He... Read more
My mother died in the hospital after being in the ICU for a week with severe breathing problems. Her symptoms matched that of a Covid patient but she tested negative for Covid twice (once was the 24 hour test).
84 2021-04-19 heart attack, increased heart rate Moderna COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED... Read more
Moderna COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) vomiting, tachycardic, and febrile with increased home oxygen use. Denies chest pain. Found to have positive blood cultures and diagnosed with NSTEMI, underwent heart catheterization and found to have severe ostial RCA stenosis, and admitted for medical management of CAD and antimicrobials. Patient discharged medically stable to home.
84 2021-04-19 blood glucose increased, chest discomfort, blood pressure increased Felt dizzy the night of, pressure on chest, shaking, blood pressure elevated more than usual, blood ... Read more
Felt dizzy the night of, pressure on chest, shaking, blood pressure elevated more than usual, blood glucose levels elevated more than normal, increased SOB, flushing of face. When walking very short distance about 5 feet would feel dizzy, winded (SOB), face would turn red and hot, and blood pressure would elevate. Treatments: 2/24/2021: EKG, Rapid & PCR COVID test, both negative. BW ordered for CBC w/autodiff, CMP, TSH 2/26/2021: Gabapentin D/C 3/04/2021: RX for Hydralazine 25mg, was too strong and D/Cd on 3/19 3/19/2021: UC visit for decreased urinary output, dizziness and elevated blood pressure. on 3/24/2021: follow up OV, patient is now feeling back to normal, but experiencing SOB with exertion 4/20/2021: follow up OV, patient is feeling normal, but experiencing SOB with exertion.
84 2021-04-20 fast heart rate Resident complained of weakness, low grade fever, and tachycardiac which led to a fall with a fractu... Read more
Resident complained of weakness, low grade fever, and tachycardiac which led to a fall with a fracture of her tib/fib. Has not returned to baseline.
84 2021-04-21 chest pain Patient reports that approximate at 4:00pm shortly after vaccine patient began to feel short of brea... Read more
Patient reports that approximate at 4:00pm shortly after vaccine patient began to feel short of breath and having chest pain. Patient reports," I took Nitro and felt better, but chest pain and shortness of breath has continued to worsen. Patients vaccine card identifies Moderna as the brand, however computer report Pfizer. This also is a concern.
84 2021-04-22 heart attack, loss of consciousness Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; Th... Read more
Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history was reported). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and medical history were not reported. The treatment received in response to the events was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
84 2021-04-25 cerebrovascular accident patient felt numbness and went to hospital on 4-6-21. was in hospital for 2 days and treated for a s... Read more
patient felt numbness and went to hospital on 4-6-21. was in hospital for 2 days and treated for a stroke. still in therapy
84 2021-04-26 cerebrovascular accident 4/16/2021 - Stroke Had left sided weakness, facial droopiness, slurred speech Hospitalization x 5 da... Read more
4/16/2021 - Stroke Had left sided weakness, facial droopiness, slurred speech Hospitalization x 5 days Currently doing PT/OT rehab in Assisted Living - started 4/21/2021
84 2021-04-26 fainting Patient had a syncopal event with fall, no injury, the morning after she received the vaccine.
84 2021-04-29 atrial fibrillation Patient recieved Moderna dose 1 02/23/2021, dose 2 03/25/2021. Nausea and vomitting after 2nd dose, ... Read more
Patient recieved Moderna dose 1 02/23/2021, dose 2 03/25/2021. Nausea and vomitting after 2nd dose, found unresponsive by son on 04/17/2021, taken to ER and diagnosed with new onset Afib with RVR, sepsis with shock. Deceased 04/18/2021
84 2021-05-06 fainting INPT STATUS 3/16/2021 AS PER EMR: PT RECEIVED HER 2ND MODERNA COVID-19 VACCINATION ON FEB. 2ND. SHE... Read more
INPT STATUS 3/16/2021 AS PER EMR: PT RECEIVED HER 2ND MODERNA COVID-19 VACCINATION ON FEB. 2ND. SHE HAD SIGNIFICANT PAIN AT INJECTION SITE FOLLOWED BY WEAKNESS, FATIGUE AND POOR APPETITE. SHE HAD SYNCOPAL EPISODE AND FELL OFF THE TOILET AND PRESENTED TO ED ON 3/16/21.
84 2021-05-06 low platelet count This 84 year old white female received the Covid shot on 3/14/21 and went to the ED on 4/7/21 ... Read more
This 84 year old white female received the Covid shot on 3/14/21 and went to the ED on 4/7/21 and was admitted on 4/8/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified
84 2021-05-12 blood clot My mother had her first Moderna COVID-19 vaccination on March 1st. On March 10th, she suffered a bl... Read more
My mother had her first Moderna COVID-19 vaccination on March 1st. On March 10th, she suffered a blood clot in her eye that caused the eye to lose vision. Her eye doctor said she is now permanently legally blind in that eye.... I do not know if the blood clot was caused by the vaccine, but I am reporting it in case there is a correlation.
84 2021-05-13 pulmonary embolism I26.99 - Pulmonary embolism SHORTNESS OF BREATH ABNORMAL LAB
84 2021-05-14 oxygen saturation decreased Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of b... Read more
Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of bilat lower abdomen. COVID test positive (4/28) despite receiving Moderna vaccines (2/4 & 3/3/21). Given drops in her O2 saturation, admitted for medical management of acute hypoxic respiratory failure secondary to COVID-19. Received dexamethasone, tocilizumab during admission and ceftriaxone for catheter-related UTI. Pt recovered and ultimately was discharged on 5/11 with followup.
84 2021-05-18 heart rate irregular Decay, irregular pulse, cardiorespiratory failure are observed.
84 2021-05-25 deep vein blood clot Upper left thigh bruised and swollen (April 20) Ultrasound (4/21) results showed DVT. Prescribed tr... Read more
Upper left thigh bruised and swollen (April 20) Ultrasound (4/21) results showed DVT. Prescribed treatment Xarelto starter pack 15/20 mg. Maintenance dose 20 mg once per day
84 2021-05-26 heart attack My mother has never had any heart issues, and suffered a heart attack on Thursday April 15. She had... Read more
My mother has never had any heart issues, and suffered a heart attack on Thursday April 15. She had 2 stints put in late Thur evening. The surgery went well, but there was too much damage to her heart and she passed away on Sat April 17, 2021
84 2021-05-27 pulmonary embolism Progressive SOB started around 3/20/21 leading to ER visit, diagnosed with bilateral pulmonary embol... Read more
Progressive SOB started around 3/20/21 leading to ER visit, diagnosed with bilateral pulmonary emboli on 3/23/21.
84 2021-06-01 blood clot Patient is hospitalized for blood clot a month after getting second moderna shot.
84 2021-06-03 cerebrovascular accident Dizziness for almost 1 week after the first dose. Hospitalized on the 13th day after second dose for... Read more
Dizziness for almost 1 week after the first dose. Hospitalized on the 13th day after second dose for stroke.
84 2021-06-12 atrial fibrillation I developed a severe case of hives at the vaccine site 5 days after the inoculation. I also had arm ... Read more
I developed a severe case of hives at the vaccine site 5 days after the inoculation. I also had arm pain. Then I developed brain fog, hallucinations, shortness of breath, worse a-fib, body pain , deep depression.
84 2021-06-14 chest pain, heart failure, fast heart rate Received COVID vaccines (Moderna) on 3/16/21 and 1/19/21. Vaccines not administered, but found via ... Read more
Received COVID vaccines (Moderna) on 3/16/21 and 1/19/21. Vaccines not administered, but found via immunization query. Presented to ED with leg pain and chest pain. CXR showed worsening heart failure. Because of tachycardia, tachypnea, keukocytotis, and lactic acidosis received 5 days of vancomycin and zosyn for possible sepsis. CPR prior to discharge positive for COVID. Currently not on any supplemental oxygen.
84 2021-06-20 chest pain Recurrent chest pain, respiratory failure
84 2021-06-23 hypertension High blood pressure, never had previous, shortness of breath , at rest and on exertion, rash, exhaus... Read more
High blood pressure, never had previous, shortness of breath , at rest and on exertion, rash, exhaustion
84 2021-06-27 blood pressure fluctuation Blood pressure kept going up and down, lost of breathe, lost of energy
84 2021-06-29 cerebrovascular accident, blood clot Pt.'s daughter states 03/14/2021 reported feeling fatigued, achy, and nauseous. *08:00pm ambulance... Read more
Pt.'s daughter states 03/14/2021 reported feeling fatigued, achy, and nauseous. *08:00pm ambulance called for transport, blood clot seen during Cat Scan/ MRI stroke reported. No change in condition/ total care needed. Currently residing with Daughter for total care.
84 2021-07-04 cerebrovascular accident Patient describes having pain behind her right eye and blindness. She says she had a stroke behind ... Read more
Patient describes having pain behind her right eye and blindness. She says she had a stroke behind her eye and that it took a long time to get anyone to see her. She is receiving shots in her eye. She thinks it is related to the vaccine. Her doctor whom she sees for the shots says it was a coincidence.
84 2021-07-13 blood clot Thursday and Friday my arm was red and sore and over the weekend on Monday I have terrible pains in ... Read more
Thursday and Friday my arm was red and sore and over the weekend on Monday I have terrible pains in the lungs I called the nurse and she said to go to the hospital. I have a pressure of 102 with terrible pain. They thought I was having a heart attack and they did an electro, echo cardiogram. They did a Ct scan and they found I have clots in the lungs. They admitted me into the hospital and stayed for 2 night and then on 3/11 they sent me home and they gave me a Blood thinner (take it twice a day).
84 2021-07-15 hypertension The patient's son said his mother complained of dizziness, headache, confusion and very high blood p... Read more
The patient's son said his mother complained of dizziness, headache, confusion and very high blood pressure. He brought her to the emergency room where her blood pressure was found to be extremely high. The staff told him she was reacting to the Moderna Vaccine.
84 2021-07-19 deep vein blood clot DVT entire left leg
84 2021-07-21 haemoglobin decreased Symptoms were first noted in March. This started two weeks after receiving the second Covid vaccine.... Read more
Symptoms were first noted in March. This started two weeks after receiving the second Covid vaccine. She has red and itchy bumps. She saw a primary care doctor who diagnosed scabies. She was treated medically and it did not work. She saw a dermatologist who twice biopsied. A skin inflammation was diagnosed and Sarna was advised. Her primary care doctor prescribed prednisone: it made her puffy but did not help much. Her primary care doctor gave her a sulfa antibiotic and she completed it without benefit. She has an ointment to mix with Sarna and it helps. She cannot sleep. She has used Zyrtec: it does help her to sleep but nothing else. Allegra did not help. Individual lesions can last a week at a time. She has a history of ?swellings? of her bones. She has had problems of her knees and heels. She has had injections of her knees, shoulders and heels. Her fingers sometimes hurt, and they have been injected. She denies any other swellings. She started Edarbyclor and Bystolic last year. She started Diltiazem in March or May. Baby aspirin was started in the early 2000s. Simvastatin in about 2003. She recently completed a week of sulfamethoxazole-trimethoprim.
85 2021-01-19 palpitations Patients heart rate went to 91 and she felt palpitations. They lasted for a few seconds and resolved... Read more
Patients heart rate went to 91 and she felt palpitations. They lasted for a few seconds and resolved on their own. Heart rate went down to 71.
85 2021-01-21 fainting After 15 minutes of observation and no adverse reactions, patient went to the restroom, and went sho... Read more
After 15 minutes of observation and no adverse reactions, patient went to the restroom, and went shopping. 30 minutes after administration, patient was extremely fatigued, unresponsive, unable to be aroused. Called 911. Blood pressure was 60/Error or blood pressure machine was not working properly. Began to gasp and vomit. Epinephrine was administered at that time. 45 minutes after administration, EMS arrived. Patient was discharged from hospital around 3pm and her diagnosis was syncope.
85 2021-01-26 hypertension Eight days after injection, the injection site was painful and red. Also had higher than normal bloo... Read more
Eight days after injection, the injection site was painful and red. Also had higher than normal blood pressure.
85 2021-01-26 oxygen saturation decreased The following day, food did not taste as it should and water tasted like metal. By January 13, 2021... Read more
The following day, food did not taste as it should and water tasted like metal. By January 13, 2021, extreme fatigue set in; lack of appetite; and extreme feelings of hopelessness, depression, etc. On January 14, 2021, I took my Aunt to Hospital ER and she received a positive COVID diagnosis. She was released to return home with instructions to use a pulse oximeter; move about every 2 hours and not sleep throughout the day; and to do breathing exercises. All were done. Symptoms did not abate. On January 17, 2021, I took my Aunt to Hospital to receive an infusion of antibodies. Unfortunately, her pulse ox readings dropped into the 80 percentile and she was admitted for care. Although she experienced pneumonia, she improved her pulse ox and was released on January 22, 2021 to (rehabilitation center) for outpatient care.
85 2021-01-26 fainting, loss of consciousness When sitting in chair during observation patient passed out. Syncopal episode. EMS was activated and... Read more
When sitting in chair during observation patient passed out. Syncopal episode. EMS was activated and patient taken to hospital for further evaluation.
85 2021-01-29 chest pain, heart rate increased At 11:30 pm the patient, my mother, experienced extreme rapid heart beat, pain in her chest and neck... Read more
At 11:30 pm the patient, my mother, experienced extreme rapid heart beat, pain in her chest and neck, and nausea. She stated it was intense and severe but can't say how long it lasted. She was about to call 911 when her symptoms subsided. She fell asleep and didn't tell anyone until the next day. She has felt ok since then but we will be following up with a doctor next week.
85 2021-02-02 stroke, cardiac arrest 85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vacc... Read more
85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine, hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not. "...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)"
85 2021-02-09 hypotension Initial temp of 100.4, upon recheck 101.9 with 650mg Tylenol given. IV initiated due to low blood pr... Read more
Initial temp of 100.4, upon recheck 101.9 with 650mg Tylenol given. IV initiated due to low blood pressure - 78/35. 400mL NS given then converted to D5 due to GFT being 55. O2 Sats 64% RA when vitals assessed and quickly climbed, ordered to apply continuous O2 at 2LPM via NC and sats climbed to 96%. Last BP 78/35, Dr. ordered for pt to be sent in to hospital if pressure doesn't come up in the next 30 minutes. Pt in trendelenberg position, responds to verbal stimuli. Denies pain. Only complaint was feeling weak. BS up to 197 after tolerating 120ml cranberry juice. Pressures continue to stay low, last BP 72/27, Discussed with Dr. with orders to send to hospital. Admitted to hospital with Hypoglycemia and Hypokalemia.
85 2021-02-10 oxygen saturation decreased Patient had no immediate reaction, vital signs remained stable, resident condition did not change, 4... Read more
Patient had no immediate reaction, vital signs remained stable, resident condition did not change, 4 days later became lethargic, O2 sats dropped and sent to the ER.
85 2021-02-11 blood pressure increased This case experienced facial flushing just after receiving the vaccination; "Felt funny"; BP values... Read more
This case experienced facial flushing just after receiving the vaccination; "Felt funny"; BP values initially normal, ( 120-130/80-90) became elevated 200/100.
85 2021-02-14 blood pressure decreased, fainting 2nd vaccine ?2nd day Blood pressure dropped to 88/55 Fainted Hit head. Couldn?t get up Bruised, sor... Read more
2nd vaccine ?2nd day Blood pressure dropped to 88/55 Fainted Hit head. Couldn?t get up Bruised, sore Early evening 2 days later Raynauds developed on finger on left hand
85 2021-02-16 blood pressure increased Patient complained of dizziness and heat during the required 15 minute observation period. Paramedi... Read more
Patient complained of dizziness and heat during the required 15 minute observation period. Paramedics were called to address patient's symptoms. Paramedics examined patient and told patient their health is ok and acceptable to just go home. Blood pressure was elevated at 175/110 per patients caregiver.
85 2021-02-17 blood pressure increased, blood glucose increased Pt reported after receiving her first dose of the Moderna COVID19 vaccine her BS went very high when... Read more
Pt reported after receiving her first dose of the Moderna COVID19 vaccine her BS went very high when she got home. Pt reported her BS was around 300. Pt reports she injected insulin. Pt states she went to her doctor for follow up and had blood work done. Pt was cleared to receive the 2nd dose of the COVID19 vaccine. After pt received her 2nd dose the pt waited for 15 minutes in observation. When she got up to leave she reported to the RN she was feeling "woozy and nauseous." Pt reported eating a small breakfast this morning, pt was accompanied by her adult son who thinks the pt did not really eat very much. EMS was on site, the pt was evaluated by a paramedic. BS was 257. BP 162/90. Pt declined to go to the hospital, signed refusal with EMS. Pt left with her adult son to go home. Pt was advised to contact her PCP asap to discuss. Pt verbalized understanding.
85 2021-02-17 nosebleed, low platelet count, haemoglobin decreased, blood glucose increased, platelet count decreased, anaemia Moderna COVID-19 Vaccine given at local health department on 2/1/21. Patient developed nausea and l... Read more
Moderna COVID-19 Vaccine given at local health department on 2/1/21. Patient developed nausea and loss of appetite post vaccine. Became weak and sought care at ED on 2/5/21. Found to have leukopenia, anemia. Hydrated and discharged home. Patient continued to feel unwell, developed vomiting and diarrhea (has chronic diarrhea since partial colectomy for remote colon CA, but symptoms were worse). Sought care at my health center on 2/9/21. In-house CBC revealed pancytopenia and patient was clinically ill-appearing and severely dehydrated. Patient was sent back to ED for further evaluation. Patient admitted and consults made to Hematology and GI. Stool culture and cdiff negative, Patient was hydrated and had electrolytes replaced. Acute renal failure present on admission resolved with IVF. Sepsis was ruled out. Developed epistaxis requiring 1 unit of platelets to which she had a moderate allergic reaction requiring steroids and benadryl. Severe thrombocytopenia treated with Peg Filgrastim. CBC improved and patient was discharged to follow up with heme/onc. Her methotrexate and eliquis was held.
85 2021-02-18 anaemia She had her vaccine, and 11 days later noticed her stool was very black like tar, and on the side ha... Read more
She had her vaccine, and 11 days later noticed her stool was very black like tar, and on the side had bright red blood. She went to the ER and she was admitted. They did an endoscopic exam but did not find anything. She then was discharged after a couple of days. She had an APT with her PCP on 2/9/21 and she had ordered blood work, and nothing changed. She ordered a repeat blood work on 2/13/21 and said that her count was 6.9, and was told to come in for some blood, and admitted again for a couple of more days. She had one unit of blood. She was discharged on 2/15/21. She saw a gastroenterology NP and she drew blood and her count was 8.4, and advised to start taking some iron. She does not show any further signs of bleeding, but does feel very weak, feels cold and the usual signs of anemia. She did have light headedness throughout this entire time as well.
85 2021-02-18 cerebrovascular accident Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a c... Read more
Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a consumer concerning an 85-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced debilitating stroke (cerebrovascular accident), affecting the left side of her body (hemiplegia). The patient's medical history was not provided. No concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced debilitating stroke, affecting the left side of her body. Treatment information was not provided. The reporter stated that the patient was now in hospice care. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, debilitating stroke, affecting the left side of her body, was unknown.; Reporter's Comments: This case concerns a 85-year-old, female patient who experienced debilitating cerebrovascular accident and hemiplegia 3 days after the first dose of mRNA-1273 (Lot number: 029L20A). Very limited information regarding this event has been provided at this time. Further information regarding patient's medical history and comorbidities has been requested.
85 2021-02-18 pulmonary embolism, blood glucose increased, fibrin d dimer increased, lightheadedness, troponin increased Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal... Read more
Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal event. The pt reported 2 episodes of SOB and lightheadedness, with the second one as the more severe. On her second episode, she felt severe shortness of breath, tried to walk quickly to her bed with her walker, and fell into her bed. CT angio demonstrated acute saddle PE, mild right heart strain, RUL pulmonary infarct, and mild multifocal pneumonia with suspicion of COVID; IR was consulted and suggested thrombectomy due to the severity of the embolism. In the ED, she was started on heparin drip and put on low-flow NC oxygen without distress. Upon arrival to the emergency department her vital signs were significant for T 36.4, SBP 120/81, HR 95 bpm, NSR, RR 18, FiO2 94% on room air. Her oxygen increased to 98% on 2 L nasal cannula. Her laboratory values revealed WBCs 15.1, Hb 14.4, HCT 43.4, PLT 321, neutrophils 68.8%, D-dimer 4642, NA 134, K3.4, anion gap 9, BUN 17, creatinine 1.00, glucose 163, troponin elevated 0.12, 0.25, and 0.41, urinalysis is unremarkable, COVID-19 swab is positive. A thrombectomy was performed 2/16/2021. She tested COVID positive on 2/16/2021 and her SpO2 remains in the high 90s with dips to mid 80s while talking, but she does not currently experience any SOB.
85 2021-02-22 atrial fibrillation New onset Atrial Fibrillation
85 2021-02-23 stroke, ischaemic stroke The patient has developed an acute ischemic stroke on the evening of receiving the COVID vaccine #1 ... Read more
The patient has developed an acute ischemic stroke on the evening of receiving the COVID vaccine #1 dose. She is in the hospital with left sided weakness, facial droop and speech changes. She is receiving blood thinner and therapies.
85 2021-02-24 cerebrovascular accident On Day 5 (February 21st) after receiving her 2nd COVID vaccine injection, the patient suffered a mas... Read more
On Day 5 (February 21st) after receiving her 2nd COVID vaccine injection, the patient suffered a massive stroke. She was rushed to an ED, arriving within 45 minutes, immediately received TPA treatment and thrombectomy from the right side of her brain. She continues to receive acute treatment inpatient.
85 2021-02-28 blood pressure increased Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint... Read more
Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint pain; A Spontaneous report was received from a Health care professional concerning a – 85 Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8-jan-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date or an unknown date, The patient experienced the events atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. with hospitilization and disability Treatment provided Tylenol, Advil, Norvasc, lisinopril, codeine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown; Reporter's Comments: This case concerns an 85-year-old female who had serious expected events of headache and serious unexpected speech disorder, increased blood pressure, renal artery arteriosclerosis and NS expected arthralgia. Event onset was the same day as the first dose of mRNA-1273. Treated with Tylenol, Advil, Norvasc, lisinopril, codeine. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
85 2021-02-28 cerebrovascular accident Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning a... Read more
Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning an 85-year-old female patient, who received Moderna COVID-19 vaccine and death occurred in two days. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination. On 29-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day, she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating, and she was breathing at that time, but did not have consciousness. According to her daughter, the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am. No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke, a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke
85 2021-02-28 loss of consciousness THE PATIENT PASSED OUT ONCE SHE WAS HOME. SHE PASSED OUT IN THE BATHROOM AND THEN AGAIN WHEN CRAWLI... Read more
THE PATIENT PASSED OUT ONCE SHE WAS HOME. SHE PASSED OUT IN THE BATHROOM AND THEN AGAIN WHEN CRAWLING TO HER BED. AFTER THAT SHE DID NOT PASS OUT. SHE WAS VACCINATED AT ABOUT 10AM AND THEN WENT HOME AND PASSED OUT AROUND 12NOON AND PASSED OUT AGAIN SHORTLY AFTER NOON. SHE HAS NOT PASSED OUT SINCE THEN. SHE DID NOT CONSULT HER PCP. SHE DID NOT CALL AN AMBULANCE. SHE SAID SHE PASSED OUT YEARS BEFORE AFTER TAKING ADVIL. THE PATIENT DID NOT KNOW IF SHE HAD EATEN BEFORE GETTING HER SHOT THAT DAY. SHE WAS NOT ABLE TO TELL ME WHAT TIME SHE NORMALLY EATS BREAKFAST. I ADVISED HER TO CONSULT WITH HER PCP REGADING WHETHER OR NOT SHE SHOULD GET THE
85 2021-02-28 loss of consciousness Moderna COVID-19 Vaccine 15 hours after I received the vaccination (3 AM of the morning of February ... Read more
Moderna COVID-19 Vaccine 15 hours after I received the vaccination (3 AM of the morning of February 24) I went to the bathroom to take two Tylenol for a headache. I then used the toilet and started walking back to bed (less than 20 feet away). About halfway there, I I realized something was wrong. The next thing I knew I was lying on the ground right next to my bed. On the way down I think I heard crashing into wood furniture. I don?t know how long I was blacked out; it might have been 10 minutes. I managed to get up onto the bed and felt something wet on my pillow case. It was blood coming from a deep laceration on my chin. My doctor told me to go to urgent care. They sent me to the emergency room. I was kept overnight for observation and give three stitches in my chin. I have felt woozy ever since, but all the tests administered in the hospital showed no damage.
85 2021-03-01 deep vein blood clot pt developed a DVT and is being treated with Eliquis for 3 months
85 2021-03-08 hypotension Red area around injection site the day of injection, lasting 48 hours. After 13 days I started feel... Read more
Red area around injection site the day of injection, lasting 48 hours. After 13 days I started feeling extremely nauseated and dizzy. For over 48 hours, I felt very weak and had episodes of very low blood pressure .
85 2021-03-10 chest discomfort, chest pain Pt stated that she received the vaccine on 02/03/2021 and started having a fever, headache, chest pa... Read more
Pt stated that she received the vaccine on 02/03/2021 and started having a fever, headache, chest pain and heaviness in her left arm on 02/06/2021. She stated that she felt better by 02/09/2021. Pt was seen in the office on 02/09/2021 and she was feeling much better. Patient also stated three to four days after vaccine her left arm turn red and was hot to the touch that lasted about 4 days.
85 2021-03-10 palpitations Heart racing, Fever, Terrible Headache, Chills, Nausea, Weakness, and Fatigue for first 48 hours or ... Read more
Heart racing, Fever, Terrible Headache, Chills, Nausea, Weakness, and Fatigue for first 48 hours or so; continued fatigue even now.
85 2021-03-11 heart attack, chest pain On 3/7/2021 the patient presented to the ED with chest pain lasting for about a week that was not re... Read more
On 3/7/2021 the patient presented to the ED with chest pain lasting for about a week that was not relieved after taking nitroglycerin. The patient does have a history of coronary artery disease. The patient was admitted for NSTEMI.
85 2021-03-13 nosebleed, hypertension Nose bleed ,Blood Pressure extremely high eg: 1oo/170
85 2021-03-14 cerebral haemorrhage At 2 PM Friday, March 12, patient was cleaning house and began speaking incoherently. Due to the aph... Read more
At 2 PM Friday, March 12, patient was cleaning house and began speaking incoherently. Due to the aphasia, her daughter called 911. The ambulance delivered her to Hospital by 2:20. She presented with a brain hemoragh. Hospital called for medivac which took her to another Hospital. The bleeding continued and the docs ruled out surgery. They were unable to slow the bleed. Patient was put on a ventilor shortly after arriving at hospital. Patient passed at 6:55 PM March 13.
85 2021-03-14 lightheadedness Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed... Read more
Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise). The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter. On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided). On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill. On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell. Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication. Action taken with mRNA-1273 in response to the events was unknown. The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
85 2021-03-15 oxygen saturation decreased, blood glucose increased On 3/23 at 0730 resdient non responsive with saliva foaming from mouth. BS 500. All vitals initiall... Read more
On 3/23 at 0730 resdient non responsive with saliva foaming from mouth. BS 500. All vitals initially Ok then sats dropped to 75. (11 was called immediately upon finding resident. Taken to hospital. Completed course there and later on to rehab. She expired 3/11/2021
85 2021-03-16 atrial fibrillation Loss of feeling in right arm within 10 mins and arm turned white/black. Had chills nausea and fat... Read more
Loss of feeling in right arm within 10 mins and arm turned white/black. Had chills nausea and fatigue **diagnosed a few days later with Atrial Fibrilation with rapid ventricular response
85 2021-03-16 blood pressure decreased, blood glucose increased Symptoms started 8 minutes after injection. Reported by patient 15 minutes after injection Symptoms ... Read more
Symptoms started 8 minutes after injection. Reported by patient 15 minutes after injection Symptoms noted: light headedness Treatments: vitals taken, water given and patient reclined Outcome: extended monitoring, patient given orders for IVF bolus, taken to hospital floor for monitoring during bolus. Per hospital staff, pt improved. Respirations 16 and Blood Pressure 95/65, BP after another 10 minutes 95/65. Finger stick glucose taken about 30 minutes later at 209. Pt encouraged to get up and walk a few steps, but was unable. BP taken again 40 minutes post injection up to 162/62. Pt stood and turned in circle then sat back down and BP was 120/65.
85 2021-03-16 loss of consciousness Weakness, vomiting, dizziness, passed out, occurred multiple times post-vaccination
85 2021-03-17 loss of consciousness Pt had same symptoms after 1rst dose. COVID + test 4/20/2020
85 2021-03-22 low platelet count Thrombocytopenia to 98. Incidental finding. Repeat on 3/18 was 120. Smear unremarkable.
85 2021-03-25 blood glucose increased headache within hours of vaccine. also had fatigue, chills, weakness, pain at injection site around... Read more
headache within hours of vaccine. also had fatigue, chills, weakness, pain at injection site around that time. was found 4 days afterwards by home health aid in bed, with bowel incontinence, disoriented, weak and unable to speak. Pt states also had diminished sight and hearing. pt is diabetic and had elevated blood glucose readings that have persisted almost a month following the vaccine, per pt report
85 2021-03-26 low blood oxigenation, chest discomfort Moderna COVID-19 Vaccine EUA 3/12/21: The patient was started on antibitoics outpatient Tuesday f... Read more
Moderna COVID-19 Vaccine EUA 3/12/21: The patient was started on antibitoics outpatient Tuesday for bronchiolitis. Covid test was done, no results yet. Pt daughter stated got better yesterday today confused. 85-year-old woman who presented with 2 days history of cough, chest discomfort and shortness of breath. She reports insidious onset of symptoms 2 days ago cough which was initially dry, then productive of scanty whitish sputum. She also reported associated shortness of breath and pleuritic mid chest discomfort. She denies any fever, chills, nausea or vomiting. She denies any known contact with individual diagnosed with been tested with COVID-19 infection, reports compliance with masking directives. She is up-to-date with her COVID-19 vaccination, 2nd short of COVID-19 vaccine was administered last Saturday. Chest in her primary care physician yesterday and been diagnosed with bronchiolitis, prescribed oral Augmentin and Medrol Dosepak without any improvement in symptoms. She presented to emergency department today and was found to be hypoxic to 82% on room air. At present she has required supplemental oxygen at 5-8 liters/minute. She will be admitted to the hospitalist service for further treatment and evaluation. 3/20/21: She is s/p plasma, antibiotics (aztreonam, vancomycin), no remdesivir due to poor renal function. She has been on decadron 3/12 to date (to complete 10 day course) She was able to be weaned down to 1 L NC oxygen while on admission with improved symptoms. Plan is to discharge to rehab today.
85 2021-03-28 anaemia Abnormal CT of the abdomen Anemia due to GI blood loss CLL (chronic lymphocytic leukemia) (CMS/HCC) ... Read more
Abnormal CT of the abdomen Anemia due to GI blood loss CLL (chronic lymphocytic leukemia) (CMS/HCC) Abnormal EKG Macrocytosis Anemia requiring transfusions Symptomatic anemia
85 2021-03-31 cerebrovascular accident Stroke
85 2021-03-31 pulmonary embolism a week after injection she gained 10 lb water weight, then over the next 2 weeks an additional 20 lb... Read more
a week after injection she gained 10 lb water weight, then over the next 2 weeks an additional 20 lb of water weight. She had decrease in activity, anorexia, and was found to have multiple bilateral pulmonary emboli.
85 2021-04-04 blood glucose increased Blood sugars running high, fever, dehydration, nausea, vomiting, poor appetite, electrolyte imbalanc... Read more
Blood sugars running high, fever, dehydration, nausea, vomiting, poor appetite, electrolyte imbalance, ?WBC, lethargic about 1 week after.
85 2021-04-05 blood pressure increased elevated B/P and facial flushing. Provider administered PO Benadryl and patient was discharged home... Read more
elevated B/P and facial flushing. Provider administered PO Benadryl and patient was discharged home.
85 2021-04-06 hypertension Worsening of hypertension and persistent headache
85 2021-04-13 body temperature decreased Fatigue, chills, anxiety, morning sweats, no appetite, hives, below normal temperature.
85 2021-04-13 cerebral haemorrhage, cerebrovascular accident Brain bleed; Stroke; She has not received the second dose; This spontaneous case was reported by a n... Read more
Brain bleed; Stroke; She has not received the second dose; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CEREBRAL HAEMORRHAGE (Brain bleed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CEREBRAL HAEMORRHAGE (Brain bleed) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of the product and the start dates of the events of the serious, a causal relationship cannot be excluded. It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events of the serious, a causal relationship cannot be excluded. It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error
85 2021-04-14 nosebleed Spontaneous nose bleeding when she woke up. It lasted around 20 minutes. I called 911 because never ... Read more
Spontaneous nose bleeding when she woke up. It lasted around 20 minutes. I called 911 because never happened before and I got scared .
85 2021-04-16 fainting admitted 3/3/2021 with syncope
85 2021-04-18 blood clot Vaccination was on Wednesday, March 17, 2021 at 3 PM. Symptoms began 8 days later, and Emergency R... Read more
Vaccination was on Wednesday, March 17, 2021 at 3 PM. Symptoms began 8 days later, and Emergency Room admission 3days later on Sunday, March 28, 2021, for Blood Clots in legs and lungs,(critical in Pulmonary Artery). Blood thinner started immediately was Zarelto, and continues daily. Pain, nausea, shortness of breath, and fatigue were the symptoms. The patient was admitted to hospital for 5 days and sent home to recuperate. 3 days later, on Sunday she was back into the emergency department with intestinal bleeding that had gone on for 2 days. She was admitted again and had a colonoscopy. Bleeding stopped and she went home after 3 more days. She is currently getting home health care.
85 2021-04-18 blood clot Patient was hospitalized due to multiple blood clots, including jugular, brachial, and others. Patie... Read more
Patient was hospitalized due to multiple blood clots, including jugular, brachial, and others. Patient was hospitalized for treatment on 4/10/21 and is still there.
85 2021-04-19 cerebrovascular accident Dies at long term care facility doe to a stroke.
85 2021-04-22 chest pain, pulmonary embolism Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell... Read more
Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MALAISE (Feeling unwell). On 15-Mar-2021, the patient experienced CHEST PAIN (Chest pain/right upper quadratic thoracic pain). On 15-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion hospitalization), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was hospitalized on 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain/right upper quadratic thoracic pain), MALAISE (Feeling unwell), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17 Mar 2021 the patient had an x-ray and EKG performed because she was not feeling well and had chest pain- no results provided. On15 Apr 2021 the patient went to emergency room and was hospitalized for multiple pulmonary embolisms with parts being infracted. No treatment information was provided. No relevant concomitant medications were reported. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
85 2021-04-22 deep vein blood clot First DVT in an 85-year-old ambulatory female on daily ASA. Also found to have pneumonia at the sam... Read more
First DVT in an 85-year-old ambulatory female on daily ASA. Also found to have pneumonia at the same time. Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours. Normal O2 sat. Pt was evaluated and seen in memory care where she currently lives. Treatment: ASA discontinued, Eliquis and Levaquin started. Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.
85 2021-04-23 transient ischaemic attack TIA; Left upper lip is turned down/face does not look normal; This spontaneous case was reported by ... Read more
TIA; Left upper lip is turned down/face does not look normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METOPROLOL for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) (seriousness criterion medically significant). The patient was hospitalized for 3 days due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Other concomitant medications included unspecified blood pressure medications. No treatment information reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-081470 (Patient Link).; Sender's Comments: Although a temporal association exist, the event of Transient ischemic attack with facial paralysis is confounded by the patient's history of Blood pressure abnormal and advanced age.
85 2021-04-24 blood clot in the brain, cerebrovascular accident A stroke cause by blood clot 3 weeks after first dose.
85 2021-04-27 blood clot, deep vein blood clot, pulmonary embolism Pt awoke on 02/28/2021 with increased lower extremity edema went to Urgent care had CXR and was told... Read more
Pt awoke on 02/28/2021 with increased lower extremity edema went to Urgent care had CXR and was told to increase Lasix to 40 mg daily for 4 days. Swelling became worse over next 2 days and patient became short of breath and on 03/02/2021 she went to Hospital and had a CT scan of chest which showed a pulmonary embolus and a bilateral lower extremity ultrasound which showed a right femoral DVT and popliteal occlusive thrombus and a posterior tibial and peroneal vein occlusive thrombus. She was started on Lovenox and admitted to the hospital . she was discharged on 03/05/2021 and had a right femoral thrombectomy as an outpatient on 03/ 08 2021 with complete resolution . She was discharged home on Lovenox and later switched to Eliqus. She is home and doing well at time ofreport.
85 2021-05-04 palpitations Racing heart started about 5 hours after second Moderna vaccine. Heart rate 143-145 for about 4 to ... Read more
Racing heart started about 5 hours after second Moderna vaccine. Heart rate 143-145 for about 4 to 4 1/2 hours. Did not go to hospital or call doctor. Waited it out. Drank a lot of water, took deep breaths. After 4 to 4-1/2 hours heart rate started to return to normal.
85 2021-05-09 chest discomfort headache, chest discomfort, dyspnea. Symptoms started approximately 18 minutes after her vaccinatio... Read more
headache, chest discomfort, dyspnea. Symptoms started approximately 18 minutes after her vaccination. she has continued to have dyspnea on exertion since. Vomited the first day after.
85 2021-05-10 heart attack I21.4 - Non-ST elevation (NSTEMI) myocardial infarction
85 2021-05-10 cerebral haemorrhage, ischaemic stroke, stroke I63.9 - Ischemic stroke I63.9 - Cerebral infarction, unspecified I61.9 - Nontraumatic intracerebral... Read more
I63.9 - Ischemic stroke I63.9 - Cerebral infarction, unspecified I61.9 - Nontraumatic intracerebral hemorrhage, unspecified
85 2021-05-10 stroke I63.9 - Cerebral infarction, unspecified ALTERED MENTAL STATUS
85 2021-05-13 pulmonary embolism, deep vein blood clot Pt was hospitalized at facility from 4/20/2021 -4/25/2021 had RLE DVT and PE. Venous Dopplers (4/20... Read more
Pt was hospitalized at facility from 4/20/2021 -4/25/2021 had RLE DVT and PE. Venous Dopplers (4/20/2021) demonstrated significant clot burden in R lower and upper legs as well as CTA (4/20/2021) which showed B significant pulmonary emboli and evidence of R heart strain. Prior to sudden onset of symptoms pt has led a very active lifestyle.
85 2021-05-20 loss of consciousness Almost immediately after vaccination, patient got very dizzy and had to lay down in vaccination room... Read more
Almost immediately after vaccination, patient got very dizzy and had to lay down in vaccination room. She then passed out while her daughter was sitting with her on the bench. She regained consciousness very quickly and was alert when the emergency personnel showed up to check her out. Her blood pressure and blood sugar was normal when taken by emergency personnel and she went home with her daughter ~30 minutes after receiving vaccine..
85 2021-06-05 heart failure, enlargement of the heart, fluid around the heart I woke up on 3/02/21 totally incontinent. I could not control my urine. The flow was bright red, f... Read more
I woke up on 3/02/21 totally incontinent. I could not control my urine. The flow was bright red, filled with blood. I called my healthcare provider and the doctor at that clinic gave me a urine test. He found nothing. There was no pain, only blood for about six bouts of irination. He sent out to a clinic and they said I had an infection caused by E-coli. (The vaccine had obvioiusly lowered my resistance to infection because I had none before at all.) Also, he found that I was in heart failure - about 30% function. They recommended I be hospitalized. My daughter and I drove back to my home state and primary care physician, who concurred. I was hospitalized for heart failure at the hospital in my home state. This was the first time ever my heart had been compromised. I have now to see a cardiologist, take meds, and do cardio rehab. They found my heart was enlarged and I had fluid build-up around my heart also.
85 2021-06-08 fast heart rate, pulmonary embolism, deep vein blood clot Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body t... Read more
Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body tremors and flu-like symptoms including body aches, headaches and lethargy. within 3 days, headaches and body aches subsided however subject remained extremely fatigued and was unable to perform ADL's. Performance status declined. Sitting in chair/laying in bed 24 hours a day. Became short of breath on minimal exertion. On 6/6/21 patient taken to ER for c/o shortness of breath, cough and tachycardia. Was found to have large pulmonary emboli.
85 2021-06-23 cerebrovascular accident . Pt was vaccinated with Moderna on 3/12 and 4/9/21 and pt was admitted on 6/15/21 with an acute str... Read more
. Pt was vaccinated with Moderna on 3/12 and 4/9/21 and pt was admitted on 6/15/21 with an acute stroke and L carotid thrombus despite being on eliquiss. CTA head and neck showed a non occlusive thrombus of the Left internal carotid artery. Pt admitted for acute L frontal lobe stroke. Was not given TPA in the ER as was out of the window and is on eliquis chronically for past hx of RLE Dvt and partially occluded IVC as a resulted of a complication she suffered from a kyphoplasty procedure in 2017. She has no hx of atrial fibrillation or clotting disorder and has been compliant with her eliquis per the pt and spouse. She does not smoke, her aic is 5.2 and her ldl is 101. Her echo showed no ventricular thrombus and was a neg bubble study with nl EF. she was transferred to a higher level of care for possible neurovascular intervention. She did not ultimately require neurovascular intervention and Her acute ischemia was presumably due to artery to artery embolus causing left ICA thrombus and was not felt to be an eliquiss failure and she was discharged home on 6/17. she was also found to have a klebsiella uti and was sent home on oral antibiotics. covid 19 neg
85 2021-06-24 cerebrovascular accident Stroke
85 2021-07-05 heart attack AKI (acute kidney injury) Hyponatremia NSTEMI (non-ST elevated myocardial infarction) ABDOMINAL PAIN... Read more
AKI (acute kidney injury) Hyponatremia NSTEMI (non-ST elevated myocardial infarction) ABDOMINAL PAIN VOMITING DIARRHEA NAUSEA
85 2021-07-05 cerebrovascular accident I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) R29.810 - Facial weakness
85 2021-07-11 troponin increased Patient presented to the emergency department with weakness, was found to have acute rhabdomyolysis ... Read more
Patient presented to the emergency department with weakness, was found to have acute rhabdomyolysis and acute renal failure with generalized muscle aches and pains all 4 extremities.
85 2021-07-12 heart failure Incontinent upon awaking 3/02/21. Blood in urine (quite a bit). Called out-of-state clinic, had te... Read more
Incontinent upon awaking 3/02/21. Blood in urine (quite a bit). Called out-of-state clinic, had tests: showed heart failure (20-25% of heart function), E-coli urinary tract infection. Told to enter the hospital.
85 2021-07-17 atrial fibrillation, fast heart rate Afib wt RVR; Tachycardia; General malaise; Refused 2nd covid vax; Fatigue; After the shot I got real... Read more
Afib wt RVR; Tachycardia; General malaise; Refused 2nd covid vax; Fatigue; After the shot I got real real dizzy; I didn't feel sick, but I didn't feel right; I slept most of the day; I didn't have appetite; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib wt RVR) and TACHYCARDIA (Tachycardia) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis in 2010. Concurrent medical conditions included Drug allergy (aspirin), Drug allergy (Avelox), Drug allergy (morphine), Hypertension since 12-Dec-2011 and Hypothyroidism since 24-Sep-2014. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 24-Sep-2014 to an unknown date, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 12-Dec-2011 to an unknown date and LOSARTAN from 17-Mar-2021 to an unknown date for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Afib wt RVR) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite). On an unknown date, the patient experienced MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue). The patient was hospitalized from 15-Mar-2021 to 18-Mar-2021 due to ATRIAL FIBRILLATION and TACHYCARDIA. The patient was treated with CARVEDILOL at a dose of 6.25 mg. On 20-Mar-2021, DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite) had resolved. On 01-Jun-2021, ATRIAL FIBRILLATION (Afib wt RVR) had resolved. At the time of the report, TACHYCARDIA (Tachycardia), MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: high (High) high. On 15-Mar-2021, Heart rate: high (High) 150. On 20-Mar-2021, Blood pressure measurement: 139/79 (normal) 139/79. On 20-Mar-2021, Heart rate: low (Low) 53. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received included: Added medical history, concomitant medications and added new event of Atrial Fib with RVR.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
85 2021-07-23 blood clot a large blood clot, which has been removed from her leg; Right side paralysis; No speaking; Unable t... Read more
a large blood clot, which has been removed from her leg; Right side paralysis; No speaking; Unable to walk, due to her paralysis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a large blood clot, which has been removed from her leg) (seriousness criteria hospitalization and medically significant), HEMIPLEGIA (Right side paralysis) (seriousness criteria hospitalization and medically significant), APHASIA (No speaking) (seriousness criterion hospitalization) and GAIT INABILITY (Unable to walk, due to her paralysis) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported. No concomitant medications were mentioned. On an unknown date, the patient was hospitalized due to a large blood clot which was removed from the patient's leg. The patient, at the time of this report, was hospitalized in the stroke center. The patient had right sided paralysis and was unable to speak or walk. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
85 2021-07-25 blood clot Blood Clot
86 2021-01-25 cerebrovascular accident high fever, severe pain, dizziness, vomitting, internal bleeding, stroke, sepsis
86 2021-01-28 heart attack, cerebrovascular accident Patient received COVID vaccine #1 at 5pm. At around 9pm, she went to bathroom and noticed that she f... Read more
Patient received COVID vaccine #1 at 5pm. At around 9pm, she went to bathroom and noticed that she felt dizzy, shortly thereafter she noticed that her speech was slurred. Her daughter saw that her mouth was droopy and called 911. Pt took 3 baby ASA at that time as well. Patient evaluated in ED for stroke, CT/CTA normal, TPA not given. Admission diagnosis CVA vs Bell's palsy (mild). MRI consistent with changes suspect acute infarct. No arrhytmias noted. ECHO unremarkable.
86 2021-01-29 fast heart rate Patient was taking her blood pressure a few days after her vaccine and noted that she was tachycardi... Read more
Patient was taking her blood pressure a few days after her vaccine and noted that she was tachycardic, heart rate in the 150s. She presented to the emergency department where we administered a diltiazem bolus via IV.
86 2021-01-31 chest discomfort Patient received vaccine on Jan 22nd at 1:42 pm. Patient stated she woke up at 2:00 am with severe s... Read more
Patient received vaccine on Jan 22nd at 1:42 pm. Patient stated she woke up at 2:00 am with severe shortness of breath and felt as if she had a cement brick on her chest. She struggled to breath all night, and paced the house. Patient states she felt as if she was going to die. Patient did not wake anyone up or tell anyone, so vitals or other information could not be obtained during the reaction. Patient felt better Saturday morning, but still very fatigued and very fearful.
86 2021-02-04 cerebrovascular accident Day 3 -experienced depth perception issues Day 4- double vision Day 4 - possible stroke, double visi... Read more
Day 3 -experienced depth perception issues Day 4- double vision Day 4 - possible stroke, double vision, admitted into hospital and treated stroke protocol Day 6 - released from hospital w double vision and depth perception issues added blood thinners and 3 meds to help prevent future strokes. Met w optimalmologist starting vision therapy. Still waiting to meet w neutrogist
86 2021-02-07 hypertension 30 minutes after vaccine administration, patient noted weakness in both legs and inability to walk. ... Read more
30 minutes after vaccine administration, patient noted weakness in both legs and inability to walk. patient was examined, in no acute distress. vitals showed mild hypertension. exam showed mild right lower extremity weakness. The patient was sent to the ER for evaluation for stroke.
86 2021-02-08 palpitations Vaccine was given on 01-29-2021 at 3 pm.On 02-05-21 patient stated she noticed her vision was blurry... Read more
Vaccine was given on 01-29-2021 at 3 pm.On 02-05-21 patient stated she noticed her vision was blurry at night when she was reading in bed--this happened 3 nights in a row and on 02-08-2021 she said her vision was blurry driving home during daylight. Had Heart palpitations on 02-08-2021 and again on 02-09-2021. On 02-08-2021 she was in shower and noticed her left arm was itching where it had been sore from getting injection and when she looked in the mirror she noticed how swollen and red it was. Stated it was very warm to touch, red and very itchy. PC today on 02-09-2021 to Health Dept requesting advice on what she could do to help it.Had taken some Benadryl the night before.Had attempted ER visit on 02-08-2021 but was there x 3- 4 hrs and was never seen so she left.
86 2021-02-11 blood pressure fluctuation After pt. received the vaccine she remained seated outside of her room for the recommended 15 minute... Read more
After pt. received the vaccine she remained seated outside of her room for the recommended 15 minutes, after her time was up she stood up to walk back into her room and fell. Pt. did not think she lost consciousness. She was immediately attended to by facility staff. She BP was unstable (high then low). She was seated back in her chair and seemed alert and oriented.
86 2021-02-11 chest discomfort, chest pain FEMALE COMPLAINING OF CHEST PAIN AND TIGHTNESS IN CHEST 10 MINUTES AFTER VACCINATION. ONSITE EMS WAS... Read more
FEMALE COMPLAINING OF CHEST PAIN AND TIGHTNESS IN CHEST 10 MINUTES AFTER VACCINATION. ONSITE EMS WAS REQUESTED. SYMPTOMS SUBSIDED AND PATIENT WAS RELEASE BP 169/75 HR 68 OX 100% ON ROOM AIR PATIENT STATES NO PRIOR ADVERSE REACTIONS TO VACCINES. SHE HAD THE INFLUENZA VACCINE ABOUT A MONTH AGO,
86 2021-02-15 fast heart rate, heart attack Resident experienced chills, fatigue, nausea, coughing, weakness, loss of appetite, and tachychardia... Read more
Resident experienced chills, fatigue, nausea, coughing, weakness, loss of appetite, and tachychardia on 2/15/21. She was transferred to the ER and admitted to the hospital (attached to nursing home) for NSTEMI and cholelithiasis/cholecystitis.
86 2021-02-16 hypotension overnight non stop Cough (first night) , "out of it feeling" , brain fog,, low blood pressure, leg w... Read more
overnight non stop Cough (first night) , "out of it feeling" , brain fog,, low blood pressure, leg weakness, nausea, dizziness, mouth ulcers outbreak, face flushing , this happened during the week following the Monday vaccination...?.still have some mouth sores and face flushing
86 2021-02-17 cerebrovascular accident, atrial fibrillation Patient went into new-onset atrial fibrillation, resulting in a catastrophic stroke. Patient passed ... Read more
Patient went into new-onset atrial fibrillation, resulting in a catastrophic stroke. Patient passed away on 2/11 as a result of the stroke.
86 2021-02-21 cerebrovascular accident daughter stated patient was found on the floor at her facility and was transported to the hospital w... Read more
daughter stated patient was found on the floor at her facility and was transported to the hospital where she was diagnosed with a CVA. Unknown if this event was related to her COVID vaccine.
86 2021-02-24 pallor, lightheadedness Pt had a near syncopal episode where she became lethargic and nauseated at 1200. Pt became pale and... Read more
Pt had a near syncopal episode where she became lethargic and nauseated at 1200. Pt became pale and diaphoretic and was assesed by paramedics. The patient stated she felt better and her skin signs became normal. AMR 235 arrived on scene and was cancelled after pt refused transport. did the AMA. Nurse did the asessment and paperwork. Pt stated she had diarhea in the morning. CAD #2021-00012425.
86 2021-02-25 platelet count decreased Petechia and bruising appeared approximately 2 days after receiving the Covid-19 Moderna vaccine. Pa... Read more
Petechia and bruising appeared approximately 2 days after receiving the Covid-19 Moderna vaccine. Patient was hospitalized for excessive petechia and bruising in bilateral lower extremities with platelet count of 2,000.
86 2021-02-26 loss of consciousness, hypotension Nausea Light headed, passing out Throw up Very low BP 11:45 AM in shower. Able to move from shower... Read more
Nausea Light headed, passing out Throw up Very low BP 11:45 AM in shower. Able to move from shower chair to a wheel chair at 12:15. Into bed by 12:30. Sleeping 3 1/2 later
86 2021-02-28 fibrin d dimer increased, blood clot Four blood clots in left leg
86 2021-02-28 heart rate increased, blood pressure increased Patient waited in parking lot 15-20 minutes . She noted a headache when she got home. About 3 pm s... Read more
Patient waited in parking lot 15-20 minutes . She noted a headache when she got home. About 3 pm she developed tingling in her face and lips (lasted 3-4 hours), increased heartrate (lasted about 3 hours), increased blood pressure (for about 2 hours), The next day she noted dizziness and weakness, lower extremity redness (redness lasted about 3 days).
86 2021-03-08 atrial fibrillation, low blood oxigenation, fast heart rate Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of ... Read more
Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of 3/6/21, she awoke short of breath, felt hot, was a little nauseated, and did not take her medication. She has gradually grown more short of breath and distressed since then. She appears weak, distressed with tachycardia and hypoxemia. Bilateral pneumonia seen on xray. She arrived to the ED in A-fib with RVR HR 150's. O2 90% on 12L NRB. After IV access was obtained and labs drawn patient was transitioned to BiPAP setting 10/5 and 30% per MD at 1300. Her saturations were not maintaining above 90% and O2 was titrated up to achieve a O2 % > 90. She was given a loading dose of Diltiazem per protocol and started on a DilIazemt gtt, the drip was titrated up to max 15 to achieve target HR <100. Her BP remained stable during this course. She received a bolus of NS. 1 gram of Tylenol via IV. 1 gram of Rocephin infusing upon transfer. D5LR infusing at 200 upon transfer.During her course in the ED she was able to communicate with staff when asked questions.
86 2021-03-15 excessive bleeding Sudden presentation of Ecoli bladder infection with numerous clotting and emergency catheterization.... Read more
Sudden presentation of Ecoli bladder infection with numerous clotting and emergency catheterization. Have not had prior UTIs that I am aware of. Urologist doesn't see any possible correlation but I am now on a third round of antibiotics. Three days after my second shot on 3/12/2021 bleeding again started so now am now back on antibiotics.
86 2021-03-16 chest pain 2:46pm patient reported mid-sternal chest pain. Checked vital B/P was 146/66 on left arm, HR 78 she... Read more
2:46pm patient reported mid-sternal chest pain. Checked vital B/P was 146/66 on left arm, HR 78 she was 98%o2. rapid response was called, they arrived at 2:33pm and patient was taken to the ER. Outcome unknown.
86 2021-03-16 fainting Presents to ED the day after 2nd covid vaccine with syncope,general weakness, nausea, headache, vom... Read more
Presents to ED the day after 2nd covid vaccine with syncope,general weakness, nausea, headache, vomiting. Admitted for 2 days for syncope workup. Improved with IV fluids. d/c'd home in stable condition.
86 2021-03-18 heart rate decreased, very slow heart rate, blood pressure increased JAN. 27, '21- NOTICED SHORTNESS OF BREATH DURING REGULAR EXERCISE ROUTINE FOR STRENGTH & FLEXIBILITY... Read more
JAN. 27, '21- NOTICED SHORTNESS OF BREATH DURING REGULAR EXERCISE ROUTINE FOR STRENGTH & FLEXIBILITY. JAN. 28, '21 WEAR A FITBIT ON WRIST- SAW READING OF REST. HEART DOCTOR. COULD NOT GET APPT. UNTIL FED. 2ND. WENT TO URGENT CARE- DIAGNOSIS OF SINUS BRADYCARDIA, DYSPNEA ELEVATED BP, CALF PAIN. REFERRED TO ER DEPT. WAITED UNTIL NEXT MORN. TO GO TO HOSPITAL.
86 2021-03-19 hypotension On 3/14/21 pt got up from bed to use BR and didn't know where she was, fell into wall and to floor. ... Read more
On 3/14/21 pt got up from bed to use BR and didn't know where she was, fell into wall and to floor. She had fatigue, headache, and generalize pain, her BP was low 100/44. All she could do was sleep and had no appetite, on the 20th she felt well enough to go for a car ride, her husband drove. She did see her PCP on the 18th who thought she was depressed, seemed unconcerned that she fell to the floor, her Bp was low this day as well, all labs were normal. This was her 2nd Covid-19 Moderna vaccine, she had no symptoms with the first injection. She has never before experienced disorientation, that she did on 3/14/21 @ 3 am.
86 2021-03-22 blood pressure decreased Patient stated she was dizzy and remained in bed for 5 days following vaccination. She said her bloo... Read more
Patient stated she was dizzy and remained in bed for 5 days following vaccination. She said her blood pressure dropped from 140 to 100. She also experienced weakness.
86 2021-03-24 platelet count decreased, blood clot Patient went to have labs done for her leukemia checkup 3/24. Patient has had leukemia for many year... Read more
Patient went to have labs done for her leukemia checkup 3/24. Patient has had leukemia for many years and has had many blood draws. Patient had blood taken at her appointment and was waiting when the nurse came back out and said her blood had clotted so they needed to redraw her blood. She states this has never happened before and wondered if her blood clotting would have been due to her covid vaccine the week prior. She states the first girl who drew her blood was slower than the second time around when a different nurse drew her blood.
86 2021-03-25 heart failure See started having shortness of breath on the night of 8/2/2021. He sends her to do tests, and she w... Read more
See started having shortness of breath on the night of 8/2/2021. He sends her to do tests, and she was taken to the hospital. She died in the hospital due to kidney and heart failure.
86 2021-03-31 chest pain January 19th I had extreme pain in my stomach and chest, I went to the hospital and they diagnosed m... Read more
January 19th I had extreme pain in my stomach and chest, I went to the hospital and they diagnosed me same day with pancreatitis, I was put on medication for it omeprazole
86 2021-04-04 chest pain Pt started late in the day w/ CP and SOB, was transported to Hospital by EMS . Pt passed away once ... Read more
Pt started late in the day w/ CP and SOB, was transported to Hospital by EMS . Pt passed away once at the facility. Time of Death was: 2011 on 4/1/21; pt was discharged from ER on 4/2/21
86 2021-04-07 blood clot, deep vein blood clot pain in legs on 3/22/21
86 2021-04-09 oxygen saturation decreased Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Additio... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: shortness of breath, drop in oxygen level, worsening of fibromyalgia
86 2021-04-10 chest pain Orange sized bruised arm Chest pains x6 lasting approx 6minutes over 7 days Very fatiqued
86 2021-04-12 heart failure She got sick, pain in the arm and neck the day after the vaccine. I called her doctors office on th... Read more
She got sick, pain in the arm and neck the day after the vaccine. I called her doctors office on the 19th of Feb and I did not get a call back. She was sick to her stomach, really tired and lost her appetite. On the 22nd I called her doctor again... no response, on the 23 I called again. On the 24th finally someone spoke to me.. they stated they had called my mom and spoke with her. They are suppose to call me, my mom could not remember by the time she would hang up. They said to let her rest and give her electrolytes and Vit. B6. On the 26th when I called the doctor and said she is lethargic they said to take her to the ER. She flat lined at the hospital and her body went into shock. She ended up having Kidney, Heart and Liver Failure. She was still driving and doing all of her cooking, banking, shopping, showering, walking every day on Feb 18th. She died on March 5th.
86 2021-04-12 blood clot Reporting for a friend she is in the hospital, all events may not be filled in, but I thought it was... Read more
Reporting for a friend she is in the hospital, all events may not be filled in, but I thought it was important to report sooner than later due to the news on other vaccines. Patient had her second shot around 3/7/2021 u sure as she is in a rehab facility time of day was 1630. On the 17 th of March she started having back pain then wasn?t able to get herself to the hospital called 911 and was transported to the hospital and that night had emergency surgery for a blood clot in her neck. She was in rehab and got rushed back to the hospital and had a pacemaker placed. She is still in a rehab facility.
86 2021-04-20 cerebrovascular accident Stroke 6 days after receiving the second dose of the vaccine; Paralysed left side; Fell on the floor... Read more
Stroke 6 days after receiving the second dose of the vaccine; Paralysed left side; Fell on the floor unresponsive; Fell on the floor Unresponsive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine), PARALYSIS (Paralysed left side) and UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine) (seriousness criteria hospitalization and medically significant), PARALYSIS (Paralysed left side) (seriousness criteria hospitalization and disability), UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) (seriousness criteria hospitalization and medically significant) and FALL (Fell on the floor Unresponsive). The patient was hospitalized on 10-Mar-2021 due to CEREBROVASCULAR ACCIDENT, PARALYSIS and UNRESPONSIVE TO STIMULI. The patient was treated with Surgery for Cerebrovascular accident and Surgery for Paralysis. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine), PARALYSIS (Paralysed left side), UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) and FALL (Fell on the floor Unresponsive) outcome was unknown. Not Provided Medical history was not reported. The patient was taking unspecified Antihypertensive medication. The patient was placed on a feeding tube and was transferred to a Nursing home and would require medical service for the rest of her life. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
86 2021-04-28 deep vein blood clot Client COVID PCR positive on 12/04/2021. Vaccinated with Moderna on 02/03/2021 and 03/03/2021. COVID... Read more
Client COVID PCR positive on 12/04/2021. Vaccinated with Moderna on 02/03/2021 and 03/03/2021. COVID PCR Presumptive on 4/26/2021 and listed as suspect reinfection. Client hospitalized on 4/26/2021 with signs of bowel obstruction, but also noted to be diagnosed with DVT. Notes indicate client was bedbound. Submitter does not have access to further vaccination or medical records for additional information.
86 2021-05-03 cerebral haemorrhage Patient had a brain hemorrhage on April 20th and died on April 25th.
86 2021-05-06 nosebleed Nose bleeding from left nostril starting on Thursday (one day after 2nd shot of vaccine). Would not ... Read more
Nose bleeding from left nostril starting on Thursday (one day after 2nd shot of vaccine). Would not stop bleeding/clot on its own. Went to emergency room three times in a 5 day span. Had nose cauterized twice and did not stop it beyond a few hours. Had nostril packed. Bled from the other nostril. Packed again. Cauterized again six days after initial bleeding started. Right now - two days after the third cauterization it has finally stopped for the time being.
86 2021-05-06 low platelet count This 86 year old black female received the Covid shot on 1/20/21 and went to the ED on 2/20/21 ... Read more
This 86 year old black female received the Covid shot on 1/20/21 and went to the ED on 2/20/21 and was admitted on 2/2/21 with the diagnoses listed below. D69.6 - Thrombocytopenia, unspecified J12.82 - Pneumonia due to Coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified
86 2021-05-20 atrial fibrillation Patient presented to the ED on 3/7/21 and was subsequently hospitalized with A-fib with RVR. Patient... Read more
Patient presented to the ED on 3/7/21 and was subsequently hospitalized with A-fib with RVR. Patient was also hospitalized on 4/6/21 with pseudoaneurysm following procedure. These visits occurred within 6 weeks of receiving COVID vaccination.
86 2021-05-23 hypertension, hypotension Covid-19 vaccine administrations (Moderna) 3/23/21 lot# 013A21A 4/20/21 lot# 013A21A Admission to H... Read more
Covid-19 vaccine administrations (Moderna) 3/23/21 lot# 013A21A 4/20/21 lot# 013A21A Admission to Hospital (5/2/21 ? 5/10/21) for hypertension and acute on chronic back pain requiring ICU admission, hyponatremia thought to be due to SIADH. CT of abdomen done at hospital noting no significant lumbar abnormalities and a plain film of her lumbar spine with no obvious compression fracture. Outside hospital notes do not further outline why she could no longer ambulate. Brain MRI done and negative during that admission. Discharged to a rehab facility for ongoing weakness. On 5/13/21, patient?s son requested admission to hospital for further evaluation. She states that she feels confused and her legs are very heavy and she can barely move them. Notably she lives alone in her own home, used to drive, did not use any assistive device to walk, and paid her own bills until 2 weeks ago. The symptoms did occur approximately a week after receiving her last Covid vaccine. Pt also notes around April 1, 2021 having taken an engorged deer tick off her head. 5/14/21 Lyme serology IgM & IgG = negative. Neurology was consulted. She had an MRI of her thoracic and lumbar spine, as well as an LP. She had had an MRI brain at a hospital. Her MRIs did not reveal a source of her weakness and pain. Her CSF revealed albuminocytologic dissociation. Given this finding and the constellation of symptoms and LP findings, it was thought she had Guillain Barre Syndrome, presumably due to her COVID vaccine. She was given IVIG for 5 days. She improved with this. As above, she had a recent admission for hyponatremia and hypertensive urgency. Here, her blood pressure was somewhat labile, but at times was low. She was started back on amlodipine and carvedilol, but at much lower doses with plan for ongoing monitoring. In terms of her hyponatremia, her salt tabs were stopped, and eventually her fluid restriction was able to be lifted. Her sodium was 136 at discharge.
86 2021-06-07 palpitations heart palpitations, nausea
86 2021-06-10 pulmonary embolism, deep vein blood clot Got second dose of Moderna 4/19/21. Was having increasing shortness of breath since 5/24/21. Admitte... Read more
Got second dose of Moderna 4/19/21. Was having increasing shortness of breath since 5/24/21. Admitted 6/8. Increasing lower extremity edema. Is obese. Coughing up phlegm. No fever/chills/chest pain/abdominal pain. COVID negative. Found to have a saddle pulmonary embolism and DVTs in the lower extremities . Appears unprovoked. Started on Eliquis. Still currently admitted 6/11
86 2021-06-15 cerebrovascular accident Pt had severe itching started shortly after 2nd shot. MD stated pt having histamine response and Ata... Read more
Pt had severe itching started shortly after 2nd shot. MD stated pt having histamine response and Atarax started 3x/day to control itching symptoms. After several weeks pt stated atarax making her drowsy and requested to decrease to 2x/day. Pt started itching severely again after frequency decreased and pt requested to be put back to 3x/day. Shortly after pt had massive stroke which led to her death a couple of days later on 4/23/2021
86 2021-06-17 blood clot On March 18, 21. pts. left fingers were blue. she was diagnosed with blood clots. Ends of fingers ... Read more
On March 18, 21. pts. left fingers were blue. she was diagnosed with blood clots. Ends of fingers died, lack of blood flow. They have been amputated. She is also swollen.
86 2021-06-30 haemoglobin decreased, body temperature decreased, anaemia Severe anemia, low hemoglobin, low body temp, weakness, confusion, shakiness, all blood levels abno... Read more
Severe anemia, low hemoglobin, low body temp, weakness, confusion, shakiness, all blood levels abnormal. Meningitis due to varicella zoster virus. Died on June 13 2021
86 2021-07-01 blood pressure decreased Within 15 minutes of receiving vaccine, client became dizzy, got a head ache. Client's heart rate wa... Read more
Within 15 minutes of receiving vaccine, client became dizzy, got a head ache. Client's heart rate was 104 bpm and blood pressure was 191/116. Oxygen stat was 95% on room air. EMTs had client lay down. Client was also given a cookie and some juice. Client was with EMTs for an hour. Blood pressure lowered to 175/110, and pulse to 80 bpm. Client refused EMTs taking her to the hospital. Client and client's daughter were advised to take client to hospital. Client stated that her daughter would take her to hospital.
86 2021-07-01 pulmonary embolism Acute pulmonary embolism with acute cor pulmonale, Acute respiratory failure with hypoxia,
86 2021-07-06 blood vessels inflammation Several days following 2nd Covid vaccine, patient began experiencing visual changes including seeing... Read more
Several days following 2nd Covid vaccine, patient began experiencing visual changes including seeing "sparkles", black spots, loss of color and blurriness. 8 days following the vaccine, patient lost vision in left eye and was taken to the ER and diagnosed with vasculitis. Large doses of Prednisone were administered as a means of protecting the other eye from loss of vision. A biopsy determined that the diagnosis was small cell vasculitis. Patient was in hospital for one week and returned home. Patient was under the care of specialists but becoming weaker. Approximately 6 weeks later, patient could no longer bear her own weight and was re-admitted to the hospital where additional tests were run. Medical staff were unclear what was causing the decline and patient passed away while still under their care.
86 2021-07-15 cerebral haemorrhage, loss of consciousness Hemorageic stroke, died next day on 03/12/21 My mother became noticeably and increasing confused, ... Read more
Hemorageic stroke, died next day on 03/12/21 My mother became noticeably and increasing confused, quiet and forgetful after the first dose. Immediately after the second dose, she became confused and shakey. On the third day after the second shot, she was disoriented and unable to communicate sufficiently. She was rushed to a local hospital, where she was diagnosed with a brain bleed. She was transported immediately to a hospital, where she was given a catscan and it showed unreparable damage to the right side of her brain, she never regained consciousness and died the next day.
86 2021-07-21 cerebrovascular accident Stroke, unable to know name, where she was, date, time of year, misusing words, speaking incoherentl... Read more
Stroke, unable to know name, where she was, date, time of year, misusing words, speaking incoherently word finding, memory issues, etc. Permanent memory/word finding disability Note: 7 days at Hospital, 7 days at Rehabilitation Hospital
86 2021-07-29 inflammation of the heart muscle heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anythin... Read more
heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anything; hard for her to breath; Could hardly walk; Arm pain; Not like herself; felt wipe out; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (heart became inflamed) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDITIS (heart became inflamed) (seriousness criterion medically significant), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated). On 07-Apr-2021, MYOCARDITIS (heart became inflamed), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated) had resolved. Treatment medication were not reported. Concomitant products were not provided. After the second dose, the patient felt wiped out, weak, couldn't do anything, which was described as "not like herself". At the same time, the patient couldn't lay down. These symptoms lasted for about five weeks. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
87 2021-01-03 hypertension Dizziness and HTN; Monitor B/P and Neurological checks Q 4 hours x 24 hours
87 2021-01-06 cardiac arrest, very slow heart rate No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at ... Read more
No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.
87 2021-01-19 oxygen saturation decreased ON JANUARY 19, 2021 THE RESIDENT WOKE FEELING "ACHES AND PAINS ALL OVER HER BODY" . SHE DID NOT TAKE... Read more
ON JANUARY 19, 2021 THE RESIDENT WOKE FEELING "ACHES AND PAINS ALL OVER HER BODY" . SHE DID NOT TAKE HER TEMPERATURE SO SHE'S NOT SURE SHE HAS A FEVER. RESIDENT STATES THAT SHE CONTINUED TO WORSEN THROUGH OUT THE DAY AND FELT "REALLY BAD" LAST NIGHT. THIS MORNING, JANUARY 20,2021 SHE WOKE FEELING "A LITTLE BETTER". HER PULSE OX WAS 94 ON ROOM AIR, PULSE 71 BPM, TEMP 98.3. SHE WAS ALERT AND COULD ANSWER ALL MY QUESTIONS. SHE DID STATE THAT SINCE THIS MORNING SHE WAS "FEELING BETTER AS THE DAY GOES ON" SHE HAS OXYGEN IN HER APARTMENT FOR HER COPD SO SHE STARTED USING THAT SINCE HER O2 LEVEL WAS LOW.. I WILL CONTINUE TO FOLLOW UP WITH HER THIS AFTERNOON. ON A SIDE NOTE SHE STATED THAT HER ARM WAS SORE FROM THE INJECTION.
87 2021-01-21 fainting, loss of consciousness 89 y/o female w/ history of syncope presented to RX for 1st dose COVID-19 vaccination. Patient buck... Read more
89 y/o female w/ history of syncope presented to RX for 1st dose COVID-19 vaccination. Patient buckled in wheel-chair, unable to walk, assisted. Requested vaccine be administered without moving patient from wheelchair. After administration, patient remained in waiting area for recommended 15 minute observation time, then patient's wheelchair was moved nearby, but still waiting area. Approximately 20 minutes after vaccination, granddaughter called me over to help. Patient was unconscious and appeared not to be breathing, but pulse was palpable. Called for code white. Pharmacist asked granddaughter to hold patient's head up. Pulse remained palpable, pharmacist administered 1 dose of 0.3mg epinephrine via epi-pen into patient's left thigh. Patient quickly regained consciousness, spoke to family, said she didn't feel well. EMS arrived. Patient began to vomit, was placed on stretcher by EMS and left with EMS. A few hours later the granddaughter reported to us that the patient had a UTI and physical exam by ER attributed her experience to untreated infection.
87 2021-01-28 cerebrovascular accident My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call ... Read more
My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call from the nursing facility that my Mother was having uncontrollable seizures and had to be transported to the nearby hospital. The ER doctor confirmed that my Mother had tested positive to Covid. She was treated for Covid and was on life support. A few days later we received a call that my Mother had a major stroke. She passed away on January 4, 2021
87 2021-01-28 heart attack Suspected myocardial infarction on 01/15/2021. Patient passed away on 01/15/2021.
87 2021-01-31 anaemia Patient arrives and appears ill but in no distress. Vital signs were concerning for fever. Given h... Read more
Patient arrives and appears ill but in no distress. Vital signs were concerning for fever. Given history of receiving the COVID-19 vaccine yesterday and concerned about an inflammatory response to the vaccine especially given she had COVID-19 infection back in October. Other residents at the nursing home are demonstrating similar symptoms after receiving the vaccine. IV was placed and labs were drawn and sent. The patient was given normal saline bolus as well as a dose of acetaminophen. Lab work is reassuring for a CBC without leukocytosis, stable anemia which is chronic for the patient, no thrombocytopenia. Electrolytes are only significant for borderline low sodium. Kidney function normal, BUN normal
87 2021-01-31 blood glucose increased, fast heart rate, palpitations, enlargement of the heart After receiving vaccine (within 30 minutes), pt presented with diaphoresis and palpitations. Rapid r... Read more
After receiving vaccine (within 30 minutes), pt presented with diaphoresis and palpitations. Rapid response was called and pt was sent to emergency room for further workup.
87 2021-01-31 palpitations After receiving vaccine (within 30 minutes), pt began complaining of chest palpations and diaphoresi... Read more
After receiving vaccine (within 30 minutes), pt began complaining of chest palpations and diaphoresis. Rapid response was called and pt was brought to the ER for follow-up.
87 2021-02-01 chest discomfort Chest tightness/SOB. BP 143/70, pulse 67, and O2 sat 97%. Patient sent to the ED.
87 2021-02-02 palpitations Just over 24 hours after vaccine patient states she developed systemic itching, racing heart, sob an... Read more
Just over 24 hours after vaccine patient states she developed systemic itching, racing heart, sob and fatigue which resolved in less than 24 hours. She did not seek care and was fine when she reported these symptoms.
87 2021-02-09 nosebleed Spontaneous 3 hours nose bleed.
87 2021-02-14 palpitations The night she received the shot she developed pain, tenderness, redness and swelling at the injectio... Read more
The night she received the shot she developed pain, tenderness, redness and swelling at the injection site. The next morning had headache, chills, heart felt loud and fast, could not think, could not remember even normal things like how to turn on TV, insomnia. Went to store and became weak and breathing hard with minimal activity, had to sit down and rest before leaving. Symptoms lasted about 3-4 days and at this point have resolved.
87 2021-02-21 pulmonary embolism blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received... Read more
blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection. On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs. Treatment details were unknown. Action taken with mRNA-1273 was unknown. The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
87 2021-02-27 chest discomfort After injection on Friday, headache, fever, tired, achy. Very tired through weekend. On Monday she... Read more
After injection on Friday, headache, fever, tired, achy. Very tired through weekend. On Monday she developed painful deep breathing , tightness in chest, more achy, extremely low energy, warranted emergency visit for chest x ray and EKG. Still has debilitating exhaustion a week later.
87 2021-02-28 hypotension At 8:30PM patient started experiencing bilateral hand numbness tingling and bilateral foot numbness ... Read more
At 8:30PM patient started experiencing bilateral hand numbness tingling and bilateral foot numbness and tingling. Patient advised that foot numbness only went away if she slept sitting up. Patient stated that the hand numbness/ tingling felt as if her hands have fallen asleep and that even her fingernails were painful. Patient had home health RN at her house and was hypotensive, oxygen saturation was ranging between 90-92. Paramedics were called for patient and vitals stabilized, patient stable enough to stay at residence. Precautions and worsening symptoms were given to patient and instructed to seek immediate medical care over the weekend if needed.
87 2021-03-02 haemoglobin decreased, cerebral haemorrhage From CT Scan in ED at 7:40 pm on 1/25/2021 -- There is a large intraparenchymal hemorrhage with Surr... Read more
From CT Scan in ED at 7:40 pm on 1/25/2021 -- There is a large intraparenchymal hemorrhage with Surrounding vasogenic edema within the left occipital lobe. There is additional subdural hemorrhage layering along the left frontal, temporal and parietal convexity which may be decompressing from the area of intraparenchymal hematoma. No visualized intraventricular hemorrhage.There is some trace hemorrhage layering along the left tentorium cerebelli. Severe associated mass effect with left-to-right midline shift of 2.1 cm. There is subfalcine and downward transtentorial herniation with complete effacement of the basilar cisterns. Evaluation of the craniocervical junction is limited due to beam hardening artifact. Near-complete effacement of the left lateral ventricle. No head trauma or fall. Deceased 1/26/2021
87 2021-03-02 palpitations, heart rate increased Details of pt. symptoms following her MODERNA Vaccine Note: She has been and was perfectly healthy ... Read more
Details of pt. symptoms following her MODERNA Vaccine Note: She has been and was perfectly healthy no health issues or symptoms of this nature until after receiving the Moderna COVID vaccination (1st dose). 26 Feb 2021 (Friday) 3:00 PM First dose Moderna vaccine given - no issues at time of vaccination. At approximately 7 hours post-dose ? severe whole body shaking, weakness, racing accelerated heart rate, difficulty walking- lasted throughout the night. 27 FEB 2021 (Saturday) Morning ? brain fog- very confused ? NO FEVER or shaking- however weak, unbalanced on her feet and confused in the afternoon we went about normal activities during the day so we thought she made it thru some acute reaction. Evening ? At approximately 9 PM ? whole body shaking, chills, weak, unbalanced. Her heart rate was not as accelerated (serious) as Friday night 28 FEB 2021 (Sunday) -seemed better but still brain fog (confusion), - by afternoon did normal things did a walk to get fresh air but she seemed to have labored breathing ? ?Huffing? and slow-she seemed better after the walk. 5 PM ? sudden and unexpectedly- she started whole body shaking, chills, difficulty walking, unsteady ? lasted about 1 hour ? unsteady on her feet needed assistance to walk. I put her to bed at 7:30 pm to rest and I was afraid she would fall because unsteady and shaking legs ? she had intermittent whole body shaking, chills, weakness 1March 2021 (Monday) ? around 10 am another episode - intermittent whole body shaking & chills, generalized weakness? developed respiratory symptoms, wheezing, deep croup- like coughing, weakness 2 March 2021 (Tuesday) ? respiratory symptoms seemed to be progressing. 3 March 2021 ( Wednesday) 3 PM Doctor evaluation ? fluid in lungs ? tested for Covid & prescribed antibiotics for lungs- 250 mg AZ ( 5 day treatment)
87 2021-03-02 fast heart rate Several minutes after vaccine patient stated that she felt dizzy and felt tachycardia.
87 2021-03-04 chest pain Received call from patient on 3/3/2021. She reports that approximately 1.5hrs after receiving her CO... Read more
Received call from patient on 3/3/2021. She reports that approximately 1.5hrs after receiving her COVID vaccine, she began having pain in the top of her head, neck, between her shoulder blades, down both arms to her fingertips, and down her spine. Reports also began having swelling in her feet. Reports having nausea and pain in her chest with walking. She reports she already had trouble with ambulation prior to vaccine, but it has been worse since receiving the vaccine. She reports as of 3/3/21, the pain is still occurring and not getting better. She has not seen her primary doctor since being vaccinated. I encouraged her to speak with her doctor or schedule a visit with them as her pain is not improving.
87 2021-03-06 body temperature decreased Got shot on Wed. 2/10/2021. Started feeling ill within a few hours. Next day, was "sick" and needed ... Read more
Got shot on Wed. 2/10/2021. Started feeling ill within a few hours. Next day, was "sick" and needed to vomit (but didn't). Temperatures for 3 days was less than normal. 95.6 to 96.1. FridayI I started vomiting and had incidents of a pain in my stomach area and by that night became sicker and dehydrated. Was so sick I couldn't get out of bed to get water (I live alone). By midnight Friday (12:00) Feb. 13 I was so sick I called daughter to take me to hospital. Went to ER and then did blood work. Blood work showed liver enzymes were over 500 and eventually reached over 600, when normal is under 100. Was admitted to hospital. My electrolytes were out of "whack" too. My doctor told me in 11 years practice she had never seen a liver enzymes reading over 600. I am scared to take another vaccine shot at this point. Note: I had blood work done Friday, March 5, 2021 and my liver enzymes was 26 -- normal but I am not interested in getting that sick again and I have concerns about my liver.
87 2021-03-17 pulmonary embolism Pulmonary embolism, asymptomatic, seen on CT angio.
87 2021-03-18 heart attack Shortness of breath, ?feeling funny?
87 2021-03-22 blood pressure increased, chest pain at approximately 10 minutes post injection, pt complained of feeling dizzy. BP was elevated at 200'... Read more
at approximately 10 minutes post injection, pt complained of feeling dizzy. BP was elevated at 200's/110's, pt was diaphoretic, c/o nausea and chest pain. NP on site and Paramedic on site immediately evaluated and sent via ambulance to ER for further evaluation.
87 2021-03-23 hypotension, loss of consciousness Death; unconscious; in and out of consciousness; weak, very weak; blood pressure was very low; littl... Read more
Death; unconscious; in and out of consciousness; weak, very weak; blood pressure was very low; little light headed; A spontaneous report was received from consumer concerning a 88 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little light headed/ dizziness, weak, very weak/asthenia, blood pressure was very low/ hypotension, in and out of consciousness/depressed level of consciousness, unconscious/ loss of consciousness and passed away. The patient's medical history was reported as heart issues. Concomitant medications taken by the patient included levothyroxine, isosorbide, acetylsalicylic acid, metoprolol, furosemide, warfarin, antibiotics. On 3 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 3 Mar 2021, when the patient got home the night, after getting the shot, patient was a little lightheaded, she seemed to be okay on 04 Mar 2021 and 05 Mar 2021. Patient had complained of being weak and her blood pressure was very low on 08 Mar 2021. She was progressively started getting weaker. On 09 Mar 2021, she was very weak and was in and out of consciousness. Patient was taken to the hospital, and she became unconscious and then passed away. Patient passed away on 09 Mar 2021. The patient died on 09 Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown. Treatment activities for event was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, unconscious, a little light headed, weak, very weak, blood pressure was very low, in and out of consciousness was unknown. The outcome was considered fatal.; Reporter's Comments: This is a case of sudden death in a 88-year-old female patient with a history of heart issues, who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
87 2021-03-28 hypotension Low BLP, dies at Hospital
87 2021-03-28 fast heart rate Patient received vaccine at 10:18am and then went home with no reaction in the vaccination POD. EMS ... Read more
Patient received vaccine at 10:18am and then went home with no reaction in the vaccination POD. EMS was called to the patients home shortly before 2:30 that afternoon. When EMS arrived patient was posturing with lower extremities extended in plantar flexion. Last seen normal 30 minutes prior. she was also tachycardic and in respiratory distress with sonorous respirations. Cranial nerve deficit present GCS 3.She was unresponsive and intubated. Airlifted after CT to hospital. She died at 1647 at Hospital from hemorrhagic stroke.
87 2021-03-31 fainting syncope/fainted; Dizziness; couldn't eat; Fatigue/ tiredness; Sore arm; A spontaneous report was rec... Read more
syncope/fainted; Dizziness; couldn't eat; Fatigue/ tiredness; Sore arm; A spontaneous report was received from a consumer concerning herself, an 87-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syncope/fainted, sore arm/pain in extremity, dizziness, fatigue/tiredness, and she couldn't eat (decreased appetite). The patient's medical history included COVID-19 in December 2020. Concomitant product use was not provided. On 11 FEB 2021, 1 day prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 FEB 2021, the patient experienced sore arm. On 12 FEB 2021, the patient experienced syncope (she fainted), dizziness, fatigue/tiredness, and she couldn't eat. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The event of syncope/fainted was considered resolved on an unknown date. The outcome of the events of sore arm, dizziness, fatigue/tiredness, and couldn't eat were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
87 2021-04-04 transient ischaemic attack 30 hours later , profound sensorineural hearing loss in right ear. Treated by steroid, hearing retu... Read more
30 hours later , profound sensorineural hearing loss in right ear. Treated by steroid, hearing returned in one week . Black tarry stools INR increased from 2 to 12 ER visit , admitted to hospital on March 23. TIAs
87 2021-04-06 low blood pressure *Orthostatic hypotension [I95.1] Yes ? Generalized weakness [R53.1] Yes ? Chronic diastolic hear... Read more
*Orthostatic hypotension [I95.1] Yes ? Generalized weakness [R53.1] Yes ? Chronic diastolic heart failure (HCC) [I50.32] Yes ? Sleep apnea in adult [G47.30] Yes ? Type 2 diabetes mellitus with both eyes affected by mild nonproliferative retinopathy without macular edema, without long-term current use of insulin (HCC) [E11.3293] Yes ? Essential hypertension, benign [I10] Yes Patient woke in middle of the nigh with confusion and tripped over furniture. Was having orthstatic S/S. Went to hospital for evaluation.
87 2021-04-07 haemoglobin decreased 09MAR2021-Patient is a 87 y.o. old female with a history of receiving her second COVID vaccine this ... Read more
09MAR2021-Patient is a 87 y.o. old female with a history of receiving her second COVID vaccine this past Friday. For the previous 2 to 3 days she has had increasing fatigue and generalized weakness. Anorexia and nausea have been noted as well. Apparently has not been eating or drinking well at all. No vomiting or diarrhea. No new medication recently. No fever or chills. Patient was seen and evaluated in the ER tonight by the ER physician. Significant acute renal failure was noted. Urinalysis was unrevealing. Mild hyperkalemia and moderate metabolic acidosis were noted as well. Initial treatment in the emergency room included a 1 L bolus of normal saline and antiemetic therapy. The hospitalist service was then consulted for admission." Discharge Summary Written 20MAR2021-Patient was admitted and started on IV fluids. Nephrology was consulted. She was started on a bicarb drip for metabolic acidosis. Renal US was negative for hydronephrosis but with incidental biliary ductal dilatation which was stable compared to a previous imaging study in 2011. Unfortunately her renal function continued to worsen and require dialysis. She had a temporary dialysis catheter placed on 3/12. She had RRT started on 3/12 and again on 3/13. Her urine output, electrolytes, and azotemia started to improve slowly. Renal function continued to improve and she no longer required any RRT. Her temporary dialysis catheter was removed on 3/19. Her Foley catheter was also removed on 3/19 and she was urinating well prior to discharge. She will go home with oral Lasix. Patient felt much improved and is agreeable for discharge on this date- 20MAR2021 Second Admission- 02APR2021-05APR2021- INDICATION FOR ADMISSION: This is an 87-year-old female with history of COPD, hypertension, and chronic lung disease, who presented to the Emergency Department on April 2, 2021 with a chief complaint of shortness of breath.. Three days prior to this admission the patient had increasing shortness of breath. The patient also had a nonproductive cough but denied any fever or chills. The patient was started on IV Lasix and IV steroids in the ED. She also had elevated BNP. She was admitted to the hospital for further medical management. Discharge Summary Written 05APR2021- She was started on IV steroids, IV Lasix, nebulization, and she was monitored closely. The patient also had HGB dropping to 8.8 from 11.3 back in March 2021. The patient was started on proton pump inhibitor. Gastroenterology and cardiology eventually were consulted to see the patient. She did have an EGD done at this time which showed gastritis. She will continue Protonix for now. She was started on IV Lasix and she improved with the treatment. Now she remains on room air. She denied any respiratory issue. Her renal function still remains at baseline. Today creatinine is 1.5. The patient can be discharged home today and continue oral Lasix at home daily for now. She was instructed to follow up with her primary care physician and also her cardiologist as outpatient in 1 to 2 weeks.
87 2021-04-12 chest discomfort patient complained of feeling unwell after second covid vaccine (which happened after first one as w... Read more
patient complained of feeling unwell after second covid vaccine (which happened after first one as well)- dizzy, shaky, chest pressure, nausea, resolved with time in clinc
87 2021-04-13 chest pain, pulmonary embolism Patient presented 3 days after her second DuoNeb vaccine with weakness dizziness chest pain or short... Read more
Patient presented 3 days after her second DuoNeb vaccine with weakness dizziness chest pain or shortness of breath and was initially diagnosed with a pneumonia by chest x-ray obtained with antibiotics without improvement. Subsequently she was hospitalized and CT of the chest showed left lower lobe segmental pulmonary embolism. The patient never had history of venous thromboembolism in the past. She had weakly positive anticardiolipin antibody of IgG type of unknown significance. She was treated initially with antibiotics but after diagnosis of the blood clot she was started on anticoagulation with apixaban with improvement
87 2021-04-14 chest pain With 1st vaccine on 1-9-21 I had severe chest pain, the NP diagnosed it as pleurisity, told to take ... Read more
With 1st vaccine on 1-9-21 I had severe chest pain, the NP diagnosed it as pleurisity, told to take Tylenol, on second vaccine 2-6-21 I had a very bad headache that went down my neck and right shoulder, and lower back, NP said it was arthritis, go to sports med. since that time the pain has covered all my joints, muscle spasms to the point of not being able to walk, completely bedridden at this time, severe pain, headache, insomnia
87 2021-04-14 deep vein blood clot, pulmonary embolism deep vein thrombosis pulmonary embolism
87 2021-04-15 heart rate increased short of breath; a fast heartbeat; dizzy; nauseous; arm was sore at the injection site; fatigue; Thi... Read more
short of breath; a fast heartbeat; dizzy; nauseous; arm was sore at the injection site; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided). On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant), HEART RATE INCREASED (a fast heartbeat), DIZZINESS (dizzy), NAUSEA (nauseous), VACCINATION SITE PAIN (arm was sore at the injection site) and FATIGUE (fatigue). On 05-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, DYSPNOEA (short of breath), HEART RATE INCREASED (a fast heartbeat), DIZZINESS (dizzy), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.
87 2021-04-15 loss of consciousness urinary tract infection; passed out; foggy; missed her second dose; This spontaneous case was report... Read more
urinary tract infection; passed out; foggy; missed her second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Urinary tract infection (She was given some medication and has significantly improved with her urinary tract infection.) on 05-Apr-2021. Concurrent medical conditions included Stomach cancer. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING ABNORMAL (foggy) and PRODUCT DOSE OMISSION ISSUE (missed her second dose). On 05-Apr-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). On 16-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed her second dose) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) was resolving and FEELING ABNORMAL (foggy) and URINARY TRACT INFECTION (urinary tract infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Her doctor and oncologist have told her to get the vaccine 1 week from today. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
87 2021-04-19 blood pressure increased Extreme fatigue, weakness, elevated blood pressure
87 2021-04-22 excessive bleeding blisters form after she eats and when they pop they bleed for a while; blood blisters in mouth worse... Read more
blisters form after she eats and when they pop they bleed for a while; blood blisters in mouth worse; blisters pop and it hurts; rash gotten worse; 45 days between the administration of the 1st dose and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) in an 87-year-old female patient who received mRNA-1273 (batch nos. 032M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No previous medical history was provided). On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose). On an unknown date, the patient experienced HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (blood blisters in mouth worse), PAIN (blisters pop and it hurts) and RASH (rash gotten worse). At the time of the report, HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while), PAIN (blisters pop and it hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose) outcome was unknown and ORAL MUCOSAL BLISTERING (blood blisters in mouth worse) and RASH (rash gotten worse) had not resolved. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-079482 (Patient Link).; Sender's Comments: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
87 2021-04-24 blood glucose increased Chills, nausea, blood sugar remaining high, no appetite, weak, enzymes high
87 2021-05-03 chest pain started with swollen legs about an hour after the shot, about 3 hours after the injection developed ... Read more
started with swollen legs about an hour after the shot, about 3 hours after the injection developed swelling in face, slurred speach, chest pain.
87 2021-05-04 cerebrovascular accident CVA
87 2021-05-05 cardio-respiratory arrest, troponin increased Vomiting and diarrhea starting 4/28/21 (day after vaccine). Came to ED today for these symptoms, fee... Read more
Vomiting and diarrhea starting 4/28/21 (day after vaccine). Came to ED today for these symptoms, feeling weak, had a cardiopulmonary arrest and died.
87 2021-05-05 loss of consciousness, fainting patient was unconscious; patient was unconscious; UTI; Bedridden; Patient began to vomit; This case ... Read more
patient was unconscious; patient was unconscious; UTI; Bedridden; Patient began to vomit; This case was received via FDA VAERS (Reference number: 0967119) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Syncope (granddaughter states patient has episodes of syncope) and Wheelchair user. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient was unconscious) (seriousness criterion medically significant) and SYNCOPE (patient was unconscious) (seriousness criterion medically significant). 22-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit). At the time of the report, LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) had resolved and URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After administration, the patient remained in waiting area for the recommended 15 minutes observation time. Approximately 20 minutes after vaccination, patient was unconscious and appeared not to be breathing, but pulse was palpable. Pharmacist administered 1 dose of 0.3mg epinephrine via epi-pen into patient's left thigh. The patient quickly regained consciousness, spoke to family, said she did not feel well. Emergency medical services (ems) arrived. The patient began to vomit, was placed on stretcher and left with ems. A few hours later the granddaughter reported that the patient had a urinary tract infection (UTI) and physical exam by emergency room (ER) attributed her experience to untreated infection.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Vomiting is consistent with event safety profile.
87 2021-05-09 palpitations Delirium, heart racing, breathing difficulties, swelling, movement difficulties.
87 2021-05-12 loss of consciousness, heart rate increased passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped o... Read more
passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped out, Fatigue; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRAVASTATIN for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on). 30-Mar-2021, the patient experienced FATIGUE (Wiped out, Fatigue). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown and FATIGUE (Wiped out, Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: result not mentioned (Inconclusive) result not mentioned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included discontinuation of glipizide. Company comment: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-070319 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information On 04-May-2021: Updated outcome of fatigue, added route of administration of suspect drug.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
87 2021-05-16 cardiac arrest Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center w... Read more
Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center within Health system with weakness and arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health system on 5/2/2021 complaining of SOB. Stated that she has had non-productive cough for months, but felt it had worsened lately. Pt. found to be COVID positive with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not intubated but expired from cardiac arrest/COVID on 5/16/2021.
87 2021-05-17 chest pain May 3, 2021, received a call from healthcare provider where the vaccine was given by healthcare prov... Read more
May 3, 2021, received a call from healthcare provider where the vaccine was given by healthcare provider. COVID 19 Prescreening Form Completed and Vaccine given 4/23/2021. Patient waited 15 minutes post vaccination no reaction. Her family also received a vaccine. Daughter and Son-In Law. Received a call that patient had died on 5/2/2021. Presented to healthcare facility for chest pain according to healthcare provider.
87 2021-06-01 chest pain felt great weight and pressure on my chest; did not get the second dose of Moderna COVID-19 vaccine ... Read more
felt great weight and pressure on my chest; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot; couldn't swallow; antibodies absent; Fatigue/tiredness; Severe sore throat/not just a severe throat; Neck swelling; Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt great weight and pressure on my chest) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Type 2 diabetes mellitus since an unknown date. Concurrent medical conditions included Drug allergy (allergic to medications), Allergy to animals and Perfume sensitivity. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high, ESZOPICLONE (LUNESTA) for Sleep disorder NOS, GLIMEPIRIDE for Type 2 diabetes mellitus. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat), SWELLING (Neck swelling), SWELLING FACE (Facial swelling) and FATIGUE (Fatigue/tiredness). On 15-Apr-2021, the patient experienced DRUG SPECIFIC ANTIBODY (antibodies absent). On an unknown date, the patient experienced CHEST PAIN (felt great weight and pressure on my chest) (seriousness criterion hospitalization), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot) and DYSPHAGIA (couldn't swallow). The patient was hospitalized from 25-Mar-2021 to 26-Mar-2021 due to CHEST PAIN. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHEST PAIN (felt great weight and pressure on my chest) and OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat) had resolved and SWELLING (Neck swelling), SWELLING FACE (Facial swelling), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot), DYSPHAGIA (couldn't swallow), DRUG SPECIFIC ANTIBODY (antibodies absent) and FATIGUE (Fatigue/tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Antibody test: negative (Negative) states that patient does not have any antibodies. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient's HCP advised to wait for two more weeks to receive the second dose of vaccine. Med Info Agent: *Crosslink with MOD21-058959, MOD21-062129, MOD21-076250, MOD21-085519* Call received from consumer who stated she had reported a previous event, but is frustrated because on the form it says if you have a problem, call us, but there is no number to call. Caller provided her address and confirmed contact information, contact information updated. The consumer stated she does not leave her house, and she does not have a fax machine, so it makes it difficult for her to send it back. The caller would like the company to know about this, but did not have any further requests. Consumer stated she will eventually have someone send it out for her. Caller stated it wasn't just a severe throat as the form mentions, she couldn't swallow, but did not elaborate. Consumer stated she is not going to get the second shot per providers direction, and stated she had no antibodies from the first dose. No further information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs. This case was linked to MOD-2021-058039 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: significant: event added On 03-May-2021: Missed dose On 20-May-2021: Significant follow-up received On 21-May-2021: VAER from uploaded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs.
87 2021-06-06 excessive bleeding Patient had bleeding in to the arm and has a large right shoulder effusion that needed ED visit and ... Read more
Patient had bleeding in to the arm and has a large right shoulder effusion that needed ED visit and now referred to orthopedic to drain.
87 2021-06-20 hypertension, oxygen saturation decreased, cardiac arrest High blood pressure, low oxidation, urine infection. cardiac arrest.
87 2021-06-23 atrial fibrillation Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vacc... Read more
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination for new onset atrial fibrillation.
87 2021-06-28 excessive bleeding Death 5/5/2021 Causes of death listed on death certificate: 1) acute bleeding 2) rupture of intern... Read more
Death 5/5/2021 Causes of death listed on death certificate: 1) acute bleeding 2) rupture of internal iliac aneurysm
87 2021-07-09 loss of consciousness, chest pain My mother had chest and abdominal pain and the passed out and died
87 2021-07-17 pulmonary embolism Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a c... Read more
Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her lungs) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her lungs) (seriousness criterion medically significant), COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever). At the time of the report, PULMONARY EMBOLISM (Blood clots in her lungs) outcome was unknown and COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 103. On an unknown date, COVID-19: positive (Positive) Positive. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 is a TCR and it is significant. Event outcome updated, Event is added2nd dose information is added.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
88 2020-12-31 heart rate increased Anaphylactic like reaction started with dizziness sweating increased heart rate wheezing in and out ... Read more
Anaphylactic like reaction started with dizziness sweating increased heart rate wheezing in and out of consciousness. administered 0.3 of epinephrine, O2 via NC at 3L. called EMS. EMS arrived with in 10 minutes and administered additional 0.5 of Epinephrine and transported patient to the ER
88 2021-01-10 blood pressure increased Fatigue and tiredness, heaviness in head, elevated blood pressure
88 2021-01-10 low blood oxigenation chills, fevers and hypoxia
88 2021-01-12 hypotension Had Covid Vaccine AM of 1.8.2021. Woke up with Nausea, Vomiting X 4, Chills the following AM. Prese... Read more
Had Covid Vaccine AM of 1.8.2021. Woke up with Nausea, Vomiting X 4, Chills the following AM. Presented to ED. Found to be hypotensive during ER. Nausea Vomiting resolved. Tx with fluid replacement and dismissed home instructed to monitor BP. B/P dropped again at home returned and admitted to hospital.
88 2021-01-14 loss of consciousness Became diaphoretic and lost consciousness after vaccine, was unresponsive for approx. one minute. Ch... Read more
Became diaphoretic and lost consciousness after vaccine, was unresponsive for approx. one minute. Checked pulse and opened airway with Jaw lift.
88 2021-01-18 cerebrovascular accident Aphasia, ,right-sided weakness and garbled speech
88 2021-01-21 cerebrovascular accident Within 1/2 hour of vaccination the patient was dizzy and was having a hard time remaining upright, a... Read more
Within 1/2 hour of vaccination the patient was dizzy and was having a hard time remaining upright, additionally the patient was less alert and oriented. Patient was observed for a few minutes and then ambulance was called. Patient was transported via EMS within an hour of being vaccinated to local hospital. Patient was found to have has had major stroke and is presently in ICU and not expected to make it.
88 2021-01-24 chest pain Was having mild chest pains after she received her first Coid-19 vaccination.
88 2021-01-31 hypotension Observed for 15 minutes without incident but while waiting for appointment scheduling pt began to fe... Read more
Observed for 15 minutes without incident but while waiting for appointment scheduling pt began to feel unwell. right and left upper quadrant ABD pain, N&V, diaphoretic, 30-40 ml emesis. Hypotensive 100/62 (baseline 144/90). No breakfast this AM. Kept under observation for additional 20 minutes. Pain resolving at time of discharge.
88 2021-02-03 blood pressure fluctuation shot at 10:50am, nausea at 10:58am, 11:04 am 160/90mmhg, 11:05am 162/98mmhg, 11:26am 140/80mmhg, 11:... Read more
shot at 10:50am, nausea at 10:58am, 11:04 am 160/90mmhg, 11:05am 162/98mmhg, 11:26am 140/80mmhg, 11:26am 98%pulse ox and 74bpm, 11:38am 25mg Benadryl given, 11:46 nausea improving
88 2021-02-04 chest pain, cardio-respiratory arrest, heart failure EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH AND CHEST AND BACK PAIN. SHE ... Read more
EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH AND CHEST AND BACK PAIN. SHE CODED WHEN SHE GOT IN THE ER AND LATER PASSED AWAY THE MONDAY. DIAGNOSIS WAS PNEUMONIA AND HEART FAILURE PER STEP DAUGHTER.
88 2021-02-04 oxygen saturation decreased, blood pressure decreased 2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of brea... Read more
2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of breath and decreased oxygen sats. temp 101.7, pulse 102, respirations 36, BP 141/92, oxygen 94%. Lung sounds crackles bilaterally with rhonchi on the left. patient worked up for sepsis, CXR shows mild atelectasis. blood pressure dropped, and continued to drop through treatment requiring levophed drop to be initiated. Patient POA determined that this would not be her sister's wishes and made the decision to make patient comfort care status. 2/3/21- patient lethargic throughout night. 0640-patient demise.
88 2021-02-09 loss of consciousness Daughter of client reported that her mother had 2 "seizures" with loss of consciousness 24 hours pos... Read more
Daughter of client reported that her mother had 2 "seizures" with loss of consciousness 24 hours post vaccination. No history of seizures. Patient reportedly had COVID with significant "brain fog" 1 month prior to 1st dose of vaccine.
88 2021-02-14 chest discomfort after 15 minute observation, pt complained of dizziness upon standing, shorty after c/o of shortnes... Read more
after 15 minute observation, pt complained of dizziness upon standing, shorty after c/o of shortness of breath, chest tightness, heavinees to tongue.
88 2021-02-18 haemoglobin decreased unresponsive, possible seizure, flushed skin, clammy, slight foamy mouth
88 2021-02-24 chest pain Emergency Room PT is a 88 y.o. female who presents with chest pain. Patient has a chronic intermitt... Read more
Emergency Room PT is a 88 y.o. female who presents with chest pain. Patient has a chronic intermittent chest pain due to coronary artery disease. She was recently evaluated and catheter to cessation demonstrated coronary artery disease that was not amenable to stenting. It was also felt that she was not a candidate for CABG due to her comorbid medical problems including renal insufficiency. Patient has been managed medically. She essentially has daily episodes of angina. Patient denies associa or lightheadedness. Patient had 1 sublingual nitroglycerin prior to arrival. The pain had been present approximately 2 hr time prior to its resolution. The pain had completely resolved prior to her arrival. In addition, she had received 324 mg of aspirin orally.
88 2021-02-27 lightheadedness C/O near syncope following vaccination. No HX of similar. No CP/SOB. No HA. No focal deficits. No HX... Read more
C/O near syncope following vaccination. No HX of similar. No CP/SOB. No HA. No focal deficits. No HX diabetes. FSBS: 86; BP: 130/80; HR: 52 (regular); no B-blockers or other rate controlling medications. EKG: sinus bradycardia. No blocks No ST/T changes. Intervals normal. Symptoms resolved at rest. HR remains in 50s. Care transferred to ambulance paramedics & patient transported to acute care ED.
88 2021-03-01 deep vein blood clot Deep vein thrombosis (DVT) of left lower extremity She reported swelling of her left leg and was s... Read more
Deep vein thrombosis (DVT) of left lower extremity She reported swelling of her left leg and was seen at Family Medicine Urgent Care on 2/19/2021 and was diagnoses with a thrombosis of the left popliteal vein. She was treated with Xarelto for anticoagulation and compression stockings. Her treatment course was uncomplicated when I saw the patient at follow up and was made aware of her condition at her appointment with me on 3/1/2021.
88 2021-03-09 arrhythmia abnormal heart beat; felt a tingling in her chest; A spontaneous report was received from a consumer... Read more
abnormal heart beat; felt a tingling in her chest; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt a tingling in her chest (paraesthesia), and abnormal heart beat (arrhythmia). The patient's medical history was not provided. No relevant concomitant medications were reported. On 3 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the patient felt a tingling in her chest. Three weeks later, on 14 Feb 2021, the patient was admitted to the hospital for an abnormal heart beat. No treatment information was provided. At the time of this report, the patient was still suffering from the symptoms. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, felt a tingling in her chest and abnormal heartbeat, were not recovered/not resolved.; Reporter's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
88 2021-03-10 palpitations Following the vaccine the next day she had the normal discomfort, tiredness and the arm was sore for... Read more
Following the vaccine the next day she had the normal discomfort, tiredness and the arm was sore for about a week. Then on 2/11/21 she had an ocular migraine, and as that ended she was hit with an intense pain in her head that she had never experienced before. It lasted for hours, for the rest of the day. She took Ibuprofen which did not do anything. She looked up online and the clinic had a report on what to do for the migraines, and she took Ibuprofen and strong coffee. She does that and was able to ward it off and stop it some. Then it continued to happen during the day and the pain is so intense. The day before yesterday, 3/9/21 the regimen of coffee and ibuprofen did not improve. It goes from the top of her head, down to her neck and sore to touch behind her ears. It is now a dull headache around her whole upper skull. She lives alone and her children do not live anywhere close to her. She is also having horrendous fatigue and is not able to get much done such as shopping, also shortness of breath and pounding heart beat generally is very active and some days she is not able to get dressed due to the symptoms. She went to UC and she had them do a COVID test, which was negative and sent to the ER at and her BP was 191/75, and was told to FU with her neurologist and internist and had no answers for her headaches.
88 2021-03-14 loss of consciousness pt got to feeling really sick w/ headache, nausea, light headed and fever of 100.9. Pts son called ... Read more
pt got to feeling really sick w/ headache, nausea, light headed and fever of 100.9. Pts son called ambulance. Pt passed out when EMTs were treating her. Pt was taken to hospital ER on 3/12/2021. They did blood work, covid test (negative) and CT. She was given fentanyl then admitted to the 2nd floor room for observation and given an IV. DX was reaction for Covid Vax. She was discharged on 3/14/2021 to FU w/ PCP within 1 week.
88 2021-03-15 hypertension, enlargement of the heart, haemoglobin decreased 3/13/21 ER HPI -> transferred to hospital 88 y.o. female who presents to the Hospital Emergency Depa... Read more
3/13/21 ER HPI -> transferred to hospital 88 y.o. female who presents to the Hospital Emergency Department by private auto with her daughter. Apparently, the patient has a 2 day history of intractable nausea and vomiting. She states she has vomited more than 5 times over the last 2 days. She has become more and more weak. She states she has been having coffee-ground emesis. No definite fever. The patient had a similar episode to this a few months ago. The patient does take nightly ibuprofen. She also take iron on a daily basis because of chronic anemia. She is not on any blood thinners. When the patient did get to the ER she had an episode of vomiting and it did appear coffee-ground. She is having a little bit of epigastric abdominal pain. No history of GI bleed in the past 3/16 note from Hospital Hospital Course: 88 y.o. female with a past history significant for hypertension, renal artery stenosis, arthritis, skin cancer presented to hospital with nausea/vomiting and transferred to another hospital on 3/13/2021 for GI evaluation. Patient developed coffee ground emesis and had NG tube placed, yielding 1800 cc of coffee-ground emesis. She was also noted to be hypertensive. A CT done at the outside hospital revealed a large hiatal hernia with a significantly distended herniated portion of the stomach and a portion in the left upper quadrant compatible with a gastric outlet obstruction. Transferred to another hospital and GI consulted. Underwent EGD on 3/14 with results as noted below. Recommended to continue PPI, avoid NSAIDs if possible and repeat EGD in 8 weeks as outpatient. NG-tube removed and tolerated diet. No further bleeding noted. Hgb remained stable. Medically stable for discharge. Counseled on medication use and diet. Patient or daughter had no further questions or concerns on discharge.
88 2021-03-15 hypertension He went to the hospital for cardiovascular problems and cholecystitis and was under treatment after ... Read more
He went to the hospital for cardiovascular problems and cholecystitis and was under treatment after the first dose. 2/26/2021 at around 11:00 pm she was complaining of high blood pressure, uncontrolled vital signs, uncontrolled sugar, at 6:00 am she has passed away. They certify respiratory failure.
88 2021-03-16 pallor, haemoglobin decreased 5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty s... Read more
5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty swallowing. 7 days post-vaccination patient looked "ashen". 12 days after vaccination patient was improving, but 14 days after vaccination patient was found to have (on lab work) critical hypernatremia (sodium level of 180 mmol/L), patient was re-referred back to hospice, and 17 days post-vaccination patient died.
88 2021-03-17 cerebral haemorrhage My mother died of a brain hemorrhage 5 days after receiving the vaccine.
88 2021-03-21 fast heart rate, heart rate irregular, hypertension Called over to the patient by EMS, patient c/o numbness to the left forearm. Patient denies any CP, ... Read more
Called over to the patient by EMS, patient c/o numbness to the left forearm. Patient denies any CP, SOB, diaphoresis, nausea/vomiting. Patient reports that she had the same reaction after the first vaccine but it resolved after 15 minutes. It has been over 30 minutes today and her symptoms have continued.
88 2021-03-22 cerebrovascular accident She got the vaccine, everything was fine, they warned her about being sick. She did not have any re... Read more
She got the vaccine, everything was fine, they warned her about being sick. She did not have any reaction at all until she woke up 13 days later on 3/5/2021 and her left eye was blind. She had some sort of blob that changes colors and moves around. It sometimes is orange. She knew she did not have macular degeneration as it centers it. Sometimes it sparkles and has grain to it. He said that she had an arterial blood, and that leaked from the carotid artery into the eye has not completely sealed off. She can see out of the right eye perfectly, but she cannot see a little out of the left eye. If she's watching the TV she can see the top of the newscasters hair, but she cannot see anything below that. Her vision is upward either, can see out of either side, but cannot below horizontal down. He told her that it was basically a stroke that didn't reach her brain and went to her eye. He told her to return to see him (ophthalmologist) on 5/18/21 at 10:00 AM. She also is to see her PCP on 5/20/21.
88 2021-03-22 haemoglobin decreased, platelet count decreased, low platelet count Patient presented to ED after abnormal labs from PCP. Platelets in ED = 2. Hgb 8.5. Possible rectal ... Read more
Patient presented to ED after abnormal labs from PCP. Platelets in ED = 2. Hgb 8.5. Possible rectal bleed at home, some bruising. Admitted and treated with dexamethasone 40mg PO daily, IVIG, platelet transfusions. EGD showed gastritis. Per hematologist "severe thrombocytopenia of acute on set after recent COVID-19 vaccination, which is likely due to ITP which has been previously reported to be associated with vaccination"
88 2021-03-28 chest pain Client was vaccinated at a community event. Twenty minutes after receiving the vaccination she bega... Read more
Client was vaccinated at a community event. Twenty minutes after receiving the vaccination she began complaining of chest pain and difficulty swallowing. Her VS remained stable, however, she reported difficulty breathing and at that time emergency responders was called. She remained alert and responsive for the 23 minutes between symptom onset and EMS arrival. She was transported out of the facility.
88 2021-03-28 heart attack, haemoglobin decreased, enlargement of the heart 3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patien... Read more
3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patient suffered MI and did not want any life-prolonging therapies. Patient was started on comfort medications and symptoms were monitored closely. The patient passed peacefully before she could be fully assessed
88 2021-03-28 oxygen saturation decreased Cold symptoms (cough with phlegm) Weakness Low oxygenation
88 2021-03-28 fainting, fast heart rate Patient began feeling hot and dizzy minutes after receiving injection. She was not 100% alert and th... Read more
Patient began feeling hot and dizzy minutes after receiving injection. She was not 100% alert and then was unresponsive for about 7min. Patient had tachycardia. Ambulance was called and patient became more alert after laying down, drinking juice, and resting. Patient was transported to ED.
88 2021-03-28 transient ischaemic attack Itching rash hive covering body, back, legs arms stomach breasts, still experiencing symptoms of hiv... Read more
Itching rash hive covering body, back, legs arms stomach breasts, still experiencing symptoms of hives for 8 plus days Treatment calamine lotion, and Zertec Also experienced two TIAs after both shots
88 2021-04-04 blood clot Blood Clot, lower leg (left calf muscle). MD. recommed Xeralto 20mg
88 2021-04-12 fluid around the heart Pericardial effusion
88 2021-04-12 blood clot Fatigue, dizziness, weakness. Issues with breathing caused hospitalization 3 days after shot. Blood... Read more
Fatigue, dizziness, weakness. Issues with breathing caused hospitalization 3 days after shot. Blood clot located in lung and 2 in right leg. Hospital stay 11 days, step down facility roughly 2 weeks, PT/OT upon arrival home.
88 2021-04-16 cerebrovascular accident, loss of consciousness Stroke; Unconscious; This spontaneous case was reported by a patient family member or friend and des... Read more
Stroke; Unconscious; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) outcome was unknown. Concomitant medications were not reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
88 2021-04-19 hypertension headache, mild hypertension, flushing of face. Started 8 hours after receiving shot, patient report... Read more
headache, mild hypertension, flushing of face. Started 8 hours after receiving shot, patient reported to ED. No treatment administered.
88 2021-04-20 body temperature decreased Later on the day of the vaccine, I developed difficulty speaking and walking. My son brought me to t... Read more
Later on the day of the vaccine, I developed difficulty speaking and walking. My son brought me to the ER the following day. They ran tests and ruled out stroke and other known causes of my neurological problems. I showed improvement the next day so they sent me home. My symptoms continued and worsened over a few weeks. My children called the ambulance on March 17. My body temp was 88 when I arrived at the ER and heartrate in 30s. I stayed in the hospital for 7 days but have no memory of that or the week before. As the Drs could not find a cause or remedy to symptoms, I was discharged to hospice care. I have improved at home with a lot of assistance but am not back to my pre-vaccine strength, energy, or coordination.
88 2021-04-28 palpitations, oxygen saturation decreased Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nau... Read more
Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nausea. Admitted to hospital 3 days after shot and quickly developed pnemonia and died 4 days later after blood O2 fell below 80%. Had periods of mild improvements followed by more severe declines each time.
88 2021-05-04 pulmonary embolism, deep vein blood clot non-provoked DVT and acute pulmonary embolism on 05/03/2021. She has no history of such diagnosis a... Read more
non-provoked DVT and acute pulmonary embolism on 05/03/2021. She has no history of such diagnosis and no risk factors otherwise for DVT.
88 2021-05-14 blood clot patient said 4 to 5 days after the vaccine, she went to the hospital and had blood clots in the lung... Read more
patient said 4 to 5 days after the vaccine, she went to the hospital and had blood clots in the lungs and legs. she said she's ok now and dr told her to get her second vaccine today. she is now on Eliquis.
88 2021-05-19 anaemia Patient presented to the ED and was subsequently hospitalized with anemia within 6 weeks of receivin... Read more
Patient presented to the ED and was subsequently hospitalized with anemia within 6 weeks of receiving COVID vaccination.
88 2021-06-01 palpitations Began experiencing palpitations
88 2021-06-27 cardiac failure congestive Fully vaccinated patient admitted to hospital with detected COVID PCR test. Patient with positive C... Read more
Fully vaccinated patient admitted to hospital with detected COVID PCR test. Patient with positive COVID swab in ED on 05/31/21. Came to ED with leg swelling, weakness. Discharged home on 1 L/NC of O2 due to lower O2 sats 92-94%. Patient seen again in ED on 06/06/21 this time for increasing shortness of breath, increasing oxygen demand, and icnreased work breathing. O2 needs since last ED visit increased to 2-3 L. Admitted to hospital for COVID infection and CHF exacerbation. Treated with aggressive diuretics, remdesivir, and dexamethasone. Blood cultures tested positive and was started on IV ATB's. Patient discharged back to AFC with Hospice services.
88 2021-07-17 cerebrovascular accident Stroke; itching/pruritus; redness/erythema; Hypersensitivity reaction; Shingles; Rash; This spontane... Read more
Stroke; itching/pruritus; redness/erythema; Hypersensitivity reaction; Shingles; Rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), PRURITUS (itching/pruritus), ERYTHEMA (redness/erythema), HYPERSENSITIVITY (Hypersensitivity reaction), HERPES ZOSTER (Shingles) and RASH (Rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010MZ0A and 0111Z0A) for COVID-19 vaccination. Concurrent medical conditions included Alzheimer's disease (Alzheimer's Disease worsened after taking vaccination.), Thyroid disorder (Thyroid Disorder), Incontinence (Incontinence), Glaucoma (Glaucoma) and Chronic kidney disease stage 3 (Chronic Kidney Disease (CKD) Stage 3 or 4 worsened after taking vaccination). Concomitant products included DONEPEZIL from an unknown date to 01-Mar-2021 for Alzheimer's disease, HYDROXYZINE from an unknown date to 01-Mar-2021 for Anxiety, LISINOPRIL from an unknown date to 01-Mar-2021 for Blood pressure fluctuation, TIMOLOL from an unknown date to 01-Mar-2021 and LATANOPROST, TIMOLOL MALEATE (LATANAPROST/TIMOLOL) from an unknown date to 01-Mar-2021 for Glaucoma, MIRABEGRON (MYRBETRIQ) from an unknown date to 01-Mar-2021 for Incontinence, LEVOTHYROXINE from an unknown date to 01-Mar-2021 for Thyroid disorder, VITAMIN D3 from an unknown date to 01-Mar-2021 for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (itching/pruritus) (seriousness criterion death), ERYTHEMA (redness/erythema) (seriousness criterion death), HYPERSENSITIVITY (Hypersensitivity reaction) (seriousness criterion death), HERPES ZOSTER (Shingles) (seriousness criterion death) and RASH (Rash) (seriousness criterion death). On 01-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death and medically significant). The patient died on 01-Mar-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: normal mmHg (normal) All within normal ranges. In 2021, Body temperature: normal DF (normal) All within normal ranges. In 2021, Heart rate: normal (normal) All within normal ranges. Additional information was provided by the reporter that 7 days after taking vaccination patient got bumps, on left leg that spreaded to her groin region and all over her thighs, which were painless but itchy. Patient's Home Health Nurse took pictures and sent to the physician on which the physician prescribed medications. Treatment information were not reported. This is a case of death in a 88-year-old female subject with a medical history of Alzheimer's disease, Thyroid disorder, Incontinence, Glaucoma and Chronic kidney disease stage 3, who died 28 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. Additional information provided was that 7 days after taking vaccination patient got bumps, on left leg that spreaded to her groin region and all over her thighs, which were painless but itchy. Patient's Home Health Nurse took pictures and sent to the physician on which the physician prescribed medications. This case was linked to MOD-2021-006200 (Patient Link). Reporter did not allow further contact; Reporter's Comments: Event Outcomes were given as Recovered in SD but the patient has passed away so captured as Fatal.; Sender's Comments: This is a case of death in a 88-year-old female subject with a medical history of Alzheimer's disease, Thyroid disorder, Incontinence, Glaucoma and Chronic kidney disease stage 3, who died 28 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Stroke
88 2021-07-20 cerebrovascular accident Stroke. Death.
88 2021-07-22 blood clot Patient said that she couldn't walk starting about 2 days after the shot. She had to go to the hospi... Read more
Patient said that she couldn't walk starting about 2 days after the shot. She had to go to the hospital and it was discovered that she had 3 blood clots, 2 in her legs and 1 in her lung.
89 2021-01-07 chest discomfort Patient reported having light headedness and then developed chest heaviness. 911 was activated to re... Read more
Patient reported having light headedness and then developed chest heaviness. 911 was activated to respond to the facility.
89 2021-01-11 chest discomfort VS: 210/100-74-98.4-98%RA. Resident called front desk and reported she wasn't feeling good after rec... Read more
VS: 210/100-74-98.4-98%RA. Resident called front desk and reported she wasn't feeling good after receiving COVID-19 vaccine. Seen resident immediately in apartment around 1310 accompanied by CM sitting in chair. Alert and oriented to person, place, time, and situation. Verbal and able to make needs known. Speech clear and coherent. No slurred speech or facial drooping noted. Resident received the 1st dose of Moderna COVID-19 vaccine around 1200. She was observed for 30 min by ARR staff immediately after vaccine was administered. She then went to grab coffee and went to her apartment. She did not yet eat lunch. Resident c/o feeling "woozy" and eyes feeling heavy/"uncomfortable". Continued from above: Resident has a history of anaphylaxis and several allergies. Called EMS around 1320. While waiting for EMS rechecked BP several times with SBP between 200-215. She denies any SOB, numbness, tingling, or indigestion. SpO2: 97-98%RA. Resident then stated she has slight tightness/discomfort to her left chest. EMS arrived and left ARR at 1414 and sent to Medical Center.
89 2021-01-12 fainting Patient was hospitalized within 24 hours after a syncopal episode due to hypotension. She was found ... Read more
Patient was hospitalized within 24 hours after a syncopal episode due to hypotension. She was found to have a UTI due to E.coli and subsequently treated for the infection. It was felt, that the syncope was due to sepsis related to the UTI caused by known chronic constipation rather than the vaccine.
89 2021-01-13 blood pressure decreased BP down to 60/50
89 2021-01-21 heart rate increased Pt sat down after vaccination and within about 5 minutes she alerted the observer that she felt like... Read more
Pt sat down after vaccination and within about 5 minutes she alerted the observer that she felt like she was "floating," dizzy, hot, racing pulse, light headed. EMS and paramedic alerted. took pt's VS. HR 80 BP 111/65 96% RR 18 . EMS arrived, they did their evaluation. Pt reported she was feeling better, wanted a coca cola. Pt waited in observation for an addition 30 minutes with no other symptoms noted. Pt signed refusal with EMS to be transported to the ED. Pt's daughter was present and suspects the pt had not felt well due to wearing a mask. Pt was given precautions to return to the ED by EMS.
89 2021-01-25 haemoglobin decreased Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill fe... Read more
Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot.
89 2021-01-27 cerebrovascular accident There were no signs of adverse affects from vaccine. She was admitted to hospital due to stroke.
89 2021-01-31 hypotension Systemic: Vomiting-Medium, Systemic: Other- low blood pressure-Medium
89 2021-01-31 oxygen saturation decreased She felt limp, couldn't speak, very weak and grey looking extremely high fever, low oxygen levels
89 2021-02-02 atrial fibrillation afib
89 2021-02-02 blood pressure increased This nurse was informed patient was experiencing dizziness approx. 5 minutes after vaccination aroun... Read more
This nurse was informed patient was experiencing dizziness approx. 5 minutes after vaccination around 11:25am. The patient's vitals were taken and were stable, though systolic BP was slightly elevated and pt with hx of HTN. Patient was given water and after a few more minutes states she felt better. Pt observed for 30 minutes.
89 2021-02-04 blood pressure increased, pallor I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14.... Read more
I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14. The nurse reports she was pale and diaphoretic while in observation at 09:20. She had no chest pain, SOB, nausea/vomiting, headache. She stated that she was feeling weak and had lost all her energy. When taken, her BP was elevated, but her other vitals signs and blood sugar were normal. Her heart rate/rhythm was normal and regular. She reported some epigastric pain. Overtime, her symptoms improved without intervention. She was given water, and rested under observation. Her daughter came to drive her home. She was released after a minimum of 45 minutes post-injection.
89 2021-02-04 pallor I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14.... Read more
I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14. Nurse noted that she was pale and diaphoretic at 09:20. She stated that she was feeling weak and had lost all her energy. She had no chest pain, SOB, nausea/vomiting, headache. When taken, her BP was elevated, but her other vitals signs and blood sugar were normal. Her heart rate/rhythm was normal and regular. She reported some epigastric pain. Overtime, her symptoms improved without intervention. Her daughter came to drive her home. She was released after a minimum of 45 minutes post-injection. Suspect vasovagal response
89 2021-02-07 cerebrovascular accident Patient was transported to a local hospital, She experienced a stroke.
89 2021-02-07 chest discomfort, heart attack, heart attack On 1/27/21, resident experienced shortness of breath and felt some pressure on her chest. Systolic B... Read more
On 1/27/21, resident experienced shortness of breath and felt some pressure on her chest. Systolic Blood Pressure was in the 200's and Diastolic Blood Pressure was in the 100's, HR 117. She was sent to Hospital and diagnosed with: St Elevation Myocardial Infarction due to occlusion of circumflex coronary artery, Acute Systolic Heart Failure, and Aspiration Pneumonia.
89 2021-02-07 ischaemic stroke On 2/6/21 at 6:00PM, resident experienced sudden left facial droop, left arm and left leg weakness. ... Read more
On 2/6/21 at 6:00PM, resident experienced sudden left facial droop, left arm and left leg weakness. She was sent to hospital and they confirmed she had an acute ischemic stroke.
89 2021-02-07 fainting I became nauseous, light headed then fainted. Had mild fever. Recovered after reclining.
89 2021-02-08 fibrin d dimer increased, chest pain, platelet count decreased Patient is a 89 y.o. female with a history of a TAVR that presented to the emergency room few hours ... Read more
Patient is a 89 y.o. female with a history of a TAVR that presented to the emergency room few hours after having a 40 min episode of chest pain. The patient states she was just eating and suddenly started having sharp pain on the left side of her chest. There was a little bit of associated shortness of breath, but not much. She states it was sharp in nature and seem to stay about the same for about 40 min. She states that she does seem to get chest pain sometimes when she vacuums, but usually if she sits down it immediately goes away. She reports that she saw PAC about a week ago and was thought to be a little bit fluid overloaded. She was started on a little bit of oral Lasix and was supposed to come see provider later in the week. She states she has diuresed very aggressively the last few days and is feeling quite a bit less short of breath. In the ER, her EKG did not show anything acute. Troponin was normal. BNP was mildly elevated, but her imaging did not show any signs of acute congestive heart failure. Her D-dimer was elevated. However, she was not having any pain while she was in the emergency room. Her pulse was normal and her oxygen saturations were in the high 90s.
89 2021-02-09 palpitations, blood pressure increased The minute I stood up after the vaccine around 5 mins post injection leg felt like I was gonna colla... Read more
The minute I stood up after the vaccine around 5 mins post injection leg felt like I was gonna collapse. I tried to walk couldn't make it found a chair. I saw one of my coworkers there helped me get a wheelchair. I immediately went to the ER Oxygen level was fine, BP elevated and exp heart palpitations. That afternoon I was able to go home.
89 2021-02-14 chest pain 1335 - Pt arrived to observation feeling dizzy and not well. MD called, no answer. BP 210/109 133... Read more
1335 - Pt arrived to observation feeling dizzy and not well. MD called, no answer. BP 210/109 1336 pt reported chest pain and 911 called. 1345 - care transferred to 911 and transferred to ED.
89 2021-02-14 hypotension, oxygen saturation decreased Resident tested NEGATIVE for COVID-19 last 1/25/2021. She was on monitoring for desaturation and low... Read more
Resident tested NEGATIVE for COVID-19 last 1/25/2021. She was on monitoring for desaturation and low blood pressure on Jan. 27,2021
89 2021-02-14 palpitations First day , Jan. 27. in the afternoon serious headaches began lasting for several days.. took Tyleno... Read more
First day , Jan. 27. in the afternoon serious headaches began lasting for several days.. took Tylenol to alleviate. Feb. 3. Very serious itching began at the injection site, on my left arm, width of my arm and down to just above the elbow and the area was very red. I used cold pack to alleviate the severe itching and redness. This lasted for approx. three days. Feb. 8. In the early afternoon my entire left arm began to ache, becoming painful as the day wore on. Then also went down into my armpit. The pain was very intense. I started having heart palpitations so totally Rested. Took a Tylenol for the pain. Took another Tylenol before bedtime and was able to sleep through the night. The pain and ache was better the next morning. By later in the afternoon I felt better,
89 2021-02-17 blood pressure increased difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was po... Read more
difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was poorly responsive had to report to the ER, had two seperate ER visits due to lethargy and unable to walk. on 2/17 patient returned to baseline.
89 2021-02-22 hypotension Vaccine was administered at Nursing Facility. Patient is an 89-year-old female with prior medical ... Read more
Vaccine was administered at Nursing Facility. Patient is an 89-year-old female with prior medical history of CVA with dysphagia, history of possible dementia, GERD, hyperlipidemia, and a pacemaker. She is a resident from town. She was sent for hypotension with a blood pressure of 90/52, tachypnea respirations of 54, possible aspiration pneumonia. Status post Covid vaccine earlier today. History is limited as patient is nonverbal on my exam. Death within 24 hours of vaccination
89 2021-02-25 cardiac arrest, cerebrovascular accident Stroke in left occipital lobe Feb 1 & Feb 2 Right peripheral vision effected in both eyes 2 heart st... Read more
Stroke in left occipital lobe Feb 1 & Feb 2 Right peripheral vision effected in both eyes 2 heart stops on Feb 10, 2021 Pacemaker implanted after heart stops
89 2021-02-26 blood clot Trouble breathing, severe fatigue, blood clots in lung and leg.
89 2021-03-01 hypotension, loss of consciousness Slight headache, feeling extreme tiredness fairly suddenly, saying ?I feel like I could pass out? a... Read more
Slight headache, feeling extreme tiredness fairly suddenly, saying ?I feel like I could pass out? and then passing out. Slight movement of mouth for air, some drooling.
89 2021-03-04 fluid around the heart, chest pain 2/22 presented to ED with chest pain. Admitted to ICU. CT/ECHO found pericardial effusion of right ... Read more
2/22 presented to ED with chest pain. Admitted to ICU. CT/ECHO found pericardial effusion of right atrium. Patient stabilized and was discharged 2/25. hospitalizations are to be reported irrespective of attribution to the vaccine.
89 2021-03-04 fainting Per patient's daughter the patient had severe flu like symptoms, shaking, extreme pain in wrists/fin... Read more
Per patient's daughter the patient had severe flu like symptoms, shaking, extreme pain in wrists/fingers/feet. Patient collapsed at home and pronounced dead at scene.
89 2021-03-08 pallor client was in observation station. became weak and daughter with her. notified EMT on site and was p... Read more
client was in observation station. became weak and daughter with her. notified EMT on site and was pale, ashen and not responding. Laid client on cot and elevated her feet. became responsive. Vital signs done and bp 157/68 and pulse 76. Became responsive. sat up client and states that she had coffee and some yogurt this morning. provided client with juice and pretzels. felt ok and declined further medical treatment.
89 2021-03-11 chest pain On 3/6/2021 the patient presented to the ED with dyspnea and substernal chest pain that pretty much ... Read more
On 3/6/2021 the patient presented to the ED with dyspnea and substernal chest pain that pretty much resolved as soon as she came in. She was admitted to rule out any cardiovascular events (none were apparent). Reason for admission: chest pain.
89 2021-03-11 nosebleed Felt feverish, fever blisters in and outside of nose and mouth, headache, swollen and sore right arm... Read more
Felt feverish, fever blisters in and outside of nose and mouth, headache, swollen and sore right arm to elbow, severe word finding deficit. Word finding problems subsided in 90 minutes. Arm swollen for 2 weeks. Headache lasted one day. Fever blisters lasted 2 weeks.
89 2021-03-15 blood pressure decreased, very slow heart rate, heart attack, blood glucose increased, haemoglobin decreased, coughing up blood, oxygen saturation decreased, platelet count decreased, cardiac arrest, troponin increased, skin turning blue, fibrin d dimer increased Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemente... Read more
Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemented our plan together. Please see PA's note for details. All relevant procedures supervised. Patient arrived to the emergency department due to respiratory symptoms, hypoxic, reported that Wednesday he received his 2nd dose of COVID vaccine. His initial workup was concern for NSTEMI with elevated troponin and peaked T-waves, his chest x-ray concerning for COVID/pneumonia. Patient initially tolerated oxygen by nasal cannula and sepsis protocol was started including IV fluid resuscitation that was done cautiously due to the concern of COVID with respiratory failure. The biotics were given. PA-C readdressed code status with patient who confirmed that his DNR DNI, she so contacted his daughter. Patient had multiorgan failure including acute kidney injury, and pneumonia with respiratory failure +/- respiratory failure. Due to the concern of NSTEMI patient was initially going to be transfer to was hospital and transfer was started. Patient respiratory status started deteriorating and his blood pressure dropped slightly but improved after 500 cubic centimeters of IV fluid and he was also placed on a NIPPV. Around 6:00 p.m. patient has significantly desaturation and he discontinued himself NIPPV. Due to inability to intubate patient, he was ventilated with BVM, patient is slowly improved saturation levels and was opening his eyes, he was placed on a non-rebreather. At this point there is high concern of ARDS and due to inability to intubate or give for the respiratory support His daughter was at bedside and updated of current medical status and poor prognosis. Patient continued deteriorating and at this point he had agonal breathing. His daughter was at bedside and she was made aware of the futile prognosis of patient due to his respiratory failure. Patient rapidly became bradycardic and went into cardiac arrest. No CPR was done due to the DNI DNR status of the patient. Critical Care Procedure Note Authorized and Performed by: MD Total critical care time: Approximately 30 minutes Due to a high probability of clinically significant, life threatening deterioration, the patient required my highest level of preparedness to intervene emergently and I personally spent this critical care time directly and personally managing the patient. This critical care time included obtaining a history; examining the patient; pulse oximetry; ordering and review of studies; arranging urgent treatment with development of a management plan; evaluation of patient's response to treatment; frequent reassessment; and, discussions with other providers. This critical care time was performed to assess and manage the high probability of imminent, life-threatening deterioration that could result in multi-organ failure. It was exclusive of separately billable procedures and treating other patients and teaching time. Please see MDM section and the rest of the note for further information on patient assessment and treatment. PE: VITAL SIGNS: BP: 126/75 Pulse: (!) 122 Resp: (!) 40 SpO2: (!) 82 % Temp: 98.1 °F (36.7 °C) Height: 5' 8" (172.7 cm) Weight: 152 lb (68.9 kg) General: Alert, nontoxic, in no acute distress. Lungs: Clear to auscultation bilaterally. CLINICAL IMPRESSION: 1. Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism (HCC) 2. Suspected COVID-19 virus infection 3. NSTEMI (non-ST elevated myocardial infarction) (HCC) 4. Multifocal pneumonia 5. ARDS (adult respiratory distress syndrome) (HCC) 6. Acute kidney injury (HCC) Further care and disposition otherwise as outlined by PA. ED on 2/14/2021 Revision & Routing History Detailed Report Note filed date Mon Feb 15, 2021 8:46 AM
89 2021-03-16 cardiac arrest Patient presented initially to the ED with complaint of body aches, myalgias, 24 hours following sec... Read more
Patient presented initially to the ED with complaint of body aches, myalgias, 24 hours following second dose of the Moderna COVID-19 vaccination. Initial ED workup was unremarkable, including CBC, CMP, Troponin, CK, Magnesium, CXR and EKG. Her vitals were normal and she was subsequently discharged home with family. She then returned several hours later following a witnessed cardiac arrest. She was resuscitated and admitted to the ICU intubated and on multiple vasopressors in critical condition.
89 2021-03-16 deep vein blood clot, pulmonary embolism Blood clots on her legs; Blood clots on her lungs; A spontaneous report was received from a consumer... Read more
Blood clots on her legs; Blood clots on her lungs; A spontaneous report was received from a consumer concerning 89-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced blood clots on legs and lungs. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, approximately 7 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the right arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient was hospitalized for blood clots on legs and lungs for 7 days and was discharged on 17 Feb 2021. Treatment include unknown injections. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested
89 2021-03-18 loss of consciousness patient reported 20 minutes of visual hallucinations about 15-17 hours after 2nd dose of COVID-19 va... Read more
patient reported 20 minutes of visual hallucinations about 15-17 hours after 2nd dose of COVID-19 vaccine and passed out for possibly 5 minutes. during fall she injured right low leg, but no evidence of DVT on exam today (6 days after fall).
89 2021-03-21 loss of consciousness The night of the vaccine she developed fever and chills. 3/17 she had bowel and urine incontinence a... Read more
The night of the vaccine she developed fever and chills. 3/17 she had bowel and urine incontinence and her daughter told her to rest and then she insisted on getting into the shower because she was upset about the incontinence 9:15 am she had gotten in the shower and her other daughter was close by when she had bowel and urine incontinence again and then lost consciousness and then she came to and had bowel and urine incontinence for a 3rd time. The bowel movements were massive diarrhea. Reporter believes she had a TIA event (Mini stroke). She was cared for at home by her daughter who is a nurse. In the past, when she has high fever and chills she tends to have TIA events.
89 2021-03-31 cerebrovascular accident Within days symptoms of likely CVA. Within one week diagnosis of shingles.
89 2021-04-02 cerebrovascular accident Received vaccine at 1:30, then ate at 2:30. Went home by 4:00 and had a stroke at 4:30 while on the ... Read more
Received vaccine at 1:30, then ate at 2:30. Went home by 4:00 and had a stroke at 4:30 while on the toilet. Was weak going into home and up stairs at 4:00.
89 2021-04-02 oxygen saturation decreased muscle weakness in her legs; oxygen level was low; could not get up or walk; This spontaneous case w... Read more
muscle weakness in her legs; oxygen level was low; could not get up or walk; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (oxygen level was low), GAIT DISTURBANCE (could not get up or walk) and MUSCULAR WEAKNESS (muscle weakness in her legs) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 immunisation. The patient's past medical history included No adverse event (No medical history reported). On 12-Mar-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen level was low) (seriousness criterion hospitalization) and GAIT DISTURBANCE (could not get up or walk) (seriousness criterion hospitalization). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness in her legs) (seriousness criterion hospitalization). The patient was hospitalized from 14-Mar-2021 to 17-Mar-2021 due to GAIT DISTURBANCE, MUSCULAR WEAKNESS and OXYGEN SATURATION DECREASED. The patient was treated with Rehabilitation therapy for Gait disturbance. At the time of the report, OXYGEN SATURATION DECREASED (oxygen level was low), GAIT DISTURBANCE (could not get up or walk) and MUSCULAR WEAKNESS (muscle weakness in her legs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood test: normal (normal) Normal. On 13-Mar-2021, Oxygen saturation: low (Low) Low. No concomitant medications were reported. The treatment information included oxygen for 2-3 days. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
89 2021-04-03 loss of consciousness, excessive bleeding That evening, I just became unconscious, fell to the floor, bled all over it and received several ma... Read more
That evening, I just became unconscious, fell to the floor, bled all over it and received several major contusions.
89 2021-04-07 hypertension Began with large baseball sized red area at site 24 hours after, then fatigue, flu like symptoms, Bl... Read more
Began with large baseball sized red area at site 24 hours after, then fatigue, flu like symptoms, Blood Pressure uncontrolled , then 3-7-21 squaded for tremor/seizure like episodes and high BP, Hyponatremia/Sodium low 135. Tremors/seizures continued, squaded on 3-14 for seizure/tremor episode, Hyponatremia Sodium 129, NS IV given. 3-17-21 Squaded again for seizure/tremor episode, admitted to hospital, Sodium 129. Calcium 8.2. Diagnosis r/o focal seizures/myoclonic episodes, Hyponatremia, r/o Moderna. Following up with Nephrology and Neurology currently. Still symptomatic.
89 2021-04-11 cardiac arrest Nausea ,shortness of breath during the day . Heart stopped 7:45 pm. Death declared at 12:45 am March... Read more
Nausea ,shortness of breath during the day . Heart stopped 7:45 pm. Death declared at 12:45 am March 09 2021.
89 2021-04-11 cerebral haemorrhage On 3/10/2021 around 2 pm reported more fatigue, low-grade fever, and weak; treated w/ Tylenol; 3/13/... Read more
On 3/10/2021 around 2 pm reported more fatigue, low-grade fever, and weak; treated w/ Tylenol; 3/13/2021 refused medications; 3/16/2021 became constipated; 3/20/2021 gait unsteady and reported feeling as though she'd fall; more fatigued; 3/20/2021 refused medications and slept excessively; 3/20/21 vomited in bed; 3/22/2021 restless and exit seeking; 3/25/2021 packed belongings and exhibited exit seeking; 3/26/2021 transported to hospital 5:15 am due to falling while attempting to pick up something off of the floor; 3/29/2021 hospital reported she had a brain bleed and had chosen hospice care at her daughter's home; resident passed away on 3/30/2021.
89 2021-04-11 deep vein blood clot profound Lethargy, difficulty ambulating and progression to DVT bilaterally(03/27/2021)
89 2021-04-11 hypertension, cerebrovascular accident Facility manager reported patient presenting with hypertension per the EMS when they were taking her... Read more
Facility manager reported patient presenting with hypertension per the EMS when they were taking her to the hospital. No reported symptoms prior to Friday. Retirement home was informed that patient had a stroke on Friday.
89 2021-04-11 loss of consciousness, fainting Approximately 4 hours after injection experienced dizzyness. Approximately 5 hours after injection... Read more
Approximately 4 hours after injection experienced dizzyness. Approximately 5 hours after injection, subject fainted and fell to the floor. Subject remained unconscious for ~ 17 hours (fainted at ~3pm and woke the next morning ~8am). No treatment, no medical care - patient did not contact her primary care doctor.
89 2021-04-12 atrial fibrillation Atrial fibrillation; This spontaneous case was reported by an other health care professional (subseq... Read more
Atrial fibrillation; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 21-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). On 23-Mar-2021, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment for the event included apixaban started on 24-Mar-2021. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
89 2021-04-12 cardio-respiratory arrest, chest pain came in with chest pain ,coded and died. Family believes it was because of COVID vaccine
89 2021-04-12 cerebrovascular accident, stroke Stroke with aphasia. Was in the hospital for shortness of breath, being evaluated. Woke up in the mo... Read more
Stroke with aphasia. Was in the hospital for shortness of breath, being evaluated. Woke up in the morning with acute onset of aphasia. Swallowing and motor strength good. Does have history of strokes in the past but didn't have residual deficits.
89 2021-04-13 deep vein blood clot Pt received her 1st Moderna covid 19 vaccination on 3/12/21. She developed sudden Left lower extremi... Read more
Pt received her 1st Moderna covid 19 vaccination on 3/12/21. She developed sudden Left lower extremity swelling on 3/17 which progressed to her hospitalization for a left lower extremity DVT on 4/6/21. she was placed on eliquiss and eventually discharged home.
89 2021-04-15 chest pain While working at my desk @ 10:00 April 1st, felt a severe jaw pain, radiated around to back of neck... Read more
While working at my desk @ 10:00 April 1st, felt a severe jaw pain, radiated around to back of neck, down back, around to chest. Became very SOB. Called 911. Ambulance took me to hospital ER then ICU. Developed exquisite headache. Given pain meds and slept. Dr saw me the next morning. I had not had a heart attack. They had no DX. I think I had a 23 day delayed reaction to shot #2.
89 2021-04-16 cerebrovascular accident Admitted on 3/11/2021 with acute stroke in the Right Thalmus
89 2021-04-17 cerebrovascular accident Stroke, loss of sight
89 2021-04-22 cerebrovascular accident First Day complaint of aching arms, light head ache. on the 19th second day she said she did not fee... Read more
First Day complaint of aching arms, light head ache. on the 19th second day she said she did not feel very well, tired, by the evening noticed she was a little disoriented, by 10pm she was in bed my sister checked on her as she got worst called ambulance and she had a stroke right before paramedics got there.
89 2021-05-03 oxygen saturation decreased, low blood oxigenation Pt w/hx of dementia brought to ED w/fevers and low oxygen saturation and worsening SOB and lethargic... Read more
Pt w/hx of dementia brought to ED w/fevers and low oxygen saturation and worsening SOB and lethargic. CXR showed chronic appearing interstitial prominence and left basilar opacity. Pt was found to be positive of COVID-19 infection. Had received both Moderna vaccines (1/19/21 & 2/16/21). Pt admitted for additional management for acute hypoxemic respiratory failure, COVID-19 pneumonia and treated with dexamethasone, combivent nebs, remdesivir, and azithromycin/ceftriaxone empirically for secondary bacterial pneumonia. Pt ultimately was discharged 3 days later to an assisted living facility where she resides oxygenating well and more alert.
89 2021-05-10 blood clot, pulmonary embolism, atrial fibrillation This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes th... Read more
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), PULMONARY EMBOLISM (blood clots in her lungs) and THROMBOSIS (blood clots everywhere) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIARRHOEA (diarrhea), BLOOD PRESSURE ABNORMAL (no blood pressure), VACCINATION SITE PAIN (arm still hurts from time to time) and FATIGUE (felt tired). On 03-Mar-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion hospitalization), PULMONARY EMBOLISM (blood clots in her lungs) (seriousness criterion hospitalization) and THROMBOSIS (blood clots everywhere) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PULMONARY EMBOLISM (blood clots in her lungs), THROMBOSIS (blood clots everywhere), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), BLOOD PRESSURE ABNORMAL (no blood pressure) and FATIGUE (felt tired) outcome was unknown and DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (arm still hurts from time to time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) haven't found anything. On an unknown date, Endoscopy: normal (normal) haven't found anything. Treatment medication included apixaban. Action taken with mRNA-1273 in response to the events was not Applicable. The patient had an endoscopy and CAT scan where they haven't found anything at when she was at the clinic. Consumer was vaccinated with first dose on 16JAN2021 (was not able to locate lot/expiration on vaccination card). She got her second dose on 17FEB2021 (was not able to locate lot/expiration on vaccination card) and she felt like she was getting the flu, felt tired and on 3MAR2021, she was rushed to the hospital because she had "no blood pressure" and presented atrial fibrillation and blood clots in her lungs and everywhere. Her arm still hurts from time to time and continues to have diarrhea. She states she is a fairly healthy person does not take any medications, only Centrum vitamins. Since then she has gone to the clinic, had an endoscopy and CAT scan where they haven't found anything. She is now on Eliquis. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-101609 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
89 2021-05-20 anaemia, haemoglobin decreased Patient was admitted for recent complaints of shortness of breath and back pain, patient was found t... Read more
Patient was admitted for recent complaints of shortness of breath and back pain, patient was found to be anemic with low hemoglobin. Patient was given a transfusion and admitted to the floor.
89 2021-05-24 palpitations, blood pressure increased Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated b... Read more
Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated blood pressures of "240 and 190/92"; "sick" ever since after first dose; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DILTIAZEM, CILOSTAZOL (CLAUDINE), MONTELUKAST and SITAGLIPTIN PHOSPHATE (JANUVIA). On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") (seriousness criterion medically significant), MALAISE ("sick" ever since after first dose), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92"), MALAISE ("sick" ever since after first dose), SLEEP DISORDER (can't sleep), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that she was likely to travel to the Emergency Room at the time of the call. Her second dose of the vaccine was scheduled to take place on 17May2021. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high
89 2021-05-25 atrial fibrillation Sustaining L2 and L3 fractures; Atrial fibrillation; Fall; Patient was not able to keep the appointm... Read more
Sustaining L2 and L3 fractures; Atrial fibrillation; Fall; Patient was not able to keep the appointment for the second dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LUMBAR VERTEBRAL FRACTURE (Sustaining L2 and L3 fractures), ATRIAL FIBRILLATION (Atrial fibrillation) and FALL (Fall) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pacemaker insertion (cardiac). Concomitant products included SOTALOL, AMLODIPINE, WARFARIN, ATORVASTATIN, CLOPIDOGREL, FERROUS SULFATE, CALCIUM CARBONATE (GAVISCON ACID BREAKTHROUGH FORMULA), ISOSORBIDE MONONITRATE, LOSARTAN, METFORMIN, NITROGLYCERIN, OMEPRAZOLE, TAMSULOSIN, VITAMIN E NOS and ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LUMBAR VERTEBRAL FRACTURE (Sustaining L2 and L3 fractures) (seriousness criteria hospitalization and medically significant), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization prolonged and medically significant), FALL (Fall) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Patient was not able to keep the appointment for the second dose). The patient was hospitalized for 18 days due to ATRIAL FIBRILLATION, FALL and LUMBAR VERTEBRAL FRACTURE. At the time of the report, LUMBAR VERTEBRAL FRACTURE (Sustaining L2 and L3 fractures), ATRIAL FIBRILLATION (Atrial fibrillation), FALL (Fall) and INCOMPLETE COURSE OF VACCINATION (Patient was not able to keep the appointment for the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were provided. SD narrative: A patient called on 18MAY2021 to report that she received the first dose of the Moderna COVID-19 vaccine (Lot #: 040A21A, Expiration Date: Unknown by Caller) in her "right upper arm" on 16MAR2021. The second dose was scheduled for 13APR2021. The patient was not able to keep the appointment for the second dose, as she has been under the care of a medical team after falling and sustaining L2 and L3 fractures. She was initially hospitalized for 18 days and developed atrial fibrillation during the hospitalization. She returned to the hospital one week after discharge and subsequently had a pacemaker placed. She would like to know if she can receive the second dose of the vaccine or if the first dose should be repeated due to the time that has passed since the first dose. Limited information regarding the events, including the circumstances that resulted in the fall and back injury, has been provided at this time and a causal relationship cannot be excluded for the fall, back injury and AF. The case This report also includes an event of incomplete course of vaccination. There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the events, including the circumstances that resulted in the fall and back injury, has been provided at this time and a causal relationship cannot be excluded for the fall, back injury and AF. The case This report also includes an event of incomplete course of vaccination. There were no AEs specifically associated with this medication error
89 2021-06-23 heart attack Death 3/23/2021 Cause of death listed on death certificate: Myocardial Infarction
89 2021-06-28 hypertension Death 5/29/2021 Causes of death listed on death certificate: 1. pneumonia 2. COVID 19 3. coronary... Read more
Death 5/29/2021 Causes of death listed on death certificate: 1. pneumonia 2. COVID 19 3. coronary artery disease, hypertensin, Non insulin dependant diabetes
89 2021-07-08 cerebral haemorrhage Onset occured 5-7 days post 2nd dose of vaccine. Developed intracranial hemorrhage / hemorrhagic bra... Read more
Onset occured 5-7 days post 2nd dose of vaccine. Developed intracranial hemorrhage / hemorrhagic brain bleed causing death.
89 2021-07-25 cerebrovascular accident 4 days after her second shot, she was sitting at the lunch table and she became unresponsive. She ... Read more
4 days after her second shot, she was sitting at the lunch table and she became unresponsive. She went into a coma and died 4 days later. Doctor said she had a stroke.