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