Moderna

Flu-like symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-01 headache Headache , Lightheaded
76 2021-01-03 chills Starting on Thursday, Dec. 31, patient began having shoulder and neck tightness. That night patient... Read more
Starting on Thursday, Dec. 31, patient began having shoulder and neck tightness. That night patient began having chills, and noticed redness at the vaccine sight and then the redness started streaking. Also complaints of itching at the vaccine sight. Started taking Tylenol for the two days following the vaccine, states feels like it is improving. Referred to PCP for evaluation. Has appt. Monday, January 4th
76 2021-01-04 body temperature increased Five days after shot I ran a temp of 99.8 degrees for four hours with aches in my neck and shoulder... Read more
Five days after shot I ran a temp of 99.8 degrees for four hours with aches in my neck and shoulders.
76 2021-01-05 fever Devoped a fever of 99.0 approximately 24 hours after the injection. Took a 600 mg Tylenol at my hom... Read more
Devoped a fever of 99.0 approximately 24 hours after the injection. Took a 600 mg Tylenol at my home.
76 2021-01-06 headache 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 2021-01-10 headache, malaise, body temperature increased 101 degree temperature, headache from day of injection which was a Saturday, Sunday and Monday, seve... Read more
101 degree temperature, headache from day of injection which was a Saturday, Sunday and Monday, severe body aches,. tender nodes in neck, felt very ill, slept 24 hours, no appetite, itching.. I have improved but still itching and have hedache
76 2021-01-10 fever, fatigue Very sore arm, low grade fever, fatigue, red rash at injection site and down the left arm to just ab... Read more
Very sore arm, low grade fever, fatigue, red rash at injection site and down the left arm to just above the elbow. Took a Tylenol for fever, lots of water and an anti-itch cream for the rash. No fever after 2 days, arm is still tender, but the rash and itching remains. The rash and itching did not occur until the third day after the injection.
76 2021-01-11 fatigue Lightheaded, woozy, tired, strange
76 2021-01-11 lethargy Client's care giver stated she was not as talkative following vaccination, was dizzy and lethargic (... Read more
Client's care giver stated she was not as talkative following vaccination, was dizzy and lethargic (Client was in a wheelchair in her van in the 15 minute waiting area from the drive thru event) VSS and not recorded. No LOC for client. Due to extensive list of allergies, client was transported by EMS to ER.
76 2021-01-13 paranasal sinus discomfort, nasal congestion 12AM awoke with R arm in pain, nose congestion and pressure in sinus, occasional urge to vomit, naus... Read more
12AM awoke with R arm in pain, nose congestion and pressure in sinus, occasional urge to vomit, nausea
76 2021-01-14 chills She reported that she began experiencing chills, muscle aches and respiratory symptoms last night. ... Read more
She reported that she began experiencing chills, muscle aches and respiratory symptoms last night. She went to see her physician today and was given a Covid test. Her results will probably not be in until next week
76 2021-01-16 chills, fever Fever TMax 102 F, chills, myalgia, R arm intense pain, but no acute inflammation in area of injecti... Read more
Fever TMax 102 F, chills, myalgia, R arm intense pain, but no acute inflammation in area of injection
76 2021-01-16 fatigue Felt fatigued and weak while taking routine daily walk (cold, clear, sunny weather). Had to stop on... Read more
Felt fatigued and weak while taking routine daily walk (cold, clear, sunny weather). Had to stop once to rest (almost never happens). Then nearing end of 2-mile walk, knees buckled and fell down on sidewalk. (Did not trip). Hurt arm, scraped face. Went home, put ice on face, laid down, rested.
76 2021-01-17 headache, fatigue, fever, chills Moderna COVID-19 Vaccine EUA administered at 10:59 am on 1/16/21. Felt ok for the remainder of the d... Read more
Moderna COVID-19 Vaccine EUA administered at 10:59 am on 1/16/21. Felt ok for the remainder of the day. Awoke at 1:25 am ith severe pain in left arm injection site, headache, nausea, fatigue, muscle and joint pain throughout body, chills and low grade fever. these symptoms persisted until mid-afternoon on 1/17/21 and gradually subsided i took ibruprofen and drank water. Finally ate a slice of toast at 5 pm and noticed the pain at injection site was improving. 12 hours later, feeling ok but still fatigued.
76 2021-01-17 fever severe pain in neck and shoulder area, slight fever, swollen glands, affected vision for over five d... Read more
severe pain in neck and shoulder area, slight fever, swollen glands, affected vision for over five days
76 2021-01-18 body temperature increased, fatigue temp 101.4 axillary , nausea ,without emesis HR 108 . weakness fatigue
76 2021-01-18 body temperature increased, fatigue temp 101.4 AX nausea without emesis HR108 fatigue weakness
76 2021-01-18 chills, headache, fatigue, fever Fever, sore muscles, sore joints, headache, fatique, nausea & chills. I had a positive Covid 19 te... Read more
Fever, sore muscles, sore joints, headache, fatique, nausea & chills. I had a positive Covid 19 test on September 9th. The symptoms I've had from the shot are pretty much the same as when I was sick. I was fortunate not to have any respiratory symptoms either time as confirmed by my oximeter. I had two Antibody tests. One on Nov. 23rd, which was positive for both IgG and IgM. I had my second anti-body test on 1/17/2021, the day of my injection which was positive for IgG and negative for IgM. I have not contacted my doctor concerning this and I am taking Advil for the fever and ached and pains. Today i feel better than yesterday.
76 2021-01-19 chills, headache Extreme pain in arm (not just sore) and body aches, as if run over by a truck, chills (could not get... Read more
Extreme pain in arm (not just sore) and body aches, as if run over by a truck, chills (could not get warm), worst headache I can ever remember having, felt like ice picks thru my head, sensitive to light and noise, lasted from 2:00am until approx. 9:00pm on 1/19.
76 2021-01-19 chills, malaise, fatigue chills, diarrhea, fatigue and not feeling well
76 2021-01-19 dehydration 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 2021-01-19 fatigue, fever, chills Patient states that she started experiencing symptoms on 1/16/21 morning. Patient notes that she had... Read more
Patient states that she started experiencing symptoms on 1/16/21 morning. Patient notes that she had a fever of 103.9. She notes weakness and wasn't able to get out of bed. Fever, weakness, chills, fatigue, unresponsiveness. Patient states at one point she became unresponsive per her daughter. EMS was called to patient's home and patient appeared not alert and wasn't able to answer EMS questions. Patient states that her fever has since broke and denies any current fevers. Patient states that she continues to feel very weak. Patient states that she has been resting in bed and increased her water intake. Patient did test positive for COVID on 10/20/20. Patient inquiring if she should receive second COVID vaccine due to symptoms she experienced with first vaccine.
76 2021-01-19 fatigue On 1/17/21 staff reported that client had episodes of diarrhea x2. Client had extreme fatigue and w... Read more
On 1/17/21 staff reported that client had episodes of diarrhea x2. Client had extreme fatigue and was afebrile
76 2021-01-19 fatigue severe fatigue, diarrhea,
76 2021-01-19 fatigue Day 1-3: Fatigue, sore arm Day 4-6: None Day 7-9: Injection site red, swollen and hot, fatigue, vert... Read more
Day 1-3: Fatigue, sore arm Day 4-6: None Day 7-9: Injection site red, swollen and hot, fatigue, vertigo, dizziness, weakness, facial swelling---experiencing now.
76 2021-01-19 fatigue Client had diarrhea x 2 on 1/17/21. Client had extreme fatigue but was afebrile
76 2021-01-19 fatigue Day 1-3: Sore arm, fatigue Day 4-6: Normal Day 7-present: Injection site is red, swollen and hot, fa... Read more
Day 1-3: Sore arm, fatigue Day 4-6: Normal Day 7-present: Injection site is red, swollen and hot, fatigue, dizziness, vertigo, weakness
76 2021-01-19 headache, fever, fatigue Fever, body aches, fatigue, headaches, dizziness, Naseaua, swollen hard injection site on arm
76 2021-01-19 headache, fever On January 18th at 1:00 am, I had a fever, headache, and horrible body aches in every joint and part... Read more
On January 18th at 1:00 am, I had a fever, headache, and horrible body aches in every joint and part of my body. I had Covid in June 2020, and 10 days prior to the test on the 17th, I was tested for antibodies, and I still had them 6 months later. Presently, my fever has subsided, headache persist, and my aches are not as bad.
76 2021-01-19 fever Nausea and vomiting on 1/16/21 early morning and then noted at 9PM with hives to back and neck area... Read more
Nausea and vomiting on 1/16/21 early morning and then noted at 9PM with hives to back and neck area-has been afebrile, 1/17/21 temp=99.7 continues with nausea and hives, 1/18/21 Hives continue.
76 2021-01-19 sleepiness weak/sleepy
76 2021-01-20 fatigue Stomach pain, nausea, and fatigue
76 2021-01-20 headache, chills, fatigue mild headache for 36 hours; exhaustion for 36 hours; sensitive to cold,unable to get warm for 36 hou... Read more
mild headache for 36 hours; exhaustion for 36 hours; sensitive to cold,unable to get warm for 36 hours, shivering a lot; vomited once after 22 hours after the injection. No fever.
76 2021-01-21 chills, influenza like illness Left arm swollen, warm, painful, and red from injection site in the left deltoid muscle to above the... Read more
Left arm swollen, warm, painful, and red from injection site in the left deltoid muscle to above the elbow. Client experienced chills and flu like symptoms. 9 days from vaccination and symptoms are starting to dissipate.
76 2021-01-21 fatigue Acid indigestion, just tired. One incident of being a little short of breath. Checked my oximeter ... Read more
Acid indigestion, just tired. One incident of being a little short of breath. Checked my oximeter and my blood oxygen level was good and heart rate was good. Oxygen 95 and heart rate 70.
76 2021-01-21 headache After 5 min, patient experienced sharp left deltoid area to left neck with ?fuzzy headache?
76 2021-01-21 sweating 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 fatigue COVID-19 Vaccine EUA Ten days after the injection of Covid 19 injection my arm swelled up, and becam... Read more
COVID-19 Vaccine EUA Ten days after the injection of Covid 19 injection my arm swelled up, and became very red and itchy at the site of the injection. It just came up out of nowhere it seems as I had no reaction at all to the vaccine during the prior 10 days since the vaccination. This continued for two days. The first day after it happened I felt tired and weak in the morning. I got into work here at the house and the weakness went away. I treated the itchy situation with Clobetasol Propionate Cream which I had here and was prescribed by my dermatologist for poison ivy. That took away the itchy situation that was very annoying. Two days into it the swelling began to go down. Today is the 4th day since the problem occurred and there is no swelling and only a slight redness. I am assuming that I can take injection #2 on February 9 as scheduled.
76 2021-01-22 headache Stabbing top back, right side, head pain ( Sat), redness and blisters on right side of face (Wed), r... Read more
Stabbing top back, right side, head pain ( Sat), redness and blisters on right side of face (Wed), right eye pain and blisters (Fri).
76 2021-01-22 headache 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 headache, chills 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 2021-01-23 headache, fever, fatigue Fatigue; Fever (101} muscle leg aches, headache, loss of appetite
76 2021-01-24 body temperature increased, chills, fatigue Day 2 - Sore arm, fatigue Day 6 - fatigue Day 7 - extreme fatigue Day 8 - 100.2 temp, aches, chills,... Read more
Day 2 - Sore arm, fatigue Day 6 - fatigue Day 7 - extreme fatigue Day 8 - 100.2 temp, aches, chills, stomach ache, mild diarrhea Day 9 - fatigue, mild diarrhea, but no temp, aches, or chills
76 2021-01-24 chills About 16 hours after injection I was struck with chills so bad that I could feel my bones hurt.. p... Read more
About 16 hours after injection I was struck with chills so bad that I could feel my bones hurt.. piled on the blankets put leggings on sweatshirt and went to bed under four heavy blankets with a heating bag. Lasted about three hours!
76 2021-01-24 chills Chills, Body aches for 24 hours
76 2021-01-24 fatigue, fever, pneumonia, chills, headache VACCINE received on Friday 1/15/2021 afternoon; Monday evening 1/18/2021 felt slight chills; early t... Read more
VACCINE received on Friday 1/15/2021 afternoon; Monday evening 1/18/2021 felt slight chills; early to bed. Tuesday AM awoke with severe 'bed-rocking' chills, nausea and fever 100-101 degrees. recommended I go to Hospital ER. At ER, temperature increased to 102 degrees. Covid test was negative, but cost X-ray showed reasons to suspect pneumonia. No one suggested I was just suffering acute reaction to vaccine. Returned home w/ prescription for doxycycline hyclate and request that I return to the ER the next day if I continued to feel ill. The next morning, 1/19/21, I again awoke with intense, somewhat frightening chills, vomiting and a mild fever. As instructed I returned to the ER. Assuming the COVID Test may have been a false negative, a second one was given; it too turned out to be negative, but I remained at the ER and then admitted to Hospital to remain under observation. Im the hospital the chills, nausea and fever came to an end, but acute headache and utter fatigue lasted until I was released on Jan 22. My discharge papers indicated no further signs of pneumonia or any other infection; my attending doctor, concluded that my experience was an unusually strong (and delayed) reaction to the 1st dose of the Moderna Vaccine.
76 2021-01-24 sleepiness, headache, fatigue Evening: around 8:00 p.m. headache, arm sore, body aches, sleepy. I slept all night Saturday nigh... Read more
Evening: around 8:00 p.m. headache, arm sore, body aches, sleepy. I slept all night Saturday night, all day Sunday except for a few minutes three or four times, slept all night Sunday night. Monday I?m still tired and sleepy, now I?m nauseous..
76 2021-01-25 fatigue, fever, chills Low grade temp; chills; fatigue. No treatment. Other than tired, was better the next day.
76 2021-01-25 malaise, fatigue One week after receiving vaccine site became itchy with small bumps. Site is growing increasingly re... Read more
One week after receiving vaccine site became itchy with small bumps. Site is growing increasingly red and swollen and itchy. General feeling of tiredness, not well.
76 2021-01-26 sweating 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 influenza like illness, lethargy, sleepiness, fatigue Very lethargic leading to flu type symptoms including achy muscles and joints, vomiting and very sle... Read more
Very lethargic leading to flu type symptoms including achy muscles and joints, vomiting and very sleepy and tired
76 2021-01-26 fever, pneumonia 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 fever 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 2021-01-26 sleepiness, sinus headache, fatigue When I woke up to use the bathroom I was ataxic and had nystagmus. A while later I became nauseous. ... Read more
When I woke up to use the bathroom I was ataxic and had nystagmus. A while later I became nauseous. I took a baby aspirin because I was afraid I was having a stroke. This lasted about 5 hours. Then I developed a head ache just behind my nose. The headache subsided in the mid afternoon, but I was wiped out and slept most of the day. Today (the next morning) I feel fine, just a little tired.
76 2021-01-27 headache, chills, fever Terrible chills, Terrible headache and a fever. started 12 hours after the shot and continued for 4... Read more
Terrible chills, Terrible headache and a fever. started 12 hours after the shot and continued for 48 hours. was noticibly better after 24 hours but lasted for about 48 hours.
76 2021-01-27 headache, fatigue Got vaccine on Wed, fatigue started on Sat at first then headaches off and on and by Sun had muscle ... Read more
Got vaccine on Wed, fatigue started on Sat at first then headaches off and on and by Sun had muscle aches that got progressively worse. Mon I worked for 4 hours at desk job and by the end my ribs and back hurt so bad I caught myself holding my breath when breathing. Went home and laid sown the rest of day. Tues slept till 4:30 in the afternoon and then laid down rest of day. Slept till 11am on Wed and rested rest of the day. Headache and muscle pain not as bad. Called doctors office Wed and doctor wasn't in. Nurse will talk to him tomorrow and call if he advises anything mofre then what she had said which was rest. drink plenty of fluids and take tylenol. She advised to sign up for v-safe to VAERS.
76 2021-01-28 chills, fatigue Chills, shortness of breath (mild) joint and muscle pain, fatigue Essentially similar symptoms to wh... Read more
Chills, shortness of breath (mild) joint and muscle pain, fatigue Essentially similar symptoms to when I had covid, towards the end of my illness. So like immune system symptoms. I had covid 3/15/20-4/30/20. I?m a long COVID sufferer, I still have resp pbs, arrhythmia, fatigue. I would like to get the second shot but am concerned about my over reactive immune response
76 2021-01-28 fever, headache, chills Chills, Body Aches , Fever, Headache, Nausea, Slept for 36 Hours, then felt fine.
76 2021-01-28 fever Muscle aches, fever 101 in past 18 hours.
76 2021-01-28 sleepiness Pt got drowsy and her eyes were droopy. Family members stated her blood sugar gets low sometimes an... Read more
Pt got drowsy and her eyes were droopy. Family members stated her blood sugar gets low sometimes and we gave her a glucose tablet and water. Pt was feeling much better and talking within ten minutes. We stayed with the patient and monitored her continuously until her observation time was complete and when she left with family she was alert, oriented, and said she felt much better. Instructed patient and her family to give us a call if they had any further questions or concerns and to go to the ER if any serious reaction symptoms occurred.
76 2021-01-29 chills, fatigue Moderna COVID-19 Vaccine EUA Chills and exhaustion started 12 hours after innoculation and continue... Read more
Moderna COVID-19 Vaccine EUA Chills and exhaustion started 12 hours after innoculation and continued for 12 to 18 hours.
76 2021-01-29 fatigue, cough, productive cough 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 fatigue exhausted and a temp of 99. My normal is 97.4. I laid down and slept until morning and felt fine.
76 2021-01-29 head discomfort, chills Very high heart rate for several hours, chills, pressure on forehead
76 2021-01-29 sweating Patient With numbness and tingling of her lips, tongue, palate. Increased BP Clammy sweating
76 2021-01-29 fever The patient experienced a fever of 100.8 F about 12 hours after administration
76 2021-01-30 headache, sleepiness I slept for more than24 hours, getting up only 3 times to use the restroom and take Tylenal. I had h... Read more
I slept for more than24 hours, getting up only 3 times to use the restroom and take Tylenal. I had headaches, body aches, dizziness and nausea. I will call my doctor tomorrow. I did not die.
76 2021-01-31 fatigue, headache, chills, fever Headache, chills, fever, muscle pain, joint pain, nausea, vomiting, diarrhea, extreme fatigue, brain... Read more
Headache, chills, fever, muscle pain, joint pain, nausea, vomiting, diarrhea, extreme fatigue, brain fog
76 2021-01-31 head discomfort, influenza like illness, nasopharyngitis My arm wasn't sore right away but I think I laid on it and the next morning it was sore. It felt lik... Read more
My arm wasn't sore right away but I think I laid on it and the next morning it was sore. It felt like a bee sting I took some medicine and it went away. On the 27th I had bad gas. I did try a new cereal and thought it was cereal. On the 28th I still gas and upset stomach like flu like symptoms and felt light headed but not bad. On the 29th still an upset stomach and had diarrhea, I was still light headed and really shaky. I was really weak. I was shaking a lot at arms (hands) and legs were both shaking and made it hard to walk. On the 30th I still really light headed and my legs and hands were still shaky, still having difficulty walking, still had an upset stomach and still felt weak. On the 31st my stomach was a lot better, I was still shaky and light headed, and I had a weak feeling. My head felt like when you feel like you have a head cold (pressure in my head). Today my stomach is better, I am still lightheaded and still shaky but not as bad. I still feel pressure in my head, but no runny nose or any other cold symptoms. These were symptoms I had in March when I was sick for 3 weeks. I was negative for COVID but didn't get back to my normal self until the June. Doctor was a private practice and recently closed so I do not see my new doctor till the 24th.
76 2021-01-31 fever, chills Moderna COVID- 19 Vaccine EUA: one day after receiving vaccination patient presented to the emergenc... Read more
Moderna COVID- 19 Vaccine EUA: one day after receiving vaccination patient presented to the emergency department with epigastric pain for three hours. Patient denies sweating, shortness of breath, nausea, vomiting, and diarrhea. Stated that soon after receiving vaccination experienced fever, chills, and myalgias. Initial vitals within normal ranges except for blood pressure of 158/77 mmHg. Patient administered antacids and lidocaine with symptom improvement. Repeat vital signs within normal ranges and patient discharged to home stable.
76 2021-01-31 fever Vomiting the night of injection Fever following morning after
76 2021-02-01 chills, fatigue, fever Patient developed chills about 9pm the night of the vaccine. She ran 101 temperature, and ached all... Read more
Patient developed chills about 9pm the night of the vaccine. She ran 101 temperature, and ached all night. She took some Tylenol when the chills started and again in the morning. She said she ran fever till about noon, and then later took some Ibuprofen. She is feeling better, but just fatigued.
76 2021-02-01 headache Patient had vaccine given at her senior living apartment by staff. She reported to her PCP today t... Read more
Patient had vaccine given at her senior living apartment by staff. She reported to her PCP today that she has upper back and neck pain, left arm pain, and headache. This started one week after the vaccination. She has had to use biofreeze, ice packs, and Tylenol to treat the discomfort. She did state that it is slowly letting up.
76 2021-02-01 lethargy Day 1 to Day 6: painful Left arm Day 3 to current Day 7: area red, hot, swollen and intense itchi... Read more
Day 1 to Day 6: painful Left arm Day 3 to current Day 7: area red, hot, swollen and intense itching, w/redness increasing in diameter each day. Now the size of a baseball, and waking me frequently during the night w/ intense itching. Lethargy, nausea on Day 7
76 2021-02-01 fever Body aches, severe arm soreness at sight of injection, 101 Fever, nausea.
76 2021-02-01 upper-airway cough syndrome, fatigue, cough Exactly one week after the vaccine, I awoke to feel the injection site very itchy and hot. When I l... Read more
Exactly one week after the vaccine, I awoke to feel the injection site very itchy and hot. When I looked, it was swollen around the injection area...previously no irritation at all. At the same time, I felt like I was catching a head cold: lots of postnasal drip and some coughing and general tiredness. Injection site symptoms lasted about 24 hours. Cold like symptoms lasted 3 days.
76 2021-02-02 chills, fever Vomiting, chills, fever
76 2021-02-02 chills Moderna COVID-19 Vaccine EUA Severe rash, welts, burning, chills; occurred 1 week after injection. V... Read more
Moderna COVID-19 Vaccine EUA Severe rash, welts, burning, chills; occurred 1 week after injection. Visited Clinic; placed on Prednisone, Hydrocortisone, & Benadryl. Next day rash spreading & worse, again visited clinic & prescribed Famotidine 20 mg; Zyrtec - 10 mg; Hydrocortisone
76 2021-02-02 fatigue Starting on 1/31/21 patient was very fatigued and continued to worsen until today (2/3/21) where the... Read more
Starting on 1/31/21 patient was very fatigued and continued to worsen until today (2/3/21) where the patient's son called 911. The patient was in a complete haze and very foggy. The pt would not open her eyes or respond when her son would ask her any questions. EMS arrived and did not take her to hospital. Stayed with her in the home for awhile and waited for recovery. EMS had her eating and drinking until she would open her eyes. They advised son to continue to give her liquids to continue recovery.
76 2021-02-03 chills, fatigue 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 headache Extreme pain and bruising in the left arm which lasted for 4 days, decreasing pain each day. I co... Read more
Extreme pain and bruising in the left arm which lasted for 4 days, decreasing pain each day. I couldn't sleep lying on my left side. Very restless the first night with little sleep. Small bruise is still showing 7 days later. Mild headache, nausea, and dizziness for 4 days.
76 2021-02-03 fever Fever, chills., muscle achyness in my back at base of lungs (hurts when I walk) area, knee joint pai... Read more
Fever, chills., muscle achyness in my back at base of lungs (hurts when I walk) area, knee joint pain
76 2021-02-04 headache Headache from days 2 - 6 Injection site inflamed and itchy, days 8-10
76 2021-02-04 headache Chronic and debilitating head ache for 3 days (still continuing). Taking ibprofin (400 mg) every 4 h... Read more
Chronic and debilitating head ache for 3 days (still continuing). Taking ibprofin (400 mg) every 4 hours.
76 2021-02-04 lethargy, headache 1. Very sore arm diminishing over 36 hours 2. diarrhea around 36 hours after 3. mildly leth... Read more
1. Very sore arm diminishing over 36 hours 2. diarrhea around 36 hours after 3. mildly lethargic for about 4-5 days 4. Mild headache for about a week. 5. after one week a large red, itchy, swollen area appeared at the injection sight (approx. 2" x 4") reduced over 12 hours to small area swollen and red at injection sight and that still exists 2 weeks later.
76 2021-02-04 malaise, headache, chills sore are, night chills, nausea, headache, muscle aches, feeling unwell for one day
76 2021-02-05 body temperature increased, fatigue SWELLING OF INJECTION SITE (~6 INCHES DIAMETER) & TEMPERATURE 106F SORENESS (MODERATE) MUSCLE ACHES ... Read more
SWELLING OF INJECTION SITE (~6 INCHES DIAMETER) & TEMPERATURE 106F SORENESS (MODERATE) MUSCLE ACHES THROUGHOUT BODY & JOINT ACHES FATIGUE FEVER (99 - 100.6F (BEGINNING ON DAY 2 AFTER SHOT @ 5:00 A.M.).
76 2021-02-05 chills, influenza like illness About 8 hours after vaccine began to feel flu like symptoms. By next am had chills, sore arm, genera... Read more
About 8 hours after vaccine began to feel flu like symptoms. By next am had chills, sore arm, generalized aches and pains, fever 101.4 and generally felt "awful".
76 2021-02-06 chills, nasopharyngitis, fever tested positive for Covid 19 on 1/17/2021 - fever, chills, slight cold - no problems after 5 days, r... Read more
tested positive for Covid 19 on 1/17/2021 - fever, chills, slight cold - no problems after 5 days, returned to work after 10 days quarantine with no symptoms. Hospital decline to give me second dose on 2/3/2021 as scheduled, stating I would have to start over in 90 days.
76 2021-02-06 fatigue Symptoms of Covid - all over aching and tired. Night sweats
76 2021-02-07 fatigue, fever fever 104 extreme fatigue loss of muscle tone: could not move
76 2021-02-07 headache, fatigue Shaking chills, body & head aches. extreme fatigue (initially couldn't get out of bed) -14 hours aft... Read more
Shaking chills, body & head aches. extreme fatigue (initially couldn't get out of bed) -14 hours after onset, much better-had slept
76 2021-02-07 headache Shingles, painful rash with blisters, burning sensation, some nausea pain on bones, head,
76 2021-02-07 headache Moderna COVID-19 Vaccine EUA 3 am - Was awakened with severe headache, which passed after several mi... Read more
Moderna COVID-19 Vaccine EUA 3 am - Was awakened with severe headache, which passed after several minutes of being up out of bed. No medication required. For 2 days had tolerable discomfort in left upper arm, especially when raised arm outward and upward.
76 2021-02-07 headache Woke up and started vomiting around 11:30 that night(2/5.) This lasted approximately 1-2 hours. Wa... Read more
Woke up and started vomiting around 11:30 that night(2/5.) This lasted approximately 1-2 hours. Was unable to eat anything until late afternoon on Sat. the 6th. Had a bad headache throughout and bad soreness at the injection site. Still have headache (approx. 5pm on Mon. 2/8) but soreness at injection site has almost disappeared. I do not have a primary physician so have not called anyone. Am now taking Advil for headache which helps but it returns if I stop.
76 2021-02-07 throat irritation Initially, my left arm had a red spot for 10-11 days. Then clear. 14 days later I went swimming in a... Read more
Initially, my left arm had a red spot for 10-11 days. Then clear. 14 days later I went swimming in a lane I had reserved at my club. Lanes are reserved for 45 minute swims. This was my second swim after my first Covid vaccine. About 15 minutes into this second swim, the outside of my throat began stinging and itching. Soon my chest was stinging and itching. A friend was swimming in the adjoining lane. I told her I was going to cut short my swim because of stinging. She reported that my throat and chest were very red. About 6 minutes later I was home, took an OTC anti-inflammatory (Zyrtec), took a shower. I believe it was vaccine belated because I also had a large, thin ring around the injection site. Over the course of the next hour the stinging, itching, redness subsided. I told my Dr. She told the allergy dept. They suggested I take a Zyrtec prior to my next swim, which I did. No reaction. I did NOT have a similar reaction the first time I swam after the injection. It was exactly 2 weeks later that I had the rash and stinging.
76 2021-02-08 headache, throat pain, fever, chills Fever up to 101 degrees 4 hr after the injection followed by chills and a headache, followed the ne... Read more
Fever up to 101 degrees 4 hr after the injection followed by chills and a headache, followed the next day by a sore throat and then by 3rd day by swelling and pain of left side of the face
76 2021-02-08 lethargy lethargic, no appetite, memory loss
76 2021-02-09 headache Red rash at injection site approximately 3-4 inches circle-fading for 5 days. On and off itch-5 day... Read more
Red rash at injection site approximately 3-4 inches circle-fading for 5 days. On and off itch-5 days. On and off slight dizziness-5 days. Headache-first evening of rash.
76 2021-02-09 headache Swelling the size of an apple which lasted for 11 days Strong joint pain left wrist and both knees ... Read more
Swelling the size of an apple which lasted for 11 days Strong joint pain left wrist and both knees still present 3 weeks after the injection Throbbing pain in all past scars from surgeries including my skull (40 years ago) abdominal sutures ( 6 years ago ) and right thigh ( 4years ago). The pain started within hours after the injection in scars which never hurt once they healed after the surgeries but now the pain is hard to bear. The strangest pain is the site of vein ablation in the right thigh where the tissue looked normal before but now it looks hollow and throbbing.
76 2021-02-10 body temperature increased Patient woke up this morning after a restless night and pain in the arm. She was nauseous more or le... Read more
Patient woke up this morning after a restless night and pain in the arm. She was nauseous more or less the whole day and now, 9pm on 2/11, her temperature is 101.4. She is taking tylenol regularly.
76 2021-02-10 chills Approximately 9:00 PM, experienced severe chills, after having zero side effects all day. She went ... Read more
Approximately 9:00 PM, experienced severe chills, after having zero side effects all day. She went to bed, and could not get warm. She was unable to use body muscles, could not stand without help, and was conscious, but was unaware of her surroundings. She started regaining muscle control about 12:30 AM, but still no awareness of things around her. Next morning, she was fine, with no remaining side effects. It should be noted that she had a small glass of red wine about 30 minutes before experiencing chills.
76 2021-02-10 fatigue, fever, chills Chills, achy bones/ joints, fatigue, 100 F fever,
76 2021-02-10 fatigue The next day after I was so weak and fatigued I couldnt get out of bed. I was literally stayed in b... Read more
The next day after I was so weak and fatigued I couldnt get out of bed. I was literally stayed in bed for 36hr because I was so weak and tired. My arm swole up just as bad as from the previous arm did from the 1st vaccination but this time when healing it was like red and pink streaks were up and down my arm.
76 2021-02-10 headache Diarrhea, headache, nausea, vomiting
76 2021-02-10 malaise Emergency Medical Technician was on-site during clinic performing medical observation of vaccine rec... Read more
Emergency Medical Technician was on-site during clinic performing medical observation of vaccine recipients. Patient complained of feeling light-headed and general uneasiness. BP taken by EMT was 170/90 and pulse 72. Patient was aware and able to walk on her own. Patient walked to her vehicle, assisted by EMT, but she returned to the building because she still wasn't feeling well. EMT contacted emergency services for transport of the patient to Hospital ED.
76 2021-02-10 fever, fatigue Later on after getting the shot I noticed that my arm was starting to feel sore, and I got real tire... Read more
Later on after getting the shot I noticed that my arm was starting to feel sore, and I got real tired so I went to bed at around 11, and I woke up a few times because I couldn't get comfortable on that sore arm. When i woke up this morning I just felt yucky and I took my temperature and I was running a fever, 101.4
76 2021-02-10 fever When I woke up the next morning my arm was super red and itchy, throughout the day it got swoller, r... Read more
When I woke up the next morning my arm was super red and itchy, throughout the day it got swoller, redder and developed a fever. About 12n my daughter took the temp of my arm and it was 102 so we made ice packs to help with the pain and swelling. Later she went an bought Cortisone and used the ice packs and Cortisone for about 3 or 4 days when the arm finally begin to get better. My arm was so painful it was almost unbareable to touch.
76 2021-02-10 fever Patient reported symptoms started on 2/11/21 with low grade fever, "fuzzy head", sore arm and body a... Read more
Patient reported symptoms started on 2/11/21 with low grade fever, "fuzzy head", sore arm and body aches. Patient will take tylenol or ibuprofen as needed.
76 2021-02-11 chills, fever chills,fever.glands in underarm swollen for a day
76 2021-02-11 cough 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 fatigue 7 days out from first vaccine I had extreme pain in my neck, shoulders and upper back. Could not tu... Read more
7 days out from first vaccine I had extreme pain in my neck, shoulders and upper back. Could not turn my head left or right because the 6 Scalene Muscles in the neck were so tight. The pain also went up the right side of my face & skull affecting my TMJ and eating. The Scalene Muscles are on the side and front of a person's neck so I looked on the web as to how to release them. I gently used my knuckles, fingers and a tennis ball for 4 days on these 6 muscles while someone used a large 2 ball massager on my spine from my bra line and up my neck, and I laid on a heating pad but the stiffness and pain remained. Pain last 2 weeks, first week the worst. Extreme fatigue for a week . I believe I might have some arthritis in my neck and I frequently have minor aches and pain in my upper back, shoulders, & neck. So this area is venerable so maybe that's why it happened. I hope my 2nd shot won't be worse.
76 2021-02-12 headache, chills, fever Fever, chills, headache,
76 2021-02-12 headache Patient stated she felt a little "woozy" for a few seconds but stated the feeling had subsided by th... Read more
Patient stated she felt a little "woozy" for a few seconds but stated the feeling had subsided by the time of staff arrival. Patient stated she only had a headache. Patient advised to call PCP, 911, or go to the nearest emergency room if she has any further symptoms.
76 2021-02-12 fever, fatigue slight fever (gone by next day) fatigue (lasted two days)
76 2021-02-13 body temperature increased, chills -swelling (5" x 3") red, sore for 7 days - chills and temperature 2/2/2021 starting at 4:00 p.m. and... Read more
-swelling (5" x 3") red, sore for 7 days - chills and temperature 2/2/2021 starting at 4:00 p.m. and lasting approximately 12 hrs. Temperature 101.2 reduced with Ibuprofen
76 2021-02-13 headache, fever, fatigue Mild fever, fatigue, mild headache, severe pain at injection site, muscle pain.
76 2021-02-13 sweating, chills, fatigue, headache approx 22 hours: Extreme arm pain; acute headache; chills; sweats; fatigue; slept almost entire time... Read more
approx 22 hours: Extreme arm pain; acute headache; chills; sweats; fatigue; slept almost entire time, then dissipated except for extreme sore arm.
76 2021-02-13 malaise, headache Sick Large red hard spot at injection sight Pain in neck and headache Repeat of large hard red... Read more
Sick Large red hard spot at injection sight Pain in neck and headache Repeat of large hard red spot a weed later
76 2021-02-14 chills, headache COVID-19 Arm Large red swelling at site of injection on Feb 9 Headache Chills Severe Vertigo
76 2021-02-14 chills, fever Extreme chills, shakes, aches, fever sore arm
76 2021-02-14 fatigue, fever, lethargy, body temperature increased 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 2021-02-14 fever, chills, fatigue, sweating less than 24 hours after shot was given, started to feel "crummy" and got worse as the day progresse... Read more
less than 24 hours after shot was given, started to feel "crummy" and got worse as the day progressed. Right arm got very sore, to the point of not being able to move it for a day; fever of 101.2, chills, sweats, stayed in bed most of Tuesday (the day after the shot was given), and then symptoms subsided Wednesday, but was weak and fatigued enough to stay in bed all day. Thursday, tried a little physical activity, and after 30 minutes playing croquet, had to stop and sit down. Went hon=me and napped again. Friday, napped most of day, as on Saturday, and yesterday, Sunday. Today is one week after the shot and I'm still feeling weak - not my normal self.
76 2021-02-14 fever Date and time of vaccination: (list both if they received both shots): 1-15-21 4:15PM MODERNA LOT # ... Read more
Date and time of vaccination: (list both if they received both shots): 1-15-21 4:15PM MODERNA LOT # 012L20A, 2-12-21 4:15PM MODERNA LOT # 010M20A. Fever 104F, took one Tylenol.
76 2021-02-15 chills, fatigue Chills, extreme fatigue, nausea, stomach pains - 48 hours; Cramps and lack of appetite 10 days
76 2021-02-15 fatigue Initially was fine but a few hours later arm hurt. Was unable to move arm the next day and felt tire... Read more
Initially was fine but a few hours later arm hurt. Was unable to move arm the next day and felt tired but on day two, felt so much better. Noticed that now her arm w as itchy and had a small round circle. Notice that the red circle was getting bigger and felt hot.
76 2021-02-15 headache, fatigue, chills headache, chills, body aches. tiredmess
76 2021-02-15 headache, fatigue headache, nausea, fatigue, muscle soreness, itching for 2 days
76 2021-02-15 headache Has a migraine earlier in the day with a scintillating scotoma. Friday, Sunday, Monday during the da... Read more
Has a migraine earlier in the day with a scintillating scotoma. Friday, Sunday, Monday during the day I had similar events twice each day. The scotoma subsided and I was left with a headache.
76 2021-02-15 malaise, headache, lethargy, fatigue 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 2021-02-15 fever, chills, headache Fever (max 102.7), chills, headache, sore arm for 36 hours.
76 2021-02-15 fever, chills Chills and fever (max 100.9), pain at injection site about 18 hours duration, took Tylenol 500 mg x ... Read more
Chills and fever (max 100.9), pain at injection site about 18 hours duration, took Tylenol 500 mg x 2 hours apart
76 2021-02-15 fever, fatigue pt stated her left arm was sore and warm to the touch after getting the vax. On the next day she d... Read more
pt stated her left arm was sore and warm to the touch after getting the vax. On the next day she developed a fever of 101-102 along with fatigue, nausea, weakness, so she slept all day. Third day her fever was 99.8, she still had fatigue and arm was hot to the touch at the injection site. She now has a rash an inch below the injection site and is about 3x4 inches in size. Pt has not contacted her PCP at this time.
76 2021-02-15 sleepiness, fatigue, fever About 12 hours after vaccine I woke up with muscle aches across shoulder going up back of neck. The... Read more
About 12 hours after vaccine I woke up with muscle aches across shoulder going up back of neck. The next morning same thing muscles ached in back...no fever, this lasted until I went toned that might. Next morning got up and was really tired and sleepy for about 5 hours, and then no more side effects.
76 2021-02-16 body temperature increased, fatigue Started to get achy later that night after shot. Achiness got worse as all joints and bones hurt. ... Read more
Started to get achy later that night after shot. Achiness got worse as all joints and bones hurt. Got up next morning with a temp of 101* and still achy all over. Slept most of the day with same symptoms. Got up next morning (Feb 17) fever was gone, aches were gone, but very very tired all day. A little unsettled stomach. Everything improved as the day went on. There is a report # 269542 from the first shot reported by telephone.
76 2021-02-16 fatigue Injection site: pain, tenderness and swelling General side effects: fatigue, muscle pain, joint pain... Read more
Injection site: pain, tenderness and swelling General side effects: fatigue, muscle pain, joint pain, nausea
76 2021-02-16 fatigue Felt fatigued the day of the shot. Arm pain came on gradually and worsened by evening, even though ... Read more
Felt fatigued the day of the shot. Arm pain came on gradually and worsened by evening, even though I was moving my arm a lot. Had trouble sleeping due to arm pain. Next day slightly better. Second day much better. Third day pain completely gone.
76 2021-02-16 headache, fatigue, chills, fever Pain, swelling, tenderness at injection site. Muscle pain in body, headache and nausea started seve... Read more
Pain, swelling, tenderness at injection site. Muscle pain in body, headache and nausea started several hours after injection and lasted about 24 hours. Fatigue lasted into second day. Fever and chills started about 12 hours later for about 6 hours. (Some of symptoms at injection site may have been a result of the administration of the injection. There was some blood at the site and I still have a black and blue mark)
76 2021-02-16 throat pain, malaise fall, sore throat, malaise
76 2021-02-17 fatigue, chills, headache Headache, nausea, chills, dizziness, exhaustion, body aches, thought process diminished, excessive u... Read more
Headache, nausea, chills, dizziness, exhaustion, body aches, thought process diminished, excessive urination....for over a week
76 2021-02-17 fatigue 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 2021-02-17 headache, fatigue Raised Rash/welts/hives at injection site and down the entire left arm/forearm.Itchy, and hot arm.. ... Read more
Raised Rash/welts/hives at injection site and down the entire left arm/forearm.Itchy, and hot arm.. started day after injection and is still ongoing now 6 days later. Now also spreading to the right upper arm( 6 days later). Headache beginning directly after injection and lasting 3 days. Extreme fatigue evening of injection and lasting foe 2.5 days
76 2021-02-19 fatigue, chills, fever, headache Developed fever up to 99, severe aching in all joints, headache, chills, loss of taste, injection si... Read more
Developed fever up to 99, severe aching in all joints, headache, chills, loss of taste, injection site in arm sore. Felt fine evening of 2/2/21 (date of injection) and awoke 0500 2/03/21 with symptoms listed here. Fever broke about midnight of 2/3/21 and only mild headache and feeling of fatigue next 2 days and then all symptoms completely disappeared.
76 2021-02-19 fatigue About 22 hours after the vaccination I became very weak, could not get up from the floor, was very f... Read more
About 22 hours after the vaccination I became very weak, could not get up from the floor, was very fatigued, disoriented, and could not walk without being held up. I went home, and slept most of the rest of the day. The following day I was listless with very little energy. I took several naps. Late in the day, the second day after vaccination, I ate food and am feeling a little better.
76 2021-02-19 headache Stomach pain , back pain, nausea, confusion, headache.. Started around 2pm in 02/20/2021. Ambulance ... Read more
Stomach pain , back pain, nausea, confusion, headache.. Started around 2pm in 02/20/2021. Ambulance was called, stated she felt like she was dying and was having severe pain
76 2021-02-19 headache Headache all day 24 hrs after receiving 2nd covid vaccine. Lasted all day until bedtime. Drank flu... Read more
Headache all day 24 hrs after receiving 2nd covid vaccine. Lasted all day until bedtime. Drank fluids and took tylenol to supress.
76 2021-02-19 nasal congestion 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 chills, fatigue, fever Woke with fever. Fever all day. Maxed out at 102.2. Chills. Took 2 Extra Strength Tylenol every 6 ho... Read more
Woke with fever. Fever all day. Maxed out at 102.2. Chills. Took 2 Extra Strength Tylenol every 6 hours. Slept MANY hours. Woke the next morning feeling fine, just a little tired. No fever.
76 2021-02-20 fatigue, headache 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 2021-02-21 fatigue, headache, sweating When I woke on the 19th I was trying read my bible and I couldn't concentrate and I was really cold.... Read more
When I woke on the 19th I was trying read my bible and I couldn't concentrate and I was really cold. I went to back to bed and slept most of the day. I was really cold and fatigued and didn't have an appetite. I took some Tylenol. I woke up about 3:30 AM Saturday and my back, arms and my head were all hurting and I took some Tylenol and went back to bed. I woke up about 6AM and was covered in sweat. I didn't want to do anything Saturday, I rested most of Saturday and Sunday. Today the 22nd I am back to my normal self.
76 2021-02-21 fatigue, fever, headache Low grade fever Aching joints Mild head ache 1 day EXHAUSTION 2 days
76 2021-02-21 headache Headache, joint pain in shoulders, fingers, legs and back; stomach pain and diarrhea. Loss of appeti... Read more
Headache, joint pain in shoulders, fingers, legs and back; stomach pain and diarrhea. Loss of appetite. All these symptoms lasted 8 hours and diarrhea continues for 48 hours. Took Tylenol and rested for first 12 hours, then continued normal daily routine. I had a severe bought of COVID 19 in March 2020, resulting in 3 weeks hospitalization. Exhaustion and pain in finger joints continue today.
76 2021-02-22 headache, fever, chills, fatigue light headedness, nausea, headache, fever 100, chills, extreme fatigue lasted 12 hours at least reco... Read more
light headedness, nausea, headache, fever 100, chills, extreme fatigue lasted 12 hours at least recovered after 24 hours
76 2021-02-22 headache, fever 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 2021-02-22 fever, fatigue Sore arm (3days), fever (100-100.5) (2 days), fatigue (3 days), Nausea (day 3 only)
76 2021-02-23 chills, headache The day after sx developed; severe chills, some nausea, some body aches, headache. Rested all day an... Read more
The day after sx developed; severe chills, some nausea, some body aches, headache. Rested all day and by the next day (day 2 after injection) I felt 95%. Took 2 Tylenol at bedtime on the day with the sx. No other OTC drugs. Did not contact my physician or felt the need to; really not bad sx.
76 2021-02-23 chills I had a sudden onset of diarrhea immediately after getting the vaccine. a couple hours later I had a... Read more
I had a sudden onset of diarrhea immediately after getting the vaccine. a couple hours later I had another onset of diarrhea. that evening I had chills so bad that I could not get warm. Left arm is sore and swollen but mobile.
76 2021-02-23 fatigue, chills, fever Ongoing symptoms for the last 2 weeks. Primary exhaustion, a few days ago fever, chills.
76 2021-02-23 head discomfort Reported that experienced the onset of dizziness, "full feeling in head" at 30 minute discharge time... Read more
Reported that experienced the onset of dizziness, "full feeling in head" at 30 minute discharge time- stated that these symptoms had started @ 2 minutes after Covid-19 vaccine was administered but was not reported until discharge ( did have multiple check-ins in waiting area) "hoping it would go away" no SOB, no urticaria, no facial swelling
76 2021-02-23 headache, influenza like illness, fatigue Had flu-like symptoms for 24 hours. Very tires, total body aches, appetite loss. Constant headache.... Read more
Had flu-like symptoms for 24 hours. Very tires, total body aches, appetite loss. Constant headache. Took Motrin as needed, and slept in naps. Took liquids. Temp 99 degrees.
76 2021-02-23 lethargy FALL AM OF 2/18/2021 T 99.5 WITH LETHARGY
76 2021-02-23 fever, chills, headache 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 2021-02-23 fever, chills pt stated the next day after getting the 2nd dose of the covid vax, she had chills, slight fever, bo... Read more
pt stated the next day after getting the 2nd dose of the covid vax, she had chills, slight fever, body aches and slightly nauseated. On 2/12/2021 she felt better, no fever, but noticed she had developed a slight rash around the injection site. On 2/14/2021 she noticed some red streaks moving down her left breast that disappeared fairly quickly. She had an apt w/ her Dermatologist on 2/15/2021 and the pt had a slight rash on her left arm. On 2/16/2021 she noticed she had a 'covid arm' rash that covered 3/4 of her left upper arm. On 2/18/2021 the rash was still noticeable and was itching so she took a Benadryl and then again on the 2/19/2021. She saw her Dermatologist again on 2/24/2021, her rash is less red and seems to be disappearing.
76 2021-02-23 fever Developed intermittent fevers to 100.5 lasting 4 days with persistent diffuse body ache.
76 2021-02-24 fatigue, headache, fever, chills, sweating chills, sweats, fever, headache, body aches and pains, fatigue, nausea
76 2021-02-24 fatigue, headache, fever, dehydration Immediately after the injection and got a pounding headache behind her eyes. Then about 7:30 PM she... Read more
Immediately after the injection and got a pounding headache behind her eyes. Then about 7:30 PM she started to ache all over and very tired. She went to bed around 8:00 PM and then she couldn't sleep all night. She kept trying to drink liquid, running fever, hot and opened a window with temp being 30 outside. She could hardly walk to the bathroom due to the muscle weakness and fear of falling. She tossed and turned all night long. She got up and her temp was 99.8, and she was told not to go to PT this morning. She is being treated for a frozen shoulder. She feels dehydrated and is drinking water, and going to drink Ginger ale and crackers due to the nausea.
76 2021-02-24 fatigue, headache headache, fatigue, 02/16 thru 03/25/21 tongue thickening, 02/18 thru 02/25/2021 swollen face, throat... Read more
headache, fatigue, 02/16 thru 03/25/21 tongue thickening, 02/18 thru 02/25/2021 swollen face, throat, 02/22 thru 02/25/2021 Doctor prescribed PredniSONE 20 MG TAB CADI beginning 02/25/2021 for 5 days, on going, no outcome
76 2021-02-24 fatigue Had big bowl of chili. Got very tired. The kind of tiredness where she had to just lie down and go t... Read more
Had big bowl of chili. Got very tired. The kind of tiredness where she had to just lie down and go to sleep. Went to bed. The next morning, she was fine.
76 2021-02-24 lethargy Initially, itching at injection site. Five hours later, swelling at injection site with itching sp... Read more
Initially, itching at injection site. Five hours later, swelling at injection site with itching spreading down arm to above elbow. Difficulty sleeping. Next day, lethargic with other symptoms continuing. Next day, swelling decreasing but itching continuing. Noticed a small cyst in upper arm the size of a small pea. Energy has returned.
76 2021-02-24 sinus congestion 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 2021-02-25 chills, body temperature increased, fatigue Night chills all night. Had 106.0 temperature. Dr.s nurse told me to take two Tylenols and if my te... Read more
Night chills all night. Had 106.0 temperature. Dr.s nurse told me to take two Tylenols and if my temperature did not go down to go to ER.. It did after a couple hours. Despite being a little tired I was ok.
76 2021-02-25 fatigue, fever Fevers: 100.7-100.9 with Tylenol Fatigue Disorientation Itching
76 2021-02-25 headache, fever, chills, fatigue Chills, fatigue, body aches, headache, fever, nausea Took Tylenol after 24 hours Helped lessen the ... Read more
Chills, fatigue, body aches, headache, fever, nausea Took Tylenol after 24 hours Helped lessen the symptoms. Took more Tylenol after 6 more hours. 48 hours later-am 70% improved.
76 2021-02-25 nasal congestion 30 minutes after shot, nose congestion and blood pressure rose to 225/100.
76 2021-02-25 fever, chills On the evening of the first vaccination, my sister experienced chills and fever. The next morning sh... Read more
On the evening of the first vaccination, my sister experienced chills and fever. The next morning she experienced a kind of paralysis, could not sit up or stand up, was falling out of bed and out of her chair, had to be carried to the bathroom, although she usually can walk by herself. This lasted about a day. I took her to the ER where they excluded other possible causes of her condition and simiply attributed it to the vaccine. No treatment was prescribed.
76 2021-02-25 fever Moderna Covid-19 Vaccine EUA Patient had low grade fever (101.1 degrees) as well as muscle aches an... Read more
Moderna Covid-19 Vaccine EUA Patient had low grade fever (101.1 degrees) as well as muscle aches and pain
76 2021-02-25 throat irritation Patient experienced razor-burn like rash all over her body, except the face. She has been drinking l... Read more
Patient experienced razor-burn like rash all over her body, except the face. She has been drinking lots of water to help with the symptoms but no help. Patient also experiencing burning sensation in throat area. She called her doctor to get medication to help treat symptoms and tried Prednisone 10mg three times per day for 5 days, but is still experiencing adverse effect.
76 2021-02-26 chills, headache, sinus disorder, fatigue Nasuea , chills, headache, joint pain, site red swollen, fatigue, stomach upset, sinus issues
76 2021-02-26 chills 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 2021-02-26 fatigue Extreme soreness at injection site. Major muscle soreness. Vomiting. Fatigue. Allover achiness.
76 2021-02-26 fatigue Extreme fatigue lasting over a week and nausea beginning 3 days after vaccine.
76 2021-02-26 headache, chills Sudden onset shaking chills , headache , body aches , joints pains , weakness. Chills relieved 30 mi... Read more
Sudden onset shaking chills , headache , body aches , joints pains , weakness. Chills relieved 30 minute after taking 500 mg Tylenal . No relief of headache , body aches and joint pains . IN pain , weak and losing balance at 7 am , temp 99 , mild nausea . Took 5/325 hydrocodone , paetial relief joint pains , headache persists .
76 2021-02-26 fever, chills Rec'd first dose on January 18, 2021, and three days following the first dose (January 21, 2021), se... Read more
Rec'd first dose on January 18, 2021, and three days following the first dose (January 21, 2021), severe arm pain in both arms (entire arm) at 2:30 P.M., accompanied with a few light chills. No fever. Pain remained for approximately 3 hours. Took 1 Advil which relieved pain. On February 23, 2021, following the second vaccine dose (administered on February 16, 2021) I experienced same arm pain in both arms at 5:30 A.M. The pain was less severe and felt in upper arms only. Duration approximately 1 hour. Took 1 Advil which relieved pain. Two days later (February 25, 2021) at 6:30 A.M., slight upper arm pain returned and remained 30-60 minutes. Took one Tylenol which relieved pain.
76 2021-02-27 sweating 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 2021-02-28 chills, headache, fatigue Chills, no fever, headache, body aches, loss of appetite, some heart palpitations, fatigue, muscle a... Read more
Chills, no fever, headache, body aches, loss of appetite, some heart palpitations, fatigue, muscle aches, shortness of breath. Unable to do daily tasks for five days. Swelling, redness and severe pain at injection site.
76 2021-02-28 chills, fever, headache Chills, 101 fever , headache, body aches, swollen arm at injection site Symptoms present for 16 hour... Read more
Chills, 101 fever , headache, body aches, swollen arm at injection site Symptoms present for 16 hours Tylenol taken - 2x500mg twice at 6-hr. intervals Sore arm lasted 5 days
76 2021-02-28 sweating The same night after receiving the vaccine, my arm starting swelling, itching. The next morning I wo... Read more
The same night after receiving the vaccine, my arm starting swelling, itching. The next morning I woke up and the rash was there, and spread over the different areas of body. I was sweating bad, muscle pain, joint pain, and nauseated for about 3 days. I had knots in my arms. I went to the doctor last week, and she gave me a shot in the hip, it helped with the swelling. Then I called her back and she called in a cream for me. The other symptom remaining is the rash at the injection site, I have been putting the cream on it twice a day, taking Benadryl and Tylenol for pain
76 2021-02-28 lethargy 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 fever, fatigue, chills Tiredness, chills, fever, arm soreness.
76 2021-03-01 chills, sleepiness, influenza like illness, fatigue 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 fatigue, chills For two days after shot #1 I felt fatigue and chills, which seemed normal. But two weeks after that ... Read more
For two days after shot #1 I felt fatigue and chills, which seemed normal. But two weeks after that shot, I developed "Covid Arm"; it lasted two days.
76 2021-03-01 fatigue, headache, chills 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 2021-03-01 fatigue 2-3 days after 2nd Moderna vaccination a 10 inch area around injection site swelled and became hot, ... Read more
2-3 days after 2nd Moderna vaccination a 10 inch area around injection site swelled and became hot, painful and hard, and a large bright red rash appeared . It persists without improvement today. I also had pain in the joints in my feet and ankles, hands. Some fatigue. No fever, no chills. I had NO reaction after 1st vaccination, although injection site was hot and very tender for days. Used left arm both times. I saw an online photo of "COVID arm" hypersensitivity reaction and looks exactly like mine. Really quite uncomfortable.
76 2021-03-01 fever 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 2021-03-02 headache, chills, fever Chills. Low grade fever, severe headache, shooting joint pain. Took Tylenol. No treatment necessary.... Read more
Chills. Low grade fever, severe headache, shooting joint pain. Took Tylenol. No treatment necessary. Symptoms gone in less than 24 hours.
76 2021-03-02 headache Severe pain in my head. Blood pressure went up high. blurred vision. Continues today.
76 2021-03-03 chills, fever From Dr. notes from the patient's visit to the office on 02/08/2021: "*ACUTE CELLULITIS OF THE RI... Read more
From Dr. notes from the patient's visit to the office on 02/08/2021: "*ACUTE CELLULITIS OF THE RIGHT UPPER ARM--I do believe that this is a result of the injection and not due to the vaccine itself. The fact that he continues to have some slight growth does necessitate that we treat this with an antibiotic. I am what have you TAKE TMP-SMX DS 1 tablet twice per day for 7 days. Elevate this arm and keep moist heat to this area and it should improve quickly. Call me if there is any worsening. I will CHECK COMPLETE BLOOD COUNT TODAY to evaluate this more fully." Also from Dr. notes from the patient's visit to the office on 02/08/2021: "This fine lady comes in today stating that she received the CoVid 19 Moderna vaccine with the first dose on 2/2/21. The patient previously had a moderately severe case of CoVid 19 in late September and early October. She states that the vaccine did cause her to have severe chills for 2 days and then she started to develop an area of erythema near the injection site and this continued to progress. She called me on Friday in regards to this and then on Saturday it had continued to grow. We did have her husband demarcate the borders of the erythema and today it seems like she has had another further growth of an inch or so in most directions. The patient has a little tingling in this area but really has no significant pains and she denies any fevers since she had fever on Thursday night and Friday with a temperature of 102."
76 2021-03-03 chills After receiving the 2nd dose of the COVID-19 vaccine on 03/02/2021, the patient states today that sh... Read more
After receiving the 2nd dose of the COVID-19 vaccine on 03/02/2021, the patient states today that she had chills yesterday starting in the morning. She said she has no chills this morning. She states that her arm where she received the 2nd dose of COVID-19 (left deltoid) is pink, warm to the touch (can feel warmth through clothes), and tender to the touch. She said her husband will use a marker to mark the borders of the area of concern on that arm to see if the borders change with time. I notified Dr. of this information. I notified her that Dr. recommends she place heat on that area of her arm and to call us if any further symptoms develop. She also said she will notify us if she develops a fever 03/04/2021.
76 2021-03-03 fatigue 18 days post injection I had severe pain in right shoulder and under scapular. pain level 9. This co... Read more
18 days post injection I had severe pain in right shoulder and under scapular. pain level 9. This continued for a few days. Made appointment with my MD. Day 4 of pain a large painful rash appeared on my R upper back, under the arm and upper chest. ( Quite sure it was shingles. Started on Famciclovir 500mg. and tramadol 50mg. Had severe case of shingles with fatigue and excruiciating pain. My MD stated he has seen a number of patients post vaccine with shingles. Was scheduled for second vaccine on February 16th. The pharmacist at the vaccine center would not approve booster, stating my immune system is already stressed. My primary also recommeded no booster at this time.
76 2021-03-03 sweating hot sweats passing out dry mouth gasping for breath extreme energy loss (couldn't stand up)
76 2021-03-03 malaise, chills, headache, fever 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 fever, chills Pt called triage line with c/o intermittent symptoms of feeling "feverish", chills, body aches, and ... Read more
Pt called triage line with c/o intermittent symptoms of feeling "feverish", chills, body aches, and diffuse ABD pain. Pt denies SOB, N/V/D, HA, sore throat, and/or CP at this time. In addition, pt reports a "period of delirium for less than 20 minutes yesterday...it has to be because of the vaccine...". Pt reports that she received her 2nd dose of the Moderna vaccine on 03/02/2021 to L deltoid. Pt advised to seek medical attention and/or evaluation with either their PCP and/or HCP with PMG IC for symptoms.
76 2021-03-03 fever, fatigue, chills severe fatigue, chills, fever 100.1, abdominal discomfort lasted 3 days
76 2021-03-03 fever Having itching red swallowed arm cant stop itching to the point i want to take my skin off.. took so... Read more
Having itching red swallowed arm cant stop itching to the point i want to take my skin off.. took so many antihistamines, rash medication nothing is calming it down... my both arms are having fever it's red and sever discomfort.... it's been over a week I still have the same symptoms
76 2021-03-04 body temperature increased Moderna COVID-19 Vaccine EUA 02/18/21 - achy back and neck (beyond ?normal? for me) - left arm sore ... Read more
Moderna COVID-19 Vaccine EUA 02/18/21 - achy back and neck (beyond ?normal? for me) - left arm sore 3/10 - pink rash near injection site - temp: 100.3 (normal 98 or below); Tylenol was not strong enough to relieve discomfort - took Aleve; improved on Friday 02/19/21; much better on Saturday 02/20/21; back to my ?normal? Sunday 02/21/21
76 2021-03-04 chills, fatigue, fever Chills, low grade fever, slight nausea, headache, body aches, fatigue. Fatigue lasted approximately... Read more
Chills, low grade fever, slight nausea, headache, body aches, fatigue. Fatigue lasted approximately 1 week; other side effects about 3 days. 2 days after injection, had a 3 by 6 inch red raised itchy welt appear about 2 inches from injection site. Gradually faded over a one week period. I had an allergy injection 2 weeks prior to Covid vaccine. Contacted allergy doctor and we agreed to postpone next allergy injection until after second Moderna vaccine, in case there was a connection.
76 2021-03-04 chills, fatigue, fever Three days after second vaccination developed red, itchy rash covering large portion of outer upper... Read more
Three days after second vaccination developed red, itchy rash covering large portion of outer upper arm,. Was swollen. Also, diarrhea that day. Later in day of shot was fatigued, during night chills and severe muscle aches. Aches and low fever the next day.
76 2021-03-04 chills In the evening lots of pain in left arm. during night chills including teeth chattering, pain all ov... Read more
In the evening lots of pain in left arm. during night chills including teeth chattering, pain all over, no sleep but slept through most of the next day, ate nothing. Was quite concerning but did not call doctor although I sure thought about it. I was wondering if I was actually infected with Covid- 19. Shot was Tuesday 2: 30 PM, felt a bit better by Thursday but arm still hurt even on Friday arm was red and swollen down to my elbow. Saturday fine. I thought someone should know about this as lost of my friends also had difficult reactions. But this was the first time I saw an opportunity to respond.
76 2021-03-04 chills Moderna COVID-19 Vaccine EUA Interrupted sleep the first night with shakes. The next day I had ch... Read more
Moderna COVID-19 Vaccine EUA Interrupted sleep the first night with shakes. The next day I had chills, shakes, and muscle weakness. I had no appetite, slept most of the day, and had a full night's sleep. I felt better about 9:00 PM and am fine today Friday, the 5th
76 2021-03-04 headache, chills Over the course of five or six days: headache, severe body aches, chills, loss of appetite, swelling... Read more
Over the course of five or six days: headache, severe body aches, chills, loss of appetite, swelling, pain and redness at the injection site, brain fog, unable to complete/execute daily chores. Weakness.
76 2021-03-04 headache, fatigue Headache, Body Aches, Fatigue. Began the morning following vaccine injection and lasted approximatel... Read more
Headache, Body Aches, Fatigue. Began the morning following vaccine injection and lasted approximately 24 hours. Left arm sore. All side effects much milder than those following first Moderna injection. Forgot to say on report of first injection that I tested positive for Covid on December 7, 2020 and had a mild case of Covid not requiring medical treatment.
76 2021-03-04 headache, fever, nasal congestion, fatigue Fever 102, nausea, dry mouth, tiredness, headache, nasal congestion, no appetite
76 2021-03-04 malaise, headache, fatigue, chills, fever About 30 hours after the second Moderna vaccine injection I experience a fever of 101 and mild chill... Read more
About 30 hours after the second Moderna vaccine injection I experience a fever of 101 and mild chills in the evening. I have a sense of malaise and fatigue. The next morning I had a severe headache so I took a Tylenol 650 and sleep for two hours. After that, I felt fine ever since .
76 2021-03-05 body temperature increased, chills, headache 18 hours after the shot: Chills, Fever 100 Severe stomach cramps Severe headache Left arm ache - se... Read more
18 hours after the shot: Chills, Fever 100 Severe stomach cramps Severe headache Left arm ache - severe Total body aches
76 2021-03-05 chills, fever, headache, fatigue 2 am (13 hrs after shot) the following day, i awoke with intermittent shooting type pain down my ar... Read more
2 am (13 hrs after shot) the following day, i awoke with intermittent shooting type pain down my arm into my finger tips and a sore upper arm at injection site. 1:30 pm (24 hrs after shot) i had a bad headache and queasy stomach, approximately 1/2 hr later had the chills and a fever of 99.8. I slept for approximately 3 1/2 hrs. Upon awakening I still had chills but no fever 98.8 and all my joints ached. 6 pm I took 2 Ibuprofen and by 7:30pm I had warmed up but was extremely tired. 10 pm I took 2 more Ibuprofen and went to bed. I slept until 7 am and feel wonderful. My arm is a little tender yet but no trouble using it.
76 2021-03-05 chills, fever, malaise, headache 18 hours after the shot - chills, severe stomach cramps, total body aches, left arm pain (severe), h... Read more
18 hours after the shot - chills, severe stomach cramps, total body aches, left arm pain (severe), hot flashes, fever 100., sever headache. Felt bad through 48 hours post vaccination.
76 2021-03-05 headache Instantly felt shot material go through veins on L side of chest, 15 minutes later extremely light h... Read more
Instantly felt shot material go through veins on L side of chest, 15 minutes later extremely light headed, 10 min later L side of face become numb, headache, 30 min later L arm swelled to side of 1/2 of baseball, lymph nodes under L arm and on L collar bone became enlarged. Arm swelling lasted 4 weeks, Lymph nodes have not gone down and it has been 5 wks, Advised by Nurse Practioner at Pharmacy advised me not to get 2nd shot. I am extremely healthy and work 5 days/wk, workout at gym 3x /wk Weights and Total Body Lift classes. Sided effects were a major surprise!
76 2021-03-05 headache Mild headache, muscle soreness, big red welt over injection site, itchy, swollen and painful
76 2021-03-05 fever, fatigue, chills fever chills body aches fatigue
76 2021-03-05 fever, headache 18 hours after Moderna shot 2 my eyes swelled up and became itchy and red. My eyes are sill inflamed... Read more
18 hours after Moderna shot 2 my eyes swelled up and became itchy and red. My eyes are sill inflamed as of now 3/06/2021. Also I have been running a low grade fever, and have headaches. These symptoms are managed with Tylenol.
76 2021-03-05 fever 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 2021-03-06 fatigue, headache Blurred vision, eyes crossed, Face swelled, Face broke out with rash, Headache, Nauseous, All happen... Read more
Blurred vision, eyes crossed, Face swelled, Face broke out with rash, Headache, Nauseous, All happened within 30 minutes. Next day backaches and feeling tired. Dr. gave me Pepcid and Xyzal. Most all thru Sunday, Still not 100%.
76 2021-03-06 headache, malaise, chills Chills first 1 hr., body aches 8-9 hrs, nausea 1- 1-1/2 hrs., sinus drainage 2 hrs. ( had to sit up ... Read more
Chills first 1 hr., body aches 8-9 hrs, nausea 1- 1-1/2 hrs., sinus drainage 2 hrs. ( had to sit up to keep from going to stomach), headache front and back. After 5-6 hours took Tylenol (no effect). Body aches start lessening about 7-71/2 hrs. Second Tylenol. Took excederin for headache after 10-11 hrs. And headaches ended after 12 hrs. Still didn?t feel good all day but couldn?t sleep. Second day softer shot not feeling well - stomach ache all day and belching all day. Next 5 days feeling ok, but not bad to normal. Did have injection sight soreness and mild itching for 9 days.
76 2021-03-06 headache, fever severe headache, backache, sore arm, severe muscle ache, frequent urination, fever 100 deg
76 2021-03-07 chills, body temperature increased Around midnight after going to bed, I started shivering with a temperature. Lasted an hour or so be... Read more
Around midnight after going to bed, I started shivering with a temperature. Lasted an hour or so before I got to sleep and was later okay. Now just a sore, red, swollen injection site.
76 2021-03-07 chills, headache, fatigue, fever, cough 1. Injection site pain, tenderness, on February 2-4 2. Fever (never exceeding 101.3), chills, muscl... Read more
1. Injection site pain, tenderness, on February 2-4 2. Fever (never exceeding 101.3), chills, muscle and joint pain, fatigue, headache, cough 3. Productive cough with greenish colored sputum first occurred on February 4 reported to personal pulmonary physician; oral antibiotic prescribed
76 2021-03-07 fatigue I lost control of muscles in my arms, legs, bladder, and mouth. I could not sit up, stand up or even... Read more
I lost control of muscles in my arms, legs, bladder, and mouth. I could not sit up, stand up or even grasp a bottle of water. I had trouble speaking and lost complete control of my bladder. My husband called 911 and the end stayed with me and took vitals. I was in this state for about 7 hours. After this I continued to be very tired for about 5 days.
76 2021-03-07 fatigue swelling of L arm's inner aspect; tenderness in entire arm especially around the inside elbow; some ... Read more
swelling of L arm's inner aspect; tenderness in entire arm especially around the inside elbow; some red areas that have diminished; fatigue. continues.
76 2021-03-07 fever, chills sore arm, chills, feverish The sore arm developed around 5 o'clock on Feb. 27 and lasted until Marc... Read more
sore arm, chills, feverish The sore arm developed around 5 o'clock on Feb. 27 and lasted until March 1. Chills started and ended on Feb. 28. Slight fever started and ended on Mar. 1. I took Tylenol.
76 2021-03-08 chills Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and ... Read more
Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and had trouble focusing them and just wanted to go to bed", Reports woke up with same symptoms and also had some confusion and had red swollen hard area on L arm were vaccine was given and it is still red and swollen today.
76 2021-03-08 headache ONCE PATIENT GOT HOME THEY CALLED AND SAID THEY HAD HEADACHE AND VOMITED
76 2021-03-09 fatigue, headache Sudden significant nausea 7 hours after vaccine. Lasted an hour. Suddenly went away. Muscle and bo... Read more
Sudden significant nausea 7 hours after vaccine. Lasted an hour. Suddenly went away. Muscle and body aches and headaches, beginning about 5 hours after vaccine, lasting for 60 hours. Swollen lymph glands in neck and under jaw on both sides, 26 hours after vaccine. Significant fatigue, beginning about 6 hours after vaccine, ongoing at hour 52. LARGE RED HARD BLOTCH on vaccinated arm, one inch+ UNDER the vaccine site (which still has bandage on it), TENDER, ITCHY, ABOUT 32 HOURS AFTER VACCINE. ONGOING, although the hardness is decreasing, and the redness isn't as angry at hour 52.
76 2021-03-09 fatigue, fever, headache Fever, headache, fatigue, body aches, weakness, loss of appetite. Lasted about 24 hours.
76 2021-03-09 fatigue 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 2021-03-09 headache Two red areas on left shoulder appeared 12 days after the first vaccination. (One oval area was at s... Read more
Two red areas on left shoulder appeared 12 days after the first vaccination. (One oval area was at shot site about 1 inch by 2 inches. Second area was below the first area and in the shape of a band around my arm 1 inch wide by 4 inches long . Treatment was Benadryl ointment on red areas and baby aspirin Also, I had headaches almost daily until the red areas appeared.
76 2021-03-09 malaise Sunday, Feb 21, 2021. Patient told her husband she didn?t feel well and she lay down next to him. Sh... Read more
Sunday, Feb 21, 2021. Patient told her husband she didn?t feel well and she lay down next to him. She was tossing and looked like she was trying to get up. He was talking to her and she wasn?t answering him. She was having trouble breathing. Took her to the hospital right away at 7:30 pm. They put her into a comma with a respirator. Finally went from emergency room to ICU on Monday. Then on Wednesday they took the respirator out and I spoke to her ? told her we all love her and she could only say hoarsely ?terrible, terrible.? They said she might get moved to regular floor. But then Wednesday night couldn?t breathe again and put the respirator back in. Thursday morning husband had it removed and she died that evening at 10:51 on February 25.
76 2021-03-09 fever, chills, headache caller states the pt woke up on 3/10/2021 w/ tender arm, headache, nauseated, dry-heaving, very weak... Read more
caller states the pt woke up on 3/10/2021 w/ tender arm, headache, nauseated, dry-heaving, very weak, diarrhea, slight fever, and chills. Pt will go to the ER if her symptoms do not improve.
76 2021-03-10 body temperature increased, runny nose Initial redness and discomfort in arm. Two days afterward, runny nose and temperature to 100.3. Extr... Read more
Initial redness and discomfort in arm. Two days afterward, runny nose and temperature to 100.3. Extremely red rash on arm, measuring approximately 4 and 1/2 x 5 inches. Had eye surgery today and the nurses strongly encouraged me to report the rash.
76 2021-03-10 chills, headache, fatigue Chills, body aches, headache, fatigue
76 2021-03-10 headache, head discomfort Severe splitting headache (starting in left temple and proceeding to encircle my head). It felt lik... Read more
Severe splitting headache (starting in left temple and proceeding to encircle my head). It felt like a vice tightening around my head. This was followed by nausea and eventually lead to projectile vomiting for about an hour. Extreme weakness.
76 2021-03-10 headache Intense pain on both sides of my torso lasting 3 days, headache, zapped all energy.
76 2021-03-10 headache within first 24 hours lots of wheezing and difficulty breathing, headache. In 3rd & 4th day morning ... Read more
within first 24 hours lots of wheezing and difficulty breathing, headache. In 3rd & 4th day morning nausea along with terrible headaches. Taken inhalers for wheezing and better by 3rd day. I've been taking Extra Strength Tylenol and Musinex to relieve headaches but still have them.
76 2021-03-10 malaise PATIENT WAS ADMINISTERED HER FIRST DOSE OF MODERNA. AFTER ABOUT 5 MINUTES THE PATIENT STATED SHE DI... Read more
PATIENT WAS ADMINISTERED HER FIRST DOSE OF MODERNA. AFTER ABOUT 5 MINUTES THE PATIENT STATED SHE DID NOT FEEL WELL. SHE STATED SHE WAS NAUSEATED AND WEAK INITIALLY. AFTER A FEW MORE MINUTES SHE STATED SHE WAS SHORT OF BREATH. AMBULANCE ARRIVED AND GAVE HER OXYGEN AND TOOK HER TO THE HOSPITAL.
76 2021-03-11 chills, fever, headache, fatigue Sore arm, fatigue, headache, muscle pain, joint pain, chills, fever all starting during the night. ... Read more
Sore arm, fatigue, headache, muscle pain, joint pain, chills, fever all starting during the night. all next day no appetite, very tired, slept most of the afternoon and evening. Went to bed slept that night, fever gone. Just very tired the day after. Two days after almost back to normal. If booster needed in the future or another shot, I would try another brand.
76 2021-03-11 fatigue, fever, chills 101.4 Fever, Chills, Fatigue
76 2021-03-11 sleepiness, chills, fever, sweating, headache, fatigue Fatigue, headache, joint pain, chills, fever, slight nausea. Started Saturday day after vaccination ... Read more
Fatigue, headache, joint pain, chills, fever, slight nausea. Started Saturday day after vaccination with fatigue to the point couldn't stay awake and weak. Sunday woke with bad ache all over and harder to move along with fatigue. Small headache along with slight nausea in afternoon. Woke about 5 am Monday with total sweat, then chills and couldn't warm up. still had fatigue but not as much pain. Called Hospital Covid Hotline as directed by my Dr.s office (never talked to my Dr.) Nurse with Hotline discussed it with me and we determined it was probably side effects. Since I am aware of allergic reactions, I didn't feel threatened, only messed up. The fatigue and some aches lasted throughout the weak, and I am still fatigued and weak compared to normal.Aches seem better.
76 2021-03-11 throat irritation Arm is red, aching, circular, raised, hard, growing slightly, warm, and itches. Also feels itching ... Read more
Arm is red, aching, circular, raised, hard, growing slightly, warm, and itches. Also feels itching in her throat, and allergies are acting up. Patient took benadryl cream along with antihistamine she usually takes.Continue using cream for symptomatic relief, if symptoms worsen feel free to call back or see your PCP. We will follow up in 2 days at around the same time.
76 2021-03-12 chills, headache, fatigue Fatigue, chills, headaches a few hours after dosage. Spending a lot of time resting, taking aspirin ... Read more
Fatigue, chills, headaches a few hours after dosage. Spending a lot of time resting, taking aspirin and vitamin D3
76 2021-03-13 chills, fever, fatigue 03/12/2021 sore arm and fatigue 03/13/2021 chills, low grade fever (100f), aches, fatigue 03/14/20... Read more
03/12/2021 sore arm and fatigue 03/13/2021 chills, low grade fever (100f), aches, fatigue 03/14/2021 fatigue but no other symptoms
76 2021-03-13 headache 2/27 Muscle aches,headache,nausea, lasting 2 weeks 3/6 Covid arm lasting 1 week 3/9 Jitteriness,d... Read more
2/27 Muscle aches,headache,nausea, lasting 2 weeks 3/6 Covid arm lasting 1 week 3/9 Jitteriness,dry heaves
76 2021-03-13 lethargy 2nd dose of covid19 vaccine administered on 1/25/21 AM. First dose was about 12/28/2021. Patient h... Read more
2nd dose of covid19 vaccine administered on 1/25/21 AM. First dose was about 12/28/2021. Patient had a change in condition noted same day PM, which included worsening mental status with increased confusion such as disorientation and decreased functional status, as well as opening of pressure ulcer on coccyx. Patient became lethargic. Patient condition worsened over the next few days. Patient decreased oral intakes, including medications. Care and comfort measures were in place. Patient expired on 2/4/2021.
76 2021-03-13 fever, headache Nausea, diarrhea, headache, Fever (101.0) general aching in muscles.
76 2021-03-14 chills Chills,,aches.
76 2021-03-14 fatigue Patient called and reported having moderna 2nd dose on 3/12/21 . Patient reports fatigue the day aft... Read more
Patient called and reported having moderna 2nd dose on 3/12/21 . Patient reports fatigue the day after but reports having rash after two days . Patient reported rash that covered both arms, back and mid chest . Patient reports rash going away after 1 day .
76 2021-03-14 fatigue March 11, at about an early 9 pm bedtime, heaviness in left shoulder, soon into both shoulders, and... Read more
March 11, at about an early 9 pm bedtime, heaviness in left shoulder, soon into both shoulders, and mild, intermittent ache in other limbs. Thereafter, through the night, a feeling of fever, back & forth: skin hot, then normal feeling. Some chills. Took my temperature several times and would only get a normal reading. Puzzled, because I thought I must have a fever.....the STRANGENESS of this was that my skin felt like it was BURNING UNDERNEATH my skin....not like any fever I might have ever had. Still normal temp readings. The next day...mostly in bed, tired, no appetite, continued fever feeling, but no fever temp reading. The second day, up and around, eating.
76 2021-03-14 headache, fatigue, chills Patient received first dose of MODERNA COVID vaccination on 3/8/21. On 3/9/21 she developed chills,... Read more
Patient received first dose of MODERNA COVID vaccination on 3/8/21. On 3/9/21 she developed chills, headache, dry heaves, and fatigue. This last 24 hours and resolved with rest.
76 2021-03-14 headache, fatigue On day four 1/2 vaccine site is itchy and red almost all around arm and 2-3 inches high. Day after ... Read more
On day four 1/2 vaccine site is itchy and red almost all around arm and 2-3 inches high. Day after shot had slight headache and fatigue.
76 2021-03-14 headache "Moderna Covid-19 EUA" Admitted inpatient after ground level fall when she fell after attempting t... Read more
"Moderna Covid-19 EUA" Admitted inpatient after ground level fall when she fell after attempting to get out of bed. right hip pain, headache Lab worrk showed stable eectrolytes, but significantly elevated myoglobin, CK, and CKMB and troponin, WBC elevated, admitted for rehydration PT/OT evaluation and pain management
76 2021-03-14 headache Fell; Severe Stiffening and Cramping up of all muscles for hours; Worse Severe Unbearable pain in bo... Read more
Fell; Severe Stiffening and Cramping up of all muscles for hours; Worse Severe Unbearable pain in body ever felt; Stiffening of muscles; Worse pain in neck and head ever. Went to the ER twice and finally got an appt at primary care, now seeking another primary care Dr.
76 2021-03-14 malaise, fatigue, headache tiredness,headache,musle pain, join pain,injection site swelling,injection site redness,feeling unwe... Read more
tiredness,headache,musle pain, join pain,injection site swelling,injection site redness,feeling unwell,swollen,throat swelling,lost appetite.
76 2021-03-14 malaise, fatigue Previously in the hospital for head injury and UTI was discovered, so home health was already in the... Read more
Previously in the hospital for head injury and UTI was discovered, so home health was already in the home and nurse noticed I wasn't feeling well by the Friday after I had the vaccine. She contacted by doctor and he had me to go to the ER. My UTI had cleared up. A CT Scan showed I was fine. I was extremely tired and achy. No issues with 2nd dose.
76 2021-03-14 fever, lethargy fever, nausea, lethargic, diaherra , soreness
76 2021-03-15 chills, fatigue Symptoms started suddenly without warning: weakness/fatigue- hard could get out of vehicle , needed... Read more
Symptoms started suddenly without warning: weakness/fatigue- hard could get out of vehicle , needed assistance. chills shortness of breath excessive thirst
76 2021-03-15 headache, fatigue, chills, fever Had severe headache, chills with body shakes, fever, body aches, dizziness, fatigue, and painful arm... Read more
Had severe headache, chills with body shakes, fever, body aches, dizziness, fatigue, and painful arm at injection site that lasted for 24 hours after second vaccine on the 13nth of March, 2021.
76 2021-03-15 headache, fatigue 72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, coul... Read more
72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, could not eat for 2 days, 3rd day lost sense of taste and smell, 3rd day rash on arms and chest (4 hours), difficult to sleep soundly but needed to stay in bed or rest for the most part. 3/16 woke up feeling much better and able to eat, smell and taste about 75%. Spoke via text with doctors office personnel for advice 3/14 and 3/15...very supportive!
76 2021-03-15 headache Day 2 site hard and inflamed Day2 and 3 headache
76 2021-03-16 fatigue, malaise, headache Woke up 3/13/21 with stomach ache, and feeling a little sickly, by next day , Sunday 3/14 stomach ac... Read more
Woke up 3/13/21 with stomach ache, and feeling a little sickly, by next day , Sunday 3/14 stomach ache was stronger, loose bowels, feeling tired and general malaise , on Monday 3/15 stomach ache still there, and loose bowels and tiredness and by Tuesday the 16th felt like vomiting (though I never did) and also developed a headache and still had loose bowels and today wednesday the 16th am feeling somewhat better, headache is slight, stomach a lot better and on the 16 took Tylenol for headache and Loperamdie for bowels, all was improved. Lived on tea and toast and bananas and crackers. It asks if I have recovered as of 3/17 am improving but not like normal yet,
76 2021-03-16 fatigue extreme tiredness, brain fog and memory lapses, redness and blister on arm , NOTE: After a week, sti... Read more
extreme tiredness, brain fog and memory lapses, redness and blister on arm , NOTE: After a week, still very tired
76 2021-03-16 nasal congestion, fatigue 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 2021-03-16 fever 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 2021-03-17 fatigue Since the vaccine was administered on 1/30/2021 the resident was complaining of tiredness. On 2/9/20... Read more
Since the vaccine was administered on 1/30/2021 the resident was complaining of tiredness. On 2/9/2021 she complains more than usual with fatigue, a lot of fatigue so they make the decision to transfer her to the hospital. In the hospital she was informed that the pain was from a gallbladder stone, also that she has a lung condition and a compromised kidney. A Dr. from Hospital tells POC that the patient was not responding to treatments and was compromised thus prolonging the hospital stay.
76 2021-03-17 fatigue Patient c/o extreme fatigue, pain and swelling to right neckline onset 3/4/21. She states the pain a... Read more
Patient c/o extreme fatigue, pain and swelling to right neckline onset 3/4/21. She states the pain and swelling increased over the next 4 days, swollen area was now the size of a golf ball. She was seen and evaluated on 3/9 by her PCP, DR. CMP, Thyroid Profile and Lipid Panel were completed, all results were within normal limits. Pain began to ease up on 3/11/21. On 3/17/21 she is still c/o extreme fatigue, no change in the swelling to her neck. She is calling her PCP to schedule another appointment for next Friday 3/26.
76 2021-03-18 fever I had fever, every joint ached extremely painfully
76 2021-03-18 fever severe nosebleed. fever 100.1, Had to go to the emergency room and they cauterized.
76 2021-03-19 chills, fatigue, runny nose Tinnitus -had it after 1st shot, but was not sure of cause- definitely stronger soon after 2nd vacci... Read more
Tinnitus -had it after 1st shot, but was not sure of cause- definitely stronger soon after 2nd vaccine; extreme chills for hours so hard to sleep, because whole body shaking; arm sore to raise and lower, all joints ache, especially knees and neck; fatigue and little energy; runny nose. Feeling better next day, but tinnitus noise still strong, left arm and joints hurt, and low energy.
76 2021-03-19 chills, fatigue Chills, fatigue, muscle aches
76 2021-03-19 chills, headache, fatigue soreness of arm, fatigue, loss of taste, loss of appetite, chills, pain in the back of head and neck... Read more
soreness of arm, fatigue, loss of taste, loss of appetite, chills, pain in the back of head and neck, nausea and vomiting, right arm numb and tingling
76 2021-03-19 fatigue, chills, fever Sore/tender arm at injection site beginning in about 2hrs after injection. Entire upper arm hot, red... Read more
Sore/tender arm at injection site beginning in about 2hrs after injection. Entire upper arm hot, red, swollen about 10 hrs - very itchy at 24 hrs. Remained extremely tender and red, itchy for a week. Still slightly sore, tender at 9 days. Had a fever of almost 100 starting next day following injection and continued for a total of 3 days. Fever accompanied by chills. Decreased appetite and extremely fatigued. Appetite now back to normal but still somewhat fatigued.
76 2021-03-19 headache, chills Reaction to the second does. Chills, body aches, headaches, and itchy rash from injection site.
76 2021-03-19 fever 1st Day after injection ran a lower grade fever (100.2), injection site itching & turning red with ... Read more
1st Day after injection ran a lower grade fever (100.2), injection site itching & turning red with moderate pain . Started taking Benedryl 10 mg and applying 1% cortisone creme ,I buprophen. Day 2 red rash spreading down arm 5" and about 4" wide. No fever but site still itiching & tender. Continued to treat the discomfort. The red rash finally fade after 9 days (3/19/2021). I had delayed reaction to the first injection of Moderna that did not start until 8 days post injection. Not as sever as the second one.
76 2021-03-20 fatigue, throat 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 2021-03-20 influenza like illness fine for first few hours then some swelling at shot site the need to lay down hit and I as out for 3... Read more
fine for first few hours then some swelling at shot site the need to lay down hit and I as out for 35 hours. Ended with flu like symptoms. Had covid in Dec 2020 with a 5 day hospital stay. The 35 hours was unnatural and mentally fuzzy. Very concerned about a second shot.
76 2021-03-21 body temperature increased, chills, fatigue, headache About 21 hours after receiving the vaccine, she developed a temp of 101.8, fatigue, headache, muscle... Read more
About 21 hours after receiving the vaccine, she developed a temp of 101.8, fatigue, headache, muscle aches and pain, chills and nausea, did not vomit. Back to normal today.
76 2021-03-21 chills Woke up about 12 hours later, teeth chattering, dizziness, nausea, arm extremely sore, chills and fe... Read more
Woke up about 12 hours later, teeth chattering, dizziness, nausea, arm extremely sore, chills and feeling really cold and couldn't get warm. She had diarrhea, lightheadedness, couldn't keep anything down. She tried drinking ginger ale. Lasted for about 20 hours. She started feeling better afterwards. Later she had no taste for food which lasted about 2 weeks. After 5 weeks, she has no taste for wine.
76 2021-03-21 headache, fatigue Headache 10 mins after shot, muscle spasm in left arm & left shoulder 15 mins after shot, pain lower... Read more
Headache 10 mins after shot, muscle spasm in left arm & left shoulder 15 mins after shot, pain lower back, weakness in both legs, aching all over, tired, started about 20 mins after shot, large raised area, red, itch, slight soreness shortly after shot
76 2021-03-21 headache, fatigue Symptoms began Saturday afternoon: fatigue, nausea, headache, chills, muscles ache. Diarrhea began ... Read more
Symptoms began Saturday afternoon: fatigue, nausea, headache, chills, muscles ache. Diarrhea began on Sunday around 3pm
76 2021-03-21 headache 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 2021-03-21 malaise, headache The day following the 2nd injection I experienced visual disturbance (similar to prior to a Migraine... Read more
The day following the 2nd injection I experienced visual disturbance (similar to prior to a Migraine headache) followed by a moderate headache and generally not feeling well, This has occurred once daily now for 11 days. Two Tylenol and resting alleviates the issue. I have also noted many episodes of the atrial tachycardia through out each day. No treatment other than rest/relaxation.
76 2021-03-22 body temperature increased Temp 101.1 and muscle aches so badly couldn't get out of bed for over 24 hrs. Took over two days to ... Read more
Temp 101.1 and muscle aches so badly couldn't get out of bed for over 24 hrs. Took over two days to recover. I am reporting this as suggested by worker at County and just found the site to do so. It may have been nothing but just making sure! Thanks
76 2021-03-22 fever, chills, headache, fatigue 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 2021-03-25 body temperature increased, sleepiness 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 chills, fever 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 2021-03-25 fatigue, headache Severe headache, fatigue, body aches
76 2021-03-25 headache, malaise headache started about 12 noon on day of, texted a friend at 5:47pm to say wasn't feeling well, hurt... Read more
headache started about 12 noon on day of, texted a friend at 5:47pm to say wasn't feeling well, hurting all over mostly in chest, shoulders and head.
76 2021-03-25 fever, runny nose, headache, sleepiness 02/25 I had my first dose- within the 15 minutes after I felt dizzy and lightheaded. it subsided eno... Read more
02/25 I had my first dose- within the 15 minutes after I felt dizzy and lightheaded. it subsided enough for me to drive home. I was tired for a few days. injection was very high up in my shoulder and about 3 weeks after I had tenderness in my elbow. My physical therapist said it was due to the injection being too high. 03/25- halfway home I had a significant headache. It diminished but I then got very very sleepy. I napped and then made dinner. 03/26 I was doing normal things and I felt cold, then my hands were very cold. I ate lunch but was very sleepy just before lunch. I then had a fever, My temp is 101.1. I have had a little drainage from one side of my nose.
76 2021-03-25 sleepiness, influenza like illness I had a severe migraine - and I don't have headaches. My whole face hurt. (I have two optic aneuris... Read more
I had a severe migraine - and I don't have headaches. My whole face hurt. (I have two optic aneurisms and I was afraid they were starting to bleed out.) My eye was running water even more at that point and I also had some mucus in my eye. I went to ER. January 8 and they did a CT scan - and they gave me something IV for pain. They told me to take extra strength Tylenol every four hours and that didn't help. After one hour, I was in severe pain again. At that point, both eyes were tearing. I went to the dentist (Monday) -and they did x-rays - ( to see if I had a tooth issue and I went to my ENT doctor (Tuesday)- and he said it didn't appear that I had a major infection. still in severe pain - she gave me a prescription to get rid of infection in my eyes. She gave me a steroid shot - which stopped the pain. The following week, I had an appt with an ophthalmologist- I was not in pain any more and my eyes had pretty much cleared up. He said I probably had a viral or bacterial infection prior and when I got the vaccine then that was why I got a migraine. 2nd vaccine - 30th of January (8:30) - I slept all that day - I was sleepy the whole day and the Sunday, I had flu like symptoms and after that I was fine. This week, I have the infection in my eyes again. I went back to the Dr yesterday to get an antibiotic because I was having the same kind of infections. This time - infection in my left eye, with tearing and mucus. They had me do the eye drops again and nasal spray I've been using.
76 2021-03-26 headache, cough, chills, influenza like illness Dry, persistent cough, chills, body ache and headache (flu like symptoms). Home treatment of plenty... Read more
Dry, persistent cough, chills, body ache and headache (flu like symptoms). Home treatment of plenty of water, orange juice, hot green tea, ibuprofen and lots of sleep. Symptoms only lasted 1 day. The 2nd day after the vaccine, there were no more symptoms.
76 2021-03-27 chills, fever Chills, fever, nausea
76 2021-03-27 fatigue, fever, headache, chills 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 2021-03-27 fever Itchiness, redness, swelling around the area of the injection in the right arm. It started 26 hours ... Read more
Itchiness, redness, swelling around the area of the injection in the right arm. It started 26 hours after the 2nd dose of moderna injection was given. I also had fever and body pain / aches within 12 hours of the 2nd dose of Moderna vaccine. Incidentally, I also had fever, chills, body pain / aches after the 1st dose of the moderna vaccine in late February. At that time, I did not have such a rash/redness/swelling etc.
76 2021-03-28 fatigue, malaise, cough Debilitating fatigue, mild-moderate nausea, increased coughing/shortness of breath, general malaise ... Read more
Debilitating fatigue, mild-moderate nausea, increased coughing/shortness of breath, general malaise for about 5 1/2 weeks.
76 2021-03-28 fever, chills, headache 1st shot given on 2/24 at 1400 second shot given 3/25 at 1110. Fever of 101, chills, body aches and ... Read more
1st shot given on 2/24 at 1400 second shot given 3/25 at 1110. Fever of 101, chills, body aches and a headache. Taken otc analgesics: Tylenol and Ibuprofen.
76 2021-03-29 chills, fatigue 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 sweating, fatigue, headache, chills 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 2021-03-29 fever, dehydration Presented like a stroke approximately 22 hours later - slouched, leaning sideways, breathing, but un... Read more
Presented like a stroke approximately 22 hours later - slouched, leaning sideways, breathing, but unresponsive. Called EMTs who transported her to ER where tests showed slight fever and minor dehydration
76 2021-03-30 chills, fatigue, headache 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 2021-03-30 fatigue, chills, fever 2/1 midnight woke up with fever, chills. 2/1 No reaction to vaccine but sore arm. 3/3 went to orthop... Read more
2/1 midnight woke up with fever, chills. 2/1 No reaction to vaccine but sore arm. 3/3 went to orthopedic dr for shoulder, put on meloxicam. Began noticing that I couldn't hear well, keep saying excuse me, trouble hearing tv, tinnitus began (Never had this problem before. (Husband could hear better than me without his hearing aids.) (3/18 went to doctor ). He thought I had fluid in my ears. Put me on fluticasone Propionate Nasal spray, stopped meloxicam. Called Dr. and he put me on antibiotic (10 days) thinking I had ear infection. Still couldn't hear well. On 3/1 at 11:45 am had 2nd Moderna vaccine shot. By midnight I had fever, chills. 3/2 fever, chills am, very tired. 3/2 in the evening I thought I would watch tv. I turned it on and the mouths were moving but I couldn't understand anything they were saying. 3/8 Went to ENT and had a hearing test. I still had tinnitus. Test results showed that I have a moderate to severe hearing loss in conversation area in both ears. 3/9 Went to ENT who prescribed prednisone beginning with 60 mg. 3/30 Had another hearing test at ENT. Test results showed no improvement, hearing still as on 3/8. So end results I have tinnitus all the time and a hearing loss that I did not have before taking the vaccine.
76 2021-03-30 fatigue The next day, I felt light headed and very tired. I felt that way for about three weeks. I had loose... Read more
The next day, I felt light headed and very tired. I felt that way for about three weeks. I had loose stool for those three weeks - it wasn't diarrhea but loose stool. And then 11 days after vaccine, I had a rash on my thighs and my lower torso. And that rash lasted for four days and it went away. Rash looked like measles or chicken pox - red dots. I went to the dermatologist as I have never had a rash in my life. Dermatologist did a Biopsy. The rash lasted for four days and cleared up.
76 2021-03-30 fever, chills 2/1 midnight woke up with fever, chills 2/1 No reaction to vaccine but sore arm. 3/3 went to orthope... Read more
2/1 midnight woke up with fever, chills 2/1 No reaction to vaccine but sore arm. 3/3 went to orthopedic dr for shoulder, put on meloxicam began noticing that I couldn't hear well, keep saying excuse me, trouble hearing tv, tinnitus began (Never had this problem before. Husband could hear better than me without his hearing aids.) 3/18 went to doctor. He thought I had fluid in my ears. Put me on fluticasonne Propionate Nasal spray, stopped meloxicam Called Dr. and he put me on antibiotic (10 days) thinking I had ear infection. Still couldn't hear well. on 3/1 at 11:45 am had 2nd moderna vaccine shot. By midnight I had fever, chills 3/2 fever, chills am, very tired.
76 2021-03-30 fever, lethargy Fevers to 103 degrees, lethargy, weakness, myalgia in neck and shoulders severe. Poor exercise tole... Read more
Fevers to 103 degrees, lethargy, weakness, myalgia in neck and shoulders severe. Poor exercise tolerance. Oxygen desaturation with walking. Symptoms of severe neck and shoulder pain persisted greater than 3 weeks. PT required. Still ongoing. Then 2nd vaccine on March 12th. Symptoms of high fevers, weakness, myalgia this time in low back and hips.
76 2021-03-30 runny nose, chills, fatigue, influenza like illness, fever She got the vaccine, did have pain at the site and thinks it was the first day at the end of the day... Read more
She got the vaccine, did have pain at the site and thinks it was the first day at the end of the day. When she laid down she could feel it and also on the 2nd day at night. On day #2 she felt like she was coming down the flu. She had skin sensitivity, chills and a fever, extreme fatigue and her nose was running. These symptoms lasted all day long and into the evening. By the third day she woke up and was fine. She was a little tired, which lasted for about 3 more days, but minimal. She cleaned an area in her kitchen and came across a detox that she had taken (herbal formula), and she thinks when she first found it she took it, and the next day she took it as well.
76 2021-03-31 headache Giant cell arteritis. Symptoms started 2 days after COVID with upper back and neck pain, lymph node ... Read more
Giant cell arteritis. Symptoms started 2 days after COVID with upper back and neck pain, lymph node enlargement and tenderness, TMJ pain/trimus. After second dose of Moderna vaccine, worsening sympotms with intermittent sharp lancing pain behind right ear, right >left frontal headache, lancing pain on forehead that radiated to back of head, scalp tenderness, no vision changes or temporal artery tenderness. Labs, exams, CT head and MRI/MRA head done. Video, telephone, office visit, ER visits. Prednisone started. Temporal artery ultrasound negative. Temporal artery biopsy consistent with temporal arteritis. Symptoms improved with prednisone.
76 2021-04-01 fever 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 2021-04-02 body temperature increased, sleepiness Red and swollen arm. Slight temp (99.7) and slept the following day ...unusual for me.
76 2021-04-03 fatigue, chills, headache DIARRHEA 3 TIMES IN 5 HOURS AND NAUSEA, EYES BURNING, HEADACHE, TIREDNESS, VACCINATION SITE VERY SO... Read more
DIARRHEA 3 TIMES IN 5 HOURS AND NAUSEA, EYES BURNING, HEADACHE, TIREDNESS, VACCINATION SITE VERY SORE WHICH LASTED 2-3 DAYS. THE TIREDNESS AND GENERAL NOT FEELING WELL RETURNED SEVERAL TIMES DURING THE NEXT 3 WEEKS. AFTER THE SECOND SHOT ON 3/31/21 AT A VACCINATION SITE. THE SIDE EFFECTS STARTED AFTER 20 HOURS AS FOLLOWS: ACHY ALL OVER, HEADACHE, CHILLS, BURNING EYES, HOT FLASHES, TIREDNESS WHICH HAS BEEN HAPPENING OFF AND ON SINCE 3/31/21. FEEL I MAY NEED BLOOD WORK TO SEE WHAT IS GOING ON. I HAVE HAD EPSTEIN BARR VIRUS AND WONDER IF THIS HAS BEEN REACTIVATED.
76 2021-04-03 fatigue, chills, sweating, headache 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 2021-04-03 throat pain rash on facew shortness of breath body ache and pain sore neck and throat
76 2021-04-04 fever, headache 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 2021-04-04 fever Pt was admitted to hospital approx 2 weeks after 2nd dose of Moderna with dx of acute metabolic ence... Read more
Pt was admitted to hospital approx 2 weeks after 2nd dose of Moderna with dx of acute metabolic encephalopathy, fiver, cervical stenosis
76 2021-04-05 fever, headache She had 102 temperature for next three days, accompanied by severe headache, extreme nausea (still a... Read more
She had 102 temperature for next three days, accompanied by severe headache, extreme nausea (still a bit nauseous today), face red and swollen, jaw hurt, stomach pains-she couldn't eat.
76 2021-04-06 fever Numbness in hands and lower arms for duration of a low grade fever (about 5-6 hrs.)
76 2021-04-06 sleepiness, fatigue This was my 2nd shot of the Moderna COVID-19 Vaccine EUA. The morning after day of shot I had a sor... Read more
This was my 2nd shot of the Moderna COVID-19 Vaccine EUA. The morning after day of shot I had a sore arm and felt tired through the day, I slept most of the day. These symptoms went away quickly from the following day.
76 2021-04-08 headache After first Moderna vaccine had several migraines with the Z's but they were unusual. Usually I have... Read more
After first Moderna vaccine had several migraines with the Z's but they were unusual. Usually I have a path of Z's going left to right and then at my age I had a very slight headache. These looked different with broken up lights. and I woke up with them.Then on Feb 24 :1t 1:15 I had my second. The next morning I woke up with a hazy eyesight but I thought it might be a migraine. I somehow knew it wasn't but didn't go to a doctor. The next morning definitely knew. Saw 2 doctors one in emergency situation he placed me on steroids but I had lost part of my eye sight.
76 2021-04-09 chills, headache Swelling in bottom and top lips, tongue, throat, knots on head, welts on both sides of abdomen, tons... Read more
Swelling in bottom and top lips, tongue, throat, knots on head, welts on both sides of abdomen, tonsils starting around March 21. Had to go to urgent care on March 28. Strange headache on left side. Finger tips and toes went numb. Covid vaccine related illness(chills, body aches, shallow breathing) started 1 week after 2nd vaccine. Ongoing shortness of breathe.
76 2021-04-10 fever Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming ... Read more
Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming from around the liver area but it radiated under my right and left breasts; Lost my appetite; Urine was gold; Lost 10 lbs; Could not get a deep breath; Temperature reached 101F; vomiting; Nauseous; A spontaneous report was received from a consumer who is 76 year female who experienced a reaction to the vaccine, experienced pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea. The patient's medical history included fibromyalgia, ulcerative colitis, and obesity. Concomitant product use included:levothyroxine 150 mg, verapamil 120 mg (blood pressure), losartan 100 mg (blood pressure), Asacol 800 mg three times a day, Eliquis 5 mg, alprazolam (Xanax) 0.5 mg up to three a day, Centrum silver once a day, iron pill once a day, B12 500 mcg once a day, GNC probiotic 50 billion CFU, vitamin D 1000 mg, Citracal max Plus D3 once a day, magnesium glycinate, diphenydrinate. On 15-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number015M20A.). On 16Mar2021,approximately 1 day prior to the onset of the symptoms, the patient received their first/second of two planned doses of mRNA-1273 (Batch number: 001B21A.) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17Mar2021 about 10 am, the patient woke up screaming with pain coming from around the liver area radiating under the right and left breasts. The patient states that taking deep breaths lead to excessive vomiting resulting in the ultimate loss of 10lbs. After the initial episode of vomiting, there was only nausea. An ambulance transported her to the hospital, as she continued to scream, resulting in being medicated to calm her down. The medication used is unknown. In the hospital, received morphine for three days In the hospital, she was told her temperature reached 101F. Upon returning home on 19Mar2021 afternoon, her temperature ranged from 99.4 to 99.8, one day peaking 101F. Today (29Mar2021) it is back to a more normal temperature: 98F. In the hospital, ultrasounds, CAT scan, and blood and urine tests was performed, results were not provided. Patient reports currently she is still in pain, that has reduced from a 10 to a 2. The outcome of the events, pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea is unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
76 2021-04-11 cough 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 malaise 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 fever complete body pain, fever, legs were killing her, back and neck, headache, thighs, and lower legs, w... Read more
complete body pain, fever, legs were killing her, back and neck, headache, thighs, and lower legs, when going to lay down it felt like pins and needles in legs, feet and ankles were swollen, ear ache, itching near vaccine site,
76 2021-04-13 fatigue, fever 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 headache 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 malaise 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 sinus headache, chills, fever 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 2021-04-14 chills, lethargy, fever Significant teeth chattering, body shaking chills starting about 3:45 am lasting about 1 1/2 hours ... Read more
Significant teeth chattering, body shaking chills starting about 3:45 am lasting about 1 1/2 hours and then fever of 101 next morning. Body aches and lethargic most of day
76 2021-04-14 headache, fever, chills Fever, chills, headache, body aches, nausea.
76 2021-04-14 headache 12:30. Complained of headache. VS: 170/74; p. 74 R 16. Sats 98% . Took Amilodopine 5mg (self med) 1... Read more
12:30. Complained of headache. VS: 170/74; p. 74 R 16. Sats 98% . Took Amilodopine 5mg (self med) 12:35. Rested quietly. Immediate evaluation by onsite EMS and NP. Offered water. 13:02 VS: 150/73; hr 70; R 14. Sat. 96% . DIscharged to home with improvement in headache at 1:05 pm.
76 2021-04-14 influenza like illness, fever Fever (went up to 102), aches, sore arm, diarehea, throwing up, tired, headache, dizziness (all las... Read more
Fever (went up to 102), aches, sore arm, diarehea, throwing up, tired, headache, dizziness (all lasted for several days). Felt like a very bad case of the flu. I also receive a flu shot each year and have almost the same reactions.
76 2021-04-15 chills, fatigue, malaise 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 2021-04-15 fever Bloody diarrhoea; diarrhea; nausea; vomiting; fever; minor sore left arm; This spontaneous case was ... Read more
Bloody diarrhoea; diarrhea; nausea; vomiting; fever; minor sore left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) (seriousness criterion medically significant), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). In March 2021, the patient experienced PAIN IN EXTREMITY (minor sore left arm) and PYREXIA (fever). On 04-Mar-2021, PAIN IN EXTREMITY (minor sore left arm) had resolved. On 15-Mar-2021, PYREXIA (fever) had resolved. On 16-Mar-2021, DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was 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 US-MODERNATX, INC.-MOD-2021-075222 (E2B Linked Report).; 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. -MODERNATX, INC.-MOD-2021-075222:crosslinked to Dose2
76 2021-04-16 headache 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 malaise, headache 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 2021-04-19 headache, fatigue, throat irritation SORE ARM--HEADACHE--BODY ACHES --SCRATCHY THROAT --FATIGUE
76 2021-04-19 fever Slurred speech. Weakness. Muscle aches. Fever.
76 2021-04-20 chills, fever, nasopharyngitis 3/19/21 2:30 am Fever lasting aprox 3 days 3/30/21 8:00 pm 100.5 Fever & aches lasting 4 hours ... Read more
3/19/21 2:30 am Fever lasting aprox 3 days 3/30/21 8:00 pm 100.5 Fever & aches lasting 4 hours 3/31/21 7:30 pm 101.1 Fever & aches lasting 4 hours 4/1/21 2:00 am Fever & Aches with EXTREME chills lasting 1 hr. 4/1/21 Cold sores and cankars lasting 1 week 4/10/21 very mild cold
76 2021-04-20 headache, influenza like illness 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 2021-04-20 headache Approximately 2 hours after 1st dose Moderna, developed right sided facial numbness and tingling and... Read more
Approximately 2 hours after 1st dose Moderna, developed right sided facial numbness and tingling and right sided headache. Symptoms lasted approximately 2 hours, then disappeared.
76 2021-04-20 influenza like illness, headache after 3 minutes of getting shot, patient developed headache, labored breathing, tongue swelling, bur... Read more
after 3 minutes of getting shot, patient developed headache, labored breathing, tongue swelling, burning sensation in the chest, and was flushed. she was at a drive through administration facility run by Hospital Systems. she was given benadryl and epinephrine and then was driven to the ED, where she was given IV steroids. she also developed flu like symptoms which she is still having now.
76 2021-04-22 headache Continued, nonstop nausea/diarrhea, headache, joint pain (back, hips, knees), circulation issues (in... Read more
Continued, nonstop nausea/diarrhea, headache, joint pain (back, hips, knees), circulation issues (in mornings hands don't open and close well)
76 2021-04-23 chills severe chills, little confused, weakness in legs could barely stand or walk, shaking of hands
76 2021-04-26 malaise, chills, fatigue Middle of night, at 02:00 am - chills, felt like I had COVID all over again - sick for two days and ... Read more
Middle of night, at 02:00 am - chills, felt like I had COVID all over again - sick for two days and then I got better. Had fatigue - and the fatigue never stops. It goes on forever.
76 2021-04-26 malaise, headache Headache, blurry/double vision, malaise for past week
76 2021-04-27 headache, chills, fever, fatigue I awoke at 1:30am 0n Tuesday April 27th shaking with chills, headache and fever that went up to 100.... Read more
I awoke at 1:30am 0n Tuesday April 27th shaking with chills, headache and fever that went up to 100.7. I had received the second Moderna shot 16 hours before at 9:30am the previous morning (Monday April 26th 2021). I had chills and shaking until noon but had the headache and some aches in my arms and legs until about midnight when I fell asleep for the night. I woke up on Wednesday April 28th at 5am exhausted but no aches, headachce or chills. I am just taking it easy today and try and recoup my strength.
76 2021-04-28 cough 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 headache 1st dose...only right arm (shot spot) sore and it's still sore today, but no other side effects at a... Read more
1st dose...only right arm (shot spot) sore and it's still sore today, but no other side effects at all 2nd dose...arm not sore, BUT I was so out of it the next day 1. Major headache...no relief with acetaminophen & didn't try anything else 2. Minor temperature...99.8 most of the day 3. Every muscle, every joint and every bone in my body ached...perhaps my skin & hair also :-) 4. Nausea...without vomiting 5. Dizziness upon standing and intermittent lying down 6. Lethargic...probably due to all the above Stayed prone all day and night except to get water and go to the bathroom Drank lots of water and hot tea with saltines Day 2: 1. Headache...gone 2. Temperature...back to normal 3. Aching...subsided, but not totally gone 4. Nausea...gone 5. Dizziness...subsided but not totally gone 6. Lethargy...hung in there, but not nearly as profound Made myself get up, eat and do minor household chores to gain better equilibrium and feel more productive plus work out the muscle tightness from being inactive
76 2021-04-30 dehydration, fever 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 2021-05-02 malaise 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 2021-05-03 headache, body temperature increased By 11:30 AM headache starting, eyes burning By 12:30 could not get warm even with thermostat at 80°... Read more
By 11:30 AM headache starting, eyes burning By 12:30 could not get warm even with thermostat at 80°. Very bad gas. By 7PM temperature 101°. By 2:30 pm severe nausea. Began vomiting and then retching by 9:30 PM which was on and off for 5 hours. From about 11 PM through the night and into the next morning so hot could not use covers even as the temperature went down to 79°. Headache was extreme. Gradually began to subside throughout the afternoon. Days 3-4-5-6 after the vaccination bright pink full body rash. bright pink covered all the skin. Itching days 5-6.
76 2021-05-04 fatigue, chills Two weeks after second shot, I experienced all over body myalgia, chills, extremely fatigue and weak... Read more
Two weeks after second shot, I experienced all over body myalgia, chills, extremely fatigue and weakness. It lasted for ten days. Extra strength Tylenol, 2 every 8 hours helped. Then the symptoms would return. This lasted off and on for weeks. Gradually feeling better but still taking some Tylenol now and then. Had blood work and my sed rate which is usually 5 was 67 and showed positive antibodies for Covid. I have not had Covid 19.
76 2021-05-05 fatigue, head discomfort, headache 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 2021-05-06 fatigue, headache 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 2021-05-08 malaise Patient presented with abdominal pain, nausea and malaise. She was diagnosed with acute idiopathic ... Read more
Patient presented with abdominal pain, nausea and malaise. She was diagnosed with acute idiopathic pancreatitis 2 days after 1st moderna vaccination. Imaging of gall bladder is normal. Triglycerides are normal. No offending medications identified.
76 2021-05-10 malaise 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 2021-05-11 chills, headache, fatigue, sweating I could not get out of bed for 3 days terrible chills weakness whole body aches crushing fatigue ver... Read more
I could not get out of bed for 3 days terrible chills weakness whole body aches crushing fatigue very bad headache . Worst symptoms abated but I still do not feel good have crippling fatigue unusual headaches & unexplained leg pains & unprededictable cold sweats & odd temperature sensitivity
76 2021-05-12 fever, chills 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 2021-05-13 headache Patient's arm started involuntarily shaking about 17 hours after vaccine administration. Patient st... Read more
Patient's arm started involuntarily shaking about 17 hours after vaccine administration. Patient states it continued for an hour then gradually subsided. She would also like to report severe headache beginning at the same time.
76 2021-05-18 fatigue Experienced intense pain in joints and muscles on 1/27. During the next 2-3 weeks, pain moved to oth... Read more
Experienced intense pain in joints and muscles on 1/27. During the next 2-3 weeks, pain moved to other joints and muscles. Intensity varied. Applied ice to back of knees and legs when movement was affected. As the weeks progressed, fatigue, weakness and pain became more intense. It became difficult to stand from a sit position, walk, turnover in a lying position, bend-over and sit-down. PCP ordered labs on 3/08, which resulted in ESR and CRP showing elevated, inflamed condition. Referred to rheumatology. Diagnosed on 4/21 with polymyalgia rheumatica. Prescribed prednisone 15mg/day. Symptoms relieved and strength returned. Gradual tapering off of prednisone is planned.
76 2021-05-19 fever Fever was the main thing. I developed a rash on the arm - on the left arm - on the 19th of January ... Read more
Fever was the main thing. I developed a rash on the arm - on the left arm - on the 19th of January with a fever. Doctor's visit on 21st. Treatment was ice. The fever went away. The rash was all the way down to my elbow and it lasted four days- through the weekend. It itchy and hot.
76 2021-05-20 headache Death Thrombocytopenia Subdural bleeding HEADACHE DIZZINESS
76 2021-05-21 headache, malaise Achy muscles, headache, general malaise
76 2021-05-23 bronchitis Admitted to facility for bilateral pulmonary embolism after bronchitis for 3 weeks
76 2021-05-25 headache, fever, chills COVID-19 Chills Body aches Fatigue, unspecified type Lyme disease Nausea and vomiting, intracta... Read more
COVID-19 Chills Body aches Fatigue, unspecified type Lyme disease Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type Acute nonintractable headache, unspecified headache type Dyspnea on exertion Acute midline low back pain without sciatica Diarrhea, unspecified type BMI 28.0-28.9,adult Close exposure to COVID-19 virus Fever, unspecified fever cause Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Post Infusion Outreach #1 Infusion Date: 05/19/21 ED Course as of May 23 1036 Sun May 23, 2021 1025 EKG shows normal sinus rhythm rate 84 axis of 61. There is no acute ST or T wave changes noted. No signs of ST elevation. [RS] 1032 Patient was given meclizine and Zofran and saline. I reevaluated her. She says she is feeling much better. She is able to stand and walk without any difficulty. I discussed keeping her for MRI as we cannot completely rule out stroke. She verbalizes understanding of this. She still wishes to go home. She will get outpatient follow-up with her family doctor and return for worsening symptoms. We will give her a prescription for meclizine. Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab
76 2021-05-26 headache Patient had severe unilateral headache, Near complete occlusion of the Right Middle cerebral artery ... Read more
Patient had severe unilateral headache, Near complete occlusion of the Right Middle cerebral artery , It is getting better so presumed diagnosis is Reversible Cerebral Vascoconstriction syndrome
76 2021-05-27 headache Unstable dizziness; Constant swishing noise in left ear; Wite blood cell at 10.8 and should be 10.... Read more
Unstable dizziness; Constant swishing noise in left ear; Wite blood cell at 10.8 and should be 10.2.; head aches.
76 2021-05-27 pneumonia 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 2021-06-02 fatigue Has felt run down and not right since second shot on 4/22/2021, then started with TIA like symptoms ... Read more
Has felt run down and not right since second shot on 4/22/2021, then started with TIA like symptoms 6/2/2021, and found to be bacteremic.
76 2021-06-02 headache, fatigue 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 head discomfort 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 2021-06-06 fever, headache, fatigue, chills Fever ,chills,headache,unable to sleep 2 wks due to tartness of both leg muscles,lose of balance & l... Read more
Fever ,chills,headache,unable to sleep 2 wks due to tartness of both leg muscles,lose of balance & leg strength, extremely tired loss of energy.
76 2021-06-06 fever, pneumonia, chills, cough Patient presented to PCP from group home residency on 05/21/21 with C/O cough, dyspnea, fever, chill... Read more
Patient presented to PCP from group home residency on 05/21/21 with C/O cough, dyspnea, fever, chills, and body aches. Known exposure to COVID-19. Rapid test in PCP office was positive for COVID-19. Chest Xray showed pneumonia. Patient admitted to hospital on 05/21/21
76 2021-06-07 fatigue 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 headache, fatigue, fever 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 2021-06-08 fever, headache, fatigue, influenza like illness I felt an immediate "anaphylaxis-like" reaction right away. I had swelling of my mouth, face, eyes ... Read more
I felt an immediate "anaphylaxis-like" reaction right away. I had swelling of my mouth, face, eyes and nausea. I felt dizzy and light headed and had fever of 101F, headache, body aches and I could not get out of bed. I had trouble sleeping. I had trouble concentrating, decrease cognitive abilities and extreme fatigue. I did take an antihistamine (Xyzal) prior to the vaccine. I took Tylenol and Zofran for nausea. The swelling subsided after 2 days, and the acute-flu like symptoms lasted about a week. I usually see my doctor every week for weekly injection for my RA . I still have nausea and he prescribed Zofran for that. I have small-medium lost my appetite and my taste and smell have change and also itchy eye. But I have noticed increased saliva excretion.
76 2021-06-12 fatigue, chills Patient described onset as 6/10/2021 into 6/11/2021 - rash on stomach, back and neck; nausea; tiredn... Read more
Patient described onset as 6/10/2021 into 6/11/2021 - rash on stomach, back and neck; nausea; tiredness; and chills
76 2021-06-12 fever, chills, fatigue PT REPORTS CHILL, FEVER, TIRED AND UPSET STOMACH AND GREEN DIARHEA
76 2021-06-13 headache, sleepiness Attempted to get out of bed to go potty and slid to floor unable to stand on legs, daughter and gran... Read more
Attempted to get out of bed to go potty and slid to floor unable to stand on legs, daughter and grandson had to help put me back to bed, went to emergency room and they couldn't figure out what was wrong but with assistance from nursing was able to walk. I came home and pretty much slept all day. The next day was weak, sore all over and had a headache
76 2021-06-14 fatigue, cough 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 2021-06-14 fatigue Pt stated that she had her Moderna covid vaccine on Thursday and woke up the next morning extremely ... Read more
Pt stated that she had her Moderna covid vaccine on Thursday and woke up the next morning extremely weak. She said her legs were so weak she couldn't stand and had to be helped back to bed. She was also very tired. This lasted for 2 days, until Sunday. She was feeling better by Monday. She contacted the doctor and is to call them again in a few days with an update.
76 2021-06-16 fatigue, throat pain, nasal discomfort PT WITH ALLERGIC REACTIONS. SORE THROAT. IRRITATIONS. SKIN IRRITATIONS. RASH . MUSCLE ACHES. NASA... Read more
PT WITH ALLERGIC REACTIONS. SORE THROAT. IRRITATIONS. SKIN IRRITATIONS. RASH . MUSCLE ACHES. NASAL IRRITATION, LOOSE STOOL FOR 3 DAYS. FATIGUE . AT FIRST, ITCHING NOW AFTER 1 MONTH . AT TIMES., WITH IMPROVED SKIN IRRITATIONS. HAIR THINING PER PT.
76 2021-06-16 fatigue Patient received the second moderna covid-19 vaccine on 4/1/21. 2 days later she developed a painfu... Read more
Patient received the second moderna covid-19 vaccine on 4/1/21. 2 days later she developed a painful itchy rash at injection site that traveled down her whole arm to her hand. Over the next few days she began to feel dizzy and weak. She had an episode where she was parked in her driveway and felt she could not get out of the car due to feeling dizzy, weak, and faint. She was able to get out of her car and to her bed were she remained for the next 8 hours. She felt she could not get our of bed due to feeling so weak and faint and she feared she would fall. She woke up the next morning able to get out of bed. She then began to develop pain and weakness in both shoulders, both arms, both hands, both knees, and both ankles. We ordered blood test on 5/11/21 including a CBC, CMP, CRP, urinalysis, ESR Wes+Fer, Rheumatoid arthritis factor, and ANA all blood test came back within normal limits. Patient was seen in the office on 5/24/21 for a physical exam and was found to have loss of range on motion in both shoulders and arms, pain and swelling at both elbows, both hands, and both knees. Patient also complained of general weakness, fatigue and a fullness or swelling in both ankles. She has been doing physical therapy, is taking tylenol for the pain, and has been on 2 rounds of steroid medrol dose packs. Patients continues to suffer with weakness, fatigue, muscle, joint pain in whole body. We have also contacted the moderna company and was told they could not help us and hand no treatment or other advise for us. We have referred our patient to a Rheumatologist.
76 2021-06-16 fever On 04/01/21 patient presented to Emergency Department with altered mental status and fever. Husband... Read more
On 04/01/21 patient presented to Emergency Department with altered mental status and fever. Husband stated that at baseline patient has no dementia and speaks and interacts normally. He stated they had their Covid vaccine on 03/31/21 in the morning (location of vaccine administration was not specified). He said beginning 04/01 in the morning she was not acting like normal self. She was not speaking as much as she normally does. He stated she did fall on 03/31, but does not believe she struck her head. He said her behavior was normal yesterday. She does not walk since a seizure 3 months ago. No shortness of breath or cough was reported. He stated her chest seemed red earlier but that has resolved. The patient was unable to give history and not responding to questions. Patient was admitted to hospital to monitor closely. On 04/02 patient was back to baseline and was discharged from the hospital.
76 2021-06-18 sleepiness, headache Day 2..and 3, headache base of skull Day day 2 to present time. Soooo sleepy. Sleep 12 hours a night... Read more
Day 2..and 3, headache base of skull Day day 2 to present time. Soooo sleepy. Sleep 12 hours a night, nap in day. June 2 start of stomach or gut hurt, constipated, until June 9, June 2, beginning of all leg, ankle, knee, hip lower spine pain could barely walk. Lasted until June 10. June 15,soreness and roughness inside cheeks, June 16, Terrible pain in left knee ,the leg with varicose veins. Feels like nerve knee, up to hip. Leg swelling. Can only walk for a little. Still happening. Also, drinking water goes right through me, comes out almost clear.
76 2021-06-21 fever This spontaneous case was reported by a physician (subsequently medically confirmed) and describes t... Read more
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica) and GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.) 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 COVID-19 on 04-Nov-2020. Concurrent medical conditions included Hypertension since 2014 and Walker user. Concomitant products included LISINOPRIL for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021 at 1:45 PM, the patient experienced GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.) (seriousness criterion medically significant), ASTHENIA (Weakness), SCIATICA (bilateral hip pain began, unrelated to any injury, gradual onset. sciatic distribution/sciatic pain), INSOMNIA (Difficulty sleeping turning in bed), DECREASED APPETITE (Lack of appetite), ARTHRALGIA (Bilateral hip pain/severe hip pain/hip pain was worse after inactivity), PYREXIA (Fever 103) and MYALGIA (Myalgias). On 20-May-2021, the patient experienced POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica) (seriousness criterion medically significant). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 220 mg twice a day; PREDNISONE ongoing since an unknown date at a dose of 15 mg once a day; PREDNISONE at a dose of 12 mg once a day; PREDNISONE at a dose of 10 mg once a day; MELOXICAM ongoing since an unknown date at a dose of 15 mg once a day and IBUPROFEN at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica), GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.), ASTHENIA (Weakness), SCIATICA (bilateral hip pain began, unrelated to any injury, gradual onset. sciatic distribution/sciatic pain), DECREASED APPETITE (Lack of appetite), ARTHRALGIA (Bilateral hip pain/severe hip pain/hip pain was worse after inactivity), PYREXIA (Fever 103) and MYALGIA (Myalgias) outcome was unknown and INSOMNIA (Difficulty sleeping turning in bed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 11.5 (Low) Decreased and 13.5 (Low) Decreased. On an unknown date, Rheumatoid factor: normal (normal) rheumatoid arthritis profile normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included small dose of unspecified of antihypertensive medication The patient had initial improvement in neck pain, and later bilateral hip pain began which was unrelated to any injury. There was a gradual onset of sciatic distribution which got worsened after inactivity. Also, the patient had difficulty in sleeping, sitting and walking which kept increasing over time. The patient had seen her physician on 30 Mar 2021 and was prescribed Aleve 220 mg, bid at its maximum dose for three days which helped with some improvement in symptoms which stopped after ten days and had rebound of symptoms within one week. The patient's rheumatoid arthritis profile was normal. Ten days after using Aleve, the symptoms soared. The patient also used Ibuprofen and had to return to use Aleve. On 01 May 2021, the patient could not climb steps. On 03 May 2021, the patient started prednisone and meloxicam. The symptoms improved within one day. The patient saw nurse practioner with rheumatologist on 20 May 2021. Later, prednisone was decreased to 12 mg, daily. The patent was diagnosed polymyalgia rheumatica. The patient saw rheumatologist on 03 Jun 2021, and prednisone was tapered beginning with 10 mg, daily. Later, it was tapered by 1 mg on a monthly basis for the next 10 months and also meloxicam was discontinued. 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. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received on on 09 Jun 2021: Patient demographics, reporter, relevant medical history, concomitant drug, events, event outcome and case seriousness were updated.; 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 2021-06-23 headache Arm soreness, welts under Bilateral breast, Buttocks, severe headache x4 days,
76 2021-06-24 malaise, chills Within 15 mins after the vaccine, I felt weakness and weak in the knees and chills; it didn't feel ... Read more
Within 15 mins after the vaccine, I felt weakness and weak in the knees and chills; it didn't feel flu-like though. and within the first few hours I had "Moderna arm" - right near the injection site - big red splotch and the arm was sore. The redness in the arm lasted a good week. It was a red blotch but not itchy or swollen. I didn't feel well for a few days after the vaccine. The symptoms came and went as far as how I felt - chills, weak, not feeling terrific for those first few days or so. A month after the second shot, I had a rash on my neck. It came and went - a little itchy and then not itchy. (This happened for a month.) And then at the same time, I felt the same original symptoms - chills and not feeling good. It lasted about three days - the chills and weakness. And then it went away. Even since, April, I get this periodically - I feel weak in the knees, I get the chills and I have to take a Tylenol or something. The middle of May, I was taking off my makeup and I felt a burning on my face (same stuff I've been using for 20 years on my face) red splotch from top of nose and all around and on cheekbones and down the face - it was puffy, swollen, red and caused bags under my eyes and redness under my eyes- and it still is. He gave me a cortisone lotion (my dermatologist) - It's not as red as it was but if I press on it the redness comes back. I have not changed anything with make-up; lotion or food. I have photos of it that I can send of my face. It's still here - maybe not as bright - and I'm not sure that I notice difference using the cortisone cream. It's been a good six weeks since it started on the face.
76 2021-06-24 throat pain Reported that she had a severe sore throat for 3.5 weeks following her first Moderna COVID-19 vaccin... Read more
Reported that she had a severe sore throat for 3.5 weeks following her first Moderna COVID-19 vaccination on 5/28/21. Did not go to a doctor. Did not report to the pharmacy until we called to schedule her second vaccination. Reported that it was "different" in nature than when she gets a sore throat from allergies.
76 2021-06-27 influenza like illness right ear fluid on may may 1 .second vaccine was 5/13 and loss hearing .
76 2021-06-29 fatigue, fever, chills Stages violent fever, chills, aches (2 days) next nausea , abdominal cramping, diarrhea, more new ac... Read more
Stages violent fever, chills, aches (2 days) next nausea , abdominal cramping, diarrhea, more new aches, weakness, exhaustion, loss of balance, another round of fever/chills and repeat again of abdominal distress. This has continued until today (Day 14 since the vaccination.)
76 2021-07-07 chills On 7/8/21, patient contacted the pharmacy to report that she experienced chills and swelling, itchin... Read more
On 7/8/21, patient contacted the pharmacy to report that she experienced chills and swelling, itchiness, and muscle pain in both legs starting on 7/6/21, Tuesday night. She took Tylenol around 8pm, which helped. The next day the chills resolved, but she is still experiencing itchy and swollen legs. She tried Cortizone 10 cream and Bactine Max spray, but neither helped. She received her 2nd COVID-19 vaccine on 6/28/21, and she has experienced an allergic reaction when taking Tylenol previously.
76 2021-07-07 cough I woke up feeling nauseous, dizziness and challenging to walk and a lot of coughing. I went to the d... Read more
I woke up feeling nauseous, dizziness and challenging to walk and a lot of coughing. I went to the dr and he gave me prednisone.
76 2021-07-08 pneumonia, headache leukocytosis--March May--pneumonia July--nausea, headache, SOB, CP, elevated D-Dimer.
76 2021-07-11 fatigue, headache fatique, headaches (still have them. They go from one side of head to the other), swollen hands (con... Read more
fatique, headaches (still have them. They go from one side of head to the other), swollen hands (continuing issue), bone spur on foot (7/10/21), sores in mouth (June 2021), bulging left eye ( June 2021). None of these issues have been resolved. Something new every week. Body's immune system is under attack. I had none of these issues prior to the 2nd vaccination. The first vaccination I got severe covid arm.
76 2021-07-15 chills, fever, fatigue Arm swelling and pain, Diaria, fever chills, extreme fatigue
76 2021-07-15 fatigue 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 2021-07-19 fatigue, chills, headache I was in bed for two weeks as if I had severe flu. Chills, headaches, muscle pains, exhaustion
76 2021-07-19 pneumonia Patient tested positive for Covid 7/19/21. Hospitalized with COVID, pneumonia, NSTEMI
76 2021-07-20 body temperature increased, chills, dehydration 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 runny nose 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.
77 2021-01-01 fatigue My right eye became very painful, hurt and felt scratchy until 12/31/2020. My arm still aches and i... Read more
My right eye became very painful, hurt and felt scratchy until 12/31/2020. My arm still aches and it is 1/2/2021. I also ache everywhere and still do. I am extrememy tired all the time and at times have to lie down. On going.
77 2021-01-04 body temperature increased T.102.9 upset stomach
77 2021-01-07 body temperature increased Elevated Temp 100.2
77 2021-01-10 malaise, chills, body temperature increased 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 body temperature increased, malaise, headache, chills 12 hours after receiving vaccination, became "delirious" temp rose to 103.+ with chills malaise, joi... Read more
12 hours after receiving vaccination, became "delirious" temp rose to 103.+ with chills malaise, joint pain, "head hurt worse than did during active Covid + HA lasted 2 days". Temp gradually decreased to 100 over 2 days. Injection site had "fever" for 3 days still sore 5 days later PCP ordered prednisone and z-pak for symptoms
77 2021-01-11 chills, body temperature increased Chills, was shaking. high temp 103 over the night, then 101, 99. Sore arm.
77 2021-01-11 chills, fever Chills, fever 103, 100, 99. Soreness in the arm.
77 2021-01-11 fatigue 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 2021-01-13 nasopharyngitis had a sever/sever head/chest cold on Monday following the shot given on Friday was on Z-pack and Muc... Read more
had a sever/sever head/chest cold on Monday following the shot given on Friday was on Z-pack and Mucinex--seems to be working
77 2021-01-14 headache The resident has redness and warmth on her LUA from her covid vaccination. The resident states she h... Read more
The resident has redness and warmth on her LUA from her covid vaccination. The resident states she has a headache and some wheezing. New order received for Benadryl 25 mg po now and in 6 hours then PRN q6h x 3 days.
77 2021-01-17 chills, headache Chills, shaking so badly could not stand up to drive home from office, headache, ache over entire bo... Read more
Chills, shaking so badly could not stand up to drive home from office, headache, ache over entire body. In bed for 2 days.
77 2021-01-17 headache Lot# not available. 32 hrs after inj 167/69 hb 84 with H/A.
77 2021-01-18 cough 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 fatigue Pain in arm ... moderate/sever nausea ... fatigue ... aches. The nausea came on within a few hours ... Read more
Pain in arm ... moderate/sever nausea ... fatigue ... aches. The nausea came on within a few hours of the shot. I have just awakened the next day and am still nauseated. Hard to keep down required morning medication taken with water.
77 2021-01-19 headache, chills, cough, sweating, fatigue dry cough, chills, sweating, fatigue, headache, pulse ox lower than normal
77 2021-01-19 headache, chills Lightheaded nausea swelling headache chills itching. Swelling continues spreading around injection s... Read more
Lightheaded nausea swelling headache chills itching. Swelling continues spreading around injection site and is hard as a tick. Sensation of stinging
77 2021-01-20 throat irritation Pt seen at COVID vaccination event at her adult health care facility. 17 min post vaccination pt com... Read more
Pt seen at COVID vaccination event at her adult health care facility. 17 min post vaccination pt complained of itchy throat, "funny feeling" and "just feel off." Pt evaluated by RN and no s/s of anaphylaxis including no respiratory distress, low 02, no evidence of uticaria or angioedema. 21 min post vaccination pt given 12.5 mg diphenhydramine IM in different limb from vaccination. RN continued to monitor and no changes in symptoms and no deterioration in symptoms or vitals. 34 min post vaccination another 12.mg diphenhydramine IM administered in different limb from vaccination and continued monitoring by RN with no changes in vitals and no s/s of anaphylaxis. At 11 am pt reported "feeling fine" with no distress. Pt discharged from RN supervision with complaints resolved.
77 2021-01-21 body temperature increased, malaise, headache Red swollen arm. Temperature up to 101-8 Terible headache. Today is the third day of not feeling we... Read more
Red swollen arm. Temperature up to 101-8 Terible headache. Today is the third day of not feeling well.
77 2021-01-21 chills, body temperature increased, malaise 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 fatigue, chills, fever, headache Wednesday and Thursday: headache, low grade fever, chills, fatigue, slight nausea, very sore arm. A... Read more
Wednesday and Thursday: headache, low grade fever, chills, fatigue, slight nausea, very sore arm. Arm still very sore and red today on Friday.
77 2021-01-21 fatigue, sweating 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 2021-01-21 headache Headache, pain in the injection site, threw up. A few hours later she died.
77 2021-01-22 chills, fever First covid given 12/23/20 side effects were sore arm. Second Covid given 1/20/21, approx. 18 hrs. a... Read more
First covid given 12/23/20 side effects were sore arm. Second Covid given 1/20/21, approx. 18 hrs. after shot: chills, fever 100 degrees. Fever through 1/22.
77 2021-01-24 chills, fever Pt was admitted to her local hospital for less than 7 hours for fever, chills, fatigue, intense body... Read more
Pt was admitted to her local hospital for less than 7 hours for fever, chills, fatigue, intense body aches, nausea and vomiting.
77 2021-01-24 headache Redness and swelling in site of injection still present 10 days after shot. My arm was sore for a c... Read more
Redness and swelling in site of injection still present 10 days after shot. My arm was sore for a couple of days as expected, no other symptoms following the shot. I began experiencing a headache January 24th and woke during the night sweating. No temperature last night or today.
77 2021-01-24 throat pain, throat irritation 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 2021-01-24 fever Symptoms started to show after 6 hours from having vaccine administered. Patient had stiffness (una... Read more
Symptoms started to show after 6 hours from having vaccine administered. Patient had stiffness (unable to sit back down from standing position), blank stare, depressed breathing and fever. Transferred to ER, seizures were witnessed. IV Keppra was initiated. Patient was discharged after 2 days and followed up with primary care provider in clinic. Primary provider documented that cellulitis is noted in right arm and antibiotic has been initiated.
77 2021-01-25 chills, fever Very high fever 6 hours after vaccine. Up to 104.3, chills, difficulty breathing, lower back sore. ... Read more
Very high fever 6 hours after vaccine. Up to 104.3, chills, difficulty breathing, lower back sore. Lasted approx 2-3 hours with shivering
77 2021-01-25 fever, body temperature increased, chills fever, chills, pain on the site of shot 100.8 fever
77 2021-01-26 chills Next morning 1/23 woke up with acute vertigo, dry heaves and chills. Next day only dizziness when r... Read more
Next morning 1/23 woke up with acute vertigo, dry heaves and chills. Next day only dizziness when raising or lowering head.
77 2021-01-26 fatigue, headache On 8th day after after the Moderna COVIDvaccine, I awoke and noted that site of inoculation on left... Read more
On 8th day after after the Moderna COVIDvaccine, I awoke and noted that site of inoculation on left upper arm was very itchy with a 2x3 inch raised, red hive. I felt woozy, unsteady, a bit short of breath, a small headache, a bit of nausea,& fatigued. These symptoms subsided gradually over the next 4 days.
77 2021-01-26 fatigue, headache On 8th day after receiving the Moderna COVID vaccine, I awoke and noted that site of inoculation on... Read more
On 8th day after receiving the Moderna COVID vaccine, I awoke and noted that site of inoculation on left upper arm was very itchy with a 2x3 inch raised, red hive. I felt woozy, unsteady, a bit short of breath, a small headache, a bit of nausea,& fatigued. These symptoms subsided gradually over the next 4 days.
77 2021-01-26 fatigue pt stated she has pain, swelling and redness in the left arm at the injection site. Also has some ... Read more
pt stated she has pain, swelling and redness in the left arm at the injection site. Also has some fatigue.
77 2021-01-26 headache, fever, chills, fatigue Chills, Headache, Fatigue, Joint Pain, Fever. Nausea
77 2021-01-27 fatigue, fever, chills, headache 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 2021-01-27 headache Pt stated about a week after covid vax her arm was very sore, swollen, red around the injection site... Read more
Pt stated about a week after covid vax her arm was very sore, swollen, red around the injection site and headache. Pt states she still has a red spot but the swelling is better today.
77 2021-01-27 sweating, chills, body temperature increased, headache, fatigue After i had my injection about 7 hours later about 4-5 o'clock I was sitting in a chair and I got up... Read more
After i had my injection about 7 hours later about 4-5 o'clock I was sitting in a chair and I got up and my balance was completely off and I almost fell into glass table. I felt very foggy and my head wasn't right. I had to hold on to things and I sat down and I kept saying I just didn't feel right. I called my daughter and my arm was hurting and I figure that's what happens, I was getting so tired and really bad headaches. My daughter asked somebody and they told me to take extra strength Tylenol (500 mg ) 2 at a time 6 hour intervals. Which i did i got up the next morning and i had to go back to bed i had no energy. I felt horrible. When i did get up in the afternoon all of a sudden i had horrible chills and that day in Florida it was 82 degrees and i put the heat on 84 and i was extremely shaky and cold. I went back to bed and later i did have a fever, not highs, it only went to 100.8 but during the evening it did break because my sheets were almost saturated. Yesterday morning 1/27 Wednesday i felt better, fever had gone down, pain was still there in my arm and swelling. I thought that was natural. In the afternoon i decided to take a shower and i noticed my left arm around the injection site was a red rash about 7inches long and 4-5 inches wide which i had to seen before i called my primary doctor just to make sure this was normal around injection site and talked to the nurse and she thought it was normal. But if there was no changes to call her back on Friday. Last night not able to sleep i saw an article that said COVID arm rash seen after Moderna vaccine, annoying but harmless it was a large article and it made me feel better but there were only 14 examples but they believe there were more because they were younger people with the health dept. that received this vaccine. It said in 1week it should go away. I still have it, its still red and sometimes itchy and i am happy to say now that i know it will be a week i feel better. it should be on the list of side effects for all.
77 2021-01-27 fever, chills, headache, fatigue I received my injection on 1/25/2021 I had my second COVID shot, everything went well, I just had a ... Read more
I received my injection on 1/25/2021 I had my second COVID shot, everything went well, I just had a little pain and swelling and was fine. About 7 hours later i got up from chair and i was dizzy and my balance was off and i almost fell into table. I didn't feel right. I went and sat back down and i was very tired and i started getting headache. I called my daughter and a nurse she knows told me to take extra strength Tylenol 500 mg take 2 every 6 hours. I started at 730 and went until 130. I slept on and off and got up Tuesday and my arm was still hurting. I was very tired and had no energy. When i got up later in the afternoon i had extreme chills. It was 83 degrees in Florida nd i turned heat up to 84 and i was still shaking. I got under covers and had a fever it was 100.8. Went to sleep that night and fever broke. Got up Wednesday and felt a little better, still had headache and tired. Decided to take a shower. I noticed my left arm where the injection was was all red. 6-7 inches long and about 5 inches wide which i never saw before. after shower I called my PCP I contacted the nurse said she thought it was normal and if there was no change to call her back on Friday. my arm is still red and warm i went to sleep but couldn't sleep. I saw an article about COVID arm rash seen after Modern vaccine and now i know that's what I had. I feel better after I read it in the magazine today and it said it will only last a week. This should be listed as a side effect so nobody else wonders what it is. I drank so much water because it said to drink plenty of water and i tried to use arm as much as possible.
77 2021-01-27 fever Light headed and dizzy 100.4 temperature
77 2021-01-28 fatigue Large 3? diameter rash, very red, itchy, tiredness - it is now 3 days later rash is lighter in color... Read more
Large 3? diameter rash, very red, itchy, tiredness - it is now 3 days later rash is lighter in color, arm tender, not itchy, still feeling tired.
77 2021-01-28 headache Large red rash area at site of injection with some hardness and more headaches than usual. Eight... Read more
Large red rash area at site of injection with some hardness and more headaches than usual. Eight days out now from receiving this dose #1 of Moderna.
77 2021-01-28 fever, chills pt developed fever, chills and backache after the vax . Pt had a tele visit w/ her PCP today 1/29/2... Read more
pt developed fever, chills and backache after the vax . Pt had a tele visit w/ her PCP today 1/29/2021 - pt tested positive for COVID. Pt will FU w/ PCP.
77 2021-01-28 fever Pt reported feeling like she was going to pass out at around 10pm on 1/26/21 and lowered herself to ... Read more
Pt reported feeling like she was going to pass out at around 10pm on 1/26/21 and lowered herself to the floor in her bathroom. Was discovered on the floor around noon, 14 hours later, by staff after noticing her food tray was untouched . Arrived in ED via EMS. Pt was febrile with rectal temp 100.7 c/o weakness. Pt had a WBC count of 11.2, absolute neutrophil 9.9, and creatine kinase 3214. Pt was alert and oriented and reported having been hospitalized for a few weeks in November 2020 with Covid-19 and having received her first dose of covid vaccine at approximately 11:30 on 1/26/21. Hospitalist voiced concerns that this may be a reaction to covid vaccination.
77 2021-01-29 fatigue, chills Moderna COVID-19 Vaccine EUA, first dose: Severe aching in both shoulders on evening/night of the va... Read more
Moderna COVID-19 Vaccine EUA, first dose: Severe aching in both shoulders on evening/night of the vaccine; chills during the night; two days later had severe diarrhea and fatigue, causing me to be down all day. General fatigue for several days after
77 2021-01-29 fever, chills Within 2 hours of receiving vaccine I began feeling achy and cold; within the next two hours was exp... Read more
Within 2 hours of receiving vaccine I began feeling achy and cold; within the next two hours was experiencing hard chills, fever of 101.7; muscle aches and pain. This lasted 33 hours; chills stopped, aches lessened and fever began dropping. By 40 hours after shot temp was normal, no chills or body aches. At 44 hours after event, am back to normal.
77 2021-01-30 chills, fever, headache, fatigue, malaise pain at injection site (beginning 4 hours after injection) sickness beginning at 3am (15 hours afte... Read more
pain at injection site (beginning 4 hours after injection) sickness beginning at 3am (15 hours after injection and continues as this is being completed 9.5 hours later) fatigue, headache, muscle pain, pain in legs, chills, nausea and periodic vomiting, fever (100.6)
77 2021-01-30 fatigue Extreme fatigue and body aches.
77 2021-01-30 fever Fever, heavy rash or hives all over front torso, body aches. Tylenol and benadryl, water and rest f... Read more
Fever, heavy rash or hives all over front torso, body aches. Tylenol and benadryl, water and rest for 24 hours.
77 2021-01-31 chills, fatigue 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 2021-01-31 fatigue, headache Her arm began to get very sore that night, then the next day it was swollen, she also had a horrible... Read more
Her arm began to get very sore that night, then the next day it was swollen, she also had a horrible head ache for two days, the third day she slept most of the day in bed(highly unusual for her). She has experienced fatigue every since the shot. and she has had some digestion issues a couple of days; upset stomach and diarrhea.
77 2021-01-31 productive cough 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 2021-02-01 headache Itchy and rash where vaccine was ministered. My husband age 80 who got the vaccine same time as I i... Read more
Itchy and rash where vaccine was ministered. My husband age 80 who got the vaccine same time as I in left arm and has the same rash , No other symptoms
77 2021-02-01 influenza like illness Woke up 3 days after the shot, feeling like I had the flu. Felt better after getting up, and sympto... Read more
Woke up 3 days after the shot, feeling like I had the flu. Felt better after getting up, and symptoms did not reappear the next day.
77 2021-02-01 fever Swollen face and eyes with deep redness and areas of purple coloring; nausea, multiple herpes zoster... Read more
Swollen face and eyes with deep redness and areas of purple coloring; nausea, multiple herpes zoster outbreak on lips, low grade fever.
77 2021-02-02 fatigue Pt. rptd. on 02/01/2021 having severe body aches, fatigue, inability to taste, (R) arm achy swollen ... Read more
Pt. rptd. on 02/01/2021 having severe body aches, fatigue, inability to taste, (R) arm achy swollen & red "looked like bite mark", & itchy rash allover body Pt. declined injection of solumedrol benadryl or treatment. Wrote script for hydroxyzine 10mg tab, po, 1tab TID, prn. Tylenol (acetaminophen) 500mg 2tab po q8hrs prn. for body aches. Called 02/02/2021 to check on pt and no answer. Left vm.
77 2021-02-02 headache, malaise, fever, chills 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 headache headache, vs taken, observation,
77 2021-02-03 fatigue Fatigue Muscle aches over back, arms, legs Red area on arm Day6. Jan 28-Hip pain and difficulty wal... Read more
Fatigue Muscle aches over back, arms, legs Red area on arm Day6. Jan 28-Hip pain and difficulty walking: ongoing feb 2 given cortisone I hip for bursitis of hip. By feb 2 fatigue and generalized muscle pain and arm redness gone. Feb 3 arm redness recurs, swollen, red, itchy and scaly. 3 and 1/2 inches by 4 inches
77 2021-02-03 headache Redness, swelling at injection site and headache
77 2021-02-04 chills, throat pain, headache, fatigue Chills, body aches, headache, sore throat, tired
77 2021-02-04 fatigue Redness, itching at site, starting suddenly on Feb, 4, Tired and slight body ache all over
77 2021-02-04 fatigue 8 days after vaccination, patient experienced new erythematous patch at the injection site which was... Read more
8 days after vaccination, patient experienced new erythematous patch at the injection site which was painful, swollen, warm, and pruritic. Also had generalized body aches and fatigue x 10 days. This eventually resolved on its own.
77 2021-02-04 headache started hurting same day of shot. i cried. i cant lift my arm at all. i cant dress or bath or anythi... Read more
started hurting same day of shot. i cried. i cant lift my arm at all. i cant dress or bath or anything. my shoulder is swollen. I can only lift it with my other arm. pain goes up my shoulder to the back of my neck and up my head. The shot was given in the muscle and joint. It was am immediate pain.
77 2021-02-04 fever Altered mental status, fever 102.7. Left sided weakness report. I did not see this on my h and p
77 2021-02-05 fatigue, influenza like illness 7 th day after vaccination, arm site began itching about 6 pm. Gradually began stinging & sore by 11... Read more
7 th day after vaccination, arm site began itching about 6 pm. Gradually began stinging & sore by 11pm. Worse the next morning [Friday 2/5j) developed a red spot size of a nickel, then grew larger over the morning with swelling around it, 4 inches across, ver sore! Morning of 2/6 redness much larger, swelling around it worse. Felt tired & kind of like I had mild case of flu too
77 2021-02-05 headache Very strong headache, body aches and weakness. Not strong enough to to leave the bed.
77 2021-02-06 chills, headache, fatigue, cough As outlined earlier
77 2021-02-06 fatigue fatigue, weakness, dizziness for 8 days after receiving vaccine
77 2021-02-06 malaise, fatigue, headache Tiredness, headache, muscle pain, nausea, feeling unwell , diahrea
77 2021-02-06 fever Fever 99.2, muscle aches, sore arm
77 2021-02-06 fever Ran a fever of 102.1. Very weak. Dry heaves. I took Tylenol for the fever. The fever broke about 4... Read more
Ran a fever of 102.1. Very weak. Dry heaves. I took Tylenol for the fever. The fever broke about 4:00 am.
77 2021-02-07 chills Injection site became reddened, swollen and quite painful, including with movement chills lasting a... Read more
Injection site became reddened, swollen and quite painful, including with movement chills lasting approximately 10 hours
77 2021-02-07 fatigue, chills, headache felt like i had covid all over again, severe head and body ache, chills, fatigue, nausea
77 2021-02-07 fatigue, fever, headache, chills 2/4/2021 fever/chills/ fatigue/headache/body aches. Most symptoms gone 2/5/2021 2/6/2021 painful, bl... Read more
2/4/2021 fever/chills/ fatigue/headache/body aches. Most symptoms gone 2/5/2021 2/6/2021 painful, blistery rash on both palms pads and index fingers peripheral. Swollen hands. Still symptomatic 2/8/2021
77 2021-02-07 fatigue Extreme fatigue. Hypertension delivery into a rash, continued itching over all the body!
77 2021-02-07 headache, chills 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 2021-02-08 chills, fever Begining Around 9:00 PM on Fri 1/22/2021 started having chills and probably had fever and became nau... Read more
Begining Around 9:00 PM on Fri 1/22/2021 started having chills and probably had fever and became nauseous. Was sick thru the night and most of day on 1/23/21.
77 2021-02-08 chills, fever No reaction after first vaccine other than soreness in injection site. Day following second vaccine... Read more
No reaction after first vaccine other than soreness in injection site. Day following second vaccine, had chills, fever up to 101, and slight nausea. Those symptoms were better the next day, but it is now day 3, and I still have redness, swelling, and redness around the injection site.
77 2021-02-08 chills, fever chills, fever, body ache, headache, weakness redness and swelling of right arm
77 2021-02-08 headache, fatigue Extreme headache on left side, numbness and swelling of face, neck and jaw pain on left side and sor... Read more
Extreme headache on left side, numbness and swelling of face, neck and jaw pain on left side and soreness of whole left side of body. Body aches and tiredness
77 2021-02-08 headache Client reports having a headache over left eye about 1 1/2 hours after injection. Client woke up on... Read more
Client reports having a headache over left eye about 1 1/2 hours after injection. Client woke up on 2/9/2021 to a swollen face. Swelling to both eyes and "bruising" under both eyes. Client is experiencing light sensitivity. Continues to have a headache and discomfort over left eye. Denies respiratory distress and reports no rash. Recommended follow up with PCP.
77 2021-02-08 influenza like illness, chills Flushed warm face, chills, aches, nausea, headaches, overall weakness. Flu-like symptons. Lasted two... Read more
Flushed warm face, chills, aches, nausea, headaches, overall weakness. Flu-like symptons. Lasted two days.
77 2021-02-09 fatigue Got the shot on 1/26/21, the next day 1/27/21 her arm was a little red and sore and was nauseous. T... Read more
Got the shot on 1/26/21, the next day 1/27/21 her arm was a little red and sore and was nauseous. Then about 8 days later, just over a week she woke up and her arm was red again and more swollen and looked like a black and blue area where the needle went in. There was a red rash around that point. The rash was larger than the palm of her hand. She was tired that day and it did go away after 2-3 days. She took Tylenol one night due to the pain to help sleep. She did not call her doctor. It has now totally resolved as of today, 2/10/21.
77 2021-02-09 headache, chills, fever Elevated Blood Pressure 168/84 ,Low Grade fever 99.3, Chills, and headache
77 2021-02-09 fever I had a raging fever of over 102, whole body aches, nausea and vomiting, weakness
77 2021-02-10 fatigue, fever, headache, chills Head ache Fatigue Joint ache: neck, lower back, knees Muscle ache: calves Loss of appetite Night sw... Read more
Head ache Fatigue Joint ache: neck, lower back, knees Muscle ache: calves Loss of appetite Night sweats/fever Deep chills Redness and swelling at shot site
77 2021-02-10 fatigue, fever On 01-25-2021, I started to experience left arm soreness. I felt like my left arm was going to "drop... Read more
On 01-25-2021, I started to experience left arm soreness. I felt like my left arm was going to "drop-off" with extremely pain. I also had a high fever, was extreme cold, was disoriented, felt my brain foggy and these symptoms lasted up until 3AM. I also felt extremely fatigued. By Friday 01-29-2021, I was getting back to normal.
77 2021-02-10 fatigue, sluggishness I took the first shot of Moderna?s COVID-19 vaccine the middle of January. Two and a half weeks lat... Read more
I took the first shot of Moderna?s COVID-19 vaccine the middle of January. Two and a half weeks later, I developed a two inch rash above my right breast even though it didn?t itch or burn, if pressed, it hurt. I treated it with antibiotic ointment and calamine lotion. During that time, I experienced tiredness, exhaustion, sluggishness as well as aches around the right shoulder. I went to get a mammogram where they told me my lymph nodes were swollen on the right side under my arm. They had seen adults who had taken the shot develop swollen lymp nodes which made it necessary to retake the mammogram. I also went to the dermatologist to see what the inch rash was, he took a biopsy, and it turned out it was shingles even though I had had the shingles shots a year before.
77 2021-02-10 fatigue 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 throat irritation Burning lips, throat tickle, 4 inch red patch raised snd located approximately 2 inches below inject... Read more
Burning lips, throat tickle, 4 inch red patch raised snd located approximately 2 inches below injection site, itchiness all over body. 12 hours after injection
77 2021-02-11 dehydration, runny nose, fatigue about 80 hours after receiving the shot, I experienced severe diarrhea , starting at about 10 PM. I ... Read more
about 80 hours after receiving the shot, I experienced severe diarrhea , starting at about 10 PM. I spend most of the night sitting on the toilet. No vomiting. Some abdominal cramping, and my nose was very runny, altho not stuffy. By morning the diarrhea had stopped, but I felt awful. Did not know if I was mainly dehydrated, exhausted from no sleep, or sick. Ate nothing that day, but drank a lot of fizzy water and herbal tea with a little honey. Following day feeling OK, and by third day, fine. The experience felt like a really bad stomach flu or food poisoning, but I haven't had either of those for over 15 years (and that was from Erythromycin prescribed by my dentist when I didn't realize I am allergic to it).
77 2021-02-11 fever, chills weak arm/pain/couldn't move, chills, fever, headache, lips swollen, face pain when touching, huge po... Read more
weak arm/pain/couldn't move, chills, fever, headache, lips swollen, face pain when touching, huge pouch under eyes/cheeks sore, hoarse
77 2021-02-11 fever, fatigue, chills Severe chills, fever, body aches, fatigue, diarrhea
77 2021-02-12 chills After 24 hours plus, chills, loss Oscar appetite, no fever, body aches Went to bed and slept 14 hour... Read more
After 24 hours plus, chills, loss Oscar appetite, no fever, body aches Went to bed and slept 14 hours. All is well now after breakfast and tea
77 2021-02-12 fatigue, fever, headache, chills ITCHING, HEADACHE, DIZZY, BODY ACHES, FEVER,CHILL, EAR ACHE AND FATIGUE
77 2021-02-12 fever High fever muscle pain ad sore red itchy arm. Today only arm symptom remains. This was my first shot... Read more
High fever muscle pain ad sore red itchy arm. Today only arm symptom remains. This was my first shot. My fever broke overnight on the 11th to 12 th of February.
77 2021-02-13 fatigue, sleepiness Feb 3, 2021 (day 8) delayed reaction -large over bright red, hard, hot to touch; took tylenol and Be... Read more
Feb 3, 2021 (day 8) delayed reaction -large over bright red, hard, hot to touch; took tylenol and Benadryl and iced arm; on Feb. 4, the oval was slightly better; on Feb 6 oval was almost faded but still red; Feb 8 slight ring around ova reaction Also, I felt very tired and tended to sleep during the day
77 2021-02-13 headache, chills Chills, headache for one day, achy feeling, blood pressure below 120 for 2 days, SpO2 between 92-94 ... Read more
Chills, headache for one day, achy feeling, blood pressure below 120 for 2 days, SpO2 between 92-94 for 2 days. Acetaminophen for 1 day at maximum dose for headache, reduced appetite for 2 days.
77 2021-02-13 headache Headache. Treated with ibuprofen . Nausea. Limited food.
77 2021-02-14 chills, headache, fatigue 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 headache Rash, swelling, itching, some lethargy and slight headache, Tylenol, Rash and itching diminishing, o... Read more
Rash, swelling, itching, some lethargy and slight headache, Tylenol, Rash and itching diminishing, other symptoms gone
77 2021-02-14 sweating, fatigue, chills, fever Convulsing; Mild diarrhea; Fatigue; Mild bladder infection; Sweating; Pain; Fever; Nausea; Chills; A... Read more
Convulsing; Mild diarrhea; Fatigue; Mild bladder infection; Sweating; Pain; Fever; Nausea; Chills; A spontaneous report was received from a consumer concerning a 77-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, fatigue, and mild diarrhea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Jan 2021, approximately the night of prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient developed pain, fever, nausea and chills. On 16 Jan 2021, the patient entire body started convulsing and sweating. She developed pain; entire body ached with uncontrollable body jerking. Patient was taken to the hospital, where she received intravenous fluid and paracetamol and was diagnosed with a very mild bladder infection. On an unknown date, the patient had mild diarrhea and fatigue. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, diarrhea, and fatigue was not reported.; Reporter's Comments: This case concerns a 77 year old, female patient, who experienced serious unexpected event of seizure, and non-serious unexpected event of hyperhidrosis and cystitis, and non-serious expected events of nausea, pyrexia, chills, diarrhea and fatigue. The event of pain, pyrexia, nausea, chills occurred 1 day (same day) date after mRNA-1273 (Lot# 011L20A), while the event of seizure, hyperhidrosis, and cystitis occurred 2 day (same day) date after mRNA-1273 (Lot# 011L20A). The event of diarrhea and fatigue occurred on an unspecified date after mRNA-1273 (Lot# 011L20A). Treatment included IV fluids and Tylenol. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
77 2021-02-14 influenza like illness Because of reaction on the first shot, when I got home after getting second shot I took a Benadryl.... Read more
Because of reaction on the first shot, when I got home after getting second shot I took a Benadryl. In the early afternoon I began to feel shortness of breath, breathing not normal and it steadily increased towards early evening when I took 2 more Benadryl which then quieted down the breathing reaction. Also that day I experienced a sore arm. The next day, breathing problems were almost all gone but decided to take 1 more Benadryl. During the day I felt flu like symptoms. The third day I feel like myself again.
77 2021-02-14 fever, pneumonia I woke up the next morning and I was very short of breath much more then usual, by the next day it w... Read more
I woke up the next morning and I was very short of breath much more then usual, by the next day it was even worse and everyday after. By Feb. 10, 2021 I had low fever and difficulty breathing so I went to Urgent Care, after blood work, received chest X-ray, EKG, CT scan. It came back with pneumonia. My biggest quest is can safely take the second one or a different one, with emphysema you need protection. Thank you
77 2021-02-15 chills, fatigue 1st of the series of the vaccine no problem...... adverse events due to 2nd shot...... felt fine al... Read more
1st of the series of the vaccine no problem...... adverse events due to 2nd shot...... felt fine all day friday following shot, but by evening, soreness was more intense...... did my pt exercises around 9pm that same evening and felt pain in both right/left groin..... took two tylenols before bed around 10:30 pm and had the chills....... by around 4am could feel intense pain/throbbing in both right/left groin areas..... hard to get up ..... woke husband up around 7:30am and asked for 2 tylenols...... relief for a few hours...... took two more tylenols mid afternoon..... spent all day saturday in bed...... by evening, pain had subsided..... do not know whether pain is related to the shot or just coincidental with my pt exercise and femoral nerve damage (left leg)..... i do have consistent slight pain in my right groin area and my left leg still has nerve damage ------ but at least, i can walk now!!!!!!! sunday am better, but slight tiredness...... monday am fine and now back to 'normal' activities....
77 2021-02-15 cough I developed all the symptoms of Covid, except fever. The cough was the worst. Had taste, but it is s... Read more
I developed all the symptoms of Covid, except fever. The cough was the worst. Had taste, but it is still off; nothing tastes right. I had a Covid test on 01/24/2021 that came back negative. I had two more tests in the hospital on 2/9/2021 that also came back negative. I went to hospital on doctor's orders due to some blurry vision and concern about blood clots, which I did not have. Symptoms persisted until 2/12/2021.
77 2021-02-15 fatigue, chills COVID-19 Vaccine EUA; chills, nausea, and fatigue, started about 4 hours after the vaccine. It was e... Read more
COVID-19 Vaccine EUA; chills, nausea, and fatigue, started about 4 hours after the vaccine. It was enough to have me stop and lay down. Lasted about 5 hours except the fatigue which lasted for a few days. The fatigue was more than my usual fatigue.
77 2021-02-15 fatigue, fever Patient received her second dose of the COVID-19 vaccine from Moderna. Patient tolerated the first d... Read more
Patient received her second dose of the COVID-19 vaccine from Moderna. Patient tolerated the first dose well, but her second dose on 02/12/2021 caused some adverse reactions. She experienced injection site pain, itching along her upper arm, fatigue, a low-grade fever, and facial flushing that lasted about 4 days with only mild relief from OTC ibuprofen. Recommended OTC acetaminophen to the patient and to report to her PCP for follow-up.
77 2021-02-15 fatigue, sneezing summary of her symptoms: 1 hr post vaccination - feeling tired and sneezing excessively for a couple... Read more
summary of her symptoms: 1 hr post vaccination - feeling tired and sneezing excessively for a couple of days. 3rd day post vaccination-skin tingling sensation all over that resolved with oatmeal bath. 5th day post vaccination-was seen by pcp who told she was fine. received a call from pa from office to inform her she had an allergic rxn and was not to receive the second vaccine. today-she is asymptomatic.
77 2021-02-15 headache, sleepiness Feb 3 afternoon developed headache, began shaking all over, sleepy. During night vomiting 3 times. b... Read more
Feb 3 afternoon developed headache, began shaking all over, sleepy. During night vomiting 3 times. began to feel very weak. Fell in floor and had great difficulty getting up due to weakness. Slept all day Feb 4. Could not eat. Slept all day Feb 5. Could not eat. Very weak. Feb 6 mouth broke out with sores. Still shaking and headache. Began to feel better Feb 7. Felt fine Feb 8 except for mouth sores.
77 2021-02-15 headache severe dizziness early next morning with nausea and slight headache. took medicine for dizziness... Read more
severe dizziness early next morning with nausea and slight headache. took medicine for dizziness and nausea but symptoms continued for two days still feel dizziness now and again
77 2021-02-16 chills, fatigue, headache excessive fatigue, mild headaches, chills with no fever, rash from my arm two inches across and two ... Read more
excessive fatigue, mild headaches, chills with no fever, rash from my arm two inches across and two inches high. Also have big hard lump about the size of plum under the skin that is tender to the touch. did take Aleve.
77 2021-02-16 fatigue, chills Moderna COVID-19 Vaccine EUA Chills and fatigue began at 11:45 pm. Chills ended at 2:30 am. Fatigu... Read more
Moderna COVID-19 Vaccine EUA Chills and fatigue began at 11:45 pm. Chills ended at 2:30 am. Fatigue most of 02/17/2021
77 2021-02-17 chills Initially, chills which has resolved. Now experiencing sensation, warm to touch, redness and inflamm... Read more
Initially, chills which has resolved. Now experiencing sensation, warm to touch, redness and inflammation to injection site (right arm)
77 2021-02-17 fatigue, chills, headache 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 2021-02-17 fatigue, malaise, fever Fever started within a couple of hours the first night, didn't take temp during night but could feel... Read more
Fever started within a couple of hours the first night, didn't take temp during night but could feel that it was VERY hot. Extreme arm pain thru night and achy. Next day, fever of just under 100o (my normal is 97.6) all day (didn't take any pain relievers or fever reducer), exhaustion, achy, felt yucky. fever started to go down very slightly until normal by bedtime. Next morning: no appetite, fever gone, exhaustion and less arm discomfort. Today
77 2021-02-17 throat pain Moderna COVID-19 Vaccine EUA Sore throat about 3 hours after shot continuing to next day so far.
77 2021-02-17 fever, nasopharyngitis Got the vaccine, went home and got home around 3:00, and all of a sudden she was extremely cold, put... Read more
Got the vaccine, went home and got home around 3:00, and all of a sudden she was extremely cold, put another blanket on, and got a heating pad and put it on her feet. She was lying in bed, her heart was hurting to the point that she could not move it. Around 8:00 she put the electric blanket on, got warm but she would still get a cold chill like she had ice water in her veins. Was this way all night. She had a fever, the swelling on her arm. She did not throw up but just the chills, fever. She tossed and turned all night until about 3:30 this morning. She then took 1/2 of Tylenol, dozed off. She is still cold, not as cold as she was. The arm is also still sore.
77 2021-02-18 chills chills
77 2021-02-18 headache 2/15: Red rash, swelling, firm, itchy, warm to touch. Approximately 3 inches in diameter; 2/16: red... Read more
2/15: Red rash, swelling, firm, itchy, warm to touch. Approximately 3 inches in diameter; 2/16: red rash spreads, doubling in size, still itchy. no medication taken; 2/17: no significant change. Late afternoon, experience left shoulder ache, headache. 9:00pm 1 tablet 500mg Tylenol taken; 2/18: red rash spread; itchy along edges. 2:00pm 1 tablet Benadryl taken; Headache 10:00pm 1 tablet Tylenol taken; 10:30 pm 1 tablet Benadryl taken 2/!9: swelling, red rash diminished by 60%. Slight itching. Still not resolved.
77 2021-02-18 lethargy Covid Arm. Red, swollen and itchy. Lethargic. Started approximately 7 days after Moderna vaccine inj... Read more
Covid Arm. Red, swollen and itchy. Lethargic. Started approximately 7 days after Moderna vaccine injection.
77 2021-02-18 fever "Moderna COVID-19 Vaccine EUA; second dose caused all COVID-19 symptoms (or so it seemed) within 12 ... Read more
"Moderna COVID-19 Vaccine EUA; second dose caused all COVID-19 symptoms (or so it seemed) within 12 hours of shot. Great discomfort for two days...and now diahrrea on the third day. Not able to eat but bits at a time. Coffee taste terrible. Fever is back to normal now.
77 2021-02-19 chills, headache, fatigue 11:00pm, Monday, 2/8/2021 began 3 hours of chills (no fever). Next day I stayed in bed entire day wi... Read more
11:00pm, Monday, 2/8/2021 began 3 hours of chills (no fever). Next day I stayed in bed entire day with extremely sore joints (ankles, knees, wrists, fingers, shoulders), sore muscles (everywhere), headache (all day and into Tuesday night ), extreme fatigue. Mostly in and out of sleep. Third day, Wednesday, symptoms mostly gone except for fatigue and headache which lasted for a couple of days longer. No fever or nausea at all. No treatment. Took Advil for headache Wednesday morning.
77 2021-02-19 headache, fatigue, fever low grade fever, nausea, headache, brain fog, fatigue for most of two days, diarrhea and slowness da... Read more
low grade fever, nausea, headache, brain fog, fatigue for most of two days, diarrhea and slowness day 3 still tired Loss of appetite still an issue day 4...hard to stay hydrated but know I'm better than day 1 and 2.
77 2021-02-19 headache, fatigue, sluggishness 2/19/2021 - 8:50AM - severe PAIN IN Back OF NECK AND ACROSS SHOLDERS, SHORTNeSS of BREATH.CHCKED B/P... Read more
2/19/2021 - 8:50AM - severe PAIN IN Back OF NECK AND ACROSS SHOLDERS, SHORTNeSS of BREATH.CHCKED B/P - 85/67. DRANK COLD WATER + LAID on COUCH - subsided in about 10min. 9:00AM - SEVeRe PAIN + MUSCLE CRAMPS, BOTH Legs, fROM knees to toes, couldn't stand up, crying with pain, leaned on walls to get to where husband was, He massaged it with Theraworx ~ 15min, got to wALK then. Exhausted NOW, Drinking a lot of fluids. 8:00am earlier syMPTOMS = Headache, PAiN IN LefT ARM, SLuggish
77 2021-02-19 fever, headache I received my injection on Thursday at 2:00 PM. Upon waking the next day, around 8AM, Friday, I ha... Read more
I received my injection on Thursday at 2:00 PM. Upon waking the next day, around 8AM, Friday, I had a bad headache, body aches, weakness, could not get warm. I laid on the couch all day and didn't eat anything until 4 in the afternoon, a little soup. Later in the day I got a fever and was so weak I could barely walk, I fell when trying to get up, fortunately I fell onto the couch, I made it to the bed and didn't get up until about 8 the next day. Saturday. I felt much better then but am still weak.
77 2021-02-21 body temperature increased extreme confusion, vomiting, temp 101.6 F
77 2021-02-21 chills, headache, fatigue, body temperature increased I had Covid on 25 Nov. 2020. I had extreme fatigue, shortness of breath, aching, headaches and abdo... Read more
I had Covid on 25 Nov. 2020. I had extreme fatigue, shortness of breath, aching, headaches and abdominal pain. I have IBS which flared up during this time. It took me December and January to finally get over the fatigue part. When I received my vaccination on Feb. 12, 2021 (Moderna) by that evening I began to run a temp. of 102-103. I had chills, headache, abdominal pain (worse than in Nov.), fatigue, some dizziness, and short of breath. I felt like I had Covid all over again! I was down for 5 days. On Sunday afternoon, Feb 14 I went to the Clinic to see the doctor on call. I was told they could not test me since I had Covid November 25 and it hadn't been 90 days and I would still have the antibodies.
77 2021-02-21 chills, fever fever: 102.8, chills, muscles aches, "fuzzy" head, took 2 advil, fever broke after few hours, aches ... Read more
fever: 102.8, chills, muscles aches, "fuzzy" head, took 2 advil, fever broke after few hours, aches remained for 42 hours, repeated advil twice during that time. much better now (vaccination was working)
77 2021-02-21 fatigue, fever On Wednesday afternoon she had a fever of 103, was very fatigued. Got up in the middle of the night... Read more
On Wednesday afternoon she had a fever of 103, was very fatigued. Got up in the middle of the night and had dry heaves, went back to bed and was okay. Her arm got really red, hot and blisters all over it like a sunburn. It is down to about the size of a half dollar today. The blisters burst and have made places, is still warm and sore and looks like it is drying up. Did look like a severe sunburn. She ran a little fever until Thursday night 2/18/21. The arm is still sore to touch today, 2/22/21. She took some Tylenol the night her fever was 103, then it went to 101. The fatigue is diminishing, she has slept a lot, but wonders if her arm is ever going to be right.
77 2021-02-21 headache I had usual aches and pains, I had extreme neck pain and I felt like someone kicked me in the back o... Read more
I had usual aches and pains, I had extreme neck pain and I felt like someone kicked me in the back of the head. My head and neck and mouth and face were in excruciating pain.
77 2021-02-21 fever, chills Chills, fever, nausea, body aches for about 36 hours
77 2021-02-21 fever, fatigue, chills Chills, slight fever, fatigue on 2/17/2012, mild achyness, fatigue 2/18/21. Rash on inside of left a... Read more
Chills, slight fever, fatigue on 2/17/2012, mild achyness, fatigue 2/18/21. Rash on inside of left arm lasted 3 days after injection . Took ibuprofen to help relieve symptoms. Soreness and tenderness at injection site lasting 4 days.
77 2021-02-22 headache patient reports swelling at vaccine site 1 week after vaccine administered. swelling accompanied by ... Read more
patient reports swelling at vaccine site 1 week after vaccine administered. swelling accompanied by itching, headache and nausea x 1 day. redness remained for 4 days
77 2021-02-22 fever, headache, chills Chills, fever, body aches, and headache for approximately 24 hours. Site of injection had a hard kno... Read more
Chills, fever, body aches, and headache for approximately 24 hours. Site of injection had a hard knot and inflamed for days
77 2021-02-22 fever Very sore arms and fever of 100.1
77 2021-02-22 fever fever
77 2021-02-23 chills Chills causing 3 hours of body shaking and teeth chattering.
77 2021-02-23 headache COVID arm Chronic headaches
77 2021-02-24 chills Patient had swollen injection arm, red rash and chills for 7 days following administration. Also had... Read more
Patient had swollen injection arm, red rash and chills for 7 days following administration. Also had pain in calves and ankles
77 2021-02-24 dehydration NVD dehydrated lead to further kidney failure
77 2021-02-24 fatigue On February 15 when I got up I had rapid, pounding heartbeat, felt exhausted, and had panic attacks
77 2021-02-24 headache, sleepiness, fatigue Redness and sore left arm, tired, headache,sleepy
77 2021-02-24 headache 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 sweating, chills vasovagal episode then perfuse sweating, then shaking chills
77 2021-02-24 fever, chills pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she... Read more
pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200
77 2021-02-24 fever, fatigue, cough, sleepiness First Day arm sore, fatigued and cough. Second day Chills and Fever, Body Aches, Headache, Nausous,... Read more
First Day arm sore, fatigued and cough. Second day Chills and Fever, Body Aches, Headache, Nausous, couldn't eat or drink, Arm sore and swollen, very fatigued, slept all day. Third day a little better, Fourth day fine.
77 2021-02-25 chills, fever High fever 101.7 Chills Muscle pain at injection site Fatigue
77 2021-02-25 chills PRURITIS, CHILLS, CHEST PAIN
77 2021-02-25 fatigue, body temperature increased At 8 PM last night, 2/25/2021 patient began to feel nauseous and fatigued. This morning the symtoms... Read more
At 8 PM last night, 2/25/2021 patient began to feel nauseous and fatigued. This morning the symtoms were more pronounced and at 8:45AM she had a temperature of 100.4. She ate a piece of buttered toast and was drinking water. Both stayed down.
77 2021-02-25 fatigue Fatigue for about a month, weight loss, no treatment, symptoms resolved before second dose (less tha... Read more
Fatigue for about a month, weight loss, no treatment, symptoms resolved before second dose (less than a month)
77 2021-02-25 headache, fatigue 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 2021-02-25 influenza like illness, chills, fever Fever (102+), chills, faintness, redness on arm the size of softball. Felt as if had flu. Could no... Read more
Fever (102+), chills, faintness, redness on arm the size of softball. Felt as if had flu. Could not eat. Lasted all day 2/20/2021. Redness on arm visible 7 days in large area. Still have visible signs. With first shot I had a metallic taste in mouth and nose about 30 minutes after, a wave of nausea the next day and felt bad the 3rd day. Then just sore arm for 2 weeks.
77 2021-02-25 malaise 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 nasopharyngitis 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 fever Pt received dose #2 Moderna COVID vaccine 2/2/21 Vaccine Clinic. 2/3/21 at 1815 presented to ED for ... Read more
Pt received dose #2 Moderna COVID vaccine 2/2/21 Vaccine Clinic. 2/3/21 at 1815 presented to ED for workup. Reported myalgias, nausea, vomiting, arm soreness, fever, diarrhea. Taking OTC Tylenol. Given IVF, Zofran, Toradol with improvement of symptoms. Dx with immunization reaction. Able to discharge home without excalation of care.
77 2021-02-25 throat clearing Patient describes "dry throat" and "metallic taste in mouth" starting immediately after vaccination... Read more
Patient describes "dry throat" and "metallic taste in mouth" starting immediately after vaccination. Patient was observed to repeatedly clear her throat. Denies shortness of breath, denies difficulty swallowing, denies cough, denies chest pain. After 30 minutes, she's no longer clearing her throat. She continued to deny shortness of breath, difficulty swallowing, cough, chest pain. She was advised to follow up with her primary care provider. Discharged with her son. Son states understanding of all. Patient was afebrile, pulse 72, BP 140/85, RR 16. Patients states that she took her hypertensive medications today and that her blood pressure is normally in this range.
77 2021-02-26 body temperature increased, sleepiness 11 hours after the vaccination I felt achy all over, my legs felt limp and lump on my arm was sore. ... Read more
11 hours after the vaccination I felt achy all over, my legs felt limp and lump on my arm was sore. Temperature measured 98.6. I took two Tylenol and went to bed. I got up two times during the night to go to bathroom. I felt more achy all over and unsteady on my feet. Did not want to get out of bed next day, so slept until noon. At noon my temperature was 100.4. I took 2 Tylenol every 6 hours. Had a very achy, miserable day and just rested. Was somewhat better by bedtime and had a better next night of sleep. Next day am still achy but much better.
77 2021-02-26 fatigue, headache Fatigue. Extreme Diarrhea. Dizziness headache nausea
77 2021-02-26 headache Very Sore arm, Bad headache, Muscle Soreness, especially in right hip and right shoulder. Arm bette... Read more
Very Sore arm, Bad headache, Muscle Soreness, especially in right hip and right shoulder. Arm better in the morning after, but headache lingers. Muscle pain a little less by 11:00 a.m.
77 2021-02-27 chills, headache, cough slight chills, head hurt only when coughing day 2 friday night, slight swelling (2inches by 3 inch... Read more
slight chills, head hurt only when coughing day 2 friday night, slight swelling (2inches by 3 inches), redness and itching below injection site days2 to 4 (friday night to sunday). all symptoms did not start until friday around 4 or 5 pm. itching was most noticible on saturday and slightly better on sunday. washed area 2 times on saturday and changed shirts just to be careful. as of now (sunday 2pm) i just have 2-3 inch swelling . redness and itching below injection site.
77 2021-02-27 fatigue Client reported feeling faint and fatigued. EMS took vitals and daughter gave client food to eat. Cl... Read more
Client reported feeling faint and fatigued. EMS took vitals and daughter gave client food to eat. Client felt better after 40 minutes. EMS assessed and gave client banana for low blood sugar.
77 2021-02-27 influenza like illness 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 runny nose, fever, headache, fatigue, chills Severe side effects including chills, fever, headache, fatigue, diarrhea, loss of appetite, runny no... Read more
Severe side effects including chills, fever, headache, fatigue, diarrhea, loss of appetite, runny nose
77 2021-02-28 body temperature increased, fatigue, head discomfort, headache, fever, chills Started out with waking the next day a fullness in her head, but kind of a headache, and very tired.... Read more
Started out with waking the next day a fullness in her head, but kind of a headache, and very tired. Then a couple of hours later she got a severe case of the chills. She laid down and slept on and off for about 5 hours. When she got up she took her temperature and it was 101. She also had body aches in her back and her legs felt very heavy. She then noticed a rash on her body from a line that went underneath her breast, and redness on the left side of her breast to her belly button, all red around the belly button. When she realized she had a fever she took Tylenol. The rash by Saturday was fading and she also had diarrhea on Saturday, persistent diarrhea. She felt almost normal except that she was tired. Today, 3/1/21 she has the returned diarrhea, doesn't k now if it was related to the vaccine. She spoke to a nurse yesterday, and she told that she had a typical side effect from the vaccine. She was not sure if the diarrhea was from the vaccine.
77 2021-02-28 chills, fatigue, headache Headache, Chills, Constant Nausea, Body Aches, Unable to sleep, Fatigue - lasted 24 Hrs.
77 2021-02-28 chills, headache, fatigue 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 2021-02-28 chills, fever Chills, fever, weakness, aching for about 36 hours, Sore, painful arm, then 3 days post injection,... Read more
Chills, fever, weakness, aching for about 36 hours, Sore, painful arm, then 3 days post injection, swollen area covering a 2-3 inch on arm with severe itching, redness lasted about 2 days.
77 2021-02-28 chills, fever 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 fatigue injection site soreness, fatigue
77 2021-02-28 headache, fatigue Headaches, shortness of breath, left droopy eye.....achy and tired....lasted 5 days.... droopy eye l... Read more
Headaches, shortness of breath, left droopy eye.....achy and tired....lasted 5 days.... droopy eye lasted a week
77 2021-02-28 lethargy Entire body ache ; Lethargic The first day. Severe rash below shot. About 2x2 inch area My Dr.... Read more
Entire body ache ; Lethargic The first day. Severe rash below shot. About 2x2 inch area My Dr. prescribed steroid and moisturizer unless you have other solution
77 2021-03-01 body temperature fluctuation, fever, sleepiness, chills I felt like I was hit by a ton of bricks. I got feverish, the chills, and muscle aches and pains to ... Read more
I felt like I was hit by a ton of bricks. I got feverish, the chills, and muscle aches and pains to the point that all I wanted to do was sleep. So I went to bed, but just as I would be close to falling asleep I'd have to get up to empty my bladder. This was happening almost every 15 minutes for a few hours. I knew I probably should hydrate, but I chose not to because I wanted to get some uninterrupted sleep which I finally did at about 4:00am which only lasted a couple of hours. Then up at about 6:30am when I took some acetaminophin and went back to sleep. I was in bed all day, sleeping most of the time. When I'd wake up I'd take my temperature and most of the time I'd hydrate. I haven't had anything to eat because I wasn't feeling strong enough to even heat water for soup. My normal temperature is about 97.6 give or take. The highest temperature I had was 100 when I took another dose of acetaminophin. But one time it was 94.3!!! I started feeling better at about 8:30pm (3/1/21) and was able to make myself some chicken noodle soup and had some cereal and cottage cheese with it. I finally felt "normal" on Tuesday morning (3/2/21) after getting a good night's sleep.
77 2021-03-01 cough, fatigue Weakness, tired, cough, dizzy. I did not seek medical care.
77 2021-03-01 malaise, fatigue, fever, body temperature fluctuation 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 2021-03-02 chills, fatigue, malaise, headache Vomited approximately 10 hours after vaccine, but no memory of it Diarrhea approximately 10 hours af... Read more
Vomited approximately 10 hours after vaccine, but no memory of it Diarrhea approximately 10 hours after vaccine, but no memory of it Malaise for 3-4 days Fatigued for 3-4 days Headache for ~2 days Chills (extreme) Arm sore for ~3 days Loss of appetite for ~3 days Confused Dizzy/equilibrium issues for ~2 days
77 2021-03-02 chills, fever, malaise, headache, fatigue, cough Vomited approximately 10 hours after the vaccine Diarrhea approximately 10 hours after the vaccine M... Read more
Vomited approximately 10 hours after the vaccine Diarrhea approximately 10 hours after the vaccine Malaise Cough Fatigued for 7+ days Headache for 4 days Slight Fever (around 99.0 for 2 days) Chills (extreme) Arm Sore Loss of appetite for 3+ days Confused Dizzy/equilibrium issues for 2+ days
77 2021-03-02 headache, chills, fatigue muscle aches, headache, loss of appetite, swollen lymph nodes, chills, tired. symptoms disappeared e... Read more
muscle aches, headache, loss of appetite, swollen lymph nodes, chills, tired. symptoms disappeared excepto for swollen lymph nodes after 2 days
77 2021-03-02 headache, runny nose PAIN IN ARM VACCINATION SITE - TO DATE. RUNNY NOSE - TO DATE HEADACHE - TWO DAYS SHORTNESS OF BREA... Read more
PAIN IN ARM VACCINATION SITE - TO DATE. RUNNY NOSE - TO DATE HEADACHE - TWO DAYS SHORTNESS OF BREATH - TO DATE RASH AND HIVES ON HANDS, RIGHT ARM, AND FACE. TO DATE
77 2021-03-02 nasal congestion, cough Next day severe heat, swelling and pain at site. 2nd day severe heat, swelling and pain of entire up... Read more
Next day severe heat, swelling and pain at site. 2nd day severe heat, swelling and pain of entire upper arm 3rd day difficulty breathing, wheezing 4th day spasmodic coughing 5 - 12 day continued pneumonia like symptoms PLEASE NOTE: I HAD PNEUMONIA IN BOTH LUNGS AND WAS HOSPITALIZED FOR FIVE DAYS IN JUNE 2017. I HAD EMBOLISMS IN BOTH LUNGS, FLUID ON THE LUNGS, AND WAS ON OXYGEN FOR ABOUT 6 MONTHS, DAILY INITIALLY AND OCCASIONALLY AFTER 4 MONTHS. Treatment: I could not reach my physician despite repeated attempts. My pulmonologist had previously prescribed a protocol of prednisone and a z-pack should those symptoms recur. Day 6 after vaccine I began the protocol. Day 10 saw improvement in breathing and coughing. Day 14 symptoms resolved. Day 14 (Feb. 16) to Present (March 3) no unusual symptoms. Some nasal congestion and mild occasional wheezing, consistent with pollen season and my usual COPD symptoms. Thank you.
77 2021-03-02 fever, sleepiness, malaise, chills Chills, 2 degrees of fever, sore arm, whole body ache, disoriented when walking & (collapsing pain ... Read more
Chills, 2 degrees of fever, sore arm, whole body ache, disoriented when walking & (collapsing pain in left leg when trying to stand the next morning), slept for 30 hours except for necessaries, didn't eat for 1 1/2 days, all in all body felt like a bad case of the flu.
77 2021-03-03 chills, influenza like illness 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 2021-03-03 chills, fever, headache Symtoms are fever/chills, weakness, headache, muscle and joint pain, nauseous, loss of appetite, lig... Read more
Symtoms are fever/chills, weakness, headache, muscle and joint pain, nauseous, loss of appetite, light headed/dizzy, lasting four days. I am still not 100 per cent recovered.
77 2021-03-03 chills, fever 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 fatigue, headache, body temperature increased Swelling; pain and rash at injection site; fatigue; headache; weakness; temperature.
77 2021-03-03 fatigue, headache, chills chils, headach, sore arm fatigue
77 2021-03-03 fatigue Severe nausea, vomited, extreme fatigue, dizziness/lightheaded disoriented. Yesterday and today. Sto... Read more
Severe nausea, vomited, extreme fatigue, dizziness/lightheaded disoriented. Yesterday and today. Stomach pains moderate
77 2021-03-03 headache, fatigue, chills sore arm, headache, chills, fatigue
77 2021-03-03 sweating Patient during routine observation a flag for 30 minutes began to feel sweaty, hot flash sensation a... Read more
Patient during routine observation a flag for 30 minutes began to feel sweaty, hot flash sensation and began tohyperventilate. Patient was identified by observation staff as follows: Awake x3, no chest pain, slight SOB, increased work of breathing without rales, rhonchi or wheeze. Pulses strong, capillary refill at 2 seconds, warm and dry. Patient is hyperventilation state without carpal spasms. Patient placed on pulse ox at 98% room air, pulse 88 and BP 174/84. No rash or hives, - supportive treatment - Refused additional treatment
77 2021-03-03 fever, chills 6 hours (3 pm) after getting the second dose, my left arm was very sore, even though I had been appl... Read more
6 hours (3 pm) after getting the second dose, my left arm was very sore, even though I had been applying ice, so I took 200 mg of Advil. At 9:15 pm, I had chills and fever for 3 hours and during that time, my right forearm, wrist and hand became very, very sore. I couldn't even flex my fingers the pain was so bad. Pain throughout my body continued during the night, including stomach cramps, back and leg pain and then I took another 200 mg of Advil at 9:15 am on 3/4. I feel I am 20% improved 25 hours after my second shot.
77 2021-03-04 chills, fatigue, fever Early evening post injection sore arm. 9 pm onset of chills, fever, continuing through night and fo... Read more
Early evening post injection sore arm. 9 pm onset of chills, fever, continuing through night and following day. Accompanied by severe fatigue, loss of appetite. Treated with acetaminophen. Fever and chills gone morning of 3/4, but severe fatigue persisted. Morning of 3/5 feeling better, but lightheaded. Improved throughout day and 3/5 evening pretty much back to normal. No medical attention required.
77 2021-03-04 chills, fever 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 2021-03-04 fatigue, headache, runny nose 2-19-21: sore arm; 2-20-21 sore arm sniffles, sometimes tingling around mouth and on left side of fa... Read more
2-19-21: sore arm; 2-20-21 sore arm sniffles, sometimes tingling around mouth and on left side of face; 2-21 - tired, tingling along jaw line; 2-24-21 - sniffles,intense tingliness on and under tongue, feeling of numb lips; 2-25-21 numb lips - called Facility, talked with advise nurse: 2-26-21 swollen gland, slight headache. Video visit with Dr,; She said if symptoms continued for another week to call back and that an MRI might be considered. . Symptoms of tingling, sense of numb lips primarily on left side have continued daily through today 3-5-21. Called advise nurse today and am waiting for a call back from Facility.
77 2021-03-04 fatigue Extremely tired, disoriented to place, time, and family, loss of appetite, cold, left shoulder and n... Read more
Extremely tired, disoriented to place, time, and family, loss of appetite, cold, left shoulder and neck pain, intermittent diarrhea that lasted for approximately 8 days before seeing improvement. Symptoms are now intermittently, states this has been the best days. continuation of medications Metoprolol, Digoxin, Diltiazem, Losartan Potassium, Chlorthalidone, Hydroxyzine, Benadryl and Tylenol as needed
77 2021-03-04 head discomfort, fatigue, headache On 3/1/21 at 11:00 AM I received my second dose of the vaccine Moderna. I was fine all throughout th... Read more
On 3/1/21 at 11:00 AM I received my second dose of the vaccine Moderna. I was fine all throughout the rest of the day. Upon awakening early on the morning of the second, I had moderate aching in all joints, headache, weakness and fatigue. I stayed quiet for day. Upon getting ready to shower on the morning of the 3rd I found I was covered with an angry bright red rash from my neck down to my knees both front and back. Because I did not shower on the 2nd of March I have no idea when it began. On Thursday my head still felt pressure but felt a little stronger and that evening I again showered and the rash looked less angry and bright. Waking this morning on Friday the 5th the rash is gone and I am feeling much better except for soreness in the armpit of the right arm that received the injection.
77 2021-03-04 headache, fatigue, chills Fatigue headache chills upset stomach some back pain
77 2021-03-05 body temperature increased Temp 101 degrees, achy, soreness in L upper arm
77 2021-03-05 fatigue, chills, headache Chills, tired, dizzy slight, dull headache
77 2021-03-05 headache, chills After 1st dose on 1/29/21, pain at shot site, some redness & swelling. Tired for 2 days. After 2nd d... Read more
After 1st dose on 1/29/21, pain at shot site, some redness & swelling. Tired for 2 days. After 2nd dose on 2/25/21, pain at shot site, redness & swelling. On 2/26/21, heavy chills, short of breath, face flushed, temp 98. Pain in low back & right upper arm (torn ligaments). Pain more severe than previously. 2/27/21 Shot site sore, itchy, red, swollen, short of breath, headache. Heavy chills towards evening. 2/28/21, Light pain at shot site, site swollen, warm to touch, labored breathing. Shakey, anxious, doom & gloom, food seems tasteless. Evening feeling better, swelling down, flashes if left eye. 3/1/21 arm itchy, no swelling, arm aches slightly. Pain in low back severe, right arm pain. There was only 26 days between the two doses. The pain in back may be from scoliosis. Pain in right arm, torn ligaments. But after receiving vaccine, these pains increased tremendously, as well as the shortness of breath and extreme groin pain (maybe from fibroids?).
77 2021-03-05 headache, fever, fatigue 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 2021-03-06 fatigue Severe fatigue, joint pains, muscle aches lasting 2 1/2 weeks from date of receiving first dose of v... Read more
Severe fatigue, joint pains, muscle aches lasting 2 1/2 weeks from date of receiving first dose of vaccine
77 2021-03-06 headache, chills Moderna COVID-19 vaccine EUA headache, chills, joint pain, nausea, body aches during the early morni... Read more
Moderna COVID-19 vaccine EUA headache, chills, joint pain, nausea, body aches during the early morning of March 4 and throughout the rest of the day. Then symptoms eased and gradually went away throughout night of March 4 but then just tired for two more days.
77 2021-03-06 influenza like illness, fatigue, headache Moderna COVID-19 Vaccine EUA Awakened in early morning hours on 2/28/21 by intense headache and inte... Read more
Moderna COVID-19 Vaccine EUA Awakened in early morning hours on 2/28/21 by intense headache and intense flu-like body aches, accompanied by extreme fatigue. Body aches lasted two days (until AM of 3/2/21) and headache lasted four days (until PM of 3/3/221). Moderate fatigue still continuing as of 3/7/21.
77 2021-03-06 fever, chills Chills Fever 100.6
77 2021-03-07 fatigue, headache, fever 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 fatigue After receiving the 2nd dose of COVID vaccine become very tired, exhausted, low energy and soreness ... Read more
After receiving the 2nd dose of COVID vaccine become very tired, exhausted, low energy and soreness in the left arm, even a month later.
77 2021-03-07 headache, chills, fever 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 2021-03-07 headache Very slight headache and minor leg cramps
77 2021-03-07 throat irritation scratchy feeling on the outside of her throat, dizzy and light headed. She carries an EPI pen for al... Read more
scratchy feeling on the outside of her throat, dizzy and light headed. She carries an EPI pen for allergic reactions.
77 2021-03-08 chills swelling, red, size of a softball, itching, burning, painful at injection site achiness and chills
77 2021-03-08 headache, fever 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 2021-03-08 sweating, chills, fever Chills and fever, beginning at app.15 hours later, around 9AM, intensifying over the course of th... Read more
Chills and fever, beginning at app.15 hours later, around 9AM, intensifying over the course of the day, with severe aching, especially over the torso. Soreness at the injection site. Fever reaching peak of 101.8 by late evening. I took two Tylenol before retiring. I woke , self and gown drenched in sweat at 3AM on 3/6. Slight chills upon rising for about 3-4 more hours on 3/6. Upper injection arm itching continues to this day, 3/9 , which is relieved with cold compresses and a 25 mg Benadryl tab.
77 2021-03-08 malaise My reaction was very mild. I received my shot at 1:30. By late afternoon I felt a little wimpy - m... Read more
My reaction was very mild. I received my shot at 1:30. By late afternoon I felt a little wimpy - maybe like I might be catching something. The feeling continued through the evening. I took an Aleve before going to bed. The next couple days my arm was slightly sore, but no other reminders of having received the vaccination.
77 2021-03-08 fever, fatigue Body aches and sore at injection site night of second injection. Morning after, fever at 101.4, bod... Read more
Body aches and sore at injection site night of second injection. Morning after, fever at 101.4, body aches, extreme fatigue. By afternoon, temp had dropped to 100.3. Still very tired, aches diminishing. Slept poorly that night. Temperature normal on second day, still a little tired. Back to "normal" on third day.
77 2021-03-09 chills, headache, malaise pt stated that became very ill when she went to bed. she woke up in a cold sweat, had vomiting and ... Read more
pt stated that became very ill when she went to bed. she woke up in a cold sweat, had vomiting and diarrhea that lasted an entire next day. she had headache and chills but no fever. pt had a phone visit w PCP and they told her to stay hydrated and get bed rest. Doctor will FU tomorrow 3/10/2021. Pt states she is feeling better at this time.
77 2021-03-09 fatigue, lethargy, chills Rash fading but continuous Chills, aches, fatigue, lethargy, poor appetite for about 60 hours No fev... Read more
Rash fading but continuous Chills, aches, fatigue, lethargy, poor appetite for about 60 hours No fever
77 2021-03-09 headache Experienced a retriggering of concussion symptoms: intense head pain, vision issues, nausea.
77 2021-03-09 malaise, throat irritation Patient received Moderna Vaccine 1/21/2021. 2 days prior to vaccine administration patient had verti... Read more
Patient received Moderna Vaccine 1/21/2021. 2 days prior to vaccine administration patient had vertigo and sinus allergies that resolved. Patient canceled her 2nd dose appointment on 2/18/2021 reporting she had been sick. She rescheduled 2 times on 3/4/2021 and 3/11/2021 but canceled those appts as well reporting still not feeling well. She called 3/10/2021 and informed nurse of persistent symptoms that started 2 weeks after receiving her 1st dose of Moderna Vaccine. The symptoms reported throat burning, metallic taste in mouth, metallic smell in urine, body weakness, warm sensation over body, ear pressure and nausea. She reports she has been to an ENT doctor 2 times, her PCP 1 time and the ER 1 time. She and her doctor's are unsure if her symptoms are related to her first injection.
77 2021-03-09 fever, body temperature increased, chills, headache Saturday, 3/6 11:00 p.m. - Left arm began to hurt Sunday 3/7 - 3:00 a.m. - Woke with chills and bod... Read more
Saturday, 3/6 11:00 p.m. - Left arm began to hurt Sunday 3/7 - 3:00 a.m. - Woke with chills and body aches Entire day - Fever from 101 to 102.7, chills, body aches, headaches, nausea, diarrhea Monday - Temp 100.7. Felt much better. Diarrhea continued Tuesday - Much better.
77 2021-03-10 malaise 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 fatigue Extreme dizziness, some nausea and total exhaustion.
77 2021-03-11 fever, headache Temp 100.5, headache, full body aches, dizzy, flushed
77 2021-03-11 fever, sinusitis, fatigue, throat pain First 6 hours post injection: localized redness RT. deltoid. Next 25 hours: febrile 101.2 to 102.6,... Read more
First 6 hours post injection: localized redness RT. deltoid. Next 25 hours: febrile 101.2 to 102.6, joint pain knees & hips, muscle pain, extreme fatigued. On Day 2: same symptoms for next 10 hours. Very similar to full-blown flu symptomatology. This event was followed 18 hours later by a sore throat & signs/symptoms of a head-cold & sinusitis, thought to be viral (clear mucous from nasopharyngeal area. Weakness & significant fatigue continues; saw my physician?s Nurse-Practitioner: mow on Ampicillin/ clavulanate 825/125 mg.
77 2021-03-12 chills, fatigue, headache chills alternating with hot spells at night painful injection site headache for several days general... Read more
chills alternating with hot spells at night painful injection site headache for several days generalize fatigue
77 2021-03-12 dehydration Patient experienced extreme nausea and vomiting and became dehydrated and had to go to urgent care. ... Read more
Patient experienced extreme nausea and vomiting and became dehydrated and had to go to urgent care. She also is experiencing mouth sores.
77 2021-03-12 fatigue, fever, sweating, headache, chills Sudden dizziness with some nausea and cold drenching sweat - no fever - extremely weak and fatigued ... Read more
Sudden dizziness with some nausea and cold drenching sweat - no fever - extremely weak and fatigued and could barely stand and then severe headache came on about 10 minutes into episode. Dizziness lasted approximately 2 hours until I could safely move and then began to subside. I noticed my eyes did not want to focus well and was seeing spots when I tried writing down what happened. Chills began and I felt extremely cold, my head felt "foggy" and tight, ringing in ears started and headache moved to migraine level. Slight fever 99.8. Main dizziness did pass after about 2 hours but other things continue to linger on an off. I just feel "off". I have actually heard other seniors mention some of these very symptoms so am not super alarmed, however, I did not have any of these side effects before the vaccine for Covid-19. I did experience extreme fatigue and bad headaches since I received the first dose on January 27, 2021. I have not called my doctor regarding these side effects since I have heard many seniors complain of very similar reactions. I have rested as much as possible, tried to stay hydrated, and taken Tylenol when needed. For the dizziness I tried to stay as still as possible and put my head between my knees until it finally passed.
77 2021-03-12 fatigue I was extremely tired the day after, and continued to be tired with gradual improvement over a few d... Read more
I was extremely tired the day after, and continued to be tired with gradual improvement over a few days. But I have not recovered my previous level of energy, which was already very, very low because of longstanding chronic fatigue syndrome. My persistent vertigo (since 1989) is also worse than it was, and continues so after 2 weeks from date of first shot.
77 2021-03-12 headache, chills, fever Moderna COVID-19 Vaccine EUA. Chills, fever, swollen throat, sore-red-itchy arm, headache, swollen s... Read more
Moderna COVID-19 Vaccine EUA. Chills, fever, swollen throat, sore-red-itchy arm, headache, swollen sore lymph nodes, mild nausea, generally felt TERRIBLE.
77 2021-03-12 fever, headache, chills chills, fever, headache, joint pain all over, red swollen arm with severe pain starting morning afte... Read more
chills, fever, headache, joint pain all over, red swollen arm with severe pain starting morning after injection and continuing for 2 day. Arm still red swolen, sor to the touch and hot to the touch
77 2021-03-13 chills, fatigue, headache Exhaustion, , body aches, headache muscle aches, chills
77 2021-03-13 headache, fever, fatigue, chills Chills, fever, headache, fatigue, soreness and redness at site of injection. Treated with Tylenol a... Read more
Chills, fever, headache, fatigue, soreness and redness at site of injection. Treated with Tylenol and/or Motrin. Symptoms lasted approximately 12-14 hrs. One week later, 02/14/2021, chills, fever, fatigue, soreness and incresed redness at injection site occurred again and lasted approximately 12 hrs. On 02/15/2021, went to Urgent Care and had a Covid Test which was neg. and was told it was a reaction to the vaccine. The next day went to my PCP due to increased redness at site, felt it was still a reactin but was given Keflex for 7 days to make sure an infection did not develope.
77 2021-03-13 headache 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 2021-03-13 fever, headache, fatigue 6 hours after injection total body muscle aches , tired, followed over next 24 hours by chilling, te... Read more
6 hours after injection total body muscle aches , tired, followed over next 24 hours by chilling, temp 100.6, nausea (vomited once), headache. Next 12 hours less ache, no fever, headache persists.
77 2021-03-14 chills, fatigue Body was extremely hot and red, and I also had chills. Arm was very hot and sore and swollen. Ent... Read more
Body was extremely hot and red, and I also had chills. Arm was very hot and sore and swollen. Entire body ached (like I have never had before) , nausated, bad headache, very weak. My urine was a different color (kinda of peach/pink). I took Tylenol to help with fever etc., for a couple of days. I still fatigued from the ordeal.
77 2021-03-14 chills, fever, headache, fatigue fever, nauseous, redness itch lower injection area, fatigue, headache, urinated 10 times that evenin... Read more
fever, nauseous, redness itch lower injection area, fatigue, headache, urinated 10 times that evening, tired, chills, itching, swollen arm
77 2021-03-14 fatigue, headache Headache, SEVERE uncontrollable shaking (don't think it was due to being cold), nausea, fatigue, all... Read more
Headache, SEVERE uncontrollable shaking (don't think it was due to being cold), nausea, fatigue, all over achey, hot/soreness at injection site. Severe symptoms lasted overnight, fatigue and aches lasted for three days. Could not function enough to get to the bathroom by myself during the night of shaking. Disoriented to the point of not knowing which direction I was going. Treated with liquids and Advil.
77 2021-03-14 fatigue, respiratory tract congestion Patient developd worsening congestion and new weakness, fatigue, shakiness days 1-6 after vaccine ad... Read more
Patient developd worsening congestion and new weakness, fatigue, shakiness days 1-6 after vaccine administration. Patient was evaluated at healthcare facility on 3/15/21 with elevated blood pressure of 200-246/80-90 and sent to emergency room via 911/EMS activation. HR 99-108, Pulse ox 94-97% room air. BP 200-246/80-90
77 2021-03-14 fatigue Trouble lifting her arm; Nausea that came and went; Felt tired and fatigued; Vaccination site pain; ... Read more
Trouble lifting her arm; Nausea that came and went; Felt tired and fatigued; Vaccination site pain; Vaccine too high on her shoulder; A spontaneous report was received from a nurse concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine too high on her shoulder/product administered at inappropriate site, trouble lifting her arm/ movement disorder, nausea, fatigue and vaccination site pain. The patient's medical history and concomitant medications were not reported by the reporter. On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A ) in the left shoulder for prophylaxis of COVID-19 infection. On 02 Feb 2021, patient believed the vaccine was given too high on her shoulder, and had nausea, fatigue and pain at the injection site (shoulder and arm) which increased with movements, radiating to the upper limb and had trouble sleeping, treated with Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of 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 the event, a causal relationship cannot be excluded.
77 2021-03-14 headache, fatigue, influenza like illness, fever received shot at ll:45 am was fine went home. about 4:00 started to get cold. developed flu like sy... Read more
received shot at ll:45 am was fine went home. about 4:00 started to get cold. developed flu like symptoms, headache, fatigue little bit of fever, pain up back of neck and to my ears. was in bed all night on 3/12/21, stayed in bed all day 3/13/21. Had some oatmeal, gatorade, juice. Could not taste anything back to bed. Sunday got up thought I was good. But dizzy and lightheaded, little itching on my legs and a little nausea. Had tuna sandwich could not taste it, thought it was awful. Back to bed all day. Monday I am up but still dizzy when standing trying to stay up but just sitting. Taste has come back.
77 2021-03-14 headache, fatigue Headache and body aches for 3-4 days fatigue and weakness for 7-10 days diarrhea for 3 weeks
77 2021-03-14 fever, headache Severe weakness, fever, headache, nausea, vomiting, diarrhea,
77 2021-03-15 fatigue, headache Day 1 sore injection site moved to shoulder and upper back, dizziness Day 2 exhaustion, dizziness, h... Read more
Day 1 sore injection site moved to shoulder and upper back, dizziness Day 2 exhaustion, dizziness, headache Day 3 exhaustion dizziness, headache Day 4 continuing headache, joint aches Day 5 back pain, pain in back of head, joint aches Day 6 back pain more severe, pain in back of head, joint aches Day 7 lessening back pain, spasms,, joint aches
77 2021-03-15 fatigue Email to COVID CARE - referred to PCP "I'm having side effects after the second shot. I'm having vom... Read more
Email to COVID CARE - referred to PCP "I'm having side effects after the second shot. I'm having vomiting, diarrhea, can barely talk, balance problems, dizziness, and back pain. I'm very tired. I had a brain bleed six years ago."
77 2021-03-15 headache, fever, chills, sleepiness 1 - redness, hot feeling, mild swelling about 3" diameter surrounding injection site, starting 1 day... Read more
1 - redness, hot feeling, mild swelling about 3" diameter surrounding injection site, starting 1 day after shot, continuing until present time, with severe tenderness for 4 days 2 - headache starting 6 hours after shot, continuing for 4 days without stop nausea, starting 1 day after shot, continuing for 4 days without stop 3 - fever between 101.6 and 102 degrees Fahrenheit, starting 1 day after shot, continuing for 3 days, dropping to 101 for 4th day before returning to normal on 5th day 4 - chills, accompanied by uncontrollable shivering accompanying fever 5 - dizziness off and on during time of fever 6 - extreme sleepiness from 1 day after shot for 5 days No treatment, other than drinking coke in effort to prevent dehydration while being able to keep it down.
77 2021-03-15 headache 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 throat pain, fever, chills, sweating, headache 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 chills, fever, headache Large, well defined, bright red, patches of confluent, non-papular, blanching rash, slightly raised,... Read more
Large, well defined, bright red, patches of confluent, non-papular, blanching rash, slightly raised, covering bilateral anterior thighs and partially covering bilateral calves and shins. areas of rash are not pruritic, but are sensitive to touch and in some areas quite painful to touch. These areas persisted relatively unchanged for four days and began to fade by day five (today), although still unpleasantly sensitive to touch. I experienced the predicted fever, chills, body aches and headache, but had no cough, wheezing or difficulty breathing. The fever, chills, body aches and headache have completely resolved.
77 2021-03-16 fatigue Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her bal... Read more
Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her balance; Had no control of her bladder and urinated on the bed; Wasn't feeling well; Tired and didn't want to get up; 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 vaccination related malaise, urinary incontinence, fatigue, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid 19. The patient's medical history, as provided by the reporter, stated she was sneezing and coughing few days before receiving her first dose vaccine. Concomitant medications reported included iron, metolazone, nicardipine, simvastatin, torsemide, levothyroxine, glimepiride, apixaban, potassium chloride, acetyl salicylic acid, and donepezil 5mg. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of COVID-19 infection. The route of administration was not provided. On an unspecified date in Jan 2021 after receiving the first dose vaccine, the patient experienced not feeling well, urinary incontinence, tiredness, and didn't want to get up. On 25 Jan 2021, the patient was losing her balance and confused. She was hospitalized and diagnosed with renal failure, as well as, severe urinary tract infection that was septic. On an unknown date post hospitalization, the patient tested positive for Covid-19. Treatment drug administered included Tylenol, Azithromycin, Promethazine, 325mg aspirin, and Vitamin D. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, like not feeling well, urinary incontinence, tiredness, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid-19 positive test were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-033912:
77 2021-03-16 headache Severe headache. Nausea. Diarrhea. Lasted 6 hours. Better next day. Scared for second dose. Do Zi ne... Read more
Severe headache. Nausea. Diarrhea. Lasted 6 hours. Better next day. Scared for second dose. Do Zi need a small person dose? I am an older , small woman. Weight 110lbs.
77 2021-03-16 lethargy, sleepiness Patient has reported lethargy and "sleeping all day" since receiving the vaccination
77 2021-03-16 fever, fatigue Swollen glands and pain on side of vaccine. Fever joint pain fatigue
77 2021-03-17 fatigue, sweating day of injection: sore arm and lightheadedness. Next day: Swollen arm with pain and redness...intest... Read more
day of injection: sore arm and lightheadedness. Next day: Swollen arm with pain and redness...intestinal tract upset slight nausea and diarrhea. Next day...arm better, lightheadedness better, very tired and slept a lot. Next day: not bad during day. in evening had shooting pains in calves, and sweated a lot at night. Arm much better. Today: arm almost painless, still a bit lightheaded, intestinal tract still "busy". no pains in legs.
77 2021-03-17 headache Patient sitting in recovery post vaccination. She began crying and complaining of a severe headache.... Read more
Patient sitting in recovery post vaccination. She began crying and complaining of a severe headache. EMS over to assist and evaluate patient. Workup completed. 20 mg of Labetalol given IV by EMS. Patient taken to local Emergency Room for further evaluation. Son contacted by phone to inform of situation. Son to meet patient at Emergency Room.
77 2021-03-17 sweating Dizziness, weakness, sweating, trembling in hands.
77 2021-03-17 influenza like illness Patient received second vaccine on 3/15/2021. Today she feels dizzy ( but stated she has history of ... Read more
Patient received second vaccine on 3/15/2021. Today she feels dizzy ( but stated she has history of Vertigo) and feels like she has the flu. She denies any other symptoms.
77 2021-03-17 fever, chills 1 day of fever & chills 1 week of arm with red rash and itched for whole week (left arm - 2nd shot)
77 2021-03-17 throat irritation tickle in throat
77 2021-03-18 headache, fatigue, chills 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 fever Developed red itchy smooth feverish rash on legs and arms starting after 7 days and still have rash ... Read more
Developed red itchy smooth feverish rash on legs and arms starting after 7 days and still have rash to this date . Joints ached. Took antihistamine tablet and also acetaminophen but that did not help so quit taking anything.
77 2021-03-18 sinus headache Pt had agreed to wait post Covid IM for observation due to history of allergeries. After 30 minutes... Read more
Pt had agreed to wait post Covid IM for observation due to history of allergeries. After 30 minutes post observation, pt reported an onset of "sinus headache" and noted redness and itching on left index finger.(injection site was in left Deltoid) Pt immediatly took her own dose of Benadryl 12.5mg ( pt stated "I have to take children's dose). Pt denied SOB, no hives noted at injections site or in left hand. Denied Nausea, denied heart palpitations (Pulse 88) no dizziness. No tightness in throat or chest. BP at 3:30 137/94 after 10 minutes 148/68. Pt sated, " I feel normal" ER visit was encouraged but Pt and husband decided to not go to ER for evaluation. "I am there for hours and they never find out what is wrong with me." Pt remain in Covid clinic under observation until 4:10pm. Upon departure, patient reports headache subsided and redness disappeared. Pt left with instructions to call 911 if she worsens. Pt and her husband agreed. Also advise patient to contact PCP for guidelines for second Covid IM.
77 2021-03-20 chills, body temperature increased, headache Headache and chills evening of shot, body aches as well. Temp was 101.4 at peak but now normal. Rema... Read more
Headache and chills evening of shot, body aches as well. Temp was 101.4 at peak but now normal. Remaining symptoms are mild headache, occasional chills, and body aches...as of 3/21/2021
77 2021-03-20 lethargy, fatigue 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 fever Fever 101.4 very unsteady stomach upset some discharge
77 2021-03-21 headache, fever I had a slight fever, body aches and headache for 2 days, after each dose. Tinnitus, which I've had... Read more
I had a slight fever, body aches and headache for 2 days, after each dose. Tinnitus, which I've had a few times over the years, started about 10 days after my first dose (01/18/21). I received my 2nd dose on 02/15/21. The tinnitus has continued, about 4-5 days per week. I have seen my ENT twice. He suggested I try melatonin.
77 2021-03-22 chills, malaise 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 headache, chills, fatigue Treatment: Tylenol Symptoms: chills, joint pain, muscle soreness, nausea, headache, extreme fatigue,... Read more
Treatment: Tylenol Symptoms: chills, joint pain, muscle soreness, nausea, headache, extreme fatigue, fatigue lasting 5 days
77 2021-03-22 headache Started with headache and mental confusion within a hour of first injection. Right eye was becoming... Read more
Started with headache and mental confusion within a hour of first injection. Right eye was becoming blurry by day 3 and loss of vision apx 6 days after first injection.
77 2021-03-22 fever, headache, fatigue Caller stated she got Moderna vaccine on Saturday and was fine. She stated yesterday she had a few s... Read more
Caller stated she got Moderna vaccine on Saturday and was fine. She stated yesterday she had a few side effects, ie fever, headache, fatigue, which she stated are gone. She stated when she woke up today she was fine but then noticed her eyes were a little bit swollen. She stated she has history of eyes swelling when she eats alot of salt. No Lot number available at the time of this notification.
77 2021-03-22 fever, headache Really bad headache Fever Body aches Really sore arm Lasted for 24 hours
77 2021-03-22 fever Date and time of vaccination: (list both if they received both shots): First dose: 02/20/2021 @011... Read more
Date and time of vaccination: (list both if they received both shots): First dose: 02/20/2021 @01130, second dose: 03/19/2021 @01130 Brand and lot of vaccine: Moderna LOT(M030M20A) (048A21A) patient reported that she developed a fever and arm sorness today (03/20/2021) @730. instructed to take tylenol to help with the fever. patient was instructed to apply cold compress to help with the arm sorness. patient was instructed to seek medical attention if the symptoms got worse.
77 2021-03-23 body temperature increased Swollen arm bright red hot to touch temperature 101.7
77 2021-03-23 chills 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 headache, chills, fever Sore muscles began soon after vaccination. In the night woke up dizzy. Then had intense chills and b... Read more
Sore muscles began soon after vaccination. In the night woke up dizzy. Then had intense chills and became nauseated. After several bouts of chills finally fell asleep again. Next morning woke up with fever of 101 F (usually body temp is around 97.5) and headache. Stayed in bed all day with fever and headache. In evening symptoms began to disappear.
77 2021-03-23 headache, fatigue, body temperature increased Nauseous ( vomiting) - Started 12 hours after 2nd injection & continued for 36 hours. Had Temp 100.... Read more
Nauseous ( vomiting) - Started 12 hours after 2nd injection & continued for 36 hours. Had Temp 100.3. Headache, body aches, and no energy. Started feeling better on 4th day after Covid injection.
77 2021-03-23 lethargy 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 fatigue, malaise, headache 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 fatigue Hit with extreme fatigue four days after 2nd shot. Legs felt rubbery. And I am a walker doing about ... Read more
Hit with extreme fatigue four days after 2nd shot. Legs felt rubbery. And I am a walker doing about 5000 steps a day. Then four days after the fatigue, I was hit with dizziness, and still experiencing both but not to the degree I was at first. Also have a red, scaly rash on the backs of both hands. Been rubbing Neutragena gel on them which has helped.
77 2021-03-24 fatigue FATIGUE
77 2021-03-24 fatigue 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 2021-03-24 malaise She got the vaccine and was sitting around that evening and discussing with the family over the phon... Read more
She got the vaccine and was sitting around that evening and discussing with the family over the phone and was explaining that everything was fine, could barely tell where the shot went in, and the next morning around 10:00 to 11:00 AM she got deathly ill. She had diarrhea but not too bad, and then started throwing up uncontrollably, violently, projectile. She goes to where she was disoriented and did not know where she was. She was reaching to touch things to figure out where she was. Her husband called the ambulance, and she went to the hospital and got her normalized but does not know how or what they did. A woman came in to register her and started talking to her and was not making any sense. They treated her in the ER, took a bunch of tests, and sent her home. They told her that she had food poisoning and hadn't had anything but some biscuit and gravy and had some crackers when she got the vaccine as she was weak. They gave her Ondansetron for her stomach to stop the diarrhea, but she is still having that. She is still having the weakness, and not back to her normal self.
77 2021-03-24 fever, chills Hallucinations; Could not eat for 2 days; On the floor for 2 days; Chills; Fever; A spontaneous repo... Read more
Hallucinations; Could not eat for 2 days; On the floor for 2 days; Chills; Fever; A spontaneous report was received from a 77 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, could not eat for 2 days/decreased appetite, on the floor for 2 days/asthenia, chills and fever/pyrexia. The patient's medical history was not provided. The relevant concomitant medications were also not provided. On 10 Mar 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA (Lot number: 001821A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced hallucinations, chills, fever, could not eat and was on the floor for 2 days. No laboratory data was provided. Patient took paracetamol and hydroxyzine as treatment. Action taken with mRNA-1273 in response to the events was not reported. The events could not eat and on the floor for two days were recovered on 12 Mar 2021. The outcome of hallucinations, chills and fever were not known.; 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 2021-03-25 chills, headache, fever Chills, 100.4 Fever, Slight Headache, SEVERE attack of Rheumatoid Arthritis One tablet of Tylenol Ch... Read more
Chills, 100.4 Fever, Slight Headache, SEVERE attack of Rheumatoid Arthritis One tablet of Tylenol Chills. fever, cured -- Headache persisted for a couple more days --RA persisted for 6-8 days
77 2021-03-28 chills Patient experienced an itchy COVID arm rash (5- 6 inches) 24hours after vaccination. She experience... Read more
Patient experienced an itchy COVID arm rash (5- 6 inches) 24hours after vaccination. She experienced chills. She went to bed and by following night symptoms left. Rash is still present. Rash is painful to touch but no itch. Patient did take benadryl, Emergen-C and tylenol
77 2021-03-28 fatigue, fever Mom became agitated. Would not sleep. Stayed continuously awake for approximately 40 hours. Could n... Read more
Mom became agitated. Would not sleep. Stayed continuously awake for approximately 40 hours. Could not be redirected. So tired she was swaying on her feet, but could not be convinced to lay down. After 2 days we were able to get 50 mg Trazadone from our doctor. After sleeping for 6-8 hours she then did another 24 hours awake. We upped the dose to 100 mg. By this point the event had started to pass. During this time we also noticed mom was running a low fever in the morning. 99.5 - 100.5. It would go away in the afternoon. During this time mom was hallucinating - having conversations with people who were not there. Mom's hearing declined during the event as well. As of 2 days ago mom's temperature seems to be back to normal in the morning. This "event" has impacted mom's mental and physical decline. She seemingly overnight now needs help showering and toileting, and sometimes dressing. (This kind of decline is common for dementia. Each time over the past 5 years that mom has had some physically stressful even such as hurting her foot or getting a bad stomach virus, she has come out the other side degraded) The reason I'm reporting this is that the behavior changes were sudden, seemed to peak, and then subside. There is a correlation with the second moderna shot, and so I though it was important to report.
77 2021-03-28 fatigue Extremely tired the day after I had my shot. I slept all day the next day and that night. I woke u... Read more
Extremely tired the day after I had my shot. I slept all day the next day and that night. I woke up feeling fine the day after.
77 2021-03-28 headache, fatigue 1st day after: fatigued. 2nd day after: nausea upon eating breakfast, tightness in neck, shoulders &... Read more
1st day after: fatigued. 2nd day after: nausea upon eating breakfast, tightness in neck, shoulders & headache. Take Tylenol. Symptoms lessen by mid-afternoon or dinner time. No symptoms first thing next day. The issue has happened for 5 days in a row. Eating oatmeal with no milk or sugar and hot tea. How long can this last???
77 2021-03-28 malaise Too ill to get out of bed for about 24 hours. I was not this sick when I actually had COVID in Novem... Read more
Too ill to get out of bed for about 24 hours. I was not this sick when I actually had COVID in November. Feeling a little fearful about getting shot #2 since I hear the reactions with shot #2 are often worse than with #1.
77 2021-03-28 fever, chills Loss of voice! No ability to make a resonant voice. Just breathiness. This was preceded by fever and... Read more
Loss of voice! No ability to make a resonant voice. Just breathiness. This was preceded by fever and chills which lasted one night, the following day, and was better after the second night of sleep. Fever was gone in the morning but SO WAS MY VOICE!
77 2021-03-29 fatigue states that approximately a week after her 2nd covid vaccine she has been having sudden episodes of ... Read more
states that approximately a week after her 2nd covid vaccine she has been having sudden episodes of fatigue, brain fog, aches in arms and memory changes where she cannot remember specific details in the afternoon that she knew in the morning such as what she paid for something. She states she has always been good with numbers, the next morning she can remember again and the next afternoon won't be able to. Family h/o dementia. She had no difficulty answering questions for this form.
77 2021-03-29 headache Headache and body aches on the next day, March 3rd, after receiving 2nd Moderna vaccine, on March 2n... Read more
Headache and body aches on the next day, March 3rd, after receiving 2nd Moderna vaccine, on March 2nd. Symptoms went away on March 4th. No problem with the 1st Moderna vaccine on Feb. 2nd. However on the 18th of March a headache started that was like the one I had after the 2nd Moderna vaccine. It has continued until today, March 30th. I have taken Extra Strength Tylenol 4-6 per day which controls the headache but it comes back before I have to take another 2 tablets. I emailed my doctor on March 29th and he said it probably is a result of the Moderna vaccine. He advised me to switch to Aleve, 2 tablets each day. I really do hate feeling these headaches and I want to know if it will ever end and what you recommend. Thank you.
77 2021-03-29 headache Vertigo, headache, nausea
77 2021-03-30 throat irritation She got moderna vaccine at 9:30 AM. She started to get itchy lips and fuzzy tongue shortly after im... Read more
She got moderna vaccine at 9:30 AM. She started to get itchy lips and fuzzy tongue shortly after immunization given. This is a similar reaction as when she has had carbocaine and novacaine. She is having no breathing issues. No facial swelling. She got benadryll at 10:04 AM. She notes that has helped - the burning in her throat is better now after the benadryl. She is currently feeling like she still something in her throat, wants to clear it. Were better then throat scratchiness occurred and same throat burning and foreign body feeling returned. Epi pen given in office and patient was sent to the ER. Her vitals were stable and she had her son here who felt comfortable transporting her to the ER.
77 2021-03-31 chills, fatigue Worst was nausea, vomiting and diarrhea for several hours; also tiredness, aches, chills and brain f... Read more
Worst was nausea, vomiting and diarrhea for several hours; also tiredness, aches, chills and brain fog for several days
77 2021-03-31 fatigue, fever, headache, chills Fever, chills, Swoellen lymph node right side, headache, fatigue just for next day after shot
77 2021-03-31 headache 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 2021-04-01 body temperature increased, fatigue severe body aches, fatigue, nausia, temperature 102.7, brain fog, virtigo
77 2021-04-01 fatigue, nasopharyngitis, headache 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 fatigue Redness in the arm that she received the vaccine, swollen, very itchy, not so painful, warm to touch... Read more
Redness in the arm that she received the vaccine, swollen, very itchy, not so painful, warm to touch, and fatigue for one day. Redness went away but now is like a rash in a smaller area, still warm to touch, itchy, and very slightly swollen. This patient was recommended to contact doctor or pharmacist about taking an antihistamine with her escitalopram due to the slight interaction they have, and if this persists to see a doctor to get assessed and see if they can prescribe something else for the itching.(do not take any immunosuppressants until 2 weeks have passed from second dose.
77 2021-04-01 fatigue 3/30-Adverse events experienced and are they still occurring now: C/o heat, redness and swelling in... Read more
3/30-Adverse events experienced and are they still occurring now: C/o heat, redness and swelling in arm at injection site & extreme fatigue after 1st shot; 11 days after 1st shot developed large lump on at injections site. Today developed red hives/lumps on chest area & trunk area. Using benadryl cream as needed, not taking any other medications. Advised tylenol or ibuprofen as well as PO benadryl, advised to f/u with PCP or urgent care due to worsening symptoms.
77 2021-04-01 headache 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 2021-04-01 headache 1st shot headache 2nd shot 5 days later about 6" hive on injected arm, swollen , hot
77 2021-04-01 malaise Gave the Vaccine at 12:42 client waited 18-20 minutes stood up to walk back to apartment and stated ... Read more
Gave the Vaccine at 12:42 client waited 18-20 minutes stood up to walk back to apartment and stated that she was not feeling well and sat back down. Stated that she was feeling short of breath and was not seeing clearling. Writer instructed Office support to call 911. Client continued to have heavy breating and pulse was weak at about 30 beats per minute. Gave epinephrine injection in Right thigh and EMS arrived. Client increased respirations and heart rate increased.
77 2021-04-01 fever, headache, sleepiness I am submitting this report not based upon adverse events I experienced after both vaccinations incl... Read more
I am submitting this report not based upon adverse events I experienced after both vaccinations including headache, eye pain, somnolence, dizziness, joint and muscle pain, low-grade fever, loss of appetite. These symptoms resolved two days after first vaccination and four days after second vaccination. No medical advice was sought and acetaminophen was taken on an as-needed basis. What I found to be unusual after both vaccinations was profound changes to the color of my urine two days after the vaccinations. I use the PureWick external catheter and urine collection system due to my NMO-related incapacitation. This system facilitates the assessment of urine output and characterisitics. After my first
77 2021-04-02 headache 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 2021-04-02 influenza like illness, sleepiness, fatigue 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 fever Fever of 101.3 Ache all over I am on the second day and the effects are subsiding
77 2021-04-04 headache, fatigue, chills Chills, severe headache, nausea, fatigue, in bed the whole day. No treatment. I fine the next day.
77 2021-04-04 fever, fatigue, chills Within 5-10 hours of the second dose: nausea, vomiting, chills, fever, fatigue. Chills, fatigue and ... Read more
Within 5-10 hours of the second dose: nausea, vomiting, chills, fever, fatigue. Chills, fatigue and nausea continued for 10 days until death
77 2021-04-05 influenza like illness, fatigue Approx 2 weeks after 2nd shot, I developed severe body aches and felt like I had the flu and a week ... Read more
Approx 2 weeks after 2nd shot, I developed severe body aches and felt like I had the flu and a week or so after that I had vertigo, tinnitus and extreme exhaustion. That lasted for 2-3 days and then dizziness to present, but lessening
77 2021-04-05 fever, headache, chills 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 2021-04-06 influenza like illness, fatigue Sore arm - Days 2 to 4 Tired and felt like fighting flu symptoms or coming down with something - Da... Read more
Sore arm - Days 2 to 4 Tired and felt like fighting flu symptoms or coming down with something - Days 2-4 Woke up with itchy rash and redness larger than a baseball at the injection site. Had pharmacist who injected the vaccine look at it and she recommended Benadryl or Hydrocortisone cream. I chose the cream as Benadryl bothers me. It took the itching away on Day 9 and 10. Thereafter, off and on, I was having a sore arm and itching at the injection site. My 2nd dose is due 4/9/21. I just have a little soreness in my left arm. Plan to have next dose in my right arm as recommended for Covid Arm reaction.
77 2021-04-06 fever, fatigue pt says her left arm was swollen and had fever in it for almost 2 weeks. The swelling has gone down... Read more
pt says her left arm was swollen and had fever in it for almost 2 weeks. The swelling has gone down now. She had fatigue that lasted almost 2 weeks. She developed diarrhea a couple of days after getting the vax and still has this today 4/7/2021. She says every time she eats she gets diarrhea. She has taken Pepto Bismol but it has not helped. Pt will contact her PCP regarding her symptoms.
77 2021-04-07 chills, fatigue chills, fatigue, upset stomach five days after vaccinations; same symptoms experienced day after vac... Read more
chills, fatigue, upset stomach five days after vaccinations; same symptoms experienced day after vaccination
77 2021-04-07 headache, fatigue Very Sore Arm. Headache, Teeth ache, extreme fatigue an muscle ache. Lasted for 2 1/2 days
77 2021-04-07 malaise intermittent dizziness poor balance, , loss of stamina , shortness of breath, foggy brain.
77 2021-04-07 nasal congestion, productive cough Nasal congestion, phlegm, and shortness of breath when laying down to sleep.
77 2021-04-08 cough, fatigue, chills Pt presented to observation post 2nd Moderna vaccine- had been advised to remain in observation for ... Read more
Pt presented to observation post 2nd Moderna vaccine- had been advised to remain in observation for 30 minutes. @6:00 PM pt walked up to observation RN to express "something is not right, I dont feel right and my teeth are chattering and my hands are tremoring" Pt was able to walk back to sit in a chair Initial BP was 225/205 and pt began to c/o feeling "I feel faint, very tired all of a sudden" RN advised CNA to alert staff for help Pt then began to wheeze and cough. Per adverse drug reaction kit IM Epinephrine 0.3 mg administered @ 6:05 pm 911 called. Within 2 minutes pt expressed "I feel better now" teeth chattering, fatigue and cough resolved. EMS arrived, son arrived Pt w/s/s similar to arrival at time of transport but lessened, pt left via stretcher to Hospital@6 bp recheck at time of discharge 169/64 Staff RN
77 2021-04-09 fatigue, headache, fever 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 malaise, chills, fatigue I have been experiencing symptoms for over a month now. Extreme fatigue, sometimes nausea and light... Read more
I have been experiencing symptoms for over a month now. Extreme fatigue, sometimes nausea and light headedness. The symptoms are better some days than others but never completely go away. Most of the shaking and shivering have gone away but still do not feel well.
77 2021-04-10 headache, fatigue, dehydration 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 fatigue, fever, chills 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 chills 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 fatigue, headache 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 fatigue Stroke, nausea, numbness, dizziness, fatigue,
77 2021-04-12 headache, fatigue 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 2021-04-12 runny nose, throat irritation drippy nose and throat congestion
77 2021-04-14 chills iST INJECTION WEAK NAUSEA RIDE CIRCLE UNDER INJECTION SITE LASTED ABOUT 4 DAYS TOOK WATER & TYLENO... Read more
iST INJECTION WEAK NAUSEA RIDE CIRCLE UNDER INJECTION SITE LASTED ABOUT 4 DAYS TOOK WATER & TYLENOL 2ND INJECTION WEAK NAUSEA DRY HEAVES EXTREME PAIN IN ALL JOINTS CHILLS CIRCLE BELOW INJECTION SITE UNABLE TO FUNCTION ON MY OWN FOR 5 DAYS WEAK AND NSUSEA LASTED 4 DAYS MORE TOOK tYLENOL AS SUGGESTED BY STAFF WHEN RECEIVING INJECTION
77 2021-04-14 pneumonia, lethargy 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 fever, chills, headache Chills, fever, headache, muscle soreness, light headed ness, fatigue, nausea
77 2021-04-14 fever, chills fever, chills, body aches. Since my second vaccine, I have had difficulty taking a deep breath. I ... Read more
fever, chills, body aches. Since my second vaccine, I have had difficulty taking a deep breath. I have seen my IM doctor, a pulmonologist and a cardiologist. I was tested for antibodies -IGG and they think I had covid. My antibodies were high. I am not 100% sure when I had Covid - I still don?t have sense of taste back. still have pain when taking a deep breath.
77 2021-04-15 chills, fever She was having difficulty moving her arms and legs; She did have a bump on the side of her head; fal... Read more
She was having difficulty moving her arms and legs; She did have a bump on the side of her head; fallen off her bed another time; she kept saying "I think I'm gonna die"; She felt delirious; did have pain with the second injection; She did have a bump on the side of her head; she experienced fever; strange behavior; chills; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (She felt delirious) 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. The patient's past medical history included No adverse event (No reported medical history). On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABNORMAL BEHAVIOUR (strange behavior), CHILLS (chills) and PYREXIA (she experienced fever). On an unknown date, the patient experienced DELIRIUM (She felt delirious) (seriousness criterion medically significant), HYPOKINESIA (She was having difficulty moving her arms and legs), the first episode of HEAD INJURY (She did have a bump on the side of her head), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), VACCINATION SITE PAIN (did have pain with the second injection) and the second episode of HEAD INJURY (She did have a bump on the side of her head). At the time of the report, DELIRIUM (She felt delirious), ABNORMAL BEHAVIOUR (strange behavior), HYPOKINESIA (She was having difficulty moving her arms and legs), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), CHILLS (chills), VACCINATION SITE PAIN (did have pain with the second injection), PYREXIA (she experienced fever) and the last episode of HEAD INJURY (She did have a bump on the side of her head) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
77 2021-04-15 fever 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 2021-04-16 lethargy swelling of ankles and feet; Difficulty breathing , Lethargic. has continued 3 weeks after 2nd sho... Read more
swelling of ankles and feet; Difficulty breathing , Lethargic. has continued 3 weeks after 2nd shot.
77 2021-04-18 fatigue 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 cough, fever, throat pain, chills 6 days after the shot I got "Covid Arm" and reported it to you. Now 13 days out, I got REALLY sick! ... Read more
6 days after the shot I got "Covid Arm" and reported it to you. Now 13 days out, I got REALLY sick! Chills, fever (102.4) nausea, sore throat, slight cough, loss of appetite and it has lasted until tonight 4/20/21/.. I am finally feeling a bit better BUT still not right. The idea of having a 2nd injection is off the table. They say you get sick with the 2nd. I surely don't want to get any sicker than I am.
77 2021-04-19 fatigue 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 2021-04-19 fever next day she had a fever the next day after taking the vax. 2 days later she had a 101 fever and sh... Read more
next day she had a fever the next day after taking the vax. 2 days later she had a 101 fever and she had severe pain shooting through her lower extremities. she contacted a physician that is a friend and asked to for an order to start therapy. On the 3rd day she started physical therapy. She started getting worse so she contacted her surgeon that ordered an MRI. DX is stenosis and bulging disc which she has had for years but has never been laid up because of it. She went to her PCP. They feel like she developed inflammation of the nerves for the weak parts of her body after taking the vax. The pain is in the nerve from her waist down to her ankle. She is still doing the physical therapy. She is scheduled to see an Orthopedic Doctor on 4/23/2021.
77 2021-04-20 head discomfort balance was weird; left side of head, above my ear felt like something inside my head popped and liq... Read more
balance was weird; left side of head, above my ear felt like something inside my head popped and liquid drained; felt really terrible; she thought that maybe she was hallucinating; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (she thought that maybe she was hallucinating) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dyslexia and Thyroid associated orbitopathy (Unspecified Allergies). On 12-Feb-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 12-Feb-2021, the patient experienced BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible). On an unknown date, the patient experienced HALLUCINATION (she thought that maybe she was hallucinating) (seriousness criterion medically significant). On 12-Feb-2021, HALLUCINATION (she thought that maybe she was hallucinating), BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible) had resolved. No treatment medications were provided. Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.
77 2021-04-21 fatigue 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 2021-04-21 fatigue 27 hours after the vaccination I suffered an episode of total body muscle weakness including my bowe... Read more
27 hours after the vaccination I suffered an episode of total body muscle weakness including my bowels. I was too weak to stand. When my husband arrived home he helped me into the tub and to bed. I was fine the next morning except for some lingering fatigue that has continued.
77 2021-04-23 dehydration, fatigue 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 2021-05-01 chills 1st dose pain in right side near small intestine 4 days after vaccine, doctor did blood work, ct sca... Read more
1st dose pain in right side near small intestine 4 days after vaccine, doctor did blood work, ct scan 2nd dose sharp pain in left lower back morning after, chills same day as vaccine - ER gave muscle relaxers, did blood work, urine test taking advil have continued warm/inflammatory feeling in abdomen 4 days after 2nd shot
77 2021-05-02 chills I experienced vomiting for several hours, as well as diarrhea and chills.
77 2021-05-02 fatigue, chills Received 2nd moderna vaccine 2/12/21. Left arm a bit sore that night at injection site. Woke up 2am ... Read more
Received 2nd moderna vaccine 2/12/21. Left arm a bit sore that night at injection site. Woke up 2am with chills, whole arm and left shoulder blade very painful, fatigue. Sunday felt a bit better. Monday improved. Now use arm to hold the phone. Would just hang at the side, very painful. Laryngitis started yesterday, has chronic PND and allergies. Still have some chills, fatigue overall improved. Took tylenol, mindful of transaminitis
77 2021-05-02 fatigue, influenza like illness At the time of both shots flu like symptoms and fatigue. On 4/2/2021 developed a shingles like ras... Read more
At the time of both shots flu like symptoms and fatigue. On 4/2/2021 developed a shingles like rash on my left ear ear and left side of neck and head. on 4/12/2021 I was diagnosed with shingles. I had been vaccinated against shingles with Shingrix. I don't know if the Moderna vaccine has anything to do with my case of shingles but my doctor suggested I should submit this. For information my husband received the second dose of Moderna approximately one month after me and he was diagnosed with shingles the same week that I was. He had also received Shingrix. I am improved but not completely recovered.
77 2021-05-02 fever, fatigue "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 2021-05-04 headache, fatigue Headache with flashing light; Hot and cold; Moderna arm / Red below deltoid muscle; Hot at the injec... Read more
Headache with flashing light; Hot and cold; Moderna arm / Red below deltoid muscle; Hot at the injection site; Itchy at the injection site; Extreme fatigue / Could not get up for 2 days / Lay down for 2 days; Headache with flashing light; Broke her L2 vertebra; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis, Blood pressure high and Migraine. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light). At the time of the report, LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra), PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light) outcome was unknown. Not Provided No concomitant medications were reported. No treatment information was provided. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for all events except Lumbar vertebral fracture which is unlikely. This case was linked to MOD-2021-092132 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for all events except Lumbar vertebral fracture which is unlikely.
77 2021-05-04 lethargy, headache 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 2021-05-06 fatigue, malaise I fully support efforts to end this COVID-19 pandemic. That is why I took these vaccinations Over t... Read more
I fully support efforts to end this COVID-19 pandemic. That is why I took these vaccinations Over the last twenty years I have taken a number of vaccination including an annual seasonal flu shot. I have learned during these years that when I take such a vaccination I need to do it when my schedule is clear to allow for several days of down time. I usually need several days to recover from such a vaccination. I also take only one vaccination at a time to lessen any problems I may have with it. Sometimes I have had a large red spot on my vaccination arm, up to four inches wide, near or around the injection site. Continued:
77 2021-05-06 fatigue, fever, chills fever, chills, body aches x 4 days fatigue and annoying earache x 2 weeks
77 2021-05-07 fatigue, sweating 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 sinus congestion Congestion, stuffy sinuses fill up drain and repeat. Feels like lump in throat and cannot get deep ... Read more
Congestion, stuffy sinuses fill up drain and repeat. Feels like lump in throat and cannot get deep breath in for 8 weeks. Anti histamines no help. Anxiety after 4-5 weeks. Lack of sleep due to drainage and asthma.
77 2021-05-09 fatigue Patient described severe itching at injection site and rash was at the injection site. The patient ... Read more
Patient described severe itching at injection site and rash was at the injection site. The patient went to the doctor and was prescribed generic Bactrim for 10 days. Patient has been extremely tired.
77 2021-05-10 headache, fatigue 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 2021-05-10 throat pain Sore throat and COVID exposure Pneumonia due to COVID-19 virus Chest pain
77 2021-05-12 head discomfort Mild Brain pause; Unable to think clearly; Vision Problem; Pressure in her head; This spontaneous ca... Read more
Mild Brain pause; Unable to think clearly; Vision Problem; Pressure in her head; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Mild Brain pause) 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 report provided by the reporter. Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL for Hypertension. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (Mild Brain pause) (seriousness criterion medically significant), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head). At the time of the report, MENTAL IMPAIRMENT (Mild Brain pause), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. The rechallenge was positive. This case was linked to MOD-2021-114463 (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.
77 2021-05-13 headache, fatigue (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 2021-05-18 headache She got her vaccine, about a day and a half her arm was sore and itchy. Then later on it was red, s... Read more
She got her vaccine, about a day and a half her arm was sore and itchy. Then later on it was red, splotchy kind of redness, but not at the point of the injection, just a couple of inches below towards the elbow. This lasted for about a week. The soreness went away but could see redness in the area, which took about 4 weeks for this to disappear completely. She had a headache which lasted for a short period of time, and disappeared. She also had a swollen lymph node along her waste that were sore about 2 days after the vaccine, which also disappeared and had it only for a day or two. She started noticing a sound, thinking it was in her old house the 2nd week of April, but moved to a quieter neighborhood and still noticed it. She was reading an article this morning in the paper and realized the sound that she was hearing was tinnitus. She was only born with one ear and it sounds more like a beeping sound than a ringing, but it continues to bother her. She does not notice it when she's out driving around from the other noises in the environment but when it's quiet due to the one ear she can hear it. With only one ear she cannot determine the direction of where the sound is coming from, but does notice it during quietness. She puts her ear up to the wall to determine where the sound is coming from and plugged her ear, and determine it was from the ear itself. She is worried about it getting worse or not getting any better with only having the one ear.
77 2021-05-24 throat pain, fever, fatigue According to the patient (my mother), and my father, the patient had her 2nd shot on 4/30/21 and wit... Read more
According to the patient (my mother), and my father, the patient had her 2nd shot on 4/30/21 and within 2 days began having a 102 fever. She continued to have that high fever off & on every other day and spoke to her primary care physician who told her he didn't know why she had the fever, then finally advised her to go to the ER. She had already recovered from COVID prior to taking the 2nd shot, and tested negative for COVID by the time she went to the ER. She went to the ER on about 5/18/21, and in addition to fever, experienced sore throat, appetite loss and fatigue. She was admitted and the doctors told her they're unsure if it's related to the experimental shot, but they can't rule it out at this time. They continue to give her drugs and run tests, with no real answers to speak of and she believes it's likely an adverse reaction to the shot(s).
77 2021-05-25 headache 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 fatigue She received her vaccine. The next few days, she was extremely tired and slept a lot. A couple days ... Read more
She received her vaccine. The next few days, she was extremely tired and slept a lot. A couple days after the vaccine, she complained that her stomach hurt slightly. Days went by and the pain slowly got worse. She didn't feel like eating. Then on 2/8/21 in the middle of the night, she woke up in excruciating pstomach pain and her husband called ambulance. They rushed her to ER. The determined that her colon had ruptured near her stomach and they took her in for emergency colonoscopy. The surgery was a success, but a couple days after, she was weak and said she didn't want to fight any longer. They put her on hospice measures and she died 2/15/21. We feel that she was doing fine before the vaccine, and then all of a sudden this occurred. Seems to be too much of a coincidence. Finally taking the time to report it, in case there are others having colon and or stomach issues.
77 2021-05-29 chills, lethargy Chills and extreme lethargy began after first dose and have continued unabated, 4 - 5 times per week... Read more
Chills and extreme lethargy began after first dose and have continued unabated, 4 - 5 times per week, until today.
77 2021-06-03 sweating, fever Night of second shot had low fever and diaphoresis lasting 3 nights. On 5th am post injection had s... Read more
Night of second shot had low fever and diaphoresis lasting 3 nights. On 5th am post injection had severe upper abdominal pain. Upon arrival in ER had bloodwork, CT, and MRI (results below) Diagnosed as idiopathic pancreatitus since no reason could be found. No alcohol at all, no stones, and no routine meds known to cause this. Admitted NPO and on IV fluids. Discharged next evening after pain resolved and tolerating po fluids. Hospital physicians told me they did not think the vaccine could have been the issue but I still feel this was such a coincidence that it should be reported.
77 2021-06-06 cough, throat pain Patient reported sore throat and cough. She doesn't feel good
77 2021-06-09 headache Light Headache in morning upon awakening - then dissipates after getting up.
77 2021-06-10 fatigue Positive covid test; shortness of breathe; diarrhea; no eating; tired; This spontaneous case was rep... Read more
Positive covid test; shortness of breathe; diarrhea; no eating; tired; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive covid test) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Hypertension. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (Positive covid test) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired). The patient was hospitalized from 17-Feb-2021 to 21-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Positive covid test), DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
77 2021-06-10 malaise, fatigue During the evening for two nights after the second one I just start not feeling well. The second day... Read more
During the evening for two nights after the second one I just start not feeling well. The second day I had very body aches and I became very fatigue.
77 2021-06-12 fatigue Symptoms began 12-13 hours after shot was given. 2-4 a.m., strong chill with whole body shaking and ... Read more
Symptoms began 12-13 hours after shot was given. 2-4 a.m., strong chill with whole body shaking and knife-like sharp pains in legs 5- 7 days heavy nasal mucus discharge painful muscles and joints; fatigue, unstable balance, sensitivity to light lasted 3-4 days 3rd day sore upper left arm with rash from injection site to elbow lasted 3-4 days Symptoms generally cleared up by June 16. Treatment: bed rest, fluids and 1000 mg Tylenol every 6 hrs over 4 days
77 2021-06-13 headache I was having shooting pains through my head which were severe and in my right ear was soar as well (... Read more
I was having shooting pains through my head which were severe and in my right ear was soar as well (tender to touch with shooting pain). I did not have any energy and couldn't concentrate since the pains were happening all the time. My doctor treated me with Valtrex and a topical pain killer (Lidocaine). I was diagnosed with Shingles but did not break out. It took about a month to recover from the Shingles and then my ear continued to hurt for another two to three weeks. Now, everything seems to be fine.
77 2021-06-14 headache, malaise can't sleep; she is angry, been crying, is depressed and is taking an antidepressant; headache; coul... Read more
can't sleep; she is angry, been crying, is depressed and is taking an antidepressant; headache; couldn't hear anything out of one of her ears temporarily; brain is ringing/debilitating/ringing in head; received vaccine and has been sick; stuttering words; body shaking; trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) (seriousness criterion medically significant), TINNITUS (brain is ringing/debilitating/ringing in head), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache). At the time of the report, SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking) outcome was unknown and TINNITUS (brain is ringing/debilitating/ringing in head), SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that, the patient was taking antidepressants for being angry, been crying, was depressed . The patient also stated that she bought silencil an over the counter medication that she bought on the internet but it didn't help. She wanted to know if she could get a tetanus shot. 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Added 1 new serious and 3 non-serious events. This case is upgraded per addition of serious 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time.
77 2021-06-15 headache I never considered it as an adverse effect. I did wonder if by stimulating my immune system if it st... Read more
I never considered it as an adverse effect. I did wonder if by stimulating my immune system if it stimulated the shingles. I had pain in my shoulder and going up the side of my bed. It wrapped around my head and behind my eye. I had had shingles before and it felt like shingles pain. I noticed I was breaking out on my shoulder and starting up the side of my neck. I went to the urgent care and they diagnosed me with shingles. They gave me some medicine and it went away 2 weeks later. It didn't affect my eye itself, but it did affect my eyelid and around my eye. I saw my regular doctor later on. I just had a prescheduled appointment with her. I did tell her about it. She looked at the area and said I was healing up nicely. She suggested I get the shingles vaccine.
77 2021-06-16 fatigue, headache Within the first 24 hours the patient manifested symptoms of headache, persisting fatigue and pain i... Read more
Within the first 24 hours the patient manifested symptoms of headache, persisting fatigue and pain in the joints of the arms and legs noting the elbows and wrists as particularly irritating. Within one day of appearance the symptoms of headache and fatigue resolved, but joint pain remains and patient has developed a 3-inch radius rash without elevation centered at the site of injection which the patient reports to be painful.
77 2021-06-16 fatigue Intense diarrhea, stomach cramps and bloating. nausea, fatigue, memory loss, incoherent, skin peeli... Read more
Intense diarrhea, stomach cramps and bloating. nausea, fatigue, memory loss, incoherent, skin peeling over entire body including face, immobile and labored breathing (over and above her COPD).
77 2021-06-16 lethargy Patient became lethargic, weak and generally debilitated with tremors and inability to complete ADLs... Read more
Patient became lethargic, weak and generally debilitated with tremors and inability to complete ADLs without assistance, beginning on 4/7/21 (date of second dose of vaccine). She was taken to see a neurologist on 4/12/21. She showed some improvement by 5/5/21 but then had a recurrence of generalized decline and on 5/28/21 she became weak and fell while ambulating. On 5/29/21, she had another event with weakness and fall and was taken to the hospital and admitted.
77 2021-06-19 headache 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 cough, pneumonia 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 bronchitis, fatigue Within 3 hours, I had aches and pains and fatigue that lasted 3 1/2 weeks. A week later, I came down... Read more
Within 3 hours, I had aches and pains and fatigue that lasted 3 1/2 weeks. A week later, I came down with bronchitis. I was on antibiotics for 7 days. The bronchitis got better but the pains and fatigue did not. That lasted another 2 1/2 weeks. I was sleeping 11-12 hours a day because of the fatigue. I felt better in 3 1/2 weeks and three days later received the second shot.
77 2021-06-21 sleepiness I got home and immediately felt awful. I felt so bad that even though the roof was being done over m... Read more
I got home and immediately felt awful. I felt so bad that even though the roof was being done over my head and the workers were banging above me, I went right to sleep. I was back to sleeping for long periods of time. This lasted 2 1/2 weeks. I took Tylenol which helped some. I also had a sore arm. After the 2 1/2 weeks, my symptoms went away.
77 2021-06-22 fever 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 2021-06-23 sweating, body temperature increased Temperature of 103, nausea and sweating
77 2021-06-27 malaise Patient was a 77 year old, resident, past medical history of dementia, hypertension, schizophrenia, ... Read more
Patient was a 77 year old, resident, past medical history of dementia, hypertension, schizophrenia, hyperlipidemia, Parkinson's disease. Patient presented to the ED with altered mental status and a potential seizure. In the morning of 3/24, patient reportedly had an episode of seizure that lasted 30 seconds, generalized tonic/clonic. It is unknown if she fell or hit her head. Per manager, patient is following Neurology, recent work up for possible syncopal month ago. Patient received her 2nd dose of Moderna Vaccine recently on 3/19. At baseline patient is independent, ambulates by her self. Patient has been ill after receiving a COVID vaccine last week. Patient has progressive weakness of the bilateral lower extremities and progressive difficulties with talking , had had multiple falls.
77 2021-06-27 pneumonia death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute... Read more
death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified
77 2021-06-29 fatigue 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 fever, headache, chills 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 influenza like illness 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 influenza like illness 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 2021-07-06 chills, fever, headache, fatigue Neuropathy in her feet (like pins and needles) and in her muscles from the waist down; Floppy ankle... Read more
Neuropathy in her feet (like pins and needles) and in her muscles from the waist down; Floppy ankles; she could not complete "stair climber" exercises up until a month ago; Can wiggle toes, but even though functioning they are numb; still suffering from long term effects (neuropathy); Caller stated her balance is off as well.; still feels exhausted.; Neck pain; Couldn't sleep; Headache; Chills; Fever; Muscle Achiness; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (Muscle Achiness). On 22-Mar-2021, the patient experienced NECK PAIN (Neck pain), INSOMNIA (Couldn't sleep), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)) (seriousness criterion medically significant), BALANCE DISORDER (Caller stated her balance is off as well.), PARAESTHESIA (Neuropathy in her feet (like pins and needles) and in her muscles from the waist down), HYPOTONIA (Floppy ankles), EXERCISE TOLERANCE DECREASED (she could not complete "stair climber" exercises up until a month ago), HYPOAESTHESIA (Can wiggle toes, but even though functioning they are numb) and FATIGUE (still feels exhausted.). On 25-Mar-2021, NECK PAIN (Neck pain), INSOMNIA (Couldn't sleep), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. At the time of the report, NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)), BALANCE DISORDER (Caller stated her balance is off as well.), PARAESTHESIA (Neuropathy in her feet (like pins and needles) and in her muscles from the waist down), HYPOTONIA (Floppy ankles), EXERCISE TOLERANCE DECREASED (she could not complete "stair climber" exercises up until a month ago), HYPOAESTHESIA (Can wiggle toes, but even though functioning they are numb), MYALGIA (Muscle Achiness) and FATIGUE (still feels exhausted.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No adverse events reported after first dose on 20 January 2021. No concomitant medications reported. Patient reported she had a COVID test on 27 March 2021 but no results were provided. Patient reported elevated blood pressure and heart rate that persisted for weeks but has since resolved. Patient reported an electrocardiogram was performed on an unknown date with a normal result. No treatment information was provided by the reporter. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
77 2021-07-06 fatigue, throat pain, cough Cough, sore throat, swollen glands, weakness, tiredness After about two weeks the symptoms lessoned ... Read more
Cough, sore throat, swollen glands, weakness, tiredness After about two weeks the symptoms lessoned substantially. I was given a Covid-19 test and a strep test. Both were negative. The PA prescribed lots of liquids and lots of rest.. That is what I have been doing and the symptoms have gradually lessened.
77 2021-07-07 chills, headache, fatigue weakness, fatigue, had a bad taste in her mouth as soon as she got the vax, shortness of breath, chi... Read more
weakness, fatigue, had a bad taste in her mouth as soon as she got the vax, shortness of breath, chills, was losing her balance, headaches, temporal artery on right side of her head is bothering her, diagnosed with gastroparesis, right arm/near breast is sore, developed tremors
77 2021-07-07 fever 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 fatigue 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 2021-07-08 fever fever (103.9) one day after last vaccination. 10 days after vaccination, visit to cardiologist wh... Read more
fever (103.9) one day after last vaccination. 10 days after vaccination, visit to cardiologist who had precribed verampamil for palpitations a few days before my vaccination - my legs and feet were swollen. She told me I had mild purpura and edema from the verampamil, and she discontinued it. I told her I suspected it was from the vaccine. I quit taking verampamil, and I still have the rashes and edema in my legs and feet, and also on my arms. I had to go to the ER for severe leg pain, I believe in March orApril, where they tested me for a blood clot, which was negative, and went away a few days later. I still have the swelling and edema and rashes. I do not have a doctor's appointment until September with the cardiologist NP, and in October with my PCP. I am sure my situation is from the vaccine.
77 2021-07-09 headache 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 2021-07-13 fever on 7/12/21 patient noticed swollen gland in right submandibular region, with mild fever off 100F las... Read more
on 7/12/21 patient noticed swollen gland in right submandibular region, with mild fever off 100F last night. Patient noticed an increase in the size of gland overnight.
77 2021-07-17 fever, headache 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 2021-07-18 cough, chills, headache Woke up 0n 4/22 /2021 with eyes blood red, headaches, chills . Called eye doctor and was given diffe... Read more
Woke up 0n 4/22 /2021 with eyes blood red, headaches, chills . Called eye doctor and was given different medication for glocoma. It made eyes swell and itch . Patient was taken off that med. and pit back on the original. Patient is still having chills and cough and headaches
77 2021-07-18 fever, chills, fatigue Fever , chills, tireness, redness and swelling after 6 hours. took tylenol every 4 hours for 2 day, ... Read more
Fever , chills, tireness, redness and swelling after 6 hours. took tylenol every 4 hours for 2 day, then starting taking 2 times daily.
77 2021-07-25 fever, sleepiness low grade fever, redness/pain at injection site, tremors, and difficulty staying awake.
77 2021-07-27 sleepiness 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.
78 2020-12-31 fatigue Increased fatigue.
78 2021-01-01 chills My arm started feeling sore the evening of the injection day. I di not sleep well that night as sli... Read more
My arm started feeling sore the evening of the injection day. I di not sleep well that night as slight chills and general achiness began. When I got of bed the following morning I felt so weak, woozy and light headed that I was afraid I would fall. I slept all day but by that evening I began feeling better and by the following day (day 2 after the shot) I felt normal except that my arm was still sore. It is now day 3 and my arm is still slightly sore but not limiting my use and is steadily getting better.
78 2021-01-02 headache 12/31/20-pm upset stomach; 1/1 /21 woke up with diarrhea and mild headache thru the day. Around 7... Read more
12/31/20-pm upset stomach; 1/1 /21 woke up with diarrhea and mild headache thru the day. Around 7 pm felt like a dizzy spell loosing ability to move with like fog in my head and uncontrolled strong shaking and vomiting. 1/2/21 woke up with no symptoms and feeling fine.
78 2021-01-07 chills Nausea, chills, constipation
78 2021-01-07 fever Pt received vaccine on 1/4/21 and then that night had a fever of 101.3 She found out she was a close... Read more
Pt received vaccine on 1/4/21 and then that night had a fever of 101.3 She found out she was a close contact to a Covid pt & tested post on 1/6/21
78 2021-01-08 fatigue Diarrhea, Fatigue.
78 2021-01-13 lethargy, body temperature increased, fatigue 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 2021-01-13 runny nose Arm was a little swollen. About 26 hours after injection, had weakness in her legs. Had a little sni... Read more
Arm was a little swollen. About 26 hours after injection, had weakness in her legs. Had a little sniffle. This morning woke up about 4:30 a.m., has some nausea but did not vomit. Had some lightheadedness. Has had vertigo in the past.
78 2021-01-14 headache, fatigue Diarrhea, sore arm, nausea, headache, and fatigue. Symptoms resolved within 24 hours except for arm ... Read more
Diarrhea, sore arm, nausea, headache, and fatigue. Symptoms resolved within 24 hours except for arm soreness. Took Tylenol and rested.
78 2021-01-14 pneumonia Patient complains of left rib pain that started 3 hours after getting her first COVID 19 vaccine on ... Read more
Patient complains of left rib pain that started 3 hours after getting her first COVID 19 vaccine on 1/4/2021. Patient did have a chest xray that showed lower left penumonia and was started on antibiotics. Patient returned to PCP on 1/8/21 with continued complaint of left rib pain that had not gotten better. Chest Xray clear on 1/8/21.
78 2021-01-17 chills Dizziness, vomiting, rapid heartbeat, chills, temperature 96.4
78 2021-01-17 headache, fever Blurred vision, headache, and fever
78 2021-01-17 headache Headache for 12 days
78 2021-01-17 sleepiness, fatigue, malaise 6:00PM R arm very sore, soreness progressed to R side of body, began to feel very weak, unable to li... Read more
6:00PM R arm very sore, soreness progressed to R side of body, began to feel very weak, unable to lift leg to bed, malaise 24-36 hrs, exhaustion, wanting to sleep all the time, extremely weak next day
78 2021-01-19 chills, fatigue Extremely sore arm - much more than flu shots and STILL very sore. Ice and Ibuprophen 400 did not h... Read more
Extremely sore arm - much more than flu shots and STILL very sore. Ice and Ibuprophen 400 did not help. Chills and shaking so much I put on flannel pj's. Very tired next day. Did almost nothing and took 2 naps. Was still some tired today but better
78 2021-01-19 chills, headache At 9:00 PM started with chills for about an hour, headache, stomach hurt, lost appetite and food and... Read more
At 9:00 PM started with chills for about an hour, headache, stomach hurt, lost appetite and food and water did not taste good just like when she had COVID, which was 10/13/20. Couldn't sleep either. Just took OTC medicine. Now feeling better about 10:30-11:00 this morning, but still does not have an appetite.
78 2021-01-19 fever I got the shot on Monday 1/11/2021, had a slight fever on the 12th and couldn't raise my arm higher ... Read more
I got the shot on Monday 1/11/2021, had a slight fever on the 12th and couldn't raise my arm higher then my shoulder. On the 13th my arm was fine. Then I didn't worry about till the 01/18/2021 in the evening and it felt warm and it was a big patch of red (looked like a rash) about 3 inches long and 2 inches wide like a oval shape. On Tuesday 01/19/2021 I called my doctor, spoke with nurse what was going on. Doctor told her to put cold compresses on the site 15 minutes on and then 15 minutes off and take Tylenol as needed. The area is still warm and the redness area is still there. Did go to local grocery store and spoke with pharmacist who advised her to contact VAERS.
78 2021-01-20 chills, fever 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 fever, chills 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 2021-01-21 chills, fever 10:30 IN BED FELT CHILLED THOUGHT SHE HAD A SLIGHT FEVER. GOT BLANKETS TO GET WARM AND FELL TO SLEEP... Read more
10:30 IN BED FELT CHILLED THOUGHT SHE HAD A SLIGHT FEVER. GOT BLANKETS TO GET WARM AND FELL TO SLEEP. WOKE UP EARLY MORNING UNSURE OF TIME HAD TO GO TO BATHROOM. PT REPORTS EXTREME MUSCLE WEAKNESS IN ALL EXTREMITIES AND COULD NOT MOVE. HAD TO SLIDE OFF BED AND CRAWL TO GET TO BATHROOM. WHEN SHE GOT TO BATHROOM, SHE DOES HAVE LIMITED RANGE OF MOTION IN L SHOULDER BUT WHEN SHE ATTEMPTED TO GRAB BAR IN BATHROOM HER R ARM WAS LIMP AND COULD NOT GRAB BAR TO LIFT SELF UP TO TOILET. WAS FOUND BY FAMILY IN BATHROOM SOILED. DID NOT APPEAR TO HAVE ANY INJURIES FROM FALL PER PTS DAUGHTER AND PT REPORTED SHE DID NOT HAVE A HARD FALL OR HEAD INJURY.
78 2021-01-21 fatigue fatigued and tired, sore arm within a day. On day 8-9 very large red area and swelling from below i... Read more
fatigued and tired, sore arm within a day. On day 8-9 very large red area and swelling from below injection site to elbow, itching and very uncomfortable.
78 2021-01-21 fatigue extreme exhaustion at 10 Wed. night. Upon awakening around 7 AM Thurs. morning, severe vertigo. Had... Read more
extreme exhaustion at 10 Wed. night. Upon awakening around 7 AM Thurs. morning, severe vertigo. Had to crawl because of room spinning. This continued all day and abated around 6 PM. Left me feeling tired, and still tired on Fri. AM
78 2021-01-22 chills Friday Evening, (7 PM) after the Thursday PM injection, I experienced extreme chills and all over bo... Read more
Friday Evening, (7 PM) after the Thursday PM injection, I experienced extreme chills and all over body aches. I took 2 Coricidin pills and went to bed at 9:30 PM. After 12 hrs. of sleep, I woke up feeling better and have not experienced a return of symptoms.
78 2021-01-22 fatigue, sluggishness, throat pain, chills Moderna COVID-19 Vaccine EUA chills, shortness of breath, fatigue, body and muscles sore to the tou... Read more
Moderna COVID-19 Vaccine EUA chills, shortness of breath, fatigue, body and muscles sore to the touch headache with funny feeling, sluggish, flushed, no taste. sore throat, nausea (not vomiting), severe leg cramps, droopy, eyes won't focus and want to close, lumpy throat that is sore to the touch
78 2021-01-22 fever Very bad back and stomach pain beginning 7:30 pm to 7:00 am the next morning when I called advice nu... Read more
Very bad back and stomach pain beginning 7:30 pm to 7:00 am the next morning when I called advice nurse, told to take Tylenol. pain got much better. Continued to take Tylenol every 6 hours, kept pain bearable, slept 12 hours the next night. Had a slight fever 100.5 the next day, still having some pain in my abdomen. Thursday night, pain in abdomen was bad again, but not as bad as the first night. Talked to my doctor on Friday about these effects. Friday night pain in my abdomen is much better but still there. No fever on Friday or today, Saturday
78 2021-01-23 body temperature increased, headache, chills, fatigue For about 4 hours, had chills, exhaustion, nausea, head ache, temperature of 99.8
78 2021-01-23 headache, cough, fever Chills, fever of 101.3 and then cough with wheezing And bad headache. Don't know if this is all re... Read more
Chills, fever of 101.3 and then cough with wheezing And bad headache. Don't know if this is all related to the vaccination.
78 2021-01-23 headache, fatigue Very extreme pains throughout my whole body, extreme exhaustion, pain in lower part of stomach and p... Read more
Very extreme pains throughout my whole body, extreme exhaustion, pain in lower part of stomach and pain when sitting. Lasted for 3 days. Headach.
78 2021-01-24 chills nausea, chills, leg aches. Tylenol, ibuprofen and Benadryl. Lasted 48 hours
78 2021-01-24 headache Severe pain in neck and shoulders Sever headache
78 2021-01-24 sweating post vaccine c/o nausea, hot and sweaty, dizzy, lightheaded, feeling faint
78 2021-01-25 chills, headache, fever chills, headache, fever, nausea ,delirious ,arm swollen and sore
78 2021-01-25 headache, chills Arm: prolonged pain, tenderness, swelling and redness (for about 5 days) Other: headache, muscle and... Read more
Arm: prolonged pain, tenderness, swelling and redness (for about 5 days) Other: headache, muscle and joint pain, chills, nausea, dizziness (for about 18 hours) oxygen level: averaged 96 but dropped to 93 one time (but that might have been equipment error)
78 2021-01-25 headache, chills chills, headache, severe body aches, diarrhea, throwing up and nausea
78 2021-01-25 fever, headache 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 fatigue, headache fatigue, headache, muscle pain, joint pain nausea. Slept most of the day. No appetite, very little ... Read more
fatigue, headache, muscle pain, joint pain nausea. Slept most of the day. No appetite, very little food consumed.
78 2021-01-28 fatigue Redness, swelling, heat, mild itching, hardness at injection site Abdominal cramps, nausea, vomiting... Read more
Redness, swelling, heat, mild itching, hardness at injection site Abdominal cramps, nausea, vomiting Mild fatigue
78 2021-01-28 nasopharyngitis Patient developed cold like s/s on the 11/12 of January 2021. By the 15th of January patient became ... Read more
Patient developed cold like s/s on the 11/12 of January 2021. By the 15th of January patient became weak with mild shortness of breath and was sent to the ER. ER sent patient home. Patient was sent back to ER on January 18th as she remained weak with shortness of breath and was unable to get out of bed. On the 19 of January the patient was sent to a SNF for rehab services in which she remains as of today. According to the patient's son the patient is doing better but still requires assist with mobility. Patient is not on oxygen.
78 2021-01-28 throat pain Sore throat - 1/28/21 woke up Arm pain - 1/28/21 woke up Itchy eyes - 1/28/21 evening and current... Read more
Sore throat - 1/28/21 woke up Arm pain - 1/28/21 woke up Itchy eyes - 1/28/21 evening and currently Itchy ears - 1/28/21 evening and currently Itchy in the arm of vaccine - 1/28/21 evening and currently
78 2021-01-28 fever 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 fatigue, chills Upon going to bed, within a matter of a few minutes, I started to get the chills real bad. Then my ... Read more
Upon going to bed, within a matter of a few minutes, I started to get the chills real bad. Then my muscles and joints started to hurt. I could not even turn over in bed without my whole body hurting. I don?t know if I had a fever or not. I was so tired, but shaking with chills and body hurting I couldn?t go to sleep. Put more blankets on and took 2 Tylenol. I was able to eventually go to sleep. I felt better in the morning but was very tired during the day. It felt like I had covid again. I had the same symptoms then. I tested positive for covid November 27 at a rehab/nursing home where I was sent after foot surgery.
78 2021-01-31 fatigue, headache site of injection red pain in Left arm Headache Fatigue
78 2021-01-31 headache head ache 3-4 hours day of vaccination, lips tingly 3-4 hours day of vaccination, shortness of breat... Read more
head ache 3-4 hours day of vaccination, lips tingly 3-4 hours day of vaccination, shortness of breath 2-3 hours (2 different times) next day after vaccination, increased vertigo symptoms since vaccination & still remains, but other symptoms are improved. Note: just wondering if interaction of the steroid injections every two weeks with the covid vaccination???? (in answer to be if recovered...all except the increase of vertigo)
78 2021-01-31 sweating, headache Approx 8 hours after receiving injection headache began, went to bed. Woke up at 3 am aching muscles... Read more
Approx 8 hours after receiving injection headache began, went to bed. Woke up at 3 am aching muscles and head. Fell going to the bathroom. Able to get up and go to bed. Got up at 6 am, went to bathroom and fell in bathroom hitting doorframe causing black and blue bruise on right shoulder. Feeling very weak, sweaty, and shaky. Laid on floor x 15 min until able to get up and scooted over to sink and pulled self up and vomited x 1. Got back to bed. Felt weak, shaky and sweaty for the whole day. Feeling better after taking Tylenol for the achiness by the end of day. Felt weak and tired the following day but better.
78 2021-01-31 sleepiness, nasopharyngitis, malaise, fatigue, headache 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 fatigue, chills After administration of the Covid-19 vaccine I had 2-3 days of chills, muscle aches, fatigue, sore a... Read more
After administration of the Covid-19 vaccine I had 2-3 days of chills, muscle aches, fatigue, sore arm. Symptoms gradually went away. Then about the 7th day I started experiencing an itchy arm and a 6 inch circle of intense red at the injection site, with a wide band of white surrounding it, that itched unbelievably, was hot and swollen. That lasted for several days, then began to subside and now is only slightly red, itches some and is no longer swollen or hot. My question is: Is it safe for me to get the 2nd dose, after experiencing this kind of reaction?
78 2021-02-01 pneumonia Pneumonia in left lung; Pain in neck; Acute serious pain under her ribs, all the way around her body... Read more
Pneumonia in left lung; Pain in neck; Acute serious pain under her ribs, all the way around her body; A spontaneous report was received from a consumer concerning a 78 year old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed acute serious pain under her ribs, all the way around her upper body, pneumonia in her left lung and neck pain. The patient's medical history was not provided. Concomitant medications included non specified medication for blood pressure, calming down, dementia and thyroid. On 04 Jan 2021, approximately 2.5 hours 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 04 Jan 2021, the patient developed acute serious pain under her ribs, all the way around her upper body that lasted ten days. The patient also experienced neck pain. On an unknown date, she was treated in the emergency room for pneumonia in her left lung and given antibiotics. She later followed up with her primary care doctor and additional x-rays were taken and she was treated with prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, acute pain under her ribs, all the way around her upper body, was considered resolved on 14 Jan 2021. The outcome of the event, pain neck was resolved on 19 Jan 2021. The outcome of the event, pneumonia in left lung, was unknown.; Reporter's Comments: Company Comment: This case concerns a 78-year-old female patient who experienced unexpected serious event of pneumonia and non-serious event of acute serious pain under her ribs, all the way around her upper body and neck pain. The event developed on the same day after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # unknown, expiration date-unknown). Although a temporal association exist between the event of pneumonia and the administration of the vaccine, in the absence of clinical details including diagnostic test, a definite diagnosis was not established. The events of acute serious pain under her ribs, all the way around her upper body and neck pain are also temporarily associated with vaccine administration and a causal association cannot be excluded. Main field defaults to ‘possibly related' for all events.
78 2021-02-02 cough 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 2021-02-02 fatigue, sweating 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 fever, chills, headache severe numbness and tingling of both lower limbs extending from the buttocks to the toes on 02/02/2... Read more
severe numbness and tingling of both lower limbs extending from the buttocks to the toes on 02/02/2021 to 02/3/2021 associated with lower limbs weakness. resolved with some residual right thigh muscle tenderness and sensitivity. chills low grade fever headache and severe nausea resolved by 02/03/2021
78 2021-02-03 cough, headache 12/28 Vaccination Later that evening, muscle aches and HA. 12/29 Joint pain, HA, and mild cough 12... Read more
12/28 Vaccination Later that evening, muscle aches and HA. 12/29 Joint pain, HA, and mild cough 12/31 Severe cough, lost voice, unable to sleep 1/2021 Urgent care; COVID test; Positive Bamlanivimab; treatment/infusion; 3 hours 15 days isolation 1/18/2021
78 2021-02-03 fatigue, sleepiness On the 4th hour I was sleepy and fatigue, 3pm, went to bed at 11pm, woke up at 2am extremely dizzy a... Read more
On the 4th hour I was sleepy and fatigue, 3pm, went to bed at 11pm, woke up at 2am extremely dizzy and the room was fiercely spinning and couldn?t get up. I tried going back to sleep and when trying to move the room spined drastically slowly sat up and went to the bathroom and laid back down and it started again, each duration lasted 10 seconds and it caused me to have 3 BMs in the next3 hours, couldn?t sleep but I have a tightness around my head and sleepiness and last event was 7am, when got up I had diarrhea and and had dry heaves that lasted 5 minutes and now fatigued and hot feeling around my eyes. My stomach feels stressed and tired and weak
78 2021-02-03 headache, fever I have extreme join and muscle pain, (shoulders, arms, hands, back, hips, knees, legs) so bad that I... Read more
I have extreme join and muscle pain, (shoulders, arms, hands, back, hips, knees, legs) so bad that I cannot sit or walk. I have a slight fever and headache.
78 2021-02-03 headache I developed a horrible headache and woke up in the middle of the night soaking wet.
78 2021-02-03 headache 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 2021-02-03 fever Moderna COVID?19 Vaccine EUA Big red circle and swelling at the location of the vaccine. It's day ... Read more
Moderna COVID?19 Vaccine EUA Big red circle and swelling at the location of the vaccine. It's day four and the swelling is larger. The red circle is large. I have a picture to send you. Fever of 102 the first night, no fever now. Not sure if it's infection or from the vaccine itself but today is the 4th at 4:45 pm and she got the vaccine on the 1st at 1:30 pm. I have yet to taken her to the doctors for the increased swelling because I caused the covid vaccine number and a vaccine specialist said this could be normal and to watch it. I have a picture it looks BIG!
78 2021-02-04 body temperature increased Elevated Temp 99.0. Loose stool
78 2021-02-04 chills, fever Sore injection site beginning last night. This morning, woke up with chills, began feeling "feverish... Read more
Sore injection site beginning last night. This morning, woke up with chills, began feeling "feverish" throughout the day. Pt took Excedrin prior to calling. Vaccine Administration dates: 1/06/2021, 02/02/2021
78 2021-02-04 fever per pt. on Monday afternoon apx 2pm started feeling feverish and tongue swelling. Stated had a stiff... Read more
per pt. on Monday afternoon apx 2pm started feeling feverish and tongue swelling. Stated had a stiff neck for a couple of hours that evening, unable to eat Tuesday, Wednesday, feverish, and shaking. Slowly recovering through week. As of today per pt. "feels perfectly line"
78 2021-02-05 chills, fatigue Chills and extreme fatigue lasting over 1 week
78 2021-02-05 headache, chills Severe headache, chills, nausea
78 2021-02-06 chills, fatigue, body temperature increased Woke next day with sore arm, chills and temp 99.6. Tired and chill all day. Took tylenol. Much be... Read more
Woke next day with sore arm, chills and temp 99.6. Tired and chill all day. Took tylenol. Much better today.
78 2021-02-06 cough Day #1 Intense itching, swelling and redness within 3 hours after injection Day #4 Swollen tongue,... Read more
Day #1 Intense itching, swelling and redness within 3 hours after injection Day #4 Swollen tongue, itching, difficulty swallowing, coughing, wheezing. Called 911 and transported to Hospital. Received Prednisone 20mg for 5 days, Famotidine 20mg Day #9 Tele-visit with Dr. Received Azithromycin 250mg for coughing. continued Azithromycin Day #10 Symptoms returned. Swollen tongue, difficulty swallowing, breathing difficulty, left arm is swollen, red and itching at injection site. continued Azithromycin Day #11 Woke up with same symptoms in addition to nausea. continued Azithromycin
78 2021-02-06 fatigue Experienced non-serious but severe side effect (pain). Unusual fatigue 7 hrs after injection. Awake... Read more
Experienced non-serious but severe side effect (pain). Unusual fatigue 7 hrs after injection. Awakened at about 10:30 p.m. (12 hrs after injection) with extreme pain at/around injection site. Very extreme pain. Had me yelling ow!ow!ow! Pain seemed to become generalized across shoulders and to right arm. Most acute phase lasted about 30 minutes. Fatigue and pain gone by next morning. All seemed normal. But every night since (including last night, 2/6/21), in the middle of the night, I have again been awakened by serious (but not nearly as extreme) pain at/around the injection site. Always gone by morning, although slight ache remains.
78 2021-02-06 fatigue Tiredness and nauseated
78 2021-02-06 throat pain Injection 2 on 2/5/2021: small red rash around injection within 12 hours of injection nausea started... Read more
Injection 2 on 2/5/2021: small red rash around injection within 12 hours of injection nausea started at 4:00 PM NEXT DAY sore throat started the evening of 2/6/2021 by evening of 2/6/21 red rash grew to approx 2 inches all the way around the injection site and became more itchy
78 2021-02-06 runny nose, fever, influenza like illness, cough Flu symptoms. with fever on and off , running nose,cough,. Dr. prescribed Decadron ,Xyzal,and Zithr... Read more
Flu symptoms. with fever on and off , running nose,cough,. Dr. prescribed Decadron ,Xyzal,and Zithromax
78 2021-02-07 fever, cough, chills, headache 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 fatigue, malaise, sweating Resident stated she felt ill, she was sweating, fatigue, decreased appetite, complaints of nausea.
78 2021-02-08 fever, headache, malaise Sore arm, fever over 101, sick feeling, headache, no appetite
78 2021-02-09 chills Injection site very hot and hard and tender. Chills and aches for a full day. Nodule in lymph area i... Read more
Injection site very hot and hard and tender. Chills and aches for a full day. Nodule in lymph area in neck.
78 2021-02-09 runny nose, fever, chills, sneezing, headache Fever of 102, chills, headache, body aches, dizziness, sneezing, runny nose
78 2021-02-10 headache Doesn't recognize Husband or family; Not eating much; Nausea; Headache; Diarrhea; Sleeping 24hs a da... Read more
Doesn't recognize Husband or family; Not eating much; Nausea; Headache; Diarrhea; Sleeping 24hs a day; A spontaneous report was received from a health care professional concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family. The patient's medical history included Alzheimer's disease. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium. On 08 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, the reporter states the patient went into a sharp decline, diarrhea, nausea, headache and sleeping 24 hours a day. A few days later, the patient was not eating much and did not recognize her husband or family. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family, were considered unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient with a medical history of Alzheimer's disease, who experienced unexpected events of diarrhea, hypersomnia, decreased appetite, confusional state and expected events of nausea and headache. The events of diarrhea, nausea, headache and hypersomnia occurred 5 days after the first dose of mRNA-1273 (Lot 025J20-2A) and, the events of decreased appetite and confusional state occurred unspecified number of days later. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Very limited information regarding this event has been provided at this time. Alzheimer's disease is a confounding factor too. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.
78 2021-02-10 nasopharyngitis, fatigue 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 body temperature increased, fever, chills Fever and chills (severe shaking) starting around 5 p.m. on the day of the vaccination (Feb. 10). T... Read more
Fever and chills (severe shaking) starting around 5 p.m. on the day of the vaccination (Feb. 10). Took 2 Tylenol around 9:30 p.m. and went to bed. Had a temperature of 100.2 on Feb. 11; no chills. Stayed in bed the whole day. By about 5 p.m. the fever was gone and I was feeling much better. Today (Feb. 12) pretty much back to normal.
78 2021-02-11 chills chills, hurting arm, lymph nodes under right arm swollen, weakness, body aches
78 2021-02-11 fatigue, chills, headache, fever I started having a headache and felt listless and tired. body aches. lack of appetite. fever of 100.... Read more
I started having a headache and felt listless and tired. body aches. lack of appetite. fever of 100. took a tylenol. I woke up at 5am the 10th and I was shaking and having chills and I was hot and cold... I was dizzy and my eyes hurt. My arm was hurting. I took another tylenol. at 6am I called my NP daughter for advice and she told her it was a reaction of the vaccine. my fever was 102.5. I was advised to take more tylenol and to rest. the fever broke later that morning but I was still experiencing those side effects. 3 days later I'm still not 100%.
78 2021-02-11 headache, fever Body aches over total body Fever: 100.9 Nausea and vomiting Headache Sore left arm
78 2021-02-12 fatigue, headache Had no reaction during my 30 minute wait after the injection. That evening at 9:15 started feeling... Read more
Had no reaction during my 30 minute wait after the injection. That evening at 9:15 started feeling really tired and was chilled feeling which made me shake. Was nauseated all night long. I had dry heaves three times. Had a headache all night. These symptoms subsided later in the morning and by noon I was feeling fine except for being tired from the night's experiences. I feel fine now.
78 2021-02-12 fatigue, throat pain, headache Hour after vaccine shot started with Slightly swollen lips & numbness in the lips red color of cheek... Read more
Hour after vaccine shot started with Slightly swollen lips & numbness in the lips red color of cheeks. . Took Benadryl and 16 ounces of water around 1hour 15 minutes after shot Two hours after shot experience slight sore throat lightheadedness head cold symptoms Symptoms lasted another six hours took a second then a drill. Rank another three bottles of water Symptoms became lighter with a little bit of a headache After 20 hours everything went away except tiredness and light headaches
78 2021-02-12 fatigue, fever, chills Chills, fever, very tired, achy
78 2021-02-12 fever, fatigue slight fever (99.5 degrees), ache in left arms, fatigue,body aches
78 2021-02-13 headache, chills extreme shivering, massive headache. Migraine type headache everyday since injection.
78 2021-02-13 headache, fatigue, fever low grade fever, fatigue, headache, muscle aches, chills, pain at injection site these symptoms star... Read more
low grade fever, fatigue, headache, muscle aches, chills, pain at injection site these symptoms started around 9:00am 24 hours after injection of second dose.
78 2021-02-13 fever, headache Pain and soreness in the arm, fever, headache, nausea, weakness, and body aches. Nausea, weakness an... Read more
Pain and soreness in the arm, fever, headache, nausea, weakness, and body aches. Nausea, weakness and body aches lasted 3 days.
78 2021-02-14 body temperature increased, chills Temp 101, chills freezing, body aches, nausea, arm at injection site hot & sore, inability to get wa... Read more
Temp 101, chills freezing, body aches, nausea, arm at injection site hot & sore, inability to get warm
78 2021-02-14 fatigue Face swollen on right side, itches, feel nauseous, tired, weak.
78 2021-02-15 body temperature increased, chills I had my second Maderna shot at 10:30 am. No problem with my first one three weeks ago. At 10:00 pm ... Read more
I had my second Maderna shot at 10:30 am. No problem with my first one three weeks ago. At 10:00 pm I started to get extremely cold and could not get warm. At 10:45 my upper body started shaking very, very bad. I couldn't control the shaking and my teeth were chattering. I had to lay down and put my arms under my body to keep them from shaking and I was so cold even though I was wearing warm things and under a comforter. The shaking lasted an hour and a half. I took my temperature during the night and it was 102. I am very week this morning, temp. is 99.9. I was expecting the temperature and pain in the injection site but I can't find out anywhere on line whether the uncontrollable shaking was normal for the second shot. .
78 2021-02-15 chills, fatigue I received the vaccine on 2/9 and started having an adverse reaction. Chills, extreme fatigue, muscl... Read more
I received the vaccine on 2/9 and started having an adverse reaction. Chills, extreme fatigue, muscle and body aches, bone and jaw pain, no appetite, nausea and diarrhea?all starting on the same day and rather severe by the next day.
78 2021-02-15 chills, headache, body temperature increased, fatigue 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 2021-02-15 chills, headache Chills. 2 hours; Headache. 3 hours
78 2021-02-15 headache, sweating, fatigue 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 lethargy Entire body hurt,Weak, lathlathergic, stomach bloated, slept through only got up to use bathroom, d... Read more
Entire body hurt,Weak, lathlathergic, stomach bloated, slept through only got up to use bathroom, drink tea and water. Next day awake 6 hours had 1 meal, cup tea and water. Slept 2 hours up til 10:30 back to sleep.
78 2021-02-16 chills Body aches, chills
78 2021-02-16 fatigue Wed Feb 17. Fatique feet seem discolored at times arm seems to feel like mild pins and needles
78 2021-02-16 sweating 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 2021-02-16 influenza like illness, chills, fever 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 fever, headache, chills Fever chills achy headache lightheaded
78 2021-02-16 fever, sluggishness, fatigue I had fever starting about 12 or 15 hours after the vaccine was given. The fever lasted for about 24... Read more
I had fever starting about 12 or 15 hours after the vaccine was given. The fever lasted for about 24 hours. Now I am very tired and sluggish and still don?t feel well five days after the vaccination was given. I felt very well, except for back pain, before being vaccinated.
78 2021-02-17 headache, fatigue 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 headache, fatigue Lost muscle control, could not raise up out of bed, could not walk, lost bladder control, slept 24 h... Read more
Lost muscle control, could not raise up out of bed, could not walk, lost bladder control, slept 24 hours, no appetite, weakness, headache, fatigue
78 2021-02-17 sweating 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 chills, headache Chills, muscle aches throughout body, headache and pain in left arm that made it too painful to move... Read more
Chills, muscle aches throughout body, headache and pain in left arm that made it too painful to move or use it. All symptoms except arm pain resolved within 24 hours. Pain in arm lessened to tenderness on touch and slight pain on movement within 48 hours. All arm pain symptoms were gone by 6th day after injection.
78 2021-02-18 chills, fever, headache 8-10 hrs post injection (this was the second dose) nausea, fever, chills, diarrhea, headache, weakne... Read more
8-10 hrs post injection (this was the second dose) nausea, fever, chills, diarrhea, headache, weakness, dizziness, could not get out of bed or stand.
78 2021-02-18 chills, fever Fever. Chills As of today 2/19 100 was as high as 101.8 Took advil
78 2021-02-18 fatigue, chills My arm was sore. there was a little itching. It was later in the evening that I felt very tired. I f... Read more
My arm was sore. there was a little itching. It was later in the evening that I felt very tired. I felt warm but I didn't have a fever. I developed chills. it lasted for several hours.
78 2021-02-18 headache, fatigue Mild headache, severe fatigue, slight nausea for 12 hours
78 2021-02-18 headache Nausea, Vertigo, mild headache. Vomiting for one and half days. Soreness at site of injection for o... Read more
Nausea, Vertigo, mild headache. Vomiting for one and half days. Soreness at site of injection for one day
78 2021-02-18 headache 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 2021-02-19 body temperature increased, chills, headache injection site started aching almost immediately but within 6-7 hours upper arm painful and hard, ba... Read more
injection site started aching almost immediately but within 6-7 hours upper arm painful and hard, back of head so painful had to go to bed. Body became like a lead weight, couldn't raise my arms, couldn't turn over, couldn't reach my phone 8 inches away. Had shaking chills for 8-9 hours even though temp. was only 99.8. This was 10 times worse than when I had Covid. Thank goodness the severe reaction only lasted a day and a half then slowly got better over the next 2 days.Took week for arm tenderness to go away.
78 2021-02-19 chills, headache Experienced severe acid reflux with white, coated tongue for 3 days 4th and 5th days nausea, headach... Read more
Experienced severe acid reflux with white, coated tongue for 3 days 4th and 5th days nausea, headache, chills aching joints from neck to feet on 2/19 left arm sore (it was not sore except for day after injection) and itchy
78 2021-02-19 fatigue Did NOT occur until 1 week AFTER injection: pain, tenderness, swelling in upper arm & pain, hardness... Read more
Did NOT occur until 1 week AFTER injection: pain, tenderness, swelling in upper arm & pain, hardness and redness; these were preceded by diarrhea and fatigue. Better in 2/3 days.
78 2021-02-19 fatigue Arm pain and fatigue from the first shot Arm pain, fatigue, burning breast shortly after receiving s... Read more
Arm pain and fatigue from the first shot Arm pain, fatigue, burning breast shortly after receiving second shot and arm was painful and weak and unable to be lifted one week after second shot
78 2021-02-19 headache, fatigue Headache, fatigue
78 2021-02-19 headache Itchiness of vaccine site, other arm and parts of body, redness on both upper arms. Continues even n... Read more
Itchiness of vaccine site, other arm and parts of body, redness on both upper arms. Continues even now. Using cortisone cream prescribed. Itchiness abating.
78 2021-02-19 influenza like illness, chills, fever, headache Flu like symptoms: chills, muscle ache, headache, low grade fever, for 2 days.
78 2021-02-19 influenza like illness Sharp pain in knees and elbow, nausea ... took pain pill and pain was gone in am. Have been feeling... Read more
Sharp pain in knees and elbow, nausea ... took pain pill and pain was gone in am. Have been feeling bad (like I was hit by a Mack truck all day. (Flu like aches) nausea on and off but cant throw up. Feeling weak.
78 2021-02-20 headache, chills, fever Chills, headache,,, fever 101..7, swelling at site of shot,, itching, I slept, took advil,, and ... Read more
Chills, headache,,, fever 101..7, swelling at site of shot,, itching, I slept, took advil,, and ate chicken soup.
78 2021-02-20 headache, fever, fatigue, chills chills, nausea, headache, some site pain, some muscle pain, fever, tiredness
78 2021-02-20 headache Massive headache for 24 hours following the 2nd dose Mini stroke (TIA)
78 2021-02-20 headache Temperature, Headache body ache
78 2021-02-21 fatigue I couldn't sleep the night of my shot. I felt like l had the flu. No fever but just so sick and beca... Read more
I couldn't sleep the night of my shot. I felt like l had the flu. No fever but just so sick and because of the myesthenia my breathing was compromised. On the oxymeter it showed 92 and 93 at times. Today, the 22nd February l feel better but weak and tired and my head feels funny Hard to describe. I still feel it's difficult to take a deep breath
78 2021-02-21 headache moderna COVID-19 Vaccine EUA rash occured on Feb. 18th on neck sides of face forhead very red very i... Read more
moderna COVID-19 Vaccine EUA rash occured on Feb. 18th on neck sides of face forhead very red very itchy also about a couple of inches on the front of my chest directly under my neck I had a similar reaction after a shingtrex second dose shot which was given January 19th 2021ad a teledoc appt. on Feb. 19th was prescribed to take an antihistamine(claritan or zyrtex and use a cream, triamcinolone acetate for the rash and if needed a benedryl tabblet at bed time but only if necessary due to severe itching the cream gave enough relief in that regard so no benedryl was necessary I also had a very light head ache and a bit of stiffness in my neck during this time also, although I don't know if this is relevant to the vaccine I am a carrier of Kennedy disease and occasionally have vessiculations I have not seen any doctor about this but I hbit of that the day after my shotad a slight
78 2021-02-21 fever, headache Fever, pain on injection site, headache
78 2021-02-21 fever Fever, pain on injection site
78 2021-02-22 cough Patient,had received second dose of Moderna COVID vaccine and was waiting the 15 minutes post inject... Read more
Patient,had received second dose of Moderna COVID vaccine and was waiting the 15 minutes post injection for observation. Patient reported that she felt her tongue swelling and had difficulty swallowing. Patient anxious, but in no respiratory distress. BP 130/72. Patient was instructed to take some slow deep breaths. Patient continued to c/o tongue feeling thick and she had hacking cough and c/o difficulty swallowing. Patient was given Epinephrine 0.3 auto injector to right thigh at 1:32 pm by RN. BP 150/92, P 90 R 20, Patient also given Diphenhydramine 50mg IM to left deltoid by RN, Supervisor. Patient remained alert and oriented. BP 176/92 at 1:37 pm. EMS arrived on site and monitored patient with EKG, Pulse oximeter, BP and pulse. Patient had some shaking. She remained alert and oriented. Patient refused transport by ambulance to ER. She did agree to go to ER by private car. Patient's husband resent and to transport patient by car to Medical Center. EMS followed patient to hospital. Confirmed that patient was taken to Medical Center ER, by RN.
78 2021-02-22 headache Bad headache, dizziness, achy, vomiting (3x) Lasted until about midnight, Monday, Feb.22. Felt to... Read more
Bad headache, dizziness, achy, vomiting (3x) Lasted until about midnight, Monday, Feb.22. Felt totally recovered by 9AM Tuesday.
78 2021-02-22 nasopharyngitis, chills, fever, fatigue 02/02- Shivering chills, 6 hrs.; muscle & joint pain, 4 days; excessive fatigue and cold, 2 1/2 week... Read more
02/02- Shivering chills, 6 hrs.; muscle & joint pain, 4 days; excessive fatigue and cold, 2 1/2 weeks; fatigue continues; 02/10- injection sight red, feverish. appt. at urgent care 02/11. entire back of right arm infected, cellulitis. RX antibiotic. End of 10 days, cellulitis appears gone.
78 2021-02-23 chills, fever, influenza like illness Patient reports that starting Wednesday afternoon she felt "yuck". Continues to state that from Wedn... Read more
Patient reports that starting Wednesday afternoon she felt "yuck". Continues to state that from Wednesday afternoon until approximately Saturday afternoon she had flu like symptoms, consisting of fever, chills, aches, muscle cramps in her legs.
78 2021-02-23 fatigue Injection site pain, Nausea, Swollen Lymph nodes, Fatigue, Diarrhea
78 2021-02-23 headache, fatigue Woken up at 0300 by severe headache along with body aches, fatigue, nausea and diarrhea. H/A and bod... Read more
Woken up at 0300 by severe headache along with body aches, fatigue, nausea and diarrhea. H/A and body aches lasted for aprox 8-10hrs., continued to have nausea, diarrhea and fatigue for about 24 hrs after initial incident. Symptoms have resolved as of today. Denies any other symptoms.
78 2021-02-23 fever, chills After vaccine I was fine went home and took a nap, when I woke up at 2pm I was a little dizzy. By 7p... Read more
After vaccine I was fine went home and took a nap, when I woke up at 2pm I was a little dizzy. By 7pm I was dizzy and nauseated, and it got worse, I got chills and shook and shook and shook, I had a fever and the next day I tried to get out of bed, and I fell to the floor and couldn?t stand up, I had no energy or appetite. I had covid in August 2020 and the wasn?t made aware of the possible side effects if you had covid. They didn?t ask if I had covid in the past and the pharmacist told me later that people who has had covid has reported having bad side effects. I had gone a couple weeks ago to see if I had the covid antibodies and I was positive for antibodies and the injection works against the antibiotics. This part of the procedure was overlooked. I have no one else to help me and going through this alone, it would have been better to have been made aware of this ahead of time.
78 2021-02-23 fever, sweating, fatigue, chills After Dose #2 Muscle swelled and red mark just below vaccination site same day. Next day fatigue, c... Read more
After Dose #2 Muscle swelled and red mark just below vaccination site same day. Next day fatigue, chills, sweats, diarrhea, low grade fever, burping Next day pain above stomach below breast bone, nauseau, vomiting, indigestion, burping. Next day arm still swollen, red spot much larger, itchy, hot.
78 2021-02-23 sneezing Beginning the next day and continuing for the next 8 days, frequent violent sneezing fits every sing... Read more
Beginning the next day and continuing for the next 8 days, frequent violent sneezing fits every single afternoon; duration of about 4 hours. Not something horrendous, but definitely, in my opinion, a side effect to the vaccine.
78 2021-02-24 headache, fatigue Evening of 1/28 I started feeling fatigue, muscle aching, stomach upset and headache which lasted ti... Read more
Evening of 1/28 I started feeling fatigue, muscle aching, stomach upset and headache which lasted till next day around noon. Then was fine for 7 days. On 2/5/2021, I went to get my B12 shot and asked the doctor to check left arm where Moderna shot was given as it was itching and a bit sore at the same time. He told me I was having reaction. By evening, a third of my arm around injected area was swollen an had red rash. Then same symptoms of fatigue, etc. came back and I was in and out of bed for the next three days....then at end had a bout of diarrhea.
78 2021-02-24 headache, malaise My antidepressant, Sertraline has stopped working. After the shot, my eyes got blurry. About 5 days ... Read more
My antidepressant, Sertraline has stopped working. After the shot, my eyes got blurry. About 5 days later I thought I had a headache from sinus. After medication and doctor visits, it is not sinus. No appetite. shaky, insomnia, no interest in ordinary activities. Constant headache. Feel very sick.
78 2021-02-25 fatigue, chills, fever Low fever, diareahea, vomiting chills, hyperventilation, sore arm, nausea, exhaustion, loss of app... Read more
Low fever, diareahea, vomiting chills, hyperventilation, sore arm, nausea, exhaustion, loss of appetite. This after both the first and second injections. It lasted one day with total exhaustion the second day.
78 2021-02-25 fatigue Severe muscle and body aches throughout my body and fatigue. Tylenol relieved the symptoms but they... Read more
Severe muscle and body aches throughout my body and fatigue. Tylenol relieved the symptoms but they lasted for 2 days.
78 2021-02-25 headache my arm was black and blue, I woke up with head hurting diarrhea for 4 days, then I started havin... Read more
my arm was black and blue, I woke up with head hurting diarrhea for 4 days, then I started having whelps all the way to my ears and down my chest and today Feb 26 I still have them but not as bad. Is it ok to take my 2nd shot March 8th ?
78 2021-02-25 malaise, chills Dizziness, chills, body pains, malaise, myalgias, nausea, tremors.
78 2021-02-25 malaise, fatigue, fever 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 malaise, fatigue Upper arm became somewhat sore by later afternoon, became excruciatingly painful by later evening. D... Read more
Upper arm became somewhat sore by later afternoon, became excruciatingly painful by later evening. Did not feel well by bedtime, and a bit fuzzy-headed. Next day, I was fuzzy-headed, body stiff and achy, very tired, upper arm excruciatingly painful. All symptoms began to clear significantly by evening, and back to normal by the following morning (2/10).
78 2021-02-25 fever, body temperature fluctuation 1:45 pm January 5, next day I was pretty good but started running a fever. 99.5 and stayed at that t... Read more
1:45 pm January 5, next day I was pretty good but started running a fever. 99.5 and stayed at that temp until 12th - went up to 101.3 and I was very dizzy. Dizziness was just for 24 hours. January 14th - at 6:00 pm - my temperature 100.9 and it started going down after that. It fluctuated to 99.5 to normal up and down - evening when temperature would come back up. I took 1 acetaminophen (phone call to dr told me to take it) to get temperature down when it was 101 but all the rest of the time I just counted on the aspirin that I take at night to help. Have to call the doctor to get the Lot numbers for the dose. Feb2 - was when I was took second dose and I was recovered from 1st dose.
78 2021-02-26 headache, cough cough and mild headache on day 3 after the vaccination not severe just annoying dry cough for about ... Read more
cough and mild headache on day 3 after the vaccination not severe just annoying dry cough for about 4 or 5 hours and headache for about 2 hours not severe enough for me to go to the clinic unless it does not go away.
78 2021-02-26 fever, nasal congestion 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 2021-02-27 chills, fever, throat pain, lethargy, sweating Same adverse effects as first short: fever of 101.6 which has slowly been going down, fluctuating, b... Read more
Same adverse effects as first short: fever of 101.6 which has slowly been going down, fluctuating, but today, 6th day after shot fever still 99.6. I have felt chills and sweats, lethargic, achy, today sore throat. Below site of shot had large bright pink 3inch circle very hot for first few days. I'm hoping the temperature stabilizes soon. It took 8 days to stabilize after first shot. My second shot's effects are the same as the first short. By the way, I suffered through Covid for 3-4 weeks from last midMarch through early April and I do still have antibodies and presume that is why I had the reaction to the first shot but I wasn't expecting the same for the second. I had also read in a magazine that people with antibodies didn't need the 2nd shot, however, my Dr. recommended that I get it. Treatment: I took Tylenol for the fever and aches. I was finally better after first shot in 8 days. I am not completely recovered yet from the second but I am confident I will have recovered completely in a few days.
78 2021-02-27 chills, runny nose, fatigue Fatigue, snotty nose, chills.
78 2021-02-27 fever, malaise, sneezing, headache, runny nose 2/23/21:Headache, sore arm 2/24/21: High Fever 100 degrees: 8:00 p.m. Blurry eyes, Stuffy, runny no... Read more
2/23/21:Headache, sore arm 2/24/21: High Fever 100 degrees: 8:00 p.m. Blurry eyes, Stuffy, runny nose. Sore arm. Sneezing. Felt ill. 2/25/21: Fever slowly came down during the day. Arm itchy and sore. Hot arm. 2/26/21: Hot, itchy, sore arm. Red area near injection site. 2/27/27: Arm still red, sore itchy. nausea.
78 2021-02-28 fatigue, headache After the second shot, I expected mild side effects and experienced some: mild headache, sore left a... Read more
After the second shot, I expected mild side effects and experienced some: mild headache, sore left arm around injection site, fatigue, brain fog. I was walking to my garage with a small package of papers when suddenly my lower back spasmed sharply. The pain was intense. I thought it would subside so I managed, with difficulty, to make it into my car. When I was seated in the car, the spasms subsided. I considered not driving to my two errands but decided that I felt well enough seated in the car to drive and deliver the papers to my tax preparer and the carful of donations to Goodwill. At the tax office, I called an assistant to come to the parking lot to pick up the papers, which she did. At Goodwill, one of the attendants emptied my car. When I got home at about 10:50, I had to call my husband to help me into the house. I spent the next several hours in agony (11 on a scale of 1-10) with spasms, punctuated by absolutly not moving. The spasms were so bad I could not breathe. My doc prescribed a muscle relaxer, then the next day prednisone, which has helped. Today I will have an mri to determine if the spasms herniated a disc.
78 2021-02-28 headache 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 2021-02-28 malaise At 24 hours after 2nd dose of vaccine; Severe back pain, all joints hurt, felt terrible like she had... Read more
At 24 hours after 2nd dose of vaccine; Severe back pain, all joints hurt, felt terrible like she had the flu, spent all day in bed. At 48 hours felt better but not well. At 72 hours, felt tired but better. at 84 hours felt much better (almost back to normal) . Her husband, myself, also had 2nd dose of vaccine. Felt fine until 36 hours, then both shoulders ached for another 24 hours. No other symptoms for husband.
78 2021-02-28 fever, chills Chills and then fever and lack of appetite. No energy
78 2021-03-01 chills, fever Fever, nausea, weakness, chills
78 2021-03-01 fatigue, cough 2 days after receiving first dose of vaccine, patient called to report worsening shortness of breath... Read more
2 days after receiving first dose of vaccine, patient called to report worsening shortness of breath, back pain, fatigue and a cough. She was sent to the emergency room for evaluation. At that time, she was given a 7 day course of antibiotics. Patient then presented to the ED on 02/25/2021, with worsening symptoms, and was found to be COVID positive.
78 2021-03-02 chills, fatigue On Saturday 02/20 twenty four hours after receiving the injection I felt fatigued with loss of ap... Read more
On Saturday 02/20 twenty four hours after receiving the injection I felt fatigued with loss of appetite and some chills. At the same time I noticed a 2inch red ring around the injection site. The next day I felt fine ,but had a very sore arm with the red circle and a large pink blush running down to my elbow which never disappeared. The following week the red circle disappeared but the pink blush remained. On Sunday, 02/28 I noted that the blush disappeared but I now had a 3inch red circle around the injection site. On Monday 03/1, the red circle grew and spread, and by 03/2 it was no longer in circular form but spread down my arm to 3inches by 6inches. It remains the same 0n 0/3. It is not painful or itchy. I am worried. I know this is called covid arm but my reaction does seem extreme. I do have some photos beginning on 02/28
78 2021-03-02 malaise 3 days after I took my first Moderna vaccine on 2/4/2021,I had a reaction on Sunday, 2/7/21. The re... Read more
3 days after I took my first Moderna vaccine on 2/4/2021,I had a reaction on Sunday, 2/7/21. The reaction was at 5:00 p.m. on 2/7, I did not feel well and my legs felt shaky and my blood pressures which are always in the 120 or 110 range over 70s or 60s were 164/86, 141/96, 199/79 and 156/132. The paramedics were called and they said it was the vaccine and my blood pressure was 151/70 at 6:15 pm.. I started to feel better but at 8 pm the same day, 2/7 m pressures from 8 pm to 11:30 pm were 158/83, 191/87, 146/106 and 144/74 and 130/67 and I was feeling better. On Monday 2/8 my blood pressure readings were normal. On Tuesday, 2/9/2021 I did not feel well at 5:00 a.m. At 5:55 a.m. my blood pressure was 188/85, 137/100, 169/89 and then was normal. The last time it happened was on Saturday, 2/13 and my pressures were 160/127 at 3:20 a.m. and 138/97. My pulse was always normal.
78 2021-03-02 fever Ran a fever at night the first 2 days, the second day my arm started getting red, swollen and painfu... Read more
Ran a fever at night the first 2 days, the second day my arm started getting red, swollen and painful
78 2021-03-03 chills, fever chills & fever (101.7), nausea, dizziness, aches & pains, I felt out of reach with reality for abo... Read more
chills & fever (101.7), nausea, dizziness, aches & pains, I felt out of reach with reality for about 24-36 hours. It never occurred to me to try to eat, drink or even to take my daily meds. I have never experienced that feeling before,
78 2021-03-03 chills Arm very sore for 2 days. Third day a rash on both arms. Very itchy so I took Benadryl and it subsid... Read more
Arm very sore for 2 days. Third day a rash on both arms. Very itchy so I took Benadryl and it subsided. On the third day the chills started around 2:00 in the afternoon. Went to bed with pajamas ,socks ,and a robe in order to keep warm because of the chills. Woke up this morning and the chills were gone and I feel great.
78 2021-03-03 chills The first night she had the chills real bad. She got up to go to the bathroom and was so could she ... Read more
The first night she had the chills real bad. She got up to go to the bathroom and was so could she didn't think she was going to get back to bed. She took 2 Tylenol, and went back and laid down. She then awoke the next day starting to have some chills but not as bad as the night before. She covered up with an electric blanket in a chair and finally passed over. She noticed Saturday that she had nausea and dizziness. She then had tenderness in her mouth, used warm salty water which seems to be helping. She cannot eat any hard food on it due to the discomfort. She has continued nausea in the evenings. No problems with the arm where she got the vaccine. She feels it it getting some better, but the dizziness and nausea is the worst issue. She did call her doctor and they told her that they could not give her anything for the rash in her mouth, and the chills. They told her that it had to run it's course.
78 2021-03-03 cough, fever 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 headache, cough 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 2021-03-03 headache, fatigue Fatigue, headache, muscle and joint pain - knees and hands
78 2021-03-03 headache Mild nausea, mild headache on Feb. 24 plus extreme joint and whole-body muscular aches that continu... Read more
Mild nausea, mild headache on Feb. 24 plus extreme joint and whole-body muscular aches that continue a week and two days after the 2nd injection
78 2021-03-03 sweating 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 2021-03-04 body temperature increased, nasopharyngitis, malaise Cold during the night and today went to lunch and does not feel well at all and threw up and has a t... Read more
Cold during the night and today went to lunch and does not feel well at all and threw up and has a tempurature of 100.4
78 2021-03-04 chills, headache LIGHT HEADED, NAUSEA, HEADACHE, TREMORS, CHILLS STARTING 15 MINUTES AFTER INJECTION
78 2021-03-04 chills, headache Injection site soreness, chills, headaches, nausea, diarrhea and vomiting
78 2021-03-04 fatigue, fever fatigue, fever (101.2), vertigo, lasted all day, fine the next day
78 2021-03-04 lethargy, fever 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 2021-03-04 fever, chills Pt. called clinic today at 8:22am to report overnight fever and chills, as well as neck, left should... Read more
Pt. called clinic today at 8:22am to report overnight fever and chills, as well as neck, left shoulder and left arm stiffness and pain at the injection site (left deltoid). Pt. advised that she may alternate acetaminophen with ibuprofen for fever/pain relief as well as heat/ice to help with muscle stiffness and pain. Clinic will call patient on Monday to re-evaluate the condition of the patient.
78 2021-03-05 fever, chills Fever chills soreness
78 2021-03-07 fatigue, chills, headache 48 hours after receiving the vaccine, I had a hive reaction (redness, slight swelling) over a roughl... Read more
48 hours after receiving the vaccine, I had a hive reaction (redness, slight swelling) over a roughly 7?x5? section of both of my upper arms. This is a typical allergic reaction I have to ibuprofen, Benadryl and occasionally to something I?ve eaten (source unknown). This is a stronger reaction than I usually have. 24 hours after the shot, I had headache, muscle ache, chills, and fatigue. Those symptoms had pretty much abated about 36 hours after the shot. I did not notice the hive reaction earlier than 48 hours after the shot.
78 2021-03-07 fatigue, fever, chills Fever as high as 101.4; Chills; Whole body aches; Whole body soreness; Weakness; Fatigue Took Tyleno... Read more
Fever as high as 101.4; Chills; Whole body aches; Whole body soreness; Weakness; Fatigue Took Tylenol Extra Strength every four hours; Increased water intake; Stayed in bed Lasted for approximately 48 hours
78 2021-03-07 fatigue, fever, chills Within two to three hours, I reacted with chills, fever, weakness, fatigue, soreness at vaccination ... Read more
Within two to three hours, I reacted with chills, fever, weakness, fatigue, soreness at vaccination site, waves of nausea, joint soreness. I can only remember a couple of times in my life ever feeling so sick. Within 24 hours my side effects subsided. Ten days later I developed itching and burning on hands, arms, chest and neck which, when scratched, turned bright red. The rash lasted about three of days.
78 2021-03-07 fatigue Dizziness and lightheadedness starting 3/3/21. Some nausea. No vomiting. Tiredness. Saw doctor 3... Read more
Dizziness and lightheadedness starting 3/3/21. Some nausea. No vomiting. Tiredness. Saw doctor 3/4/21. Physical examination and lab tests done. Will take Prometazine 12.5 mg , 1/2 to 1 tablet every 6 hours as needed for feeling of being lightheaded. No further dizziness after 3/6/21.
78 2021-03-07 headache PATIENT RECIEVED 2ND DOSE OF MODERNA AND AFTER ABOUT 10 MINUTES SHE SAID SHE COULD NOTICE SOME DISCO... Read more
PATIENT RECIEVED 2ND DOSE OF MODERNA AND AFTER ABOUT 10 MINUTES SHE SAID SHE COULD NOTICE SOME DISCOMFORT IN HER BREATHING- NOTHING SIGNIFICANT BUT ENOUGH IT BOTHERED HER. SHE WAS MONITORED AND FELT SHE NEEDED A BENADRYL 25 MG CAPSULE. SHE ALSO COMPLAINED OF A SLIGHT HEADACHE. INJECTION SITE WAS NORMAL. SHE CONTINUED TO BE MONITORED AND CONTINUED TO FEEL THE SAME OVER THE NEXT 10-15 MINUTES BUT AT THE 20 MINUTE MARK SHE SAID SHE DID FEEL BETTER. SHE WAS NOT DRIVING AND SHE DID FEEL WELL ENOUGH TO GO HOME. SHE WAS COUNSELED TO BE SEEN AND SHE AGREED SHE WOULD BE IF SHE HAD ANY MORE SYMPTOMS. PATIENT WAS FOLLOWED UP 6 HOURS LATER AND STATES SHE HAS HAD NO ADDITIONAL PROBLEMS AND FEELS PERFECTLY NORMAL.
78 2021-03-07 malaise, body temperature increased, chills About 4-5 hours after receiving vaccine: Severe Chills- Arms shaking, freezing, hands like ice, Temp... Read more
About 4-5 hours after receiving vaccine: Severe Chills- Arms shaking, freezing, hands like ice, Temp 99.6; Tylenol, to bed sleep 4-5 hrs, Temp 100.??; sleep; awoke middle of night Temp 107.2, legs very warm to touch; into shower; Temp came down to 99.??; sleep, Temp OK. Later in day Temp 100.4. Some muscle pain but not too bad. Didn't feel good rest of day/night. Next day felt OK. All lasted about 36 hours. After 1st vaccine, I felt somewhat same as above - except Temp 104 and lower; Very sever muscle pain initially- hard to get out of bed and walk. Started 4-5 hours after injection and lasted about 36 hours. severe chills but not freezing. Taste and smell were not affected either time.
78 2021-03-07 throat pain, fever, chills, fatigue, headache I had the predicted fever 99.9 and chills and headache and sore throat the next day after injection.... Read more
I had the predicted fever 99.9 and chills and headache and sore throat the next day after injection. Recovered as expected after 24 hours, then the day after was very tired and the day after that. My question is, could the symptoms have triggered a chronic fatigue episode? I?m still very tired so that I can?t exercise to rehabilitate my left rotator cuff.
78 2021-03-08 fatigue, fever, headache aches at injection site, body aches, slight headache, fatigue, fever.
78 2021-03-08 fatigue, sleepiness, headache Began with feeling exhausted and sleepy within a few hours. Progressed to aching throughout body, p... Read more
Began with feeling exhausted and sleepy within a few hours. Progressed to aching throughout body, painful L arm and stiff neck. By 9pm unable to elevate L arm, unable to turn head and blazing headache. Symptoms continued for 24 hours. Began to decrease and bu the 36th hour was nearly normal. It has now been 4 days since vaccination and I?ve resumed normal lifestyle......but have residual ?fatigue? in late afternoon.
78 2021-03-08 headache, fatigue Day after vaccine, I was very sick as though I had the flu. Had a severe headache above both eyes, ... Read more
Day after vaccine, I was very sick as though I had the flu. Had a severe headache above both eyes, was nauseous and vomited, slightly off-balance, and tired.
78 2021-03-08 headache Head ache, nausea, weakness to the point of near helplessness,. I couldn?t eat & just slept for appr... Read more
Head ache, nausea, weakness to the point of near helplessness,. I couldn?t eat & just slept for approximately one day/night & into second day.
78 2021-03-08 sleepiness 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 chills, headache, sinusitis, fatigue With the first shot, I experienced chills for a day and a half. Absolutely could not get warm. W... Read more
With the first shot, I experienced chills for a day and a half. Absolutely could not get warm. With the second shot, I experienced chills; was clammy at the same time as the chills; very fatigued and could not stay awake; my muscles, joints and my whole body ached; headache; sinus infection (for which I am currently on an antibiotic); nausea; loss of appetite (lost 5 pounds); loss of taste and smell for 2-3 days. Too weak to make it to the bathroom by myself. I felt like I was in a delirium but my husband said that I was not incoherent. Appetite is still not normal. Mouth was so dry that I was not able to feel any moisture at all which I feel led to my sinus infection.
78 2021-03-09 cough, influenza like illness 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 2021-03-09 headache Retinal hemorrhage inside left eye; Impaired vision; Occular migraine; Swelling inside left eye; Sev... Read more
Retinal hemorrhage inside left eye; Impaired vision; Occular migraine; Swelling inside left eye; Severe headache; A spontaneous report was received from a reporter like consumer concerning a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like retinal haemorrhage, eye inflammation, headache, visual impairment, retinal migraine. The patient's medication history was not provided. Concomitant medications were not provided. On 17 Feb 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 030M20A) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection. On 18 Feb 2021, 28 hours following the vaccine administration, the patient experienced events like very small hemorrhage inside left eye, swelling inside the left eye, headache, impaired vision, ocular migraine with swelling inside the eye being medically significant. Laboratory details were not provided. No treatment information was provided. The outcome of the event was unknown. Action taken with mRNA-1273 in response to the events were not reported.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
78 2021-03-09 lethargy On day 3 there was slight swelling, tenderness and heat at injection site. On the fourth and subse... Read more
On day 3 there was slight swelling, tenderness and heat at injection site. On the fourth and subsequent days there has been a red rash. It is about 2+ inches wide and 3+inches long. Still quite red and tender to touch. Muscle underneath the injection site is still tender. It has been eight days since the injection. I also experienced some lethargy for the first two or three days.
78 2021-03-09 fever Patient stated that 3 hours (7:40 pm)after receiving her vaccine she experience symptoms of: low gra... Read more
Patient stated that 3 hours (7:40 pm)after receiving her vaccine she experience symptoms of: low grade temp of 93.6 (3 digital thermometers and 2 mercury thermometers) light headedness felt unsteady but blood pressure was ok per patient throat started to feel tight -these symptoms lasted for approx. 1/2 hour (8:10 pm) after giving herself an epi-pen injection, which she carries for bee stings -patient stated the next day on 02/19/2021, she took 2 tablets each 25 mg. of benadryl and never experienced the symptoms again from the previous day.
78 2021-03-10 body temperature increased Left are was warm to the touch and slight sore, started throwing up around 5:45 pm and temperature w... Read more
Left are was warm to the touch and slight sore, started throwing up around 5:45 pm and temperature was 102.3. Threw up again in the night and started having diarrhea. Still running 99.8 fever on 3/11/21
78 2021-03-10 chills, fever Severe body aches, chills, fever, backache, unable to lift R arm
78 2021-03-10 fatigue, headache Fatigue 8:30 pm, 2:30 am upset stomach, slight head ache, (unable to go back to sleep) 9:00 am extre... Read more
Fatigue 8:30 pm, 2:30 am upset stomach, slight head ache, (unable to go back to sleep) 9:00 am extreme fatigue rash around the injection site (not sure when) Approximately 3pm (following day10th) upset stomach and head ache stopped. Fatigue diminished. Fatigue gone 6am on the 11th. Rash still visible and minor itch.
78 2021-03-10 head discomfort daily migraine headache which does not respond to medication. Initially a constant migraine type... Read more
daily migraine headache which does not respond to medication. Initially a constant migraine type headache for 1 1/2 weeks. Then 1 day headache free. Followed by headache, followed by 4-5 days being headache free. Since then a migraine type headache daily or every other day. Sumatripin orally has no effect, tramadol decreases pain slightly, Lortab takes away pain, but head pressure still here. Just started on a decreasing doses (day two) of steroid, with no effect.
78 2021-03-11 body temperature increased, nasopharyngitis The following day she was at the clinic (she said to make sure you knew she was a cancer patient) an... Read more
The following day she was at the clinic (she said to make sure you knew she was a cancer patient) and experienced uncontrollable cold & shaking, they took her temperature at clinic which registered 101 degrees, and she was disoriented and unable to move to get out of her vehicle. She then reported the day after the side effects she woke up and was fine.
78 2021-03-11 chills, fever, fatigue 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 2021-03-11 runny nose Backache, Runny Nose, Sensitivity to Light, Vertigo which lasted 2 Weeks
78 2021-03-12 fatigue Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite a... Read more
Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite and shortness of breath immediately following vaccination. Hospice medications were ordered and patient began receiving morphine and nebulizer treatments. She then started having dysphasia. She then died on 3/5/21 from presumed respiratory failure.
78 2021-03-12 headache, chills, fatigue Day 3 Chills ,fatigue and headache that lasted 24 hours . On day 9 developed, swelling ,heat ,rash a... Read more
Day 3 Chills ,fatigue and headache that lasted 24 hours . On day 9 developed, swelling ,heat ,rash and itching at injection site that lasted 48 hours.
78 2021-03-13 fatigue, headache Nausea, diarrhea, slight headache, lightheadedness and discomfort at injection site. no muscle or jo... Read more
Nausea, diarrhea, slight headache, lightheadedness and discomfort at injection site. no muscle or joint pain but slight fatigue.
78 2021-03-13 fatigue, malaise About six hours after the second vaccine my whole body began shaking that lasted several hours. At ... Read more
About six hours after the second vaccine my whole body began shaking that lasted several hours. At the same time I had general malaise. By morning the tremors were gone but malaise and profound fatigue lasted through the day. By morning of the third day I was feeling better, just still a bit tired. I did not seek any treatment.
78 2021-03-13 malaise 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 fever, chills Chills and fever (100.3) Increased fluids, tried to stay warm, slept symptoms disappeared by 8 p.m.
78 2021-03-13 fever, headache, chills Fever, extreme back pain, nausea, lightheaded, headache, chills, redness, bruising and swollen arm w... Read more
Fever, extreme back pain, nausea, lightheaded, headache, chills, redness, bruising and swollen arm where injection was given.
78 2021-03-14 chills First dose was on 01/12/2021 at 9:30 am. No reaction until Feb.7. 2021, when left leg began to swell... Read more
First dose was on 01/12/2021 at 9:30 am. No reaction until Feb.7. 2021, when left leg began to swell, but not seriously. Feb.8, 2021 leg was continuing to swell. went to doctor's office where he prescribed an ultrasound. Was told there was a clot behind my left knee and in some of the smaller veins. I had the chills, joint pains all over, which lasted about the three weeks, but was slightly different every day. When I began the 20 mg dose of Xarelto, every symptom cleared up and I felt great. I am continuing on the 20 mg Xarelto.
78 2021-03-14 dehydration 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 fatigue Thursday Morning had covid vaccine, felt tired, Friday night diarrhea, vomiting and stopped during t... Read more
Thursday Morning had covid vaccine, felt tired, Friday night diarrhea, vomiting and stopped during the day, stayed in bed all day saturday, was able to eat saturday again, continues to have loose stools, is taking pepto bismol. There is not any data regarding this as a reaction however will file a VAERS report per pt request. Is pushing fluids and does not have any further concerns. Will call provider if symptoms continue.
78 2021-03-14 headache, body temperature increased Got the vaccine and was fine, on the 2nd day 3/12/21 she got so weak, was freezing, her legs and fee... Read more
Got the vaccine and was fine, on the 2nd day 3/12/21 she got so weak, was freezing, her legs and feet were cold. She turned the AC off and the temp in the house was 82 and she was still cold, had a headache and felt so bad. She took her temperature and it was 101.6, she felt nauseous. She had eaten a protein bar at 11:00 AM on then at 1:00 PM had the above symptoms. She continued to drink water and kept it down, took her temp about 2 hours later and it was 100.4. About 4 hours later she continued drinking water, and her temp had dropped to 99._. She was so weak that she could hardly get off the bed to go to the bathroom and urinated on herself trying to get up out of the bed. After her fever went down she was able to get up. Her husband was almost total care and she was not able to take care of him. She went to sleep and woke up at 3:00 AM and felt so much better, and ate some crackers and took some Tylenol for the headache and felt like she was OK. She did not eat anything on Friday and on Saturday ate lightly. The vaccine area is warm to touch, sore and swollen but not much.
78 2021-03-14 headache 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 malaise Malaise, nausea
78 2021-03-15 fatigue Extreme exhaustion for four hours the morning after receiving the vaccine. No treatment; stayed in ... Read more
Extreme exhaustion for four hours the morning after receiving the vaccine. No treatment; stayed in bed for those four hours, then felt better and got up.
78 2021-03-15 headache, chills, fatigue Chills, headache, nausea, fatigue - 3 days. Aspirin 1x per day.
78 2021-03-15 headache, fatigue weakness in legs, collapsed onto floor, unable to control bladder, headache, Legs continued to give ... Read more
weakness in legs, collapsed onto floor, unable to control bladder, headache, Legs continued to give out while walking, fatigue
78 2021-03-15 headache headache diarrhea of 3+ weeks duration treated with imodium, ibuprofen and bland diet
78 2021-03-16 fever, headache, chills 3 days after vaccine experienced fever, extreme muscle pain, extreme bone pain, head ache, chills. ... Read more
3 days after vaccine experienced fever, extreme muscle pain, extreme bone pain, head ache, chills. 13 days after vaccine experienced extreme swelling in glad under left ear and down the neck under chin. Ear ache in both ears but worse in the left ear. Visited physician next day and was prescribed an antibiotic. Was better in 14 days.
78 2021-03-17 chills Pain at site of injection. Swelling of arm down to elbow, chills, aches especially in fingers and ... Read more
Pain at site of injection. Swelling of arm down to elbow, chills, aches especially in fingers and wrists, temp 100.2, nose bleed (minor).
78 2021-03-17 chills 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 2021-03-18 fatigue, fever low fever, up to 100.0, aches, nausea, fatigue, arm continues to be sore. Symptoms on and off since ... Read more
low fever, up to 100.0, aches, nausea, fatigue, arm continues to be sore. Symptoms on and off since vaccination; worse today
78 2021-03-18 headache 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 2021-03-19 body temperature increased Felt achy and had a temp of 100.6 very weak. This happened the next afternoon from being given the s... Read more
Felt achy and had a temp of 100.6 very weak. This happened the next afternoon from being given the shot. Injection site very sore also. Went to bed early at 7:00 p.m when I got up on Saturday the 20th. I was better.
78 2021-03-19 headache, fatigue Brain confusion (1 hour), headache (3 days), body aches (3 days), vomiting (2 days). weakness & tire... Read more
Brain confusion (1 hour), headache (3 days), body aches (3 days), vomiting (2 days). weakness & tiredness (5 days). No treatment for any of above.
78 2021-03-19 fever, headache, chills, fatigue Fever 102, chills, muscle/bone aches, extreme fatigue, headache. Slept most of March 13/14. March ... Read more
Fever 102, chills, muscle/bone aches, extreme fatigue, headache. Slept most of March 13/14. March 15 awoke totally symptom free
78 2021-03-19 fever, sleepiness, lethargy Moderna Covid Vaccine EUA: Sent to ED from adult care facility (resides at home; PACE program parti... Read more
Moderna Covid Vaccine EUA: Sent to ED from adult care facility (resides at home; PACE program participant with care center attendance multiple days per week. Received vaccine on 2/3/21 at care center. On 2/5/21 care center staff sent patient for ED evaluation due to decreased oral intake and activity, general weakness and lethargy, and fever. Cannot determine exact onset of symptoms but ED presentation was 1 pm on 2/5/21. Fever on ED presentation recorded as 101.9 F. Patient noted to be very sleepy/lethargic; appropriately responding to questions but requiring nearly constant stimulation to stay awake to answer questions. Workup revealed procalcitonin 0.08, serum creatinine 1.3 (baseline 1.0 to 1.1). Blood cultures and urine culture negative. CBC not available due to refusal of additional blood work. Received IV acetaminophen with improvement in fever and mental status. Discharged home.
78 2021-03-21 fatigue, headache, chills, body temperature increased temperature 102 Chills Headache Upset stomach tired rash on injection arms that was swollen and hot
78 2021-03-21 fever red upper arm. swelling /redness/itchy skin, starting from injection site, and slowly moving down ... Read more
red upper arm. swelling /redness/itchy skin, starting from injection site, and slowly moving down to inner aspect of elbow. accompanied by slight fever. site of injection is now losing its redness and itchiness. did apply Benadryl cream twice to relieve the itching.
78 2021-03-22 fatigue, headache 6 hours after having shot it triggered PTSD because she couldn't lift her feet (like heavy rocks) st... Read more
6 hours after having shot it triggered PTSD because she couldn't lift her feet (like heavy rocks) staggering to lay down, diarrhea, nausea, poor appetite, headache, fatigue throughout body, aching bones/joints
78 2021-03-22 fatigue joint ache, nausea, fatigue, no appetite, no taste, very weak, difficult swallowing, memory problem... Read more
joint ache, nausea, fatigue, no appetite, no taste, very weak, difficult swallowing, memory problems,. Start evening of 2/25 to present - 3/22/21 Emergency room treatment: blood profile, X-rays, Cat Scan, urine analysis, etc. All OK.
78 2021-03-22 fatigue 3ays after shot massive depressive episode, suicidal. 4 days after, exhaustion, muscle weakness (I ... Read more
3ays after shot massive depressive episode, suicidal. 4 days after, exhaustion, muscle weakness (I normally walk 2 - 4 miles daily)- this continued for almost two weeks. Along with weakness, extraordinary "brain fog", vertigo, loud tinnitus (buzzing). 2 1/2 weeks in I found an elliptical itching rash at the vaccine site. almost a month later I'm still suffering from dizziness, brain fog, and exhaustion. 2nd dose due 26th March and I'm scared to proceed.
78 2021-03-22 fatigue 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 chills, headache Additional side affect on Saturday night episode where my lips became numb, my balance was unsteady,... Read more
Additional side affect on Saturday night episode where my lips became numb, my balance was unsteady, and I had difficulty walking, my head was foggy-- and additionally I felt shaky inside. Just as if you have the shivers. This is in addition to my events with the headaches. I am very worried about the second shot in the vaccine.
78 2021-03-23 headache about one month after #2 shot in L arm, whole left side from toes toes to head affected. toes/left ... Read more
about one month after #2 shot in L arm, whole left side from toes toes to head affected. toes/left foot/side tingling, constant felt like foot asleep continuously even awakening in sleep at night L calf on outer side felt cramped occiput, left side of head achy some constipation tired every late afternoon
78 2021-03-23 headache Headache and loss of balance within 1 .5 hrs. after vaccine, recurring, at 8:30 pm. Recurring next ... Read more
Headache and loss of balance within 1 .5 hrs. after vaccine, recurring, at 8:30 pm. Recurring next day at noon and then at 12:00 am. My lips became numb( like I had a nova cane shot) upon standing I had difficulty with balance and walking and my head felt foggy until 3 A.M. I almost called 911. I took Tylenol, Claritin and Pepsid and finally felt better. On Sunday my head felt foggy and my balance was not good. Then again on Tuesday, I had intermitent episodes.
78 2021-03-24 chills, headache Headache for 36 Hours and Chills. Patch and itch developed which lasted until 03/26/21
78 2021-03-25 headache, chills, fatigue Both arms, and only the arms, became swollen, red with rash, itchy and painful. Other more common si... Read more
Both arms, and only the arms, became swollen, red with rash, itchy and painful. Other more common side effects included fatigue, chills, nausea, severe headache, which occurred in the evening of the day vaccine was administered
78 2021-03-25 nasal congestion On 03/24/2021 around 10PM my left arm started to ache, was itching & stinging. On inspection, a red ... Read more
On 03/24/2021 around 10PM my left arm started to ache, was itching & stinging. On inspection, a red tender slightly swollen area where I had the injection. Also had more body aches than usual. On 03/25/2021 upper left arm showed more redness & swelling. Also had nasal congestion & an episode of diarrhea in the PM.
78 2021-03-26 chills, fever, malaise diarrea, vomiting, cant walk, dizzy, chills, fever SICK SICK SICK SICK SSICK SICK SICK SICK HOW DO Y... Read more
diarrea, vomiting, cant walk, dizzy, chills, fever SICK SICK SICK SICK SSICK SICK SICK SICK HOW DO YOU EXPECT A SICK PERESON TO FILL OUT THIS long form????????????????????????? I AM STILL ALIVE BUT THE CHECK MARK WON'T LETY ME CHECK SOMETHING ELSE.
78 2021-03-26 fatigue, fever, throat pain, headache, chills Low grade fever (100), chills, slight sore throat, mild headache, eyes burning, lassitude, lack of a... Read more
Low grade fever (100), chills, slight sore throat, mild headache, eyes burning, lassitude, lack of appetite
78 2021-03-27 fatigue, fever Loud Tinnitus Fever Body pains Tiredness
78 2021-03-28 headache, chills Headache., Chills, Body aches & pain, dizziness, backache,. All symptoms gone in 24 hours.
78 2021-03-28 headache, fatigue, chills Chills, pain in legs, back, neck, teeth, headache, chest pain, site pain, weakness, fatigue
78 2021-03-28 sweating 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 2021-03-29 lethargy 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 pneumonia pneumonia
78 2021-03-31 fatigue itching on her back, hands and wrists (severe), and behind her ear by her hairline; delayed types of... Read more
itching on her back, hands and wrists (severe), and behind her ear by her hairline; delayed types of reactions; dizzy whenever she lays down; rash going up her arm.; exhausted, fatigue, and couldn't get out of bed.; pulmonary fibrosis was also exacerbated.; A spontaneous report was received from a consumer, concerning a 78 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions). The patient's medical history had pulmonary fibrosis.No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in the Left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient experience exhausted, fatigue, and couldn't get out of bed, pulmonary fibrosis was also exacerbated and On 03 Feb 2021 ,the patient experience itching on her back, hands and wrists (severe), and behind her ear by her hairline,rash going up her arm, dizzy whenever she lays down,delayed types of reactions. The patient was treated with lidocaine for itchiness on her hands and wrists. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions) were considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The pulmonary fibrosis and dizziness events are probably related to the patient's comorbidities. Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site rashes and fatigue, a causal relationship cannot be excluded.
78 2021-03-31 fatigue Covid Arm. Large red area appeared at injection site 7 days after second shot was administered. (Sec... Read more
Covid Arm. Large red area appeared at injection site 7 days after second shot was administered. (Second Covid shot administered on March 24. Sore arm and some fatigue the next day. Covid Arm appeared on March 31). Slight soreness. This is the second day and it is still there. I understand that it will fade and isn't dangerous.
78 2021-03-31 sweating 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 2021-03-31 malaise Patient is a 78 year old female with background medical history notable for for COVID 19 on 30th Jan... Read more
Patient is a 78 year old female with background medical history notable for for COVID 19 on 30th Jan 2021 presented with progressive dyspnea and generalized malaise . She was dependent on oxygen. IV antibiotics, breathing treatments, steroids were initiated. Her symptoms slowly improved with the above-mentioned treatments. Once she was off oxygen and clinically improved she was discharged home.
78 2021-04-01 chills, headache, sweating, malaise sever head ach, stiff neck, freezing chills to sweating,aching all over not feeling good
78 2021-04-01 fatigue 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 headache, chills 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 chills, fatigue Dizziness; Weakness; Swollen lymph nodes; Barely walk; Fatigue; Larger patch of hives; Arm pain; lar... Read more
Dizziness; Weakness; Swollen lymph nodes; Barely walk; Fatigue; Larger patch of hives; Arm pain; large hives as well as small patches of hives; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Larger patch of hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ANGIOEDEMA (Larger patch of hives) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives) and CHILLS (Chills). On 27-Feb-2021, the patient experienced GAIT INABILITY (Barely walk), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, ANGIOEDEMA (Larger patch of hives), GAIT INABILITY (Barely walk), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case concerns a 78 Y/O M with a serious unexpected event of angioedema and non-serious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. 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.; Sender's Comments: This case concerns a 78 Y/O M with a serious unexpected event of angioedema and nonserious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. 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.
78 2021-04-03 fatigue Friday, April 2nd, in the late afternoon, I began to feel very weak . I had difficulty breathing th... Read more
Friday, April 2nd, in the late afternoon, I began to feel very weak . I had difficulty breathing throughout the night. Saturday, April 3rd, from the moment I woke, I had difficulty focusing due to severe dizziness and extreme weakness, unable to function normally. Shortness of breath continued and I remained in bed throughout the day. Today, April 4th, I am stronger, but unable to physically do more than necessary because of tiring easily with the weakness.
78 2021-04-03 headache, chills Headache lasting for ten minutes; chills lasting for 2 hours
78 2021-04-04 headache 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 sleepiness, fatigue The patient received the second dose of the COVID19 vaccine. There were rather normal symptoms the w... Read more
The patient received the second dose of the COVID19 vaccine. There were rather normal symptoms the week after receiving it. However, a few weeks later the patient acutely developed shingles (as determined by her primary care provider). Symptoms experienced: numbness in the mouth and tongue, red, enlarged bumps at the tip of the tongue, itchy skin and bumps in the skin surrounding the mouth, pain in and behind the left ear, tiredness, drowsiness. The symptoms developed all within the same day and still persist at the writing of this report. The doctor does not know if this was a result of the vaccine, but says we should not discard the possibility. The patient did have varicella in her youth
78 2021-04-05 fatigue, fever, chills, sweating fever for 55 hours. 101.1 to 103.4,last temp 4pm Sunday 99.8. vomiting , severe body pain, chills,... Read more
fever for 55 hours. 101.1 to 103.4,last temp 4pm Sunday 99.8. vomiting , severe body pain, chills, shaking, no taste, weak, sweating . took tylenol and advil. called my pcp she said it should last about 24 hours. As of tuesday 4/6/21 still very tired.
78 2021-04-06 headache, chills NAUSEATED, CHILLS, MUSCEL ACHES, AWFUL HEADACHE,ALL DAY FROM 6AM UNTIL 9PM.
78 2021-04-06 headache Pt c/o bad head ache, and neck pain, non stop since the vaccine, went to ER 4/6/21 was treated
78 2021-04-06 sweating Hypoglycemic crash; Feet cramping; Sweating; Feeling cold; Arm soreness; Brain fog; This spontaneous... Read more
Hypoglycemic crash; Feet cramping; Sweating; Feeling cold; Arm soreness; Brain fog; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOGLYCAEMIA (Hypoglycemic crash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and VACCINATION SITE PAIN (Arm soreness). On 21-Mar-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic crash) (seriousness criterion hospitalization), MUSCLE SPASMS (Feet cramping), HYPERHIDROSIS (Sweating) and FEELING COLD (Feeling cold). The patient was hospitalized on 21-Mar-2021 due to HYPOGLYCAEMIA. At the time of the report, HYPOGLYCAEMIA (Hypoglycemic crash), MUSCLE SPASMS (Feet cramping), FEELING ABNORMAL (Brain fog), HYPERHIDROSIS (Sweating), FEELING COLD (Feeling cold) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
78 2021-04-07 chills Pt stated had diarrhea, chills, pain with her joints just weak
78 2021-04-08 chills, cough Respiratory arrest and was out; Diaphragmatic breathing (could not breathe) was on vent mask that de... Read more
Respiratory arrest and was out; Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen; Cough that felt like coming from another human being; Felt crappy; Covid red arm; Intermittent Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy), ERYTHEMA (Covid red arm) and CHILLS (Intermittent Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029120A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (patient reported hypertension as one of the health issues that she has.). On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-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 RESPIRATORY ARREST (Respiratory arrest and was out) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen) (seriousness criterion hospitalization), COUGH (Cough that felt like coming from another human being) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt crappy) (seriousness criterion hospitalization), ERYTHEMA (Covid red arm) (seriousness criterion hospitalization) and CHILLS (Intermittent Chills) (seriousness criterion hospitalization). At the time of the report, RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy) and ERYTHEMA (Covid red arm) outcome was unknown and CHILLS (Intermittent Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Erythema: (abnormal) (big - diameter 3.5 X 6 inches). In February 2021, White blood cell count: 15.5 (High) Her white blood cells were 15.5. In February 2021, X-ray abnormal: (abnormal) lung X-rays were horrible and was "tanked" due to all the diaphragmatic breathing (could not breathe). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received treatment with 3 antibiotics, steroids and oxygen. Patient reported that they wanted to intubate her and ativan was pushed by RN. Patient was on "vent mask" that delivered oxygen and was in cardiac intensive unit for 4 days and then the doctor decided it was not covid or pneumonia and were looking at cardiac issues.They had to give Narcan to reverse the effects of Ativan. Patient stated in the call that Moderna pushed her off the end of the cliff and reports that prior to this she was healthy and walked daily on regular basis. Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder. This case was linked to MOD-2021-065711 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder.
78 2021-04-08 chills, headache Chills, Headache, Nausea lasted for 36 hours
78 2021-04-08 headache, chills, fatigue Chills, Headache, extreme fatigue, slight nausea which lasted for 70 hours.
78 2021-04-08 headache, chills Chills started at 4:00 PM on 3/26/2021, I woke up at 1:30 AM, chills were gone but had a headache wh... Read more
Chills started at 4:00 PM on 3/26/2021, I woke up at 1:30 AM, chills were gone but had a headache which lasted 2 days. Nausea started that morning and increased in intensity associated with dry mouth. The nausea was constant. I couldn't stand the smell of food. I drank lots of water, forced myself to eat some crackers, lay on the sofa all day for several days. On 3/29 I started taking Omeprazole. On 4/3 my nausea started improving and by 4/5 was gone.
78 2021-04-08 fever, chills, fatigue 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 2021-04-09 fatigue nausea, dizziness, lightheaded - lead to fall, fatigue
78 2021-04-10 sweating Relaxing on couch-normal day. Suddenly felt very sweaty-hair wet - decided to wash face - went into... Read more
Relaxing on couch-normal day. Suddenly felt very sweaty-hair wet - decided to wash face - went into bathroom- Quick reaction - Instant diarrhea and vomiting in bucket. Very scary - asked husband for more toilet paper. After cleaning up, I was extremely COLD. Put on extra clothes sweatshirt - got 3 blankets, by now it is 1:30 A.M. Slept in recliner. Next morning - felt weak, unsteady - afraid to eat anything but did drink lots of water. Today is Sunday April 11th, still very cautious about eating and still taking it easy. Seem to have a little discomfort in sternum area (thinking this could be my "years ago diagnosed hiatal hernia ??
78 2021-04-11 chills, fatigue, fever She got her vaccine, and within a couple of hours had fever, cold chills, achy body, fatigue. The f... Read more
She got her vaccine, and within a couple of hours had fever, cold chills, achy body, fatigue. The following week she lost her taste, and ever since she has cold chills constantly, is weak, cannot do anything. She is light headed, her vision is sometimes blurred and will not go away. She has been taking Tylenol for fever. She went to the ER because it was so bad, and they did a CT scan, EKG, chest x-ray for pneumonia, and did blood work. They could not find anything wrong with her. She has also been to her doctor who checked her over and could not find anything wrong either.
78 2021-04-11 fever, chills SEVERE CHILLS - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) LOW GRADE FEVER - TYLENOL EFFECTIVE (START... Read more
SEVERE CHILLS - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) LOW GRADE FEVER - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) NAUSEA - NO TREATMENT BETTER (STARTED 8 HOURS AFTER AND LASTED 12 HOURS) PAIN IN ARM AND BELOW LEFT RIB CAGE - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) RED RASH AT INJECTION SITE - NO TREATMENT BUT NO PAIN (STARTED NEXT DAYS 4/10/21 STILL GOING AS OF 4/12/21 11:00AM CST) COLD SWEATS - NO TREATMENT (STARTED NEXT DAY 4/10/21 STILL GOING AS OF 4/12/21 11:00 AM CST) STIFFNESS IN NECK AND SHOULDERS - NO TREATMENT (STARTED NEXT DAY 4/10/21 AND ENDED 4/11/21 IN THE EVENING)
78 2021-04-11 sleepiness PATIENT AFTER ADMINISTERING DOSE FELT A SLEEP AND FELT DIZZY
78 2021-04-12 headache 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 2021-04-12 malaise Patient received her second dose of the Moderna COVID vaccine in 3/2021 (unknown which specific date... Read more
Patient received her second dose of the Moderna COVID vaccine in 3/2021 (unknown which specific date) and presents on 4/10/21 with feeling ill, shortness of breath, myalgias, and loss of appetite. Patient has h/o asthma, DM, HTN, COPD, CHF with pEF, severe OA b/l knees/r hip, and neurogenic bladder
78 2021-04-12 malaise 3-11 didn't feel well, passed away later that day
78 2021-04-12 sleepiness, headache, chills Approx. 11 am on 4/2- begin to unbearable chills, headache, lost appetite, sleeping, lost of energy ... Read more
Approx. 11 am on 4/2- begin to unbearable chills, headache, lost appetite, sleeping, lost of energy . 4/4, starting having diaherra, lasting until 4/6. On 4/8, begin to start feeling better.
78 2021-04-13 fatigue, sweating Patient called pharmacy 4/14 stating that she experienced nausea, persistent fatigue when walking, a... Read more
Patient called pharmacy 4/14 stating that she experienced nausea, persistent fatigue when walking, and hyperphoresis the day of and the day after the immunization on 3/29.
78 2021-04-13 fever Covid Pneumonia; High fevers; This spontaneous case was reported by a consumer and describes the occ... Read more
Covid Pneumonia; High fevers; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Covid Pneumonia) 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 Leukemia. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced COVID-19 PNEUMONIA (Covid Pneumonia) (seriousness criteria hospitalization and medically significant) and PYREXIA (High fevers). At the time of the report, COVID-19 PNEUMONIA (Covid Pneumonia) and PYREXIA (High fevers) outcome was unknown. Hospitalization- treatment with remdesivir x 2 courses and other unknown monoclonal antibodies. Is on oxygen. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
78 2021-04-15 fatigue Fatigue for 2-3 weeks. Sore arm for 10 days. Shortness of breath for 2 weeks. All symptoms have ... Read more
Fatigue for 2-3 weeks. Sore arm for 10 days. Shortness of breath for 2 weeks. All symptoms have resolved.
78 2021-04-15 headache 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 sweating, headache 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 fever Bell's Palsy; Enlargement of lymph node; No appetite; High fever; This spontaneous case was reported... Read more
Bell's Palsy; Enlargement of lymph node; No appetite; High fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol (Tressor for cholesterol), Stress (Takes "stress pills") and Drug allergy (azithromycin (Zithromax)). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 19-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On 05-Mar-2021, LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever) had resolved. At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 10-Apr-2021, she experienced right-sided facial paralysis and was unable to keep her eyes closed. Her doctor subsequently diagnosed Bell's Palsy. The patient inquired if there were patients who have experienced the same thing. Action taken with mRNA in respect to the events was not applicable. Concomitant medications included stress pills and tressor for cholesterol. Treatment included prednisone, unspecified antiviral medication and eye drops for the right eye. 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 2021-04-16 fatigue, chills Chills, severe aches in eyes, cheek bones, teeth, hands, feet, dizziness, weakness, gas, fatigue
78 2021-04-16 sweating 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 sleepiness, chills, fatigue Chills, fatigue, muscle and body aches, sleepiness this lasted 36 hrs
78 2021-04-18 runny nose, cough, throat pain 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 2021-04-18 sluggishness, sleepiness On Mar 9 @1:30am I went to sleep and woke-up at 1:30am on 10 Mar. I was out for 24 hours. Sluggi... Read more
On Mar 9 @1:30am I went to sleep and woke-up at 1:30am on 10 Mar. I was out for 24 hours. Sluggish the next day. Okay the third day.
78 2021-04-19 chills, headache, fever About 10 p.m. on 2-22, sore arm. About 2 a.m. on 2-23, very dizzy During the day on 2-23, headaches,... Read more
About 10 p.m. on 2-22, sore arm. About 2 a.m. on 2-23, very dizzy During the day on 2-23, headaches, muscle aches, fatigue About 7:30 p.m. on 2-23, chills and fever
78 2021-04-19 chills, fever 1st Dose: 10 days after vaccine my left arm and right breast swelled and reddened for a few days. I... Read more
1st Dose: 10 days after vaccine my left arm and right breast swelled and reddened for a few days. I had a masectomy and breast reconstruction on my right breast in 05/1998. Breast cancer 2nd Dose: The day after the shot I had chills, fever, etc which is normal but my right breast got swollen, hot and red. as of this date, 2 month later my breast still is slighty red but not as bad as in the beginning . I know this probably from the shot but is a little scary.
78 2021-04-20 chills, fever chills. vomitting. fever
78 2021-04-20 fatigue, fever Tiredness (sleep), loss of appetite (ate Jello), fever of 101 (Tylenol), = day after injection and ... Read more
Tiredness (sleep), loss of appetite (ate Jello), fever of 101 (Tylenol), = day after injection and next day Diarrhea/very loose bowels (Immodium) = second day after injection
78 2021-04-21 body temperature increased, fatigue, influenza like illness Within 12 hours elevated temperature,extreme fatigue, flulike feelings lasting 2 days. On 03/24/20... Read more
Within 12 hours elevated temperature,extreme fatigue, flulike feelings lasting 2 days. On 03/24/2021 back discomfort worsening every day. To Emergency Room on 03/31/2021 confirming diagnosis of Shingles
78 2021-04-21 fatigue Shortness of breath and whizzing; Not receiving the 2nd dose; Tiredness; Dizziness; This spontaneous... Read more
Shortness of breath and whizzing; Not receiving the 2nd dose; Tiredness; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath and whizzing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath and whizzing) (seriousness criterion hospitalization). On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Tiredness ). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose). The patient was hospitalized from 28-Mar-2021 to 06-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Shortness of breath and whizzing), DIZZINESS (Dizziness) and FATIGUE (Tiredness ) had not resolved and PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose) had resolved. 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 concomitant medications were provided. Patient received a lot of medications at hospital Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; 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.
78 2021-04-24 malaise, fever weak, fell down, confusion, in hospital for 5 days, sick to stomach, 102 fever
78 2021-04-25 pneumonia Hospital admission for pneumonia due to Covid post vaccination
78 2021-04-25 fever Early morning after 2nd vaccination, 2/19/21), patient was what is best described as in a comatose ... Read more
Early morning after 2nd vaccination, 2/19/21), patient was what is best described as in a comatose type state. Symptoms where unresponsiveness, fever (101 degrees), unable to eat, drink or open eyes. Was able to suck on a washcloth. The following day, 2/20/21, same symptoms as day before but fever went down. Took blood sugar in the morning and it was good. Was able to give minimal liquids by a bottle. Got about 4 ounces of water in about 2 days. On 2/21/21 around midday patient was able to get out of bed and was on way to recovery.
78 2021-04-26 fatigue 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 2021-04-26 headache dizziness, diarrhea, headaches and weakness lasting 9 days thus far
78 2021-04-27 chills, sleepiness Sleepiness, Soreness and Achy, Covid Arm, Chills lasting five hours, nausea.
78 2021-04-29 influenza like illness Severe exacerbation of autoimmune symptoms. Ten weeks after shot, still mostly bedridden with very ... Read more
Severe exacerbation of autoimmune symptoms. Ten weeks after shot, still mostly bedridden with very low energy and flu-like symptoms. Increased MCAS symptoms. CCI worse.
78 2021-04-30 chills, fever CONFUSION, HALLUCINATIONS, FEVER (103), INCREASED BLOOD PRESSURE, CHILLS
78 2021-04-30 cough, nasal congestion, chills COVID Diagnoses After Vaccination; Nasal congestion; Cough; Diarrhea; Loss of taste; Chills; Nausea;... Read more
COVID Diagnoses After Vaccination; Nasal congestion; Cough; Diarrhea; Loss of taste; Chills; Nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID Diagnoses After Vaccination) 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. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID Diagnoses After Vaccination) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID Diagnoses After Vaccination), NASAL CONGESTION (Nasal congestion), COUGH (Cough), DIARRHOEA (Diarrhea), AGEUSIA (Loss of taste), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Source of sample- Nasopharyngeal. 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. Relevant concomitant medications were not reported. Treatment information included Monoclonal antibody therapy as bamlanivimab infusion for the virus start on 19 Jan 2021. Company Comment: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information included adverse events (chills, cough, nausea, diarrhea, nasal congestion and loss of taste), hospitalization confirmation, laboratory exam performed date and treatment information as bamlanivimab infusion.; Sender's Comments: This case concerns a 78-year-old female with a serious unexpected event of COVID-19, and nonserious unexpected nasal congestion, cough, diarrhea, ageusia, and nonserious expected chills, nausea. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
78 2021-04-30 fatigue, fever, chills 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 chills, headache, fever Late afternoon of 2/18/21 developed high fever, chills, nausea, headache, severe dizziness. I was l... Read more
Late afternoon of 2/18/21 developed high fever, chills, nausea, headache, severe dizziness. I was literally unable to think or move. I was totally bedridden until the next day when I started to feel some better.
78 2021-05-03 body temperature increased, chills, headache, fatigue She got her vaccine, she had a different person than the first one and didn't even feel anything and... Read more
She got her vaccine, she had a different person than the first one and didn't even feel anything and was fine. With this one she felt when she was stuck with the needle. She got a flush of heat that went down to her elbow. She stayed there for the allotted time period and went home. She got up the next morning, the first she realized that she could hardly stand up due to the pain and aching everywhere. She then started getting chills, and went in to eat and not able to eat, but no appetite. She laid around all day and started taking her temperature and the last time she took it it was 100, then didn't take it after that. She had a massive headache, in fact that evening she put an ice pack on her head as was told not to take Tylenol. She states that this lasted all day, she went to bed early and the next day had exhaustion, unable to do anything, took it easy. She did have her appetite back, and was able to eat. By the 3rd day she was back to her normal self. She did call the paramedics to ask questions as they are around the corner, and they told her to wait 24 hours and see if it resolved, which she did.
78 2021-05-03 bronchitis Bronchitis; Rash that would appear on various parts of her body like her arms, legs, and back, but i... Read more
Bronchitis; Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy). At the time of the report, RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy) outcome was unknown. Information about concomitant medication was not reported. Follow up information was received on 29-APR-2021, regarding the patients second vaccine. The patient was hospitalized for 5 days after receiving the second vaccine. Her primary care doctor does not have any information regarding her symptoms yet. The patient was admitted with shortness of breath and was diagnosed with bronchitis. The patient also developed a rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area. The rash was very itchy. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant Follow up, Case upgraded to serious; 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 2021-05-04 chills, fatigue I had the normal chills and tiredness after the second dose. But ln late March, I began tr have mus... Read more
I had the normal chills and tiredness after the second dose. But ln late March, I began tr have muscle and joint pain that got so bad I had to go to ER. I couldn't walk or get in and out of bed. I was diagnosed with Polymyslgia Rheumatica, an immune disorder which I exp[erienced in 2013.
78 2021-05-05 headache, chills woke up and had chills and shaking then a very bad headache until about 5am i got up and took some ... Read more
woke up and had chills and shaking then a very bad headache until about 5am i got up and took some tylenol slept about an hour then got up and felt bad the rest of the day slept off and on all day
78 2021-05-06 lethargy Admitted with generalized weakness, lethargy, and muscle aches for a couple weeks (since receiving v... Read more
Admitted with generalized weakness, lethargy, and muscle aches for a couple weeks (since receiving vaccine). Planned to rule out atypical PNA. Blood cultures positive for bacteroides, likely abdominal source. Abdominal CT scan showed portal vein thrombosis, confirmed on MRI.
78 2021-05-10 headache, chills 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 2021-05-11 pneumonia, cough 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 2021-05-12 chills, fever hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was ... Read more
hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was reported by an other caregiver and describes the occurrence of HALLUCINATION (hallucinating) 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 Chronic lymphocytic leukemia. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucinating), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Concomitant medication was not reported. Treatment of these events were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described This case was linked to MOD-2021-104070 (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. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described
78 2021-05-12 chills Day one typical chills starting at 10 hours post-vaccine. By 16 hours she had all-over body aches a... Read more
Day one typical chills starting at 10 hours post-vaccine. By 16 hours she had all-over body aches and a migraine, treated with 4x Motrin 200 mg tabs with good improvement by 28 hours. Chills again at 36 hours and some shoulder and low back muscle aches, treated with 3 x Motrin 200 mg tabs. She did well the rest of day 2. Day 3 started by feeling well, but by 9 am she felt cold, weak, and nauseated. I covered her with multiple blankets and a heating pad and lay her in bed. About an hour later she felt less nauseated but still cold.
78 2021-05-13 body temperature increased, sleepiness, chills, fatigue Patient stated next day after taking the vaccine, she had 102.7 temp, fatigue, nausea, chills, body ... Read more
Patient stated next day after taking the vaccine, she had 102.7 temp, fatigue, nausea, chills, body aches and pains. Her legs hurt and she had trouble staying awake. She took Tylenol which helped bring down the temp but did not make it go away. On 5/14/2021, patient stated she still has 100.7 temp and is nauseated but the other symptoms have subsided. She had the COVID virus on January 23, 2021.
78 2021-05-14 fatigue, fever 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 2021-05-14 headache, fever, sleepiness Low grade fever, nausea, extreme pain in all joints, hands swollen and stiff, headache. diaherra for... Read more
Low grade fever, nausea, extreme pain in all joints, hands swollen and stiff, headache. diaherra for 2 days,, sleep on and off for 3 days. Just starting to feel a little better. It was hell. 10 days.
78 2021-05-18 cough PATIENT DEVELOPED A CHRONIC COUGH AND SEVERE MUSCLE ACHES WITHIN 48 HOURS OF MODERNA DOSE 2
78 2021-05-19 fatigue Client received the 2nd COVID vaccine of Moderna (Lot# 021C21A expiration 05/26/21). Client has comp... Read more
Client received the 2nd COVID vaccine of Moderna (Lot# 021C21A expiration 05/26/21). Client has completed 10 minutes in the observation room before reporting an outbreak of hives on her left arm at 1344. Client is accompanied by husband. At 1344, EMT responded and notified RN and PHN. Client reports no adverse effects with the 1st dose of COVID vaccine of Moderna. At 1344, vital signs are blood pressure 130/72, heart rate 92, oxygen saturation 98%. PHN educated Client in regards to ED precautions and common adverse effects of the COVID vaccine. PHN offered 50 mg of Benadryl by mouth. Client accepted 50 mg of Benadryl by mouth. At 1346, 50 mg of Benadryl by mouth was administered to Client. Client was advised to stay in the observation area for an addition 30 minutes. Client agreed. Client was offered supplemental nutrition and fluids. Client denied nutrition, but accepted water and juice. Visible hives are present on left arm, right forearm, and right clavicle. At 1352, vital signs are blood pressure 132/78, heart rate 84, oxygen saturation 98%. Client reports no headache, no shortness of breath, no tightness in the throat, no chest pain, no blurred vision, no nausea. Client reports a history of diabetes type 2 and osteoporosis. Client reports taking medication: Metformin, Benazepril, and vitamin supplements. Client has allergies to Penicillin, shellfish, and iodine. At 1402, vital signs are blood pressure 120/73, heart rate 79, oxygen saturation 98%. Client reports no new symptoms. Hives on the right forearm are lightening up and skin tone is returning back to appropriate coloration to ethnicity. Hives on the left arm and right clavicle are still present, but have lightened to a pink coloration from red. At 1412, vital signs are blood pressure 130/78, heart rate 77, oxygen saturation 96%. Client reports no new symptoms and is talking with EMT. At 1422, vital signs are blood pressure 120/70, heart rate 77, oxygen saturation 96%. Client reports no new symptoms. At 1432, vital signs are blood pressure 130/72, heart rate 80, oxygen saturation 97%. Client reports no new symptoms, talking to EMT and husband. At 1442, vital signs are blood pressure 120/70, heart rate 76, oxygen saturation 96%. Client reports no new symptoms. At 1445, hives have significantly lightened and have gone down, but are visibly present only on the left arm. Client reports no itching and is reminded of ED precautions. At this moment, Client reports feeling "a little tired". At 1450, Client reports no new symptoms and leaves facility. Client stood up with no complaints and walked out with a steady gait accompanied by husband.
78 2021-05-19 sweating, headache 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 fever Felt lightheaded; Neurologic event; left cheek, arm and leg on the left side felt numb; can't stand ... Read more
Felt lightheaded; Neurologic event; left cheek, arm and leg on the left side felt numb; can't stand on the left leg; falling; fell in the bathroom and cut eye and got black and blue, knocked head; pain; fever of 99 and something, which is high for her, usually her temperature is around 97; aches; sleeping a lot; weak, could not get up, right hand is weak, progressive weakness; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak, could not get up, right hand is weak, progressive weakness), HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb), DYSSTASIA (can't stand on the left leg), FALL (falling) and INJURY (fell in the bathroom and cut eye and got black and blue, knocked head) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020621A and 003AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes, Hypertension and COPD. Concomitant products included GLIPIZIDE and METFORMIN for Diabetes, SERTRALINE for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ASTHENIA (weak, could not get up, right hand is weak, progressive weakness) (seriousness criteria medically significant and intervention required), HYPERSOMNIA (sleeping a lot), PAIN (pain), PYREXIA (fever of 99 and something, which is high for her, usually her temperature is around 97) and MYALGIA (aches). On 29-Apr-2021, the patient experienced HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb) (seriousness criteria medically significant and intervention required), DYSSTASIA (can't stand on the left leg) (seriousness criteria medically significant and intervention required), FALL (falling) (seriousness criteria medically significant and intervention required) and INJURY (fell in the bathroom and cut eye and got black and blue, knocked head) (seriousness criteria medically significant and intervention required). On 30-Apr-2021, the patient experienced NERVOUS SYSTEM DISORDER (Neurologic event) and DIZZINESS (Felt lightheaded). The patient was treated with Rehabilitation therapy for Asthenia; Rehabilitation therapy for Hypoaesthesia; Rehabilitation therapy for Dysstasia; Rehabilitation therapy for Fall; Rehabilitation therapy for Injury; Rehabilitation therapy for Nervous system disorder and Rehabilitation therapy for Hypersomnia. At the time of the report, ASTHENIA (weak, could not get up, right hand is weak, progressive weakness) and NERVOUS SYSTEM DISORDER (Neurologic event) had not resolved and HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb), DYSSTASIA (can't stand on the left leg), FALL (falling), INJURY (fell in the bathroom and cut eye and got black and blue, knocked head), HYPERSOMNIA (sleeping a lot), DIZZINESS (Felt lightheaded), PAIN (pain), PYREXIA (fever of 99 and something, which is high for her, usually her temperature is around 97) and MYALGIA (aches) outcome was unknown. Events began after second dose of vaccine. Treatment included ibuprofen. Patient was taken to an emergency room on 30-Apr-2021. CT scan (computed tomography) and blood tests performed. Patient was not admitted to the hospital, but was transferred to a rehabilitation center. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
78 2021-05-21 chills, sleepiness shivering, general body pain, extreme weakness, severe sleepiness ( sleeping 24 hours ), nausea (una... Read more
shivering, general body pain, extreme weakness, severe sleepiness ( sleeping 24 hours ), nausea (unable to drink water or eat) , no fever
78 2021-05-21 fever, chills, headache Chills, fever,,headache, vomiting stars headache apps 1 hr after shot, chills, vomiting started arou... Read more
Chills, fever,,headache, vomiting stars headache apps 1 hr after shot, chills, vomiting started around 1:30 am and continued until 2:30 pm on the 21st
78 2021-05-23 headache, fatigue 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 malaise, dehydration, fever 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 2021-05-25 chills, cough 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 fever, chills Resurge in aplastic anemia; Been cold; Swollen arm; Chills; Running Fever; This spontaneous case was... Read more
Resurge in aplastic anemia; Been cold; Swollen arm; Chills; Running Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication. On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant), FEELING COLD (Been cold), VACCINATION SITE SWELLING (Swollen arm), CHILLS (Chills) and PYREXIA (Running Fever). On 08-Mar-2021, FEELING COLD (Been cold), VACCINATION SITE SWELLING (Swollen arm), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (High) Platelet was 60. On 18-Dec-2020, Red blood cell count: 14 (High) Red blood cell count was 14.. On 23-Feb-2021, Haemoglobin: 10.8 (Low) hemoglobin 10.8. On 23-Feb-2021, Platelet count: 21 (Low) platelets 21. On 14-May-2021, Haemoglobin: 8.8 (Low) hemoglobin was 8.8. On 14-May-2021, Platelet count: 13 (Low) platelets 13. On 14-May-2021, White blood cell count: 2.2 (Low) white blood cell count 2.2.. Treatment included platelet transfusion, blood transfusion, cyclosporine 100mg, eltrombopag 150mg, and acetaminophen. Per report, her aplastic anemia had gotten worse and her hemoglobin, platelet and white blood count all dropped after receiving the vaccine.Her symptoms started same day and lasted for two days after receiving the first and the second vaccine. She said she has been under a lot of stress because her husband was sick, and she is not sure if that is also a contributing factor. Based on the current available information and temporal association between the use of the product and the start date of the events Vaccination site swelling, feeling cold, chills and pyrexia, a causal relationship cannot be excluded. Very limited information on Aplastic anaemia has been provided at this time. Further information has been requested. This case was linked to MOD-2021-141615 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19-MAY-2021 has patients date of birth updated; 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 Vaccination site swelling, feeling cold, chills and pyrexia, a causal relationship cannot be excluded. Very limited information on Aplastic anaemia has been provided at this time. Further information has been requested.
78 2021-05-26 headache 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 2021-05-31 headache Three days after vaccination, sight became red and itchy. Also, warm to the touch. Symptoms cleared ... Read more
Three days after vaccination, sight became red and itchy. Also, warm to the touch. Symptoms cleared in about 3 additional days. I had a slight headache the day of the vaccination but cleared the 2nd day. I did call to report these symptoms. Therefore, this reporting form is being filed. I DID NOT have to contact a doctor.
78 2021-05-31 fever, chills Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was... Read more
Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever). On 23-Feb-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (Inconclusive) Inconclusive. On 18-Dec-2020, Red blood cell analysis: 14 (Inconclusive) hemoglobin. On 23-Feb-2021, Haemoglobin: 10.8 (Low) dropped. On 23-Feb-2021, Platelet count: 21 (Low) dropped. On 14-May-2021, Haemoglobin: 8.8 (Low) dropped. On 14-May-2021, Platelet count: 13 (Low) dropped. On 14-May-2021, White blood cell count: 2.2 (Low) dropped. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated her aplastic anemia gotten worse after taking vaccine. The patient also stated that she had been under a lot of stress because her husband was sick, and she was not sure if that also a contributing factor. 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 19-May-2021: Additional information received captured patient demographics.; 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 2021-06-02 headache 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 2021-06-03 headache Patient felt a pounding headache and severe back pain
78 2021-06-03 sweating insomnia, sweats, icy feet,
78 2021-06-06 body temperature increased, chills Started with heartburn which I never had. Took Prilosec. Covid tested negative on May 3 at the loc... Read more
Started with heartburn which I never had. Took Prilosec. Covid tested negative on May 3 at the local urgent care clinic. On May 4 at 9 am went to the emergency room of hospital. Blood test and ultrasound done. I was low on sodium, but my organs around my stomach were fine. On May 7 at 2 am, woke up with 103 degree temerature, felt chilled and shaking/spasms violently which I had never experienced before. EMS came at about 3 am, and shaking subsided after drinking hot water. Had follow up visit with my primary care doctor on May 11 at 1 pm Still experience heartburn and am taking Sucralfate and Nexium.
78 2021-06-07 malaise, fever 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 2021-06-08 fever, chills 102 fever and chills and she hadn't been having a fever before that.
78 2021-06-10 chills very sore left arm for 4 days. No energy, shivers, muscle aches, mild ear ache with ringing in ears,... Read more
very sore left arm for 4 days. No energy, shivers, muscle aches, mild ear ache with ringing in ears, light headed for 13 days
78 2021-06-15 chills 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 2021-06-17 fatigue 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 2021-06-21 influenza like illness The day after I received the second dose, I woke up and felt like I had the flu. I called to make an... Read more
The day after I received the second dose, I woke up and felt like I had the flu. I called to make an appointment with my family doctor and I couldn't get in to see someone until March 25th, 2021. I saw his PA. The reason I didn't go to the doctor right away is because the pain lasted about 2 full days and then it was gone. The PA thought that I may have had a 24 hour flu.
78 2021-06-23 headache sleep for 36 hours, then nauseas, headache, After that four 4 months no taste or smell Terrible t... Read more
sleep for 36 hours, then nauseas, headache, After that four 4 months no taste or smell Terrible taste in mouth
78 2021-06-24 chills, fever Pt states night of the 2nd vaccinations fever, chills lasted several days. Violent loose stool, vom... Read more
Pt states night of the 2nd vaccinations fever, chills lasted several days. Violent loose stool, vomiting, night sweats . Dr. visit 05/26/2021 - 06/16/2021. Gastro 06/22/2021, still waiting for results. Symptoms still continuing
78 2021-06-26 headache, fatigue, fever Patient ran fever of up to 102, reports headache, fatigue, body aches, lack of appetite, redness, he... Read more
Patient ran fever of up to 102, reports headache, fatigue, body aches, lack of appetite, redness, heat at site of injection. Patient used only Tylenol to treat. Patient states that 5 days later she is finally feeling a little better
78 2021-06-28 pneumonia PNEMONIA, ARDS, VENT REQUIRED 4 DAYS DOD3/19/21
78 2021-07-05 fatigue, throat pain, cough, fever 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 2021-07-05 headache, fever Muscle joint aches, terrible headache, 106 fever and slept for 36 hours. I had hives spots again and... Read more
Muscle joint aches, terrible headache, 106 fever and slept for 36 hours. I had hives spots again and i grabbed the leftover predinione and took them. I went to the doctor and she gave me another prescription of predinisone.
78 2021-07-06 malaise Heavy breathing, sick, can?t walk, loss of memory, incoherent, couldn?t sleep, no appetite
78 2021-07-07 throat irritation Terrible itch and whelps on palm of hand and bottom of foot, then lip , tongue and throat , used epi... Read more
Terrible itch and whelps on palm of hand and bottom of foot, then lip , tongue and throat , used epi pen to control. this is on going and keeps happening
78 2021-07-08 fatigue Acute hepatitis; Fatigue; Diarrhea; This spontaneous case was reported by a physician (subsequently ... Read more
Acute hepatitis; Fatigue; Diarrhea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEPATITIS ACUTE (Acute hepatitis) 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 Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATITIS ACUTE (Acute hepatitis) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, HEPATITIS ACUTE (Acute hepatitis) was resolving, DIARRHOEA (Diarrhea) had resolved and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Alanine aminotransferase: 653 (Inconclusive) 653. On 29-Jun-2021, Aspartate aminotransferase: 283 (Inconclusive) 283. On 29-Jun-2021, Bilirubin conjugated: 0.3 (Inconclusive) 0.3. On 29-Jun-2021, Blood alkaline phosphatase: 90 (normal) 90. On 29-Jun-2021, Blood bilirubin: 1.3 (Inconclusive) Gilbert's. On 29-Jun-2021, International normalised ratio: 1.03 (Inconclusive) 1.03. On 29-Jun-2021, Ultrasound liver: abnormal (abnormal) +ANA chronic for years , low suspicion. On an unknown date, Alanine aminotransferase: high (High) 20 -> 250 -> 950. On an unknown date, Aspartate aminotransferase: high (High) 20 -> 147 -> 256. On an unknown date, Blood bilirubin: 1.2 (Inconclusive) 1.2. On an unknown date, International normalised ratio: <1.2 (Inconclusive) <1.2. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other laboratory included test for Acute hepatitis- Negative for Hep A/B/C , IgG Treatment information was not provided. The physician reported that previous labs suggest underlying Gilbert's 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 2021-07-08 fever She got her vaccine, she was fine, drove herself home 5-10 minutes, felt fine until her arm started ... Read more
She got her vaccine, she was fine, drove herself home 5-10 minutes, felt fine until her arm started to feel hot and a rash broke out. There was lump at the injection site. Then she felt like she had a lightening strike through her body, and felt like she had the flu the next day. She could not move and it lasted only a day and she stayed in the bed, and it went away. She had a low grade temp of 100, normal temp 97. She then woke up on Wednesday with a rash at the injection site to the elbow but used hydrocortisone cream which did not release the pain and used a cold compress to remove the heat from her arm. The cortisone cream did not work and she called the doctor who prescribed Benadryl cream and Benadryl to take (allergic to). Cream worked, Benadryl made her sick so now lists that as an allergy. She then took Claritin and it worked, but the rash remained. She got a rash then on the back of her right thigh, and she had hives on both knees (one on each knee and on the elbows). The rash on her arm was there and had to use cold compresses and eventually by Friday of that week it subsided . Annoying due to the itching, but not painful. The rash on the thigh went away the next day. Also had rash on her buttocks, which went away the next day as well. Has been fine since the Friday after the vaccine. She saw her doctor who told her to take the shot, her son is a Dr. and they told her to take it. All of her family members and friends had no reactions.
78 2021-07-11 fatigue 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 2021-07-12 fatigue Pain, swelling, redness @ injection site, extreme fatigue next day, month later (April 7th) , devel... Read more
Pain, swelling, redness @ injection site, extreme fatigue next day, month later (April 7th) , developed total body rash
78 2021-07-12 fever 5/28/2021 Patient started experiencing sharp pain in her left ear. In May patient had stroke symptom... Read more
5/28/2021 Patient started experiencing sharp pain in her left ear. In May patient had stroke symptoms for about 15 mins. Speech was slurred and she could not remember people. In June stabbing pain and left feverish and had a episode of loose stool.
78 2021-07-15 fever a very sore painful arm and a fever up to 102.8 We called the doc
78 2021-07-22 headache, malaise About an hour after getting the shot I started not feeling to good. I ended up with a headache, shor... Read more
About an hour after getting the shot I started not feeling to good. I ended up with a headache, shortness of breath, and swollen glands. I tried to wait it out but it continued to get worse so I went to the emergency room and was admitted.
78 2021-07-22 sweating, fatigue Fatigue, short of breath, night sweats, fingers tremble constantly. Healthcare professional provide... Read more
Fatigue, short of breath, night sweats, fingers tremble constantly. Healthcare professional provided antibiotics. Still experiencing symptoms.
78 2021-07-28 chills Pt reports the day after vaccine feeling chills, slept all day, felt "out of it.". 7/28 she noticed... Read more
Pt reports the day after vaccine feeling chills, slept all day, felt "out of it.". 7/28 she noticed her arm was red and swollen. advised these would all be considered normal side effects. Need to monitor arm. If size increasing please notify dr. If getting smaller should resolve on its own. All other symptoms other than arm have since resolved.
79 2021-01-01 headache, fatigue 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 2021-01-01 fever, malaise 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 2021-01-04 malaise, body temperature increased Malaise, Wobbly, T. 99.2
79 2021-01-08 nasopharyngitis Swollen red and sore, itchy right arm, five inches spread, Cold symptoms .
79 2021-01-12 fatigue, fever 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 2021-01-12 fever Fevr,vomiting, hurt all over, short of breath
79 2021-01-13 fatigue, lethargy, fever EXTREME LETHERGY, ELEVATED HEARTRATE, ELEVATED FEVER, NAUSEA, FATIGUE
79 2021-01-14 throat pain Sore throat, pain across shoulders and down arms and earaches , all of which came on suddenly while ... Read more
Sore throat, pain across shoulders and down arms and earaches , all of which came on suddenly while walking outside some 7 hrs after vaccination
79 2021-01-18 fatigue, chills, headache, fever 12 hours after injection had chills Temp of 100, severe body and joint pain, headache, fatigue for ... Read more
12 hours after injection had chills Temp of 100, severe body and joint pain, headache, fatigue for 12 hours Headache lasted for 48 hours I did have the virus in April. Took 7 months to fully recover
79 2021-01-19 fatigue Eleven hours after receiving COVID vaccine, client started experiencing stroke-like symptoms legs/ar... Read more
Eleven hours after receiving COVID vaccine, client started experiencing stroke-like symptoms legs/arm weakness, couldn't speak, shortness of breath, and throat swelling. Hospital ruled out acute stroke but could not entirely exclude a cerebellar stroke due to her dizziness with vertigo and nystagmus (per hospital report). Client was in hospital 2.5 days, per hospitalist. note-all work up including MRI and tte were negative for acute findings- symptoms have resolved. Hospitalist noted symptoms may be worse following second shot. Spoke with client 1/19/21 and she reported feeling weak and tired only.
79 2021-01-21 fatigue, headache All joints sore and swelling, nausea, tired, headaches.
79 2021-01-22 chills January 13, 2021 - received injection and didn't feel it going in, shortly after got sore arm Januar... Read more
January 13, 2021 - received injection and didn't feel it going in, shortly after got sore arm January 14 - 9:00am arm very sore and had diarrhea, clammy and very hot. Had diarrhea 3 more times until around 11;30. Nothing else until about 4:00 pm - had chills, didn't last very long after covering up. January 15th - just sore arm, no redness at injection shot. January 22 - noticed injection site had a 3" x 1 1/2" red place and warm to touch. Doctor said to ice it and take Zrytec and put Benadryl cream on it. January 23 - not as red, but a little sore. Had some diarrhea, but don't know if that is what it is from.
79 2021-01-22 fever, headache, fatigue About 20 hours after receiving the COVID vaccine she was tired and lay down to nap. Shortly thereaft... Read more
About 20 hours after receiving the COVID vaccine she was tired and lay down to nap. Shortly thereafter she became very dizzy even while lying down. As time went on she started burping loudly and developed nausea. She also has developed a headache and has a low fever of 101.5. This all continues until now, 48 hours after the injection and she is still dizzy in bed with the above symptoms.
79 2021-01-23 cough, fever 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 2021-01-23 fatigue 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 2021-01-24 fatigue, headache Bad headache, sore arm , tired.
79 2021-01-24 sweating 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 2021-01-24 fever, chills, headache Headache, nausea, fever, chills,body ache, high blood pressure
79 2021-01-24 fever, fatigue Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be ... Read more
Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed.
79 2021-01-27 fatigue 79 y/o female patient presents with "shakes" after having received the Moderna COVID Vaccine. Pt sta... Read more
79 y/o female patient presents with "shakes" after having received the Moderna COVID Vaccine. Pt state she "feels like a mac truck hit her". Her hands are shaking but it feels like her insides are shaking. "Too much trouble to stand up, really, really tired." General Examination: GENERAL APPEARANCE: alert pleasant, in no acute distress female. HEAD: normocephalic atraumatic. ORAL CAVITY: mucosa moist. THROAT: clear, no erythema or swelling. LYMPH NODES: no cervical adenopathy. SKIN: warm and dry. HEART: regular rate and rhythm. LUNGS: clear anteriorly and posteriorly good air movement no wheezes, rales, rhonchi. CHEST: normal shape and expansion. ABDOMEN: soft and nondistended. NEUROLOGIC: alert and oriented. Adverse effect of other viral vaccines, initial encounter - T50.B95A Patient observed for a full hour after vaccine administered. No signs of anaphylaxis appreciated. Patient warned of warning signs of worsening adverse reaction and allowed to go home. Patient was somewhat improved prior to allowing to leave. Adverse reaction will be reported to CDC.
79 2021-01-27 fatigue Extreme fatigue/weakness Muscle aches Blood glucose levels over 300
79 2021-01-28 body temperature increased Did not have an immediate reaction to injection. 8 days after injection. started to have discomfort,... Read more
Did not have an immediate reaction to injection. 8 days after injection. started to have discomfort, swelling, temperature went up to 100.3 that lasted for a couple of hrs and then went away. slept real good and woke up and not long after waking up my arm started feel very uncomfortable and swelling, turning red and a little itchy. and took a little Acedimidafin and now its back to normal.
79 2021-01-28 fatigue At 3:00 am on 1-27-21 I awoke unable to control my mouth. Face, arms, Legs and whole body. My entire... Read more
At 3:00 am on 1-27-21 I awoke unable to control my mouth. Face, arms, Legs and whole body. My entire body was shaking violently. Finally able to get to my feet and stumbled trying to notify 911. Stumbled to room closest the front door. Husband opened front door for EMS. For about 1 hour I sat and my whole body trembled. Finally the thrashing about slowed down and stopped. Today I am very tired and achey.
79 2021-01-28 headache, fatigue feeling hot but no fever, slight headache, slight nausea, general tiredness . atypical for me. 36 ... Read more
feeling hot but no fever, slight headache, slight nausea, general tiredness . atypical for me. 36 hours
79 2021-01-28 sweating 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 headache This is patient (self) report: ?Covid arm? noticed on day 10 post vaccine. Itchy, achy. Classic siz... Read more
This is patient (self) report: ?Covid arm? noticed on day 10 post vaccine. Itchy, achy. Classic size as determined by newspaper article/ about 4 inches long/2inches wide. Red, firm swollen area very gradually fading in color. Size, sensations and swelling remain the same. Last two day have had mild yet annoying headache starting mid day. No temp.
79 2021-01-30 chills, fever, fatigue Reaction started about 22 hours after the shot. Reaction included tenderness, swelling and redness (... Read more
Reaction started about 22 hours after the shot. Reaction included tenderness, swelling and redness ( 4 in. diameter ) at the injection site, chills, low grade fever, fatigue, nausea and vomiting. Symptoms, except fatigue, subsided in about 12 hours. It took about a week for the fatigue to subside
79 2021-01-30 fatigue, fever, chills Next night vomited, fever, chills, back pain, extreme fatigue, inability to eat, lack of coordinatio... Read more
Next night vomited, fever, chills, back pain, extreme fatigue, inability to eat, lack of coordination in legs, confusion ...lasted for 4 days now. Worse symptoms when temperature is high.
79 2021-01-31 chills Severe chills nausea severe stomach pain and lower back pain , diarrhea. At times felt like throat ... Read more
Severe chills nausea severe stomach pain and lower back pain , diarrhea. At times felt like throat closing but kept clearing throat and okay, then drinking water Lasted Over 48 hours
79 2021-01-31 fatigue Started with stinging and then itching in her arm on 1/31/21. Deep red rash noted to area on this da... Read more
Started with stinging and then itching in her arm on 1/31/21. Deep red rash noted to area on this day as well, very itchy if she touches this at all. Arm was so sore after injection she could barely move her arm. She was also extremely tired for two days after getting the vaccine.
79 2021-01-31 headache, runny nose, sneezing, upper-airway cough syndrome, fatigue, cough right arm pain, swelling, and warmth which has been progressive after receiving her first Moderna Co... Read more
right arm pain, swelling, and warmth which has been progressive after receiving her first Moderna Covid vaccine on 1/22/21. No weakness, numbness, or paresthesias of the right upper extremity. Affected area has remained isolated around the injection site without significant spread. No fevers, chills. Patient has noted fatigue, headache, body aches, isolated rhinorrhea/sneezing a few days ago, and intermittent cough. Known issues with postnasal drip.
79 2021-01-31 throat irritation Patient reported tingling to left side of face-after 10 more minutes-itching to left side of throat.... Read more
Patient reported tingling to left side of face-after 10 more minutes-itching to left side of throat. Diphenhydramine 50 mg IM resulted in subsiding of symptoms.
79 2021-02-01 head discomfort Delayed localized swelling, erythema, warmth to the injection site Increased dizziness from baselin... Read more
Delayed localized swelling, erythema, warmth to the injection site Increased dizziness from baseline Increased head pressure
79 2021-02-01 headache, fatigue Body aches, muscle pain, fatigue, headache. Tylenol given. Symptoms resolved after 24 hours.
79 2021-02-01 fever Had reaction in November to tetanus vaccine. Had flu vaccine with no reaction. Then had this vacci... Read more
Had reaction in November to tetanus vaccine. Had flu vaccine with no reaction. Then had this vaccine, no reaction initially, came home, feeling fine but an hour later had flushing in her left ear, just creeping over to her eye and the side of her face. This lasted for about 15 minutes and left the feeling of something not quite right around her eye. Nothing compared to her reaction in November from a tetanus booster. Still has the feeling but not an adverse reaction. Then at 10:00 PM all of a sudden her face went really hot, and presumed she had a fever, started feeling badly. Started walking around the house, took Tylenol. That feeling lasted for about 30 minutes and resolved. Went to bed and did not feel anything but a funny feeling. All symptoms have subsided except for a weird feeling around her eye.
79 2021-02-02 cough, fatigue, fever, runny nose Had Moderna Covid vaccine 1/21. 3 days later she had nausea and dry heaves, cough, & clear rhinorrhe... Read more
Had Moderna Covid vaccine 1/21. 3 days later she had nausea and dry heaves, cough, & clear rhinorrhea. The next day she had a fever, Max 101, poor appetite and nausea. Fever last 3 days, then went away. Still having fatigue 1 week out
79 2021-02-02 headache, throat pain, fatigue Sore throat, severe fatigue, body aches, persistent headache.
79 2021-02-02 throat redness 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 2021-02-02 fever, headache Low grade fever, shaking, body hurts so bad could hardly walk headache....did not go to my doctor
79 2021-02-02 sleepiness, lethargy lethargy, somnolence x 3 days
79 2021-02-03 chills chills, shaky, neck pain, arm pain, stomach upset
79 2021-02-03 fatigue pt stated that she was fine and then in 2 days seemed to have fatigue. Within in 5 days pt noticed ... Read more
pt stated that she was fine and then in 2 days seemed to have fatigue. Within in 5 days pt noticed it was sore under the left arm. Within 7 days it became itchy red and swollen. Pt contacted her PCP on 2/3/2021 and she was told to take an antihistamine but she didnt take it since she has dry eyes. She used hydrocortisone to help with the itching.
79 2021-02-04 fatigue 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 2021-02-04 paranasal sinus discomfort Sinus pressure, soreness at injection site
79 2021-02-04 fever Elevated Temp 100.8
79 2021-02-05 chills, fever weakness chill fever lack of appitate sore shoulder about 2 inch red spot around shot sitel.
79 2021-02-05 fever Rec'd vaccine at 1:30 pm on 02/03/21. Next morning, diarrhea, fever, and was unable to stand up, ev... Read more
Rec'd vaccine at 1:30 pm on 02/03/21. Next morning, diarrhea, fever, and was unable to stand up, even with aid of a walker and my husband's help. Muscle weakness, which lasted about 24 hours. . After 24 hours, took 2 Tylenol, Next day problem was gone. And no further problem with muscle weakness. Did read CDC recommendations, not to take 2nd dose if there were problems. And I will not be t aking the second one on 03-03021. Did call Health Dept and reported it but not sure what staff member I visited with, but it was not the nurse who gave injection nor the Administrator.
79 2021-02-06 fever, headache fever of 102 decreased with Tylenol. Pain in arm very strong headache
79 2021-02-07 chills, fatigue total fatigued, chills and ache. I slept and i slept. lasted all day and about 3:00 the next afterno... Read more
total fatigued, chills and ache. I slept and i slept. lasted all day and about 3:00 the next afternoon i started feeling human again and by the 3rd day i was over it.
79 2021-02-07 fever, chills Fever Chills Muscle weakness
79 2021-02-08 fatigue After experiencing expected sore arm and fatigue the day after vaccination, I was symptom free for t... Read more
After experiencing expected sore arm and fatigue the day after vaccination, I was symptom free for three days. On the evening of the fourth day I developed pain, itching and redness around the vaccination site that is still present the following day.
79 2021-02-08 fatigue pt states that later the day of the vax that her left eye lid was dropping and she had a blood blis... Read more
pt states that later the day of the vax that her left eye lid was dropping and she had a blood blister develop a couple of inches below injection site. The next day she had sore left arm with some fatigue. Pt states all symptoms have subsided but still has a droopy eyelid and has an apt w/ an eye doctor today. She states she has had cataract eye surgery on 1/13/2021 and on 1/26/2021 had Botox injection on brow. Pt has appt w/ PCP on 2/18/2021.
79 2021-02-08 malaise one week after vaccine noted red spot 2 inches below injection site sl itch note. Two weeks after... Read more
one week after vaccine noted red spot 2 inches below injection site sl itch note. Two weeks after vaccine was red to elbow and was not feeling well, itching was worse, went to Urgent Care saw Doctor who order Preisone and K-flex
79 2021-02-09 headache Patient observed for a total of 30 minutes. Stated headache and some chest discomfort, back aches as... Read more
Patient observed for a total of 30 minutes. Stated headache and some chest discomfort, back aches as well. stated pain 1/10. BP 151/86, HR 71 and 98% on room air. after 30 minutes stated feels achy and slight headache. Denied chest discomfort. Able to be released to home.
79 2021-02-09 influenza like illness 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 2021-02-10 headache, chills Patient reported she had second dose of COVID vaccine (moderna) on 2/8. She states later that evenin... Read more
Patient reported she had second dose of COVID vaccine (moderna) on 2/8. She states later that evening developed severe headache, and vomiting- which lasted 36 hours. Nausea and slight chills during that time. Injection sight sore but no redness, swelling, rashes. Today patient has been able to eat and drink fine, and feels much better.
79 2021-02-10 headache, influenza like illness Monday Eve.: Typical flu-like symptoms: Dizziness, Nausea, Headache, Bone Pain, sore arm Tuesday: A... Read more
Monday Eve.: Typical flu-like symptoms: Dizziness, Nausea, Headache, Bone Pain, sore arm Tuesday: Arm hard, warm, very sore --continued Wednesday: Black and Blue around injection site Thursday: Red rash that extended to elbow. Checked with NP who said could be cellulitis or inflammatory reaction --put topical Hydrocortisone on it and watch. It did shrink some, but still present through this evening.
79 2021-02-11 chills 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 2021-02-11 fatigue, chills, headache, fever (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 headache, fatigue, fever Woke up this morning with fevers, headache, body aches, nausea, general weakness and fatigue.
79 2021-02-11 headache headache 2 days after receiving vaccination
79 2021-02-13 nasal congestion, fever, fatigue, cough Dry Cough, nasal congestion, low grade fever and fatigue. Concern about cough and nasal congestion.... Read more
Dry Cough, nasal congestion, low grade fever and fatigue. Concern about cough and nasal congestion. Could this be due to vaccine? No problem with smell or taste.
79 2021-02-13 fever Fever and some joint aches. Took ibuprofen. Started feeling better after 5 pills.
79 2021-02-14 body temperature increased, malaise, cough, headache 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 chills, fever, fatigue, headache NAUSEA, FEVER (100.3), CHILLS, HEADACHE, MUSCLE ACHES FOR 24 HOURS. EXTREME FATIGUE CONTINUEING FOR ... Read more
NAUSEA, FEVER (100.3), CHILLS, HEADACHE, MUSCLE ACHES FOR 24 HOURS. EXTREME FATIGUE CONTINUEING FOR 3 DAYS.
79 2021-02-14 fatigue 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 pneumonia, chills, fever Moderna COVID?19 Vaccine EUA Patient received her first dose of Moderna on 2/10/2021. On 2/11/2021 ... Read more
Moderna COVID?19 Vaccine EUA Patient received her first dose of Moderna on 2/10/2021. On 2/11/2021 she developed chills and fever of 104. She was sent to Hospital. Was admitted and chest Xray showed patchy spots suspicious of pneumonia. She remained inpatient for two days with antibiotic treatment. Was discharged home on 2/13/2021 with oral antibiotic and follow up appointment with pulmonary. PCR and rapid COVID testing while inpatient was nagative for COVID-19
79 2021-02-15 chills Laid down to take nap four hours after shot, woke suddenly with two different severe cases of vertig... Read more
Laid down to take nap four hours after shot, woke suddenly with two different severe cases of vertigo. I have history of vertigo but haven't had it in over a year. After I sat up and was shaking and had chills. Have had no other reoccurrences and have felt fine.
79 2021-02-15 fatigue, headache, chills 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 2021-02-15 fever, cough, headache 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 sleepiness She was in bed after her vaccine, she had to go to her sisters to get her to sign a will. She actua... Read more
She was in bed after her vaccine, she had to go to her sisters to get her to sign a will. She actually slept for 4 days. Tuesday was the worst day, it got slightly better. She was just feeling lousy. She felt fuzzy and weak. On 2/8/21 her temp was 97.3, she felt well. On 2/14/21 and it was 97.5, before that she had been in bed and did not take her temperature. Today she is feeling like a human being, but does not feel as though she is functioning normally mentally. She is upset about her sister who is dying and plays a large part in how she feels mentally.
79 2021-02-16 body temperature increased, chills, headache Temperature 99.3 F (unusual for the patient even when ill). Sore Arm. Chills, headache,
79 2021-02-16 fatigue Mild nausea, strong fatigue, very bad muscle and joint pain lasted about 3 to 4 days
79 2021-02-16 headache, fever, fatigue I had a moderate reaction. I was slightly dizzy. I was weak. I had a low grade fever for a few days.... Read more
I had a moderate reaction. I was slightly dizzy. I was weak. I had a low grade fever for a few days. I had a headache for a few days. I had "covid arm". It was red, sore, it had some swelling, and intense itching. I am still tired. I have diarrhea as well.
79 2021-02-16 malaise, lethargy, fever Patient developed lethargy and malaise several hours after vaccine with a low grade fever. The follo... Read more
Patient developed lethargy and malaise several hours after vaccine with a low grade fever. The following morning she reported to her husband inability to taste food or drink. She developed nausea and vomiting which persisted from 1/30/21 through her death. She was found deceased in bed by her husband this morning.
79 2021-02-16 nasal congestion Face became very hot, vision blurred momentarily; I continued to feel very hot although the car wind... Read more
Face became very hot, vision blurred momentarily; I continued to feel very hot although the car window was down and it was a cool day; then I realized that my nasal passages were swelling. First symptoms subsided after 10 min, nasal passages were returning to normal after 15 min. No treatment given. I didn't even report it as I didn't see anyone to report it to until I was pulling out of the Fairgrounds.
79 2021-02-17 fatigue, fever, headache Up to 72 hours after the shot: * Headache * Pain in the injection site (described as sharp pain) * H... Read more
Up to 72 hours after the shot: * Headache * Pain in the injection site (described as sharp pain) * Her face would get very bright, red and flushed; it would remain this way for about an hour, and then go back to normal. Then the cycle would repeat about 2 hours later. * Patient reports alternating between feeling "feverish" or "really hot" alternating with feeling "really cold" * Dizziness, and very unbalanced on her feet * She fell twice the first two days while trying to walk to the bathroom * Extreme fatigue - she slept most of the first 48 hours * Extreme confusion (more than what was presenting with the Alzheimer's prior to the shot) - she could not remember where she was Ever since the shot/still experiencing: * Persistent nausea * Constant "achy" feeling in her arms, legs and feet * Panic and anxiety (again, more than is common with her daily routine) * Severely decreased appetite - unable to finish more than half a meal or not being able to eat at all due to nausea/a feeling like she is going to vomit * Her arms and legs are visibly shaky * She is too weak often to lift herself out of her recliner (she was able to do this prior to the shot)
79 2021-02-17 headache Extreme weakness leading to patient falling and unable to get up. Nausea, headache, large itchy wel... Read more
Extreme weakness leading to patient falling and unable to get up. Nausea, headache, large itchy welt on arm lasting 7 days.
79 2021-02-17 throat irritation Within 15 minutes of the vaccination, the patient reported scratchiness in her throat to an RN. I wa... Read more
Within 15 minutes of the vaccination, the patient reported scratchiness in her throat to an RN. I was notified and immediately went over to the patient. She did not have any chest tightness, chest itchiness, or swelling of the throat, mouth, tongue, or facial areas. No visible rashes. Patient then reported the scratchiness in the throat to me and seemed to be panicked. I recommended one dose of 25 mg diphenhydramine. Roughly 15 minutes after the dose, the patient told me the scratchiness went away. She was given a glass of water with the dose of Benadryl and had another full glass as well. She was continuously monitored throughout the process.
79 2021-02-18 body temperature increased with first injection muscle was toxic for 36 hours, T t 100, diffuse myalgias, arthritis, felt miser... Read more
with first injection muscle was toxic for 36 hours, T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours as couldn't lift head even to drink water. Second injection was toxic for 36 hours , T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours,also temp of 100.4. When I could drink I took a tylenol. questionaire did not ask, but I had covid in mid August
79 2021-02-18 chills, sinus congestion, fatigue, headache 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 2021-02-18 headache, fatigue Swelling, Redness, Rash on vaccination site, rash on back, stomach pains, diharrea, headache, fatiqu... Read more
Swelling, Redness, Rash on vaccination site, rash on back, stomach pains, diharrea, headache, fatique.
79 2021-02-18 lethargy, fever 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 2021-02-19 body temperature increased, fatigue 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 2021-02-19 chills, body temperature increased, throat pain, sneezing, headache Acute sneezing x 10 Min followed by shacking chills, temp 102, severe muscle aches, headache, sore t... Read more
Acute sneezing x 10 Min followed by shacking chills, temp 102, severe muscle aches, headache, sore throat lasting 16 hours
79 2021-02-19 chills On the 19th by about 4 pm pain in both arms not just the pain in a left arm muscle which was expecte... Read more
On the 19th by about 4 pm pain in both arms not just the pain in a left arm muscle which was expected Pins and needles and pain in both hands Neck and shoulder pain Later that night chills Stomach ache and constipation followed by loose bowel later These were milder versions of my reaction when I had Covid-19 in November except the pins and needles in hands. That came on after I got over Covid. These pains went away after a couple of courses of Tylenol extra strength. Except the chills and stomach ache recurred and my stomach is still a little achy
79 2021-02-19 fatigue, headache moderate headache, fatigue, diarrhea, stomach upset (no vomiting)
79 2021-02-20 chills, fatigue Symptoms: large red itchy spot on arm, chills, fatigue, slight nausea, mild general headache that be... Read more
Symptoms: large red itchy spot on arm, chills, fatigue, slight nausea, mild general headache that became piercing,painful and intermittent for several hours Symptoms lasted for approximately 36 hours ,arm remains red and slighty itchy 4 days later, slight headache Treatment:tylenol,liquids,rest
79 2021-02-21 body temperature increased Temp 101.8 for about 30 hours. Vomiting multiple times in 24 hour period.
79 2021-02-21 cough, upper-airway cough syndrome, runny nose 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 fatigue very bad pain from head to toe in every muscle, bone and joint, nausea, weakness, freezing cold and ... Read more
very bad pain from head to toe in every muscle, bone and joint, nausea, weakness, freezing cold and the worst was from about 10 pm feb 18 to about 11 am feb 19 but the weakness went on through feb 20. Felt pretty much over it by Feb 21 but still some weakness and fatigue. Also a very sore arm that turned pink and feb 22 is still sore and pink and itchy but not as bad as the previous days. I have always gotten a sore arm with flu shots but not as bad as this time so I didn't consider that a bad reaction.
79 2021-02-21 fatigue Confusion, Fatigue
79 2021-02-22 chills, fatigue, fever 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 chills, fever 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 dehydration Patient received her Covid 19 Vaccination on 2-11-21. I counselled her about side effects and asked... Read more
Patient received her Covid 19 Vaccination on 2-11-21. I counselled her about side effects and asked her to wait 15 minutes. She waited and as she was leaving she fell to the floor and hit her head. The other patients around her said it looked like she slipped, but when speaking to her it seemed that she had become dizzy and fell. I spoke with her after she fell, she did not loose conscienceness, but was disoriented. She did know what day it was, who she was and where she was. She said her head hurt and she could move all her limbs. I asked the store director, to call for an ambulance. I sit with her for a few minutes and talked to her, then asked store director to stay with her until the ambulance arrived. They arrived and spoke with her and decided to transport her to the hospital. Later that day, her sister in law came by and said she was doing fine and had been released. The doctors indicated they thought she because dizzy due to dehydration
79 2021-02-22 fatigue, fever On Feb 21, fever of 101 discomfort in arm, extreme tiredness. Difficulty sleeping. On February 22, f... Read more
On Feb 21, fever of 101 discomfort in arm, extreme tiredness. Difficulty sleeping. On February 22, fever of 99.1 , increased redness, heat, and swelling at site (about the size of my palm). Iced site for about an hour and took citirezine antihistamine. Feb 23, today AM temp 98.6, perhaps size of swelling has decreased. Still painful to raise arm there. Can do all household activities.
79 2021-02-22 fatigue nausea/vomiting; tiredness
79 2021-02-22 headache, malaise, fever Got the shakes at 11PM on sat. night and at 2Am in the morning i am throwing up. I have a fever my h... Read more
Got the shakes at 11PM on sat. night and at 2Am in the morning i am throwing up. I have a fever my head hurts and my neck. I am still sick. I do not feel good. I am not getting the 2 shot.
79 2021-02-22 malaise She woke up on the morning of 2/14/21, was not feeling real good, but noticed a tightness in her mou... Read more
She woke up on the morning of 2/14/21, was not feeling real good, but noticed a tightness in her mouth. Her cheeks were swollen, she felt that maybe her tongue was as well. She got the liquid Benadryl and let it stay there and it helps that feeling. She had taken the Zyrtec and Singulair the night before. She did the inhaler puff in the morning, the feeling did not go away. She then took the Ventolin and it seemed to calm down. The symptoms then went away and didn't come back, and thought that she was ok. She felt bad for about a week and a half like she wanted to sleep all the time, but did what she had to do. She is fine now.
79 2021-02-22 nasal congestion Difficulty breathing as a result of swelling back of nose, diarreha, nausea,
79 2021-02-22 nasopharyngitis, chills, headache Woke up Sunday morning 02/21/2021 with cold chills, quickly turning to hot flashes, continuing with ... Read more
Woke up Sunday morning 02/21/2021 with cold chills, quickly turning to hot flashes, continuing with a severe headache,vomiting,diarrhea ,and nausea. Continuing thru Monday 02/22/2021 and Tuesday 02/23/2021. Called my Dr?s office at 9:00;AM 02/23/2021. Have not heard back. There message recording asks not to duplicate calls, which I did not do.
79 2021-02-22 fever, chills allergic skin response with swelling and redness at the injection site and down the upper arm. feve... Read more
allergic skin response with swelling and redness at the injection site and down the upper arm. fever, chills
79 2021-02-23 cough, fatigue, malaise, fever Really tired on Monday the 22nd and I felt fatigued. I began to get nauseated and then I began to vo... Read more
Really tired on Monday the 22nd and I felt fatigued. I began to get nauseated and then I began to vomit. I vomited 5-6 times even though I had not eaten anything. I also had diarrhea. I had chills. Some point during the night I spiked a fever, I woke up and drenched. Yesterday the 23rd I had a fever, my stomach still does not feel settled. I have not ate much since Sunday but have been trying to stay hydrated with lots of water. I also developed a cough yesterday. Tuesday night my temperature 100.6 and I think it got higher because I woke up once again drenched in sweat. This morning my temperature was 99. I am achy today with muscle and joint pain, my stomach feels better but I still leery of eating. I did eat some Ginger ale and eat some saltine crackers. I also feel horse. I called my doctor yesterday and still have not heard back. I will call again today. It feels like I feel better in the morning but as the day goes on I get worse and start feeling worse. I have been resting a lot in bed.
79 2021-02-23 fever, chills, runny nose My concern is I had no side effects except a runny nose for 2 days but then after 7 days, on 19th,... Read more
My concern is I had no side effects except a runny nose for 2 days but then after 7 days, on 19th, I started with severe chills and fever and went to ER for 5 hours; lots of blood work and urine specimens and influenza tests and covid test showed all negative with a few smaller flags like leukocytes and ph in urine greater than 8.9, had urinalysis and negative. But still today 6 days after being in ER I still have severe chills and fever, last eve was oup to 100.4, most of the time during day hours it is 99.9 to 100 but has gone at night higher. MY QUESTION IS IS IT POSSIBLE FOR THIS KIND OF REACTION TO OCCUR 7 DAYS AFTER VACCINE AND THEN LAST ALL OF THIS TIME AND NOT SURE WHEN IT WILL END. The chills are so bad my teeth chatter, I have to curl up in a ball until the tylenol takes effect.
79 2021-02-24 chills, fever, headache, fatigue Fever(101.2), 4 degrees above my normal(97.4). Shaking chills. Generalized body aches, Fatigue, Sli... Read more
Fever(101.2), 4 degrees above my normal(97.4). Shaking chills. Generalized body aches, Fatigue, Slight Headache, Sore arm. Refrained from Ibuprofen and Tylenol. Rest. Fluids, All better in 48 hrs.
79 2021-02-24 malaise Swelling, redness, oozing, pain of injection arm, general malaise- returned to vaccine site at CVS a... Read more
Swelling, redness, oozing, pain of injection arm, general malaise- returned to vaccine site at CVS and had NP examine, steroid prescribed, also made visit to my mother?s internal medicine dr and he examined as well; my mom was told to discontinue steroids and not to get 2nd dose of vaccine.
79 2021-02-25 chills, fatigue, headache, fever fever, chills, headache, night sweats, sore arm, fatigue lasted 24 hours- night sweats and slight fe... Read more
fever, chills, headache, night sweats, sore arm, fatigue lasted 24 hours- night sweats and slight fever and headache returned the next night and the third day I was still slightly fatigued
79 2021-02-25 fatigue, headache Patient tested positive for COVID 7 days after receiving her first COVID 19 vaccine. She developed ... Read more
Patient tested positive for COVID 7 days after receiving her first COVID 19 vaccine. She developed symptoms including shortness of breath, fatigue and headache. She tested positive outpatient for COVID on 2/9
79 2021-02-25 headache, body temperature increased headache and temp of 99.7
79 2021-02-25 malaise, fatigue Tiredness, queasy, itching/rash, feeling of not being well. On days 9 & 10, arm was painfully itchy ... Read more
Tiredness, queasy, itching/rash, feeling of not being well. On days 9 & 10, arm was painfully itchy and a rash developed on my stomach and breasts. Exhaustion lasted 3 weeks.
79 2021-02-25 nasopharyngitis 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 pneumonia 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 fever, body temperature increased One Wednesday - I had a temperature - this time it went to 101.8 and when I got up on Thursday morn... Read more
One Wednesday - I had a temperature - this time it went to 101.8 and when I got up on Thursday morning, I had a fever of 100.2 - Friday - it was 97.8 and in PM it went up to 99.5; Saturday the 6th - 99.5 Sunday the 99.5. 8th - 98.6 and I have been normal ever since. No dizziness with second dose of vaccine.
79 2021-02-25 fever, influenza like illness 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 2021-02-26 headache, fever Swollen, red, hard and feverish knot at injection site. Severe headache and slept for over 24 hour... Read more
Swollen, red, hard and feverish knot at injection site. Severe headache and slept for over 24 hours. Was unable to leave bed for 24 hours except for necessities and experienced dizziness and disorientation when trying to get up. Fever over 100 degrees and no appetite and no food taken. Still no appetite on 02/27/21.
79 2021-02-26 headache Seizure on 02/19/2021 Narrative: Patient had a Seizure last Friday 02/19/2021. This is new-onset sei... Read more
Seizure on 02/19/2021 Narrative: Patient had a Seizure last Friday 02/19/2021. This is new-onset seizure activity started on Keppra. PMH of a Hemorrhagic stroke October 2020. Patient received the Moderna vaccine on 2/13 developed dizziness, headache and nausea all day on Monday then 4 days later had a seizure and ended up hospitalized so per hospital report may have been a combination of a weakened immune system and old stroke that included the seizure.
79 2021-02-27 fever, chills, fatigue, headache HEADACHE, FEVER,CHILLS, TIRED,
79 2021-02-27 fever fever, syncope after vaccine
79 2021-02-28 cough, headache, fever, chills "Moderna COVID-19 Vaccine EUA" Immediately felt routine pains in right arm at shot sight and j... Read more
"Moderna COVID-19 Vaccine EUA" Immediately felt routine pains in right arm at shot sight and just out of sorts. By 6 PM I felt nauceous , headache, pains in every joint of my old body , cough, chills, virgo, weakness , low grade fever, unsteady on my feet. Unable to sleep finally took Tylenol . This lasted 48 hours!
79 2021-02-28 fatigue, headache, chills Fever, /headache, Chills, Sore, itchy Arm, body aches, Tired
79 2021-02-28 headache, chills, fatigue 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 fever, chills Chills, fever, body aches for 2 days (1-2 Feb., 2021). Drank water as able. Felt like being hit/ru... Read more
Chills, fever, body aches for 2 days (1-2 Feb., 2021). Drank water as able. Felt like being hit/run over by a 10-ton truck. By the late afternoon of day 2, I began feeling better, but felt weak for the next day. I lost 2 1/2 pounds.
79 2021-02-28 fever, fatigue I had very little reaction to the first fax on Feb. 11 other than a slight fever and extreme fatigue... Read more
I had very little reaction to the first fax on Feb. 11 other than a slight fever and extreme fatigue through the 3rd day. However, on the 9th day after the vax, I got "COVID Arm" which included upper arm swelling, red, itchy and achey at the vax site and another few days of extreme fatigue. Today (18 days after vax) I am no longer fatigued, felt good when I woke up and I am finally getting some energy back. The redness, swelling and itching is subsiding but is not gone totally and there is only a slight discomfort in my arm. Moderna Vaccination #2 is on March 11 and it will be in my other arm. Only took Aleve twice for pain.
79 2021-02-28 fever, headache, fatigue, chills Nausea, vomiting, weakness, confusion, headache, body and joint pain, fever, tiredness, arm soreness... Read more
Nausea, vomiting, weakness, confusion, headache, body and joint pain, fever, tiredness, arm soreness,chills. started within 15 hours of injection. Uncontrolled vomiting and weakness necessitated going to emergency room. She had had severe covid 19 in 2020 and was hospitalized for 5 days. Received remesdivir and dexamethasone
79 2021-03-01 chills, malaise, fever Dry heaves, general malaise, chills, slight fever.
79 2021-03-01 chills Chills, shortness of breath, body aches
79 2021-03-01 dehydration 2/17 kidney failure, lost electrolytes,
79 2021-03-01 headache 2 days later began with headache, dizziness, weakness, on 1/25/21 was admitted to hospital with seve... Read more
2 days later began with headache, dizziness, weakness, on 1/25/21 was admitted to hospital with severe leg weakness, inability to walk, urinary incontinence
79 2021-03-01 lethargy, fatigue Systemic: Exhaustion / Lethargy-Mild, Systemic: tingling all over. patient reported feeling better a... Read more
Systemic: Exhaustion / Lethargy-Mild, Systemic: tingling all over. patient reported feeling better after about 20-30 minutes of watching/waiting.-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in extremities
79 2021-03-01 malaise, headache CHIEF COMPLAINT Chief Complaint Patient presents with ? Abdominal Pain ? Headache a 79 y.o. femal... Read more
CHIEF COMPLAINT Chief Complaint Patient presents with ? Abdominal Pain ? Headache a 79 y.o. female who presents with chief complaint of not feeling well. Patient is unable to be any more specific about what it is that is wrong. She denies fever chills nausea vomiting abdominal pain diarrhea constipation or urinary tract symptoms. She does state that she has been feeling somewhat weak. Her appetite has been fine.
79 2021-03-02 headache, runny nose ON FEBRUARY 11, I AWOKE WITH A RUNNY NOSE WITH HEADACHE, EYE ACHE, TEOOTHACHE ON RIGHT SIDE OF MOUTH... Read more
ON FEBRUARY 11, I AWOKE WITH A RUNNY NOSE WITH HEADACHE, EYE ACHE, TEOOTHACHE ON RIGHT SIDE OF MOUTH--UPPER AND LOWER. I ALSO FELT A COLD SORE COMING ON. I TOOK SUDAFED PE AND VALCYCLOVIR, WHICH USUALLY SOLVES THE ISSUE. THESE SYSMPTOMS CONTINUED AND I CONTINUED WITH SUDAFED AND VALCYCLOVIR. I SAW MY DENTIST ON FEBRUARY 11 AND WAS TOLD THERE THERE WERE NO ISSUES AND PERHAPS THE PAIN WAS CAUSED BY SINUS ISSUES. I INCREASED THE VALCYCLOVIR TO THREE TABS A DAY RATHER THAN ONE. THE TEETH ISSUE SPREAD TO THE LEFT SIDE OF MY MOUTH AND TWO MORE COLD SORES APPEARED, ANOTHER ON MY UPPER LIP AND ONE AT THE EDGE OF MY LEFT NOSTRIL. I HAD A ZOOM MEETING WITH MY DOCTOR ON MARCH 1. SHE INCREASED THE VALCYCLOVIR TO 1000M. THREE TIMES A DAY. THE COLD SORES HAVE DISAPPEARED, BUT THE OTHER SYMPTOMS CONTINUE, BUT THE PAIN HAS LESSENED SOMEWHAT. I TAKE TYLENOL WHEN THE DISCOMFORT BEGINS TO INTERFERE WITH MY DAILY LIFE.
79 2021-03-02 headache 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 2021-03-02 malaise Patient had general malaise unknown cause. Onsite EMS was called vitals BP 154/66 HR 96 . Patien... Read more
Patient had general malaise unknown cause. Onsite EMS was called vitals BP 154/66 HR 96 . Patient refused evaluation/care and released agianst medical advice.
79 2021-03-03 cough, chills, headache, fatigue Extreme chills and shaking - 5 hours, nausea, aches, headache, fatigue, cough, shortness of breat... Read more
Extreme chills and shaking - 5 hours, nausea, aches, headache, fatigue, cough, shortness of breath , no appetite after shaking stopped.
79 2021-03-03 fatigue, dehydration, fever The next day of the vaccine I had fever, felt really fatigued, I felt very low of energy, my head fe... Read more
The next day of the vaccine I had fever, felt really fatigued, I felt very low of energy, my head felt like I had brain freeze it felt was worse every time I stood up, I saw my doctor he ordered lab work & urine test my urine test comeback as I was a little dehydrated & lab work came back normal. This has not resolved as it right now I still feel very low of energy. My energy is still not the same.
79 2021-03-03 fever, influenza like illness 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 2021-03-04 headache, cough, throat pain headache, cough, sore throat
79 2021-03-06 chills, fever "Moderna COVID-19 Vaccine EUA" Severe chills, fever 100, nausea started at 2:00 AM. Threw up 3 time... Read more
"Moderna COVID-19 Vaccine EUA" Severe chills, fever 100, nausea started at 2:00 AM. Threw up 3 times, fever and chills ended about 4:30 after hubby gave me Tylenol. Next day stayed in bed with weakness and achy body. 2nd day still weak but did move around with naps in-between. Sunday stayed up and feeling much better.
79 2021-03-06 fatigue, sleepiness Extraordinary fatigue & sleepiness. As of today, back to normal for 2 days. Right eye bloodshot & ... Read more
Extraordinary fatigue & sleepiness. As of today, back to normal for 2 days. Right eye bloodshot & painful with feeling of something big in the eye. Left eye not affected. Vision not lost. Examined by two of the ophthalmologists. Could not find anything in the eye or any sign of disease, i.e. glaucoma. Prescribed steroidal eye drops. As of today, condition worse in the morning, but bloodshot fading and pain subsiding. May be going back to see them March 11, 2021.
79 2021-03-06 fatigue Fatigue lasted 4-5 days then gradually dissipated
79 2021-03-06 lethargy Swollen arm( 3 inch circle), red, painful, diarrhea, lethargy. Took Tylenol 1000mg prn for pain, Alt... Read more
Swollen arm( 3 inch circle), red, painful, diarrhea, lethargy. Took Tylenol 1000mg prn for pain, Alternated heat & cold to arm for two days, Nothing for diarrhea
79 2021-03-07 fatigue, chills, fever Fever, chills, skin hurt, fatigue.
79 2021-03-07 fatigue, headache, fever Following the vaccine she noticed the same day fatigue. She was so tired that she didn't understand... Read more
Following the vaccine she noticed the same day fatigue. She was so tired that she didn't understand it. Then had headaches off and on, as well as muscle and joint pain everywhere, weakness all over her body. She also had a low grade fever Saturday and Sunday. She did have the Corona Virus in July of 2020. She is feeling better today as far as the weakness, just a little bit of muscle and joint pain. She did have a trace of nausea this morning, but took her medication and it subsided. The weakness was something like she had never had before. She took Tylenol for her symptoms. She did not call her doctor. Just has a small amount of symptoms, but still not feeling herself yet.
79 2021-03-07 fatigue Weakness, tiredness, body discomfort no appetite for 2 days
79 2021-03-07 fever, headache First 2-3 days felt normal discomfort at injection sit. It got progressively worse and began to feel... Read more
First 2-3 days felt normal discomfort at injection sit. It got progressively worse and began to feel like a torn rotator cuff. A lot of pain (7-8) unable to sleep on that side and unable to lift more than two pounds or drive or reach above my shoulder without pain of about a 10 on scale of 1-10. Saw orthapedic physician assistant on 03/26 who gave me a steroid shot in that shoulder with 75% relief by the next day. Still some minor residual discomfort at this writing. Also ran a fever with nausea and headache exactly two weeks after first shot.
79 2021-03-07 fever Fever resolved in 24 hours, red itchy painful 2" diameter rash, brain fog, cellulitis outer bicep
79 2021-03-07 fever Red rash a litte swollen and feverish 6 inches long.
79 2021-03-07 fever Redness, itch, fevered, soreness at injection site
79 2021-03-07 sleepiness Her Husband was unable to wake her the the next morning 03/04/21 0730 ,she would not respond to him... Read more
Her Husband was unable to wake her the the next morning 03/04/21 0730 ,she would not respond to him , finally he was able to get her sitting up but she would never open her eyes or talk ,he took her to the hospital where she was admitted.
79 2021-03-08 fatigue, fever Fever, nausea, fatigue, headache, hardness, pain and redness at injection site
79 2021-03-08 fatigue heavy fatigue, mild nausea, loss of appetite, soreness in upper arm. was at worst from about 18-3... Read more
heavy fatigue, mild nausea, loss of appetite, soreness in upper arm. was at worst from about 18-32 hours after getting the vaccine. took some aspirin for the soreness, slept much of the day.
79 2021-03-08 fatigue Couldn't get up; Couldn't breathe; Lost voice; Felt very tired; A spontaneous report was received fr... Read more
Couldn't get up; Couldn't breathe; Lost voice; Felt very tired; A spontaneous report was received from a consumer concerning a 79 years old, female patient who received Moderna (mRNA-1273) vaccine and experienced couldn't get up/mobility decreased, couldn't breathe/dyspnoea , lost voice/aphonia and felt very tired/fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, approximately three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) in the left arm for prophylaxis of COVID-19 infection. 15 Feb 2021, the patient couldn't breathe, felt very tired, lost her voice, couldn't get up, and was hospitalized following a visit to urgent care. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, Dyspnoea, Fatigue, Aphonia, Movement disorder and Hospitalization was unknown.; Reporter's Comments: This case concerns a 79-year-old female who was hospitalized with serious unexpected events of dyspnea, mobility decreased, and aphonia and a serious expected event of fatigue. The events occurred 3 days after the first dose of mRNA-1273. Treatment not reported. 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 fever, fatigue 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 2021-03-08 throat clearing, headache Patient begin to experience throat tightening, sensation of need to clear throat frequently, voice ... Read more
Patient begin to experience throat tightening, sensation of need to clear throat frequently, voice hoarseness, trouble swallowing, choking sensation and headache 45 minutes after receiving 2nd moderna vaccine. Patient took Benadryl 50 mg OTC and went to ED. Treated with racemic epinephrine, IV benadyl, IV decadron, IV pepcid. Given script for epipen by ED provider, but has not needed to use.
79 2021-03-09 body temperature increased Sore left arm, temperature of 100.4, red rash on upper left arm from injection site to crook of elbo... Read more
Sore left arm, temperature of 100.4, red rash on upper left arm from injection site to crook of elbow.
79 2021-03-09 chills, headache Headache the evening of the vaccination. The next day I had headache, chills, whole body ache, stoma... Read more
Headache the evening of the vaccination. The next day I had headache, chills, whole body ache, stomach upset. I took Tylenol, as directed, for two days.
79 2021-03-09 chills PATIENT STARTING EXPERIENCING NAUSEA, VOMITING, AND CHILLS ALMOST 2 HOURS AFTER RECEIVING THE VACCIN... Read more
PATIENT STARTING EXPERIENCING NAUSEA, VOMITING, AND CHILLS ALMOST 2 HOURS AFTER RECEIVING THE VACCINE. PATIENT WAS NOT EXPERIENCING AN ALLERGIC REACTION.
79 2021-03-09 sleepiness COVID-19 Vaccine EUA I had a sore arm at the spot; then I was in a sleepy condition. Then I too... Read more
COVID-19 Vaccine EUA I had a sore arm at the spot; then I was in a sleepy condition. Then I took 2, 81 mg aspirins.
79 2021-03-10 bronchitis 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 chills, body temperature increased, headache Moderna C19 Vaccine EUA Mar 5: 3:15 AM arm started hurting. 8:30AM chills, body ache. 11:40 temp 98... Read more
Moderna C19 Vaccine EUA Mar 5: 3:15 AM arm started hurting. 8:30AM chills, body ache. 11:40 temp 98.6. arm stopped hurting. 12:05 temp 99.5. slight headache. 12:25 temp 99.9. 1PM temp 101. 5PM temp 99.8. Mar 6: 12:30 PM feeling better. no fever, chills, body ache Mar 9 very difficult bowl movement. Mar 10/11 stomach problems diarrhea
79 2021-03-10 chills, fever About a week after I got the shot my whole upper arm was red and itchy. I had fever and chills, that... Read more
About a week after I got the shot my whole upper arm was red and itchy. I had fever and chills, that didn't last long- 2-3 hours maybe. A week after I got a not in my throat. I went to my Dr he did an ultrasound and sent me to an ENT. The ENT did an ultrasound as well and said he would follow up with me in 3 months, but everything looked fine. The lump went away.
79 2021-03-10 chills 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 cough Patient said she developed local erythema/swelling/itching to injection site and that it spread to h... Read more
Patient said she developed local erythema/swelling/itching to injection site and that it spread to her chest and abdomen. She developed a "bronchial cough" about 48 hours after receiving vaccine. She wanted antibiotics for cough from her primary care because her husband is having surgery on 3/15/21 and wanted to make sure she could go into the hospital with him. Her primary care provider prescribed her Ceftin 500 mg. She has taken Ceftin before without any allergic reaction. She said as soon as she started taking the Ceftin her entire body became itchy "down to her fingers" and had hives from head to toe. Also reports mild shortness of breath. Her provider was unsure whether the reaction was from the Ceftin with the vaccine or the Ceftin itself. Patient said her primary care may do some testing to find out if she is allergic to Ceftin.
79 2021-03-10 fatigue 2/26/21 History & Physical- History of present illness: "Pleasant 79 years old female who started to... Read more
2/26/21 History & Physical- History of present illness: "Pleasant 79 years old female who started to develop recurrent episodes of nausea and vomiting of nonbilious none bloody material 1 week ago then started to have frequent watery bowel movements with the last bowel movement was associated with rectal bleeding, she started to develop generalized weakness and fatigue, she had 3 falls in the last week without hitting her head, she did not have loss of consciousness, over the last 2 days she has been complaining of numbness and tingling to the hands and feet, she was not able to walk due to generalized weakness. She denied fever or chills she had no chest pain or shortness of breath. 2 weeks ago she got her second dose of COVID-19 vaccine. There was no change to her medications according to her, she denies sick contacts." Intubated and ICU transfer 2/28/21 for "Possible Guillain-Barré syndrome and impending respiratory failure" extubated 3/10/21.
79 2021-03-10 fatigue Redness, sore and very tired
79 2021-03-11 chills, fever 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 fatigue, fever, influenza like illness, malaise, headache Within 24 hrs was having flu like symptoms, headache, body ache, fatigue, general malaise, skin reac... Read more
Within 24 hrs was having flu like symptoms, headache, body ache, fatigue, general malaise, skin reaction inflamed (3x7 inch), soreness in arm, fever starting 7 pm second day, fever 100.2,. After 72 hrs soreness and inflammation in left arm remain other symptoms generally gone except tired.
79 2021-03-11 headache, malaise Nausea, dizziness same day Day 2 headache and all over malaise
79 2021-03-11 malaise 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 fever, headache, fatigue, chills fever and chills, headache, nausea muscle aches, fatigue treated with tylenol felt fine after 24 ... Read more
fever and chills, headache, nausea muscle aches, fatigue treated with tylenol felt fine after 24 hours
79 2021-03-11 sleepiness 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 2021-03-13 headache, fatigue Headache, fatigue, sore arm, joint pain
79 2021-03-13 pneumonia 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 2021-03-13 fever, chills chills, upset stomach, fever, muscle/body aches
79 2021-03-14 fatigue, chills Cold chill, severe fatigue, body aches, lasted one day.
79 2021-03-14 fatigue On 3/2/21 had arm discomfort into next day, felt tired, on 3/11/21 started with body rash on back, s... Read more
On 3/2/21 had arm discomfort into next day, felt tired, on 3/11/21 started with body rash on back, stomach, groin area, base of skull, and chest. Dr. said to take Zyrtec or Benadryl, neither had any effect. I was then prescribed Methyl PREDNISolone tablets 4 mg.
79 2021-03-14 headache, fever, fatigue Fatigue, fever (101.7F), nausea w/o vomit, headache
79 2021-03-14 malaise Patient reported swollen arm, and feeling sick for 4 days
79 2021-03-14 fever, fatigue next day- fever, tired sore at injection site 9 days after vaccination-large red area 3-5 inches of ... Read more
next day- fever, tired sore at injection site 9 days after vaccination-large red area 3-5 inches of warm, sore and itchy upper arm a few inches lower than injection site (Covid Arm)appeared. Nurse observed and prescribed an antibiotic for 5 days , then 5 days more. Slowly decreased after 3 days until it disappeared after 9-10 days.
79 2021-03-15 fatigue 5 days later reports extreme dizziness/fatigue. No other symptoms noted. Reviewed severe side effect... Read more
5 days later reports extreme dizziness/fatigue. No other symptoms noted. Reviewed severe side effects and what to do including calling 911, call doctor.
79 2021-03-16 fatigue 3/12 (day of #2 vaccine) typical warm, slightly swollen injection site on RIGHT deltoid. 3/14 LEFT a... Read more
3/12 (day of #2 vaccine) typical warm, slightly swollen injection site on RIGHT deltoid. 3/14 LEFT arm had shooting pains from deltoid to fingers that would clench involuntarily (similar symptom as with #1 vaccine) Intensely itchy skin developed over entire body late in day. Intensity increased to burning sensation, extreme fatigue, mental fog, and inability to fall sleep. This lasted all night until about mid-day 3/15. 3/16 Symptoms began to subside. 3/17 Close to normal .... I hope!
79 2021-03-16 sweating Blood Glucose 59 signs of hypoglycemia shaking sweating queasy
79 2021-03-17 chills, headache Headache chills muscle aches weakness vomiting
79 2021-03-17 fever, headache, chills, fatigue, runny nose 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 chills, fatigue, headache 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 2021-03-18 chills, fever 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 fatigue, chills very splotchy rash and very sore above and at injection site, mild chills, very tired and achy
79 2021-03-18 fatigue, headache, body temperature increased, chills Temperature elevation, chills, headache, joint pain nausea, dry heaves...I had COVID IN NOVEMBER, DI... Read more
Temperature elevation, chills, headache, joint pain nausea, dry heaves...I had COVID IN NOVEMBER, DIAGNOSED Nov.19, had double pneumonia , released from hospital Dec. 6....I waited over 90 days to have vaccine...adverse effects lasted around 48 hours, I?m still fatigued, no temperature elevation, but the whole episode was like my first stages of Covid. I do not want to get my second shot in April and go through this again..what are studies showing about vaccine given after having had Covid...have you learned anything from them yet? Will I be certified as being vaccinated with only the one shot?
79 2021-03-18 influenza like illness Every part of body hurt one day after the injection, didn't eat, Second day everything ran out of m... Read more
Every part of body hurt one day after the injection, didn't eat, Second day everything ran out of me until I pooped yellow liquid. Third day started to eat and be up more and moving around. Felt like flu. Day 4 checked weight and lost
79 2021-03-19 headache, cough Cough, headache, body aches, neck pain, generalized weakness.
79 2021-03-20 cough, chills 1st day all joints stiff 2nd day chills head ache body pain coughing third day neck stiff backache ... Read more
1st day all joints stiff 2nd day chills head ache body pain coughing third day neck stiff backache and stomach pain fourth day coughing and generally body ACHES
79 2021-03-20 headache, fatigue Patient came to the pharmacy 3/20/21 complaining of Gas, uncontrollable diarrhea, fatigue and headac... Read more
Patient came to the pharmacy 3/20/21 complaining of Gas, uncontrollable diarrhea, fatigue and headache for the last 5 days. She stated that the symptoms started 3/16/21 the day after vaccination. Anti-diarrhea medication was unsuccessful at stopping the symptoms.
79 2021-03-21 dehydration Pt received 1st Covid Shot Saturday 10:30am. Felt some abdominal cramping that evening, and when sh... Read more
Pt received 1st Covid Shot Saturday 10:30am. Felt some abdominal cramping that evening, and when she woke up on Sunday, had abdominal pain, nausea, vomiting, and a small amount of diarrhea. She continued to vomit all day, and became weak/dizzy. Went to ER, where she was found to have Diverticulitis and Dehydration. She was given IV fluids and anti-nausea medicine and hasn't had any further vomiting over Sunday Night. Patient will continue oral antibiotic treatment for Diverticulitis at home.
79 2021-03-21 fatigue, chills, headache Approx. hour after injection started with a nagging headache for over a week, chills, muscle aches, ... Read more
Approx. hour after injection started with a nagging headache for over a week, chills, muscle aches, joint pains, fatigue, tireness, and nausea all lasting for over a week. On 1/16/2021 vomited all day - no stomach cramps or any other indication of that being a "stomach virus". Continued nauseated feeling resulted in cancelling a dental appt on Tuesday after injection.
79 2021-03-21 headache Severe headache 1 week and 2 weeks after vaccination and ongoing low grade headache since first epis... Read more
Severe headache 1 week and 2 weeks after vaccination and ongoing low grade headache since first episode. Partial response to acetaminophen.
79 2021-03-21 headache 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 malaise, chills Approximately 24 hours after injection (March 20, 2021) I became nauseous and started vomiting. Th... Read more
Approximately 24 hours after injection (March 20, 2021) I became nauseous and started vomiting. Then chills set.. Felt like I had COVID 19 all over again. I did not have fever. Did not start feeling until 12:00 P.M. March 21, 2021. I did have the Corona virus in December of 2020. Waited 90 days to get the first vaccine shot on March 18, 2021.
79 2021-03-21 pneumonia, malaise, lethargy, fatigue 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 2021-03-22 fatigue, headache I felt very bad that evening. I couldn't eat. I felt a little nauseated. my arm was sore across my s... Read more
I felt very bad that evening. I couldn't eat. I felt a little nauseated. my arm was sore across my shoulders and down my left arm. I had fatigue, headache (I felt like my head was going to explode) , muscle pain and general pain all over. My heart rate was 96 and my BP was 62/36. I felt Dizzy, weak. 03/16/21 I went to the ER Still feel hazy and foggy. I feel like my limbs are disconnected and dont respond as easily as they should.
79 2021-03-23 bronchitis 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 fatigue, fever, headache swelling of left arm and shoulder from shoulder to below elbow, extreme itching and rash, fatigue, ... Read more
swelling of left arm and shoulder from shoulder to below elbow, extreme itching and rash, fatigue, headache, loss of appetite, low-grade fever. This has continued for two weeks.
79 2021-03-23 fever Had a type of E-coli; Fever; UTI; A spontaneous report was received from a consumer who was also a 7... Read more
Had a type of E-coli; Fever; UTI; A spontaneous report was received from a consumer who was also a 79-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who fever/ pyrexia, UTI/ urinary tract infection, and had a type of E-coli/ enterococcal infection. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 27 Feb 2021, prior to the onset of the symptoms, the patient received a dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date the patient developed a type of E-coli infection, Urinary tract infection and fever. 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: This case concerns a 79-year-old female who had a medically significant and serious unexpected event of Enterococcal infection along with NS events of unexpected urinary tract infection and expected pyrexia. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
79 2021-03-24 fatigue 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 headache, fatigue, body temperature increased Felt very cold on first day of vaccination. Insomnia. Soreness. Fever of 101 24hr after injection. S... Read more
Felt very cold on first day of vaccination. Insomnia. Soreness. Fever of 101 24hr after injection. Slight headache. Fatigue.
79 2021-03-27 fatigue After going to bed I woke up around 12:30 pm with itchy sensations on my hands, underarms and torso;... Read more
After going to bed I woke up around 12:30 pm with itchy sensations on my hands, underarms and torso; also my tongue became swollen. I Felt weak and nauseous but did not vomit. After drinking a glass of water I went back to sleep. I awoke in the morning 3/28/21 @ 8am My itchy areas were gone. I did not feel weak, just tired. The swelling of my tongue gradually reduced during the day and now it is normal (7:30pm). There was no treatment.
79 2021-03-27 fever, fatigue, headache High fever,weak, fatigue, cold, sweats, headache on friday following shot. Also, A continuance of... Read more
High fever,weak, fatigue, cold, sweats, headache on friday following shot. Also, A continuance of cold "flashes" at times comes on me since. and still contujnues
79 2021-03-28 chills, sweating, fever Symptoms began 15 Hrs. after receiving my 2nd Moderna vaccine. Chills, Frozen joints (couldn't walk... Read more
Symptoms began 15 Hrs. after receiving my 2nd Moderna vaccine. Chills, Frozen joints (couldn't walk) lasted for 3 Hrs. Then profuse sweating with a fever that lasted for 3 Hrs. I was back to my normal self 24 Hrs. later. This 2nd vaccine was given 4 wks. 5 days after I received the 1st. vaccine. I reported my reaction to the 1st. vaccine on 02/28/2021 Temporary that I developed Covid Arm (Red Rash around the injection site) four days later ...Benadryl taken for 4 days with Mometasone cream and it cleared up.
79 2021-03-28 fatigue, chills, cough, fever, throat pain Beginning the day after the shot, I started having chills in the afternoon and then would get a feve... Read more
Beginning the day after the shot, I started having chills in the afternoon and then would get a fever. Also had a sore throat, cough got worse. I was tired and didn't sleep well. Fevers were as high as 101. 5 and my body temperature is usually lower than 98.6. This continued for over a week and on the 28th, I went to hospital for a covid test, chest x-ray and blood work. All tests were negative and blood work was find. About two weeks after I received the vaccine, the symptoms stopped.
79 2021-03-28 fatigue, chills Second day after the vaccine in March, I had fatigue, aches, AND CHILLS IN MY LOWER EXTREMITIES. Th... Read more
Second day after the vaccine in March, I had fatigue, aches, AND CHILLS IN MY LOWER EXTREMITIES. These symptoms carried over until noon on the third day. THEN I developed weak muscles in my legs and sprained my R knee. I continue to have weak muscles and the knee (R) was swollen. I have alleviated the swelling but continue to practice stretching to strengthen the leg. The leg is still not as strong as it was before the vaccine in March.
79 2021-03-28 throat pain, fatigue, fever Fever nausea, loss of appetite, sore throat, fatigue, Fluids and Aspirin used for fever.
79 2021-03-28 fever, fatigue Rapid heart rates of about 200 for 3 times this past week, two times lasting about 20 minutes, yeste... Read more
Rapid heart rates of about 200 for 3 times this past week, two times lasting about 20 minutes, yesterday lasting three hours. My husband has experienced fatigue, low fever, weakness starting 5 days after second shot, also.
79 2021-03-30 chills, fatigue, cough, fever Pt admitted to the hospital with fever, cough, chills, diarrhea, and fatigue with an abnormal chest ... Read more
Pt admitted to the hospital with fever, cough, chills, diarrhea, and fatigue with an abnormal chest X-Ray.
79 2021-03-30 sweating Pt presented w/crushing chest pain, diaphoresis, and SOB. Unlikely from vaccination, but entering V... Read more
Pt presented w/crushing chest pain, diaphoresis, and SOB. Unlikely from vaccination, but entering VAERS for "Serious adverse event requiring hospitalization" 39 days COVID vaccination
79 2021-03-31 fatigue Body aches. Arms, legs esp Tiredness, loss of appetite
79 2021-03-31 headache, cough, fatigue, throat pain 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 GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry), OROPHARYNGEAL PAIN (Sore throat from vomiting often) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), PAIN (Body aches) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), DECREASED APPETITE (Wasn't hungry) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (Sore throat from vomiting often) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to COUGH, DECREASED APPETITE, DIARRHOEA, FATIGUE, GAIT DISTURBANCE, HEADACHE, OROPHARYNGEAL PAIN, PAIN and VOMITING. At the time of the report, GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Noting the history of COVID infection (Nov 2020) may remain as risk factor. Further information has been requested.
79 2021-03-31 headache, fever, influenza like illness Immediately after injection Lips tingled and swelled. difficulty swallowing, On day after: two days ... Read more
Immediately after injection Lips tingled and swelled. difficulty swallowing, On day after: two days of intense headaches, followed by two days of flu-like symptoms and 99.0 fever and heart palpitations, and for the next two weeks intense frequent diarrhea and continuing heart palpitations, which continue to current date.
79 2021-03-31 headache Severe headache after second vaccination which has lasted over a month.Occurs daily
79 2021-03-31 malaise, fatigue, fever Patient admitted to local hospital for new onset atrial fibrillation/flutter with rapid ventricular ... Read more
Patient admitted to local hospital for new onset atrial fibrillation/flutter with rapid ventricular response. Patient last known well at time of vaccination (no reported complications with 1st vaccination). After 24 hrs, began feeling fatigued, with general malaise, and fever. Presented to hospital ED 4 days after vaccination and found to be in new onset afib/flutter. Required admission and introduction of diltiazem and metoprolol for rate control and started on rivaroxaban for anticoagulation
79 2021-03-31 fever, cough Patient developed Covid; Breathing dificulties; Hallucinating; Legs felt like rubber; Coughing; 104 ... Read more
Patient developed Covid; Breathing dificulties; Hallucinating; Legs felt like rubber; Coughing; 104 fever; 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 developed COVID, 104 fever (pyrexia), hallucinating, legs felt like rubber (skin atrophy), coughing and breathing difficulties (dyspnoea). The patient's medical history was not provided. Concomitant medications were not provided. On 05 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 18 Feb 2021, patient was hospitalized for Covid infection. He had a fever of 104, hallucinating, legs felt like rubber, coughing, and breathing difficulties. Labs and treatment information was not reported. Action taken with response to mRNA-1273 was not reported. The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
79 2021-04-01 chills, cough vomiting, chilled, cough, shortness of breath
79 2021-04-02 fever fever, generalized muscle ache, diarrhea, loss of appetite, weakness - lasted for three days - took... Read more
fever, generalized muscle ache, diarrhea, loss of appetite, weakness - lasted for three days - took 1 1/2 week to fully recover
79 2021-04-03 fever Slight cellulitis at the injection site; Sore arm; Fever of about 102.4°; Nausea; A spontaneous rep... Read more
Slight cellulitis at the injection site; Sore arm; Fever of about 102.4°; Nausea; A spontaneous report was received from a consumer who is a 79-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) vaccine and experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia, nausea. The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 05-FEB-2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number:011M20A) intramuscularly on arm for prophylaxis of COVID-19 infection. On an unknown date, after receiving the first dose of vaccine, patient experienced feeling a sore arm, like a slight cellulitis at injection site, fever of 102.4 and nausea. The event injection site cellulitis was considered as serious (Medically Significant). Treatment medication included alcohol which was used at the injection site. Laboratory tests were not reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia and nausea were considered as 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.
79 2021-04-04 fatigue, sleepiness The day after the vaccine I was tired, sleepy and "groggy". I went to the toilet and passed out aft... Read more
The day after the vaccine I was tired, sleepy and "groggy". I went to the toilet and passed out after standing up and turning toward the sink to wash my hands. My husband (retired internist) heard a thump and found me on the floor. It took him calling my name 10 times before I woke up. My pulse was strong and heartbeat regular. I don't remember being dizzy or lightheaded, only remember going to the toilet and then waking up and wondering why I was lying on the bathroom rug. I would very much like to know if other people have passed out the day after getting the vaccine.
79 2021-04-04 fatigue Five days following vaccine #2, pt presented to the emergency department on 3/2/21 with complaint of... Read more
Five days following vaccine #2, pt presented to the emergency department on 3/2/21 with complaint of severe generalized arthralgias and fatigue. Completely different from her chronic osteoarthritis. Complete work-up including labs were negative. Normal CBC; normal electrolytes; normal inflammatory markers (ESR and CRP); rheumatoid factor was normal; urinalysis was normal; chest x-ray was normal. She was discharged home on no medication. She was seen by primary care on 3/29/21 and reported her symptoms, although not completely resolved, were markedly improved. Because of her autoimmune liver disease, she did not take Tylenol or Ibuprofen for her discomfort.
79 2021-04-04 malaise, headache, fever Patient received the above Friday p.m., woke up Saturday with 101.7 temp. Had all day, finally broke... Read more
Patient received the above Friday p.m., woke up Saturday with 101.7 temp. Had all day, finally broke during the night. Sunday & Monday still feel out of sorts. Temp normal but blood pressure on lower side. Reports today still feel unwell; injection site slightly warm, feeling light-headed, slightly nauseous, headache, again lower BP. Took 2 Tylenol @ 4pm.
79 2021-04-04 runny nose, bronchitis, cough feels like she is still not okay; choking on the mucus; 7 minutes after first dose immediate allergi... Read more
feels like she is still not okay; choking on the mucus; 7 minutes after first dose immediate allergic reaction; mucus in her nose,terrible back drip; Tickle in her chest,tickle in her throat; heaviness in her chest; hoarseness; cough; lost her voice; described her symptoms as bronchitis like; described her symptoms as laryngitis; felt like she had an entire respiratory infection; A spontaneous report was received from a consumer concerning a 79-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 7 minutes after first dose immediate allergic reaction(hypersensitivity), mucus in her nose and terrible back drip(secretion discharge), tickle in her chest and tickle in her throat(general discomfort), heaviness in her chest(chest discomfort) choking on the mucus(choking), hoarseness(Dysphonia), cough, lost her voice(aphonia), described her symptoms as bronchitis like(bronchitis), described her symptoms as laryngitis(laryngitis), felt like she had an entire respiratory infection,(respiratory infection) feels like she is still not okay(feeling abnormal). The patient's medical history was not provided. Concomitant medications reported were Claritin, Vit D, Calcium Pills, Mirtazapine, antidepressants, multivitamins for drug use for unknown indication. On 16 Feb 2021, approximately 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004MZ0A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the event(s) 7 minutes after first dose immediate allergic reaction , mucus in her nose , terrible back drip , tickle in her chest, tickle in her throat , heaviness in her chest ,choking on the mucus, hoarseness, cough , lost her voice ,described her symptoms as bronchitis like, described her symptoms as laryngitis, felt like she had an entire respiratory infection . Event choking on the mucus was considered medically significant. On 24 Feb 2021, the patient experienced the event(s) feels like she is still not okay. Treatment details included Robitussin and Honey, she has taken Tylenol for symptoms with only 20% relief. Her doctor states that if she does not, improve he will give her prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), 7 minutes after first dose immediate allergic reaction, mucus in her nose,terrible back drip, tickle in her chest, tickle in her throat, heaviness in her chest, choking on the mucus, hoarseness, cough, lost her voice, described her symptoms as bronchitis like, described her symptoms a laryngitis, felt like she had an entire respiratory infection, feels like she is still not okay was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected choking and NS unexpected hypersensitivity, rhinorrhea, discomfort, chest discomfort, dysphonia, cough, aphonia, bronchitis, laryngitis, respiratory tract infection, feeling abnormal. Event onset 7 minutes after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
79 2021-04-05 headache, chills Swelling,redness, warmth,Pain at site. Chills,Bodyaches. Headache,Major. Generalized Weakness. L... Read more
Swelling,redness, warmth,Pain at site. Chills,Bodyaches. Headache,Major. Generalized Weakness. Lasting three days. Ice compresses continuously. Tylenol OD. Decreased gradually. Today the 5th Day still visible redness, and slightly painful.
79 2021-04-07 chills, fever Aside from aching vaccination site I felt OK until 9:00 am. Then I was struck with violent vertigo, ... Read more
Aside from aching vaccination site I felt OK until 9:00 am. Then I was struck with violent vertigo, which lasted about an hour. I practiced controlled breathing for about 10 minutes and the vertigo gradually subsided. Then for the rest of the day I had chills and a low fever. I also noticed that my thyroid was very swollen and remains so today, approximately 3 weeks later. However, I have no pain in the thyroid.
79 2021-04-07 fatigue, chills Chills; extraordinary, unslakable thirst; exhaustion; detachment from reality; crankiness--duration ... Read more
Chills; extraordinary, unslakable thirst; exhaustion; detachment from reality; crankiness--duration about 8 hours
79 2021-04-08 cough, throat irritation pt began coughing, complaining of scratchy throat, tongue became swollen and pt had difficulty swall... Read more
pt began coughing, complaining of scratchy throat, tongue became swollen and pt had difficulty swallowing
79 2021-04-08 throat redness The morning after I woke up and got out of bed and I was extremely dizzy to the point that I went do... Read more
The morning after I woke up and got out of bed and I was extremely dizzy to the point that I went downstairs on my seat (bottom) so I could go down. I then stayed on the couch and called for help. My tongue swelled up and filled my mouth. My neck glands were swelling and my hands itched and they were red (no welts) like crazy. I took Benadryl and it eased up and I went back to bed. The next morning that was gone. I have had another allergic reaction since then and this time I thought I was getting shingles - my throat got very very red, ears itched and my hands itched and I had ropey welts where my bra sat. My whole stomach area was very itchy. I called the doctor (after hours phone call - on the 31st) - and she assured me that I wasn't getting shingles as I already have had them twice. I took Benadryl and then the doctor prescribed a non-drowsy antihistamine - Claritin - and I am taking that every day. I am not someone that has allergic stuff occur. These took it down and I haven't had it again.
79 2021-04-08 pneumonia, fever Unable to get second dose; physiologic arthritic flare; Physiologic arthritic flare; High Temperatur... Read more
Unable to get second dose; physiologic arthritic flare; Physiologic arthritic flare; High Temperature; Small patches of pneumonia (pleuritis); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Small patches of pneumonia (pleuritis)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D1DM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PNEUMONIA (Small patches of pneumonia (pleuritis)) (seriousness criterion medically significant), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature). On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose) had resolved. At the time of the report, PNEUMONIA (Small patches of pneumonia (pleuritis)), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter. Based on the current available information and the Temporal association between the use of the product and 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 use of the product and start date of the events a causal relationship cannot be excluded.
79 2021-04-09 fatigue, lethargy Out-of-sorts feeling, lethargic, achy, tired, sore arm, itchy eyes This continued for 4-5 days but t... Read more
Out-of-sorts feeling, lethargic, achy, tired, sore arm, itchy eyes This continued for 4-5 days but the out-of-sorts, zoomed out feeling returned yesterday. The itchy, runny eyes has been constant
79 2021-04-09 fatigue Tiredness, extreme emotion - tears out of proportion to stimulus, inability to focus following one o... Read more
Tiredness, extreme emotion - tears out of proportion to stimulus, inability to focus following one of sleeplessness
79 2021-04-11 fatigue arm swollen, red, very warm to touch. Fatigue
79 2021-04-11 headache, head discomfort Headache started at top of head and then moved all over, pressure on head,behind ears, forehead Thou... Read more
Headache started at top of head and then moved all over, pressure on head,behind ears, forehead Thought pain was from high blood pressure but that is under control and pain continued. Had a MR I which showed nothing wrong, prednisone pack, doubled up on nortriptiline,am now on butalbital,accetamophen,caffeine Nothing has taken it away although doesn?t cement to jump around head like it did
79 2021-04-11 headache Confusion, headache, numbness/weakness of left side. c/o extreme headache
79 2021-04-11 influenza like illness, fever, chills Severe Flu like symptoms. Fever, chills, weakness, muscle aches,
79 2021-04-14 malaise, headache Patient states she started having a headache, sore arm, and feeling generally unwell the day after t... Read more
Patient states she started having a headache, sore arm, and feeling generally unwell the day after the vaccine. She stated she had "little red dots" in her mouth that were fluid filled which appeared the day after her second dose. No adverse events reported after the first vaccine dose.
79 2021-04-17 fatigue Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate rangin... Read more
Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate ranging between 37 and 180; nausea; repeated sensation that I might pass out. These symptoms began on 2/23/21, 5 days after receiving the 2nd Moderna vaccine. Symptoms were similar to but more intense than symptoms experienced after my 1st Moderna vaccine. I was taken to the ER during the night of 02/24/2021 beause of intensification of symptoms. Symptoms continued intermittently until 03/23/202 when a cardiac ablation was performed at a Cardiovascular Center. I also experienced some post-op Afib in first 2 weeks following the procedure.
79 2021-04-17 fatigue Fatigue; dizziness; light-headedness; repeated episodes of atrial fibrillation and vascillation betw... Read more
Fatigue; dizziness; light-headedness; repeated episodes of atrial fibrillation and vascillation between low and high heart rates (ranging between 42 and 130 BPM) These symptoms began 2 days after I received the 1st Moderna vaccine and lasted approx. 7 days. Though I was diagnosed with Afib 10 years ago, my prior experience with Affib was limited to 3-4 isolated episodes per year, lasting only 1-3 hours each. My past Afib experiences were never as long or as intense as this experience. It is not clear whether this worsening Afib experience simply coincided with my Covid vaccination or whether there may have been a causal relationship.
79 2021-04-17 malaise, headache, fatigue Reporting side effects for Moderna COVID-19:first injection March 2. No effects. Second injection Tu... Read more
Reporting side effects for Moderna COVID-19:first injection March 2. No effects. Second injection Tuesday, March 30: Wednesday- fatigue, muscle weakness and tender injection site; Thursday: cancelled appointments due to serious muscle weakness with pain and recurring strong headache; Friday: fatigue with weakness, hard, hot, painful, reddened area at injection site, occasional headache, episodes of nausea; Saturday: itching reddened injection site ( approx. 3"x2"), leg muscles very weak, general malaise; Sunday: itching light reddened injection site (all day), extreme muscle weakness with significant pain, swelling of lips and glands under jaw bone (11 pm), Monday, April 5: all effects subsiding; Tuesday (today): beginning to feel more like myself.
79 2021-04-18 headache POST VACCIANTION, PT. REPORTS RINING IN BIALTERAL EARS, TRANSFERRED TO MED OBS VIA WHEELCHAIR ACCOMP... Read more
POST VACCIANTION, PT. REPORTS RINING IN BIALTERAL EARS, TRANSFERRED TO MED OBS VIA WHEELCHAIR ACCOMPANIED, UPON ASSESSMENT IN MED OBS, PT. REPORTS RINGING IN EARS SUBSIDED, CONTINUES TOREPORT MILD HEADACHE, VS OBTAINED. OFFERED LITE SNACK AND WATER. REPORTS SYMPTOMS SUBSIDED. PT. ESCORTED TO EXIT WITH STAFF AND FAMILY MEMEBR VIA WC AT 1429. VS AS FOLLOWS 1412 BP SITTING 144/61 HR 68 RESP 17, O2 SATS 94% 1417 BP SITTING 134/62 HR 68 RESP 17 O2 SATS 98% 1421 BP STANDING 135/72, HR 69, RESP 17, O2 SATS 98%
79 2021-04-18 lethargy, sleepiness 3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who p... Read more
3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also cites dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. At the present again, she just feels achy. There is no chest pain or shortness of breath. No abdominal pain or urinary symptoms. No rash. 3/26/21 admitted 80 y.o. female with a PMH notable for COPD, atrial fibrillation, hypertension, diabetes and obesity who presented on 3/26/2021 for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital from 03/21 through 3/26/2021. Hospital course - The patient is an 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also states dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the machine. Since admit, patient admitted to pain in her back. CT spine showed L1 compression fracture which appeared new. PT worked with patient and felt she should go to rehab for continued therapies.Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. 4/17 ER: 80 y.o. female who presents with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. 4/18/21 ER to admit: dx sepsis 80 y/o F with PMHx COPD with chronic CO2 retention and respiratory failure on 2L NC, OSA, non-compliant with CPAP, myoclonic jerks, essential tremor, type 2 DM, HTN, paroxysmal a.fib on eliquis, essential tremor and recurrent falls with recent L1 compression fracture s/p brace placement, presented to ED on 4/18/2021 for shaking and AMS.
79 2021-04-18 throat irritation patient complained of tingling through whole body, itchy and swollen throat and tongue
79 2021-04-21 sweating, fatigue Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her ches... Read more
Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her chest started really getting tight she was sweating really bad went to bed slept all day tried walking on Wednesday put a heating pad on her legs with muscle spasms called me at 5 AM to get her to the ER she couldn?t walk her leg swelled up really bad
79 2021-04-21 lethargy, headache, chills, fever After 4 hours of the vaccine dose, but within 6 hours; the patient experienced: patient reported let... Read more
After 4 hours of the vaccine dose, but within 6 hours; the patient experienced: patient reported lethargy, "blood spots" in the hand (possibly petechiae), itchiness all over body; bruises on arms; fever and chills; headache; muscle pain. Received the 1st dose vaccine on 3/1/21. Then, on 3/3/21, patient reported fainting, and hospitalized (duration of hospital stay was about 12 hours). After hospital discharge; patient reported that felt all symptoms were resolving.
79 2021-04-22 fever, fatigue, headache, malaise, chills Extreme fatigue, chills, muscle pain in back, slight headache, fever, lack of appetite - for 3 days;... Read more
Extreme fatigue, chills, muscle pain in back, slight headache, fever, lack of appetite - for 3 days; then Diarrhea & bloating for 24 hrs; then prior symptoms gone but very weak & tired - for 4 days (the first day had low blood pressure); then general malaise for 1 week
79 2021-04-24 headache Starting early February about 2 weeks after vaccine administration pt began having intermittent head... Read more
Starting early February about 2 weeks after vaccine administration pt began having intermittent headaches and jaw pain, which progressed to rapid and complete painless vision loss 4/20/21 to right eye. Seen same day in ophthalmology clinic, diagnosed with optic nerve ischemia, likely GCA, Rx'd 80mg PO prednisone, lab evaluation started which revealed elevated CRP. This, in combination new new grey 'veil' over vision of L eye the next day 4/21/21, led to admission and initiation of 1,000mg daily IV methylprednisolone. Unfortunately pt then progressed to complete painless loss of vision of left eye as well on 4/23/21 while inpatient on high dose steroids. Patient is now completely blind in both eyes.
79 2021-04-24 fever Eight sessions of diarrhea which led to internal bleeding; fever of 102, and an inability to verbali... Read more
Eight sessions of diarrhea which led to internal bleeding; fever of 102, and an inability to verbalize thoughts with clarity without tremendous concentration.
79 2021-04-25 fatigue Patient lost memory, had vomiting, and very tired, patient had incontinence. patient also went into ... Read more
Patient lost memory, had vomiting, and very tired, patient had incontinence. patient also went into afib.
79 2021-04-28 headache, sleepiness STILL WAITING, SUBSEQUENT EKG, OKAY NOW.. WILL BE HAVING FURTHER TESTING TO SEEK FURTHER INFO ON HE... Read more
STILL WAITING, SUBSEQUENT EKG, OKAY NOW.. WILL BE HAVING FURTHER TESTING TO SEEK FURTHER INFO ON HEART. PRESENTLY AM GOING THUR EXPECTED EFFECTS OF BACK TO SLEEP 14/16 HRS DAILY, SWOLLEN LYMPHS UNDER LEFT ARM ONLY, BACK HEAD PAIN WHEN RESTING, PAIN, PALMS HANDS, SAME PAIN, LEFT AREA ABOVE EAR, INTERMITTENT HEADPAIN DIFFERENT AREAS OF SKULL...
79 2021-04-28 fever, malaise, chills STATES SHE HAS BEEN FEELING RUN DOWN AND SICK FOR SOME TIME. STATES SHE HAS COVID IN NOV 2020 AND HA... Read more
STATES SHE HAS BEEN FEELING RUN DOWN AND SICK FOR SOME TIME. STATES SHE HAS COVID IN NOV 2020 AND HAS NOT FELT WELL SINCE THEN. MADE AN APPT WITH HER HEART DOCTOR FOR FOLLOW UP TO TRY AND SEE IF THEIR WAS ANYTHING SHE COULD FIND TO HELP IMPROVE HER FEELING. WENT ON 4/22 FOR APPT AND MD SENT HER STRAIGHT TO THE HOSPITAL. WAS ADMITTED THAT NIGHT WITH FINDING OF BLOOD CLOT IN HER LUNG. CLIENT REPORTS AFTER EACH VACCINE SHE HAS SEVERE WEAKNESS WITH CHILLS AND FEVER OF 99-100. FEVER CHILLS RESOLVED WITHIN 1-2 DAYS BUT WEAKNESS JUST PROGRESIVLY GOT WORSE.
79 2021-04-29 chills, fatigue Presyncope directly after injection. SIRVA directly after injection and prolonged. Fatigue, Chills,... Read more
Presyncope directly after injection. SIRVA directly after injection and prolonged. Fatigue, Chills, Muscle Aches in chest and back set in 4/30/21 at 12:00 pm.
79 2021-04-29 paranasal sinus discomfort, head discomfort, nasal congestion, nasal discomfort, throat irritation Stuffed nose, scratchy throat, pressure in head and sinus area. Burning swollen mouth and nose. Te... Read more
Stuffed nose, scratchy throat, pressure in head and sinus area. Burning swollen mouth and nose. Teeth feel gritty.
79 2021-05-02 chills, fever, headache First night, low energy, upset stomach, brain fuzz. Next day, chills and fever, nausea, heart pain, ... Read more
First night, low energy, upset stomach, brain fuzz. Next day, chills and fever, nausea, heart pain, headache. 3rd day, same, but no heart pain. By 5th day all okay, except some cognitive issues (slower thinking, searching for words, poor memory) still with me on May 3, these are subtle changes, but it's obvious to me they began after this vaccine shot. SERIOUS REACTIONS BEGAN AFTER 2ND COVID SHOT ON 2/26/2021: Pain in neck, hips, head, down left leg. Diagnosed as inflammation and bursitis in left hip, which still remains in May and limits my life in the extreme.
79 2021-05-03 fever Whenever I move my head I get very dizzy. I had a very negative response to the second Moderna shot ... Read more
Whenever I move my head I get very dizzy. I had a very negative response to the second Moderna shot and ran a fever and was unable to get out of bed the next day. This continued for about 24 hours. I am still experiencing intervals of dissiness to this day. I have been taking over the counter motion pill to alleviate the problem. They help somewhat.
79 2021-05-04 malaise, fatigue, headache, sleepiness, fever Very tired prior to bed. Woke up in the night with bad headache followed by body aches. On Tuesday t... Read more
Very tired prior to bed. Woke up in the night with bad headache followed by body aches. On Tuesday the 4th, I had fever (highest 101.3) couldn't eat, headache continued all day and into the night. I felt very ill as if I had Covid again. I slept on and off all day and felt too weak to do anything. Wed, the 5th, I still had the headache which wore off around 10 or 11. I felt stronger as the day progressed I was able to eat and do some activities. Now, Wed evening, I feel fine and no more side effects.
79 2021-05-05 chills, fatigue Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt... Read more
Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt like something was stuck in her throat and not feeling right for the past one week had the chills; legs weak, EKG showed ST segment elevation. Patient was transferred to hospital ED and admitted
79 2021-05-06 fatigue, fever Patient reports fatigue and arm soreness that started immediately after second Moderna shot and have... Read more
Patient reports fatigue and arm soreness that started immediately after second Moderna shot and have not improved (currently > 7 weeks post-vaccination). Additionally, she experienced a fever for about 2 days, as well as "terrible" fatigue and "odd thoughts" for about 24 hours,.
79 2021-05-06 fatigue very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder;... Read more
very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder; found two blood clots on lungs and two in legs; found two blood clots on lungs and two in legs; there was damaged to his wife's heart too; weighed165 pounds initially and then went down to 145; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) and CARDIAC DISORDER (there was damaged to his wife's heart too) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A2 or 078A2 and 028A2 or 078A2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing) (seriousness criterion hospitalization), ARTHRALGIA (pain in back of right shoulder) (seriousness criteria medically significant and life threatening), FATIGUE (very tired, slept all day) (seriousness criteria hospitalization, medically significant and life threatening), HYPERSOMNIA (slept all day) (seriousness criteria hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (there was damaged to his wife's heart too) (seriousness criterion hospitalization) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145). At the time of the report, DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs), CARDIAC DISORDER (there was damaged to his wife's heart too) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: two blood clots on lungs and two (abnormal) two blood clots on lungs and two in legs. On an unknown date, Weight: 145 (Low) weighed 165 pounds initially and then went down to 145. The patient was hospitalized for around four days. The patient size of clots as 10 cm and 9cm in the lungs. The reporter stated that Heparin was used in the hospital and after the discharge the patient was put on Eliquis for the next 6 months. The reporter reported that the patient weighed165 pounds initially and then went down to 145 afterwards. Action taken with the mRNA-1273 is considered as not applicable. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.
79 2021-05-06 fever 3/12 ED female that has chronic respiratory failure at baseline and uses walker in assisted living h... Read more
3/12 ED female that has chronic respiratory failure at baseline and uses walker in assisted living had her second vaccine dose on 3/11 and within 24 hours had body aches and fevers. Patient admitted for IVF and observation by the next day patient reported feeling much better. No other acute process identified and symptoms felt most likely to the "reactogenic vaccine" patient got for COVID-19. Patient seen by PT, tolerated PO without symptoms and discharged to home.
79 2021-05-07 malaise Nausea and vomiting, which I have not done since chemo in 2015. Atrial fibrillation occurring most ... Read more
Nausea and vomiting, which I have not done since chemo in 2015. Atrial fibrillation occurring most of the time for four days afterwards. I usually only get a short episode once every two or three weeks. Feeling very weak and sick.
79 2021-05-09 headache headache. Assessed an treated on site.
79 2021-05-11 headache Patient said that got Moderna vaccine on Thursday in her left arm and that on Sunday night she start... Read more
Patient said that got Moderna vaccine on Thursday in her left arm and that on Sunday night she started have pain on the left side of her head. She described the pain as a throbbing pain with a "boom" that would come every few seconds. It was painful to touch that side of her head. The discomfort kept the patient disoriented for a few days where she was only just today (05/12/21) able to report the pain. She said as time has passed that the duration between the throbbing (or "booming") seemed to get longer and she thinks it is getting better. Tylenol has provided some relief.
79 2021-05-12 headache, chills, cough, fever, productive cough, malaise ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Gen... Read more
ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient reports that she received her second COVID-19 vaccine approximately 1 week ago. Tolerated this without any particular symptoms. She has had 2 days of watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting earlier today. She is denying any particular abdominal pain. Does believe she felt her urine burning earlier today but has had no gross hematuria. Denies any flank pain. No ill contacts although her husband has been at home with a slight cough. Patient does have a cough presently but it is nonproductive. She is denying any particular chest pain or subjective shortness of breath. No rash or unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19. She had however received a second dose of COVID-19 a week before and was discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911. Upon EMS arrival patient was saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was eventually placed on 10 L oxygen support. She was noted to be in significant respiratory distress during speech. Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia. She had evidence of acute on chronic hypoxic respiratory failure as well. She was started on IV antibiotics, as well as remdesivir and Decadron at high dose. Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy. She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment. She did not respond to remdesivir or steroids or antibiotics. Post intubation, she also developed acute renal failure during the course of her admission. Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive. She received full medical treatment, including life support, with minimal improvement. Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia. She was proned, and was unable to sustain oxygen saturations when supine even for short period. Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again. They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy. Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection. She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5. New small left pleural fluid collection. 6. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Portable Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic Echo (tte) Complete Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D, Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is normal in size. Ejection Fraction 55% (normal range 50-70%). All wall segments showed normal motion. Mild concentric LVH. Trivial aortic regurgitation. No additional significant valvular abnormality. No prior study for comparison. Presentation and History: Indication: The patient presents for evaluation of arrhythmia. The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications. Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size. There is mildly increased left ventricular wall thickness. The left ventricular systolic function is normal. The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis. There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison. Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final electronically signed on 4/11/2021 5:10:04 PM with status of Final Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD
79 2021-05-13 lethargy, throat pain Symptoms onset 1 day after vaccination. Symptoms include: nausea, lethargy, sore throat that has no... Read more
Symptoms onset 1 day after vaccination. Symptoms include: nausea, lethargy, sore throat that has not resolved since onset on 4/22.
79 2021-05-14 headache diagnose with subdural Severe headaches
79 2021-05-16 sinus pain, sinus disorder corroded artery pain into face on left side, sinus drippage, sinus cavities hurting, lump on neck
79 2021-05-19 headache My mom, patient was a health 79 year old women, only two health issues were COPD and moderate dement... Read more
My mom, patient was a health 79 year old women, only two health issues were COPD and moderate dementia. She had even gotten her annual labs done recently which came back all with in normal range, she as far as we knew did not have any issues with her heart. After her first vaccination in March she started to lose interest in things and didn't have energy to be as active as she was. After the second shot with in two days she started to report pain in chest and head and trouble breathing, She went to her PCP on 5/12 and he wanted her to go to a cardiologist, this referral was made but by the 16th she was in the ER due to extreme chest pain and trouble breathing, a stent was placed in her heart on 4/17/21 my mom's 80th birthday. with in 4 days she died. Her heart just deteriorated. i feel that if she didn't get this shot she would be alive today, she was healthy, now she is dead.
79 2021-05-20 chills, fever Nashua , Chills , Fever
79 2021-05-22 headache, fatigue body aches, headaches, dizziness, muscle aches in one or both legs, tiredness all the time,
79 2021-05-23 sleepiness Cleared pharmacist verification with no red flags. Administered in the shot booth in chair and info... Read more
Cleared pharmacist verification with no red flags. Administered in the shot booth in chair and informed patient to wait the designated 15 minutes. Patient seemed fine with no distress. Color normal. I came back into the pharmacy and seen patient doing well. Patient then a couple minutes later stood up and took a couple steps which put her out of my view. technician the asked if she was ok and the I could see the shot booth going sideways. Then I could see her fall. I then ran out the pharmacy to check and she landed in the chair sitting up right. she was still semi-conscious and I talked to her. I got a pulse and told the technician to call an ambulance. while trying to keep the lady awake she drifted unconscious but was breathing ok. Pulse was low but didn't lose. Had the help of a nurse at this time and ambulance arrived. Patient was awake by this point with drowziness and could talk.
79 2021-05-24 sweating Second dose not given; it was like if periaureal area felt some numbness; there was no visual swelli... Read more
Second dose not given; it was like if periaureal area felt some numbness; there was no visual swelling just the feeling of swelling and numbness; Flushed; Sweaty; possible allergic reaction; Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine; the top of her lip was numb; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to vaccine (Allergy to Hepatitis B vaccine.), Psoriasis, Chest pain and Sinus disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (the top of her lip was numb). On 04-Feb-2021, the patient experienced ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness), VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness), FLUSHING (Flushed), HYPERHIDROSIS (Sweaty) and HYPERSENSITIVITY (possible allergic reaction). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not given). On 04-Feb-2021, HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness) and VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness) had resolved. At the time of the report, ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (Second dose not given) outcome was unknown and FLUSHING (Flushed), HYPERHIDROSIS (Sweaty), HYPERSENSITIVITY (possible allergic reaction) and HYPOAESTHESIA ORAL (the top of her lip was numb) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 198/80 193/80 at 14:38 144/66 at 15:58. On 04-Feb-2021, Body temperature: 97.4 97.4 at 14:48 97.6 at 15:58. On 04-Feb-2021, Heart rate: 77 77 at 14:38 71 at 15:58. On 04-Feb-2021, Mean arterial pressure: 117 117 at 14:38 92 at 15:58. On 04-Feb-2021, Oxygen saturation: 98 percent 98 percent at 14:38 99 percent at 15:58. On 04-Feb-2021, Pain assessment: 4 pain level 4/10. On 04-Feb-2021, Respiratory rate: 18 18 at 14:38 20 at 15:58. 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. Follow up received on 13-May-2021 was significant and included the completed VAERS form. The new events of missed second dose of covid-19 vaccine, angioedema, allergic reaction, flushing, sweaty, numbness top lip were added and medical history was updated. On 04-Feb-2021, it was reported that the patient developed perioral swelling and numbness that came on approximately fifteen minutes after receiving her first covid-19 vaccine. The patient was taken to the emergency department, and was kept under observation for two hours with no worsening of her condition. Treatment medication included 50 milligram of Benadryl (diphenhydramine). The patient was given a prescription for diphenhydramine and asked to follow-up with her primary care physician/ emergency department if symptoms worsened. Company comment This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received included the completed VAER form and medical records from the emergency department. Additional information included medical history, patient demographics, age of patient, patient contact details, concomitant medication, new events with outcome of events, missed second dose.; Sender's Comments: This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. 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 2021-05-27 headache, chills Over the next two months, 4 instances of piercing headache accompanied by blurred vision lasting for... Read more
Over the next two months, 4 instances of piercing headache accompanied by blurred vision lasting for more than 2 hours and resistent to regular strength acetimeniphan. Over the same two months, continuous low level headaches, chills, disrupted sleep.
79 2021-05-27 fever, sinus congestion, headache, cough Cough, shortness of breath, sinus congestion, headache, generalized body aches, fever, nausea and vo... Read more
Cough, shortness of breath, sinus congestion, headache, generalized body aches, fever, nausea and vomiting.
79 2021-05-27 sinus pain, fatigue Left side of her face seemed frozen; Gland and cheeks were swollen; Super tired; Carotid artery was ... Read more
Left side of her face seemed frozen; Gland and cheeks were swollen; Super tired; Carotid artery was hurting; Sinus was hurting; Could taste the medicine; Little lump on her neck by her ear; Bacterial infection at the injection site; Black scab and a lot of pus at the injection site; Black scab and a lot of pus at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Left side of her face seemed frozen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Left shoulder). Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE, LORATADINE (CLARITIN [LORATADINE]) and COLLAGEN for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear) and FATIGUE (Super tired). On 06-Apr-2021, the patient experienced FACIAL PARALYSIS (Left side of her face seemed frozen) (seriousness criterion medically significant) and LYMPHADENOPATHY (Gland and cheeks were swollen). In April 2021, the patient experienced INJECTION SITE INFECTION (Bacterial infection at the injection site), INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site). On 29-Apr-2021, INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site) had resolved. At the time of the report, FACIAL PARALYSIS (Left side of her face seemed frozen), NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear), INJECTION SITE INFECTION (Bacterial infection at the injection site) and FATIGUE (Super tired) outcome was unknown and LYMPHADENOPATHY (Gland and cheeks were swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Other concomitant medication included: high blood pressure medicine (unspecified), "calfix 10 mg, and "a whole lot of holistic medicine for arthritis." The patient's 2nd dose of the Moderna COVID--19 vaccine was supposed to be on 07-May-2021 but the pharmacy denied her the second dose due to their reaction she had to the first dose given in her left non-dominant arm. The doctor advised that the patient had a bacterial infection at the injection site. The patient was still swollen as of 07-May-2021 and was unsure when all the symptoms began and resolved. The vaccine provider advised the patient that she would be unable to get the second dose unless she went to the hospital. 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 MOD21-091284, US-MODERNATX, INC.-MOD-2021-138847 (E2B Linked Report).; 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. MOD21-091284:crosslinked US-MODERNATX, INC.-MOD-2021-138847:Daughter's case
79 2021-05-31 influenza like illness, fatigue By May 3 onset of fatigue, generalized aching in all muscles, soreness in shoulders, wrists, fingers... Read more
By May 3 onset of fatigue, generalized aching in all muscles, soreness in shoulders, wrists, fingers, back, knees. By week of May 10 felt as though I had the flu. Saw rheumatologist on May 14 who drew labs and prescribed Prednisone for diagnosis of Polymyalgia Rheumatica
79 2021-06-02 lethargy, sleepiness Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental s... Read more
Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly. Mild bibasilar volume loss is again seen. Remaining lungs are clear. No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy. There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash. On 26-Mar-2021, patient presented for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice. Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m. Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may re; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may remain as confounding factors.
79 2021-06-03 body temperature increased, pneumonia 5/23/21 ER to Admission, HPI: Patient is a 79 y.o. female admitted to acute care from ED per Dr. wi... Read more
5/23/21 ER to Admission, HPI: Patient is a 79 y.o. female admitted to acute care from ED per Dr. with septicemia, acute UTI, pneumonia of right upper lobe.. The patient presented to ED brought in by EMS from local residence complaining of altered mental status. Patient states she woke up yesterday morning chilling. States she just could not get warm. Went back to bed for I while. States she did get up and go to church. After eating dinner had went over to her grandson's. She became confused at that point. Has been states that speech was difficult to follow. Did become slightly slurred. EMS was called and patient was brought to ER for further evaluation. Upon arrival to ER patient's temp is 102.4°. CT scan head negative for acute changes. Chest x-ray did show right upper lobe changes questionable infiltrate. Lactic acid 1.1 procalcitonin negative. Urine was highly positive with GNR on gram stain. Patient given L of normal saline along with Zosyn in ER. Subsequently admitted to acute care for further evaluation and treatment including IV antibiotics and further monitoring. Foley catheter placed ER.
79 2021-06-07 fatigue, lethargy She got her vaccine, she felt very weak, woozy, tired, lethargic. Her blood pressure went up to 196... Read more
She got her vaccine, she felt very weak, woozy, tired, lethargic. Her blood pressure went up to 196/116 several days later. She was sick for 5 weeks. Her arm was a little achy, which was normal to her as she gets allergy shots which she has the same reaction to. She called her doctor who was out on leave and they told her to go to UC. She went to UC twice and the ER twice due to her BP and her weakness and dizziness. She was not able to drive due to these symptoms. They did increase her BP medication and he said that if it did not help then go to the ER. She went to the ER and was still feeling very weak, and they told her that it was from the vaccine as they have seen other people with the same reactions, and it can last up to 6 weeks. She said nobody knew what happened, she had CT scan of the head, EKG, blood work, chest x-ray and other tests. She went to the cardiologist who believed that she had the COVID virus, and he ordered an echocardiogram that was normal. She also had a LEXI-scan that was normal as well. The symptoms finally went away and is back to normal now and said that it was exactly 5 weeks later that she finally felt better and was not dizzy or woozy any longer. She felt as though she was going to die as she was so weak. She feels that it needs to be explained further that it is not FDA approved and that the elderly do not understand what EUA means.
79 2021-06-08 fatigue, chills On 5/28/2021 pt started feeling light-headed, dizzy, chest heaviness, chills and her arm and legs we... Read more
On 5/28/2021 pt started feeling light-headed, dizzy, chest heaviness, chills and her arm and legs were burning. Her husband eventually called 911 and they told him it "sounded like a reaction to COVID vaccine" and "if she got worse they would send someone out". Pt stated these feelings lasted until about 0300 on 5/29/21 and after she fell asleep most things resolved expect the light-headedness. Pt reports she is still fatigued and has bouts of dizziness and lightheadedness and she has no energy. Pt was encouraged to call and report her symptoms to her primary provider and seek their guidance on when to receive her second injection.
79 2021-06-09 headache, fever, malaise Patient developed malaise and a red swollen face on 3-2-21 after her second vaccination on 2-25-21. ... Read more
Patient developed malaise and a red swollen face on 3-2-21 after her second vaccination on 2-25-21. She was afebrile, and her doctor instructed her to take OTC Benadryl, which seemed to help. On 3-8-21, her symptoms returned with a persistent headache. Her facial problems came and went over the following month and were accompanied by malaise. On 5-4-21, patient went to the nurse practitioner at her primary care physician's office and was prescribed 40mg of Prednisone for 5 days. Symptoms returned and worsened 4 days later and she was referred to a dermatologist, who prescribed a longer "step-down" course of Prednisone over a 16 day period, which ended a few days ago, patient reports being asymptomatic at this time.
79 2021-06-15 cough, fever Around 02/05/2021-02/06/2021 she started having a cough, upset stomach, and a fever. On 02/09/2021 w... Read more
Around 02/05/2021-02/06/2021 she started having a cough, upset stomach, and a fever. On 02/09/2021 we both got the Covid antibodies but they did not work for her. It ended up going into Covid pneumonia and she was treated for that and once she got over that she got bacterial pneumonia and we have been going through that since (still ongoing). She has seen specialists and had a hospital stay for 9 days. She has had all kinds of blood tests. She just had a test on 06/16/2021 to see if she has an immunity to Covid. She has had overall weakness and when we took her to hospital she fainted.
79 2021-06-16 chills, headache Patient had loss of Vision. Patient stated seeing round black spots immediately and could not see. P... Read more
Patient had loss of Vision. Patient stated seeing round black spots immediately and could not see. Patient started experiencing loss of hearing around may 30th. Patient only had simple side effects from the first shot. The patient had chills, shakes and headaches.
79 2021-06-16 fatigue FATIGUE,
79 2021-06-23 headache pt felt strange followed 5 min later by feeling short of breath and severe pain in head, mild wheezi... Read more
pt felt strange followed 5 min later by feeling short of breath and severe pain in head, mild wheezing auscultated
79 2021-06-30 fever, influenza like illness, chills, headache Diagnosed with breast cancer; Flu like symptoms; Body Ache; Fever; Chills; Headache; This spontaneou... Read more
Diagnosed with breast cancer; Flu like symptoms; Body Ache; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LOSARTAN, METFORMIN, EZETIMIBE (ZETIA), CALCITRIOL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Surgery (Double Mastectomy) for Breast cancer. At the time of the report, BREAST CANCER (Diagnosed with breast cancer), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information in response to events 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 of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded. Although a temporal association exists, based on the current available information , the mechanism of action of mRNA-1237 vaccine, and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only. This case was linked to MOD-2021-227876 (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 of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded. Although a temporal association exists, based on the current available information , the mechanism of action of mRNA-1237 vaccine, and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.
79 2021-07-02 chills, fever, fatigue SEIZURE, FOLLOWED BY FEVER (102.4), FATIGUE, MUSCLE PAIN, JOINT PAIN, CHILLS
79 2021-07-05 sleepiness, fatigue autoimmune hepatitis; Pain in various parts of the body; Slept for 15 hrs a day; Constant ring in th... Read more
autoimmune hepatitis; Pain in various parts of the body; Slept for 15 hrs a day; Constant ring in the ears; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE HEPATITIS (autoimmune hepatitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CICLOSPORIN (RESTASIS), QUETIAPINE FUMARATE (SEROQUEL) and AZATHIOPRINE for an unknown indication. On 05-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 PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (autoimmune hepatitis) (seriousness criterion medically significant). On 15-Mar-2021, PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, AUTOIMMUNE HEPATITIS (autoimmune hepatitis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient 's Concomitant medications reported were PII(36):AaS6l0Skg/HfTSAD212iZdgVLaJ0VFhupdqo 10mg daily No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 25-jun-2021; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
79 2021-07-08 cough Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with ne... Read more
Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family
79 2021-07-11 headache, chills She got the vaccine, had the chills and headache, then the next day started with rash from wrist to ... Read more
She got the vaccine, had the chills and headache, then the next day started with rash from wrist to her shoulders, which she still continues to have. She has seen her allergist and her dermatologist and they have give her treatment for that. With her allergist several weeks after he put her on a steroid, once a day for 3 days, which did not work. So then she went back to him about a rash ago and she still had the rash. He wanted to be sure as well as her dermatologist, said that he has seen the rashes associated with the vaccine, but they disappear in a month or so. She has a rash but no itch, the first time she had an itch with no rash. He did a SED rate to see if there was inflammation going on with her body and there is no inflammation in her body. They did find out that her autoimmune system is very high, which she did not have COVID virus. In the meantime her dermatologist is going to see if he is going to get rid of it with an ointment. Her dentist also has the same reaction but on his legs from Moderna as well. She was given Triamcinolone ointment. Initially the allergist said to use it twice a day, rub it in thoroughly for 2 weeks and she still has the rash. She used this for a month, but has stopped due to it having cortisone in it. She had never had any issues before, no surgeries, and was very healthy. Her dermatologist and the allergies want to do a biopsy of the rash to see if anything else is going on. She has an appointment with the allergist, but has to wait for 6 weeks after stopping the ointment, and is to see him on future date for the biopsy. She had a black and blue area that came out on her arm a week or so later.
79 2021-07-12 headache I had a slight headache immediately after vaccine, I had a tennis ball sized red area where I receiv... Read more
I had a slight headache immediately after vaccine, I had a tennis ball sized red area where I received the vaccination. My joints started to really bother me about 2-3 weeks after vaccination. It started in my knees and went to my wrists and hips. It was extremely painful, I couldn't walk and couldn't sleep.
79 2021-07-15 fatigue Very tired.
79 2021-07-18 fatigue Right arm noted with redness, warmth, states she thinks it has gotten worse since it has started. Wa... Read more
Right arm noted with redness, warmth, states she thinks it has gotten worse since it has started. Was initially noted 2 hrs post administration, applied vics mentholatum then ice pack. States she did not notice any other symptoms for the next 2-3 days as she was sleeping due to the excessive fatigue from the vaccine as well.advised pt to see physician or to go to ER to seek treatment if her physician is not available for the redness on her arm.
79 2021-07-18 throat irritation I have had an allergy to propylene glycol. I got the first dose of my vaccine I woke up during the n... Read more
I have had an allergy to propylene glycol. I got the first dose of my vaccine I woke up during the night three days after the vaccine. My lips were swelling up and I had a tickling feeling at the back of my throat. My lips were getting bigger and bigger. I went to the ER and I was given prednisone and Benadryl. My symptoms subsided a little but when the prednisone wore off, I started to have lingering symptoms. The symptoms returned and I had another course of prednisone. I still have permanent swelling in my hands five months later which started about two weeks after the vaccine. My fingers are puffy and swollen in both hands. My index fingers are the worst. I have white knuckles.
79 2021-07-20 malaise, chills, headache interstitial cystitis; feeling very sick in the morning; After not much sleep; projectile vomiting; ... Read more
interstitial cystitis; feeling very sick in the morning; After not much sleep; projectile vomiting; shaking and teeth chattering; impossible to eat w/out vomiting / She couldn't eat or; she had all over excruciating pain; UTI; extreme back pain; weak legs and unsteady/ very unsteady; arm was sore at the site; aching head to feet, body that had ever been in pain was more painful; rigor chills, teeth chattering; Nauseated; cytokine reaction; headache; sick to her stomach; dizziness/; This spontaneous case was reported by a consumer and describes the occurrence of CYTOKINE STORM (cytokine reaction) in a 79-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 Cystitis interstitial from 1996 to 1999. On 05-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) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CYTOKINE STORM (cytokine reaction) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), HEADACHE (headache) and NAUSEA (Nauseated). On an unknown date, the patient experienced CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), MYALGIA (aching head to feet, body that had ever been in pain was more painful) and CHILLS (rigor chills, teeth chattering). At the time of the report, CYTOKINE STORM (cytokine reaction), CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), HEADACHE (headache), MYALGIA (aching head to feet, body that had ever been in pain was more painful), CHILLS (rigor chills, teeth chattering) and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 degree Celsius (High) 100.6 and 99.1 degree Celsius (High) 99.1. Relevant concomitant medications were not reported. Treatment information was not provided. Patient visited her cardiologist and primary care doctors and they reported good strong immune response. Patient also visited oncologist; he reported cytokine reaction. Patient also had a medical history of interstitial cystitis for 3 years but again she developed interstitial cystitis after the 2nd dose. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Additional information received on 10-JUL-2021 regarding the 2nd Dose events and lab data. On 12-Jul-2021: Follow-up information received on 12-JUL-2021 contains updated event onset date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
79 2021-07-22 headache Joint pain and headache that lasted three days
79 2021-07-28 fatigue Fatigue after the 1st dose. Extreme fatigue and development of vertigo soon after the 2nd shot. Went... Read more
Fatigue after the 1st dose. Extreme fatigue and development of vertigo soon after the 2nd shot. Went to the doctor several times, had therapy for the vertigo several times with little improvement. Wasn't able to walk stable until late May. Doctor ordered MRI and MRA (scans done 6 years prior completely clear)
79 2021-07-28 fever Patient presented to the ED and was subsequently hospitalized for fever and sepsis within 6 weeks of... Read more
Patient presented to the ED and was subsequently hospitalized for fever and sepsis within 6 weeks of receiving COVID vaccination.
80 2020-12-31 fatigue, chills, headache fatigue, headache, muscle pain, joint pain, chills
80 2021-01-04 headache, headache NAUSEA, DRY MOUTH, HEADACHE
80 2021-01-04 headache Dry mouth, Nausea, Headache
80 2021-01-05 chills, headache 12/30/2020 around 2:00 nausea, vomitting, diarrhea, and chills started. Insomnia x3 days. Patient st... Read more
12/30/2020 around 2:00 nausea, vomitting, diarrhea, and chills started. Insomnia x3 days. Patient states she felt "wired and worked up". Noises made her anxious. Patient states "everything smelled bad". Patient had hallucinations seeing the devil and satanic thoughts 12/31/2020 to 1/4/2021 when patient finally fell asleep. 1/5/21 patient woke up with a headache and took ibuprofen and used a heating pad with relief. Patient took melatonin 1/5/21 before bed to go to sleep. Diarrhea stopped 12/31/20. Nausea stopped 1/5/21.Vomitting stopped 12/31/2020. Chills stopped 1/5/21. Patient has been eating bananas and chicken noodle soup and drinking sweet tea. Patient not as nervous 1/6/21 when she woke up.
80 2021-01-12 fever, fatigue, chills, headache Fever of 101 degress, took tylenol, 3 times throughout the day. Fever broke during the night Fat... Read more
Fever of 101 degress, took tylenol, 3 times throughout the day. Fever broke during the night Fatigue - lasted from early morning throughout the day through the evening. Did not continue the next day Chills- Intense chills appreared around 11:00 a.m. and continued until about 1:00 p.m. After that the chills were moderate and stopped around 4:00 p.m. Headache - tylenol take for fever and headache. Headache lasted through the evening and early night. Was gone by morning. Muscle ache - extreme, sharp muscle pain in both thighs. Appeared intermittently thoughout the day. Subsided by evening, but returned briefly the next morning.
80 2021-01-13 fever rapid heart rate starting when she got the shot, nausea and fever 99.8 around 5 pm. Symptoms gone b... Read more
rapid heart rate starting when she got the shot, nausea and fever 99.8 around 5 pm. Symptoms gone by about 10 pm. She took her heart medication as ordered and felt better by bedtime.
80 2021-01-13 fever Patient presented to urgent care clinic approximately 24 hours after receiving the Moderna Covid-19 ... Read more
Patient presented to urgent care clinic approximately 24 hours after receiving the Moderna Covid-19 vaccine with complaints of fever and myalgia. She had mild confusion with the fever which resolved after acetaminophen. However, due to the confusion, she received an extensive work-up in clinic for other causes of altered mental status.
80 2021-01-15 fever, chills, fatigue fatigue, chills, fever, nausea and light headed
80 2021-01-17 fatigue 1st day (10:30 am):- left arm sore/painful, overnight : freezing, burning sensation and extreme fat... Read more
1st day (10:30 am):- left arm sore/painful, overnight : freezing, burning sensation and extreme fatigue. 2nd day(01/15/21):- left arm still sore not painful but fatigue continued 3rd day(1/16/21):- 10:30 am, Temple left vein burst at the fore head from middle to left eye, covered with red dots bleeding from left temple eye until 6:00 pm throbbing pain all day and night. 4th day (01/17/21):- Swollen left side of face, internal bleeding around the left eye, slight throbbing pain, extreme fatigue. 5th day (01/08/21):- Swelling/bruises and internal bleeding visible. Less fatigue, able to go to pharmacy to report. *Report as presented by the Patient.
80 2021-01-17 fever, headache Had pain, tenderness, swelling, redness, itchy, difficulty moving arm, headache, nausea, fever.
80 2021-01-17 fever Patient reported to the emergency room from fever and shortness of breath the day after receiving th... Read more
Patient reported to the emergency room from fever and shortness of breath the day after receiving the COVID-19 vaccine. Patient was found to have a UTI and possible sepsis. Unknown if truly related to COVID vaccine.
80 2021-01-19 chills 1/19/21 chills for a few hours starting 7pm. Put on a vest, turned up the heat, took a tylenol. 1/20... Read more
1/19/21 chills for a few hours starting 7pm. Put on a vest, turned up the heat, took a tylenol. 1/20/21 Feel fine today except slight itching at vaccine site.
80 2021-01-19 malaise Got sick this morning, vomiting with some dry heaving.
80 2021-01-20 chills Morning after receiving vaccine (01/14/2021), woke up and was having chills, weakness, "head felt li... Read more
Morning after receiving vaccine (01/14/2021), woke up and was having chills, weakness, "head felt like it did when having covid, dizziness, light-headed". Urinary incontinence and memory loss, and hallucinations on 01/14/2021. Blue color to left deltoid started 01/13/2021 in PM and on 01/14/2021 when waking up, left upper arm was blue and redness noted down to elbow. "I have laid on the couch and that's basically all I've done since getting the shot."
80 2021-01-20 headache first day after sore arm and swelling with redness at injection site. Next days increased swelling, ... Read more
first day after sore arm and swelling with redness at injection site. Next days increased swelling, hotness and redness and intense itching. The swelling and redness increased in area from shoulder to elbow front and back of arm. Slight and persistent headache. Notified health department.
80 2021-01-20 fever grand mal seizure and temperature of 101.3
80 2021-01-20 sneezing, nasopharyngitis, runny nose cold symptoms, runny nose, sneezing
80 2021-01-21 fatigue, body temperature increased, headache Fever 101.1, fatigue, headache.. It feltjust like Covid all over again, I was in bed for twenty-fo... Read more
Fever 101.1, fatigue, headache.. It feltjust like Covid all over again, I was in bed for twenty-four hours. I had three extra. Strength tylenol during that time.my
80 2021-01-21 headache, chills, fatigue Headache, chilling, tiredness.
80 2021-01-22 chills, headache Muscles very sore. Headache. Sick to my stomach. Light headed. Chills
80 2021-01-22 fever Starting around 6 pm the following day, awoke with fever of 103 degrees. Significantly compromised ... Read more
Starting around 6 pm the following day, awoke with fever of 103 degrees. Significantly compromised muscle weakness and gross motor coordination. Had difficulty sitting up and walking. Compromised speech and altered mental status. Took Tylenol at advice of GP administered by husband. By 10 pm fever down to about 99 degrees. Speech and mental status recovering. By the next day, still felt quite weak and shaky, but fever 99, speech and mental status basically recovered. A week later, still feel slightly weak and shaky
80 2021-01-22 fever Starting the following evening around 6 pm, upon waking up from a nap, spiked a fever of 103 degrees... Read more
Starting the following evening around 6 pm, upon waking up from a nap, spiked a fever of 103 degrees. Experienced significant muscle weakness with gross motor coordination compromised. Could not sit up. Had to rock back and forth to try to sit up. Difficulty walking. Difficulty speaking and altered mental status. Speech not clear. Took Tylenol on advice of GP administered by husband. Temperature fell to 101, then 99 degrees by 10 pm. By 4 am Sunday morning, temperature was 99 degrees, speech had returned to normal. Sunday 8 am, sleeping normally. Sunday during the day, felt shaky and weak, still slight fever of 99 degrees but normal mental status and speech. Continued taking Tylenol periodically. By Sunday evening, felt mostly back to normal, but have continued to feel somewhat weak/shaky for the last week.
80 2021-01-23 nasopharyngitis, fever middle of the night awakened by terrible shakes, uncontrollable, feeling very cold. fever of 101.2, ... Read more
middle of the night awakened by terrible shakes, uncontrollable, feeling very cold. fever of 101.2, brain fog, severe body aches, every joint unable to eat forced myself to drink fluids; anxious and depressed, felt weak and unable to assist my husband who was having adverse effects as well(mobility issues: he fell on the floor and was unable to get up. I had to call fire department to get him back to be. Later on he could not reposition himself in bed and I had to do my best to help him. hydration, Tylenol x2 q6 hours, bed rest
80 2021-01-23 fever Redness swelling extreme pain at vaccination site -48 hours following vaccination Nausea, diarrhea,... Read more
Redness swelling extreme pain at vaccination site -48 hours following vaccination Nausea, diarrhea, fever, light headed -48 hours following vaccinations
80 2021-01-24 headache Subject: COVID-19 Vaccine I received my COVID-19 vaccine (right arm) on January 24, 2021 at 2 pm. T... Read more
Subject: COVID-19 Vaccine I received my COVID-19 vaccine (right arm) on January 24, 2021 at 2 pm. The purpose of this note is to let you know that on Saturday 1/23 i started having sharping (icepick) pains in my head -right side, behind ear and the pains are continuing today 1/25/2021.
80 2021-01-25 headache, body temperature increased, chills 12 hours after receiving first dose of Moderna, Chills, temp of 103, intractable nausea and vomiting... Read more
12 hours after receiving first dose of Moderna, Chills, temp of 103, intractable nausea and vomiting and severe headache lasting for 30 hours.
80 2021-01-25 headache, fatigue, headache, fatigue The patient received the Moderna Covid 19 vaccine on 1/19/21 and reported to the pharmacy that durin... Read more
The patient received the Moderna Covid 19 vaccine on 1/19/21 and reported to the pharmacy that during the night on 1/20/21, she passed out. She reported having a mild headache all day but no other problems. She was putting drops in her husband's eyes around 11pm and told him she needed to sit down that she was going to "pass out." Her husband said she did pass out and he called 911. He said she was unconscious maybe 3 or 4 minutes. She woke up alert and knew what had happened. The EMT's checked her out--said she had no temperature, blood pressure was ok, and blood sugar was 280. They told the couple they thought it was probably from the vaccine. They wanted to transport her to the ER to be "checked out" but the patient refused to go. She has not had any problems since the incident except some fatigue
80 2021-01-25 lethargy, fever, chills, headache High fever 103 degrees; Arm totally immobile with severe pain; Lethargy; Headache; Chills; Same symp... Read more
High fever 103 degrees; Arm totally immobile with severe pain; Lethargy; Headache; Chills; Same symptoms as when I had Covid in March 2020
80 2021-01-25 fever Red welt around shot site that started a couple of days later and grew to palm size over several day... Read more
Red welt around shot site that started a couple of days later and grew to palm size over several days and ran fever for first week. Since Jan 23, it has grown down approx 1/8 inch. Knot under it has gone away. Have been taking baby. Benadryl, 2 a day.
80 2021-01-26 fatigue Left arm around the vaccine shot site became extremely itchy and very red. The site expanded on the ... Read more
Left arm around the vaccine shot site became extremely itchy and very red. The site expanded on the next day (Friday, the 22nd), and by Sat. it was swollen. Sunday the swelling subsided and the redness expanded around my arm. By Monday the redness had moved down my arm with the upper part clearing. Tuesday the new site had swelling, and today it is not swollen but continues to be red and a little itchy. It was my only reaction with no fever but a little tiredness. (not adverse event, but just reporting my reaction to vaccine...)
80 2021-01-26 headache swelling, redness, and itching at injection site, along with a slight headache.
80 2021-01-27 headache, fatigue, malaise 10 days after injection, 01/25/2021, left arm became itchy at injection site. When I looked at arm, ... Read more
10 days after injection, 01/25/2021, left arm became itchy at injection site. When I looked at arm, it has a large pink oval spot, warm to the touch, under the injection site. Itching stopped overnight. Woke up next day 01/26/2021, with headache, very tired and nausea and gagging. This is my third day feeling sick. Not as bad but still turned from eating.
80 2021-01-27 headache late Saturday, headache, buzzing in head, doctor Monday steroid shot, Thursday night buzzing in head... Read more
late Saturday, headache, buzzing in head, doctor Monday steroid shot, Thursday night buzzing in head again soreness of shoulder
80 2021-01-27 fever, chills, headache fever, headache, muscle and joint pain, headache, chills
80 2021-01-28 body temperature increased elevated temperature
80 2021-01-28 headache, fever, malaise Headache, body ache, arm swollen, 100.1 temp, nausea and overall very sick
80 2021-01-30 body temperature increased, chills, fever Sore arm Midnight 01 30 am 100 Fever early am 01 31 20 Chills same Lite headed same ... Read more
Sore arm Midnight 01 30 am 100 Fever early am 01 31 20 Chills same Lite headed same Took one tylenol 325 aT midnight 01 30 am 2cd Tylenol at 5 am 100. 9 temperature. Took 3rd tylenol 800am Temperature steady. Slept.
80 2021-01-30 malaise 8 days after the first dose, my Mom developed a rash at the site of the injection. It lasted for abo... Read more
8 days after the first dose, my Mom developed a rash at the site of the injection. It lasted for about 6 days and it was the size of the palm of a hand. She saw her primary care Doctor on 1/25/21 for a regular physical. He saw the rash (which had subsided) and advised her to take one Benadryl 30 minutes before she has the second dose of the Moderna vaccine on 2/10/21. On 1/30/21 she had an episode where her face was tingling and she was not feeling well and a somewhat out of it. Today, 1/31/21, she is feeling better but still has tingling in her face.
80 2021-01-31 headache, fatigue, sinus disorder hours after vaccination arm soreness, stiffness in hands, two days after vaccination fatigue, breath... Read more
hours after vaccination arm soreness, stiffness in hands, two days after vaccination fatigue, breathing difficulty-feeling of tightness around rib cage, heart felt tight, headache, body aches, sinus trouble
80 2021-01-31 sweating Patient complain of feeling weak, faint, and sweaty 2 minutes after injection.
80 2021-02-01 fever, chills Patient called the pharmacy this morning complaining of chills and body aches. She was going to tak... Read more
Patient called the pharmacy this morning complaining of chills and body aches. She was going to take some Tylenol for the symptoms. She said her temperature has gone down from 101 to 99, by 4pm this afternoon.
80 2021-02-01 fever, headache, chills Really bad headaches chills, fever, body soreness,
80 2021-02-02 chills Client complained of "feeling odd" during the nite and slightly disoriented in the morning. Had some... Read more
Client complained of "feeling odd" during the nite and slightly disoriented in the morning. Had somewhat strange behavior in the morning of confusion and chills.
80 2021-02-03 fever, chills PER PATIENT, FULL BODY RASH ONSET 8 DAYS AFTER VACCINATION STARTING 1/28/21. INTENSIFIED TO AXILLAR... Read more
PER PATIENT, FULL BODY RASH ONSET 8 DAYS AFTER VACCINATION STARTING 1/28/21. INTENSIFIED TO AXILLARY SWELLING/DISCOMFORT ~3 DAYS LATER 1/31/21 AS WELL AS CHILLS AND LOW GRADE FEVER. AS OF 2/4/21, PATIENT INDICATES MAJORITY OF SYMPTOMS HAVE RESOLVED. PATIENT INSTRUCTED BY PCP TO AVOID DOSE 2 OF MODERNA AND SEEK AN ALTERNATIVE, NON MRNA FORMULATION OF VACCINE WHEN MADE AVAILABLE. MANAGED SYMPTOMS WITH METHYLPREDNISOLONE DOSE PACK, BENADRYL Q4H PRN SYMPTOMS, AND TOPICAL HYDROCORTISONE.
80 2021-02-04 chills Chills, no fever, lasted 2 days. Not severe. Severe inflammation at injection site with soreness, ve... Read more
Chills, no fever, lasted 2 days. Not severe. Severe inflammation at injection site with soreness, very red skin shoulder to elbow and all around upper arm, Turgid, painful, and itchy. Still spreading, ongoing at 6 days. Beginning to "fade" a little at injection site area, but still spreading downward.
80 2021-02-04 fatigue, headache Severe headache, severe joint pain, fatigue, nausea lack of appetite and weakness
80 2021-02-04 headache, fatigue Woke w/headache..........after exercising started to feel very tired.......... spent the whole after... Read more
Woke w/headache..........after exercising started to feel very tired.......... spent the whole afternoon on the couch
80 2021-02-04 sweating 80-year-old female with a history of atrial fibrillation and coronary artery disease, was obtaining ... Read more
80-year-old female with a history of atrial fibrillation and coronary artery disease, was obtaining her first dose of the Moderna COVID-19 vaccine today, and about 10 minutes afterwards began feeling warm and diaphoretic and developing left chest pains and nausea, at approximately 11 AM. This lasted about 5 minutes and then subsequently resolved. She then got up to leave and again began feeling the left chest pain, diaphoresis, and again lasting about 5 to 6 minutes and then subsequently resolving. She does state a history of anxiety but did take Xanax this morning preventatively. However, she states she has had similar pains in her chest over the past month. She states these are not necessarily associated with any exertion and seemed to be somewhat better after antacids. She notes she has not had anything to eat or drink this morning which is not unusual for her and her blood sugar was 117 this morning.
80 2021-02-05 chills, fever After second Moderna dose: First night: insomnia, agitation during the night, flashes in brain like ... Read more
After second Moderna dose: First night: insomnia, agitation during the night, flashes in brain like electrical discharges between ears and sharp pain in joints.. In morning chills, sharp pain in joints that made walking difficult, fever of 100.1. Felt miserable all day. Second night: slept well and felt much better in morning and almost myself again. Still some muscle pain in injection arm. No adverse effect after first dose on January 10.
80 2021-02-06 body temperature increased, headache, fatigue, chills I developed headache, chills , 99.3 temperature, very tired with pain all over my joints particularl... Read more
I developed headache, chills , 99.3 temperature, very tired with pain all over my joints particularly my back , shoulders, right arm at the site of the inyection and these symptoms lasted for 24 hrs . I feel fine and normal after one day of feeling these symptoms.
80 2021-02-06 dehydration, fever Daughter reported that beginning 1-23-2021 after vaccine, patient experienced a red, swollen arm. Sw... Read more
Daughter reported that beginning 1-23-2021 after vaccine, patient experienced a red, swollen arm. Swelling present down to elbow of right arm. From 1-24-2021 to 2-6-2021, patient experienced diarrhea and fever. Daughter was concerned that patient was becoming dehydrated so patient was given IV fluids for replenishment. Facility where fluids received and length of stay in facility are unknown at this time.
80 2021-02-06 fatigue Extreme fatigue, had trouble getting out of bed and needed help. Slept most of the 24 hours after th... Read more
Extreme fatigue, had trouble getting out of bed and needed help. Slept most of the 24 hours after the adverse even started. Diarrhea upon getting up and lasted approximately 6 hours. Soreness in left arm.
80 2021-02-07 chills, headache area of injection on upper left arm (ovoid rash about 6 inches by 3 inches) red and sore and warm (b... Read more
area of injection on upper left arm (ovoid rash about 6 inches by 3 inches) red and sore and warm (began a few hours after injection and continues now) Headache, body aches, chills and discomfort began a few hours after injection and lasted about one and a half days (totally gone now)
80 2021-02-07 chills Shaking with chills. Could not warm up. Nausea. Pain in chest. Temperature of 99.9, lasted about 7 h... Read more
Shaking with chills. Could not warm up. Nausea. Pain in chest. Temperature of 99.9, lasted about 7 hours and then I felt fine, but tired. The next day felt normal, except for arm being slightly sore. The worse part was the severe shaking from chills and nausea. I did take a Tylenol before going to bed.
80 2021-02-07 fatigue, headache Extreme Fatigue, headache, stomach ache, swollen tongue, ankle swollen, constipation, limited cognit... Read more
Extreme Fatigue, headache, stomach ache, swollen tongue, ankle swollen, constipation, limited cognition, unsteady gate, loss of appetite. Weird feeling in head to the point of losing focus and almost passing out. Severe symptoms lasted for five days until 2/6/21. Currently limited fatigue, slight cough.
80 2021-02-07 headache, lethargy, malaise lethargic, malaise, complaining of a headache
80 2021-02-07 headache Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, te... Read more
Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself, she fell 3 times on Feb. 3, I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand. Feb. 4 she had the dry heaves all morning, she slept all afternoon. I called the doctors office @ 8:00am and again later @ 8:30am. He said he wanted her to have a CAT scan Medical Center. He said they would call
80 2021-02-07 sweating Patient had increased BP, felt flush, sweaty, and shaky about 15 minutes after receiving the vaccine... Read more
Patient had increased BP, felt flush, sweaty, and shaky about 15 minutes after receiving the vaccine. Patient vitals taken every 10 minutes and monitored until she returned to her baseline. Patient also provided a water and snack. After about 20 minutes of additional observation the patient was fine and able to leave.
80 2021-02-08 chills, fever Severe Chills Fever 102 Hot burning whole body Dry Heaves Weakness Took Tylenol, pushed fluids--last... Read more
Severe Chills Fever 102 Hot burning whole body Dry Heaves Weakness Took Tylenol, pushed fluids--lasted 24 hours
80 2021-02-08 chills Moderna COVID 19 Vaccine EUA Very sore arm, queasiness, chills. Next day, threw up cere all, had ... Read more
Moderna COVID 19 Vaccine EUA Very sore arm, queasiness, chills. Next day, threw up cere all, had many bowel movements.
80 2021-02-08 fatigue Client felt tired on Friday after vaccine, on Saturday (2/6) clients arm was red and swollen, and sh... Read more
Client felt tired on Friday after vaccine, on Saturday (2/6) clients arm was red and swollen, and she had some shortness of breath. Daughter said these symptoms progressively got worse. On 2/8 client went to MD who told her it was an allergic reaction and that she should report it to her local Health department.
80 2021-02-08 fatigue Resident had emesis and fatigue.
80 2021-02-08 fatigue tired, freezing, tongue swollen, abrasive soreness in mouth
80 2021-02-09 body temperature increased Body aches, pains, temp, sore lt arm
80 2021-02-09 headache, fatigue lst and 2nd day: sore arm 3rd day: shortness of breath, fatigue, body aches, headache one week lat... Read more
lst and 2nd day: sore arm 3rd day: shortness of breath, fatigue, body aches, headache one week later: arm itching , red and blotchey and warm Time Course: symptoms lasted 4-5 days
80 2021-02-09 headache, lethargy SORE ARM AND SHOULDER, HEADACHE, LETHARGIC
80 2021-02-10 chills, headache, body temperature increased constant headache, pain throughout my body, mild temperature (99.3) with chills off and on, restless... Read more
constant headache, pain throughout my body, mild temperature (99.3) with chills off and on, restless sleep. Symptoms gradually declined and disappeared within 24 hours. No reoccurrence.
80 2021-02-10 chills, fever, headache, fatigue Evening chills the night of the vaccine (2/8) Slight headache and fever (low 100 degrees) and very t... Read more
Evening chills the night of the vaccine (2/8) Slight headache and fever (low 100 degrees) and very tired on 2/9
80 2021-02-10 fatigue Six to Seven days of moderate to severe body aches: back shoulders hips with heavy fatigue; loss of ... Read more
Six to Seven days of moderate to severe body aches: back shoulders hips with heavy fatigue; loss of appetite and total exhaustion inhibiting ability to perform ADLs (generally very high functioning). Ibuprofen for several days and in bed for nearly a week and after that time symptoms improved. delayed response. only sore arm until about 72 hours. now, 14 days later near resolution of all symptoms.
80 2021-02-11 headache I do not know if this is related to the vaccine or is an vaccine Adverse Event; however, I experienc... Read more
I do not know if this is related to the vaccine or is an vaccine Adverse Event; however, I experienced bronchospasm, relieved by two actuations of the albuterol inhaler about 25 minutes after injection. Also experienced moderate, intermittent occipital headache for approximately 6-7 hours following injection. Soreness in L. arm following two days.
80 2021-02-11 fever, chills, headache Reports pain and itching in left arm, in addition to a headache, on 02/09/2021. Arm became reddened,... Read more
Reports pain and itching in left arm, in addition to a headache, on 02/09/2021. Arm became reddened, hard, and warm to touch on 02/10/2021. Also reports chills and fever 02/10/2021. Presents to the health department today, 02/12/2021, with symptoms still persisting. Reports taking benadryl this morning with some resolution in itching but not completely.
80 2021-02-12 fever, fatigue shaking, fever of 101.7, body felt like it had been beaten, very tired
80 2021-02-12 fever Fever of 99.6 for several hours during night. Temperature 97.1 upon awakening in a.m.
80 2021-02-13 cough, influenza like illness, fatigue, chills Fly like symptoms, fatigue, chills, fluid cough more than usual, left side pain under navel
80 2021-02-13 throat irritation Patient received vaccine on 2/13/21 at 2:30pm. went home called after 2 hours around 4:30pm stating ... Read more
Patient received vaccine on 2/13/21 at 2:30pm. went home called after 2 hours around 4:30pm stating that her face turned red& puffy, lips swollen & throat feel funny. Instructed patient to go ER right away. Doctor at the ER diagnosed the patient & mentioned that she had an allergic reaction to the vaccine & put her on prednisone Taper dose. Patient mentioned that she is home & doing fine now, on prednisone taper schedule.
80 2021-02-14 fatigue fatigue, moderate site pain
80 2021-02-14 headache, fever Fever, Headache, Nausea, Whole Body Ache, Weakness Inability To Sit Up In Bed, 40 Hours, Have develo... Read more
Fever, Headache, Nausea, Whole Body Ache, Weakness Inability To Sit Up In Bed, 40 Hours, Have developed red spots on arms several days later, which now seem to be fading
80 2021-02-14 sleepiness Pt awoke early the morning following vaccine with overall shaking, dizziness, and increased confusio... Read more
Pt awoke early the morning following vaccine with overall shaking, dizziness, and increased confusion and somnolence. Evaluated in ER; Back to baseline at end of ER visit.
80 2021-02-15 chills, fatigue Chill (overnight); fatigue(2 1/2 days); temp. (only 1 brief time); diarrhea (about 24 hrs)
80 2021-02-15 chills, headache PT HAD CHILLS, NAUSEA AND VOMITING. STOMACH UPSET, HEADACHE, FOR 6 DAYS, TOOK TYLENOL. ONDANSETRO... Read more
PT HAD CHILLS, NAUSEA AND VOMITING. STOMACH UPSET, HEADACHE, FOR 6 DAYS, TOOK TYLENOL. ONDANSETRON
80 2021-02-15 chills, headache Severe pain ln neck, back, up the back of the head and behind the ears. Some rash around the waist. ... Read more
Severe pain ln neck, back, up the back of the head and behind the ears. Some rash around the waist. Chills for several hours one night. Pain lasted about 9 days. Yesterday and today, 15 and 16 February, no energy.
80 2021-02-15 chills, fever Fever and chills with long period of shuddering despite being under a heated blanket. Shaking cont... Read more
Fever and chills with long period of shuddering despite being under a heated blanket. Shaking continued uninterrupted for more than 20 minutes. Now at1:06, no shaking but still chilled.
80 2021-02-15 fatigue, headache, sweating Day 1: sore arm. Day 2: severe bladder pain with chemical smell to urine ( 6 hours), mild headache ... Read more
Day 1: sore arm. Day 2: severe bladder pain with chemical smell to urine ( 6 hours), mild headache resolved with APAP, fatigue, mild stiffness. Day 3: bladder pain gone but mild chemical smell to urine, increasing stiffness and joint pain, mild muscle pain. Day 4: chemical smell in urine slight but still present, severe joint pain and swelling requiring narcotics, mild muscle pain, moderate stiffness, moderate fatigue. Day 5: chemical smell gone, severe joint pain and swelling requiring narcotics, drenching sweats, significant stiffness, fatigue with 12-14 hours sleep, inability to manage ADL w/o help; Days6-8 same as Day 5; Day 9-10 mod fatigue, less jt pain, no narcotics, able to do ADL's w/o help;
80 2021-02-16 chills, fatigue, cough Pt reports coughing spasms, chills and fatigue. She says the symptoms are exactly like the symptoms... Read more
Pt reports coughing spasms, chills and fatigue. She says the symptoms are exactly like the symptoms she had when she had Covid.
80 2021-02-16 cough, throat irritation, headache, fever next day woke up with fever 104 headache diaherra tickle or cough arm site red and sore no apperite... Read more
next day woke up with fever 104 headache diaherra tickle or cough arm site red and sore no apperite and wanted to just sleep temp all day run between 101 to 104
80 2021-02-16 fatigue Developed 4 inch red band around arm under injection site. Extremely itchy. Took topical and oral ... Read more
Developed 4 inch red band around arm under injection site. Extremely itchy. Took topical and oral Benedryl (Note: Patient was extremely nauseated and tired with sore arm for 24 hours after vaccination, but got better then on day three, rash appeared.)
80 2021-02-16 headache, fatigue Immediate reaction was the headache at the time of the vaccine, and has had headaches on and off but... Read more
Immediate reaction was the headache at the time of the vaccine, and has had headaches on and off but nothing like the initial one. Started to get dizzy and felt weird on the ride home from the vaccine. The headache lasted a fairly long time and got tired by the evening and the next morning. The headache has still continued a little off and on until now, 2/17/21. The dizziness has gone away, the feeling "out of it" feeling has gone away, does not feel well about the concentration. The tiredness and fatigue started the day after the vaccine and has gotten worse, has to drag herself through the day and by 1:00 PM is done through the day due to the fatigue. Some days can go to 4:00 but most days only lasts until 1:00. She gets up at 7:30 and today at 10:37 has the feeling of tiredness. The gland under her arm a couple of weeks ago was swollen, which is still sensitive but not as bad as it was. The fatigue is the main thing that continues to bother her. She has not taken anything for these reactions. She has seen her doctor, and is supposed to get some blood tests today, 2/17/21.
80 2021-02-16 fever, fatigue, headache Sore and swollen gums, tongue and roof of mouth; fatigue, low grade fever, aches, head ache
80 2021-02-18 body temperature increased This resident sustained 2 seizures, 45 minutes apart, and an elevated temperature of 101 F on 2-19-... Read more
This resident sustained 2 seizures, 45 minutes apart, and an elevated temperature of 101 F on 2-19-21. The first seizure occurred at approximately 8:45 am and the second at approximately 9:30 am. The resident does not have a seizure disorder or history of seizure activity other than 1 day after receiving the first dose of the same vaccine on 1-20-21.
80 2021-02-19 headache, chills, body temperature fluctuation Got shot at 8:15am and got reaction at 9:45pm with violent chills-got into hot shower & got temp up ... Read more
Got shot at 8:15am and got reaction at 9:45pm with violent chills-got into hot shower & got temp up to 95 degrees; went to bed with several blankets; temp went up to 100 degrees about 11pm with stomach ache, horrible headache, & loose stool; lasted all night all next day; day 3 Saturday 4am got up to pee dizzy & faint & fell into glass closet doors then into wooden door then to floor & broke nose & bruised several other areas besides face. Now 11am still dizzy & sick to stomach & loose stool so called CDC but no help so took meds on hand. Zofran 4mg & Loperamide 2mg.
80 2021-02-20 fatigue Arm pain, swelling, red rash around injection site. a bit queasy initially., tired. Queasiness s... Read more
Arm pain, swelling, red rash around injection site. a bit queasy initially., tired. Queasiness started Sunday - first full day of side effect. lasted maybe 24 hours. arm pain worse first day or so, slowly decreased. rash slowly went away - took at least a week. swelling also slow to go down.. only minimal issue with itchiness. used topical Avena twice.
80 2021-02-20 head discomfort 10:30 pm same day/night -- extreme cold; dizziness; 4 fainting spells; head rush-inflamation extreme... Read more
10:30 pm same day/night -- extreme cold; dizziness; 4 fainting spells; head rush-inflamation extreme the next day and Saturday. I found myself looking up at the ceiling 4 times during the night after fainting dead away. Frightening as that has never happened to me before. It was the weekend; I was unable to reach any doctor for advice. Plus with a major snow storm we were snowed in and I couldn't get out. This was the sickest I've ever been in my life!
80 2021-02-20 headache, chills, fever Chills all day, confusion beginning early. light headache. Next day low grade fever for half day. ... Read more
Chills all day, confusion beginning early. light headache. Next day low grade fever for half day. Confusion gone. Noticed two days ago left arm very red and blotchey from injection site to elbow..
80 2021-02-20 headache, fatigue On 5th day, I started with headaches that continued for 6 days, woke up tired and wanted to go back ... Read more
On 5th day, I started with headaches that continued for 6 days, woke up tired and wanted to go back to sleep in the daytime. Also developed hard red hot patch on left arm above the injection site that also lasted about 6 days.
80 2021-02-21 chills Chills, pain throughout body, fainting (30 hours after injection, general weakness for 40 hours
80 2021-02-21 chills approx 1am I woke up and I was shivering so hard the bed was shaking and I could not get up out of b... Read more
approx 1am I woke up and I was shivering so hard the bed was shaking and I could not get up out of bed safely. I have never experienced a chill like this before. 3-4am I was shivering and shaking and so very cold again. this lasted until at least 4-5pm. I was shaky and my voice was shaky. no appetite.
80 2021-02-21 fatigue Sore arm, fatigue, muscle aches, loss of appetite.
80 2021-02-21 head discomfort BOTH SHOULDERS HURT. HEAD AND BODY FELT HEAVY COULD NOT GET UP. LEFT ARM SWOLLEN, RED AND PAINFUL FO... Read more
BOTH SHOULDERS HURT. HEAD AND BODY FELT HEAVY COULD NOT GET UP. LEFT ARM SWOLLEN, RED AND PAINFUL FOR 5 DAYS
80 2021-02-21 nasopharyngitis Wednesday i had vomiting This time i had diarrhea and like i had cold symptoms we gone by Friday.
80 2021-02-21 fever, fatigue, headache 02/11/21: Fever 100.1 @ 8:00 a.m. ; mild headache; extreme fatigue 02/12/21: Fever 101.5 @ 8:00 a... Read more
02/11/21: Fever 100.1 @ 8:00 a.m. ; mild headache; extreme fatigue 02/12/21: Fever 101.5 @ 8:00 a.m.; headache worse; extreme fatigue Fever 101.9 @ noon ; headache same; extreme fatigue 02/13/21: Fever 100.9 @ 8:00 a.m.; mild headache; mild fatigue 02/14/21: temp normal; no headache; mild fatigue
80 2021-02-22 chills, headache Client stated she "felt odd/disoriented" and exhibited strange behavior, unaware of surroundings. Ha... Read more
Client stated she "felt odd/disoriented" and exhibited strange behavior, unaware of surroundings. Had chills/headache.
80 2021-02-22 fever, headache Patient received vaccine on 2/3/21. Developed headache, fever and red warm rash to injection site on... Read more
Patient received vaccine on 2/3/21. Developed headache, fever and red warm rash to injection site on 2/21/2021. Applied ice and took Tylenol. Symptoms starting to resolve today
80 2021-02-22 fever Rash at injection side, swelling, redness, fever, sore to touch Had prescription cream from derm for... Read more
Rash at injection side, swelling, redness, fever, sore to touch Had prescription cream from derm for another skin issue, used on rash on 2-23-2021 Has taken tylenol with arthritis for pain as well as regular tylenol
80 2021-02-23 sweating, lethargy, fatigue Dr. called (pt's PCP) to report reaction that was reported to her by pt's sitter and husband. Stat... Read more
Dr. called (pt's PCP) to report reaction that was reported to her by pt's sitter and husband. States pt would not eat and was lethargic the night after receiving the vaccine. The next morning pt was extremely fatigued and "not acting like herself." By Tuesday night, pt was experiencing rapid breathing, sweating, and was very agitated. PCP states sitter reported that she heard "rattling" in pt's chest. Pt short of breath this morning with heart rate of 123. Pt will not eat or drink and is very weak. Pt has not been communicating with them like she normally does. Can only walk a few steps before having to rest. Pt was on her way to ED when PCP called to report this.
80 2021-02-24 chills, fatigue had shot 2/11, on 2/18, left arm was red, swollen,extreme sting, also, chills,no fever, felt tired. ... Read more
had shot 2/11, on 2/18, left arm was red, swollen,extreme sting, also, chills,no fever, felt tired. took tylenol. 2/19, was better, less tired no chills. arm was still same, took benadryl.arm did not settle down until 2/21. on 2/24 stinging rash appeared across upper chest, small areas on both arms, took benadryl, symptoms went away. 2/25, small area had rash, more benadryl.
80 2021-02-24 chills, sweating, headache, fever No side effects from shot #1 on 1/24. Second shot on 2/22 = approx. 14 hours after shot I started... Read more
No side effects from shot #1 on 1/24. Second shot on 2/22 = approx. 14 hours after shot I started with chills for 2 hours, then had about 18 hours of a low grade (100.3) temp., dizziness & slight headache - then had sweats when it broke, then I was fit as a fiddle.
80 2021-02-24 sweating hypotension, diaphoresis, dyspnea
80 2021-02-24 throat pain, fatigue Patient feels Hot/Cold, Arm is sore, Weak and tired, Sore throat.
80 2021-02-24 fever Received the vaccine at 1:45 AM. At 9 PM I became very cold. The following 2 days I had fever (100.4... Read more
Received the vaccine at 1:45 AM. At 9 PM I became very cold. The following 2 days I had fever (100.4 and 99.9), aches and was feeling lousy. My right arm was very red, warm and itchy. (Ten days after receiving my first vaccine my left arm became warm, red and itchy for about several days). On the 3rd day the discomfort began to diminish. Today I am fine.
80 2021-02-25 headache Headache around her temples and nose; Did not get full shot since syringe messed up; Did not get ful... Read more
Headache around her temples and nose; Did not get full shot since syringe messed up; Did not get full shot since syringe messed up; A spontaneous report was received from a consumer concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that she did not get the full shot since the syringe messed up/device connection issue, vaccine underdose and headache. The patient's medical history was not provided. Concomitant medications were not provided. On 15 FEB 2021, the patient received her second dose of mRNA-1273 (lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient stated that she received her vaccine on 15 FEB 2021, but the syringe messed up and she didn't get the full dose. The healthcare professional (HCP) told her to come back on 18 FEB 2021 for the full dose. On 16 FEB 2021 the patient woke up with a headache around her temples and nose. Treatment for these events were not reported. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, device connection issue and vaccine underdose were recovered. The outcome of the event, headache was unknown.; Reporter's Comments: This case concerns a 80-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 025L20A), reporting device connection issue, vaccine underdose and associated headache. 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.
80 2021-02-26 chills Vomiting, chills
80 2021-02-26 fatigue the first 3 days sore muscle near shoulder when lifting it up, warm at injection site , swollen at i... Read more
the first 3 days sore muscle near shoulder when lifting it up, warm at injection site , swollen at injection site. third day back hurts and a little fatigued.
80 2021-02-26 nasopharyngitis Cold, loss of consciousness, vomiting that lasted 1 - 2 hours.
80 2021-02-26 fever fever,body aches tired. 100.9 first day 99.7 second day better after 48hours. took Advil
80 2021-02-27 malaise, chills Patient said she felt "unwell" day following vaccine, but that passed the following day. Her symptom... Read more
Patient said she felt "unwell" day following vaccine, but that passed the following day. Her symptoms fell within the typical expected side effects post-vaccination. However, Friday 2/26 (9 days after 2nd dose) she said she woke up around midnight with chills, vomiting, and diarrhea. This lasted 5-6 hours and then stopped. She hasn't had any problems since and was encouraged to report this event via. She was advised to contact her doctor is symptoms reappear/persist.
80 2021-02-28 body temperature increased, fatigue Sore Arm Temperature of 99.8 degrees all day Fatigue all day Difficulty in walking more than 15 mins... Read more
Sore Arm Temperature of 99.8 degrees all day Fatigue all day Difficulty in walking more than 15 mins without sitting down Legs felt very tired all day Lack of energy by 5:00 PM
80 2021-02-28 chills, headache, sweating Woke up at 2:30 am and was incoherant, difficulty walking and was assisted to bathroom, chills, head... Read more
Woke up at 2:30 am and was incoherant, difficulty walking and was assisted to bathroom, chills, headache. Next morning had soaked through pajamas with sweating.
80 2021-02-28 chills, headache, fever Extreme headache lasting 36 hours. Chills intermittent 36 hours. Fever between 101-102.2 lasting 48... Read more
Extreme headache lasting 36 hours. Chills intermittent 36 hours. Fever between 101-102.2 lasting 48 hours. Unable to be reduced taking Tylenol
80 2021-02-28 fatigue Sore arm next day. 6 days later : extreme dizziness, nausea, vomiting, fatigue, severe confusion
80 2021-02-28 malaise I had the vaccine at 1:00 PM, and that same night I attended the wake of a family member, and I wasn... Read more
I had the vaccine at 1:00 PM, and that same night I attended the wake of a family member, and I wasn't feeling well and I was feeling itchy and burning. That night I didn't sleep at all. So that night I called the doctor and I went to the doctor Friday morning, and was diagnosed with the worst case of Shingles she had ever seen. She prescribed prednisone on a taper, Valtrex (generic) 1 gram tablet 3x daily for one week, and topical ointment (flutisone propionate) .005 strength twice daily, and 500 mg tylenol every six hours.
80 2021-03-01 fever, chills, headache I woke up around 1:30 in the morning I had fever and chills (100.3 temperature), and shaking. When I... Read more
I woke up around 1:30 in the morning I had fever and chills (100.3 temperature), and shaking. When I checked my temperature at 7:30 AM and it was 100.7. I have a slight headache and injection site pain.
80 2021-03-01 fever, cough, bronchitis Patient admitted to hospital with Covid-19 Pneumonia on 02/19/2021. Diagnosed with bronchitis prior ... Read more
Patient admitted to hospital with Covid-19 Pneumonia on 02/19/2021. Diagnosed with bronchitis prior week. Having cough and shortness of breath with associated fever x1week
80 2021-03-02 body temperature increased, chills First dose was in the right arm and it it became inflamed about a week after the shot. Itchy, hot, i... Read more
First dose was in the right arm and it it became inflamed about a week after the shot. Itchy, hot, inflamed, and pink. I visited the doctor advised warm compresses and the problem subsided in a few days. After the second dose I woke up in the middle of the night with the chills and chattering teeth. It was uncontrollable shaking. My temperature of 102 degrees in the morning. I had shooting pains in my arms and legs. Felt terrible all day. Took Tylenol no effect. Advil worked better. The lymph nodes were sore under my arm. On the third day I felt a little better but on the fourth day I felt a little better.
80 2021-03-02 chills, headache 02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then w... Read more
02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then woke up flat on back-no memory of falling , had to get up 2 more times in night, same thing happened, lost consciousness waking up flat on back both times as well. Slept the next day, headache similar to sinusitis, lost her appetite and swollen glands for 2 days. Today 2/26 appetite returning, scheduling MRI next week per primary care
80 2021-03-02 sleepiness, fatigue, fever FEVER AND SWELLING AT INJECTION SITE. BODY ACHE, FEVER 100.1, FATIGUE, SLEPT FOR MOST OF DAY ANF ... Read more
FEVER AND SWELLING AT INJECTION SITE. BODY ACHE, FEVER 100.1, FATIGUE, SLEPT FOR MOST OF DAY ANF NITE BETTER ON 3/3/21
80 2021-03-03 chills, sweating, fever After 20 hours of receiving vaccine, I had chills, fever, sweats, dizziness, & nausea feeling. ... Read more
After 20 hours of receiving vaccine, I had chills, fever, sweats, dizziness, & nausea feeling. Returned to bed; slept 4 hours; & then ate & began to feel better.
80 2021-03-03 fatigue, sleepiness My mom was difficult to awaken and took 35 minutes for her to respond. Increased confusion (did not... Read more
My mom was difficult to awaken and took 35 minutes for her to respond. Increased confusion (did not know me, nor did she know her own name). Extremely unsteady on feet. She had slept from 5pm to 9am. After breakfast and an hour she regained her knowledge of her name and mine and could correctly recite her DOB. She continues to have difficulty ambulating complaining her legs ache. She is also extremely tired.
80 2021-03-04 chills, fatigue, fever Chills, Body Ache, Fever, Tired, Sore Arm for three days up to today
80 2021-03-04 fatigue Patient complained of lightheadedness, dizziness, and fatigue the next morning. That afternoon she ... Read more
Patient complained of lightheadedness, dizziness, and fatigue the next morning. That afternoon she experienced Afib.
80 2021-03-04 fatigue Passed out; Felt tired; A spontaneous case report was received from a consumer concerning an 80 year... Read more
Passed out; Felt tired; A spontaneous case report was received from a consumer concerning an 80 years-old female patient who experienced passed out (MedDRA PT: loss of consciousness) and felt tired (MedDRA PT: fatigue) The patient's medical history included cancer. Concomitant product use included chemotherapy and other medications (not specified). The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on an unknown date. On 16 Feb 2021, approximately one day prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #011M20A) intramuscularly in an unspecified site for prophylaxis of COVID-19 infection. On 17 Feb 2021, one day after receiving the vaccination, the patient felt tired and passed out. The patient inquired if this was a normal side effect. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events passed out and felt tired is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
80 2021-03-04 fever, throat pain, cough, headache, nasopharyngitis, runny nose the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I nev... Read more
the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell, 2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today
80 2021-03-05 chills By afternoon I felt a little chilly and achy and took Tylenol. I woke at 2:00am the following morni... Read more
By afternoon I felt a little chilly and achy and took Tylenol. I woke at 2:00am the following morning to go to the restroom and my dog needed to go out. I felt light headed as soon as she was back in the house. I felt things going dark and I passed out in the hallway. I don't know how long I was out but when I came to, I felt like I couldn't move. I laid there for a while and finally crawled back to my bed. I was able to get back in bed. By then it was 3:00am. The next night I woke in the night and had an irregular heartbeat. I could not get back to sleep until it finally went away. For several days after the vaccination, I had very little energy.
80 2021-03-06 fatigue, chills Chills x 3 days Shaking, tremor x 1 day Fatigue x 3 days Brain fog x 3 days
80 2021-03-06 headache HA not severe.
80 2021-03-07 body temperature increased Husband called our clinic on Saturday, March 6th at approximately 10:15 to report that on 3-5-21, t... Read more
Husband called our clinic on Saturday, March 6th at approximately 10:15 to report that on 3-5-21, this patient seemed confused, was not responsive to questions he asked her, and did not make any meals. He does report that she was oriented to person, place and time, but did not eat any food, would not shower and could not use the phone. Her temperature at bedtime was 101 degrees. The husband was offered an office visit for evaluation of symptoms, but he declined stating that she seemed to be coming around on Saturday 3-6-21. The husband was advised that pt. could take Tylenol for fever. Husband was advised that if symptoms worsened over the weekend that she should be evaluated by the nearest ER.
80 2021-03-07 fatigue I was just very fatigued for two days and could hardly get out of bed to work.
80 2021-03-08 chills, fatigue, headache, lethargy, fever Severe grade 3 Headache, high fever, chills, grade 3lymphadenopathy, pain and swelling, high fever (... Read more
Severe grade 3 Headache, high fever, chills, grade 3lymphadenopathy, pain and swelling, high fever (grade 3) persisting several days, fatigue, lethargy, myalgia, arthralgia, grade 3 chills.
80 2021-03-08 headache, fatigue Beginning about 4 hours after receiving shot, muscle aches in arm, from elbow radiating up the arm, ... Read more
Beginning about 4 hours after receiving shot, muscle aches in arm, from elbow radiating up the arm, over the shoulder thru collarbone & up the side of the neck to the ear. By 6 hours after the shot, pain was excruciating and I was in literal Agony for the next 8 hours. It felt like a hot poker was being pushed along that pathway. Tylenol & ibuprofen had no effect. I could not sleep & could barely move the arm at all. (I am Not a pain Wimp) I would say this was the longest lasting without relief/strongest pain I have ever experienced and I have had one child;+ hip & shoulder surgery which required almost no after surgery medication at all. By 5 a.m. I was able to sleep a bit & most of the extreme pain was gone by 8 a.m. I had some headache the following day and was barely able to function (I live alone) just from all over tiredness. About 36 hours after injection, I was back to normal.
80 2021-03-08 lethargy, fever, fatigue, chills, headache Headache (severe), chills, fever, fatigue (severe), injection site pain, lethargy, loss of appetite.... Read more
Headache (severe), chills, fever, fatigue (severe), injection site pain, lethargy, loss of appetite. Most of these lasted at least 3 days, up to 5.
80 2021-03-09 chills, headache Chills headache muscle and joint pain
80 2021-03-09 fever, headache, fatigue, chills Low fever, fatigue, headache, chills, imbalance, and weakness that lasted from early A.M. 3/9/21 to... Read more
Low fever, fatigue, headache, chills, imbalance, and weakness that lasted from early A.M. 3/9/21 to P.M. 3/10/21.
80 2021-03-10 chills, fever, headache, fatigue Started with chills, Dizziness. weakness, mild headache, injection site soreness & stiffness, nausea... Read more
Started with chills, Dizziness. weakness, mild headache, injection site soreness & stiffness, nausea, vomiting, dry heaves,, fever 101.3. and fatigue. Was transported to Emergency Department via ambulance. At ER given saline IV, ran chest xrays, blood test and observation. Transported around 11:00-11:30, discharged 4:45 pm.
80 2021-03-10 lethargy, fever Swelling, aching arm. Lethargic (slept all day). Slight fever, but that passed.
80 2021-03-11 chills, body temperature increased Around noon I felt as though I should take my temperature. At 12:16 it was 99.0. At 1:14, it was 1... Read more
Around noon I felt as though I should take my temperature. At 12:16 it was 99.0. At 1:14, it was 100.2. At 4:15, it was 100.2 with chills. I took 2 Tylenol. At an early bedtime, 9:00, I took 1 Advil PM. I slept well. The next day I felt OK and did not have a fever. My left arm had a bruise at the injection site and it was rosy color and itchy. with a red blotch. It was the same the next day. That eventually went away.
80 2021-03-11 chills, fever For about 12 hours I was spiking fevers of 101 degrees. I had shaking chills and couldn't get warm... Read more
For about 12 hours I was spiking fevers of 101 degrees. I had shaking chills and couldn't get warm even though my body felt like I was burning up. The arthritic joints in my hands became so inflamed that I could hardly use them and over all I felt like I had a terrible case of the flu.
80 2021-03-11 fatigue Post-second Moderna vaccine: initial heaviness of arm, for first 12 hours, a little soreness, some m... Read more
Post-second Moderna vaccine: initial heaviness of arm, for first 12 hours, a little soreness, some muscle fatigue - felt like I couldn't stand up straight = too much effort. Went to bed, with 2 @400 mg. Tylenol boosted during the night with Tramadol 50 mg. Was able to drive & swim in the morning (21 hours) post. 24 hours post: extreme fatigue (kept falling asleep), then felt like I'd been run over by a rototiller. Aches in joints, body, and skin. 2 @ 400 mg Tylenol alleviated symptoms enough to sleep for 2 hours. Arose at 3:30 pm feeling better. Not great, but better ! Better enough to feed animals and prepare dinner for myself.
80 2021-03-11 headache 2 inch of redness at injection site, hardness, headache,
80 2021-03-12 chills, headache body aches, chills, headache
80 2021-03-12 fever, chills Nausea, fever, fainted, chills.
80 2021-03-13 fatigue, chills, headache, fever 2 weeks after Moderna vaccine for COVID. Low fever 99.7, Chills, headache, Joint/muscle body Aches... Read more
2 weeks after Moderna vaccine for COVID. Low fever 99.7, Chills, headache, Joint/muscle body Aches, Fatigue, no appetite, and abdominal pain. Duration was 24 hours. Took Tylenol.
80 2021-03-13 headache, chills, fever By 8:00 pm on day of vaccination, chills, headaches, low fever (101 degrees) which lasted until Sund... Read more
By 8:00 pm on day of vaccination, chills, headaches, low fever (101 degrees) which lasted until Sunday morning. Took Tylonol, l tab, the same evening, the following morning and evening. Feel much better today, Sunday, March 14.
80 2021-03-13 sleepiness, headache, fatigue Exhaustion, quisiness, headache - first through third day after injection. Took extra strength tyle... Read more
Exhaustion, quisiness, headache - first through third day after injection. Took extra strength tylenol, and slept most of two days.
80 2021-03-14 fatigue, chills, fever, headache pain, tenderness, fatigue, headache, chills, nausea and fever. No treatment. Symptoms gone by the... Read more
pain, tenderness, fatigue, headache, chills, nausea and fever. No treatment. Symptoms gone by the following day. First shot experienced rash in left arm after 10 days. This disappeared in about 6 days. It did not itch and did not bother me.
80 2021-03-14 fatigue, headache Started March 6 about 4:00 Headache Very tired muscle aches Upset stomach
80 2021-03-14 fatigue, fever, headache The administration of the vaccine was extremely painful. Began to feel hot flashes about a half hour... Read more
The administration of the vaccine was extremely painful. Began to feel hot flashes about a half hour after the vaccine was administered, nausea and feverish symptoms. The site of injection began to swell to the size of a half dollar; the next day she could not move her arm. Describes pain from the site of injection all the way down to her wrist. The symptoms have persisted for two weeks, headache, exhaustion, and aching at the site of injection.
80 2021-03-14 fever Stabbing abdominal pain for a week that was diagnosed as shingles 3/15/21. Recurrence of trigeminal ... Read more
Stabbing abdominal pain for a week that was diagnosed as shingles 3/15/21. Recurrence of trigeminal ear pain 2 days after shot. 102 fever the whole day after the shot
80 2021-03-15 fatigue, headache Severe headaches, nausea, unsteady, restricted diet (crackers, potatoes, farina, oatmeal, bananas),... Read more
Severe headaches, nausea, unsteady, restricted diet (crackers, potatoes, farina, oatmeal, bananas), fatigue
80 2021-03-15 sweating With in the 30 minutes after vaccine administration, became diaphoretic, racing heart, and shaky. Se... Read more
With in the 30 minutes after vaccine administration, became diaphoretic, racing heart, and shaky. Sent to ED for further evaluation
80 2021-03-15 influenza like illness Chest Pain Pt has been having flu like sxs the past few days and tonight was woken out of her sleep ... Read more
Chest Pain Pt has been having flu like sxs the past few days and tonight was woken out of her sleep by chest pain. (3/13/2021) pericarditis, atrial fibrillation, and CHF
80 2021-03-15 fever, headache Fever for 36 hours, head, muscle, joint pain, weakness (unable to walk without support for 30 hours,... Read more
Fever for 36 hours, head, muscle, joint pain, weakness (unable to walk without support for 30 hours, fatigue lasting three days. Temp=100?
80 2021-03-16 chills, fever, sweating A spontaneous report was received from a consumer concerning a 80-year-old, female patient who sudde... Read more
A spontaneous report was received from a consumer concerning a 80-year-old, female patient who suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), head fell forward and she was out for 20-30 seconds (loss of consciousness), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 01-FEB-2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 01-MAR-2021, the patient received her 2nd dose of the Moderna COVID-19 vaccine (Batch number: 023M20A) in her left (dominant) arm. On 02-MAR-2021, she experienced a side effect which was not listed in the sheet she was given. She wanted to call and report the side effect. She said that she was at the stove cooking and suddenly felt very weak and felt that her vision started to flip. She called for her husband to come over who seated her on a chair. After that she says she doesn't remember what happened, but her husband told her that her whole body was shaking, her head fell forward and she was out for 20-30 seconds. When she came back, she could hear a rushing sound coming out of her left ear. She was also drenched in perspiration. She felt very nauseated and cold the whole afternoon. On 03-MAR-2021 she felt better. She had a low grade fever of 99.4 degrees Fahrenheit. Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, suddenly felt weak (asthenia), vision started to flip (visual impairment), whole body started shaking (tremor), rushing noise in left ear, drenched in perspiration, nauseated (nausea), cold (chills), low grade fever (pyrexia) was considered recovered/resolved on an unknown date. The out come of the event, head fell forward and she was out for 20-30 seconds (loss of consciousness), was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
80 2021-03-17 body temperature increased Patient received 2nd dose of Moderna COVID-19 vaccination on 3/10. Husband reported AMS and temp sta... Read more
Patient received 2nd dose of Moderna COVID-19 vaccination on 3/10. Husband reported AMS and temp starting 3/11 at 0530 and that she was in a daze and staring into space. Husband also reported that her temperature was elevated to 105F while at home. She was brought in by EMS and had a temperature of 101.5F and a BP of162/75.
80 2021-03-17 chills, fever chills, fever 100.7 - 24 hours achiness, extreme weakness - 4 days
80 2021-03-17 fatigue Tired, Facial swelling (Took zyrec), looks like chipmunk, swelling of left eye brow,
80 2021-03-17 headache, fatigue As requested, "Moderna COVID-19 Vaccine EUA" to be included in the first line of box #18 of the repo... Read more
As requested, "Moderna COVID-19 Vaccine EUA" to be included in the first line of box #18 of the report form. Monday, 3/15/2021: 6 hours post-injection tenderness began at injection site continuing throughout entire upper arm; greater than usual fatigue. Tuesday, 3/16/2021: woke up with a headache (which she doesn't commonly get); extremely fatigued; continued pain at injection site and throughout entire upper arm, worse than day of vaccination; exertion from activity greater than normal; nausea and dry heave vomiting around 6:30pm; felt very shaky and cold sweats; recovered from episode of nausea and weakness after an hour, but remained extremely fatigued and low on energy. Wednesday, 3/17/2021: injection site and upper arm pain continued Thursday, 3/18/2021: less pain in arm, but still at injection site
80 2021-03-17 headache, fever, chills Pt received her 2nd Moderna covid 19 vaccination on 3/10/2021 and the following day woke up severely... Read more
Pt received her 2nd Moderna covid 19 vaccination on 3/10/2021 and the following day woke up severely weak with chills, fever, vomiting and diarrhea and headache and was found on the floor by family at 2:30 pm. She reported she was so weak she lowered herself to the floor around 7:30and lie there till she was found in the afternoon. She was given IVF and admitted to the hospital for further work up and physical therapy.
80 2021-03-18 chills, headache, fever Chills, nausea, headache, muscle aches. fever took 2 Tylenol fever dropped went to bed all morning
80 2021-03-18 fatigue, headache Generalized body aches, mild headache, feeling extremely cold, extra tired
80 2021-03-18 lethargy, fever, chills Fever chills lethargic unable to use legs loss of appetite
80 2021-03-20 body temperature increased 102.5 temp., off balance and brain fog. Fine two days, then down again with same symptoms and 99 ... Read more
102.5 temp., off balance and brain fog. Fine two days, then down again with same symptoms and 99 temp. Have had no temp since, but brain fog and off balance like having gotten off a boat and sea legs, occasional nausea. All lab tests fine.
80 2021-03-20 fatigue, headache I had all symptoms ofcovid except arm pain and diarreha fever. I had Extreme fatigue, nausea, hea... Read more
I had all symptoms ofcovid except arm pain and diarreha fever. I had Extreme fatigue, nausea, headache, balance was off, muscle and nerve and back pain. Just took covid test and just got results--Negative. (3-19-21) The symptoms subsided March 12. Still vaguely experiencing all of them. Should I take the 2nd shot. Feel those results would return at an even heightend level. Pharmacist said I was probably 85 % covered now with these effects from the 1st shot and should not take the 2nd. My Dr. said the 2nd shot was my call to make and that I should report it to CDC.
80 2021-03-21 chills, headache pt had pain in arm iced and took tylenol --- orginally -- late rin day pt experienced chills/ h... Read more
pt had pain in arm iced and took tylenol --- orginally -- late rin day pt experienced chills/ hot flash diarrhea / vomitting and headache lasted 2 days/ symptoms had resolved today 3/22 -- same day as reported to us.
80 2021-03-21 malaise, chills - Started with weakness and ?feeling bad? 03/16/2021 at 4pm. Stated she developed nausea but no vo... Read more
- Started with weakness and ?feeling bad? 03/16/2021 at 4pm. Stated she developed nausea but no vomiting and severe, jerking chills overnight. C/o leg weakness that caused her to need assistance of cane to ambulate that night and next day. 3/19 patient saw her PCP and the PCP suggested she report her symptoms to the HCHD. Patient stated the weakness to her legs is slightly better, but not 100% resolved.
80 2021-03-22 malaise, body temperature increased temperature of 101. Arm achy, mild general malaise. Lasted 5 hours.
80 2021-03-22 sleepiness Red, itchy area about 6x4 left arm; severe cold and sleepy started next day and lasted about 8 hou... Read more
Red, itchy area about 6x4 left arm; severe cold and sleepy started next day and lasted about 8 hours then went away. Had no fever. Later about 10 pm I got up to go to bathroom and my legs just gave out. I could not move my legs or feet at all. Called paramedics who got me up and walked me for at least 30 minutes. I was very weak and unsteady. I did improve slowly. By morning I could walk cautiously. Seem to be ok now.
80 2021-03-23 cough PATIENT HAD ANAPHYLAXIS. IT PRESENTED AS A LIGHT COUGH THAT GOT WORSE AND BEGAN PROGRESSING TO SHOR... Read more
PATIENT HAD ANAPHYLAXIS. IT PRESENTED AS A LIGHT COUGH THAT GOT WORSE AND BEGAN PROGRESSING TO SHORTNESS OF BREATH . THIS HAPPENED APPROXIMATELY 15 MINUTES AFTER SHE RECEIVED THE VACCINE. I ADMINISTERED AN EPIPEN THAT IMPROVED SYMPTOMS FOR ABOUT 5 MINUTES. THE EMT'S ARRIVED AT THAT TIME AND TOOK OVER CARE.
80 2021-03-23 fatigue, headache Dizzy headache fatigue swollen arm rash itching nasea diarrhea nausea
80 2021-03-23 malaise No reaction to first shot on January21. After 2nd shot on February 23, had one day of soreness in ... Read more
No reaction to first shot on January21. After 2nd shot on February 23, had one day of soreness in arm, feeling achy and ill. Then on March14 face started going numb on left side, eye drooping. Went to ER and after tests, diagnosed Bell?s Palsey. Was given Valacyclovir Hcl and Prednisone 20 mg. for 5 days. Still experiencing these symptoms.
80 2021-03-24 fatigue, headache, chills Chills, extreme soreness on left arm where I got the 2nd vaccine. Hurt from my wrist, all the way u... Read more
Chills, extreme soreness on left arm where I got the 2nd vaccine. Hurt from my wrist, all the way up to my left shoulder across shoulder and up side of left neck, headaches, body aches, no appetite. Extreme fatique. was up all night
80 2021-03-24 fever filled with gas, muscles hurt, bones hurt,fever
80 2021-03-25 pneumonia Pneumonia with collapsed lung; Pneumonia with collapsed lung; Scheduled to take 2nd dose of vaccine ... Read more
Pneumonia with collapsed lung; Pneumonia with collapsed lung; Scheduled to take 2nd dose of vaccine on 26 Mar 2021, 6 weeks after; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia with collapsed lung/pneumonia and scheduled to take second dose of vaccine on 26 Mar 2021/inappropriate schedule of vaccine administration. The patient's medical history was not provided by the reporter. No concomitant medications were reported. On 06 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 61016308) in the right arm for prophylaxis of COVID-19 infection. On 06 Mar 2021, the patient experienced pneumonia with collapsed lung and was hospitalized. She was scheduled to take second dose of vaccine on 26 Mar 2021. Treatment for the event included hospitalization for pneumonia with collapsed lung. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, pneumonia with collapsed lung was unknown. The outcome of the event, inappropriate schedule of vaccine administered was considered to be resolved.; Reporter's Comments: This case concerns an 80-year-old who had second dose scheduled 6 weeks after first dose (inappropriate schedule of product administration) and also experienced collapsed lung/pneumonia. Although a temporal association exist, based on the information provided, the event of collapsed lung/pneumonia is assessed as unlikely related. Pneumonia is due to an infective etiology. The event of inappropriate schedule of product administration is assessed as not applicable.
80 2021-03-27 headache Aching, headache, feeling faint
80 2021-03-28 fatigue Fatigue
80 2021-03-28 headache, chills, fever, fatigue I had a severe headache for several hours, a fever of 100.8 at the highest, chills and tired for sev... Read more
I had a severe headache for several hours, a fever of 100.8 at the highest, chills and tired for several days.
80 2021-03-28 sleepiness, fever, fatigue, chills Red, swollen arm down to elbow, fever, chills,(for both shots) very tired and sleepy most of the tim... Read more
Red, swollen arm down to elbow, fever, chills,(for both shots) very tired and sleepy most of the time. Bad several days, better each day thereafter except for tiredness and sleepiness.
80 2021-03-29 fatigue Exhaustion Erratic blood pressure spikes Switch from am active time to pm active Afternoon naps Sh... Read more
Exhaustion Erratic blood pressure spikes Switch from am active time to pm active Afternoon naps Shortened less active dog walks
80 2021-03-30 headache, fatigue Moderna COVID-19 Vaccine EUA Mod. severe muscle pain, esp across back/shoulders, incr, weakness, hea... Read more
Moderna COVID-19 Vaccine EUA Mod. severe muscle pain, esp across back/shoulders, incr, weakness, headache, pain at injection site, fatigue, nausea and dizziness. Retired early and got up during night with GI distress. Before getting back to bed passed out hitting my head and lower back on a metal door frame. I did not recall this but found myself back in bed partially dressed. Husband found a hallway Persian rug (heavy) displaced in AM. Slept until 3PM following day and awoke with lg. bump on head and pain in sacral area. Self treated with ice to painful areas plus Tylenol 500 mg. After 6 days with no relief saw orthopedist who took x-rays and diagnosed bruise to sacrum and post-concussive syndrome. Offered visit to neurologist which was declined as cognitive ability seemed intact, Treated with ice to sacrum 20 min. x 5 daily, Tylenol 1000 mg. and Aleve 1 q 12h x 5 days. Sx continued for 8 days requiring Tylenol, Aleve, iceand/or heat. Feeling less pain by Day 20 post vaccine.
80 2021-03-30 headache After 2nd shot, sore arm and achy joints for about 2-3 days. Then, about 5 weeks, developed headach... Read more
After 2nd shot, sore arm and achy joints for about 2-3 days. Then, about 5 weeks, developed headaches, ear aches and achiness in neck and lower skull. Then about 6 weeks later (3/29/21) got dizzy and felt no energy, still had headaches, slight ear aches and achiness in neck and lower skull. Lasted about 3 days but seems to be better (took Meclazine starting on 3/30. This all concerned me until I saw my chiropractor today (3/31) and he told me 2 of his patients had dizziness too. They took Benedryl and that helped immensely. They told him that they looked it up and dizziness can be a an adverse reaction to the Covid vaccs. I looked it up on FB and saw that dizziness can be a reaction although the timeline for it to happen varied greatly - from immediately after to 3 weeks after. In my case it's about 6 weeks after. Felt ok in between the vacc #2 and first reaction of sore arm. 5 weeks after til next reaction of achy neck, skull and earaches. 6 weeks after Vacc # 2 til dizziness.
80 2021-03-31 cough Client developed a cough on approximately 3/23. She also has been experiencing diarrhea, nausea, wea... Read more
Client developed a cough on approximately 3/23. She also has been experiencing diarrhea, nausea, weakness, and confusion. Diagnosed with possible Covid-pneumonia. Client also states that she has been having various symptoms for the previous 4 months. She had been seen by her outpatient primary care doctor and gastroenterology for abdominal pain symptoms, ultimately found to have C. difficile and treated for this.
80 2021-03-31 fatigue, chills chills & tiredness had to sleep one full day
80 2021-03-31 headache, fatigue fatigue, mild soreness, headache, coldness,
80 2021-03-31 nasopharyngitis Throwing up; Colds; Bowel movement was not going anywhere; A spontaneous report was received from a ... Read more
Throwing up; Colds; Bowel movement was not going anywhere; A spontaneous report was received from a consumer concerning an 80-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced cold/nasopharyngitis, throwing up/vomiting and bowel movement was not going anywhere/constipation. The patient's medical history was not provided. No Relevant concomitant medications were reported. On 23 Feb 2021, approximately two weeks prior to the onset of symptoms, the patient received their first of the two planned vaccine doses of mRNA-1273 (Lot number: 010T00A21A), on an unspecified arm with unknown dose and route of administration, for prophylaxis of COVID-19 infection. On 9 March 2021, the patient was hospitalized for colds. On 12 Mar 2021, the patient was discharged. On 13 Mar 2021, the patient was throwing up and was again brought back to the hospital. The patient was told that their "bowel movement was not going anywhere." On 17 Mar 2021, Diagnostic procedure, Endoscopy was performed on the patient and the result was normal. No Treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was unknown. On 12 March 2021, the outcome of the event, cold was considered resolved. On an unknown date, the outcome of the events, throwing up and bowel movement was not going anywhere were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Constipation and vomiting, a causal relationship cannot be excluded. The event of Nasopharyngitis was assessed as Unlikely Related to study drug, as this could be due to spread of virus droplets.
80 2021-03-31 pneumonia pneumonia; A spontaneous report was received from consumer, concerning an 80-Year-old female patient... Read more
pneumonia; A spontaneous report was received from consumer, concerning an 80-Year-old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced Pneumonia and hospitalized. The patient's medical history was not provided. concomitant product use was not provided. On 17-Feb-2021 the patient received first dose of the mRNA-1273 vaccine (Batch number 024M20A ) in left non-dominant arm for the prophylaxis of COVID-19 infection. On 23-Feb-2021 the patient hospitalized. the cause of hospitalization was pneumonia. Treatment included antibiotics and steroids. Action taken with mRNA-1273 in response to event was unknown. Outcome of the event, pneumonia was considered to be unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
80 2021-03-31 fever 2.2.21 - 2nd COVID inj. 2:50pm 2.3.21 - Fever - 101.0 deg Fever 5:00pm - arm swe... Read more
2.2.21 - 2nd COVID inj. 2:50pm 2.3.21 - Fever - 101.0 deg Fever 5:00pm - arm swelling, some redness 2.4.21 - Fever - 102.2 deg Fever 8:30am 2.5.21 - Fever - 99.9 deg. off and on all day - arm swelling, more redness 2.6.21 - Fever - 99.2 deg - redness around inj site growing - itching 2.7.21 - temp - 97.9 deg - ER visit - prescribed Benadryl & steriod cream 2.12.21 - visited,- prescribed XCyzal & cream (redness now 7-1/2" dia.) 2.19.21 - itching mostly gone. 3.16.21 - Breast cancer oncologist visit - found enlarged lymph nodes, revisit 4.16.21 for added testing due to recent Covid shot.
80 2021-04-01 nasopharyngitis, chills Cold, chills, imbalance, overall weakness, difficulty speaking thickness of the throat
80 2021-04-02 body temperature increased, chills, sinus headache, throat pain By 4 PM 3/30/2021 , I had chills. The next morning I had a congested headache that was really bad,... Read more
By 4 PM 3/30/2021 , I had chills. The next morning I had a congested headache that was really bad, chills, and a slight sore throat at times. And a temp of 100.9. A day later I also had a large red area on my arm....under the injection site. It was smooth....and approximately 3 inches width and height. It itched slightly. Today 4 days later, it is still red but a slightly smaller area. I have not gone for any treatment. I drank gatorade the first two days and took tylenol. But I have not taken any of that yesterday or today.
80 2021-04-02 chills, fatigue, headache head ache, chills, tired, quezie stomach
80 2021-04-04 chills, headache, fatigue, fever Head ache, fever, chills, tired, muscle ache lasted 5 days, less severe on day 4 and 5. Treated wit... Read more
Head ache, fever, chills, tired, muscle ache lasted 5 days, less severe on day 4 and 5. Treated with rest and lots of water.
80 2021-04-05 fever allergic reaction on left arm increasing in size daily. Red, itchy, swollen, feverish, slightly pain... Read more
allergic reaction on left arm increasing in size daily. Red, itchy, swollen, feverish, slightly painful. The redness is beginning to cover the entire arm. Benadryl and Ibuprofen are not relieving the symptoms. Symptoms occured on day 2 and are continuing adversely.to day 6 with no relief
80 2021-04-06 chills, fever 1st dose; Nausea, vomiting, 101 fever, chills, weakness
80 2021-04-06 fever Dizziness, nausea, vomiting, dry heaves, 100.3 fever, weakness
80 2021-04-08 dehydration No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had ... Read more
No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia. The patient's medical history was not provided. concomitant product used not provided by reporter. On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak). On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body). On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs). The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported. The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
80 2021-04-08 fatigue, headache Low temperature; Fatigue; Headache; Joint pain; nausea; Body aches; R arm of injection rash of 6-7 i... Read more
Low temperature; Fatigue; Headache; Joint pain; nausea; Body aches; R arm of injection rash of 6-7 inches from high arm down to elbow; R arm of injection soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Low temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic bronchitis since 2020 and Allergy. Concomitant products included MONTELUKAST, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN, ATORVASTATIN CALCIUM (LIPITOR), FISH OIL (OMEGA 3 [FISH OIL]), CALCIUM, COLECALCIFEROL (CALCIUM+VITAMIN D), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POTASSIUM for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 HYPOTHERMIA (Low temperature) (seriousness criterion medically significant), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness). At the time of the report, HYPOTHERMIA (Low temperature), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness) outcome was unknown. Concomitant medication includes joint pain medicine and eye medicine. The patient has allergies. The patient robbed cream on knees and muscle left heart to relief. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
80 2021-04-10 headache Dizzy, couldn?t do normal housework, breathless after little exertions, terrible headaches . After 1... Read more
Dizzy, couldn?t do normal housework, breathless after little exertions, terrible headaches . After 10 Days went to Yavapai Regional Medical Center ER and was admitted with high blood pressure 225/97.
80 2021-04-11 fatigue Soreness started at injection site about 2 PM and migraded down my arm into fingers sending sharp pa... Read more
Soreness started at injection site about 2 PM and migraded down my arm into fingers sending sharp pains. By 6 PM my shoulder was very sore and couldn't lift my arm. I woke and 12:14 and my left side was sore and stiff, including ribs and collar bone. My left breast felt like it was in a vice. I woke at 6:18 and my ribs were better but the pain in the shoulder and arm is still very painful. I am very tired.
80 2021-04-12 headache, chills Chills lasting 6 hours with headache .
80 2021-04-12 fever Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several da... Read more
Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several days, along with light headedness. ED visit on 3/14 diagnosed with COPD flare advised to follow up with PCP. 3/22 follow up with PCP, discovered blood in stool sent to ED. Admitted on 3/22 with low hemoglobin and blood in stool. Endoscopy on 3/23 and coloscopy on 3/24. Source of bleed undetermined. Released on 3/23. 4/1 returned to ED as symptoms continued. D-dime blood test and CAT found blood clots in lower right lung. Prescribed Eloquis and released. Returned to ED on 4/5 admitted with low hemoglobin (7.1) bleeding, breathing difficulty. Endoscopy repeated on 4/6 not bleeding found. Released on 4/9.
80 2021-04-15 chills, fever every afternoon she gets chills; blood pressure extremely low; pelvic fracture; Fell in her bedroom;... Read more
every afternoon she gets chills; blood pressure extremely low; pelvic fracture; Fell in her bedroom; legs felt very weak, like they were giving out; she was in lot of pain; sick with fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PELVIC FRACTURE (pelvic fracture) and FALL (Fell in her bedroom) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (sick with fever). On 27-Feb-2021, the patient experienced FALL (Fell in her bedroom) (seriousness criterion medically significant), MUSCULAR WEAKNESS (legs felt very weak, like they were giving out) and PAIN (she was in lot of pain). On 10-Mar-2021, the patient experienced PELVIC FRACTURE (pelvic fracture) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced HYPOTENSION (blood pressure extremely low). On an unknown date, the patient experienced CHILLS (every afternoon she gets chills). At the time of the report, PELVIC FRACTURE (pelvic fracture), FALL (Fell in her bedroom), MUSCULAR WEAKNESS (legs felt very weak, like they were giving out), HYPOTENSION (blood pressure extremely low), PAIN (she was in lot of pain), PYREXIA (sick with fever) and CHILLS (every afternoon she gets chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, X-ray: normal (normal) normal. On 10-Mar-2021, X-ray: abnormal (abnormal) pelvic fracture. On 09-Apr-2021, Blood pressure measurement: extremely low (Low) Extremely low. No relevant concomitant medications were reported. On 28-FEB-2021, patient went to emergency room and x-rays were normal. On 10-MAR-2021, she went to her orthopedist, and repeat x-rays showed pelvic fracture. Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided. This case concerns an 80-year-old female with serious unexpected events of pelvic fracture and fall, and nonserious unexpected hypotension, muscle weakness, pain, and expected pyrexia, chills. Event onset on Day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 80-year-old female with serious unexpected events of pelvic fracture and fall, and nonserious unexpected hypotension, muscle weakness, pain, and expected pyrexia, chills. Event onset on Day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
80 2021-04-15 chills States she had the shot in the morning, states in the evening she had a stiff neck that radiated dow... Read more
States she had the shot in the morning, states in the evening she had a stiff neck that radiated down into her R side (the side she got her shot on). States she went to bed and woke up at about 3 a.m. and she was so sick vomiting/dry heaves (2-3) and having diarrhea (approx 3). She also had chills. States she could hardly use her R hand. States her wrist is just now getting better. She notes she was able to walk but she was very careful. She did not try to speak. She does not have residual symptoms other than some residual stiffness. She had to use her rescue inhaler the morning prior to the vaccine, and again in the evening after the vaccine.
80 2021-04-18 headache Next day pain to right tempel. 3 short violent stabs of pain. Couldnt move, scared I get to the p... Read more
Next day pain to right tempel. 3 short violent stabs of pain. Couldnt move, scared I get to the phone to call for help. Then it was gone.
80 2021-04-18 nasopharyngitis, headache, malaise, fever Started to ache everywhere, headache across eyes, pressure in ears, cold, fever, upset stomach. @ 2 ... Read more
Started to ache everywhere, headache across eyes, pressure in ears, cold, fever, upset stomach. @ 2 AM had severe pain in left arm, could not move it. Experienced light-headedness, all over body ache. Arm pain was so bad i didn't want to move. couldn't sleep all night. tried to eat breakfast but got dizzy, cold and clammy, couldnt eat. Stayed in bed until around 5 PM because of arm pain and general malaise Was finally able to eat and took a tylenol and fell asleep as light-headedness abated and arm pain was better. Next day was better but couldn't lift arm well until 15th still some pain to this day
80 2021-04-18 fever Loss of control of bladder; Patient got her second dose after 35 days of first dose; fever; Convulsi... Read more
Loss of control of bladder; Patient got her second dose after 35 days of first dose; fever; Convulsions; terrible contractions of muscles; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Convulsions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) and PYREXIA (fever). On 09-Apr-2021, the patient experienced URINARY INCONTINENCE (Loss of control of bladder). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) had resolved. At the time of the report, SEIZURE (Convulsions), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), URINARY INCONTINENCE (Loss of control of bladder) and PYREXIA (fever) had resolved. No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
80 2021-04-19 cough Taken to the Hospital due to COVID-like symptoms (strong cough). At the Hospital she is diagnosed wi... Read more
Taken to the Hospital due to COVID-like symptoms (strong cough). At the Hospital she is diagnosed with COVID-19, problems with kidney and hemoglobin levels. Dies at the Hospital due to COVID-19.
80 2021-04-19 malaise autoimmune hemolytic anemia; Evans Syndrome; Jaundice (presumed from hemolysis) weakness light-head... Read more
autoimmune hemolytic anemia; Evans Syndrome; Jaundice (presumed from hemolysis) weakness light-headedness Patient received first COVID-19 Moderna vaccination ~10-14 days prior to onset of hospitalization. Presented with weakness, malaise, jaundice. Lab tests revealed severe anemia that did not respond to transfusions (presumed due to ongoing hemolysis). Began treatment with corticosteroids (IV Solu-Medrol) and IV immunoglobulin to attempt to treat immune-mediated hemolysis.
80 2021-04-22 fatigue Redness at the injection site the same day, followed by a rash and hot to the touch on 4/22/21. Al... Read more
Redness at the injection site the same day, followed by a rash and hot to the touch on 4/22/21. Also reports fatigue.
80 2021-04-24 fatigue Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 da... Read more
Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 days after vaccine
80 2021-04-25 headache, fatigue Day 1-3 Left upper shoulder pain from injection. Day 4-8 Headache, tiredness, fatique, nausea, v... Read more
Day 1-3 Left upper shoulder pain from injection. Day 4-8 Headache, tiredness, fatique, nausea, vomit (1), knees joint pain. Day 4 to present - some tiredness, continued severe knee joint pain (left and right)
80 2021-04-26 headache, sluggishness Severe thrombocytopenia requiring hospitalization Subdural hematoma from low platelets Pt in excell... Read more
Severe thrombocytopenia requiring hospitalization Subdural hematoma from low platelets Pt in excellent state of health until about 2 weeks after vaccine. Pt started exhibiting spontaneous bruising and petechia without external causes of trauma. Days later patient started exhibiting signs of confusion and sluggishness and complaining of headache. On post vaccination day 21 patient taken to ER where platelets found to be 18 and CT scan showed a subdural hematoma. patient continues to be hospitalized and workup is underway to determine cause. My belief is the severe thrombocytopenia is related to the vaccine.
80 2021-04-27 fatigue Shortness of breath, fatigue, blood clots in right lung diagnosed in ER, Medical Center
80 2021-04-29 headache reports having severe headache
80 2021-05-02 fatigue, headache 3-4 hr onset fatigue. for 3 days confined to bed from fatigue. Has slowly remitted. - Now - 8 weeks... Read more
3-4 hr onset fatigue. for 3 days confined to bed from fatigue. Has slowly remitted. - Now - 8 weeks after second shot still daily fatigue, pedal edema with activity. Nap required daily. Occasional episodes of sleep disruption. 2-4 days severe arthritis flare with rheumatoid joints swelling as well as mild swelling in OA joints: fingers, wrists, elbows, neck, back, hips, knees and ankles. deformity of dips, not previously present. Now, 8 weeks later, swelling resolved but arthritis still worse than prior to 2nd immunization. Severe bruising in R upper arm. 8 weeks later still have brown discoloration over6 inch area - INR increased to 5.4 3-4 hour mild headache lasted 2 days reoccurred 2 or 3 times over the week
80 2021-05-04 chills, headache couldn't think of words; Severe headache - mostly on left side; severe chills; This spontaneous case... Read more
couldn't think of words; Severe headache - mostly on left side; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think of words) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CR1A) 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 METOPROLOL TARTRATE (LOPRESSOR) and LATANOPROST for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MENTAL IMPAIRMENT (couldn't think of words) (seriousness criterion medically significant), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills). On 28-Apr-2021, MENTAL IMPAIRMENT (couldn't think of words), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No laboratory details was given. No treatment information was given. Patient stated two occurrences of this type of episode on 27 Apr 2021 and 28 Apr 2021. 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
80 2021-05-04 pneumonia March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary car... Read more
March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary care doctor, blood work shows significant drop in platelets March 9 - first visit with oncologist/haematologist & hospitalized March 9-19 - hospitalized for tests, treatment to increase platelets, & many blood panels. No official diagnosis, treat as ITP. Follow up visits with oncologist/haematologist to keep an eye on platelets as they increase. March 30-Apr 4 - ER visit due to swelling of ankles, feet, and left arm. Tests show superficial blood clot, fluid on lungs, and pneumonia. Oncologist said that "we have no official diagnosis", that she's being treated for ITP. April 6-14 - follow up visit to oncologist/haematologist show elevated kidney enzymes, then later liver enzymes, low sodium. April 14 - decision to move to short term rehab for regular PT and OT. Continued swelling (fluid in third spaces.) April 21 - visit to cardiologist to perform cardioversion, successful (during first week of hospital stay, heart rhythm med had to stop). April 23 - facility nurse discovered significantly low Hemoglobin and a blood transfusion was ordered. April 24 - returned to short term rehab facility. April 25 - discovered my mother on O2 and state of health was different, extremely weak and not moving, arm hurting badly. I insisted that her oncologist is contacted. Transported to ER. Discovered her blood work abnormal. After stabilizing her, rushed to the hospital ICU. April 26 - Discussed with her ICU doctor the history of what you have read above. He explained that the covid-19 vaccination has a tendency to affect three proteins specifically that clot and thin blood. I begged him to "get it out of her system." Her bleeding was significant and platelets dropped, again. Still has her mental facilities. Responding well to aggressive treatment: albumin transfusion, plateletpheresis, and CRRT. Pleural catheter to remove fluid from the lungs. Mention of Sepsis. April 27 - Lifted her head up today, opened her eyes, making doctors very happy. Her cardiologist and the ICU doctor both said they were "confused" and everything happening to my mom was "a mystery." Though going in to the evening, her nurse expressed to me that she's worried. The ICU oncologist called me at home in the evening. He asked me if she had been having a fever on a regular basis. He said he thought it could be TTP or a rare disease called HTH, but both results wouldn't be back for one week. He planned to consult with a doctor. He explained to me that the blood was attacking itself and "confused," and that her organs were shutting down. He indicated that the blood work wasn't indicating significant infection. He referenced how the vaccination has made her auto immune system "go crazy." April 28 - I get a call very early from the nurse that she has been fighting with my mother's blood pressure all night, trying to keep it elevated. She told me to come to the hospital, because she had taken a turn for the worse. I arrive to find my mother's eyes wide open, breathing shallow, and blood pressure steady, but drops without assistance from medication. She continues to have her mental facilities. She passed away, organs shutting down, and blood pressure dropped.
80 2021-05-05 body temperature increased, dehydration, fatigue Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and th... Read more
Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination
80 2021-05-05 malaise kidney infection; tested positive for COVID-19; not feeling well; This spontaneous case was reported... Read more
kidney infection; tested positive for COVID-19; not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KIDNEY INFECTION (kidney infection) and COVID-19 (tested positive for COVID-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic (diabetic and uses insulin). Concomitant products included INSULIN for Diabetes. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced KIDNEY INFECTION (kidney infection) (seriousness criterion hospitalization), COVID-19 (tested positive for COVID-19) (seriousness criterion hospitalization) and MALAISE (not feeling well). At the time of the report, KIDNEY INFECTION (kidney infection), COVID-19 (tested positive for COVID-19) and MALAISE (not feeling well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
80 2021-05-11 chills, fever atrial fibrillation; itching on right scapula, intense incredible itching, whole body itching; face ... Read more
atrial fibrillation; itching on right scapula, intense incredible itching, whole body itching; face was flushed; led to intense red marks; Scratching would make blood vessels burst underneath; swollen armpits; Chills; big rash all over body; low grade fever of 99.1F; Itching on left scapula; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Drug allergy (Augmentin and Demerol). Concurrent medical conditions included Allergy (banana and plantain). Concomitant products included AMLODIPINE, EZETIMIBE (ZETIA), ATORVASTATIN CALCIUM (LIPITOR), NEBIVOLOL HYDROCHLORIDE (BISTOLIC), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN 2000), CENTRUM SILVER +50 and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Itching on left scapula). On 31-Jan-2021, the patient experienced PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F). On 13-Feb-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized on 13-Feb-2021 due to ATRIAL FIBRILLATION. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), PRURITUS (Itching on left scapula), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included Diphenhydramine, Cetirizine, OTC Cortisone cream, Methylprednisolone. Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
80 2021-05-11 cough COUGH
80 2021-05-12 fever, chills, headache My Mom had headache, body pain, chills and fever and very weak on the 29, and 30 of April. On May t... Read more
My Mom had headache, body pain, chills and fever and very weak on the 29, and 30 of April. On May the 3,2021 I found my Mom Dead in Bed. My Mom was a very active lady for her age.
80 2021-05-13 lethargy Patient stated to PCP that she developed significant weakness 2-5 days post second COVID vaccine. Pt... Read more
Patient stated to PCP that she developed significant weakness 2-5 days post second COVID vaccine. Pt also developed significant SOB. Pt is now unable to walk short distances and is unable to lift her legs, gets lethargic easily, and uses a wheelchair.
80 2021-05-13 sleepiness, fatigue pt became very sleepy immediately after taking the vax. She got home and was so fatigued and in so ... Read more
pt became very sleepy immediately after taking the vax. She got home and was so fatigued and in so much pain she went to bed and slept for almost 2 days. She says she has severe body aches and pains and is having major problems with both hands going numb, tingling, and hurting. On 4/20/21 she went to her PCP, Dr. and she was told to take Ibuprofen for her pain. On 5/6/21 she went to Dr. He did blood work. No Arthritis or other problems were found. CRP was elevated at 14. She has been to her Chiropractor on 2 different occasions to help with pain. She has had this pain going on 2 months and will see her PCP again at the end of the May.
80 2021-05-19 fatigue, headache Extreme fatigue, Bad body aches, mild headache. From about 1Am on Wed. May 19 , Very restless all n... Read more
Extreme fatigue, Bad body aches, mild headache. From about 1Am on Wed. May 19 , Very restless all night, not able to sleep. Fatigued all day. Took two 2Hr. naps, then slept from 9PM to 8:40AM. May 20th feeling pretty normal now.
80 2021-05-20 headache, fatigue Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of d... Read more
Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of desperation , crying episodes, sob
80 2021-05-20 fever, chills, fatigue pt says she developed fever, was shivering, and was very weak and tired. She went to bed. She woke... Read more
pt says she developed fever, was shivering, and was very weak and tired. She went to bed. She woke up to use the restroom. Next thing she remembered was waking up on the bathroom floor. She didnt know where she was or what had happened. She was finally able to reach her son to come help her get up and get back into bed. She was extremely weak for a couple of days. She contacted her PCP and was told to file a VAERS report. She no longer has any symptoms.
80 2021-05-24 influenza like illness, cough After first vaccination, patient experienced sever flu-like symptoms with body aches, fatigue and ch... Read more
After first vaccination, patient experienced sever flu-like symptoms with body aches, fatigue and chills. After second vaccination, similar though less severe flu-like symptoms occurred likely because the patient pre-treated with Essential Defense, an herbal blend. Shortly after the second vaccination, she began to experience loss of asthma control with worsening cough, wheezing and shortness of breath. Asthma regimen was maximized with nebulized inhaled steroids and both short and long acting beta agonists but she failed to improve significantly. Ultimately the patient required oral steroids after lung function dropped to 35% of normal.
80 2021-05-26 pneumonia, cough, respiratory tract congestion Immediately after receiving her second Moderna vaccine, patient states that she felt a tightness in ... Read more
Immediately after receiving her second Moderna vaccine, patient states that she felt a tightness in her chest. No shortness of breath noted. She did not tell anyone at the clinic, but went home to rest. She states that immediately after vaccine, she began to have cough, chest congestion and tightness. Two days later, she went to PCP for evaluation. The Dr diagnosed her with pneumonia and prescribed treatment of antibiotics, steroids and albuterol. Per patient, she has gone back to see the Dr four times and been on treatments continuously. She was referred to Pulmonologist and was seen on 4/14/21. She states that the insignificant nodules that were previously in her lungs were more pronounced. She continues to have cough and chest congestion. No fever has been noted. She will follow up with pulmonologist in July 2021. Patient states that she feels like she still has pneumonia.
80 2021-05-27 headache Had a Bad Headache for 2 Days took Tylenol. Muscle Aches had to take tramadol. Weak Legs blood pres... Read more
Had a Bad Headache for 2 Days took Tylenol. Muscle Aches had to take tramadol. Weak Legs blood pressure was high
80 2021-05-27 sinusitis Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SI... Read more
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection) (seriousness criterion medically significant). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
80 2021-05-29 fever, lethargy Received her second dose of Moderna Covid vaccine yesterday (5/23), subsequently this morning (5/24)... Read more
Received her second dose of Moderna Covid vaccine yesterday (5/23), subsequently this morning (5/24) noted to feel lethargic, dizzy, and had elevated temperature. She sought medical attention and in the ER was found to have temperature of 104°F, tachycardia, and elevated lactic acid. The patient has had no headache, change in vision, photophobia, neck stiffness, abdominal pain, cough. There is no report of sick contacts the patient resides with daughter-in-law and son. She received Rocephin empirically in the emergency room along with 30 mL/kg IV fluid bolus.
80 2021-06-01 fever, lethargy The day after the shot, patient developed low-grade fever which lasted 3 days. For 3 days, the pati... Read more
The day after the shot, patient developed low-grade fever which lasted 3 days. For 3 days, the patient was lethargic and had no energy to perform normal household duties. On the 3rd day after the shot, patient developed tachycardia for several minutes, became feverish with a clammy sweat and had vertigo saying the room was spinning and said she felt like fainting. She could not recognize her son, asking him, "Who are you?" Patient lost site in her eyes which was recovered several minutes later. Patient felt better starting the 4th day.
80 2021-06-02 lethargy severe muscle and joint pain for 6+ weeks, lethargic, weakness.
80 2021-06-02 fever, malaise, headache, chills A few hours after vaccine, right arm started to get red and swell. Patient had chills, fever, headac... Read more
A few hours after vaccine, right arm started to get red and swell. Patient had chills, fever, headache. Feeling unwell. Two to three days later she felt like she had Covid-19 again. Right Arm continued to swell from shoulder to elbow for 3 weeks. The arm was hot to the touch. Fever, headache, chills, diarrhea for 3 days. Had Covid-19 feeling all over again. Poor taste and sense of dread. Did not seek medical treatment for swelling in arm or symptoms.
80 2021-06-07 fever The following day I had a fever of 102 and was achy. In February, I developed a horrendous ringing i... Read more
The following day I had a fever of 102 and was achy. In February, I developed a horrendous ringing in my ear. I went to the doctor and my BP was high, but the ringing persisted even when it was regulated. I was sent to an ENT and was told that tinnitus is usually a nerve issue. Initially, I didn't think it had anything to do with the vaccine until my neighbor told me about her experience. She said that there isn't any treatment for it, so I'm still dealing with the ringing.
80 2021-06-09 cough, fever Patient feeling weak And was acting confused per husband today. She has a chronic cough- no change... Read more
Patient feeling weak And was acting confused per husband today. She has a chronic cough- no change. Received second dose of Moderna Covid vaccine yesterday. Denies headache, chest pain, shortness of breath, nausea, vomiting, diarrhea, fever, chills or dysuria. Has not taken anything for her temperature today. Denies recent illness.
80 2021-06-10 headache Overlapping symptoms and treatment, so reports were combined. Dose 1 - The following Tuesday, I was... Read more
Overlapping symptoms and treatment, so reports were combined. Dose 1 - The following Tuesday, I was hospitalized with very bad dizzy spells. They did a CT Scan and couldn't find anything. They also performed a chest x-ray. I was there for two days and I was fine up until the second dose. Dose 2 - 03/11/21 - The following Wednesday, I started having the dizzy spells again. They wanted me to go in the following Tuesday, but had me to come in on Friday instead due to the severity of the spells. They told me to go to an ear specialist. On 3/30, I was given a hearing test and also tested to see if there were crystals in my head, which there were none. They suggested that I see a neurologist and I met with him on 4/27. On 5/27, he performed an EEG and some type of ear test where they put ear muffs on you and play high pitched sounds. On 6/3, I received my results and both were negative. After that, I was fine until 6/7. I woke up really dizzy and I had a severe headache, which I never have. I went to the ER and also discovered that my BP was elevated. They gave me the choice of staying there and seeing the neurologist the next day or going home and making an appt. I chose to go home. I was given Meclizine 25mg to take 3 times a day for dizziness. I saw the neurologist yesterday (6/10) and he suggested therapy to help with the dizziness. I was told to cut the meds in half and wait on my therapy, which begin on 6/22. I've also had a regular eye and dental appt and both said neither of those areas are the issue.
80 2021-06-15 fatigue Client reports that 2 weeks after the second dose she had difficulty speaking and her voice sounded ... Read more
Client reports that 2 weeks after the second dose she had difficulty speaking and her voice sounded differenet. She was told by friends that she sounded different, also. She also has chronic fatigue, which worsened. She met with her NP who said she may have had a stroke, per the client. She was given a prescription for a speech therapy and a swallowing eval. She also said that she has difficulty swallowing sometimes, and feels as if her throat is closing up, but then it resolves. Client was instructed, by this nurse, to go to the hospital for this symptoms. She said she can manage it and always "comes out of it." Client was instructed to make sure she calls 911, if she has this symptom again.
80 2021-06-17 headache As far as I know, I was sitting after dinner reading and I was aware that I could not see well out o... Read more
As far as I know, I was sitting after dinner reading and I was aware that I could not see well out of my right out, it was very blurry and at the very same time though I had a very sharp pain in the left occipital region. So I was most worried about my eye because I know something was wrong. First thing in the morning I called my eye DR and she told me that I had a right side occlusion in my right eye. So then what she had me do was wait a couple weeks to see if it would go away spontaneously and it didn't. So I went to a retinal specialist and they gave me shots in that eye because I could still not see out of my eye. It has not completely cleared but it is much better. I also had a severe pain in my neck and brain. I went to the ER and the DR that evaluated me there didn't know what my diagnosis was at the time but he put me on some medications that he thought would help with the inflammation. So he put me on cortisone and gave me a prescription for valacyclovir, because I have a history of herpes infections all over my body. SO that was on the Sunday that I went to the ER. Then by Wednesday the pain was so severe that I went to the ER at the hospital because I was so uncomfortable and worried. At the end of five weeks it just went away. I did see a neurologist but it was over by then, he said the diagnosis was occipital issues.
80 2021-06-22 headache The patient reported that after receiving the second Moderna Covid-19 vaccination that she had a hea... Read more
The patient reported that after receiving the second Moderna Covid-19 vaccination that she had a headache for 3 days. Additionally, she has been experiencing a stiff neck, has been passing out, her toes have been turning blood red, and she feels like she has not been able to function during the past 3 months. She reported that she went to the hospital to have multiple tests ran, and no unusual lab values were noted. The patient went to the hospital due to the adverse effects she experienced from the vaccine. Upon speaking to the patient it was not noted how long the patient remained in the hospital.
80 2021-06-22 throat irritation Patient complained of "burning in her throat" immediately after receiving the vaccine. I gave her a ... Read more
Patient complained of "burning in her throat" immediately after receiving the vaccine. I gave her a bottle of water to drink. She then complained of a lump in her throat. I gave her a dose of benadryl, and I monitored her for over 30 minutes. She said she did not feel any better and went to the ER where they monitored her for several hours, sent her home, and told her to take more benadry.
80 2021-06-23 dehydration Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; ... Read more
Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; Dehydrated; Nauseous; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Constipation (Normally she is constipated). Concurrent medical conditions included Hypertension. On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) (seriousness criteria hospitalization and disability), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting). The patient was hospitalized on 19-May-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: 250/110 (High) High and 200/110 (High) High. Concomitantly the patient was receiving unspecified medication for hypertension . Reportedly, the patient was taken to the hospital on 19 May 2021. At the hospital, the patient's blood pressure was high and the doctors were not able to bring it down. Since the second vaccine, the patient's blood pressure has gotten much worse. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.
80 2021-06-28 influenza like illness flu-like feeling; Redness; Plague pileup; Itchiness; This spontaneous case was reported by a health ... Read more
flu-like feeling; Redness; Plague pileup; Itchiness; This spontaneous case was reported by a health care professional and describes the occurrence of PLAGUE (Plague pileup) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA), GLIPIZIDE, VITAMIN D3, FISH OIL and FLAXSEED for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-Mar-2021, the patient experienced ERYTHEMA (Redness), PLAGUE (Plague pileup) (seriousness criterion medically significant) and PRURITUS (Itchiness). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like feeling). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like feeling), ERYTHEMA (Redness), PLAGUE (Plague pileup) and PRURITUS (Itchiness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment medications were provided Action taken with mRNA-1273 Is not applicable Concomitant medication includes Cocoa butter This case was linked to MOD-2021-100453 (Patient Link).
80 2021-07-07 headache, fever, throat pain, fatigue, chills chest tightness; loss of appetite; irregular heart rate/palpitations; irregular heart rate/palpitati... Read more
chest tightness; loss of appetite; irregular heart rate/palpitations; irregular heart rate/palpitations; extreme PMS; Diarrhea; Fatigue; sleeping on and off all day; shakes; trouble moving and walking; terrible cramping like menstruation; bloated; had a painful stomach; pain moved to the chest area; body aches; chest pain; body pain; lung congestion; so much muscle pain - Muscle pain throughout the body was intense; sick; Muscle pain; fever; Nausea; Headache; chills; Fatigue/ extreme fatigue; shortness of breath; Weakness in her body, muscle and legs; Intense pain; Sore throat; Shaking; Diarrhea; Dizziness; severe stomach cramps - PMS type; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lung congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma since an unknown date, Bronchitis, Hives since an unknown date, Hypersensitivity reaction since an unknown date, Irritable bowel syndrome in 2000 and Reflux esophagitis. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Irritable bowel syndrome, Penicillin allergy (penicillin allergy), Drug allergy (arestin), Allergy to antibiotic (allergy to macrolides) and Allergy to antibiotic (ketolides used for red rashes). Concomitant products included ERYTHROMYCIN, DENOSUMAB (PROLIA), ARTHROBENE PLUS, VITAMIN D3 and DOXYCYCLINE HYCLATE for an unknown indication. On 07-Mar-2021 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), the first episode of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced ILLNESS (sick) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense). On 12-May-2021, the patient experienced PULMONARY CONGESTION (lung congestion) (seriousness criterion medically significant). On 24-May-2021, the patient experienced CHEST PAIN (chest pain) and PAIN (body pain). On 08-Jun-2021, the patient experienced MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL DISTENSION (bloated), ABDOMINAL PAIN UPPER (had a painful stomach), CHEST PAIN (pain moved to the chest area), TREMOR (shakes), HYPOKINESIA (trouble moving and walking) and MYALGIA (body aches). On 09-Jun-2021, the patient experienced HYPERSOMNIA (sleeping on and off all day), the second episode of DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations) and HEART RATE IRREGULAR (irregular heart rate/palpitations). The patient was treated with PARACETAMOL (TYLENOL) on 28-Mar-2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 08-Jun-2021 at a dose of 500 mg; ARNICA MONTANA (ARNICA 30C) at a dose of 2 Tablets; MAGNESIUM at a dose of 500 mg four times per day; LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing from 09-Jun-2021 for Diarrhea, at a dose of 2 mg as required and CHLORPHENAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (ALLERGY RELIEF MEDICINE) ongoing since an unknown date at a dose of 180 mg once a day. On 18-Mar-2021, DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), DIZZINESS (Dizziness), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache) had resolved, ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type) had not resolved. At the time of the report, PULMONARY CONGESTION (lung congestion), ILLNESS (sick), ABDOMINAL DISTENSION (bloated), CHEST PAIN (pain moved to the chest area), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest tightness), TREMOR (shakes), HYPOKINESIA (trouble moving and walking), HYPERSOMNIA (sleeping on and off all day), PAIN (body pain), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations), HEART RATE IRREGULAR (irregular heart rate/palpitations), FATIGUE (Fatigue), MYALGIA (body aches) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense) outcome was unknown and MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL PAIN UPPER (had a painful stomach) and the last episode of DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 193/75 mmhg (High) 193/75 mmHg. On 17-Mar-2021, Body temperature: 98.8 degree celsius (Inconclusive) 98.8 degree Celsius. On 17-Mar-2021, Heart rate: 60 breaths per minute (Low) 60 breaths per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took 2 papaya chewable tabs for stomach. The patient is taking allergy 10 -plus, refresh lubricant eye drops, refresh optive advanced eyedrops every 2-3 hours as needed for both eyes, trace mineral drops -8 drops(3-4 water bottles per day). Company Comment: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Concomitant medication Prolia, Treatment medication Arnica tablets were added. New events severe stomach cramps - PMS type, extreme fatigue, too sick, so much muscle pain - Muscle pain throughout the body was intense were added. On 10-May-2021: Reporter's FAX number was added. On 10-Jun-2021: Treatment medication Imodium and Magnesium were added. New events were added. On 23-Jun-2021: Outcome, FAX number updated On 01-Jul-2021: event added, lab data, medical history, con-med added; Sender's Comments: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested.
80 2021-07-07 malaise Arm pain, swelling at site. Sick feeling for 4-5 days, malice, flu symptoms aches/pains for weeks, n... Read more
Arm pain, swelling at site. Sick feeling for 4-5 days, malice, flu symptoms aches/pains for weeks, now. Swelling on right side= arm, legs, breast pain still continues, also.. no treatment other than aspirin and or Tylenol initially.. swollen right side has still persisted as well as painful breast nipple area.
80 2021-07-12 pneumonia, fever could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizzin... Read more
could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizziness; Pneumonia; nausea; had a temperature; sick for five days; vomited for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAMIPEXOLE for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), VACCINATION COMPLICATION (sick for five days), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), VOMITING (vomited for 3 days), NAUSEA (nausea) and PYREXIA (had a temperature). At the time of the report, PNEUMONIA (Pneumonia), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), NAUSEA (nausea) and PYREXIA (had a temperature) outcome was unknown and VACCINATION COMPLICATION (sick for five days) and VOMITING (vomited for 3 days) had resolved. It was reported that the blood pressure intervals were high mainly during the day time. The patient stated that prior to getting the vaccine, she was healthy and was baby sitting for 10 hours. The patient said she had to do stop doing that because she felt like she may drop her grandson since she felt like passed out. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-023313 (Patient Link).
80 2021-07-12 fever, headache Mild fever, headache, pains in shoulder and neck, hair loss.
80 2021-07-22 headache, fatigue headaches, dizziness , fatigue , shaking .
80 2021-07-23 headache Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could n... Read more
Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (The patient stated she has a lot of allergies). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested. This case was linked to MOD-2021-035954 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.
81 2021-01-08 fever, nasal congestion, headache, chills On Jan 7, 2021 I developed a low fever (100.1), chills, scratchy throat, stuffy nose, and headache. ... Read more
On Jan 7, 2021 I developed a low fever (100.1), chills, scratchy throat, stuffy nose, and headache. On Jan 8, I was tested positive for Covid with the quick result test. Fever and headache are now gone, but I continue to have scratchy throat and nasal congestion. No medical treatment sought but I am now quarantined for 2 weeks.
81 2021-01-10 fever Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted i... Read more
Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted increased confusion. Temp. 99.6 FBS 114. Resident had been provided tylenol just prior in shift for general discomfort (sore muscles) and low grade temp. On call for Dr notified of all and received order to send to ER.
81 2021-01-11 fatigue Fatigue, Dizziness, Weakness
81 2021-01-11 fever, lethargy Fever (101.4 F), lethargy, and no appetite elevate BP 133/113, P-129
81 2021-01-13 chills, lethargy Chills early AM Dizziness Evening Lethargic All day
81 2021-01-13 fatigue After the vaccine was administered , she stared and said "I feel really tired." Then she looked at ... Read more
After the vaccine was administered , she stared and said "I feel really tired." Then she looked at this vaccinator and said "You better keep an eye on me." She continued to ask if she should feel tired, ask questions, speak coherently, move all extremities. BP 110/80. No respiratory distress noted. Skin dry. No diaphoresis. Color pale. Patient's daughter was present. She stated that her mother sometimes liked to seek attention. Patient taken to medical area for monitoring. Monitored by nursing staff for 30 minutes. symptoms resolved per patient and family member.
81 2021-01-13 headache Systemic: Headache, Systemic: IRREGULAR HEARTBEAT (HAS HISTORY OF AFIB), COMPLAINED OF BEING HOT; sy... Read more
Systemic: Headache, Systemic: IRREGULAR HEARTBEAT (HAS HISTORY OF AFIB), COMPLAINED OF BEING HOT; symptoms lasted 0 days
81 2021-01-13 sleepiness Swollen to 1 and a half times normal, not red; "like a big pad on top", severe pain in left arm. Na... Read more
Swollen to 1 and a half times normal, not red; "like a big pad on top", severe pain in left arm. Nausea but it passed; feels weak and slept 6 extra hours today. Joint pain in shoulders and legs. No fever.
81 2021-01-14 sleepiness, body temperature increased Temp of 100.3 for about 12 hours, sleeping all day , couldn't seem to stay awake. Temp of 97.7 on 0... Read more
Temp of 100.3 for about 12 hours, sleeping all day , couldn't seem to stay awake. Temp of 97.7 on 01/15/2021 and feeling fine.
81 2021-01-18 chills, nasal congestion BODY AHCES, CONGESTION, CHILLS
81 2021-01-18 headache Sore arm for 2-3 days Headache for 4 hours the same evening
81 2021-01-19 fatigue, fever Patient states that the night of her vaccine she felt feverish, and had extreme shortness of breath ... Read more
Patient states that the night of her vaccine she felt feverish, and had extreme shortness of breath for about 5-6 hours, and she has been exhausted ever since. She states there has been a few days she has not even been able to get out of bed.
81 2021-01-19 sleepiness, fever, headache Vomiting, drowsiness, fever, diarrhea, headache
81 2021-01-20 fatigue, headache, chills, fever Over the course of about 12 hours I experienced extreme fatigue (sleepy state), muscular pain at t... Read more
Over the course of about 12 hours I experienced extreme fatigue (sleepy state), muscular pain at the site of the injection, chills, nausea and vomiting, fever and lingering headache.
81 2021-01-21 chills the night of vaccine Started feeling bad all over about 7 pm aching and chills all over. went to bed... Read more
the night of vaccine Started feeling bad all over about 7 pm aching and chills all over. went to bed early because i felt so bad a little nauseous. about an hr later i got up and threw up. i took 1 tsp of pepto, before i threw up and after. I only weight 89 pounds so i feel like it affected me differently. the next day (today) had nausea when i woke up but am starting to feel a little better. able to keep down a little yogart.
81 2021-01-21 headache Patient c/o headache. She was an older women in a wheel chair and the temperature in the stadium wa... Read more
Patient c/o headache. She was an older women in a wheel chair and the temperature in the stadium was extremely cold and most of the people were shivering even if they had no other problems. The patient complained of headache after 12-15 minutes. She was alert and oriented X3 in NAD. Vital signs: BP-118/82 HR-86 O2 Sat-98%. She did not have any visual problems, nausea, vomiting ,chest pain ,stridor, SOB , or rash. I listened to her with the stethoscope. Her lungs were clear . No rales or wheezing and heart rate was normal. She was watched for almost 40-45 minutes .She had headache but it improved somewhat. I informed her to drink enough fluids, take pain killer either Tylenol or Advil whatever her MD recommends- to take when she has pain. I also informed her daughter to keep a close watch on her for 2 days and if any problems call her MD and take her to ER. I watched her very closely in the post vaccination area before she left.
81 2021-01-22 fatigue, fever, chills Ran a fever, chills, and body aches. Dizzy causing me to fall & exhaustion.
81 2021-01-23 body temperature increased, headache Headache, slight elevated temperature, sore arm
81 2021-01-23 fever Fever of101.0 for approximately 24 hours with muscle and joint discomfort no temperature on 1/24/202... Read more
Fever of101.0 for approximately 24 hours with muscle and joint discomfort no temperature on 1/24/2021 feeling better today
81 2021-01-25 body temperature increased Temperature of 103.3 degrees Fahrenheit on 1/18/2021 @ 5:42pm. Acetaminophen 650mg administered as w... Read more
Temperature of 103.3 degrees Fahrenheit on 1/18/2021 @ 5:42pm. Acetaminophen 650mg administered as well as cold compresses. Temperature of 101.5 degrees Fahrenheit on 1/18/2021 @ 9:18pm. Orders obtained to administer one liter of normal saline via intravenous route due to patient's poor oral intake. IV fluids initiated. Temperature of 99.9 degrees Fahrenheit on 1/18/2021 @ 11:25pm. Patient resting comfortably. Temperature of 98.4 degrees Fahrenheit on 1/19/2021 @ 05:47am.
81 2021-01-25 chills Had Covid in December, the day after receiving the vaccine around 11AM I developed chills and my sh... Read more
Had Covid in December, the day after receiving the vaccine around 11AM I developed chills and my shoulder/arm was sore and achy this morning made it up to my neck I started experiencing chills.
81 2021-01-25 fatigue On the first day, my arm was sore and I was a little tired. I had some abdominal pains on the day af... Read more
On the first day, my arm was sore and I was a little tired. I had some abdominal pains on the day after the vaccine with diarrhea. After 24 hours of that pain, I could get up and move around. About a week I felt better.
81 2021-01-25 sweating Patient was in 15 minutes observation after COVID vaccination when she started experiencing SOB at 4... Read more
Patient was in 15 minutes observation after COVID vaccination when she started experiencing SOB at 4:18 pm. Started with O2 treatment at 3 ml flow rate, notified site lead immediately. Under site lead supervision, attempted to take VS : HR 90 irregular, RR 40 irregular, unable to take BP due to equipment malfunction. No T due to no thermometer in observation room. Patient is diaphoretic states SOB, dizziness. Denies Chest pain. No N/V. At around 4:20 pm, one dose ( 0.3 ml) of epi-pen adult was administered left lateral thigh and called Emergency service ambulance per protocol. At 4:30 pm, EMS ambulance and police were arrived. Detailed patient care information was provided and handed over the care to the team. At 4:40 pm, patient left with emergency ambulance team.
81 2021-01-26 sneezing, fatigue, headache, fever, runny nose, sluggishness 1/22 day of vaccination pt started experiencing extreme tiredness, pain in right arm/tender, low gra... Read more
1/22 day of vaccination pt started experiencing extreme tiredness, pain in right arm/tender, low grade fever, headache, sluggish, trouble sleeping, runny nose, sneezing, fever 100 after a couple days. PT is still experiencing tired, headache, extreme sluggish.
81 2021-01-27 chills night of injection chills lasted about an hr. this morning when i woke up i felt very weak and went ... Read more
night of injection chills lasted about an hr. this morning when i woke up i felt very weak and went to the bathroom and tried to sit down and i passed out.
81 2021-01-28 fatigue Sore Arm Tired fatigue
81 2021-01-28 fever 1/27/21 - Woke up at 5 am, and felt awful, it was dark outside. Symptoms included; Difficulty walkin... Read more
1/27/21 - Woke up at 5 am, and felt awful, it was dark outside. Symptoms included; Difficulty walking Felt Shaky Feverish and hot Very confused, could not tell if it was day or night Did not take any medication that day Slept all day, and woke up several times At 5 pm, ate sandwich (but was not hungry) drank water Went back to bed and slept until the next day 1/28/21 Woke up 1/28/21 and felt fine
81 2021-01-28 fever Weakness, appetite loss, fever of 102 degrees 24 hours, generalized aches
81 2021-01-29 chills, fatigue Within 2 hours of receiving the first Covid19 Moderna vaccine injection I suddenly became very tire... Read more
Within 2 hours of receiving the first Covid19 Moderna vaccine injection I suddenly became very tired and with strong chills throughout rest of day and throughout the night. No fever that I am aware of. I slept on and off for many hours. It actually continued for 4 days in varying degrees and on Day 5 I woke up that morning feeling like my old self, energized and ready to have a normal day...which I did!!
81 2021-01-30 chills, fatigue Vomiting and diarrhea at the same time/ then chills and extreme fatigue then diarrhea continued for ... Read more
Vomiting and diarrhea at the same time/ then chills and extreme fatigue then diarrhea continued for two days this began at about 8 pm the day of the shot.1/27 lasted until 1/30/2021. Sunday am of 1/31 mild fatigue fading away.
81 2021-01-31 chills, fever Chills, fever, nausea
81 2021-01-31 fever Redness, fever on injection site, inflammation, swelling, hardness
81 2021-02-01 headache I got shot on Friday and the next morning at 2 am i got a really bad head ache that last about half ... Read more
I got shot on Friday and the next morning at 2 am i got a really bad head ache that last about half hr. It started getting better after i took a 650 mg Tylenol. Worse when i lay down. Saturday it happened again at 2:30 am it was not a bad pain more like an ache to a pain but nothing like the 1st night. Sunday i had no pain. Then Monday at 3 Am it was a really bad pain again. Today i was sleeping and at 7:30 Am I woke up with headache that was very uncomfortable. Got out of bed and took my Tylenol about 30 mins later the pain went away. Today it went away much quicker then the 1st couple of nights.
81 2021-02-03 headache headache, dizzyness, nausea, body aches
81 2021-02-04 chills, fever Sore arm on 2nd day lasting one more day. On day 8 post injection, arm hurting and sore with itchy ... Read more
Sore arm on 2nd day lasting one more day. On day 8 post injection, arm hurting and sore with itchy red rash approximately 2-3 inches in diameter.. Low-grade fever, some chilling and heat at site.. on-going.
81 2021-02-04 chills warm arm at the site, then 4 hours later chills, and having vomiting over night
81 2021-02-04 fatigue, headache No reaction day1. Day 2 swelling and redness size of dime. Day 3-6 no reaction. Day 7 pm red, swolle... Read more
No reaction day1. Day 2 swelling and redness size of dime. Day 3-6 no reaction. Day 7 pm red, swollen , itchy red spot size a little larger than golf ball and slight headache . This lasted 5 days with red area 31/2? wide and feeling tired and slight headache. Days 12and 13 all symptoms vanish. This morning, 2/05/2021 my arm is again 3? area red, itchy, slight headache and fatigue. I hear that this called Covid arm and seems to affect about .06 % of those who have had the Moderna vaccine. I thought I should report this because my husband who had the same injection had no symptoms at all...not even redness at the site.
81 2021-02-04 fatigue Day 1: 01/07/21 Moderna Vaccine Dose #1 was given in left arm. No side effects noticed. Day 2: 01/08... Read more
Day 1: 01/07/21 Moderna Vaccine Dose #1 was given in left arm. No side effects noticed. Day 2: 01/08/21 No side effects noticed. Day 3: 01/09/21 Left arm slightly sore (no action taken). Days 4-9: 01/10/21 to 01/15/21 No side effects noted. Day 10: 01/16/21 (T:98.0) Woke up to a large welt, hot to the touch, no pain on upper left arm - below injection site. Began 25mg Benadryl (25 mg) 2 doses taken. Day 11: 01/17/21 (T:98.2) Welt increasing, hot to the touch, slight burning on back of neck also. Took Benadryl (25mg) twice during the day and Tylenol (650 mg) twice during the day. Day 12: 01/18/21 (T:98.0) Rash seems to be flattening out spreading a little, neck rash seems slightly worse. Burns. Day 13: 01/19/21 (T:98.6) No change in symptoms Took Benadryl (25mg) twice Day 14: 01/20/21 (T:98.3) Rash seems to be spreading into the armpit area. Neck area is larger and burning. Took three Benadryl (25mg) during the day-Tylenol 2 tabs (650 mg) at bedtime. Day 15: 01/21/21 (T:98.3) feeling tired. Rash is spreading under both armpits and neck. Back seems to be itching a lot too. Took Benadryl (25mg) three times. Day 16: 01/22/21 (T:98.6) Rash is really bad! Area of original welt is slightly larger. Took Benadryl (25mg) 6 am, 12pm, 6pm 10, pm and 3am. Will call MD on Monday. Used Shea Butter lotion (little help). Day 17: 01/23/21 (T:98.0) Rash is worse, both arms and larger neck areas hot to the touch burning sensation. Benadryl (25mg) 6:30 am. (37.5mg)10:30sm, (37.5 mg) 3:30 pm, (25mg.) 8:30 pm. 2 Tylenol (650 mg.) 9:00 pm. Day 18: 01/24/21 (T:98.8) Rash is still worse and spreading (will call MD tomorrow). Benadryl (25 mg) 6:30 am and 11: 45 am, 2 tabs of Tylenol (650 mg) noon and 4:00 pm. Shea butter lotion not helping. Applied ice, seemed to ease burning sensation but still miserable. Day 19: 01/25/21 (T:98.4) Saw Dr. who prescribed RX: Prednisone 60 mg daily for 5 days, Benadryl 25-50 mg for itching, oatmeal baths, cortisone 1% cream or lotion, I picked up my RX and a new package of Benadryl/Banophen. Went home and took Benadryl (50 mg) 2 tablets at 9:30 am,1:30 pm and 5:15 pm, mistakenly believing they were 25mg tabs because of packaging change and miniscule text on bottle and difficult to find directions. Also Prednisone 60 mg, 10:00 am. Took 2 Tylenol (650 mg) 12:45pm and5:20 pm. I did not realize that the Benadryl dosage was different! Actually double! So I took 300 mgs of Benadryl. Took an oatmeal bath at 5:30 pm. Around 6:30pm I felt a little dizzy. So I went to bed because I did not feel right. I was not making any sense. When my daughter FaceTime?d me and realized I was slurring my words. She phoned her sister to do a wellness check. 2021 Covid Vaccine They found me still incoherent and unsteady. I did not realize that the bottle of Benadryl was a different dosage! Dr. office and spoke to doctor on call. They suspected steroid psychosis. We had not yet puzzled out the exceeded dose of Benadryl/Banophen. Used oximeter during night to monitor breathing, which was normal. Day 20: 01/26/21 (T:98.2) Prednisone dosage was decreased to 40 mg daily (due to question of psychosis). No cortisone cream or lotion. The dosage of Benadryl was discovered and resolved. Rash is still spreading over body. Now on lower stomach. Benadryl (25 mg), one tablet at 9:30am, Benadryl (12.5mg) at 2:00 pm, 9:30 pm. 2 Tylenol (650 mg) at 1:20 am, Pepcid AC (new addition at 10:00 am, Prednisone (40 mg) noon. Trying aloe and calamine. Day 21: 01/27/21 (T:98.4) Rash on neck and underarms spreading, also back is now raw. Feeling less fidgety. Pain slightly better. Benadryl (25mg) 7:30 am, 3:30 pm, 10:00 pm, Prednisone (40 mg.) 9:00 am, Pepcid AC, 2:00 pm. Day 22: 01/28/21 Feeling slightly better, Benadryl (25 mg) 6:50 am,1:00 pm, 7:30 pm. Prednisone (40 mg.) 6:15 am. Pepcid AC, 1:00 pm. Day 23: 01/29/21 (T:98.6) Rash is still spreading. Benadryl (25mg.) 3:30 am, 9:00 am, 2:30 pm, 8 ;38 pm, Prednisone 7:30 am, Pepcid AC 2:00 pm. Day 24: 01/30/ 21 really itching, neck burning, Benadryl (25mg) 2:05 am,8:00 am, 2:30 pm, 8:30 pm, 1:30 am. Prednisone (30 mg) 8:00 am, Pepcid AC 3:30 pm Day 25: 01/31/21 Oatmeal bath at 1:30 am. Benadryl (25 mg) 7:35 am,1:45 pm, 7:10 pm, Prednisone (20 mg.) 7:30 am & 1:00 pm total 40 mg. Pepcid AC 5:00 pm. 2 Tylenol (650 mg) 6:00 pm. Neck bright red again and rash worse on forearms and hands. Wearing gloves in effort not to scratch. Misery continues. 2021 Covid Vaccine Day 26: 02/01/21 (T:98.6) Benadryl (25 mg.) 2:30 am, 7:50am, very itchy, did not use ice for last 12 hours. Rash is now in the groin area. 20mg prednisone at 9:55am. 2 Tylenol (650mg) 11:45am. 12:10pm Pepcid AC. Saw new dermatologist who prescribed Rx strength steroid cream.
81 2021-02-05 headache, fever, chills Chills, slight fever, intense headache, nausea - vomiting and dry heaves Nausea treatment = pedia... Read more
Chills, slight fever, intense headache, nausea - vomiting and dry heaves Nausea treatment = pedialite freezer pops Nausea = 12 hours/ fever = 24 hours/ headache & chills = 36 hours
81 2021-02-06 chills, nasal congestion, sneezing No side effects on day of vaccination. Next a.m. (Feb. 5): sneezing, stuffy nose, chills, aches; t... Read more
No side effects on day of vaccination. Next a.m. (Feb. 5): sneezing, stuffy nose, chills, aches; these symptoms lasted until evening of Feb. 6. I take a natural antihistamine during pollen seasons (Natural D-Hist)--started that 3X a day a.m. Feb. 6, and also echinacea and astragalus tinctures 3X a day through Feb. 7. These remedies helped, and I was feeling ok by evening of Feb. 6.
81 2021-02-06 fatigue Burning skin, nausea, tiredness, burning internally, insomnia
81 2021-02-07 body temperature increased, headache Woke up Friday with terrific headache, darts shooting through head, sore neck, sore back, sore arm, ... Read more
Woke up Friday with terrific headache, darts shooting through head, sore neck, sore back, sore arm, pretty much sore all over, had temp of 101 in afternoon, felt weak and very, very bad, did not visit dr. felt really bad for 1 day and 1 night, am a bit afraid to take second dose, was much better on Saturday
81 2021-02-07 chills chills and hypertension. systolic bp 200s
81 2021-02-07 head discomfort 7-10 days after vaccine head was itchy, enough to wake client up at night. Scratching. Started at cr... Read more
7-10 days after vaccine head was itchy, enough to wake client up at night. Scratching. Started at crown of head and approximately half of clients hair fell out.
81 2021-02-07 sweating, cough, fever pt started feeling weak, deep dry cough 6 hours after vaccination, pt took robitussin dm to help, ... Read more
pt started feeling weak, deep dry cough 6 hours after vaccination, pt took robitussin dm to help, fever low grade, increased fluid intake, muscle/joint aches , cough worsened, pt tried Mucinex to try and break up mucus if there was any, sweats, next day mucus was beginning to loosen, fever low grade, pt also had to take Aleve twice daily to help with symptoms, body aches, flu like symptoms
81 2021-02-07 fever 81 year old female presents to the urgent care with a raised red rash to her left arm. States she re... Read more
81 year old female presents to the urgent care with a raised red rash to her left arm. States she received her COVID-19 vaccination on 1/23, denied having any symptoms except for a subjective fever about 36 hours following her vaccine. Patient stated on 1/31 she noted a coin sized red spot to her left arm, then placed vitamin A ointment to arm, then throughout the week it has continued to grow and feels that it has started to "swell". Patient denies fever, difficulty breathing, pain, itching, or fluid from red area on arm.
81 2021-02-08 lethargy, chills Painful neck and shoulders, right arm, followed by chills. Also lightheadedness and slight dizziness... Read more
Painful neck and shoulders, right arm, followed by chills. Also lightheadedness and slight dizziness. Temp 90.1 degrees (at highest). Total lack of energy and appetite. Next day, lethargy and some diarrhea (not bad). side effects lasted from Feb. 7 evening to Feb. 8 evening. On Feb. 9, just some lightheadedness.
81 2021-02-09 fatigue Patient assessed and monitored by EMS on 2/4/2021 post vaccination: Chief Complaint: Difficulty brea... Read more
Patient assessed and monitored by EMS on 2/4/2021 post vaccination: Chief Complaint: Difficulty breathing; tremors Secondary Complaint: Dizziness; full body weakness History of Present Illness: Patient was receiving COVID 19 vaccine. After injection, patient began experiencing labored breathing, full body tremors, and became extremely weak. Patient requested to be checked out. Medical History: Obtained From: Not Recorded Current Medications: None - Reported By Patient Allergies: Albuterol Lidocaine Sulfur Neurological Exam Level of Consciousness: Alert Loss of Consciousness: No Chemically Paralyzed: No Stroke Scale: Cincinnati Negative Mental Present: Oriented-Time, Oriented-Event, Oriented-Place, Oriented-Person, Normal Baseline for Patient Pupils Left, Right Size: Normal, Normal React: Reactive, Reactive Motor, Sensory LA: Normal, Normal RA: Normal, Normal LL: Normal, Normal RL: Normal, Normal Airway Status: Patent Performed By: Patient Outcome: Unchanged Respiratory Effort: Normal Sounds: L: Clear R: Clear Sounds: breath sounds clear all fields Cardiovascular JVD: Not Appreciated Cap. Refill: Less than 2 Seconds Edema: Not Appreciated Pulses Left, Right Carotid: Not Checked, Not Checked Radial: Strong, Strong Femoral: Not Checked, Not Checked Injury Details Reason for Encounter: Injury/Trauma Drugs/Alcohol?: None Initial Physical Findings Assessment Skin: Capillary Nail Bed Refill less than 2 seconds, Dry, Normal, Warm Skin Findings: Skin CTC normal, warm, dry, pink Left Shoulder Findings: Injection site of vaccine; no swelling noted Mental Status: Normal Baseline for Patient, Oriented-Event, Oriented-Person, Oriented-Place, Oriented-Time Impression / Diagnosis Symptoms: Breathing Problem, Tremor, unspecified, Weakness, Tachypnea, not elsewhere classified Impression: Dizziness, Weakness Initial Patient Acuity: Emergent (Yellow) Activity 15:40: HR=98, BP= 106/70, Alert, RA SpO2=99, Resp.= 22 Labored Crew was requested over to RN vaccine station to assess female patient presenting with labored breathing, slight tachypnea, full body tremors, and general body weakness. Patient had just received first dose of Moderna COVID-19 vaccine. Patient is AAOx4, (-)LOC, (-) signs of anaphylaxis. Patient is assisted onto stretcher, secured with straps x3 and side rails raised and brought over to ems triage area. Patient denies any pain, complains of uncontrolled full body tremors. 15:47: HR=78, BP=134/90, Alert, RA SpO2=98, Resp.=20 Labored, Cincinnati Negative Crew assesses, patient shows no signs of anaphylaxis, lung sounds clear in all fields. Patient feels light headed and is lowered to supine position. Patient states she has had an episode similar to present in doctors office a few years ago when administered albuterol, and event had subsided approx. 30 minutes later. 16:01: HR=78, BP=136/p, Alert, Resp.= 18 Labored, Cincinnati Negative Vitals reassessed. Still above normal baseline for patient. 16:10: HR=80, BP=120/p, Alert, RA SpO2=98, Resp.=18 Labored, Cincinnati Negative Vitals reassessed, patient now showing full body involuntary tremors and complains of extreme weakness when moved to fowlers. Patient Cincinnati negative, no signs of anaphylaxis. Patient moved back to supine position. 16:18: HR=76, BP=122/68, Alert, RA SpO2=97, Resp.=18 Normal Vitals reassessed, breathing no longer labored, patient states she feels better and wishes to go to bathroom. Patient is assisted to bathroom with assistance from RN. 16:35: HR=74, BP=126/68, Alert, RA SpO2=97, Resp.=18 Normal Vitals reassessed, patient wishes to walk around and see how they feel, crew monitors. No tremors are noted for several minutes, patient now sitting fowlers on stretcher. Patient is advised that at any time they can call 911 if they feel they don't feel right or are unsure of condition. Patient is always made aware that ems crew does not diagnose and does not have the ability to see and diagnose underlying conditions that a hospital would have the capabilities to do so. After several more minutes of walking and discussion of patient condition, patient wishes to sign RMA , and go home with husband, daughter was waiting at residence. patient signs RMS, AMA, RN signs as witness. Patient care diminished. 2/5/2021 at 11:08am: Public health nurse called patient at for follow-up. Patient stated she was ?not steady on feet for a while? on prior night. Patient stated she started to feel ?back to normal? today. The only symptom patient is reporting today is feeling tired. Received verbal consent from patient to update her HCP, Dr. , about her reaction post vaccine. , RN
81 2021-02-09 influenza like illness Flu like symptoms and treated with Tylenol every 4 hours.
81 2021-02-10 fatigue, influenza like illness Felt like I had the flu. All I wonted to do was sleep For 3 days. The first day I felt a little sic... Read more
Felt like I had the flu. All I wonted to do was sleep For 3 days. The first day I felt a little sick , then mostly Felt real bad.
81 2021-02-10 fever Patient had a sore arm and achiness for 2-3 days after the shot, but then a week later on 2/10/21, s... Read more
Patient had a sore arm and achiness for 2-3 days after the shot, but then a week later on 2/10/21, she developed a hard knot at the site that was red. The red coloring has intensified today, 2/11/21, and the knot is palpable to the touch. She is also running a low grade fever that she was not running before. Patient is concerned there may have been something in the vaccine that caused her an allergic reaction.
81 2021-02-11 chills, fatigue, fever Fever, chills, body aches, fatigue, fainting through first night. Body aches and fatigue next day an... Read more
Fever, chills, body aches, fatigue, fainting through first night. Body aches and fatigue next day and night. Still have some aching and fatigue on fri, second full day after vaccination
81 2021-02-11 headache PATIENT CHOSE TO WAIT 30 MINUTES AFTER VACCINE FOR OBSERVATION. AT 25 MINUTES SHE BEGAN EXPERIENCE A... Read more
PATIENT CHOSE TO WAIT 30 MINUTES AFTER VACCINE FOR OBSERVATION. AT 25 MINUTES SHE BEGAN EXPERIENCE A HEADACHE. PATIENT STATES SHE NEVER GETS HEADACHE. SO THE EMS UNIT AT OUR LOCATION WAS REQUESTED. HEADACHE WAS RANKED A #2 FROM 1-10 PAIN SCALE. PATIENT STATED HER HEADACHE MAY HAVE BEEN AUSE BY THE FUMES FROM THE PROPANE HEATERS IN THE GARAGE, PATIENT RECOVERED AND WAS RELEASED
81 2021-02-13 chills Chills
81 2021-02-13 fatigue, fever Woke up with 101.6 fever; took Tylenol and fever only dropped to 99.9. Later in day went back up to ... Read more
Woke up with 101.6 fever; took Tylenol and fever only dropped to 99.9. Later in day went back up to 101.6. Next day fever gone, but left me very tired.
81 2021-02-14 nasopharyngitis, malaise My entire body really ached. I was freezing. I was feeling absolutely miserable. Very physically unc... Read more
My entire body really ached. I was freezing. I was feeling absolutely miserable. Very physically uncomfortable. No appetite whatsoever. I was feeling close nauseated. I almost felt shaky. I took an Advil about four hours later and I felt a little better. I had diarrhea that afternoon. I turned up the heat and started drinking chamomile tea to warm up. I didn't eat anything anything until about 6:00, when I had toast and banana. Feelin 95% better by Monday.
81 2021-02-14 fever, sleepiness, chills Extreme chills andfever. Dry mouth,edema, of etrmities,weakness,loss of appitite,sleepiness
81 2021-02-14 throat irritation, fatigue, respiratory tract congestion, chills pt stated that she has had difficulty breathing at night, congestion, thickness in her throat, chill... Read more
pt stated that she has had difficulty breathing at night, congestion, thickness in her throat, chills, nausea, constant dizziness, has a rash around her neck, has fatigue and weakness. Pt also has had pain in her right knee the night of the vax. Pt just feels bad, raised blood pressure, has numbness in both hands and is very uncomfortable. Pt called her PCP and was told to her to take an extra HBP pill. Since pt is still having most of these symptoms she will call her PCP back for more medical advice.
81 2021-02-15 fatigue Muscles in both upper arms ached for several days. A small patch of rash appeared below the injecti... Read more
Muscles in both upper arms ached for several days. A small patch of rash appeared below the injection spot, General feeling of being tired or exhausted at times.
81 2021-02-16 fever, chills 2/13/21 None 2/14/21 Late morning, body aches, chills, fever (101.8) Tylenol, 12 hours. symptoms g... Read more
2/13/21 None 2/14/21 Late morning, body aches, chills, fever (101.8) Tylenol, 12 hours. symptoms gone morning 2/15 2/15 evening checked injection site, pressure sensitive, warm slightly swollen large red area, cool wet compress, no temp 2/16 same as 2/15, took antihistamine 25mg, informed primary physician 2/17 better, spot that looks like a permanent injection spot. no temp, waiting for doctor reply
81 2021-02-17 headache Started at 5 am throwing up, sore, weak, headache, freezing On Sunday 2 days after shot felt better,... Read more
Started at 5 am throwing up, sore, weak, headache, freezing On Sunday 2 days after shot felt better, still weak and started canker sores in mouth and swelling. Still have symptoms as of today 2/18/21. Doctor calling in steroid.
81 2021-02-18 fever, chills 8 days later I collapsed. 6 days later I had a 4 inch very red and itchy elevation, it was very swol... Read more
8 days later I collapsed. 6 days later I had a 4 inch very red and itchy elevation, it was very swollen and itchy and black and blue at the site. My skin, I had a rash, I was weak, chilled, nausea and I felt feverish. I had aches.
81 2021-02-18 fever Vaccine site on rt arm began to get red.. Was 3 inches in diameter by evening of 02/18/2021. This wa... Read more
Vaccine site on rt arm began to get red.. Was 3 inches in diameter by evening of 02/18/2021. This was accompanied by fever which lasted 24 hrs. Area becoming less red today but still about 2 inches in diameter. I feel this will subside as I have had adverse reaction to a shingles shot before.
81 2021-02-19 fatigue, headache (Sorry, couldn't read 2 numbers of the lot number) I did experience the shot hurting just a little ... Read more
(Sorry, couldn't read 2 numbers of the lot number) I did experience the shot hurting just a little on first and second day, not unlike any other injection I have had in the past. On or around 2/14/21, I started experiencing itching/redness and a lump and warming of the skin which got a little worse in the next few days. The lump went away first. I still have a small amount of warmth and redness/itching today 2/20/21. Yesterday on the 19th, I did have a slight headache (not usual for me) and was a little more tired than normal. Today, so far, I feel fine other than the small amount of itching and redness.
81 2021-02-19 headache, chills, fever Fever of 102.7 chills nausea headache
81 2021-02-19 sweating Profuse sweating, no fever, aching throughout body starting at midnight. Lasted until 9 a.m. on 2/... Read more
Profuse sweating, no fever, aching throughout body starting at midnight. Lasted until 9 a.m. on 2/16/21
81 2021-02-19 fever, chills Nearly 1 week after, I developed a rash, redness, and swelling at injection site. I also experience... Read more
Nearly 1 week after, I developed a rash, redness, and swelling at injection site. I also experienced a low grade fever ( 99.7) with chills, muscle and joint aches.
81 2021-02-21 fatigue, chills I had some shortness of breath. I had chills. 99.4 temp. I was nauseated but never vomited. irregula... Read more
I had some shortness of breath. I had chills. 99.4 temp. I was nauseated but never vomited. irregular heartbeat. very tired most of the day. 3 days later I broke out in a rash on my arm below the injection site and around my arm.
81 2021-02-21 headache, chills, fever A few hours after the vaccine, came home and got a headache, then she got nausea. She went to bed, ... Read more
A few hours after the vaccine, came home and got a headache, then she got nausea. She went to bed, and all night and into the next day had fever/chills. She got up during the night to get some water she collapsed and could not get up as she was so weak. Her husband found her and helped her back to bed. Today, 2/22/21 she is better today and feels almost to normal. She took Pepto-Bismol for the nausea. Tylenol/Ibuprofen did not take the headache, but it did finally go away. The headache was on the top of her head.
81 2021-02-21 headache, fatigue Rash,itch, swelling. Headache, fatigue.
81 2021-02-22 chills, headache I had my first dose of the Moderna vaccine on Feb. 10, 2021. I had about three days of chills, aches... Read more
I had my first dose of the Moderna vaccine on Feb. 10, 2021. I had about three days of chills, aches, headache, very sore arm. etc. On Feb. 22,2021 a red area about 3 or 4 inches around the site of the injection was noticed. It was itchy and uncomfortable. I spoke to my internist and allergist. There is some disagreement about whether I should take the second dose. I have taken benadryl and tylenol. Both doctors said it was unusual for such a reaction 2 days after receiving the vaccine. What information do you have about rashes occurring so long after the vaccination? What is the recommendation about the second vaccine? Thank you.
81 2021-02-22 sweating Patient presented with three weeks of progressive back pain and bilateral lower extremity radiculopa... Read more
Patient presented with three weeks of progressive back pain and bilateral lower extremity radiculopathy, associated with night sweats (no fevers, no leukocytosis), found to have extensive T9-S1 spinal epidural abscess due to MSSA. Symptoms started at around the time the patient received her first COVID-19 vaccination on 1/26/2021. No other obvious source of infection (she does have an ear wound but this did not appear infected). She was admitted to the Hospital on 2/17/2021. Adverse event reported on 2/23/2021. She remains hospitalized as of this report.
81 2021-02-22 malaise, influenza like illness 12:01 am 2-18-21 pt. felt sick went to bathroom, passed out and lost control of bowel. Said she fel... Read more
12:01 am 2-18-21 pt. felt sick went to bathroom, passed out and lost control of bowel. Said she felt like she had the "flu".
81 2021-02-22 fever, malaise, fatigue Had body aches and low grade fever 99 +, took Tylenol 500mg, and fever broke. Next day just didn't f... Read more
Had body aches and low grade fever 99 +, took Tylenol 500mg, and fever broke. Next day just didn't feel well, tired and little nauseated. That lasted all day but next day felt fine.
81 2021-02-23 chills, headache, fever #1 Moderna 1/24/2021 1500 #2 Moderna 2/21/2021 1500 #1Moderna lot 029L208 #2Moderna lot 039K208 Side... Read more
#1 Moderna 1/24/2021 1500 #2 Moderna 2/21/2021 1500 #1Moderna lot 029L208 #2Moderna lot 039K208 Side effects started that day after, that include pain to abdomen, chest, pelvic area and chills, felt feverish did not check temp, headache, injection site pain. Did the adverse event start after the first or second vaccination? Side effects started after each vaccines the following day, she just now realized this today. Symptoms severity about the same compared to 1st shot. Symptoms started resolving after a week or so.
81 2021-02-23 chills, fever, fatigue fever, chills body aches, shortness of breath, urinary frequency, factigue, headache, body aches, wa... Read more
fever, chills body aches, shortness of breath, urinary frequency, factigue, headache, body aches, water does not taste good.
81 2021-02-23 headache Rash on chest area, headache and muscle aches Lasted 2 days. Rash still on chest
81 2021-02-23 headache Upon getting up next day felt like I was having vertigo It became full blown on the 19th (two days l... Read more
Upon getting up next day felt like I was having vertigo It became full blown on the 19th (two days later). Was unable to get out of bed that day. But got medicine to help with dizzy ness and nausea. No fever. Just headache and dizziness
81 2021-02-24 sinusitis, headache 8 days after vaccination pt noted a 1.5 - 2 in diameter pale red area with speckled dots around her ... Read more
8 days after vaccination pt noted a 1.5 - 2 in diameter pale red area with speckled dots around her injection site. 4 days later on 2/22/2021 area was larger at 2.5in x 3in area that was pale red with red dots dispersed around the injection site. Pt did take antihistamine on 2/21/2021 for headache and sinus. Reported very minor itch or irritation to the area but not pain, warmth or swelling. Pt saw her primary provider on 2/24/2021 due to area still present. No treatment course given per her primary provider. Pt reported on 2/25/2021 that the area was not a pale pink color and less noticeable but the size was the same. She feels it is starting to subside. No other s/s of reaction reported.
81 2021-02-27 chills chills, fatigue, sever arm pain, nausea, dizziness
81 2021-02-27 headache I got Delayed Cutaneous Sensitivity from this vaccine .It was painful and debilitating - headache pa... Read more
I got Delayed Cutaneous Sensitivity from this vaccine .It was painful and debilitating - headache pain, painful vaccine site, red rash lasted several days. Don't as I am still in it.
81 2021-03-01 chills, body temperature increased Temperature of 101 degrees Fahrenheit lasting 3 days Severe chills Nausea and vomiting Headache with... Read more
Temperature of 101 degrees Fahrenheit lasting 3 days Severe chills Nausea and vomiting Headache with sensitivity to light, continuing to today's date. Rash on back developed on day 5, treated with diphenhydramine cream
81 2021-03-01 throat pain, cough, headache, influenza like illness Severe flu-like symptoms: sore throat. headache, rhinitis, cough for 4 days
81 2021-03-02 chills, headache, fever slow onset of fever, aches, chills, stiffness and pain in lower extremities and back (entire), pain ... Read more
slow onset of fever, aches, chills, stiffness and pain in lower extremities and back (entire), pain in center of chest, neck, head no trouble breathing, greast weakness, difficulty rising and standing -- best lying in bed under warm covers- Like the worst cases of flu or virus I've ever had.. Very thirsty
81 2021-03-02 chills, headache Patient received the COVID Moderna vaccination on 3/1/21. On 3/2 she reported chills, nausea and an... Read more
Patient received the COVID Moderna vaccination on 3/1/21. On 3/2 she reported chills, nausea and an arm ache Spoke with patient today, she is feeling much better, has a slight headache that is resolving as the day goes on Advised on supportive care (fluids, rest, good nutrition) and to call back if symptoms returned or worsened.
81 2021-03-02 headache, chills Dizziness, lightheadedness, wheezing, chills, headache, body aches, sore arm - 6 to 8 hours Arm swel... Read more
Dizziness, lightheadedness, wheezing, chills, headache, body aches, sore arm - 6 to 8 hours Arm swelling, hard lump, redness near injection site - began on day February 15. Hardness lasted five days, redness lasted 13 days Sleep disturbances - difficulty getting to sleep, waking in middle of night with feeling of disorientation - began on February 15 and lasted for four nights. Eye pain with feeling of object in eye and red, itchy eyelids. Began February 17 and recurred intermittently for six days.
81 2021-03-03 body temperature increased Ran a temperature of 100; Had to up my oxygen rate from 2.5 to 3 liters as was having trouble breat... Read more
Ran a temperature of 100; Had to up my oxygen rate from 2.5 to 3 liters as was having trouble breathing; left arm got red over a wide area about the size of my hand, and is still a little pink. lost appetite for a day. Bruising seemed to increase some on my arms.
81 2021-03-03 chills Chills and dizziness
81 2021-03-03 headache, fatigue, sweating, chills Fatigue, exhaustion, headache within five hours of vaccination. Severe abdominal cramps, diarrhea, s... Read more
Fatigue, exhaustion, headache within five hours of vaccination. Severe abdominal cramps, diarrhea, sweating, chills, and nausea 34 hours later (03-03-21) ? lasting one hour. Another bout of diarrhea mid morning on 03-4-21. Did not seek medical help.
81 2021-03-03 headache Covid arm. Red, swelling, large bump., hot, sore. Called clinic told it was probably nothing. CDC we... Read more
Covid arm. Red, swelling, large bump., hot, sore. Called clinic told it was probably nothing. CDC website said go to dr or ER. Dr there glanced at my arm and said it was an infection and gave me antibiotic, Cephalexin 500mg, 10 days. Feel really bad but maybe better today and that is after tramadol and tylenol. Headaches. Tylenol helps.. now afraid to take 2nd shot.
81 2021-03-03 malaise JOINTS AND MUSCLE ACHES GENERAL MALAISE EAR PLUGGED BLADDER URGENCY, BURNING TYLENOL STEROID SHOT
81 2021-03-04 chills, body temperature increased approximately 8 hours after the injection a sudden case of chattering chills come on - temperature c... Read more
approximately 8 hours after the injection a sudden case of chattering chills come on - temperature checked soon after was 103 - followed approx. an your later by vomiting and then restless night of sleep due to body aches and stiffness in trying to get out of bed. Following day improved but no appetite or energy and mild headache. Well by 32+ hours after incident
81 2021-03-04 headache Entire body ached, headache, felt warm, dizzy
81 2021-03-04 malaise, fever reported severed arm pain, "bone pain" fever up to 102, insomnia, and general unwell
81 2021-03-04 fever, fatigue The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burn... Read more
The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg. She had fatigue and myalgias. Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine. She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain. Ambulated in to ER. After her work up she was discharged home - she present back to the ER within 30 minutes. PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious. She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective
81 2021-03-05 body temperature increased, headache 3:am on Friday I woke up with severe generalized pain , headache and temp of 102 . My left I too... Read more
3:am on Friday I woke up with severe generalized pain , headache and temp of 102 . My left I took 2 Tylenol. It didnt help. The next morning the pain level was about 5 and fever was down to 100. By the 3rd day my temp was normal and I just had mild muscle aches
81 2021-03-05 malaise, nasal congestion Symptoms: ulcers inside lower lip, mild swelling inside mouth, roof of mouth, tongue, throat, nasal ... Read more
Symptoms: ulcers inside lower lip, mild swelling inside mouth, roof of mouth, tongue, throat, nasal swelling. Same reaction I've had to penicillin, etc. No rash. Same symptoms occur with ACE inhibitor reaction. 60 mg Allegra taken every 12 hours made symptoms milder, but didn't go away. Did not feel well in general, no appetite. Today, March 6, almost no symptoms, it has been more than 12 hours since the last Allegra.
81 2021-03-05 fever, chills, fatigue, headache Shaking,teeth chattering chills, splitting headache, fever of 102, ,bone and muscle aches, vomiting ... Read more
Shaking,teeth chattering chills, splitting headache, fever of 102, ,bone and muscle aches, vomiting from 7:15 p.m. until 2:00 a.m. It all started and stopped at about the same time. Now it is just extreme fatigue.
81 2021-03-07 chills, fever, headache 103 fever, chills, aching, vomiting, headache, weak. For two days. Could not get out of bed except t... Read more
103 fever, chills, aching, vomiting, headache, weak. For two days. Could not get out of bed except to bathroom
81 2021-03-07 chills Chronic Diarreah started early Friday morning, March 5, eased by Saturday evening, and started again... Read more
Chronic Diarreah started early Friday morning, March 5, eased by Saturday evening, and started again early Monday morning, March 8. This is accompanied by feeling very cold, and chills, but no fever.
81 2021-03-08 fatigue, fever, chills Chills fever up to 100.2 & very tired, all lasted only about 5 hours, fever peaked @100.2 & then ... Read more
Chills fever up to 100.2 & very tired, all lasted only about 5 hours, fever peaked @100.2 & then it was over.
81 2021-03-09 fatigue Lightheaded, palpitations, very pale face and extremities, dizzy very tired, fatiguesd
81 2021-03-12 fever Vomiting, fever 99 degrees, muscle aches
81 2021-03-14 chills, fatigue, headache pt states that she developed headache, chills, and could not move. She stayed in bed in 48 hours. ... Read more
pt states that she developed headache, chills, and could not move. She stayed in bed in 48 hours. Headache and chills subsided in 24 hours and fatigue that for 48 hours. She says had the coronavirus in Sept 2020. She says she still has fatigue that comes and goes since getting the vax. Pt will contact PCP regarding getting the 2nd dose.
81 2021-03-15 sweating, chills, fatigue, headache, lethargy Severe chills started on Saturday, March 6 at11 pm, lasted thru night. Headache, body aches. In morn... Read more
Severe chills started on Saturday, March 6 at11 pm, lasted thru night. Headache, body aches. In morning 6:30 am weak, nausea, dry heaves, sweating, lethargic till Sunday morning at 9:30 am. Able to eat toast and tea, most symptoms abated, just extremely tired rest of day. By 12 noon on Monday back to normal routine.
81 2021-03-17 chills, cough, fever Feverish, chills, wheezing, dry hacking cough.
81 2021-03-17 productive cough, influenza like illness 1/13/21 Evening of vaccination pt experienced body aches. States she feels like she had the flu. R... Read more
1/13/21 Evening of vaccination pt experienced body aches. States she feels like she had the flu. Reports feeling better Friday, Sat and Sunday. Cough productive of green phlegm. Weakness and dizziness that kept her from getting off toilet. Fell or passed out upon return to bed.
81 2021-03-18 body temperature increased Muscle weakness in the legs, nausea, and body temperature of 99.9 degrees F.
81 2021-03-18 fatigue Unresponsive; extreme fatigue that is getting worse, not better; A spontaneous report was received f... Read more
Unresponsive; extreme fatigue that is getting worse, not better; A spontaneous report was received from caregiver for an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme fatigue that is getting worse (fatigue), unresponsive (Unresponsive to stimulus) and barely speaks The patient's medical history was not provided. No concomitant product use was reported. On 24-Feb- 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 05-MAR-2021, 10 days after receiving the vaccine, the reporter stated that the patient became unresponsive and was taken to the ER (emergency room). She was taken to the ER and discharged twice on the same day. The reporter also stated that his mother had extreme fatigue that was getting worse, not better and that the patient barely speaks. The The caregiver was headed to emergency room at the time of this report. Treatment information was not 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, extreme fatigue that is getting worse, unresponsive and barely speaks 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.
81 2021-03-18 fatigue ON 03/17/2021 - FATIGUE- THAT I EXPECTED. ON 03/18/2021 I DEVELOPED LARGE HIVE, COVERING THE FRO... Read more
ON 03/17/2021 - FATIGUE- THAT I EXPECTED. ON 03/18/2021 I DEVELOPED LARGE HIVE, COVERING THE FRONT OF MY THROAT & CONTINUEING UP ON MY LOWER FACE AREA & ON MY FOREHEAD. I CONTACTED PHARMACY, THEY RECOMMENDED I TAKE BENADRYL & I USED SOME HYDROCORTISONE CREAM THAT I ALREADY HAD. NO SWELLING OF THE TONGUE OR SHORT OF BREATH SYMPTONS. I'M NOT WORRIED - I THINK IT'S BY BODY DOING WHAT IT SHOULD BE DOING TO FIGHT OFF COVID.
81 2021-03-19 fatigue Within a week of 1st shot, I began to have joint pain... shoulders/neck, hips/top of legs, & knees. ... Read more
Within a week of 1st shot, I began to have joint pain... shoulders/neck, hips/top of legs, & knees. Called Dr. after 2 weeks. He said common complaint. Wait Took 2nd dose of Moderna. 2/3/21. Pain continued. By March 1st Dr. setup lab work. Diagnosis: PMR - polymialgia rheumatica My symptoms were fatigue-physical & mental, loss of appetite & weight, aching muscles, and stiffness. Rx: 15mg prednisone which will be reduced gradually. Also worked with physical therapist for 4 sessions to gain strength & flexibility. Still tired, but gradually becoming more active. In
81 2021-03-20 fatigue, fever Extreme Fatigue for 2 1/2 days, arm slightly swollen at the vaccination site and below, with a red... Read more
Extreme Fatigue for 2 1/2 days, arm slightly swollen at the vaccination site and below, with a reddish blotch about 1 1/2 inches wide and 3 or 4 inches long around my arm below the vaccination site with much itching for 5 days, lost of appetite and maybe low grade fever.
81 2021-03-20 fever Fever x 3 days with left upper arm circumferential cellulitis and swelling and streaking down left l... Read more
Fever x 3 days with left upper arm circumferential cellulitis and swelling and streaking down left lateral chest wall and breast.
81 2021-03-21 headache I had a painful stiff neck, the back of my head hurt and there was a slight headache and the stiff n... Read more
I had a painful stiff neck, the back of my head hurt and there was a slight headache and the stiff neck was the most painful I've ever head. It lasted several days.
81 2021-03-23 chills Chills, body aches
81 2021-03-24 fever Spasms like seizures; Fidgeting non-stop; Barring their teeth like a grimace; Low-grade fever; A spo... Read more
Spasms like seizures; Fidgeting non-stop; Barring their teeth like a grimace; Low-grade fever; A spontaneous report was received on 10 Mar 2021 from a consumer concerning a 81-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spasms like seizures/ seizure, fidgeting non-stop/restlessness, barring their teeth like a grimace/bruxism and low-grade fever/pyrexia. The patient's medical history included COVID-19 and severe Alzheimer's disease. Concomitant product use was not provided. On 09 Mar 2021, approximately 1 day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced low-grade fever, spasms like seizures, fidgeting non-stop and barring their teeth like a grimace. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, spasms like seizures, fidgeting non-stop, barring their teeth like a grimace, and low-grade fever, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-03-25 headache Headache; Serious convulsion; Slight tenderness at the injection site; A spontaneous report was rece... Read more
Headache; Serious convulsion; Slight tenderness at the injection site; A spontaneous report was received from a consumer concerning an 81-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious convulsion/seizure, slight tenderness at the injection site/vaccination site pain and headache. The patient's medical history included blood pressure high, diabetes and rheumatoid arthritis. Concomitant medications included methotrexate. The patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) on 04 Feb 2021. On 08 Mar 2021, prior to the onset of the event, the patient received the second of two planned doses of mRNA-1273 (batch number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Mar 2021, the patient experienced slight tenderness at the injection site. On 09 Mar 2021, at 12.30 and 1.30 AM the patient experienced medically significant event of serious convulsion with no previous history of seizures. Since patient has a disabled husband, she didn't call ER (emergency room) and went to the neurologist next morning who told her to report it. On 10 Mar 2021, the patient experienced headache attributed to migraines. Treatment for the event headache included paracetamol. Treatment information for the events serious convulsion and slight tenderness at the injection site was not reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the event slight tenderness at the injection site was resolved on 08 Mar 2021. The outcome of the event serious convulsion was resolved on 09 Mar 2021. The outcome of the event headache was resolved on 10 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-03-28 cough, fever, fatigue Since A week or so after second shot I have been fatigue, feverish, brain fog, cough, achy Have be... Read more
Since A week or so after second shot I have been fatigue, feverish, brain fog, cough, achy Have been to doctors on antibiotics Still not feeling up to par
81 2021-03-28 fatigue On the date of first occurance March 10, felt fatigue and muscle ache in groin and legs, on first ... Read more
On the date of first occurance March 10, felt fatigue and muscle ache in groin and legs, on first night felt restless, and sleepless with pain occuring in more joints. Next morning March 11, could not get up out of bed without assistance. Excruitiating joint and muscle pain . Sleeping 10-12 hours during day. Could barely walk pain persisting. Foggy brain, unable to consentrate. Feeling depressed. This last through weekend, subsiding some on Sunday March 14. Visited family physician, Dr. on Monday. Diagnosed with Serum Sickness. It has been a gradual decrease in joint pain, but still persists in my hips and legs as I write this on March 22.
81 2021-03-28 fever, headache, chills 2/18/21 11 pm Weak, aches 2/18/21 11:30 pm Chills, Shaky, Fever 101* Tylenol 2/19/21 12:55 am Fever... Read more
2/18/21 11 pm Weak, aches 2/18/21 11:30 pm Chills, Shaky, Fever 101* Tylenol 2/19/21 12:55 am Fever 101.6 2/19/21 6:20 am Fever 102.4*, Weak, Headache Tylenol 2/20/21 12:45pm 12:45pm Fever 101.4, Weak, Headache, Tylenol 2/21/21 Through 2/24/21 All day Weak, Shaky, Muscle Cramps in Neck, Left Shoulder to Shoulder Blade X-Strength Tylenol 2/25/21 Weak
81 2021-03-29 fever, headache, chills Moderna COVID-19 Vaccine EUA: Fever, large swelling at injection site, dizziness and weakness, short... Read more
Moderna COVID-19 Vaccine EUA: Fever, large swelling at injection site, dizziness and weakness, shortness of breath, headache, body ache (joint and muscle pain), chills
81 2021-03-30 chills, fatigue I got the "Covid arm" twice, after first and second injection. First did not come on until day #11 ... Read more
I got the "Covid arm" twice, after first and second injection. First did not come on until day #11 after vaccination, second only after 3 days. Besides this were chills, extreme tiredness, a sort of "brain fog," general aches and pains with the second shot and knees weak and feeling like a rag doll which lasted a couple days. Several episodes of urgent diarrhea with the first dose. First "Covid arm" lasted 8 days, the second just 4. With both, there was an almost constant feeling of queasiness.
81 2021-03-30 chills Excessive Stiffness of arms. chills, nausea
81 2021-04-01 headache, fever, chills Began running a fever, chiils, headache, temp reached 104 degrees the day after the injection. Wen... Read more
Began running a fever, chiils, headache, temp reached 104 degrees the day after the injection. Went to ER to be seen. Several tests run all negative Discharged same evening advised to take Tylenol and reaction should be gone within 24 hours. Arm began to swell in the area of the injection site and that continues 2 days after the injection. Arm at injection site is warm to the touch.
81 2021-04-01 headache A spontaneous report was received from a consumer concerning an 81 years old, female patient who exp... Read more
A spontaneous report was received from a consumer concerning an 81 years old, female patient who experienced headache, heart flutter and skip a beat/extra systoles. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 02 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient experienced headache, heart flutter and skip a beat. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events headache, heart flutter and skip a beat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-04-01 fever, chills Fever, Weakness, Chills, Body aches Stared on 3/9/21
81 2021-04-01 fever On that Friday, I had a fever and started shaking. I took my temperature the next morning, it was 10... Read more
On that Friday, I had a fever and started shaking. I took my temperature the next morning, it was 100.7 and my normal temp is 97.7. I felt bad all day. I took some Tylenol, my temperature came down, I started feeling better and haven't had a temp since. Didn't seek treatment because I had already been warned about the side effects.
81 2021-04-01 throat irritation, nasal discomfort A spontaneous report was received from a 81-year-old, female patient, who received Moderna's COVID-1... Read more
A spontaneous report was received from a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive 2nd dose within recommended time frame/product dose omission issue and experienced 2 busted blood vessel in left eye/eye hemorrhage, throat burning sensation/throat irritation, nasal irritation/nasal discomfort, breast burning/breast pain and red spots on face and face turned bright red randomly/erythema. The patient's medical history included cataract surgery. Products known to have been used by the patient, within two weeks prior to the event, include Loteprednol etabonate, Bromfenac Sodium, and Gentamicin Sulfate. On 05Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch: 041120A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient did not receive 2nd dose within recommended time frame. On 02 Feb 2021, patient had red spots on face and on 04 Feb 2021, her face turned bright red randomly, throat, nose and breast were burning and on 10 Feb 2021, she had 2 busted blood vessel in left eye. The event 2 busted blood vessel in left eye was considered as medically significant. Treatment medication for the event included Diphenhydramine, unspecified steroid and Cortisone cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event did not receive 2nd dose within recommended time frame was resolved on an unspecified date, throat, nose, breast burning was resolved on 11 Feb 2021, 2 busted blood vessel in left eye was resolved on 15 Feb 2021 and red spots on face and face turned bright red randomly was not resolved at the time of this report. Reporter's Comments: Based on the HCP reporter's assessment the events are assessed as unlikely related to mRNA-1273.The patient had eye surgery and was on medications causing the reported events as side effects.
81 2021-04-02 fever, fatigue, chills 3/30/21 to 4/2/2021 Arm hurt and Hot, Fever, Chills, throwing up, body aches, Fatigu... Read more
3/30/21 to 4/2/2021 Arm hurt and Hot, Fever, Chills, throwing up, body aches, Fatigue Lasted about 2 days No treatment
81 2021-04-04 fatigue, fever 4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date... Read more
4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date per pt's daughter) 2/21/21 onset SOB/DOE, fever 2/24/21 Seen at Urgent Care: RML crackles and infiltrate on CXR, given azithromycin and Augmentin 2/27/21 Presented to ED with progression of SOB/DOE, fatigue, diarrhea. Hypoxemic requiring low-flow NC, B/L basilar crackles noted; started on CTX/azithro (2/27-3/3) for presumed CAP 3/08/21 Required HFNC; first seen by me personally: diffuse, distinct velcro crackles, lower > upper fields 3/12/21 Started on high-dose steroids without improvement; unable to wean from HFNC with progressively worsening hypoxemia; pt declined intubation. 03/22/21 Patient died in Palliative Care Unit Diagnosis: Interstitial lung disease of uncertain etiology, acute interstitial pneumonitis vs. undiagnosed connective tissue disease
81 2021-04-04 fatigue Sudden onset nausea, lower GI distress, continues somewhat abating over 24 hrs, great fatigue. GI ... Read more
Sudden onset nausea, lower GI distress, continues somewhat abating over 24 hrs, great fatigue. GI upset and extreme fatigue continue for a week.
81 2021-04-05 cough, throat irritation Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy bod... Read more
Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. On 26-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 VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) had resolved. 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 concomitant medications provided. No treatment was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
81 2021-04-05 fatigue 2/1/2021 4" bright red splotch on shot arm, no pain, no fever faded away in two days 2/20 12:20PM #2... Read more
2/1/2021 4" bright red splotch on shot arm, no pain, no fever faded away in two days 2/20 12:20PM #2 shot 1PM Tylenol 2 pm Fatigue+ feeling strange Restless night 2/21 tired + a bit unsteady 2/22 Redness starting on shot arm 02/25 Redness faded away. Rock-hard bowel movement. 03/1 shot arm almost itchy, almost burning tiredness linger
81 2021-04-07 fever, chills PATIENT HAD COVID VACCINE ON 03/26/21 FOR A FEW DAYS AFTER VACCINE PATIENT HAD FEVER CHILLS. PATIENT... Read more
PATIENT HAD COVID VACCINE ON 03/26/21 FOR A FEW DAYS AFTER VACCINE PATIENT HAD FEVER CHILLS. PATIENT ALSO REPORED REDNESS AND SWELLING TO INJECTION SITE. ON 04/01/21 PATIENT WOKE UP WITH A ITCHY RASH FROM HEAD TO TOE THAT PROGRESSIVELY BECAME WORSE DURING THE DAY. PATIENT WAS SEEN AT URGENT CARE BY APRN. PATIENT WAS INSTRUCTED TO TAKE BENADRYLY 2-3 TIMES A DAY A FOR 2-3 DAYS AND IF NO IMPROVEMENT NOTED TO RETURN TO URGENT CARE. PATIENT REPORTED HAVING RASH FOR SEVERAL DAYS WITH IMPROVEMENT NOTED WITH BENADRYL.
81 2021-04-11 cough, sneezing, runny nose, headache Increase ringing in right ear. Ringing started in left ear. Headaches & Dizziness. Cold like s... Read more
Increase ringing in right ear. Ringing started in left ear. Headaches & Dizziness. Cold like symptoms--some coughing, sneezing, runny nose. Shortness of breath.
81 2021-04-12 chills fainting spells; Chills; Pain at site of the injection; itchiness at the site of the injection; rash... Read more
fainting spells; Chills; Pain at site of the injection; itchiness at the site of the injection; rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting spells) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection). On 02-Apr-2021, the patient experienced SYNCOPE (fainting spells) (seriousness criterion medically significant) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainting spells), CHILLS (Chills), VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not reported. Treatment included Tylenol. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-04-13 fatigue Deceased unexpectedly. From day of second dose 3/18/21, patient reported feeling tired ( no fever, n... Read more
Deceased unexpectedly. From day of second dose 3/18/21, patient reported feeling tired ( no fever, no shortness of breath) but was able to walk 3 flights of stairs on 4/11/21 and felt slightly better. Went to church that Sunday 4/11. Was not seen after that, then found deceased at home 4/14/21 with blood in mouth, no other signs such as lacerations or incontinence or other vomitus.
81 2021-04-14 fever, chills I woke up the next morning with bad muscle and joint pain, chills, nausea, threw up and had fever. T... Read more
I woke up the next morning with bad muscle and joint pain, chills, nausea, threw up and had fever. This was worse than when I had covid.
81 2021-04-15 dehydration, fever, lethargy Patient received Moderna Dose #1 on 1/11/2021. Later that day, her armpit had a swollen lymph node.... Read more
Patient received Moderna Dose #1 on 1/11/2021. Later that day, her armpit had a swollen lymph node. This was treated topically with clindamycin for hidrandenitis suppurative for about 2 weeks. Then patient received Moderna Dose #2 on 2/8/21. By 2/11/21, patient had some intermittent confusion noted. Vitals were mostly WNL. On 3/4, patient observed with SOB and restlessness. SPO2 was 86%, Temp 98.4, HR 59, BP 136/59. Oxygen started. Later on 3/4, patient had change in mental status, lethargy, SOB and SPO2 90% on PRN oxygen. Transferred to hospital. Patient was admitted to hospital on 3/4/21. She was readmitted to nursing home on 3/12/21. Discharge diagnosis included: altered mental status, acute expiratory failure, fever, atypical pneumonia, CHF exacerbation, HTN, DM, dementia, asthma/restrictive lung disease.
81 2021-04-15 headache, chills CHILLS, HEADACHE, SWOLLEN/PINK ARM
81 2021-04-15 fever, sleepiness, chills 4:00a.m., next morning,chills (couldn't get warm), fever ( temp 102.8) , difficult to stand, no app... Read more
4:00a.m., next morning,chills (couldn't get warm), fever ( temp 102.8) , difficult to stand, no appetite, very sleepy all day. Had to hold onto walls just to walk felt dizzy, weak, aching and confused. Right shoulder swollen, not red. No desire to eat,and forced myself to take fluids. Lasted 4 days.
81 2021-04-15 fever nausea, elevated blood pressure, stiff neck, and stiff back, low grade temp
81 2021-04-16 fatigue, chills, paranasal sinus discomfort Sinus irritation after four hours, mucous and nose-blowing, stopped after four hours. General chills... Read more
Sinus irritation after four hours, mucous and nose-blowing, stopped after four hours. General chills; not too bad. Tiredness; not too bad. "Covid-Arm": large 5" swelling around injection site; feeling hot to the touch; sore/painful arm for the last four days.
81 2021-04-16 fever patient hospitalized secondary to fever, generalized weakness and myalgias and had a fall. she wa... Read more
patient hospitalized secondary to fever, generalized weakness and myalgias and had a fall. she was hospitalized for 2 days.
81 2021-04-18 fever fever and altered mental status
81 2021-04-22 headache, fatigue tenderness, warm to touch at injection site (left arm) Patient has taken Tylenol and applied ice pac... Read more
tenderness, warm to touch at injection site (left arm) Patient has taken Tylenol and applied ice packs to relieve symptoms with some effect 4/13-Spoke with pt today and she said that she is feeling much better only having a slight headache that goes away with Tylenol. She also complains that her arm is itchy now. She has a doctor's appt this Thurs and would like if we call back on Friday. 4/16- PharmD Rcvd follow up called on 4/16/2021 at 2:06pm: Pt reports that she is feeling much better today, and all the symptoms she reported having on the follow up call on 4/13/2021 has resolved. Pt reports feeling fatigue, lightheadedness, and a headache that comes and goes. Pt stated that she took Tylenol on 4/15/2021 for the headache. ***NOTE*** Recommend pt to monitor her symptoms of lightheadedness and headache. Recommend to continue to stay hydrated and consume adequate meal, and take Tylenol PRN. Also rec pt to get up from sitting and bending position slowly, and to see if the lightheadedness occurs during resting positions. If her symptoms has not gotten better over the weekend, rec for pt to contact MD.
81 2021-04-24 headache, sweating, chills 8 days intense itching and rash at and around injection site, chills, headache every day, saw doc an... Read more
8 days intense itching and rash at and around injection site, chills, headache every day, saw doc and was given a pain shot and cream on March 22, March 24th given prescription of 25 mg Hydroxyzine Pumoate 3 X a day took for 2 days; March 25, broke into sweats in am. itch starting to become bearable, pain also tolarable
81 2021-04-24 headache, fever chill fever, cramps, headaches, couldn't breath, blur vision, disoriented, weakness, no appetite, h... Read more
chill fever, cramps, headaches, couldn't breath, blur vision, disoriented, weakness, no appetite, had to pee every 10 min.
81 2021-04-25 sweating, fatigue, chills, fever Nausea chills sweating diarrhea fever cramps fatigue
81 2021-05-02 fever On April 6th, the vaccine site was a little red and began to itch. By April 9th, the are of redness... Read more
On April 6th, the vaccine site was a little red and began to itch. By April 9th, the are of redness had grown larger and still itched. By April 11th, the area of redness had grown yet larger and was still itching. The area today is larger, somewhat swollen, red, itching and feverish.
81 2021-05-04 sleepiness, fatigue, chills, headache About 1pm I got really tire and sleepy. About 6pm I started getting small headache. Not serious. But... Read more
About 1pm I got really tire and sleepy. About 6pm I started getting small headache. Not serious. But at 1 am in the morning of May 5th I started having stomache pain cramping. Alos cols childs ,that lasted for 4 hrs. Unable to sleep. Finally after 4 hrs the chills subsided. I was able to sleep a couple hours. BY 10 am on May 5th I was able to get up and eat some breakfast. Also had swelling of shot location like a hard knot. Still there as of 11:30am. Had some loose stool and pains in stomach. I talked to many people who had the Maderma and no one had any of these systems. This means I will really be sick for the second shot.
81 2021-05-05 malaise Started feeling sick day of 2nd dose of the Moderna vaccine. never felt good. personal journal e... Read more
Started feeling sick day of 2nd dose of the Moderna vaccine. never felt good. personal journal entries testify of this. never felt good before she died. Had a massive thrombophlebotic stroke 10 days later causing death.
81 2021-05-10 fever, sinus disorder, chills She got her vaccine, the arm was a little sore. Then about 30 minutes had sinus problems, but then ... Read more
She got her vaccine, the arm was a little sore. Then about 30 minutes had sinus problems, but then for 2 days she had fever and chills. Then the ringing in her ears started within a week after that. She does have tinnitus but it intensified since the vaccine. She had a teleconference call with her doctor who told her that it was not one of the symptoms of the vaccine and told her to have her hearing checked.
81 2021-05-14 sweating, fever, fatigue MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 da... Read more
MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 days Not only tired, but seemed to be passing out Neck ache--third day Fever/sweating for 4 days and nights Swollen, painful, numb and itchy left inside arm from pit to elbow Previous one--numb and swollen through 5 days
81 2021-05-20 pneumonia, headache, influenza like illness flu like sxms, acute exacerbation of copd/pneumonia starting 02/08/21, headache, chx pain all night ... Read more
flu like sxms, acute exacerbation of copd/pneumonia starting 02/08/21, headache, chx pain all night starting 02/13/21. Pt admitted to hospital 02/14/21. Performed lab work, elevated troponin level which continued to climb. Discovered two blockages and installed two stints to primary artery. Pt was discharged 02/16/21
81 2021-05-25 malaise, sweating Pt called and stated she received her vaccine on 05/18/2021, started having arm and neck pain, nause... Read more
Pt called and stated she received her vaccine on 05/18/2021, started having arm and neck pain, nausea, lightheadedness, stomach cramping, on 05/19/2021 in the afternoon. She sat up to get some saltine crackers to help her feel better, and she started to get dizzy. She then remembers trying to hold herself up, and then the next thing she recalls is laying on her back on her kitchen floor. It was then she felt dizzy again and then sat herself up enough so she could vomit 3 times. She also reported having profuse sweating and dry heaves. Her husband found her about 30 minutes later when he returned home from picking up lunch for them. She refused to go in the hospital to get checked out until she called her PCP on 05/21/2021 because she still was not feeling well. They recommended that she go into the ER. She had a CT scan, UA, troponin levels checked, and other blood work. Was treated with IV lactated ringers in the ER, and given meclizine for the dizziness. UA showed positive E. coli, indicative of a UTI. Pt chose to be discharged home instead of staying overnight because she stated she would get plenty of rest at home. Spoke with pt 05/25/2021 after she had called to let us know what happened. Pt has scheduled additional CT scan on 06/08/2021 and follow-up with a neurologist 06/10/2021.
81 2021-05-26 head discomfort 4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVE... Read more
4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVENING OF NEXT DAY) ABOUT 40 MINUTES AFTER RECEIVING VACCINE. 4/29/21: EVER SINCE VACCINATION, EXPERIENCING EXCESSIVE THIRST. ONGOING 5/1/21: PATIENT DESCRIBED SYMPTOM AS SKULL BONE PAIN (TENDER SCALP WHEN TOUCHED) UNTIL 5/5/21 5/3/21: ONGLING BLADDER IRRITATION. NO BLOOD IN URINE, BUT SOME SPOTTING (~2TSP) ON PADDING 5/17/21 . NO BLOOD PRESENT SINCE 5/4/21 MORNING: LYMPH NODE SWOLLEN UNDER THE LEFT ARM (INJECTION WAS IN RIGHT ARM). SIZE OF A TENNIS BALL, VERY PAINFUL, AND PAIN RADIATED TO AROUND THE LEFT BREAST AREA. PAIN LASTED UNTIL THE AFTERNOON OF 5/6/21. 5/9/21: BLOOD CLOT IN LEFT LEG REACTIVATED IN THE MORNING, ACCOMPANIED BY EXTREME PAIN, SWELLING, WARM TO THE TOUCH. PAIN AND SWELLING HAS BEEN MINIMAL BEGINNING 5/24/21, AND HAS NOT BEEN AS WARM TO THE TOUCH AS IT HAS BEEN. TREATMENTS: TOOK IBUPROFEN AND TYLENOL AS NEEDED FOR PAIN. USED ARNICA GEL ON THE ARM AT THE INJECTION SITE + MASSAGE+ CONSTANT MOVEMENT FOR PAIN/STIFFNESS. USED ARNICA GEL ALSO ON LYMPH NODE UNDER LEFT ARM ELEVATED CLOTTED LEG AND STAYED ACTIVE TO OPTIMIZE BLOOD FLOW, USED LIGHTLY HEATED PAD TO EASE THE LEG PAIN
81 2021-05-27 sleepiness, fatigue Injection pain and headache patient took some of Tylenol. This pain lasted for a few days. On the se... Read more
Injection pain and headache patient took some of Tylenol. This pain lasted for a few days. On the second shot patient was fatigued and slept all day. Only fatigued for one day and went back to normal
81 2021-05-29 chills, headache Herpes on lip, all joints aching, temperature, hot and cold shivering, headache, moaning in pain. To... Read more
Herpes on lip, all joints aching, temperature, hot and cold shivering, headache, moaning in pain. Took Excedrin. 24 hours
81 2021-05-31 malaise, fatigue, chills Onset began the evening of the vaccination severe chills and did not feel well. On the first week ha... Read more
Onset began the evening of the vaccination severe chills and did not feel well. On the first week had extreme fatigue. The second week I lost my sense of smell and taste. The fatigue and lost of smell and taste lasted up to five weeks. I gradually felt better, but it took about 8 weeks before I felt better.
81 2021-06-02 fever, headache The patient recieved the second dose of Moderna vaccine on 5/10/2021, she called us today 6/3/2021, ... Read more
The patient recieved the second dose of Moderna vaccine on 5/10/2021, she called us today 6/3/2021, and reported that on third day after the shot , she had slight fever then she felt severe side effects: she lost smell and taste, headache, pain and swelling in joints and dizziness. The symtoms still last till now and we advised her to see her doctor right away.
81 2021-06-07 malaise, sinusitis stated a little of everything going on, not feeling good, UTI and sinus infection, had last covid va... Read more
stated a little of everything going on, not feeling good, UTI and sinus infection, had last covid vaccine on March 4, was on 4 different kinds of HTN meds that were being adjusted, woke up Thursday AM 6/03 with dizziness, went to ER, Stated concern about symptoms after taking covid injection 5 wks after second dose, had second dose March 4 of Moderna injection for covid, received in left arm, soreness in muscle very little that lasted one day, stated on April 18 LLE cellulitis and went to urgent care, rash to chest 3 days after taking tetracycline, was told she had statis dermatitis by doctor, stated went away after 1-2 days of using hydrocortisone and compression stocking, HTN meds changed one week before rash
81 2021-06-13 fatigue pt says she developed a rash and has progressively gotten worse since then. The rash is red, with l... Read more
pt says she developed a rash and has progressively gotten worse since then. The rash is red, with little pea shaped pimples that are burning and spreading all over her body. The skin is prickly and very sensitive. She still cannot think clearly and still has fatigue. Her legs are bothering her know as well. She saw PCP Dr on 2/19/21 and told to take Claritin which did not help. On 2/26/21 she saw Dermatologist PA. She was given a skin biopsy. She was diagnosed w/ spongiotic and interfaced dermatitis w/ rare eosinophils. She was prescribed triamcinolone. She has since developed nose bleeds that would come every couple of days then started happening daily. She has had blood test which white blood count cells were up, the doctor thinks the steroid cream may have caused this so she is no longer using it. She has been to the doctors several times due to the skin rash and nose bleeds and nothing the doctors have done for her has helped with her symptoms thus far. She goes back to the doctors in a couple of weeks for another biopsy. These has had these symptoms for months.
81 2021-06-15 malaise Patient has been in and out of hospital; Patient has not received second dose within the appropriate... Read more
Patient has been in and out of hospital; Patient has not received second dose within the appropriated window of time between two doses; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (Patient has been in and out of hospital) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient has been in and out of hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses). At the time of the report, MALAISE (Patient has been in and out of hospital) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses) 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 considered MALAISE (Patient has been in and out of hospital) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses). Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on reporter's causality, the events are assessed as unlikely related to mRNA-1273.
81 2021-06-16 chills On the second day I was shivering and freezing. Despite testing my temperature, it never registered ... Read more
On the second day I was shivering and freezing. Despite testing my temperature, it never registered as a fever. I went to the doctor and was given a prescription for doxycycline. It did not make any difference. I went back a second time because I was concerned that the redness and swelling was not going away. I was not experiencing any pain. Somewhere along the line I had developed hives on my head and face. I as put on doxycycline again and a strep test was done. The strep tests was negative. After a few days I went to an allergist. The allergist said she did not see anything indicating I needed a food allergy test. They also tested me for a penicillin allergy which came back negative. The allergist sent me to an ENT. No one was able to determine a cause. I went back to my PCP. He put me on singular and Allegra. He also drew blood to be tested for food allergies so I am awaiting the results of that.
81 2021-06-16 fatigue, chills 01/22/2021- Chills, sore arm, fatigue 01/25/2021- That morning, I was walking up stairs that I walk ... Read more
01/22/2021- Chills, sore arm, fatigue 01/25/2021- That morning, I was walking up stairs that I walk up everyday, I could not breathe by the time I got to top of stairs, that never happens. Lasted through next day then got a little better as long as I was sedentary. I had continuing shortness of breath with any kind of physical activity. Still having shortness of breath to this day.
81 2021-06-16 throat pain, sluggishness, throat redness The following day I felt a little sluggish the next day. 4-5 days later my throat began bothering. I... Read more
The following day I felt a little sluggish the next day. 4-5 days later my throat began bothering. It was extremely red and constantly painful. I also had a few blister looking spots on the sides of my tongue.
81 2021-06-20 pneumonia Acute respiratory failure; pneumonia; Strep pneumonia
81 2021-06-22 fatigue This spontaneous case was reported by a health care professional and describes the occurrence of RHE... Read more
This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease. The patient's past medical history included Pain in hip since 2019, Osteopenia, Stenosis, Femur fracture and Back surgery. Concurrent medical conditions included Alcohol use (occasionally) since 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,1 in 2 Weeks. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoids), PAIN (Pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), HAEMORRHOIDS (Hemorrhoids), SWELLING (Swelling), PAIN (Pain), PAIN IN EXTREMITY (Hand pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown, CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) had not resolved and FATIGUE (Tiredness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219975 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
81 2021-06-23 malaise Patient was given her first dose of the moderna covid vaccine. She briefly waited around the pharmac... Read more
Patient was given her first dose of the moderna covid vaccine. She briefly waited around the pharmacy afterwards then began wandering to the back of the store. Roughly 30 minutes after administering the vaccine, she came back to the pharmacy and vomited. Pharmacy staff checked on her and she stated she felt weak, nauseaus, and sick. She stated she just needed a moment to recover and did not need EMS, but the feeling did not pass, so a code white was called and EMS were called to check out the patient. They checked vitals and spoke with the patient, but she did not want to go to the hospital at that time, so she was allowed to rest in the immunization booth until she felt comfortable driving herself home. However, the feeling still did not pass, so roughly 45 minutes later she requested EMS be called again, and she was taken to the hospital.
81 2021-06-27 pneumonia Death J18.9 - Pneumonia of both lower lobes due to infectious organism
81 2021-06-29 fatigue redness and swelling of left bicep; redness and swelling of left bicep; fatigue; itching; pain at le... Read more
redness and swelling of left bicep; redness and swelling of left bicep; fatigue; itching; pain at left arm "neuropathy"; pain at left arm "neuropathy"; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") (seriousness criterion medically significant) and PAIN IN EXTREMITY (pain at left arm "neuropathy"). On 13-Jun-2021, the patient experienced PRURITUS (itching). On 14-Jun-2021, the patient experienced FATIGUE (fatigue). On 15-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at an unspecified dose and frequency and ETHANOL (ALCOHOL SWABS [ETHANOL]) at an unspecified dose and frequency. On 20-May-2021, NEUROPATHY PERIPHERAL (pain at left arm "neuropathy") and PAIN IN EXTREMITY (pain at left arm "neuropathy") had resolved. On 15-Jun-2021, FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itching), VACCINATION SITE ERYTHEMA (redness and swelling of left bicep) and VACCINATION SITE SWELLING (redness and swelling of left bicep) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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.
81 2021-06-29 fatigue Flashing light hallucinations; Pain in joints; Numbing of toes both sides; Toes tingling/ Fingers ti... Read more
Flashing light hallucinations; Pain in joints; Numbing of toes both sides; Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands; Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night; Pain in hips and legs up to knees/ Pain in legs feet and fingers; Bone pain; Sleep seven hours in raw; "could not drive"; Body pain/ Constant pain in body; Tiredness/ Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Flashing light hallucinations) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Drug allergy (Macrobid allergy), Fibromyalgia (Fibromyalgia was under control. Unbearable now.), Arthritis (Arthritis was under control. Unbearable now.) and Myalgia. Concomitant products included DOXYCYCLINE, VITAMIN A [RETINOL], VITAMIN B NOS, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue). 06-Mar-2021, the patient experienced HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive"). On 22-Mar-2021, the patient experienced HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night) and PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers). On an unknown date, the patient experienced HALLUCINATION, VISUAL (Flashing light hallucinations) (seriousness criterion medically significant) and ARTHRALGIA (Pain in joints). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Myalgia, at a dose of 2 dosage form. On 08-Mar-2021, HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive") had resolved. At the time of the report, HALLUCINATION, VISUAL (Flashing light hallucinations) and ARTHRALGIA (Pain in joints) outcome was unknown and HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night), PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers), BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue) had not resolved. The patient had implant dental work near 2 weeks ago around 10-Apr-2021 and received Doxycycline. The patient reported that the doctor won't return the call. 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 20-Jun-2021: Additional information received included patient demographics race, relevant history details including Macrobid allergy, current condition fibromyalgia and arthritis; new concomitant medications added; Treatment medicines were added . Added New adverse event Flashing light hallucinations.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-06-29 headache, cough, fever covid; cough; aches all over; fever; headache; This spontaneous case was reported by a consumer and ... Read more
covid; cough; aches all over; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (seven and half years ago). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced COVID-19 (covid) (seriousness criterion hospitalization). The patient was hospitalized for 24 days due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid), COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.3 °F (High) 100.3°F. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Concomitant products included blood pressure medicine (unspecified). Reportedly, the patient had COVID five days after the first shot of vaccine. The patient had to stay three and a half weeks in hospital that destroyed her immune system and she said that it was coming back after medications. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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 21-Jun-2021: Case upgraded to serious, includes- serious event of covid-19 (hospitalization) and historical condition of cancer and had chemotherapy.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
81 2021-07-09 malaise, fever, fatigue, chills On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she de... Read more
On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.
81 2021-07-18 cough Hospitalized with COVID-19, tested +7/17/21. Pt has a cough, SOB, CP.
81 2021-07-20 headache Severe headaches, eye pain, ear pain, jaw pain on the left side, extreme stiffness in neck. Sent to... Read more
Severe headaches, eye pain, ear pain, jaw pain on the left side, extreme stiffness in neck. Sent to hospital. Outpatient surgery on both temples. Biopsy. Diagnosed with Greater Cell Arteritis. Inflamation of the temporal arteries. On medication- pregnezone 50 mg daily, fosamax 70 mg weekly. Also dealing with a side effect of the prenezone- elevated blood pressure and on medication 5ml amlodipine daily.
81 2021-07-26 dehydration, fatigue Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experie... Read more
Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experiencing nausea, vomiting, and diarrhea, as well as loss of taste and smell. She presented to the ED with these symptoms and fatigue. She was diagnosed with COVID pneumonia and dehydration and admitted to the COVID Unit. Problem list: -Severe Covid pneumonia with pulmonary infiltrates and new hypoxia. Symptom onset 7/11/2021 -Hypoxic respiratory failure secondary to above -mildly elevated troponin w/o chest pain -Nausea/vomiting/diarrhea, suspected to be secondary to coronavirus -Acute kidney insufficiency, suspect prerenal azotemia from volume depletion -History of hypertension, currently hypotensive -Weakness -new dx of DMII with steroid induced hyperglycemia Plan: -Continue inpatient level of care in the Covid unit -Dexamethasone (7/18/2021-) and completed remdesivir (7/17/2021-7/21), supplementary oxygen, Mucinex, albuterol, proning, is at the spirometry. CRP elevated at 19, D-dimer elevated at 1200 will trend CRP but currently not severely hypoxic enough to qualify for Tocilizumab. Troponin downtrended. TTE with right sided heart dyfxn, likely at least partially chronic as CTA does not show any evidence of pulmonary embolus. Would recommend repeat transthoracic echocardiogram after recovery from acute illness and consideration of right heart catheterization if right ventricle dysfunction appears to be persistent. -Sliding scale of insulin started given her history of borderline diabetes with the expectation of hyperglycemia on dexamethasone. 7.5. Continue lantus, medium dose SSI -Resume amlodipine. Continue holding ACE inhibitor given acute kidney insufficiency -Renal function improving, appreciate assistance -PT/OT consulted and rec -Acetaminophen and Zofran for symptomatic management
81 2021-07-29 influenza like illness admitted for further management of a PNH flare; severe hemolysis; heme pigment-associated acute kidn... Read more
admitted for further management of a PNH flare; severe hemolysis; heme pigment-associated acute kidney injury; Condition aggravated; Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms; One day after dose 2, she developed dark urine; One day after dose 2, she developed generalized weakness; One day after dose 2, she developed abdominal pain; One day after dose 2, she developed odynophagia; This literature-non-study case was reported in a literature article and describes the occurrence of PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare), ACUTE KIDNEY INJURY (heme pigment-associated acute kidney injury), HAEMOLYSIS (severe hemolysis), and CONDITION AGGRAVATED (Condition aggravated) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Autoimmune- and complement-mediated hematologic condition recrudescence following SARS-CoV-2 vaccination. Blood Adv. 2021;5(13):2794-8 Previously administered products included for an unreported indication: SHINGRIX (Flare 2 years earlier which was triggered by her second Shingrix vaccine. She had never been treated with terminal complement inhibition.). Concurrent medical conditions included Paroxysmal nocturnal haemoglobinuria (long-standing history of steroid-responsive granulocyte clone size, 98%). 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 PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare) (seriousness criteria hospitalization and medically significant), ACUTE KIDNEY INJURY (heme pigment-associated acute kidney injury) (seriousness criteria hospitalization), HAEMOLYSIS (severe hemolysis) (seriousness criteria hospitalization), CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), INFLUENZA LIKE ILLNESS (Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms), CHROMATURIA (One day after dose 2, she developed dark urine), ASTHENIA (One day after dose 2, she developed generalized weakness), ABDOMINAL PAIN (One day after dose 2, she developed abdominal pain) and ODYNOPHAGIA (One day after dose 2, she developed odynophagia). The patient was treated with METHYLPREDNISOLONE for Adverse event, at a dose of 1 gram; ECULIZUMAB (intravenous) for Adverse event, at a dose of 600 milligram and RAVULIZUMAB for Adverse event, at an unspecified dose and frequency. At the time of the report, PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare), ACUTE KIDNEY INJURY (heme pigment-associated acute kidney injury), HAEMOLYSIS (severe hemolysis), CONDITION AGGRAVATED (Condition aggravated), INFLUENZA LIKE ILLNESS (Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms), CHROMATURIA (One day after dose 2, she developed dark urine), ASTHENIA (One day after dose 2, she developed generalized weakness), ABDOMINAL PAIN (One day after dose 2, she developed abdominal pain) and ODYNOPHAGIA (One day after dose 2, she developed odynophagia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) Negative. In 2021, Blood bilirubin: 1.8 mg/dl (Inconclusive) 1.8. In 2021, Blood creatinine: 0.91 mg/dl (Inconclusive) 0.91 and 1.69 mg/dl (Inconclusive) heme pigment–associated acute kidney injury (baseline: 0.79 mg/dL). In 2021, Blood lactate dehydrogenase: 1272 (Inconclusive) 1272 U/L and 3282 (High) On day 2 after admission to the emergency department. In 2021, Haematocrit: 30 percent (Inconclusive) 30. In 2021, Haemoglobin: 10.0 g/dL (Inconclusive) 10.0. In 2021, Laboratory test: demonstrated severe hemolysis (abnormal) demonstrated severe hemolysis. In 2021, SARS-CoV-2 test: negative (Negative) after admission to the emergency department. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA (admitted for further management of a PNH flare), CONDITION AGGRAVATED (Condition aggravated), INFLUENZA LIKE ILLNESS (Approximately 8 hours after receiving dose 2 she developed Flu-like symptoms), CHROMATURIA (One day after dose 2, she developed dark urine), ASTHENIA (One day after dose 2, she developed generalized weakness), ABDOMINAL PAIN (One day after dose 2, she developed abdominal pain) and ODYNOPHAGIA (One day after dose 2, she developed odynophagia) to be possibly related. Concomitant medications were not provided. The patient received a transfusion of 2 U red blood cells (RBCs) as a treatment and received a transfusion of 1 additional unit of RBCs after admission to the emergency unit. On day 2, the patient received a transfusion of 1 additional unit of RBCs to suppress erythropoiesis. The patient received meningococcal prophylaxis with meningococcal B and ACWY vaccines without complications and was discharged on day 6 and continued on terminal complement inhibition with ravulizumab in the outpatient setting. This case was linked to MOD-2021-263889, MOD-2021-263970, MOD-2021-264203 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's medical history of paroxysmal nocturnal haemoglobinuria (including flare ups) is a confounder.
82 2021-01-04 body temperature increased 1. She was found with her skirt up around her neck and normally is oriented 2. Speech slightly off 3... Read more
1. She was found with her skirt up around her neck and normally is oriented 2. Speech slightly off 3. Left sided facial drooping 4. At time of EMS transfer BP 156/22, P 118, R 18, Temp 104
82 2021-01-06 headache Nausea, vomiting, diarrhea, headache beginning about 11 hours after vaccination
82 2021-01-09 cough, headache, chills strong headache, bad teeth chattering chills, nausea, aches, possible sinus drainage, cough - lasted... Read more
strong headache, bad teeth chattering chills, nausea, aches, possible sinus drainage, cough - lasted from Friday night one week after shot until Sunday afternoon. Only reporting for your information.
82 2021-01-13 lethargy Extreme Lethargy
82 2021-01-16 fatigue First mild symptoms were sore arm and mild aches, tiredness. On approximately Jan 11 started notici... Read more
First mild symptoms were sore arm and mild aches, tiredness. On approximately Jan 11 started noticing itching at injection point and by Jan 16 2021 had red swollen area around injection point. Red area approximately three inches in diameter. .
82 2021-01-20 fatigue, sleepiness Patient called yesterday, 1/20/2021 and stated since getting the vaccine she has been overwhelmingly... Read more
Patient called yesterday, 1/20/2021 and stated since getting the vaccine she has been overwhelmingly tired and is sleeping all the time. No other symptoms stated.
82 2021-01-21 headache After about 10 mins i started to get headache, dizzy,. Got pale. Was put on cot. had heart palpitati... Read more
After about 10 mins i started to get headache, dizzy,. Got pale. Was put on cot. had heart palpitation felt cold and shaky. After about an hr and half i started to get back to normal. When i got up i started to walk funny. I was able to drive home. took Tylenol when i got home. ate a little soup. laid down and fell asleep. when i woke up a couple hrs later i still had a headache. took another tylenol.
82 2021-01-21 runny nose Called at 8 am this morning to inform me of a reaction to her COVID vaccine. She received the vaccin... Read more
Called at 8 am this morning to inform me of a reaction to her COVID vaccine. She received the vaccine on Tuesday, 1/19/21. The next day she noted the back of her tongue on the R side was swollen. On Thurs, 1/21/21, she reports she woke up with the back of her tongue swollen on both sides such that she had some trouble speaking and needed to be very careful with chewing so she would not bite her tongue. She stated she also had drippy sinuses and an earache which then woke her up several times during the night last night. Today she reports the tongue swelling is only to the back R side of her tongue. She continues to have ear pain. She states she had not reported the symptoms to anyone before her call because she had not felt the symptoms were life-threatening. I asked her if she had taken any benedryl, and she stated the only medication she had taken was her analgesic herbal supplement. She states she has never had a vaccination reaction in the past. I advised her to call her PCP and be seen, which she was able to do. After she was seen, she called and stated while the clinician was looking at her tongue, it started to have shooting pains when she moved it to the right. The clinician stated her tongue and throat were not visibly swollen, noted no swollen lymph nodes, and noted no ear abnormalities.
82 2021-01-23 chills, fever Chills, fever, severe muscle pain, nausea, sudden onset BM, Weakness, shakey, Pretty much all the a... Read more
Chills, fever, severe muscle pain, nausea, sudden onset BM, Weakness, shakey, Pretty much all the adverse sympton reaction listed on the information paper given me at the Clinic
82 2021-01-23 fever, chills mild fever (101-102), chills, intermittent chest pain (she said it was likely related to muscle cont... Read more
mild fever (101-102), chills, intermittent chest pain (she said it was likely related to muscle contractions due to chills), pulse ox 91-92, pulse 110, finger bone ache. the following morning, vomited water, diarrhea symptoms resolved over the next 2-3 days.
82 2021-01-25 fever, lethargy, chills Presented to ED with complaints of Fever, chills, and myalgia. Symptoms transitioned into lethargy a... Read more
Presented to ED with complaints of Fever, chills, and myalgia. Symptoms transitioned into lethargy and weakness. Treatments: Physical Therapy for strengthening, lab work, fever reducing medications!
82 2021-01-28 cough Confusion, brain fog, loss of appetite, extreme muscle weakness with inability to stand by herself a... Read more
Confusion, brain fog, loss of appetite, extreme muscle weakness with inability to stand by herself and walk, intermittent dry cough, decreased oxygen level
82 2021-01-28 fatigue, sleepiness Major fatigue (can't awaken), Mass confusion (doesn't know what she is doing. Not eating or drinkin... Read more
Major fatigue (can't awaken), Mass confusion (doesn't know what she is doing. Not eating or drinking. Can't get dressed.)
82 2021-01-29 headache, fever Nauseous Weak Slight fever 99 Headache
82 2021-01-31 chills, fatigue Chills,Fatigue,arms and muscles unresponsive unable to move
82 2021-02-01 fever, fatigue Fever, fatigue, some nausea, body aches
82 2021-02-02 body temperature increased temperature 99.7, dizziness, nausea
82 2021-02-02 headache Dizziness, severe headache, fainting
82 2021-02-02 fever, fatigue, headache The following symptoms began the day after the shot: headache, dizziness, tiredness, fever, complet... Read more
The following symptoms began the day after the shot: headache, dizziness, tiredness, fever, complete loss of hearing in right ear, partial loss of hearing in left ear, Hearing loss lasted 6 hours before beginning to improve. Most symptoms were gone by end of 4th day. Tiredness remains along with occasional dizziness.
82 2021-02-02 fever, headache Nausea, dull headache, dizziness, fever (101.1), soreness at sight of injection
82 2021-02-05 chills, headache Chills Headache Nausea Rapid Heart Beat
82 2021-02-05 fatigue, headache, chills Headache, back pain, joint pain, chills, fatigue. No fever.
82 2021-02-05 fatigue, fever, malaise Severe fatigue, malaise, low grade fever, loss of appetite, body aches, nausea
82 2021-02-05 fatigue Arm: itching, redness, slight swelling, noticed the site mark (not seen at time of injection) Weakn... Read more
Arm: itching, redness, slight swelling, noticed the site mark (not seen at time of injection) Weakness, internal shakiness, tiredness, overall lack of energy
82 2021-02-05 head discomfort Moderna COVID-19 Vaccine EUA First day, Jan. 28, head felt funny and went to bed at 6:30 pm and by ... Read more
Moderna COVID-19 Vaccine EUA First day, Jan. 28, head felt funny and went to bed at 6:30 pm and by 9:30 pm when I work up, I felt fine. Day 8: felt itchy on left arm where vaccine took place and pink. Same thing this morning.
82 2021-02-06 chills, fatigue, headache Extreme Head Ache, Leg cramps in both legs, chills and fatigue
82 2021-02-06 chills, fatigue, headache It started about 14 hours later. (around 10 pm) Chills and then terrible shaking and trembling. That... Read more
It started about 14 hours later. (around 10 pm) Chills and then terrible shaking and trembling. That lasted about 3 hours when it slowed down and finally stopped. I slept. in the morning I awoke, with a terrible headache and was completely exhausted. I slept all day. (taking Advil and Tylenol for the headache. Nothing helped. I finally took an Imitrex, when I went to bed again. During the day, when I woke I had about a bottle of water during the entire day and all night . Didn't feel like eating anything. Today I was still tired and the headache was back, but not as bad. I had breakfast and supper and slept in between. Tonight I feel much better.
82 2021-02-06 headache Severe headache 3 days, nausea 3 days, weakness 5 days, pain upper part of body 5 days, unable to wa... Read more
Severe headache 3 days, nausea 3 days, weakness 5 days, pain upper part of body 5 days, unable to walk w/o assistance 2 days, red feverish arm, on 6th day could be up but only 20-30 min at a time. 9th day back to normal.
82 2021-02-06 headache Sharp shooting pain in right ear, sharp pain in forehead. Red, hard blotch on left upper arm measuri... Read more
Sharp shooting pain in right ear, sharp pain in forehead. Red, hard blotch on left upper arm measuring 3" x 6". Decreasing redness each day since Feb 4th.
82 2021-02-07 chills, headache, fatigue First day after injection all of these events came at one time: Muscle soreness in thighs & lower b... Read more
First day after injection all of these events came at one time: Muscle soreness in thighs & lower back, headache, stiffness both sides of neck, temperature: 101, exhaustion (much like covid), vomiting, severe chills (first day) , burning bottom of feet and palms of hands. Redness and swelling vaccination site. Day 2: muscle and joint soreness, no temperature, no appetite, continued fatique, vaccination site redness, hard. Site is currently only reaction left..still quite sore and heated, red , swollen and hard.
82 2021-02-07 fever 3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R ... Read more
3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R face Bells Palsey
82 2021-02-08 body temperature increased, fatigue Tired, change of gait, temp of 102.2 7pm
82 2021-02-08 fatigue, chills chills started about 4:00 pm ABOUT HOUR LATER EXTREME BODY ACHES MUCH MORE THAN NORMAL, TIRED AND ... Read more
chills started about 4:00 pm ABOUT HOUR LATER EXTREME BODY ACHES MUCH MORE THAN NORMAL, TIRED AND SLEPT A LOT. ARM WAS SORE FROM THE TIME OF THE SHOT AND KEPT GETTING WORST AS TIME, DAYS WENT ON MY ARM WAS BRUISED WHERE THE SHOT WAS GIVEN AND JUST BELOW THAT IT WAS SWOLLEN - RED - SORE. THE REDNESS WAS ABOUT THE SIZE OF A SMALL SAUCER, EXTENDING ALMOST TO MY ELBOW AREA. COULD NOT LAY ON MY RIGHT SIDE WHEN SLEEPING AND IF I DID IN MY SLEEP IT WOULD AWAKE ME RIGHT AWAY ON SATURDAY MY ARM ITCHED IN THE RED AREA UP TILL ABOUT MONDAY - MY ARM HURT EVERY TIME I MOVED IT OR USED IT - BUT EACH DAY IT WAS LESS TODAY 2-9-21 MY ARM IS NOT SWOLLEN OR RED ANYMORE BUT SLIGHTLY SORE TO THE TOUCH
82 2021-02-09 headache sore arm, nauseous, headache, stomach ache
82 2021-02-09 influenza like illness, fever Fever: 102*F, Flu like symptoms.
82 2021-02-10 chills, headache, fever Chills, low grade fever, headache
82 2021-02-10 fever, fatigue Body aches in am. Fever, body aches, tiredness in pm. Feeling ok this am.
82 2021-02-10 fever Fever 101 degrees no energy
82 2021-02-11 fatigue, influenza like illness COVID-19 Vaccine EUA; I and 1/2 days after shot came down with flu like symptoms, nausea and couldn... Read more
COVID-19 Vaccine EUA; I and 1/2 days after shot came down with flu like symptoms, nausea and couldn't stay up, had to lay down. No fever and passed after 24 hrs. A week later shot area swelled and had an itchy rash which went away after 24 hrs.
82 2021-02-11 headache, chills, fever Arm started hurting, chills, back ache, extremely smelly diarrhea, lots of gas, headache, back ache,... Read more
Arm started hurting, chills, back ache, extremely smelly diarrhea, lots of gas, headache, back ache, joint aches, weakness, and a 100.1 fever that lasted 24 hours only.
82 2021-02-12 chills, sneezing, nasopharyngitis, malaise, runny nose Shaking chills, much sneezing, runny nose. Much like common cold. Sore arm, malaise. No fever or cou... Read more
Shaking chills, much sneezing, runny nose. Much like common cold. Sore arm, malaise. No fever or cough.
82 2021-02-12 fatigue, throat pain Extremely painful sore throat. Gargled with peroxide and water. Slowly getting better today 2-13. ... Read more
Extremely painful sore throat. Gargled with peroxide and water. Slowly getting better today 2-13. Fatigue
82 2021-02-12 headache, sleepiness muscle soreness, mild headache, no appetite, slept more than 18 hours during the next 24 hours. ... Read more
muscle soreness, mild headache, no appetite, slept more than 18 hours during the next 24 hours. All symptoms gone by ten AM 2,13/21.
82 2021-02-12 headache Vaccine received 2/5/21. At about 12:30 AM on 2/8/21 she had diarrhea for about 6 hours, severe head... Read more
Vaccine received 2/5/21. At about 12:30 AM on 2/8/21 she had diarrhea for about 6 hours, severe headache at back of head above occiput and all over body ache for about 48 hours.
82 2021-02-12 nasopharyngitis, chills, headache At 1:10 pm on Feb. 11, 2021 received vaccine in upper left arm. Felt fine, very little arm soreness... Read more
At 1:10 pm on Feb. 11, 2021 received vaccine in upper left arm. Felt fine, very little arm soreness, no other reaction. Around 8:30 pm that evening started getting terrible stomach cramps and then terrible diarrhea started. Continued with awful stomach pains and diarrhea for about 2 hours. Had somewhat of a headache and chills. Next morning felt better but still had slight stomach cramps and slight diarrhea., felt cold. Better 3rd day.
82 2021-02-13 fatigue I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was... Read more
I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was talking in complete sentences and responded appropriately. She was upright in bed and made eye contact. She smiled and denied pain. By Sunday, she was extremely weak and unable to sip water with a straw. Her health had changed dramatically and rapidly. She moaned in pain and was very fatigued. Her condition continued to deteriorate over the week and she stopped talking and was constantly sleeping. They started antibiotics for the oozing cancer lesion and then morphine for pain and end of life care. She passed away on January 22nd which was 15 days post vaccination.
82 2021-02-15 fever, pneumonia Fever by the next day, difficulty breathing, pneumonia, and then DEATH within a few days. (Died 02/0... Read more
Fever by the next day, difficulty breathing, pneumonia, and then DEATH within a few days. (Died 02/01/2021)
82 2021-02-16 fatigue, headache No side effects until 9 days after vaccination. No sore arm or no feeling bad. On the 9th day my... Read more
No side effects until 9 days after vaccination. No sore arm or no feeling bad. On the 9th day my arm at the vac. Site (right arm) got very swollen and very itchy. Headache and diarrhea also. Feeling very tired.
82 2021-02-16 fatigue Patient had a reaction 4 days after the 2nd Covid vaccination. She began to experience vomiting that... Read more
Patient had a reaction 4 days after the 2nd Covid vaccination. She began to experience vomiting that lasted 24 hours, accompanied by extreme fatigue and dizziness. Fatigue and dizziness are still peristing in a mild manner.
82 2021-02-16 malaise, body temperature increased Increased Temperature and general Malaise
82 2021-02-16 malaise, fever General Malaise, fevers, swollen/tender at injection site
82 2021-02-17 fatigue, chills Pt had general weakness, fatigue for 3-4 days prior to her ED visit on 2-17-2021. No fever or sig... Read more
Pt had general weakness, fatigue for 3-4 days prior to her ED visit on 2-17-2021. No fever or significant pains. Some chills. Oral intake OK. Had second Covid shot a week ago on 2-8-2021. . Had paracentesis 2 days ago on 2-15-2021, gets them every 10-14 days for liver disease. B/P 98/33
82 2021-02-17 sweating, fatigue, chills the day she received the vaccine: that night she had fatigue the entire day and major sweating. 7 da... Read more
the day she received the vaccine: that night she had fatigue the entire day and major sweating. 7 days later She developed a rash on her left arm, and has enlarged lymph nodes under her left arm and is still sweating. Since the vaccine she has experienced achy body, chills, and fatigue like the flu symptoms.
82 2021-02-17 malaise, sleepiness, influenza like illness, fatigue Vaccine #1 had no issues. Vaccine # 2 had the following: Site of shot was hot, large, inflamed 4 da... Read more
Vaccine #1 had no issues. Vaccine # 2 had the following: Site of shot was hot, large, inflamed 4 days/ started to imrove on day 5 Day #1 Woke up at midnight with severe shooting pain in neck and went straght up head/followed by inability to move legs/eased off and the next morning could use legs and pain gone, but arm had started to swell at site of shot Day #2 Very sick, flu like symptoms, sleepy, no headache, chills Day #3 same as day 2 Day #4 Same as day 2 and arm easing off Days 5-9 severe fatigue , abnormally tired and unable to function normally Day nine severe dizziness started and has continued to day 13. Cannot drive, wobbly
82 2021-02-17 fever, influenza like illness, chills severe dizziness, severe chills, fever (101.6) , body aches, weakness and flue like symptoms
82 2021-02-18 chills Chills day after vaccine. Subsided after drinking cup of tea and going to bed. Itchy rash left lower... Read more
Chills day after vaccine. Subsided after drinking cup of tea and going to bed. Itchy rash left lower arm and hand day after vaccine. Right arm and hand, right and left upper thighs, left buttock, left mid-back and abdomen. No treatment yet.
82 2021-02-18 fever, fatigue Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went... Read more
Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date). See following discharge summary from ED: 82 y.o. female who initially presented to the ED with complaint of generalized weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt. During her stay in the hospital, pt did test positive for Covid 19. She developed rapidly progressive respiratory failure, felt to be secondary to ARDS. There was also question of contributing pulmonary edema, however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately, she continued to suffer greatly with the BiPAP in place, and therefore made the decision to transition herself to comfort measures only after visitation from her family. Her other medical issues were supported as appropriate during her stay, with dextrose infusion for hypoglycemia and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine­ enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia.
82 2021-02-18 fever, malaise, chills Fever, chills, severe malaise, nausea, diarrhea, confined to bed With permission of physician, took... Read more
Fever, chills, severe malaise, nausea, diarrhea, confined to bed With permission of physician, took ibuprofen at 1:pm that day. Symptoms eased General malaise continued for 2 more days
82 2021-02-19 chills, fever, influenza like illness, fatigue new muscle pain and increased old pain. neck pain. flu-like systems. fever chills, tired for two day... Read more
new muscle pain and increased old pain. neck pain. flu-like systems. fever chills, tired for two days.
82 2021-02-19 chills, fever COVID Moderna on 2/11/21 On 2/12/21 the patient present with possible reaction to covid shot. She de... Read more
COVID Moderna on 2/11/21 On 2/12/21 the patient present with possible reaction to covid shot. She developed fever/chills/diarrhea about 10 hours after shot. Lots of injection site pain. Symptoms seem to be improving after taking some tylenol though. She does have sickle cell trait but denies joint pain.
82 2021-02-19 fatigue symptoms: aches, fatigue 2 days
82 2021-02-21 fever The patient started running a fever of 101 within 12-24 hours of receiving her second covid vaccine ... Read more
The patient started running a fever of 101 within 12-24 hours of receiving her second covid vaccine and was suffering from altered mental status. She was transported via EMS where she was admitted until her d/c home on 2/20/21.
82 2021-02-22 fatigue Muscle and joint aches, no fever, general tiredness. Went to bed, slept all night, felt pretty goo... Read more
Muscle and joint aches, no fever, general tiredness. Went to bed, slept all night, felt pretty good when I woke up, felt fine by noon that day.
82 2021-02-22 headache Pt has hx of rash on bil arms with her first dose of Moderna and she denies no other reactions inclu... Read more
Pt has hx of rash on bil arms with her first dose of Moderna and she denies no other reactions including shortness of breath , chest pain, dizziness, headaches, fever, difficulty breathing, dyspnea,dysphagia or wheezing. Pt does notes to have underlying dysphagia which is a chronic issue for pt. Today pt was here for her second Moderna Imm which she tolerated well but at 0845 am reported mild headache which to her seemed similar to her previous migraine headaches which she gets off and on . Denied any nausea vomiting, dizziness, chest pain, shortness of breath, dysphagia, dyspnea, wheezing or coughing or difficulty breathing. Pt was given water and crackers which helped her sx immediately. BP: 134/83 HR: 76 O2: 98% RR: 17. Neuro: pt A&O and able to follow instructions. Pt was monitored for 40 mins total and she left in stable condition.ER precautions were given to pt incase she has any worsening of sx, shortness of breath, chest pain, wheezing , difficulty breathing. She reported understanding.
82 2021-02-23 chills, fever, headache headache, chills, fever, palpitations found to have NSVT, A Fib with RVR and hypomagnesemia
82 2021-02-23 fever right arm cellulitis. had to be hospitalized due to tachycardia, fever, clinical exam consistent wi... Read more
right arm cellulitis. had to be hospitalized due to tachycardia, fever, clinical exam consistent with cellulitis
82 2021-02-24 headache About 4 hours after receiving the first dose of the Moderna COVID-19 Vaccine, patient felt headache... Read more
About 4 hours after receiving the first dose of the Moderna COVID-19 Vaccine, patient felt headache, itchy face/neck, right side ear ache. Headache persisted into the next day. Took Tylenol which mildly relieved symptoms of headache and ear ache.
82 2021-02-24 sleepiness Patient reported that during the first hour after vaccine she felt pain in her shoulders and back, a... Read more
Patient reported that during the first hour after vaccine she felt pain in her shoulders and back, and "intense chest tightening". She took a children's tylenol tab and put heat on her back and then rested and fell asleep for a period of time. SHe woke up to "pins and needles" feeling in her head and face that felt "intense" to her maybe 4-5 hours after vaccination. She continued to feel "discomfort, tightness in chest/back" for 2-3 days. SHe then stated around day 10 she had abdominal tightening, overwhelming nausea, and pressure in her stomach, but no diarrhea for about 6-7 days. She also states she had "bad reflux". Around Feb 14th-16th she started feeling a rash on both arms/neck/chest and then hives that were red/blotchy a few were raised and hard on thighs/hip/arms. She went to physician and was given Benadryl and Steroid cream. She then reports that on Feb 20th she had swollen lymph nodes under arm.
82 2021-02-25 chills, headache WITHIN THREE HOURS AFTER VAX, FACE BECAME REALLY FLUSHED, WOKE UP AT 2AM WITH SEVERE CHILLS, BODY & ... Read more
WITHIN THREE HOURS AFTER VAX, FACE BECAME REALLY FLUSHED, WOKE UP AT 2AM WITH SEVERE CHILLS, BODY & JOINT ACHES AND STIFF NECK ALONG WITH POUNDING HEADACHE.
82 2021-02-25 fatigue RASH ON ARM AND ACROSS CHEST; GLANDS SWELLED A LITTLE; BURNING, ITCHING AND STINGING ARMS AND LEGS;... Read more
RASH ON ARM AND ACROSS CHEST; GLANDS SWELLED A LITTLE; BURNING, ITCHING AND STINGING ARMS AND LEGS; CONTINUED FOR 5 WEEKS AND STILL CONTINUES ALTHOUGH SUBSIDING. STOMACH MUSCLES HURT BUT NO NAUSEA. EXPECTED FATIGUE, DIZZINESS AND WEAKNESS BUT NOT CONCERNED ABOUT THAT. RAISED BLOOD PRESSURE AND PULSE RATE ON 2/3/2021. STILL EXPERIENCING VARIATIONS IN HEAT/COLD FEELINGS..MAY OR MAY NOT BE RELATED.
82 2021-02-25 lethargy, headache lethargy, numbness in legs, nausea, headache
82 2021-02-25 fever, chills patient called pharmacy on 2/26/2021 to report that on 2/21/2021 arm became "really sore, red, swoll... Read more
patient called pharmacy on 2/26/2021 to report that on 2/21/2021 arm became "really sore, red, swollen, itchy and warm to the touch" and she had a fever and chills; patient states she took Tylenol for the fever and applied Benadryl gel for the itching; patient states color is back to normal today (redness lasted until 2/25/2021), slight itch (1 on scale of 1 to 10) remains today
82 2021-02-26 cough, chills, headache, fever, sinusitis, sneezing, fatigue Chills, fever, headache, body aches, A couple of nosebleeds, and my arm hurt from the injection site... Read more
Chills, fever, headache, body aches, A couple of nosebleeds, and my arm hurt from the injection site down to the end of my fingers. Headache continued for four days and fever would come and go but usually at night. I did not receive treatment but I did let my cardiologist office know what was going on. When I continued with the headache, I contacted the internist?s office and I only had a TelMed visit with them. My nostrils had something like cold sores but then I started sneezing and realize there was infection also. Had a second TelMed visit with the PA who started me on an anabiotic Amoxicillian. The infection is clearing up in my sinuses but I am coughing a lot. Overall continue to feel very tired and weary
82 2021-02-26 fatigue tiredness , diarrhea onset 2/15/21
82 2021-02-26 malaise, chills, headache 10 min. was fine, then all of a sudden my whole body felt flushed and overcome with nausea, light he... Read more
10 min. was fine, then all of a sudden my whole body felt flushed and overcome with nausea, light headedness, ,my face was hot and had an overall feeling of being unwell. It is hard to describe. I did not think I could drive home safely, so I sat back down and told the girl. She let me sit quietly and than took my blood pressure which was either 185 or 189. She let me rest and then took it again. This time it was 167. I left there about 8:30a.m., came right home and went to bed. Got up after a long nap and B.P. was 165/82 61 at 6:45p.m. My face is still flushed, have chills and slight headache, took aspirin. At 9:45 B.P. was 150/92 64, felt the same. B.P. at midnight was 130/73 73
82 2021-02-27 fatigue, headache The next day I had fatigue, headache, sore arm. The following day I felt ok but my left eye. Same si... Read more
The next day I had fatigue, headache, sore arm. The following day I felt ok but my left eye. Same side as shot became red an d swollen. Emer Room diagnosis is Chemosis of left conjunctiva
82 2021-02-28 fatigue Itchy, red rash around the injection site which lasted 4 days plus burning down her arm and fatigue ... Read more
Itchy, red rash around the injection site which lasted 4 days plus burning down her arm and fatigue for 2 days.
82 2021-03-01 fatigue Complain of extreme dizziness that started on yesterday, 3/1/2021 at 5:30 PM and stopped on this mor... Read more
Complain of extreme dizziness that started on yesterday, 3/1/2021 at 5:30 PM and stopped on this morning, 3/2/2021 at 1:00 AM. Initially felt tired and washed out after injection on 1/25/2021 and 1/26/2021. States she is currently is little lightheaded. Advised patient to seek healthcare is symptoms does not go away.
82 2021-03-01 headache, chills, fatigue, fever 5:00am 2/21/21 thru 5:00am 02/22/21 (24 hrs) chills, fever (99.7), headache, nausea, muscle/joint p... Read more
5:00am 2/21/21 thru 5:00am 02/22/21 (24 hrs) chills, fever (99.7), headache, nausea, muscle/joint pain; For reainder of 2/22/21 thru 2/2/24/21 experienced Fatigue, lack of energy and did have swelling, soreness, redness/heat Upper Right Arm where had injection.
82 2021-03-02 chills, fever, headache Fever, chills, headache, body ache
82 2021-03-02 fatigue, chills I started having chills and loss of energy. The second day really felt very tired. When I took my ... Read more
I started having chills and loss of energy. The second day really felt very tired. When I took my blood pressure it was very high. Twice in the next few days I went to the ER with over 200 over 79 I saw my family doctor and they did a k g and said my heart was out of rhythm and they sent me to the cardiologist. I still feel light headed and blood pressure still high and heart rate low.
82 2021-03-02 fatigue So tired; No energy, very weak; Same night went into afib; A spontaneous report was received from a ... Read more
So tired; No energy, very weak; Same night went into afib; A spontaneous report was received from a 82 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced atrial fibrillation, so tired and no energy, very weak. Patient's medical history included atrial fibrillation. Relevant concomitant medications included prednisone and benadryl. On 28 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On the same day, patient experienced atrial fibrillation. On 29 JAN 2021, she was so tired and had no energy and was very weak which lasted for 6 days. She thought that this was due to prednisone and Benadryl prophylactically. On the same day, her sinus rhythm was found to be back to normal. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events atrial fibrillation was considered resolved on 29 JAN 2021 and the events so tired and no energy, very weak were considered resolved on 04 FEB 2021.; Reporter's Comments: This case concerns an 82 year old female patient, with medical history of paroxysmal atrial fibrillation (2016), who experienced a serious unexpected event of atrial fibrillation, among other non-serious events, after receiving first dose mRNA- 1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
82 2021-03-02 headache, body temperature increased headache 24hrs starting the 4th day after the injection Full body aches 12 hrs Temp 99.1 12hrs. ... Read more
headache 24hrs starting the 4th day after the injection Full body aches 12 hrs Temp 99.1 12hrs. took buffered aspirin diarrhea 1 time dizzy episodes. 6 & 7 days after vaccine. (no medical attention needed)
82 2021-03-02 fever Low grade fever and nausea
82 2021-03-02 fever Disorientated; racing heart rate; fever of 101, had to call paramedics
82 2021-03-03 headache Post vaccination inmate reports feeling dizzy w/headache; BP 150/ 65 P82; minimal improvement post... Read more
Post vaccination inmate reports feeling dizzy w/headache; BP 150/ 65 P82; minimal improvement post medical monitoring x 30 min, continues to c/o dizziness and headache, Inmate transported to hospital for further evaluation/ treatment.
82 2021-03-03 fever, chills, headache I developed chills later that evening. I took Tylenol and went to bed. Middle of the night I had chi... Read more
I developed chills later that evening. I took Tylenol and went to bed. Middle of the night I had chills again and took more Tylenol. In the morning I had a fever of 102. I took Tylenol every 6 hours and in-between doses I had headaches and chills as the Tylenol wore off. 6:30 am the next day I had a fever just below 100. My arm is also warm and achy and I have body aches.
82 2021-03-04 chills Muscle and joint pain , chills, and weakness
82 2021-03-04 cough Patient presented on 2/16 with SOB and cough over past 3 weeks. Patient treated with antibiotics, st... Read more
Patient presented on 2/16 with SOB and cough over past 3 weeks. Patient treated with antibiotics, steroids and nebulizers.Patient improved and discharged 2/24 with plan for outpatient biologic treatment for eosinophilic asthma. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. .
82 2021-03-04 pneumonia Nurse called clients' son to remind her of the second dose needed and was informed that client had p... Read more
Nurse called clients' son to remind her of the second dose needed and was informed that client had passed away from Pneumonia the Sunday after she received the vaccine 1/17/2021.
82 2021-03-05 body temperature increased, headache, chills 03-04-2021: 12 hours temp 101.4 10hours temp 99.9 headache. body aches . relentless chills. mil... Read more
03-04-2021: 12 hours temp 101.4 10hours temp 99.9 headache. body aches . relentless chills. mild nausea. no appetite . Aleve 03-06-2021 Return to perfect normalcy. temp 97.8 (typical for my body)
82 2021-03-07 chills SOB, nausea, chills, chest pain, tachycardia. Went to ED.
82 2021-03-07 headache, malaise Headache, Malais, nausea
82 2021-03-07 headache, fever, chills Potential vaccine-associated AE noted onset 4 days after Moderna dose 1: "Covid arm", but also had c... Read more
Potential vaccine-associated AE noted onset 4 days after Moderna dose 1: "Covid arm", but also had chills, headache, nausea, feverishness. Headache lasted about 10 days. Patient did not seek medical evaluation.
82 2021-03-07 headache Severe Headache
82 2021-03-07 headache Dizziness, Nausea, Exacerbation of arthritis pain, one severe episode of vertigo, headaches
82 2021-03-08 fatigue, fever On the first evening I had a fever and joint pains which resolves by the next morning, On 02/03/2021... Read more
On the first evening I had a fever and joint pains which resolves by the next morning, On 02/03/2021 I had diarrhea on awakening and about two hours later, after doing morning chores including carrying and lifting 4 gallons of water, I fainted,which included having another episode of diarrhea while I was out. I was seen by emergency medical personnel, had an EKG, and then my children, with whom I live, took me to see my primary care provider who ordered some basic blood tests: a CBC and panel. All blood tests were normal as well as the EKG, I assume. We think the faint was perhaps triggered by the diarrhea and exertion of chores in addition to the vaccine's effect . Since then I have had fatigue.
82 2021-03-09 headache, fever Day 7 started feeling dizzy took blood pressure and was 188/80. Fever was 99.8. Achey body and heada... Read more
Day 7 started feeling dizzy took blood pressure and was 188/80. Fever was 99.8. Achey body and headache. After 3 days blood pressure went down and all was back to normal.
82 2021-03-09 fever, fatigue, malaise Patient reports fever, diminished activity, and fatigue; Had two days fever after her second shot as... Read more
Patient reports fever, diminished activity, and fatigue; Had two days fever after her second shot as well as weakness and fatigue - rough 2-3 days but now feeling somewhat better. Feels like she has weakness in her legs - has been very fatigued since the second shot. She reports itchiness, redness, and rash; RIGHT arm at the site of the second COVID vaccine - initially redness, edema and pain - now just redness (like sunburn). had balance issues after the shot - has improved.
82 2021-03-10 chills Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultim... Read more
Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultimately succumbed to cardiac arrest.
82 2021-03-11 fatigue, fever I had no effect until after i went to sleep.. After midnight i awoke to itching all over. By mornin... Read more
I had no effect until after i went to sleep.. After midnight i awoke to itching all over. By morning my eyes were closed to slits and beneath my eyes were bags as large as teabags, i also had a low grade fever, aches and pains and extreme fatigue. This lasted for a while so ,on Feb 2.. I went to the doctor who gave me a steroid shot. On the 4th i was not as achy though still tired and the bags under my eyes persisted ...My eyes were still itchy and almost closed... She gave me another steroid shot.. i was also advised not to get second steroid shot by several doctors, a doctor and a Immunologist.. also advised against getting second dose. The fatigue remains and the swelling under eyes remains though not as pronounced as it was at first. I would like to be safe. Is the johnson and johnson an option for me? I would not like after effects Please get back to me with some suggestions and advice as to my being fully safe. thank you.
82 2021-03-11 fatigue Daughter provided the information for her elderly mother who, at this time, was being evaluated in... Read more
Daughter provided the information for her elderly mother who, at this time, was being evaluated in the ED at Medical Center . 3/5/21 - approximately 16.5 hrs after her mother's second dose of Covid 19 vaccination, she woke up very weak and felt very tired. 3/6/21 Patient noticed rash (not raised) but reddened in the left upper arm where the injection was given. She stated it was oval in appearance and covered most of the upper arm. She noted a lump in her underarm of the left axilla also. Denied any fever or other symptoms and otherwise felt fine. On 3/9/21 she noticed a lump in the groin area and noticed that walking was a little more difficult than usual since both of her knees bothered her. 3/12/21Pt went to orthopedic surgeon and had a "cortisone injection" in the right knee. This afternoon, the patient's daughter suggested that she go a local Urgent Care because the patient stated that the lump (previously in groin area) "was moving." She waited in there for over one hour and then a nurse came out and told her to go to the ED for evaluation of her left upper arm for the redness and swelling. She went directly to the ED and is being evaluation and having bloodwork done. Daughter said if the lab results are normal, her mother will be discharged with an oral antibiotic and benadryl
82 2021-03-11 fever, sweating, influenza like illness Flu like symptoms including but not limited to fever, aches, sweating, dizziness. Resulted in faint... Read more
Flu like symptoms including but not limited to fever, aches, sweating, dizziness. Resulted in fainting and falling, proceeded to faint multiple times - lost all bodily functions, eyes rolled in back of head multiple times and 911. Did get back to ability to get home but now repeats herself more than before and seemed to have lost some mental capacity till Wednesday March 10 / she now is better but scared to do anything on her own as fearing issues again
82 2021-03-12 fatigue First shot: Itch at first Then very large red area about 3? x 5? Redness lasted more than a week ... Read more
First shot: Itch at first Then very large red area about 3? x 5? Redness lasted more than a week Second shot: redness after about a day and a half. Mild itch. Extreme tiredness for about 48 hours. Rash fades after a few days
82 2021-03-13 body temperature increased woke up with red rash all over body but worse on face and arms, and fever of 99.7 on the 6th day. tr... Read more
woke up with red rash all over body but worse on face and arms, and fever of 99.7 on the 6th day. treating with tylenol, benadryl and hydocortizone cream. still treating so we don't know the outcome as of yet.
82 2021-03-14 headache, fever March 7, 2021 at about 6:30 p.m. I had two spells where I had no control over my body. I fell and c... Read more
March 7, 2021 at about 6:30 p.m. I had two spells where I had no control over my body. I fell and could not get up. I had no strength and was unable to get up. Each time it only lasted a few seconds or minutes. It was sort of like I fainted but stronger. I had spent most of the day resting as I had a very bad headache but that was about gone when I had the two spells. I had also had a small patch of hives (fever and swelling) about the size of my hand at the site of the shot. That lasted about a week after each shot. I thought this was something I should report. Thanks.
82 2021-03-15 cough, fatigue Fatigue on that same day . Second day bad cough all night . Third day. Very dizzy like vertigo. Had... Read more
Fatigue on that same day . Second day bad cough all night . Third day. Very dizzy like vertigo. Had to take sea sick pill for two days .
82 2021-03-15 fatigue Patient said she was fatigued and had to sleep all day. She was also confused and disorient. She cou... Read more
Patient said she was fatigued and had to sleep all day. She was also confused and disorient. She could not remember where she was and forgot to take her medications. Her family almost called 911 because they were very concerned. She said her experience lasted for 24 hours.
82 2021-03-15 fever, fatigue, malaise generally felt bad and tired, some soreness at injection site, red spot on the left arm with a small... Read more
generally felt bad and tired, some soreness at injection site, red spot on the left arm with a small lump (not at injection site) the red spot is still visible, had fever the day after shot. Day of the shot I slept all day and that night.
82 2021-03-16 fever, chills, headache 18 days after 2nd injection I developed headache, chills, and fever. Also had abdominal bloating and... Read more
18 days after 2nd injection I developed headache, chills, and fever. Also had abdominal bloating and gas cramps. The headache and fever lasted 30 hours. Is it possible this is a reaction to the vaccine? Had no other symptoms, but had had headache and achiness for 2 days right after vaccine.
82 2021-03-17 fatigue The patient reported feeling tired and diziness beginning February 20, 2021 and had a stroke later t... Read more
The patient reported feeling tired and diziness beginning February 20, 2021 and had a stroke later that day. She was treated in the hospital for 4 days and later released. She did not get her second dose.
82 2021-03-18 chills, headache arm soreness, thirsty, at 5pm. pain in shoulders, elbows, hips, back overnight and in am following... Read more
arm soreness, thirsty, at 5pm. pain in shoulders, elbows, hips, back overnight and in am following. chills, shaky. headache nausea late afternoon over 24 hrs after injection. arm soreness three days. other effects 24 hrs.
82 2021-03-18 dehydration blood pressure was going real high, then go low; dehydration; diarrhea; blood pressure would drop to... Read more
blood pressure was going real high, then go low; dehydration; diarrhea; blood pressure would drop to 40; will go upto walking rate 95 to lower 100s; heart rate normally stays 60s - 70s (averages 66 for resting rate); heart rate going up now; A spontaneous report was received from a consumer who is a 82-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase, which led to hospitalization. The patient's medication history included diabetes and high blood pressure. Concomitant medications included amlodipine , irbesartan and pravastatin. On 21-Jan-2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 012L20A ) intramuscularly in the the left arm for prophylaxis of COVID-19 infection. The patient referred he had diarrhea prior to the administration of the vaccine. Following the vaccine administration, he continued having the diarrhea during 3 weeks that made him lost a lot of fluids. He attended to the ER several times for dehydration but in the last visit, he got admitted due to increased blood pressure, dehydration, increased heart rate and prior history of diabetes. Laboratory details included electrocardiogram, stress test. Treatment information included fluids,taken off metformin and metoprolol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
82 2021-03-18 headache, fatigue, throat irritation, sleepiness I woke at 1:30 in the morning to a burning throat, head ache, upset stomach, nausea. When I arose... Read more
I woke at 1:30 in the morning to a burning throat, head ache, upset stomach, nausea. When I arose I started the dry heaves. This lasted all day. I was also very tired and slept on and off all day. I slept well that night and woke feeling fine but still a bit on the tired side. Thankfully, no more nausea or headache. I had no treatments except what I did for myself which was to drink lots of fluids and have very bland food and little of it. I live alone and have no family near so I take care of myself. I do need to know if I should have the second shot. I have one scheduled but would rather not go through that nasty experience again.
82 2021-03-18 headache Body aches. Headaches balance and leg pain
82 2021-03-21 chills Began approx 36 hours after injection. Extreme chills, threw up > 5 X, Lip Swelled, eyes (1 more th... Read more
Began approx 36 hours after injection. Extreme chills, threw up > 5 X, Lip Swelled, eyes (1 more than the other). Did not take a hydrocodone this day.
82 2021-03-21 fatigue, cough, nasal congestion Experiencing similar symptoms of those of heart failure; Feeling bad; Congestion; Coughing a lot; Ti... Read more
Experiencing similar symptoms of those of heart failure; Feeling bad; Congestion; Coughing a lot; Tired alot; A spontaneous report was received from a consumer concerning an 82-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced feeling bad/feeling abnormal, had similar symptoms of those of heart failure/cardiac failure, coughing a lot/cough ,congestion/nasal congestion and tired a lot/fatigue. The patient's medical history included heart failure and hypothyroidism. Concomitant medications reported included medication for heart failure and hypothyroidism. On 19-JAN-2021, approximately three weeks prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10-FEB-2021, the patient reported that three weeks after receiving the vaccine she started feeling bad, had similar symptoms of those of heart failure (which he has had), cough/coughing a lot, congestion and tired a lot. The event similar symptoms of those of heart failure is considered as medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events feeling bad, similar symptoms of those of heart failure, cough (coughing a lot),congestion and tired a lot, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
82 2021-03-21 headache, body temperature increased, body temperature fluctuation As reported yesterday, temp keeps going up & down, while the itching in my left forearm has stopped,... Read more
As reported yesterday, temp keeps going up & down, while the itching in my left forearm has stopped, last night about 11:00 that part of my arm was burning altho there was no redness or itching. My face was burning as well. My temp was 100.1 & I took a Tylenol for that. No redness. I had a very bad headache that started about 6:00. I take Butalbital as needed & by 11:00 it was so bad I had taken 3, starting at 6:00. Today I feel a slight heaviness in my chest, & have no energy at all.
82 2021-03-21 headache Severe dizziness, vertigo, nausea, vomiting,headache, fast heartbeat, over period of two days. Occu... Read more
Severe dizziness, vertigo, nausea, vomiting,headache, fast heartbeat, over period of two days. Occurred on the 11th and 12th days after my second Moderna vaccination shot. Ressol,ved after two days
82 2021-03-22 chills Chills 1 hour after injection, tightness and aching in upper arm just below injection site and radi... Read more
Chills 1 hour after injection, tightness and aching in upper arm just below injection site and radiating down arm to hand, sleepless night, took two oxycodone during night to alleviate pain
82 2021-03-22 fatigue, chills, fever After injection a little itching . The next day I had what is called 'Covid Arm'. Rash and itchin... Read more
After injection a little itching . The next day I had what is called 'Covid Arm'. Rash and itching on the arm. Had fever, muscle pain, tired and chills
82 2021-03-23 chills, headache extreme chills and shakes lasting several hours. / headache/
82 2021-03-23 malaise, fatigue PATIENT RECIEVED VACCINE ON FEBRUARY 12, 2021. BEGAN FEELING VERY FATIGUED AND SHORT OF BREATH ABOUT... Read more
PATIENT RECIEVED VACCINE ON FEBRUARY 12, 2021. BEGAN FEELING VERY FATIGUED AND SHORT OF BREATH ABOUT ONE WEEK LATER. AFTER A WEEK OF FEELING UNWELL SHE DECIDED TO GO TO LOCAL CLINIC. THEY DID AN EKG AND SENT FOR A HEART MONITOR. SHE WAS SENT HOME AND WAITED FOR THE MONITOR TO ARRIVE BY MAIL. IN ABOUT ANOTHER WEEKS TIME SHE WAS RUSHED TO EMERGENCY AND WAS HAVING A MASSIVE HEART ATTACK. SHE PASSED AWAY MARCH 2, 2 1/2 WEEKS AFTER HER FIRST MODERNA VACCINE. I BELIEVE IT WAS THE VACCINE THAT CAUSED THE HEAT ATTACK.
82 2021-03-23 fever, fatigue fever 102 degrees, fatigue lasting several weeks, weakness lasting several weeks, pain at injection ... Read more
fever 102 degrees, fatigue lasting several weeks, weakness lasting several weeks, pain at injection site
82 2021-03-24 fever, chills, headache Fever, Chills, Headache
82 2021-03-25 fatigue Fatigue, weakness, dizziness, mild confusion, decreased PO intake lasting >36-48 h
82 2021-03-26 headache headache on the right side of forehead and face, some nausea,
82 2021-03-26 headache approximately 10 days after injection, my upper left arm became red, hot and bumpy. Following, I de... Read more
approximately 10 days after injection, my upper left arm became red, hot and bumpy. Following, I developed a very severe headache off and on for 3-4 days. All settled down after about 5 days.
82 2021-03-28 malaise Last Moderna vaccine March 3, 2021. On March 17 began not feeling well. Never felt this way. Then ... Read more
Last Moderna vaccine March 3, 2021. On March 17 began not feeling well. Never felt this way. Then on March 25 had severe low abdominal pain that sent her to ER.
82 2021-03-29 headache, fever, chills Headache began around 8:30 PM and went from my temples and forehead to the base of my neck, followed... Read more
Headache began around 8:30 PM and went from my temples and forehead to the base of my neck, followed a while later by pain in both arms between my shoulders and elbows. Knowing sleep would be difficult, I stayed up until 2:00 AM and fell asleep about 3:00 AM. I awoke at 3:20 AM trembling so badly that I couldn't hold a thermometer in my mouth. So, it was time for "chills and fever" and I put sweat pants and a sweat shirt over my flannel Pjs, heavy socks on my feet, and socks on my hands. My entire body felt ice cold. Back under the covers, I finally warmed up and slept off and on for almost eight hours.Woke up around noon on Saturday, feverish, feeling nauseous, exhausted, and still feeling the headache and arm pains. My "normal" temperature runs from 97.1 to 97.6, but ranged from 100.2 to 100.5 for two days after the vaccine. Slept off and on around the clock on Saturday and Sunday, and by Monday the headache, pain, and fever were gone. Slight nausea remained as well as the fatigue on Monday. On Tuesday, my legs felt wobbly, like "sea legs." By Wednesday, I was back to normal catching up on email and reading my books, and on Thursday drove out to the county to bring food to my sister and fix her PC. I understand that seniors do not usually get the side effects as I did, because the immune system declines with age. Apparently, my immune system is not aware of my birth date. Can't help but wonder if taking Co-Q-10, as I've done for almost twenty-four years, has anything to do with it.
82 2021-03-30 chills, headache Found on unconscious on the floor, I have no memory of coming of bathroom; I felt weak and hot; I fe... Read more
Found on unconscious on the floor, I have no memory of coming of bathroom; I felt weak and hot; I felt shaking extremely cold; I felt weak and hot; I felt shaking extremely cold; Nausea; Headaches; Soreness to left arm; A spontaneous report was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was found on unconscious on the floor/loss of consciousness, hit me like a ton of bricks, soreness to left arm/pain in extremity/, I felt shaking extremely cold/feeling cold, I felt weak and hot/feeling hot; asthenia, I felt shaking extremely cold/tremor, nausea and headaches. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, vitamin D, calcium and senior vitamin not specified. The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 06 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, patient experienced sore arms which was resolved on 08 Feb 2021. On 06 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Mar 2021 the patient experienced headaches, nausea, felt shaking extremely cold, hot and weak, the patient was found unconscious, hitting patient with a ton of bricks and was taken to emergency room on an ambulance. Treatment for the event included hydration fluids, tylenol and aspirin. The action taken with the drug in response to the events was not applicable. The all events were recovered except tiredness which was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
82 2021-03-30 fatigue struggled to get out of bed and stayed in bed all day; no appetite; vaccination site pain; Felt mise... Read more
struggled to get out of bed and stayed in bed all day; no appetite; vaccination site pain; Felt miserable; Felt knocked out; Short term memory feels affected more once again; A spontaneous report was received from a consumer concerning 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt knocked out/ loss of consciousness, felt miserable/ feeling abnormal, struggled to get out of bed and stayed in bed all day / bedridden, short term memory feels affected more once again/ amnesia, no appetite/ decreased appetite. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included lisinopril, levothyroxine sodium, omeprazole. On 22 Feb 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 001A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, patient experienced arm sore for a few days. On 25 Feb 2021, patient had experienced hurting all over body and couldn't do anything for 5 days (very painful). Short term feels affected. On 22 Mar 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 037A21A) through unknown route at right arm for prophylaxis of COVID-19 infection. On 22 Mar 2021 in the evening after second dose, patient felt knocked out and miserable and struggled to get out of bed. She had short term memory feels affected more once again. On 23 Mar 2021 patient stayed in bed all day and had no appetite. On 24 Mar 2021, patient was feeling a lot better. The event patient felt knocked out was a medically significant condition. Treatment activities for event was done with paracetamol. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event, felt knocked out, felt miserable, struggled to get out of bed and stayed in bed all day, short term memory feels affected more once again, no appetite was recovering/resolving.; 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.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-056390:Dose 1
82 2021-03-30 pneumonia, malaise Had pneumonia; Loss of smell; Loss of taste; received her first Moderna vaccine on 22JAN2021 and has... Read more
Had pneumonia; Loss of smell; Loss of taste; received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet; Tested positive covid; Felt not right; A spontaneous report was received from a consumer concerning herself, a 82-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell / anosmia, loss of taste/ageusia, had pneumonia, felt not right / malaise, tested positive for Covid and received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet/product dose omission issue. The patient's medical history, as provided by the reporter, included high blood pressure and high cholesterol. Concomitant medications reported included medications for high blood pressure and for high cholesterol. On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced loss of smell, loss of taste, and had pneumonia. The event, pneumonia, was found to be medically significant. On 03 Mar 2021, the patient was not feeling right and on 04 Mar 2021 she was tested positive for Covid-19. Treatment details included the use of some nebulizers and quarantine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, loss of smell, loss of taste, pneumonia, felt not right, and tested for Covid-19 was unknown and of event and has not received second vaccine yet was 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 event, a causal relationship cannot be excluded except for the events of COVID-19 and Pneumonia. The events of COVID-19 and Pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain infectious elements capable of causing infection.
82 2021-03-31 fatigue Severe auto immune flare--terrible unrelenting muscle aching all over body--profound weakness and fa... Read more
Severe auto immune flare--terrible unrelenting muscle aching all over body--profound weakness and fatigue necessitating bedrest for hours at a time. This has continued for 4 WEEKS and is just beginning to slightly let up. My immune system has been in the worst flare I have ever experienced in all the 20 years I have had auto- immune flares--it just cannot seem to down regulate itself and I have crippled up badly as a result. Every movement hurts--even my chest hurts every time I take a breath!
82 2021-03-31 fever, pneumonia tested positive for Covid infection; BP: 130/68; loss of taste; loss of smell; right lower lobe pneu... Read more
tested positive for Covid infection; BP: 130/68; loss of taste; loss of smell; right lower lobe pneumonia; A Spontaneous was received from a Consumer concerning a 82-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right lower lobe pneumonia (Pneumonia), loss of taste (Ageusia), loss of smell (Anosmia), tested positive for Covid infection (COVID-19) and BP: 130/68 (Blood pressure abnormal). The patient's medical history was included Chronic Obstructive Pulmonary Disease(COPD), blood pressure and Obstructive sleep Apnoea. Concomitant medications was included ATORVASTATIN CALCIUM for cholesterol, ACETYLSALICYLIC ACID for unknown indication, Advair for COPD, SALBUTAMOL for COPD, TIOTROPIUM BROMIDE for COPD and CPAP for Obstructive Sleep Apnoea. On 22-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch no: 013L20) via unknown route in the Left arm for prophylaxis of COVID-19 infection. On 03-MAR-2021, It was reported that the patient experienced loss of taste, loss of smell and BP: 130/68. On 04 Mar 2021, the patient was tested positive for Covid infection . On 09 Mar 2021, the patient was experienced right lower lobe pneumonia. The pneumonia was medically significant. Treatment information was Nebulizer treatment, Antibiotics for 5 days for Pneumonia and Tylenol. Action taken with mRNA-1273 in response to the events was not reported. On 19 Mar 2021, the outcome of the event, tested positive for Covid Infection was resolved. On an unknown date, the outcome of the events right lower lobe pneumonia, loss of taste, loss of smell, and BP: 130/68 was unknown.; Reporter's Comments: This case concerns an 82 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected COVID-19, anosmia, ageusia, and blood pressure abnormal. Event onset 19 days after first dose mRNA-1273. Treated with antibiotics and Tylenol. COVID-19 resolved, but other 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.
82 2021-03-31 fever A spontaneous report was received from a consumer concerning a 82-years-old, female patient who rec... Read more
A spontaneous report was received from a consumer concerning a 82-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on her legs/ urticaria, a very bad rash/ rash, blood was coming out in her stool/ hematochezia, ulcerative colitis/ colitis ulcerative, her lips swollen/ lip swelling, her face turned red and hot/ erythema, she feels her teeth burning/ oral discomfort, lips turned blue/ cyanosis, had a 98 °F temperature/pyrexia and had a lump on her back/ vaccination site mass. The patient's medical history as provided by the reporter included prior breast cancer. No relevant concomitant medications were reported. On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 011A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced hives on her legs and a very bad rash. She had to go back to the ER (emergency room) because blood was coming out in her stool, she had a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis, she had never had that before. On an unspecified date she had her lips swollen, her face turned red and hot and she feels her teeth burning. Her lips turned blue. The patient had a 98 ° F temperature and she had a lump on her back. The event ulcerative colitis and hematochezia were medically significant. Treatment for the events included Benadryl. Lab data included on an unspecified date, the patient had a 98 ° F temperature and underwent a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis on 27-FEB-2021. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, hives on her legs, a very bad rash, blood was coming out in her stool, ulcerative colitis, her lips swollen, her face turned red and hot, she feels her teeth burning, lips turned blue, had a 98 °F temperature and had a lump on her back was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
82 2021-04-03 body temperature increased, fatigue Fatigue and. Body temp of 102.00 F
82 2021-04-03 fatigue, lethargy Severe tiredness/lethargy started on 01/28/2021. Died at home around noon on 01/29/2021.
82 2021-04-05 body temperature increased, fatigue Fatigue; Dizziness; Light temperature; This spontaneous case was reported by a consumer and describe... Read more
Fatigue; Dizziness; Light temperature; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DIZZINESS (Dizziness) and BODY TEMPERATURE INCREASED (Light temperature) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ARFORMOTEROL TARTRATE (BROVANA) and BUDESONIDE for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (Fatigue), DIZZINESS (Dizziness) and BODY TEMPERATURE INCREASED (Light temperature). At the time of the report, FATIGUE (Fatigue), DIZZINESS (Dizziness) and BODY TEMPERATURE INCREASED (Light temperature) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. This case concerns an 82-year-old female with serious unexpected events of dizziness, fatigue, and temperature increased. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 82-year-old female with serious unexpected events of dizziness, fatigue, and temperature increased. 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.
82 2021-04-05 sweating I was in the kitchen fixing food when I started having pain in my back, it went up into my shoulders... Read more
I was in the kitchen fixing food when I started having pain in my back, it went up into my shoulders. It was an intense pain. I became extremely weak, I started vomiting, my blood pressure was 196/117 BP, and I was sweating. My grandson called 911 and I was taken to the hospital Cardiologist said heart was fine. I did NOT have a heart attack. He thinks it is due to the vaccine. Advised that I take the second shot.
82 2021-04-05 malaise, fatigue, headache hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeli... Read more
hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeling the same symptoms as she did when she had covid; taste not the same; headache; Fatigue; mucsle aches; slight nausea; problem with a lymph node in that arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (hit her head and blacked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (also treated with 5 days of Remdesivir) in January 2021 and Lumpectomy. Concomitant products included NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS], ZINC, APIXABAN (ELIQUIS), CARVEDILOL, ATORVASTATIN and LETROZOLE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (hit her head and blacked out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm). At the time of the report, LOSS OF CONSCIOUSNESS (hit her head and blacked out), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: sensitive (Inconclusive) Sensitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included was acetaminophen for headache. The patient was hospitalized with coivd in January and had 5 days of Remdesivir. The patient also had problem with a lymph node in that arm. She had a Lumpectomy. They took at a lymph node in the left side of that armpit to see if it had spread. It was sensitive when she had a breast exam and was sent to get a mammogram. Got the breast exam last week in February. Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.
82 2021-04-06 fatigue Fatigue the day after increased and progressed to weakness and confusion for the week following the ... Read more
Fatigue the day after increased and progressed to weakness and confusion for the week following the vaccine, culminating in Emergency Department visit with hypercalcemia and acute kidney failure and subsequent 9 day hospitalization.
82 2021-04-08 fever, fatigue She got the vaccine and did not get an immediate reaction, and on Thursday morning she was tired and... Read more
She got the vaccine and did not get an immediate reaction, and on Thursday morning she was tired and couldn't get out of bed. So her husband kept her in bed all day and by Friday morning things didn't get any better, and he helped her to get to the end of the bed and went into the kitchen to get breakfast and he heard her fall, and she fell off the bed and was semi-consciousness, and was able to get her back into the bed and called the ambulance. She was taken to the hospital Friday morning and she's still in there. She has been diagnosed with hydronephrosis, and they keep going back and forth on her diagnoses. At first they said that she had a UTI, and then they said she didn't, and then said that she did. The son feels that all three of the doctors feel that it was some sort of reaction to the vaccine. They did give her steroids at one time, and she developed severe tremors when she moved which have subsided. She also has had fever, in a weakened state due to this condition. She is still being treated for this still and said that she will be having to go to rehabilitation before going home.
82 2021-04-09 chills Fainted and fell to ground, dry heaving for 30 min and chills,
82 2021-04-09 fatigue Fatigue, achy all over, pain under right rib cage that hurt threw to my back. Went to med center and... Read more
Fatigue, achy all over, pain under right rib cage that hurt threw to my back. Went to med center and was seen by Dr. He was concerned so that he insisted that I go to the hospital to be admitted on Tuesday 4/6/21. Was admitted and blood work was done and ct abdomen and car which was negative. More lab work was done on 4/7/21 which showed a elevated d-diner. At that time a ultrasound of legs done which showed a clot in my right leg. Then a ct chest was scheduled and done 4/8/21 which showed a clot in my right lung.
82 2021-04-12 malaise, cough Sight has gotten worse; Hearing is worse; Taste is weird; Normal cough; Tested positive for COVID a ... Read more
Sight has gotten worse; Hearing is worse; Taste is weird; Normal cough; Tested positive for COVID a few days after vaccination; Felt so sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID a few days after vaccination), MALAISE (Felt so sick), COUGH (Normal cough), VISUAL IMPAIRMENT (Sight has gotten worse), HYPOACUSIS (Hearing is worse) and TASTE DISORDER (Taste is weird) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Tested positive for COVID a few days after vaccination) (seriousness criterion hospitalization). On 18-Jan-2021, the patient experienced MALAISE (Felt so sick) (seriousness criterion hospitalization) and COUGH (Normal cough) (seriousness criterion hospitalization). In February 2021, the patient experienced VISUAL IMPAIRMENT (Sight has gotten worse) (seriousness criterion hospitalization), HYPOACUSIS (Hearing is worse) (seriousness criterion hospitalization) and TASTE DISORDER (Taste is weird) (seriousness criterion hospitalization). The patient was hospitalized from 18-Jan-2021 to 01-Feb-2021 due to MALAISE. At the time of the report, COVID-19 (Tested positive for COVID a few days after vaccination), MALAISE (Felt so sick), COUGH (Normal cough), VISUAL IMPAIRMENT (Sight has gotten worse), HYPOACUSIS (Hearing is worse) and TASTE DISORDER (Taste is weird) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment information was not provided. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-064065 (Linked Report).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. US-MODERNATX, INC.-MOD-2021-064065:serious_case
82 2021-04-13 dehydration Patient 10 hours after injection developed generalized itching with no rash..She then devoped waterr... Read more
Patient 10 hours after injection developed generalized itching with no rash..She then devoped waterry diarrhea that led to severe dehaydration leading to ICU admisiion for treatment and close observation.There was some suspicion of mild CHF but this subsequently was negative
82 2021-04-13 headache, fatigue Headache ,nausea ,vomiting ,extreme fatigue .15 hours.
82 2021-04-13 malaise Started feeling weak next day after shot. As days went by I became increasingly short of breath. T... Read more
Started feeling weak next day after shot. As days went by I became increasingly short of breath. This continued for over 2 weeks and then started having chest pain. Went to ER and admitted with pericarditis. 2 days later I went into Atrial fib. The next day I had a cardioversion. Home the following day. One week at home not feeling well, I was readmitted with increased chest pain and shortness of breath. Pulse very low and needed a pacemaker which was inserted Easter Sunday. Home now and still not feeling well.
82 2021-04-15 chills, throat pain sore throat, arm, aching, chills
82 2021-04-17 lethargy, chills, fatigue, headache Chills and headache from 9:30am-3:30am; Lethargy and tiredness through 5pm
82 2021-04-18 fatigue 3 days post vaccination patient experienced diarrhea, 10 days post vaccination patient experience fa... Read more
3 days post vaccination patient experienced diarrhea, 10 days post vaccination patient experience fatigue, loss of taste and smell and was "bedridden"
82 2021-04-18 fever Client reported felt fine after 2nd dose Moderna on 4-8-21, until the next morning. Daughter tried t... Read more
Client reported felt fine after 2nd dose Moderna on 4-8-21, until the next morning. Daughter tried to call & could not get her to answer. A son checked on her & found her half on & half off the couch disorient forgetful, could not finish sentences, did not know recent events or year, B/P was 179/129-ambulance called & transported to Hospital. Client was admitted, CT scan, UA, chest x-ray & MRI with no results or evidence. Client did have low grade fever- was kept in hospital 3days Client home, doing better & daughter staying with her
82 2021-04-20 headache First Moderna vaccine given on 03/18/21. On 4/13/21 her left eye was red and she had a headache, bu... Read more
First Moderna vaccine given on 03/18/21. On 4/13/21 her left eye was red and she had a headache, but 4/14/21 she was unable to see clearly out of the left eye. She saw an ophthalmologist on 4/15/21 and the eye started improving on 04/16/21. On 04/16/21 she received her second moderna vaccine and the next day she had another headache and was unable to see out of her right eye. She had an emergency appointment with the ophthalmologist on 04/19/21 and a recheck on 04/19/21. By 04/20/21 the right eye started improving.
82 2021-04-25 fatigue, lethargy My mother suffered a massive stroke 40 days after receiving the 2nd dose of the cover 19 vaccine. Sh... Read more
My mother suffered a massive stroke 40 days after receiving the 2nd dose of the cover 19 vaccine. She fell sick the day after the injection and suffered with brain fog, memory issues, lethargy from that day forward. On day 36 after the 2nd dose she developed a debilitating stomach issue that cause explosive diarrhea that lasted 4 days/nights. This bout with stomach issues left her extremely weak and exhausted. On the 4th night of the diarrhea she got up in the middle of the night to go to the bathroom and couldn't lift herself off of the commode. It took two hours for her to call for help. Once admitted to the ER the stroke was confirmed. Because they could not pinpoint the first stroke symptom she was not eligible for the life saving blood thinning meds and suffered complete paralysis of her right side.
82 2021-04-26 headache Moderna COVID-19 Vaccine EUA: one month after vaccination patient presents to emergency department r... Read more
Moderna COVID-19 Vaccine EUA: one month after vaccination patient presents to emergency department reporting worsening headache for three months. Diagnosed with dural venous sinus thrombosis, admitted to hospital, anticoagulated, and discharged to home stable with symptom resolution.
82 2021-04-26 headache Bilateral Facial Weakness., Difficulty Swallowing & Bilateral lower extremity Weakness
82 2021-04-28 fever The patient was admitted for hospitalization on 4/28/2021 from a Unit with an ongoing COVID outbreak... Read more
The patient was admitted for hospitalization on 4/28/2021 from a Unit with an ongoing COVID outbreak. Patient presented with a fever and hypotensive. Patient also reports a UTI. Tested for COVID has a part of hospital admission guidelines. The test returned positive.
82 2021-04-29 lethargy, pneumonia Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen... Read more
Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.
82 2021-04-30 chills, fatigue On 3/25/21, patient presented to the ED with several days history of nausea, vomiting, and upper abd... Read more
On 3/25/21, patient presented to the ED with several days history of nausea, vomiting, and upper abdominal pain, and 1 day history of shortness of breath and wheeze. Patient recently received her first dose of Moderna COVID vaccination on March 10. Patient's daughter first developed COVID symptoms approximately 1-2 weeks prior, and was tested positive. Patient developed nausea, vomiting, and upper abdominal pain 6 days prior on March 19. She was tested positive for COVID several days prior to admission (either the 22 or 23rd, patient not sure). On the morning admission, patient had significant worsening of shortness of breath and wheeze. Patient also became significantly more weak and fatigued, and was eventually brought to ED. Patient reported chills, but denied headaches, chest pain, or diarrhea. Patient admitted to the hospital on 3/25/21 with main diagnosis COVD-19 pneumonia and patient expired on 4/13/21.
82 2021-05-02 fatigue On third day had extreme pain in abdomen (felt like huge air bubble) for 24 hours; Saw acupuncturist... Read more
On third day had extreme pain in abdomen (felt like huge air bubble) for 24 hours; Saw acupuncturist, which helped relieve it; then for 4 weeks was extremely fatigued....I am healthy and exercise regularly and I could not do anything like shop, cook, except briefly....less than 2 hours and then would need to lay down to recoup.....no energy at all...the stress and not knowing what was happening increased my blood pressure and my anxiety greatly. After 4 weeks, energy began to come back gradually over the next two weeks. Am now fine.
82 2021-05-05 influenza like illness Flu-like symptoms, body aches, shaking, nausea, vomiting
82 2021-05-09 malaise PATIENT REPORTS THAT AFTER HER FIRST COVID 19 VACCINATION SHE HAD INCREASED MALIZE (COULD NOT GET UP... Read more
PATIENT REPORTS THAT AFTER HER FIRST COVID 19 VACCINATION SHE HAD INCREASED MALIZE (COULD NOT GET UP OUT OF BED), SEVERE BODY ACHES, SORE ARM AT THE INJECTION SITE BUT NO REDNESS REPORTED. SHE DID NOT SEEK ANY MEDICAL TREATMENT AND ONLY TOOK OTC MEDICATIONS AT HOME. SHE STATES THAT S/S RESOLVED IN 5 DAYS WITHOUT INTERVENTION
82 2021-05-09 fever, chills, headache PATIENT STATES THAT 1 DAY AFTER THE SECOND INJECTION SHE STARTED HAVING FEVER, CHILLS, HEADACHE, AND... Read more
PATIENT STATES THAT 1 DAY AFTER THE SECOND INJECTION SHE STARTED HAVING FEVER, CHILLS, HEADACHE, AND BODY ACHES. A DAY LATER SHE HAD ABDOMINAL CRAMPING AND DIARRHEA THAT LASTED 4 DAYS. SHE HAD ALL S/S FROM ABOVE LASTED 5 DAYS. PATIENT DID NOT SEEK MEDICAL TREATMENT AND ONLY USED OTC MEDICATIONS IE..TYLENOL FOR ISSUES. SHE DID NOT REPORT TO HER PCP.
82 2021-05-11 malaise pain on site, general malaise, no other symptoms reported
82 2021-05-13 chills, sweating, headache Moderna COVID-19 Vaccine EUA. Approximately 4 hours of extreme chills, followed by a heavy sweat. Re... Read more
Moderna COVID-19 Vaccine EUA. Approximately 4 hours of extreme chills, followed by a heavy sweat. Returned to "normal. Following morning, period of lightheadedness, followed by a brief fainting spell. Return to "normal" but experienced recurring vague headaches, treatable with double doses of aspirin for about a week afterwards. Nothing since.
82 2021-05-14 fever 3/28/21 - Fever, Shortness of Breath - (Transfer to Emergency Room and admitted to hospital)
82 2021-05-18 influenza like illness My mother was in generally good health for her age, known as the strongest woman to many. She defie... Read more
My mother was in generally good health for her age, known as the strongest woman to many. She defied covid for over a year, despite living in an assisted living facility in one of 2020's "hot zones". After taking the vaccine, she died within 2 months. I definitely believe 100% the vaccine in the very least hastened her health as she began declining immediately after the first dose, with on/off flu like symptoms until her death.
82 2021-05-19 cough Patient developed a cough a week or so after getting the vaccine. Unclear if clots were starting to ... Read more
Patient developed a cough a week or so after getting the vaccine. Unclear if clots were starting to develop at the same time.
82 2021-05-20 chills, fever, cough, fatigue Symptom onset 4/12/21 (cough, diarrhea, feverish, nausea, chills, fatigue and abdominal pain). 4/14/... Read more
Symptom onset 4/12/21 (cough, diarrhea, feverish, nausea, chills, fatigue and abdominal pain). 4/14/21 PCR positive for COVID-19 virus. Admitted inpatient 4/14/2021.
82 2021-05-20 fatigue Patient called the pharmacy to report that she was having leg cramps/aches, no bowel movement since ... Read more
Patient called the pharmacy to report that she was having leg cramps/aches, no bowel movement since vaccine yesterday, is very tired, and generally "feels bad". Advised her to stay hydrated and make sure she is eating to keep strength up. Get plenty of rest and contact us if any further or worsening symptoms develop.
82 2021-05-22 chills The day after my 2nd shot I had chills all day. I remained bedridden and tried to keep warm. I also... Read more
The day after my 2nd shot I had chills all day. I remained bedridden and tried to keep warm. I also had no appetite, so forced myself to eat 1/3 can of chicken soup. On the 4th day after my shot and taking a morning shower (within about 15 minutes), I had a sudden itchy, pink body rash with water blisters on my thighs. It was awful! I applied frozen food packages continually, back and forth, trying to alleviate the itchy rash. I must add that everyone I have talked to since, also have had an adverse reaction to the 2nd shot but they are not reporting it. I didn't go to the doctor because I have no insurance. I am ok now, aside from the small scars from my bloody scratches.
82 2021-05-23 fatigue Within 10 minutes of receiving the injection, the patient felt like her chest was expanding and was ... Read more
Within 10 minutes of receiving the injection, the patient felt like her chest was expanding and was going to explode. Waited 20 more minutes and finally had some relief from the chest pressure, but then was completely exhausted for 10 days, finally went to urgent care. Urgent care diagnosed her with an allergic reaction to the vaccine. Was told that 10% of the population with allergy-induced asthma have a reaction to the vaccine. Was prescribed a Medrol dose pack and was told to follow up with her primary care physician in 4 days. Due to the Scripps outage, the patient followed up in our office and was told that she would recover within a month's time.
82 2021-05-27 fatigue, fever Bleeding internally; Internal intestinal bleeding; Kidney function changed; Arm bothered her after r... Read more
Bleeding internally; Internal intestinal bleeding; Kidney function changed; Arm bothered her after receiving the vaccine; Very tired; Slight low-grade fever/Felt warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) and RENAL IMPAIRMENT (Kidney function changed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gastrointestinal bleeding, Kidney function abnormal and Aortic aneurysm. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Blood pressure management, SUCRALFATE, PANTOPRAZOLE, POTASSIUM CITRATE, SIMVASTATIN, METOPROLOL, IRBESARTAN and VITAMINS NOS for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm). On 07-May-2021, the patient experienced INTERNAL HAEMORRHAGE (Bleeding internally) (seriousness criterion medically significant), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) (seriousness criterion medically significant) and RENAL IMPAIRMENT (Kidney function changed) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding), RENAL IMPAIRMENT (Kidney function changed), LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included acetaminophen. Company Comment There is not enough information to ass the event of renal impairment as the exact condition was not describe. However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded; Sender's Comments: There is not enough information to ass the event of renal impairment as the exact condition was not describe. However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded
82 2021-06-02 cough, runny nose, fatigue, chills lyme disease type symptoms; blood sugar decreased; right arm pain at injection site; fatigue; genera... Read more
lyme disease type symptoms; blood sugar decreased; right arm pain at injection site; fatigue; generalized body ache; chills; runny nose; cough; left arm pain-no injection; left eye twitch; This spontaneous case was reported by a nurse and describes the occurrence of LYME DISEASE (lyme disease type symptoms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014MZ01) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis, Arm injury (left arm cannot raise arm) in 2012, Dislocation of vertebra (3 vertebrae out of place), Radiofrequency ablation (ablation in neck), Low back pain (bilateral), HLA-B*27 positive, Kidney stones, Reiter's syndrome, Salmonella infection, unspecified (dating back to 1981) and Knee replacement (two knee replacements). Concurrent medical conditions included Diabetes, Asthma, Lyme disease and Fibromyalgia (fibromyalgia with neck and shoulder pain). Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for Asthma, INSULIN GLARGINE (LANTUS) for Diabetes, MINOCYCLINE, DAPSONE, ATOVAQUONE, PROGUANIL HYDROCHLORIDE (MALARONE) and LEUCOVORIN [FOLINIC ACID] for Lyme disease, CODEINE PHOSPHATE (CODINE), PARACETAMOL (TYLENOL) and DIAZEPAM (VALIUM) for Pain. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced BLEPHAROSPASM (left eye twitch). On 15-Mar-2021, the patient experienced RHINORRHOEA (runny nose), COUGH (cough) and PAIN IN EXTREMITY (left arm pain-no injection). On 12-Apr-2021, the patient experienced LYME DISEASE (lyme disease type symptoms) (seriousness criterion medically significant), BLOOD GLUCOSE DECREASED (blood sugar decreased), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills). On 20-Mar-2021, BLEPHAROSPASM (left eye twitch), RHINORRHOEA (runny nose) and COUGH (cough) had resolved. At the time of the report, LYME DISEASE (lyme disease type symptoms), PAIN IN EXTREMITY (left arm pain-no injection), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills) outcome was unknown and BLOOD GLUCOSE DECREASED (blood sugar decreased) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood glucose: abnormal (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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.
82 2021-06-03 fatigue, pneumonia 1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days... Read more
1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days post Vax) 2. Baseball sized lump , iced, resolved (occured 2 days post Vax) 3. approximately 2 weeks post Vax - began difficulty breathing and chest pains, elevated heart rate. Went to clinic , was sent via ambulance to ER . Admitted with diagnosis of pneumonia, fluid retention /edema . Spent 6 days in the hospital. Was told by hospital staff to report to VAERS. Covid test was negative. 4. Today - 15 weeks post Vax, never recovered energy, has severe fatigue, weakness, unable to stand for long periods of time or walk more than a minute. Saw Dr. - look work showed severely elevated Ferritin levels 900+. Still battling and treating with home heath care 4 days a week / OT x2 and PT x2. Home bound. This is ALL since Vax #2....she was walking 30 minutes a day and completely self sufficient before this shot.
82 2021-06-07 body temperature increased, headache started running temp and had pain in the left side of her neck and head. Next day left jaw and lips... Read more
started running temp and had pain in the left side of her neck and head. Next day left jaw and lips were numb so could barely talk. Pt saw her PCP Dr. and was told it was a side effect from the vax. Left eye started swelling so went to eye Dr. on 4/14/21. She was prescribed eye drops but continued to use her regular eye drops. At times her eye continues to feel hard and that the vision has been impaired and jaws feels funny.
82 2021-06-07 headache Headache for 2 days and nose bleed that lasted 25 minutes in left nostril. Nose bleed started the e... Read more
Headache for 2 days and nose bleed that lasted 25 minutes in left nostril. Nose bleed started the evening that vaccine was given. Patient had received Pfizer vaccine (one dose) on February first and then caught Covid-19 three weeks later. Her doctor at emergency room told her to start the series over again. She wanted to then get Moderna since she had such bad side effects with Pfizer brand.
82 2021-06-08 fever Daughters report that mother, pt., was sleepy with a possible fever the day after the 1st Moderna CO... Read more
Daughters report that mother, pt., was sleepy with a possible fever the day after the 1st Moderna COVID-19 vaccine which was administered on 5/5/2021. On 6/2/2021 she received the 2nd Moderna dose. The following morning, 6/3/2021, at 7am she was awaken by her daughter and had a fever of 101 degrees F, began vomiting shortly after and whole body was shaking. Ambulance was called and transported her to Hospital ER where she was admitted. Several tests were performed. Diagnosed with a UTI, treated and released on 6/7/2021 to Rehab center for therapy for 3-6 weeks.
82 2021-06-14 fatigue, headache Developed body aches, headaches which worsened over the course of a week or more progressing to arth... Read more
Developed body aches, headaches which worsened over the course of a week or more progressing to arthralgia and severe fatigue. Treated with prednisone. Symptoms have currently resolved after treatment. Follow up testing planned for July 2021.
82 2021-06-14 headache Debilitating headache and high Blood Pressure
82 2021-06-17 fatigue, chills, fever February 16 at night, I had temperature of 99 degrees, fever and chill. I have been taking my temper... Read more
February 16 at night, I had temperature of 99 degrees, fever and chill. I have been taking my temperature reading every morning. On the 17th, chills and pain started. On the 18th, temperature was 100, chills and fatigue. On the 19th, temperature was 99 and I had trouble breathing, abdominal pain, chills and fever. On the 20th, temperature was 99, dizzy, chills, ache, pain and fatigue. On the 21st, all the way across. On the 22nd, temperature was 100 degrees and I was experiencing everything else. On the 23rd, I went to the emergency room at 6am. I was in the hospital through the 24th. They discharged me on the 24th. I had a nurse who told me about the diastolic heart failure so I made an appointment to see the cardiologist which I could see on the 4th of March. A nurse had pointed out the EKG test results indicating not heart failure but excess fluid in your lungs.
82 2021-06-18 chills, fatigue, malaise not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph no... Read more
not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved. Concomitant medications were not reported. Company Comment ; Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR) upgraded case to serious, new event added, action taken updated; new reporter added.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Massive heart attack
82 2021-06-20 chills Client stated that night after receiving the vaccine she became dizzy, had chills, had vision issues... Read more
Client stated that night after receiving the vaccine she became dizzy, had chills, had vision issues where her eyes could not focus, and her vision was blurry. Client stated that she felt like she was doomed, and maybe having a stroke. Said her symptoms lasted about 2-3 days.
82 2021-06-24 fatigue Hemorrhoids; Stomach cramps; Osteoarthritis; Pain; Diarrhea; Tiredness; Rheumatoid arthritis; Swelli... Read more
Hemorrhoids; Stomach cramps; Osteoarthritis; Pain; Diarrhea; Tiredness; Rheumatoid arthritis; Swelling; Hand pain; CARPAL TUNNEL OF BOTH HANDS; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. The patient's past medical history included Hip discomfort in 2019 and Alcohol use in 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HAEMORRHOIDS (Hemorrhoids), ABDOMINAL PAIN UPPER (Stomach cramps), OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS), ABDOMINAL PAIN UPPER (Stomach cramps), SWELLING (Swelling), PAIN IN EXTREMITY (Hand pain) and FATIGUE (Tiredness) had not resolved, DIARRHOEA (Diarrhea) and HAEMORRHOIDS (Hemorrhoids) was resolving and OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. 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, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.; 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, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.
82 2021-07-11 fever The day following the second Moderna imz, pt went to ER due to high fever, weakness and exacerbation... Read more
The day following the second Moderna imz, pt went to ER due to high fever, weakness and exacerbation of COPD with wheezing and difficulty breathing
82 2021-07-16 fatigue admitted into hospital; admitted into hospital; tired; Very bad reaction after the first shot; breat... Read more
admitted into hospital; admitted into hospital; tired; Very bad reaction after the first shot; breathing problems; close to death; Diarrhea; threw up - couldn't keep anything down for 2 days; was incapacitated, Weak; couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of HOSPITALISATION (admitted into hospital), the second episode of HOSPITALISATION (admitted into hospital) and NEAR DEATH EXPERIENCE (close to death) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in August 2020. Concurrent medical conditions included Coronary artery disease, Peripheral arterial disease, Breast cancer, Heart failure (More events at night) and Heart disease, unspecified. Concomitant products included APIXABAN (ELIQUIS), LORATADINE, LOSARTAN, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K) and EZETIMIBE (ZETIA) for Heart failure, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid enlarged. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (was incapacitated, Weak) and GAIT INABILITY (couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk). On 19-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (threw up - couldn't keep anything down for 2 days). On an unknown date, the patient experienced the first episode of HOSPITALISATION (admitted into hospital) (seriousness criterion hospitalization), the second episode of HOSPITALISATION (admitted into hospital) (seriousness criterion hospitalization), NEAR DEATH EXPERIENCE (close to death) (seriousness criterion medically significant), VACCINATION COMPLICATION (Very bad reaction after the first shot), DYSPNOEA (breathing problems) and FATIGUE (tired). The patient was hospitalized from 01-May-2021 to 06-May-2021 due to HOSPITALISATION, and then from 13-May-2021 to 21-May-2021 due to HOSPITALISATION. The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, last episode of HOSPITALISATION (admitted into hospital), NEAR DEATH EXPERIENCE (close to death), VACCINATION COMPLICATION (Very bad reaction after the first shot), DYSPNOEA (breathing problems) and FATIGUE (tired) outcome was unknown and DIARRHOEA (Diarrhea), ASTHENIA (was incapacitated, Weak), GAIT INABILITY (couldn't walk/could not get out of bed/couldn't sit and wait at the ER,unable to walk) and VOMITING (threw up - couldn't keep anything down for 2 days) had not resolved. 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. 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. Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received contain information about patient information, medical history, vaccine facility information, and concomitant medications, new serious events and updated out come of events.; 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
82 2021-07-21 fatigue developed tear on retina; " trouble in eyes"; annoyance in her right ear; noise in her ear, going aw... Read more
developed tear on retina; " trouble in eyes"; annoyance in her right ear; noise in her ear, going away and she does have Tinnitus; severe fatigue and vaccine made her tired; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL TEAR (developed tear on retina) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired). On an unknown date, the patient experienced RETINAL TEAR (developed tear on retina) (seriousness criterion medically significant) and OCULAR DISCOMFORT (" trouble in eyes"). The patient was treated with Laser therapy for Retinal tear and Laser therapy for Ocular discomfort. At the time of the report, RETINAL TEAR (developed tear on retina), OCULAR DISCOMFORT (" trouble in eyes"), EAR DISCOMFORT (annoyance in her right ear), TINNITUS (noise in her ear, going away and she does have Tinnitus) and FATIGUE (severe fatigue and vaccine made her tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. The patient started having trouble in eyes and developed tear on retina(retinal tear) two weeks ago. She went to her doctor and received laser treatment. Very limited information regarding the events has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16-Jul-2021 added new events.; Sender's Comments: Very limited information regarding the events has been provided at this time. No further information is expected.
83 2021-01-04 headache swelling at injection site, some redness, some headache
83 2021-01-10 body temperature increased Patient had a rash prior to COVID vaccine. Prednisone 10mg started on 1/5/21 (only one dose administ... Read more
Patient had a rash prior to COVID vaccine. Prednisone 10mg started on 1/5/21 (only one dose administered) 1/6/21, 1am - Rash worsened with increase redness, warmth and extending of body surface, Temp 100.4, 1/6/21, 1:20am Benadryl 25mg administered, (Keflex was ordered at this time, however never administered). 1/6/21, 3am rash improved, temp 99.1 1/6/21, 6:50am Right facial droop and right sided weakness, sent to ER 1/6/21 transferred to hospital, continues to be hospitalized 1/11/2021
83 2021-01-10 cough, fever Resident vomited several times throughout the night, started running a fever as high as 102.3, devel... Read more
Resident vomited several times throughout the night, started running a fever as high as 102.3, developed a cough, c/o dizziness and increased confusion. Went out EMS, BP was low, will be kept for obs at hospital.
83 2021-01-10 headache, sluggishness, throat pain, chills, nasal congestion, sleepiness The injection did sting, but didn't think anything about it. For the first 30 minutes I did seem to ... Read more
The injection did sting, but didn't think anything about it. For the first 30 minutes I did seem to be fine, so I was released, but my shoulder was not looked at. It was itching some. About an hour later I started getting a headache, some nasal congestion and a sore throat. I took a couple of Tylenol and went to bed early. Day 2 I felt sluggish and achy and my stomach was bothering me some. Day three my chilling was worse, but after Tylenol I began feeling better around 6:00 pm. The rest of the week I felt sleepy and achy. My shoulder was feeling sore. I am the type of person that tries to push through when I feel bad because I live a very busy life. On day 5 I finally looked at my left. It had a large red area beginning at the injection site. I got a tape measure and found it was 10 inches long and 3 inches wide. Today is day 6. I have finally admitted I feel bad and will rest a few days. I am wondering if I should skip taking the 2nd vaccination? . I am also taking some 60mgjAllegra on ce a day.
83 2021-01-14 fatigue, fever, headache brieflysevere muscle pain approx 15 hrs later; following day[day #1] severe headache, nausea, chill... Read more
brieflysevere muscle pain approx 15 hrs later; following day[day #1] severe headache, nausea, chills, low grade fever, fatigue; #2-intermittent headache, loose stools x3, nausea, fatigue; #3- nausea, loose stool x2; fatigue; slight intermittent headache; #4- nausea , weakness; #4- better with some hives at injection site and upper arm
83 2021-01-14 headache, fatigue, sleepiness, chills day #1- 4;15 AM w severe muscle pain for brief period. Day #1- severe headache; nausea; intermittent... Read more
day #1- 4;15 AM w severe muscle pain for brief period. Day #1- severe headache; nausea; intermittent chills; very tired [slept most of day]; #2- intermittent headache [scale 5-6] nausea; loss of appetite; loose stools x3; fatigue; weakness; #3-better- still nausea, weakness' loose stool x2; loss of appetite; vague headache; #4- better w mild hives and itching at injection site and upper arm below site. lasted for two days.#5- no further symptoms
83 2021-01-14 headache, fatigue slight headache, throat tight, tired, very very warm.
83 2021-01-15 fever, chills Total body pain. Fever. Chills. Stomach pain.
83 2021-01-17 fatigue Friday night between 6 or 6:30 lost apatite, began to feel like had the flu, body aches. fatigue. pa... Read more
Friday night between 6 or 6:30 lost apatite, began to feel like had the flu, body aches. fatigue. pain in knee worsened, very tired. had to take half of a perkaset. and did not help. could not sleep because of the pain. the next day. felt really horrible, bad body aches. Could not stay awake. no apatite, eating made stomach upset Went to bed early about 9:00 and slept all night and all that day. just felt like fighting the flu. Had no energy. Felt better on the third day.
83 2021-01-17 headache Few hrs after getting shot at mid day, lower back started aching. By 10:00 p.m. my lower back, sid... Read more
Few hrs after getting shot at mid day, lower back started aching. By 10:00 p.m. my lower back, sides were in pain and abdominal muscles and stomach were like frozen in place. Couldn't move anything and the area seemed to be swollen. Had lost appetite in late afternoon so had not eaten dinner, only liquids since figured I needed something. Couldn't sleep, aspirin didn't help. Next day around noon my abdominal area was better and pain decreasing on sides. Still no desire to eat. Trouble sleeping, 2nd day after shot, still lower back pain, feel bloated, no desire to eat. Very little side pain. Had slight headache This third night after shot I could finally sleep. This fourth day I felt back to normal. During all this time, the arm that had the shot never really bothered me
83 2021-01-19 body temperature increased TEMP OF 100.2 AX
83 2021-01-19 headache, throat irritation, malaise Patient received first dose of Moderna vaccine today at 2:20pm. She was asked to wait in observation... Read more
Patient received first dose of Moderna vaccine today at 2:20pm. She was asked to wait in observation area for 30 minutes which went without incident. At 3:10pm husband came into clinic to notify staff was feeling unwell. Recipient was found in car to be alert and oriented X3 but complaining of scratchy throat with difficulty swallowing and 10/10 headache. VS at 3:15pm were HR 78 BP 142/84 and O2 SAT 97% RA. Patient able to verbalize her condition and able to follow instructions. Denies dizziness or loss of consiousness. Denied nausea, vomiting. Epinephrine on hand but not administered as patient declined and patient was responding to commands appropriately. 911 called and assessed patient at scene. After being assessed in ambulance, patient declined being transported to hospital and signed release with ambulance staff.
83 2021-01-20 headache Numbness both upper extremities, Nausea, Dizziness, Headaches, Face numbness right side
83 2021-01-21 fatigue, malaise 1/13/21 pt came into clinic for vaccine. Had difficulty remembering age. Called me Mon. 1/18/21 st... Read more
1/13/21 pt came into clinic for vaccine. Had difficulty remembering age. Called me Mon. 1/18/21 stating she was sick. When asked what her sx were, she stated fatigue. She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun. I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those. I questioned her about eating and drinking and she said she ate and drank water. She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911. She agreed. Two staff from clinic called her Mon. and Tues, (1/18 and 1/19). On Tues. she may have had sl slurred speech. She was found deceased on
83 2021-01-24 malaise, fatigue She was admitted to the hospital on 1/24/21 with acute symptoms of fatigue, malaise and some increas... Read more
She was admitted to the hospital on 1/24/21 with acute symptoms of fatigue, malaise and some increased confusion. Patient also developed a junctional heart rhythm on night of admission.
83 2021-01-24 malaise About 2 hours started to feel sick to her stomach. All of a sudden felt heart pounding and racing.... Read more
About 2 hours started to feel sick to her stomach. All of a sudden felt heart pounding and racing. Could hear her heart pounding and racing really fast. Laid down and after 45 minutes to an hour was still racing, so laid back down and when got up the 2nd time her heart was still beating fast but not as bad as when it first happened. Gradually the symptoms subsided. Not having problems now. Did not feel very good Saturday or Sunday, but today is feeling fine. The first day was the worst.
83 2021-01-25 fatigue Patients states within 12 hours of vaccine administration she had urinary incontinence and butterfly... Read more
Patients states within 12 hours of vaccine administration she had urinary incontinence and butterfly rash developing into full facial rash and ear flushing. Incontinence resolved after 10 hours and facial flushing continues to improve 2 days later. Other more common symptoms included myalgias and fatigue. NO oral swelling/symptoms or difficulty swallowing
83 2021-01-28 runny nose, headache 01-07-21 Headache, Runny nose
83 2021-01-30 cough, fatigue, respiratory tract congestion, sneezing Intense congestion, frequent sneezing and coughing, with gradual reduction, until midnight. Slept t... Read more
Intense congestion, frequent sneezing and coughing, with gradual reduction, until midnight. Slept then continued somewhat throughout next day. Red rash over torso - front and back - and inner arms. Slight nausea, no desire to eat. Extreme fatigue, off-balance Continuance of reduced symptoms, today the fourth day.
83 2021-01-30 malaise Initially itching, painful burning hives and welts on both arms began about Jan 12-13. Began low... Read more
Initially itching, painful burning hives and welts on both arms began about Jan 12-13. Began low dose benedryl from 1/13 - 1/25. Second adverse event on Jan 25; began sudden onset of dizziness, weakness, nausea, vomiting and unusual blood pressure elevation. Went to ER @4 pm.. Released after 6 hours. Same occurrence next day, similar symptoms. Began to feel 'bad'; BP still elevated. Went to closest ER at 3 pm. Discharged after 5 hours with clonidine. Skipped a day, but could not resume normal activities. On Jan 29 returned to ER early afternoon, admitted for observation. Discharged ~6:30 pm on Jan 30. Currently only on higher dose of losinipryl. Rash bumps persist as 'red streaks', elevated BP and not feeling well. Streak is inner right arm above elbow. Rash streaks continue but are not bother some. Including morning of 1:30 after night in hospital. Rash usually appears after sleeping and early a.m. No medication. Still unable to resume normal activities. "feel terrible".
83 2021-01-31 headache redness, soreness, itchy, swollen glands in armpit and top of my arm, continues to be red hives on m... Read more
redness, soreness, itchy, swollen glands in armpit and top of my arm, continues to be red hives on my arm and has not cleared up. Took a Claritin to stop itching . Also had a very bad headache on sat.
83 2021-02-01 fever, headache, fatigue Patient reports headache, fatigue/weakness, diarrhea, sore stomach, unable to eat solid food beginni... Read more
Patient reports headache, fatigue/weakness, diarrhea, sore stomach, unable to eat solid food beginning 1/29/2021 and a fever of 100.9 beginning 1/31/2021. Patient is scheduled for series 2 of COVID Vaccine on 2/25/2021. Patient evaluated by Primary Care physician on 2/2/2021- Patient's symptoms continue, fever reduced to 99 with Tylenol on 2/2/2021. Patient advised to continue Tylenol & increase fluid intake (Gatorade).
83 2021-02-02 headache My mother, received the 1st vaccine for COVID 19 last week on Tuesday, Jan 26th. On Friday, Jan 29t... Read more
My mother, received the 1st vaccine for COVID 19 last week on Tuesday, Jan 26th. On Friday, Jan 29th, she started having diarrhea and continues to experience the same. She feels bad all over, can't get up and move around. When she stands and walks, she said she feels pain in the back of her neck and head. She is out of breath and generally laid in bed all day today. She is not eating much on a daily basis, today just some cheese and crackers and orange juice.
83 2021-02-02 sleepiness, fever, fatigue fever, muscle aches, headache, shortness of breath, loss of appetite, fatigue sleep, Tylenol, ... Read more
fever, muscle aches, headache, shortness of breath, loss of appetite, fatigue sleep, Tylenol, cpap with oxygen, aspirin (Bufferin) 2.5 days I am up and dressed on 2/3 (third day), but very tired and sleepy.
83 2021-02-03 head discomfort didn't sleep well the night of injection, about an hr ago my stomach started cramping and it went to... Read more
didn't sleep well the night of injection, about an hr ago my stomach started cramping and it went to my throat like i was gaging and it went through your arms and into your head.
83 2021-02-03 fever, fatigue, headache same day: fatique,headache,fever, next day fever[101] redness at site, dizziness,headache next day ;... Read more
same day: fatique,headache,fever, next day fever[101] redness at site, dizziness,headache next day ;fatigue,redness down to elbow next symptoms gone except for soreness at site and redness to elbow
83 2021-02-04 headache, chills, cough, fatigue, fever, runny nose Sudden onset of red and swollen arm, tiredness, weakness, trembling, chills, fever (100.1), dizzine... Read more
Sudden onset of red and swollen arm, tiredness, weakness, trembling, chills, fever (100.1), dizziness, headache, runny nose, loss of appetite,cough After 24 hours began to dissipate. It is now the 3rd day and except for tiredness I'm feeling more normal
83 2021-02-04 sweating pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt wi... Read more
pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt within 5 minuted developed resp distress, sob, chest pain and crushing chest feeling along with lip tongue mouth tingling, difficulty swallowing, increasing anxiety and diaphoresis.
83 2021-02-06 chills, body temperature increased, sleepiness 24 hours after vaccine, temperature 101.8, chills, slight nausea, no appetite, sleepiness. 48 hours ... Read more
24 hours after vaccine, temperature 101.8, chills, slight nausea, no appetite, sleepiness. 48 hours after vaccine just fine, health back to normal!!
83 2021-02-07 body temperature increased temperature 100.4 orally . usual temperature is 97.8
83 2021-02-07 fatigue 1/28/21 5:35 p.m. extreme fatigue (useless), 1/29/21 Muscle pain in both upper arms all day, 1/30/21... Read more
1/28/21 5:35 p.m. extreme fatigue (useless), 1/29/21 Muscle pain in both upper arms all day, 1/30/21Intense joint pain in left hip continued 1/31 and 2/1 plus painful to walk, sit down and get up again, Unable to lead with (before vaccine) good left leg to go up stairs and now am unable to walk on my own because of the hip joint pain and must use a walker or furniture to get around. Muscle pain in upper left arm has continued and frequently in the upper right arm. I am scheduled for the second dose of Moderna Covid-19 vaccine and am concerned about having same.
83 2021-02-07 headache, fever Started with intense abdominal pain and need to evacuate/nearly fainted ... Read more
Started with intense abdominal pain and need to evacuate/nearly fainted Started to run a fever accompanied bu aching in joints, muscles, head. The fever has continued for two days (low grade 100.8 plus or minus No appetite for two days so far
83 2021-02-07 headache Dizziness and near faint; unsteadiness; headache, three days after shot.
83 2021-02-07 fever I had shot on Thursday morning 2/4, and didn't get fever till Saturday morning and Sunday morning. ... Read more
I had shot on Thursday morning 2/4, and didn't get fever till Saturday morning and Sunday morning. Two days. I'm OK today
83 2021-02-08 lethargy pt reported sore arm days 1-4. lethargy days 5-8. itchy erythematous rash at site of vaccination day... Read more
pt reported sore arm days 1-4. lethargy days 5-8. itchy erythematous rash at site of vaccination days 9-12, approx 2 inches in diameter that expanded to 5 in diameter before reducing day 12.
83 2021-02-09 fatigue About 25 hrs after 2nd injection; experienced violent shaking and cold. My husband took me to place... Read more
About 25 hrs after 2nd injection; experienced violent shaking and cold. My husband took me to place in our home that is warmer. After about 2 hrs, felt better. Shaking and cold had ceased. I had a cup of Tomato Soup. Dozed on and off before going to bed. Slept until 5:00 AM as usual, got up at 6:00AM My husband got soufflés from store. I've been taking it very easy today. Feeling better though tired.
83 2021-02-09 fever, sleepiness low grade fever 100.8 for 3 days Cold feet and hands for 7 days Slept for most of the day for 7days
83 2021-02-09 fever arm pain, fever, tachycardia, tachypnea
83 2021-02-10 cough Cough developed mid-day. This is new.
83 2021-02-10 fatigue Nothing bad, just very tired...
83 2021-02-10 headache, throat pain, nasal congestion Bad headache, very stuffy nose, I couldn't breathe and almost went to the hospital. Ears were ringin... Read more
Bad headache, very stuffy nose, I couldn't breathe and almost went to the hospital. Ears were ringing, my eyes were ready to pop out of my head. Temples hurt, lymph glands were swollen, sore throat. Mostly in upper part of anatomy above collar bone. It made me very weak, I had trouble getting out of rocking chair to answer phone. So I took another Tylenol. I usually only take 1-2 Tylenol a day and that was my second one by the middle of the day. I had to lay down and I live alone so I was nervous and had phone beside me and debated calling 911 which I have never done. I dozed and when I woke up about a couple of hours later it was much better. Still had headache and a little stuffiness but anybody can handle that. Also, I was very nauseated and couldn't eat but I did drink water.
83 2021-02-10 malaise Significant dizziness for several mornings after vaccination. General malaise for several days. Poss... Read more
Significant dizziness for several mornings after vaccination. General malaise for several days. Possibly triggered Shingles virus to emerge as she got shingles the next day after the first dose of the COVID-19 vaccination. After the second dose of the COVID-19 vaccination, the dizziness and malaise returned the very next morning (today 02/10/2021).
83 2021-02-10 fever, headache Starting on 2/9/2021 patient experienced symptoms of dizziness, body aches, fevers, headaches, and w... Read more
Starting on 2/9/2021 patient experienced symptoms of dizziness, body aches, fevers, headaches, and weakness. After taking Tylenol patient's symptoms improved.
83 2021-02-11 fatigue, chills, fever Chilling, Body Aches, High Fever, Light Headed, Very Tired, Arm swollen and very red. Had fever an... Read more
Chilling, Body Aches, High Fever, Light Headed, Very Tired, Arm swollen and very red. Had fever and stayed in bed all day. Still had fever the next day. Arm on third day still very red and swollen.
83 2021-02-11 fatigue, headache, chills Chills, slight headache, muscle aches, much fatigue.. Took Tylenol.
83 2021-02-11 fatigue, headache Headache, body ache,tiredness
83 2021-02-11 fatigue First, pain in arm before bed. Took Tylenol so I could sleep. Next day toward late afternoon, had s... Read more
First, pain in arm before bed. Took Tylenol so I could sleep. Next day toward late afternoon, had soreness somewhat at upper center between shoulders. Tired and listless.
83 2021-02-11 headache 02/10/21: 09:45 PM headache. 02/11/21: 01:45 AM severe abdominal pain. ... Read more
02/10/21: 09:45 PM headache. 02/11/21: 01:45 AM severe abdominal pain. From ribs to pubic bone. And body aches and leg pain. 02/11/21: Appox. 06:00 PM severe, uncontrollable Diarrhea.
83 2021-02-11 malaise, fever, cough Patient called on 2/11/2021 reporting fever and swollen left arm. On 2/11/2021 I, assessed patient's... Read more
Patient called on 2/11/2021 reporting fever and swollen left arm. On 2/11/2021 I, assessed patient's arm and the left deltoid and the muscle was tender, warm and there was firm baseball size swelling. Patients temp was 100.4. She reported that she didn't feel well and had a wet cough. I recommended Tylenol for temp and arm pain and encouraged an ice pack to her arm 15 minutes every hour for reduce swelling. Spoke with patient on 2/12/2021. She reports she called her Doctor and he prescribed her an antibiotic and she states she is feeling better and the swelling in her arm has gone down.
83 2021-02-11 fever, chills shortness of breadth;chills;fever 101;muscle aches;neck stiffnes/;site soreness
83 2021-02-11 fever -Pt had her 2nd COVID vaccine on 2/5/21, and during the night at 2 am on Saturday, 2/6/21, she woke ... Read more
-Pt had her 2nd COVID vaccine on 2/5/21, and during the night at 2 am on Saturday, 2/6/21, she woke up to go to the bathroom; she noticed numbness around the left side of her mouth affecting her lips; she also noted drooping of the left side of her mouth at this time -She did not have a headache -She did not think she was having a stroke as she had no numbness or tingling or weakness in her extremities, so she didn't go to the ER -She is having trouble closing her left eyelids -She feels like she had novocaine injected into the left upper/lower lip -When she tries to drink, liquid dribbles out of the side of her mouth -She can still taste, but her mouth tastes like salt -On Saturday, she had a fever of 100.6 -No trouble walking-No confusion -No h/o stroke or TIA -No weakness, numbness or tingling in extremities -No vision changes -No slurring of speech -No recent infections -No ear pain or tinnitus -She is allergic to iodinated contrast, but has never had gadolinium
83 2021-02-13 malaise Injection instantly felt hot. Within 5 minutes patient was flushed and not feeling well to the point... Read more
Injection instantly felt hot. Within 5 minutes patient was flushed and not feeling well to the point she had to drink water and ingest candy. I offered her to lay on the ground but she just had to silence herself from the commotion in the pharmacy closed her eyes and slowly inhaled and exhaled to calm her thoughts and reaction to the vaccine. Offered her to call 911 but she declined. Her daughter was with her and waited in the vaccine room for about thirty minutes.
83 2021-02-13 pneumonia contracted pneumonia 2 days after receiving vaccination
83 2021-02-14 chills COVID like symptoms-chills, body aches, weakness,
83 2021-02-15 fatigue, headache Since around the 10th, not quite sure, but around that time, I have been feeling very, very tired an... Read more
Since around the 10th, not quite sure, but around that time, I have been feeling very, very tired and weak and slight headache. It did not occur to me until about 1/2 hour ago that these feelings could be related to the 2/5 shot. Not bad enough to go to the doctor, just not feeling normal. Blamed it on the lack of sun (SADS). I have a special light that I just started to use 3 days ago. Therefore, I am now reporting my feelings.
83 2021-02-16 chills, body temperature increased Shaking chills for 2 nights, Temp 99.2 or lower, starting on 2-13-21 at about 6:30 pm until bedtime... Read more
Shaking chills for 2 nights, Temp 99.2 or lower, starting on 2-13-21 at about 6:30 pm until bedtime. May or may not be related to vaccine. I felt fine otherwise. No resulting illness. Did not seek treatment.
83 2021-02-16 fatigue Bout of Diarrhea on Thursday and Friday. Maybe a little fatigue for a couple of days. Otherwise - ... Read more
Bout of Diarrhea on Thursday and Friday. Maybe a little fatigue for a couple of days. Otherwise - no other problems.
83 2021-02-16 headache 2/16/21 New swelling and pain at injection site. Oval slotchy hot rash around the injection site. 2/... Read more
2/16/21 New swelling and pain at injection site. Oval slotchy hot rash around the injection site. 2/14/21 Swelling soreness at injection site and headache
83 2021-02-16 fever, fatigue S.ymptoms: fever 2/14, 2/15 Muscle back pain severe 2/15, Diarrhea 2/14,2/15. Weakness, tired 2/14... Read more
S.ymptoms: fever 2/14, 2/15 Muscle back pain severe 2/15, Diarrhea 2/14,2/15. Weakness, tired 2/14, 2/15, 2/16, 2/17
83 2021-02-16 throat irritation Patient received the first dose of her covid vaccine by Moderna in her left arm at 1445. Lot number ... Read more
Patient received the first dose of her covid vaccine by Moderna in her left arm at 1445. Lot number 023M20A. Exp. 8-10-2021. Patient had no pain with injection. Tolerated well. Approximately 30 seconds to one minute after injection patient reported to nurse that her mouth and throat felt dry. This nurse asked the patient if she was feeling anything else different and if her throat felt itchy. Patient reported that her throat did feel a little itchy. This nurse called for assistance. RN obtained Dynamap to take patient vital signs. This nurse stayed by patient's side at all times. NP responded and was by patient's side throughout event. Patient now reporting feeling very hot. Ice pack applied to back of her neck. Initial vital signs 184/87, Map 123, HR 119. Patient tachypnic and tachycardic. Pulse ox WNL at 99%. Lung sounds clear. Radial pulse obtained, rapid. First responder called for with overhead page. Next vital signs 189/79.map of 113. HR 116. Patient still tachypnic and tachycardic with a pulse ox of 99%. Patient reports she is feeling dizzy and hot still. Able to answer questions and was oriented at all times. Dr and first responder team arrived at scene. Patient able to answer questions. Is still dizzy and not feeling well. Patient transferred safely to cart and strapped in with safety straps. All patient belongings placed on cart with her. Patient taken to ED for evaluation.
83 2021-02-17 chills Chest pains, vomiting, chills, aches, dizziness, swollen and red face and neck. Also hallucinating.
83 2021-02-17 fatigue AFTER RECEIVING THE VACCINE SHE COMPLAINED OF BEING TIRED. ONSITE EMS/PHYSICIAN RESPONDED. BP 154/90... Read more
AFTER RECEIVING THE VACCINE SHE COMPLAINED OF BEING TIRED. ONSITE EMS/PHYSICIAN RESPONDED. BP 154/90 HR 88 SHE REFUSED FURTHER EVAL AND CAREE AND WENT HOME
83 2021-02-17 headache, fever arm sore at vaccination site, headache, fever, muscles/joint aches, chills
83 2021-02-18 chills, headache Chills and headache
83 2021-02-18 malaise Feeling very unwell, nauseated and cold (Not chills) No treatrment needed
83 2021-02-18 fever 100.2 fever nausea reaction to shot area: inflamed arm, red, the size of the top of a can
83 2021-02-19 chills, fever Chills, shaking, fever and body aches. Lasted from Wednesday evening to Thursday evening. Still fe... Read more
Chills, shaking, fever and body aches. Lasted from Wednesday evening to Thursday evening. Still feeling lifeless on Friday no appetite. Saturday feeling weak. Arm is bruised and itches terrible.
83 2021-02-20 cough Approximately 2 hours after the vaccination was given patient experienced shortness of breath, cough... Read more
Approximately 2 hours after the vaccination was given patient experienced shortness of breath, coughing, and decreased 02 stats with a pulse oximeter. Caregiver applied oxygen supplementation which improved 02 stats. Vaccinating pharmacist and home health nurse were notified and returned to facility. When pharmacist arrived patient was eating lunch and appeared to be normal. No observable breathing problems or swelling. Local inject site appeared normal with no rash or swelling. Patient tolerated 1st dose well previously. Nurse and caregiver attempted to measure oxygen while pharmacist was there but could not obtain a reading. Observed patient for an additional half an hour with no observable issues.
83 2021-02-21 chills, fatigue Patient felt fine on Friday afternoon and evening after shot. Felt fine on Saturday until the aftern... Read more
Patient felt fine on Friday afternoon and evening after shot. Felt fine on Saturday until the afternoon when she started feeling fatigued and chilled. Decided to take a warm bath at about 6pm. Was found dead in bathtub at approximately 7pm with blisters on arms, legs, and face.
83 2021-02-21 headache Within about 20 minutes, pt began to feel dizzy, had a headache and had tightness in chest. Her blo... Read more
Within about 20 minutes, pt began to feel dizzy, had a headache and had tightness in chest. Her blood pressure and pulse were normal. She had water and cold compress. I sat with her and her caretaker for another 15 minutes or so. The caretaker left to bring car around and we used wheelchair to help her to car. She never did pass out, and was feeling a little better. The caretaker was going to stay with her to keep a watch over her. Patient called a couple of hours later to let us know she was doing ok and had been lying down. She wasn't having the chest tightness anymore and her head felt better, but she had developed a rash across the chest.
83 2021-02-21 headache difficulty breathing, tightness in chest, dizziness, weakness, headache, rash-immediately after vacc... Read more
difficulty breathing, tightness in chest, dizziness, weakness, headache, rash-immediately after vaccination
83 2021-02-21 headache arm pain, diarrhea, headache, no appetite within 3 days
83 2021-02-22 cough Develope a cough with chest pain
83 2021-02-22 fever Sudden onset of low grade fever at 100.1 F, decreased verbal responsiveness with mild confusion, gen... Read more
Sudden onset of low grade fever at 100.1 F, decreased verbal responsiveness with mild confusion, generalized weakness, and unsteadiness 18 hours after getting the second covid vaccine. Recent strong smell in urine. Numbness on left arm and left leg
83 2021-02-24 fatigue Five days ago, patient received her 2nd COVID vaccination. Following that she had myalgias and some... Read more
Five days ago, patient received her 2nd COVID vaccination. Following that she had myalgias and some sedation/confusion. She apparently stumbled and struck her head. She did not lose consciousness. She did recover from her symptoms by the next day. She has some soreness on her scalp in the scratch but no significant hematoma. However, she then developed some swelling and redness beneath her eyes. She is here to evaluate that. She she is back to her normal self. Comments: Patient has ecchymosis in swelling beneath both eyes and the bridge of her nose. It is nontender. Scalp-minor area of tenderness in the right vertex. There is a slight abrasion on the skin. No signs of hematoma. Assessment / Plan: 1. Contusion of scalp, initial encounter Contusion right scalp-I suspect patient's lungs are delicate skin informed a small hematoma. The swelling and bruising and 5th settle down into her eye sockets. I reassured patient that this will resolve the next 1-2 weeks. I believe patient had some severe myalgias and fatigue after a COVID shot. I do not think this is a longstanding problem. Expect her to get back to her normal self. Patient did have COVID-19 approximately 3 and half months ago. I told her that people have more significant reaction to the COVID vaccine after having had the illness. At this point, I do not agree need further workup.
83 2021-02-24 fever On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2... Read more
On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021, she was transferred to Rehabilitation Center for continued treatment. She spent 16 days there. She developed UTI and CDIF infections and was on/off oxygen. She started physical therapy. She was scheduled to be released to go home on January 27, 2021. On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine. On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative). Two days later, she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative. The only thing they could trace it to was an adverse reaction to the vaccine. After spending 11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly.
83 2021-02-25 cough Pt immediately began to cough after vaccine given and her O2 saturation dropped to 45%. Her HR dropp... Read more
Pt immediately began to cough after vaccine given and her O2 saturation dropped to 45%. Her HR dropped to 40-45 and she was given oxygen and epi-pen administered. Ambulance called during that time and she was taken to ED.
83 2021-02-25 headache, chills Chills, Headache, Body aches, weakness (unstable standing up), nausea (throwing up)
83 2021-02-25 sleepiness, body temperature increased About 24 hours after receiving the vaccine she was running 100.8 temperature, aching to the point of... Read more
About 24 hours after receiving the vaccine she was running 100.8 temperature, aching to the point of soles of her feet hurt, wanting to sleep. Went to bed at 4:00 PM and stayed asleep until 11:00 AM the next morning. Her arm swelled very high, there was a bruise at the site of the injection and itching all around it with a rash. Arm is still swollen and tender to touch, but the rash is not bothering her to the point of scratching. She did take Tylenol for the fever several times.
83 2021-02-26 fatigue Severe exhaustion lasting all day, every day since morning of 2/24/2021.
83 2021-02-28 chills, headache, fever Chills, fever, headache, intense all-over body aches, unable to sit up or turn over in bed, loss of ... Read more
Chills, fever, headache, intense all-over body aches, unable to sit up or turn over in bed, loss of appetite.
83 2021-02-28 fatigue, fever, chills Six hours after administration patient was feverish (temp over 101), nausea, vomiting, exhausted and... Read more
Six hours after administration patient was feverish (temp over 101), nausea, vomiting, exhausted and chills that lasted for 2 days. Then last Friday February 26, 2021 exact same symptoms recurred that lasted 2 days as well. Called doctor both times to get nausea medication. Doctor prescribed 25 mg of Promethazine.
83 2021-02-28 fatigue pt stated that about 2 days after she got her 2nd dose of the covid vax that her right arm was sore ... Read more
pt stated that about 2 days after she got her 2nd dose of the covid vax that her right arm was sore and itchy and red from the shoulder down about 2/3 down her arm. She also had experienced some fatigue and loss of appetite. She has been using Zyrtec and using cortisone cream. The NP at the independent living has taken at look at it and her PCP has seen a picture of it but she has not been prescribed any medicine at this time.
83 2021-02-28 fever, chills Patient states she had a 101.7 fever and chills after receiving her 2nd dose of COVID vaccine. After... Read more
Patient states she had a 101.7 fever and chills after receiving her 2nd dose of COVID vaccine. After 2 days she developed a 8-10" oblong red, hot, hard spot about 1" below the injection site. Pt has not contacted a healthcare professional.
83 2021-02-28 fever, chills Evening of day of vaccination, had fever, chills high blood pressure and pulse. Lasted all night an... Read more
Evening of day of vaccination, had fever, chills high blood pressure and pulse. Lasted all night and next day started to get less until Friday morning. Feeling good that day and went to friends house for dinner. At end of dinner felt like going to throw up but instead I passed out for 1-2 minutes (have never passed out in my life!). Medics came and ran several tests but all was okay and I have had no trouble since.
83 2021-03-01 fatigue, sweating, headache Got the vaccine and was feeling tired, and her arm hurt, an all she wanted to do was lay in bed with... Read more
Got the vaccine and was feeling tired, and her arm hurt, an all she wanted to do was lay in bed with her heating pad. The following day she woke up with a headache, some nausea but nothing came up. She also had diarrhea and her arm was sore. She felt weak, and since she had COVID she has had shortness of breath. She stayed in the bed all day unless she had to as her arm felt like it was made of metal and was extremely tired. She was moving around upstairs and somewhere around 8:00 PM she went to the bathroom, was sweating profusely and wiping herself with tissue, and apparently turned out the light and apparently passed out as she woke up on the floor in the hallway and could not get up right away. She could not use the left arm, was able to get herself up with the help of the door to stand on her feet. She walked into her room and sat on the bed, and did not lay back down and greatful that she did not fall down the steps. She went back to bed, but in the morning she was terrified and her family heard her talking to the doctor on call who told her to go to the ER. In the ER they told her that she had syncope, seen by Dr. at Health Care. She was admitted at 11:11 AM on 2/27/21. She was given IV, had a CAT scan of her head, told her that it did not reveal any blood. After several hours they discharged her. She called her doctor and she has an appointment tomorrow morning. She is feeling tired, not sleeping well.
83 2021-03-01 fever, chills, influenza like illness Patient described a severe rash at the injection site that increased over time. Also had some fever... Read more
Patient described a severe rash at the injection site that increased over time. Also had some fever, chills, and flu like symptoms. Patient has had COVID previously.
83 2021-03-02 body temperature increased PAIN, SWOLLEN, RING OF INFLAMMATION, PURPLE KNOT AT INJECTION SITE. WENT TO ER 2/27 WITH TEMP OF 1... Read more
PAIN, SWOLLEN, RING OF INFLAMMATION, PURPLE KNOT AT INJECTION SITE. WENT TO ER 2/27 WITH TEMP OF 101.54. CHEST XRAY, BLOOD WORK, UNINALYSIS,. IV FLUIDS, IV ANTIBIOTIC, ZOFRAN FOR VOMITING. MD CONCLUDED REACTIN TO VACCINE. FILL RX FOR ZOFRAN LATER THAT EVENING
83 2021-03-02 malaise Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizzi... Read more
Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizziness; Nausea; Vomited; Blood pressure fluctuation; Hives on inner arms; A spontaneous report was received from a consumer and physician concerning a 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt was going to die, general malaise, red streak on inner side of left arm, hives on inner arms, weakness, dizziness, blood pressure fluctuating, nausea and vomited. The patient's medical history included breast cancer, breast cancer surgery and hives. Concomitant product use was not provided. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 039K20A) (route of administration not specified) in the right arm for prophylaxis of COVID-19 infection. On 17 Jan 2021, 12 to 13 days after the vaccination, the patient developed hives on inner arms which would come and go, appearing in the morning and disappearing during daytime. Patient took Benadryl for it and applied cortisone cream. On 26 Jan 2021, after taking a walk, the patient experienced weakness, slight dizziness, and nausea. Patient was taken to the emergency room (ER) and vomited. The patient was sent home the same day but the patient's blood pressure was noted to be fluctuating. On 27 Jan 2021, the patient "felt that she was going to die" and had general malaise. The patient was brought to the ER of another hospital but again was sent home. On 29 Jan 2021, with the symptoms still ongoing and a red streak noted on the inner side of the left arm, the patient was admitted for observation at the second hospital. Laboratory details included Blood works and radiologic tests were done with normal results. The patient's blood pressure was stabilized but patient was still experiencing malaise and still had the on and off rash on both inner arms. Treatment information included Benadryl and Cortisone Cream for the indication hives. Action taken with mRNA-1273 in response to the events was not reported. The event, blood pressure fluctuation, was considered resolved/recovered on 01 Feb 2021. The outcome of the events, hives on inner arms, red streak on inner side of left arm, weakness, dizziness, nausea, vomited, felt was going to die and general malaise, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case concerns an 83-year-old female hospitalized with serious unexpected malaise, erythema, anxiety, and NS unexpected urticaria, asthenia, dizziness, BP fluctuation and NS expected nausea, vomiting. Event onset 23 days after the first dose of mRNA-1273. BP changes resolved, other events unknown. As above, a causal relationship cannot be excluded.
83 2021-03-04 fatigue, headache patient had severe headache, felt extremely tired, her face was very pale. she said she had some cer... Read more
patient had severe headache, felt extremely tired, her face was very pale. she said she had some cereal in the am and that she was a little tired even before the shot, gave her some orange juice. she said she is going to wait a little bit till she feels better. she get worse, her chest was heavy but she was still talking normally. called 911, EMS came and transported her to the hospital
83 2021-03-05 fatigue fatigue beginning 18 hours after vaccination ending 39 hours after vaccination, body aches beginnin... Read more
fatigue beginning 18 hours after vaccination ending 39 hours after vaccination, body aches beginning 40 hours after vaccination ending 41 hours after vaccination--took advil; no fever
83 2021-03-06 chills, fatigue, fever Fever 101, chills, tiredness, urinary incontinence Went to ER early morning of 3rd day 3/6, ,give... Read more
Fever 101, chills, tiredness, urinary incontinence Went to ER early morning of 3rd day 3/6, ,given 1000 mg. ascetaminaphen, urine culture taken, blood work done, CT scan. Stayed there only about 2 hrs. and released 3/6
83 2021-03-06 chills, headache First night...Severe Chills. Day 2..Loss of appetite & weakness. 3rd day Loss of appetite Headache.
83 2021-03-08 chills Rigors and pre-syncope with fall and right hip fracture
83 2021-03-09 fatigue, headache, fever Pt. reports waking around 6am on Saturday, March 6th with a temperature, headache, body aches and na... Read more
Pt. reports waking around 6am on Saturday, March 6th with a temperature, headache, body aches and nausea. She reports that this lasted all day on Sunday, March 7th as well. Woke Monday, March 8th and Tuesday March 9th fatigued and rested or slept most of the day. Pt. was advised that she could use Tylenol for fever and generalized achiness. Pt. woke today, Wednesday, March 10th with no symptoms and felt "like her normal self".
83 2021-03-09 headache daughter stated the pts left arm is very red, itchy, and swollen about 4 days after getting the vax.... Read more
daughter stated the pts left arm is very red, itchy, and swollen about 4 days after getting the vax. Pt has also has headaches that come and go. Pt went to CVS and the nurse told her to take Benadryl and cortisone cream. Pt is only using the cortisone cream and no Benadryl. Pt still has some itchiness and headaches but is getting better.
83 2021-03-09 fever, chills Extreme bodily pain all over, fever not exceeding 101, chills, responded to Tylenol, lasted about 2... Read more
Extreme bodily pain all over, fever not exceeding 101, chills, responded to Tylenol, lasted about 24 hours.
83 2021-03-11 chills, fatigue Moderna COVID-19 Vaccine EUA injection side pain, swelling and redness, fatigue, muscle and joint pa... Read more
Moderna COVID-19 Vaccine EUA injection side pain, swelling and redness, fatigue, muscle and joint pain, chills, nausea. also some dizziness, and weakness, no energy. This is still ongoing on 3/12/2021, 10:00AM MST
83 2021-03-11 cough uncontrolled cough that last for 2-5 minutes
83 2021-03-11 fever, headache Starting 3/11 Left arm with warmth, itch and redness. Onset of headache and fever 3/11 in afternoon
83 2021-03-12 fever 1st day - 0, day 2 slight fever, sore injection site, red lasted 3 days, March 11th itching, slightl... Read more
1st day - 0, day 2 slight fever, sore injection site, red lasted 3 days, March 11th itching, slightly sore, quite red 3 days so far itching
83 2021-03-13 fatigue The day following the vaccine, I experienced extreme fatigue and body aches. I took naps several tim... Read more
The day following the vaccine, I experienced extreme fatigue and body aches. I took naps several times during the day. A red rash appeared just below the injection site. The next day I did not experience the fatigue and body aches. The red rash is still present. There is some itching, but not severe. I have been applying Benadryl Cream two to three times a day.
83 2021-03-13 fever About 52 hours later I had chills, fever & diarrhea. Five days later I had an Atrial Fibrillation a... Read more
About 52 hours later I had chills, fever & diarrhea. Five days later I had an Atrial Fibrillation attack and ended up in the ER. Was given Metoprolol infusion plus 2 Metoprolol pills to get me back into normal rhythm. Was in ER about 5.5 hrs.
83 2021-03-14 chills, body temperature increased Chills, temperature 103.6, nausea, chest pain, vomiting progressively (temperature went below normal... Read more
Chills, temperature 103.6, nausea, chest pain, vomiting progressively (temperature went below normal after vomiting) for 15 hours total. Left arm still red, swollen and hot.
83 2021-03-14 chills, fatigue knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spin... Read more
knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain. The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain. Treatment details included Tylenol and ibuprofen Action taken with mRNA-1273 in response to the events was not reported. At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
83 2021-03-14 fatigue 3 DAYS EXHAUSTION EXPLOSIVE DIARRHEA
83 2021-03-15 sinus headache, fatigue, headache, malaise, sinus congestion Patient had a reaction on 3/3/21, one day after 3/2/21 Nivolumab (immunotherapy tenth cycle) dose fo... Read more
Patient had a reaction on 3/3/21, one day after 3/2/21 Nivolumab (immunotherapy tenth cycle) dose for her melanoma treatment and second Moderna vaccine was given on 2/28/21. She'd had her first Moderna vaccination with the same timing- three days prior- to her 9th Nivolumab infusion. She did not have any prior symptoms after the Moderna vaccines were given. On 3/3/21 the arm where the vaccine was given became swollen, red, and hot. She developed a severe sinus headache and sinus congestion with no fluid draining. The headache pain was more severe than she'd ever experienced and was not like a migraine. "It hurt to blink." She was sick through 3/7 with symptoms progressing to fatigue "too tired to write a note" and nausea and "violent" dry heaves. The symptoms resolved quickly and completely on Sunday 3/7/21 and she felt well for the days after.
83 2021-03-16 headache Started in the morning with injection site swelling . itching and inflamed. Intense headache and nau... Read more
Started in the morning with injection site swelling . itching and inflamed. Intense headache and nauseous & upset stomach. Lasted all day (approximately 11 hours) Used ice bag on arm and head. Took an Advil. Finally subsided in the evening. Swelling went down on my arm by next day but stayed red for 2 days.
83 2021-03-17 chills mild swelling of tongue & lips lasted till around 2pm but came back off and on till that evening li... Read more
mild swelling of tongue & lips lasted till around 2pm but came back off and on till that evening lie a wave passing thru my mouth. Only other effect was around 5pm got the chills & didn't get warm till went to bed at 10pm. End of tongue has not been same since like constantly irritated
83 2021-03-17 sneezing, lethargy, fatigue Soreness, lethargy/fatigue, and sneezing for approximately 3-4 days. Patient now feels completely fi... Read more
Soreness, lethargy/fatigue, and sneezing for approximately 3-4 days. Patient now feels completely fine.
83 2021-03-17 sleepiness, sweating Groggy, sweating, has trouble concentrating and talking, dizzy, trouble sleeping, and confused. Pt t... Read more
Groggy, sweating, has trouble concentrating and talking, dizzy, trouble sleeping, and confused. Pt thought was in Mexico. Symptoms are normal, if they do not subside within a few days seek medical help.
83 2021-03-18 body temperature increased, headache Fever, right deltoid swelling, hot to touch and redness. High fevers of 102.0-103.0F Patient report... Read more
Fever, right deltoid swelling, hot to touch and redness. High fevers of 102.0-103.0F Patient reports having high fevers, headache and nausea. Presented to ED with the mentioned symptoms. Swelling approx. size of softball.
83 2021-03-18 fatigue, headache, chills faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday... Read more
faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday started to get itch and rash around the injection site; Was sick for days; joint pains; fatigue; headache; muscle pain; chills; sore arm; A spontaneous report was received from a consumer who was an 82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills, itch and rash around the injection site and faints when I get up. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03-Mar-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection. On 03-Mar-2021, the patient experienced the events sore arm. She reported that she was sick for days, suffered fatigue, headache, muscle and joint pain and chills. On 06-Mar-2021, she stated that her vaccination site started to itch and a rash developed around it and that she felt tired all day. On 07-Mar-2021, she reported that the redness and itchiness at the injection site was gone and that she felt better but still like when she had Covid in the past. Additionally, patient reported that she fainted when she got up (date unknown). Treatment included paracetamol 2 tablets on 06-Mar-2021 in the evening. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, itch and rash around the injection site, was considered recovered/resolved. The outcome of the events, sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills and faints when I get up, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
83 2021-03-18 head discomfort Patient left facility after vaccination was complete and monitored for 15 minutes. patient stated sh... Read more
Patient left facility after vaccination was complete and monitored for 15 minutes. patient stated she felt a head rush and didnt want to go to the hospital. Vitals were taken and everything within normal limits.
83 2021-03-18 sweating, cough My mom lhad been up walking around for maybe an hour or so. She then laid down across the bed & whe... Read more
My mom lhad been up walking around for maybe an hour or so. She then laid down across the bed & when I looked at her, she was drenched with sweat, then she started hacking, almost like she was choking or couldn't breathe. She also started mumbling & called on Jesus. I tried sitting her up, her eyes then rolled back in her head, then this very gold colored stuff started coming out of her mouth (which scared me to death). Her body was so limp, she slid on the floor. I wiped her mouth & also put a cold rag on her forehead to try to cool her down. I dialed 911 & continued talking to her. She started to respond to me & along with my help we were able to sit her back on the bed. EMS arrived, took her vitals.
83 2021-03-20 fever, headache, fatigue, chills Immediately following the second vaccination, the individual's arm felt heavy and she had pain at t... Read more
Immediately following the second vaccination, the individual's arm felt heavy and she had pain at the injection site. Around 10-11 hours later that evening, the individual started feeling dizzy, experienced fever and chills, had shooting pain in her arm at the injection site, severe fatigue, appetite loss, headache and experienced diplopia. These symptoms lasted about a day and a half. The first 24 hours were the worst.
83 2021-03-21 respiratory tract congestion Date and time adverse event started: 2 weeks ago, caller unsure of exact time (3/18/2021) dizziness,... Read more
Date and time adverse event started: 2 weeks ago, caller unsure of exact time (3/18/2021) dizziness, wheezing, congestion, states lungs feels like "it is filled with fluid". Has taken neb tx to alleviate symptoms but has no relief. Recommended to see primary provider. Caller states will take patient to urgent care today, 3/18/21.
83 2021-03-23 chills Chills on Feb 12, day after shot. On Feb 16, left upper arm above elbow began to itch. Next day Feb ... Read more
Chills on Feb 12, day after shot. On Feb 16, left upper arm above elbow began to itch. Next day Feb 17, red and swollen, with a round, hard swelling the size of a half dollar around injection site. Continued Feb 18, VERY itchy, very red, continued Feb 19 and by Feb 20, subsided. On March 11, 2021, 2pm, same location, I received Covid shot #2, also Moderna, in right arm. Next day March 12, chills, March 13, 14, 15, arm red, swollen, itchy, as before, but onset sooner, same intensity, slightly briefer.
83 2021-03-23 fatigue, sweating Day 2 severe pain in upper arms and shoulders (both). Same pain as I experience after a nuclear str... Read more
Day 2 severe pain in upper arms and shoulders (both). Same pain as I experience after a nuclear stress. test. Vaccine site was badly inflamed and itchy for next 4-5 days.. Also noticed a scale-y patch at the injection site. Use Cortizone on it and it made the pain in my left arm and shoulder really hurt. Severe diarrhea all day the 18th. No known reason for it. 19th very tired. 20th unable to go to sleep all night. Body aches travelled up and down my body. 3/21, up at 1:30, took shower and started to fix breakfast. Suddenly felt like I was going to vomit. Very sweaty and dizzy on the way to the bathroom. Threw up, no diarrhea. Vomit was yellow, foamy liquid. 3/22 left shoulder much pain at bedtime. Took tramadol and applied heat pad to shoulder. Shoulder still has issues.
83 2021-03-23 lethargy Mom has secondary progressive MS and had not had an exacerbation in over 30 years. The vaccine gave... Read more
Mom has secondary progressive MS and had not had an exacerbation in over 30 years. The vaccine gave her an exacerbation - lethargic, unable to stand, crippled her 2 fingers and new a new lesion on her brain. This caused her to be in the hospital for a week and now in skilled care (going on week 3) for PT to learn how to walk again. She has been on steroids and also needs to take a Hepron injection 4x:day since she can?t get out of bed on her own.
83 2021-03-24 headache, fever, influenza like illness, dehydration severely dehydrated; cramping lower abdomen; flu like symptoms; intense vomiting; headache; fever; n... Read more
severely dehydrated; cramping lower abdomen; flu like symptoms; intense vomiting; headache; fever; nausea; disoriented; cramping; A spontaneous report was received from a consumer who was also an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dehydration/Dehydration, cramping in lower abdomen/ abdominal pain lower, fever/pyrexia, nausea, headache, disorientation, flu like symptoms/ Influenza like illness, intense vomiting/ vomiting and cramping/ muscle spasms. Patient's medical history was not provided, and concomitant medicines were not reported. On 25 Jan 2021, the same day as the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient reported that she initially had an "extreme reaction" with severe, flu-like symptoms, headache, fever, disorientation, nausea and dehydration. She reported that she had a fever within three hours of receiving the vaccination. She stated that she suffered extreme vomiting for three and a half weeks along with ongoing headache, fever and cramping. On an unknown date, she was in the hospital, or ER, where she received medication for nausea and intravenous medication for dehydration (unknown if hospitalized}. She reported eight hours of pain/cramping in her lower abdomen, and again, stated that she was severely dehydrated. (The duration of hospitalization or ER visit was not reported). At the time of reporting, she said that her symptoms were ongoing, however, much less severe. Treatment included was nausea medication (patient did not remember the drug's name), intravenous (IV) medication for dehydration, IV antibiotics and dicycloverine. Action taken with mRNA-1273 was not reported. The outcomes of the events, dehydration, cramping in lower abdomen, fever, nausea, headache, disorientation, flu like symptoms, intense vomiting and cramping, were considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
83 2021-03-25 dehydration became dehydrated in spite of drinking water and started Pedialyte right before the stroke Admitted... Read more
became dehydrated in spite of drinking water and started Pedialyte right before the stroke Admitted into the hospital on March 19th late morning early afternoon. via ambulance to helicopter At hospital
83 2021-03-25 sleepiness felt groggy; sick to the stomach; passed out; felt very weak; cold sweat; shaky; A spontaneous repor... Read more
felt groggy; sick to the stomach; passed out; felt very weak; cold sweat; shaky; A spontaneous report was received from a consumer who was also an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out/loss of consciousness, felt very weak/asthenia, sick to the stomach/ nausea, cold sweat, shaky/ tremor, could not see straight/ blurred vision and felt groggy/ somnolence. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, calcium, tramadol and vitamin B complex. The patient received their first of two planned doses of mRNA-1273 (Batch number:02AL20A) on 29 Jan 2021. On 01 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, 10 hours after getting the 2nd dose, the patient felt very weak, sick to the stomach, cold sweat, shaky, could not see straight and she passed out. On 02 Mar 2021, the patient felt groggy. The patient stated that she did not take any medications for her symptoms. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, passed out, felt very weak, sick to the stomach, cold sweat, shaky and could not see straight, were considered resolved on 02 Mar 2021. The event felt groggy was considered resolved on 03 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
83 2021-03-27 runny nose Three weeks after the second vaccine, I had a snotty nose and low voice, I was Itchy all over, the n... Read more
Three weeks after the second vaccine, I had a snotty nose and low voice, I was Itchy all over, the next morning I had red spots ALL over head, torso that really itched. The next day the spots had joined into blobs and continue to be really itchy. I have been taking Benadryl every four hours since the break out.
83 2021-03-29 fatigue, malaise, headache significant rash to bodies worse in arms and feet swelling to site significant headache fatigue -gen... Read more
significant rash to bodies worse in arms and feet swelling to site significant headache fatigue -general malaise
83 2021-03-29 fatigue Within two hours the arm became itchy, swollen and red hot. It continued to get worse over three day... Read more
Within two hours the arm became itchy, swollen and red hot. It continued to get worse over three days. In additional I had exhaustion. The symptoms continued for the next four days and began to subside on the sixth day. At this writing I am at the seventh day and till have residual symptoms which are gradually diminishing. The degree of itchiness could be described as like bad shingles. The degree of redness could be described as a bad sunburn. The degree of swelling was like a hard muscle cramp in my deltoid, triceps, and biceps widespread across most of the upper arm and shoulder.
83 2021-03-29 fatigue Utter Exhaustion lasting 5 weeks and continuing.
83 2021-03-29 fever, headache Fever of 102, nausea, flu symptoms i.e. muscle aches, headace. Lasted about 8 hours, felt normal af... Read more
Fever of 102, nausea, flu symptoms i.e. muscle aches, headace. Lasted about 8 hours, felt normal after symptoms abated
83 2021-03-30 fatigue She got the vaccine, she had no problems, felt rather fatigued for a day or so. Then on 3/18/21 she... Read more
She got the vaccine, she had no problems, felt rather fatigued for a day or so. Then on 3/18/21 she had a bright rash on her thighs, it didn't itch, just ridges and red marks. Then her lips were swelling, used what she uses on fever blisters. She has used what she has used before which has not helped her. She has not called her doctor. She still does have the rash, it has faded some but it did come back.
83 2021-03-31 fatigue fatigue, arm soreness down to fingers, decreased appetite, head feeling "foggy" and high blood press... Read more
fatigue, arm soreness down to fingers, decreased appetite, head feeling "foggy" and high blood pressure
83 2021-03-31 lethargy Client came in accompanied at approx. 1150 for 2nd Moderna vaccine. Roughly 5 min post vaccine (1200... Read more
Client came in accompanied at approx. 1150 for 2nd Moderna vaccine. Roughly 5 min post vaccine (1200) clients asked for water so her mother could take meds. Client took her prescribed Norco and around 1205 began feeling very lethargic. Vitals were taken and were WNL with the exception of an irregular heartbeat as well as being significantly lethargic and unable to ambulate. At that time denied that client had a Hx of an abnormal heart rate and that this was not a normal occurrence for the client after taking her prescribed pain med. It was recommended that the client be seen at the clinic however the clinic was busy so opted to an ambulance ride to the ER as she was concerned about her ability to transfer to and from the vehicle.
83 2021-03-31 fever 102.0 now 102.8 F Fever.; Can't walk; Can't form a sentence; Extremely weak; A spontaneous report wa... Read more
102.0 now 102.8 F Fever.; Can't walk; Can't form a sentence; Extremely weak; A spontaneous report was received from a consumer concerning a 83 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, weakness/asthenia, can't walk/gait inability, couldn't form a sentence (aphasia). The patient's medical history was not provided by the reporter. Concomitant product use was not reported. On an unknown date in Jan 2021, patient received their first of two planned doses of mRNA-1273 vaccine (Batch number: Unknown). On 15 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection. After receiving the mRNA-1273 vaccine, on 16 Feb 2021, the patient experienced a fever of 102-102.8 degrees Fahrenheit. She was extremely weak, couldn't walk or form a sentence. Treatment details for events were not reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, fever/pyrexia, weakness/asthenia, can't walk/gait inability, can't form a sentence/aphasia were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (Pyrexia, asthenia) a causal relationship cannot be excluded. Very limited information regarding the event (gait instability, aphasia) has been provided at this time. Noting advance age is a risk factor. Further information has been requested.
83 2021-04-01 lethargy felt weak; some side effects from the vaccine; lethargic; This spontaneous case was reported by a ph... Read more
felt weak; some side effects from the vaccine; lethargic; This spontaneous case was reported by a physician concerning a 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt weak/asthenia, lethargic/lethargy. No Medical History information was reported. Concomitant medications were not reported. On an unknown date, prior to the onset of the events, the patient received a dose of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection. On an unknown date, 3 days after receiving mRNA-1273, patient just felt weak, lethargic, had some side effects, and patient was taken to hospital and has been in the hospital for 3 weeks now. Doctors could not find anything wrong with them; they're going through the last set of labs which they think is going to be normal also. Caller's mother got the vaccine through the primary contact on this case. Treatment was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events felt weak, had some side effects, and lethargic is unknown..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
83 2021-04-02 fever day after the administration patient presents very high fever with severe pain in the injection sit... Read more
day after the administration patient presents very high fever with severe pain in the injection site., received attention in emergency room abd was diagnosed with cellulitis in the arm. Was in hospital until 04/02/2021. Now in her home.
83 2021-04-03 fatigue After first vaccination mom was tired in bed flu symptoms for a few days. Had MG symptoms come back ... Read more
After first vaccination mom was tired in bed flu symptoms for a few days. Had MG symptoms come back and talked to her Dr. Went for 2nd vaccination and very tired &had Severe MG symptoms dr said to take then stop taking Mestinin as she continued getting sicker he called and said not to get any therapeutic drugs called Solaris not to see a dr and she died few days after.
83 2021-04-05 malaise The morning after her shot she felt unwell and did not get up for any meals. She said she couldn't ... Read more
The morning after her shot she felt unwell and did not get up for any meals. She said she couldn't lift her legs and she could not tell when she had to go to the bathroom. Prior to this shot she was able to walk with a walker ; she knew when she had to go to the bathroom and she got up by herself in the morning and knew what her routine was. Now she is unable to walk and is totally incontinent. She does not know her routine anymore and is waiting for directions from her caretakers on when to get up, when to go to the bathroom and sits in bed all day or is moved to a chair by caretakers. She needs pillows propped around her in order to sit upright.
83 2021-04-06 chills (197/101) high blood pressure; Blood sugar was up to 196; Extreme dizziness; Could not get warm (chi... Read more
(197/101) high blood pressure; Blood sugar was up to 196; Extreme dizziness; Could not get warm (chills); Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ((197/101) high blood pressure) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ATENOLOL, LISINOPRIL, METFORMIN, SIMVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, ANASTROZOLE and AMLODIPINE for an unknown indication. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED ((197/101) high blood pressure) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), DIZZINESS (Extreme dizziness) and CHILLS (Could not get warm (chills)). On 26-Mar-2021, BLOOD PRESSURE INCREASED ((197/101) high blood pressure) and DIZZINESS (Extreme dizziness) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), PAIN IN EXTREMITY (Sore arm) and CHILLS (Could not get warm (chills)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: 196 (High) high. On 25-Mar-2021, Blood pressure measurement: 197/101 (High) High. On 26-Mar-2021, Blood glucose: 190 (High) high. On 26-Mar-2021, Blood pressure measurement: (normal) normal. No treatment was provided.; Sender's Comments: This case concerns an 83-year-old female with a serious unexpected event of increased blood pressure, and nonserious unexpected dizziness, pain in extremity, glucose increased and expected chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
83 2021-04-06 runny nose tarry black diarrhea; swollen foot; vomiting; possible gout attack; possible cellulitis; shceduled t... Read more
tarry black diarrhea; swollen foot; vomiting; possible gout attack; possible cellulitis; shceduled to receive the second dose after 58 days; Runny nose; hard area at injection site; tender to touch the injection site; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CITALOPRAM, RIVASTIGMINE (EXELON [RIVASTIGMINE]), FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID], ZOLPIDEM TARTRATE (AMBIEN), XANTOFYL (LUTEIN OPT), KRILL OIL, CALCIUM, VITAMIN B3, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and EVOLOCUMAB (REPATHA) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling). On 15-Feb-2021, the patient experienced FAECES DISCOLOURED (tarry black diarrhea) (seriousness criterion hospitalization), PERIPHERAL SWELLING (swollen foot) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOUT (possible gout attack) (seriousness criterion hospitalization), CELLULITIS (possible cellulitis) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days). The patient was hospitalized for 8 days due to CELLULITIS, FAECES DISCOLOURED, GOUT, PERIPHERAL SWELLING and VOMITING. On 03-Feb-2021, RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling) had resolved. At the time of the report, GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was started on antibiotics and prednisone treatment for possible gout attack or cellulitis. No treatment information regarding other events was available.; Sender's Comments: This case of an 83-year-old female patient who experienced inappropriate schedule of vaccine administered after first dose of mRNA-1273 (58 days). Based on temporal association between mRNA-1273 use and onset of the events of runny nose, vaccination site induration, pain and swelling, a causal relationship cannot be excluded. There is not enough information to assess the other events due to lack of critical details in patient's medical history. Additional information is being requested.
83 2021-04-08 chills, fatigue Day of shot - sore arm all day 2pm day of shot - very exhausted 8pm - leg cramps + very exhausted ... Read more
Day of shot - sore arm all day 2pm day of shot - very exhausted 8pm - leg cramps + very exhausted March 13 & 14 - very exhausted, less sore arm March 15 & 16 - dizzy, very exhausted, diarrhea, chills, itchy arm March 17 side effects but milder March 18 side effects ended
83 2021-04-08 fatigue, sweating, chills, sleepiness Today April 9 returned from getting 2nd dose. By 5pm exhaustion and sleepy. Slept for a few hours. ... Read more
Today April 9 returned from getting 2nd dose. By 5pm exhaustion and sleepy. Slept for a few hours. Around 8pm broke out in sweats, 9pm chills, backache
83 2021-04-08 fatigue itching swelling rash from shoulder to below elbow for 7 days. Tired and in bed for day and half
83 2021-04-10 chills, fatigue, fever chills fever 99.6 tired for 2 days
83 2021-04-11 sinus disorder, headache, throat pain, sleepiness second shot, 3/17, next day muscle aches and sleeping 3/18. on 3/19 sinus flared up with headaches, ... Read more
second shot, 3/17, next day muscle aches and sleeping 3/18. on 3/19 sinus flared up with headaches, sore throat, swollen glands, ear aches and yellow discharge from sinus
83 2021-04-12 headache Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she... Read more
Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 1023. Alert and oriented. Patient says as soon as she received her vaccine and sat down for her 15 minute observation, she started feeling like she was going to pass out, feeling dizzy. She was taken to the triage area via w/c, BP 85/39, P 51, then 88/35 P 49. She was not in any distress, no sweating, alert and answering questions. 1026: EMS called. 1028: BP 99/50, P 52, c/o headache, drinking water. 1034: BP 106/46, P 50; 1043: BP 96/47, P 56, EMS arrived at 1045. Actions taken: Vitals sign taken EMS called at 1026. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 1045. Medications administered: No medication administered. Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 1055.
83 2021-04-12 nasopharyngitis, malaise really sick; chest pains; will not take the second shot; pretty bad cold; This spontaneous case was ... Read more
really sick; chest pains; will not take the second shot; pretty bad cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (really sick) and CHEST PAIN (chest pains) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced NASOPHARYNGITIS (pretty bad cold). On an unknown date, the patient experienced MALAISE (really sick) (seriousness criterion hospitalization), CHEST PAIN (chest pains) (seriousness criterion hospitalization) and TREATMENT NONCOMPLIANCE (will not take the second shot). At the time of the report, MALAISE (really sick), CHEST PAIN (chest pains), TREATMENT NONCOMPLIANCE (will not take the second shot) and NASOPHARYNGITIS (pretty bad cold) outcome was unknown. Not provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's weight is 170 (units not reported). Whilst hospitalized, all laboratory tests (unspecified) were normal. Concomitant medication included unspecified medication for asthma. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
83 2021-04-14 body temperature increased, fatigue, headache, malaise Sick feeling , tired, 100.4 temperature, headache, muscle aches in legs and small of the spine, h... Read more
Sick feeling , tired, 100.4 temperature, headache, muscle aches in legs and small of the spine, had to stay in bed 13,14th and am up today the 15th but still feeling tired.
83 2021-04-15 fatigue Pt. c/o symptoms of fatigue and dizziness on 3/2. On 3/3 pt. presents to ER, afebrile, c/o fatigue, ... Read more
Pt. c/o symptoms of fatigue and dizziness on 3/2. On 3/3 pt. presents to ER, afebrile, c/o fatigue, feeling of being lightheaded, reports syncope and falling x's 2. Pt. according to MD documentation was in good health. Denies any recent illness. Pt. was found to be bradycardic, sick sinus syndrome, r/o MI. Pt. was transferred to higher level of care hospital on 3/3. Pt. had emergency pacemaker insertion. She became hypotensive and hypoxic post-op and was found to in lactic acidosis. Pt. expired on 3/3/21.
83 2021-04-18 fatigue Fatigue/ severe SOB
83 2021-04-20 fever @am Sun morn woke up couldnt get out of bed 2am felt like covid all over again fever, weakness, slep... Read more
@am Sun morn woke up couldnt get out of bed 2am felt like covid all over again fever, weakness, slept till6pm on Sunday had been in hosp in Dec for a week with long term covid. Spent Sun and Mon in bed up Tues, weak head going in circles. Today, Wed is first day ive felt like doing anything Daughter had to help me out of bed Sun and Mon just couldnt stand up.
83 2021-04-22 fatigue extreme fatigue
83 2021-04-22 fatigue 4-19-21 afternoon hearing was failing in left ear. Loss of hearing has only gotten worse over the la... Read more
4-19-21 afternoon hearing was failing in left ear. Loss of hearing has only gotten worse over the last 5 days. Sounds like a tunnel and echoing - can not hear conversations. 4-7-21 Muscle and joint pain/soreness, extreme tiredness symptoms lasted for 3 days
83 2021-04-25 headache, fever After 7 days, patient got a covid arm rash, gi issues, low grade fever, headache; They lasted about ... Read more
After 7 days, patient got a covid arm rash, gi issues, low grade fever, headache; They lasted about 1 week. She still has a small bruise and hurts when lifted high.
83 2021-05-02 cough This is an 83 years old lady who was presented to the emergency department because of increasing dif... Read more
This is an 83 years old lady who was presented to the emergency department because of increasing difficulty breathing, coughing, generalized body ache, and weakness. She was diagnosed with COVID-19 on April 9, 2021. The patient chest x-ray showed ill-defined bilateral opacities. She was hypoxic on presentation. 1. Bilateral COVID-19 pneumonia. Present on admission. Associated with hypoxia. The patient was diagnosed with COVID-19 on April 9th but her initial symptoms started even earlier
83 2021-05-03 malaise, body temperature increased Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, t... Read more
Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy infiltrates. COVID test positive. Respiratory failure and COVID19 pneumonia. Patient referred to hospice.
83 2021-05-04 headache Started not able to eat or drink, then started throwing up and not sble to keep anything down. Then... Read more
Started not able to eat or drink, then started throwing up and not sble to keep anything down. Then had diarrhea somewhat also had a headache. Then wasn't voiding at all either one. Turned into kidney failure. Shut down her kidneys.
83 2021-05-09 malaise, headache Severe L. arm pain and swelling, L. neck, L. face and head severe pain w/headache; chest pain w/m... Read more
Severe L. arm pain and swelling, L. neck, L. face and head severe pain w/headache; chest pain w/malaise and felt sick. Incapacitated for 5-6 days . Symptoms lasted for over a week
83 2021-05-16 headache, fever, chills My mom died one month after the second maderna shot it made her very sick and she never recovered . ... Read more
My mom died one month after the second maderna shot it made her very sick and she never recovered . Headache stomach ache chills fever shaking and death
83 2021-05-17 pneumonia I went to doctor appt was having pain in my left lung right under rib cage. I was transferred t to... Read more
I went to doctor appt was having pain in my left lung right under rib cage. I was transferred t to ER cause of severe pain. I was hospitalized for two days for pneumonia received antibiotics. The next day I asked to go home to take care of my spouse on Oxygen and he also exp pneumonia after vaccine.
83 2021-05-19 chills, sweating, fever, headache Started having cognitive problems; severe chills; sweating; headaches; Fever; Felt extremely weak; T... Read more
Started having cognitive problems; severe chills; sweating; headaches; Fever; Felt extremely weak; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CHILLS (severe chills), HYPERHIDROSIS (sweating), HEADACHE (headaches), PYREXIA (Fever) and COGNITIVE DISORDER (Started having cognitive problems) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDRALAZINE, TOFACITINIB CITRATE (XELJANZ), SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL and CALCIUM for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 18-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Felt extremely weak). On 01-Apr-2021, the patient experienced CHILLS (severe chills) (seriousness criterion hospitalization), HYPERHIDROSIS (sweating) (seriousness criterion hospitalization), HEADACHE (headaches) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). On 08-Apr-2021, the patient experienced COGNITIVE DISORDER (Started having cognitive problems) (seriousness criterion hospitalization). At the time of the report, CHILLS (severe chills), HYPERHIDROSIS (sweating), HEADACHE (headaches), PYREXIA (Fever), COGNITIVE DISORDER (Started having cognitive problems) and ASTHENIA (Felt extremely weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that the patient became very ill starting around 01-Apr-2021 and had two emergency room visits and was hospitalized. The tests from her hospital visit came back without a specific diagnosis and the doctors did not feel her hospital admittance or symptoms were due to having received the Moderna COVID-19 Vaccine. The reporter felt a possibility, although not officially diagnosed and strictly in his opinion that the patient might have sudden onset of Alzheimer's. The patient was treated with antibiotic starting on 03-Apr-2021 and tylenol. Action taken with mRNA-1273 in response to the events was not applicable. No reported past medical history The patient did not have COVID-19 Based on the current available information and temporal association between the use of the product and the start date of the event of asthenia, a causal relationship cannot be excluded, however based on reporter causality and lack of temporal association the events of chills, fever, headache and hyperhidrosis were assessed as unlikely related; 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 of asthenia, a causal relationship cannot be excluded, however based on reporter causality and lack of temporal association the events of chills, fever, headache and hyperhidrosis were assessed as unlikely related
83 2021-05-19 fatigue, chills Severe weakness, severe fatigue, muscle pain, joint pain, chills, nausea, vomiting
83 2021-05-19 fever Patient presented with fever, shaking, confusion and difficulty speaking
83 2021-05-20 bronchitis, productive cough, nasal congestion, headache, cough Moderna COVID 19 Vaccine EUA Hospitalized for productive cough, weakness and headache. Nasal conges... Read more
Moderna COVID 19 Vaccine EUA Hospitalized for productive cough, weakness and headache. Nasal congestion, hoarse voice. Aches and pains to bilateral lower legs. COVID negative. Dx acute viral bronchitis
83 2021-05-22 fatigue The morning after the vaccine, the patient experience extreme weakness and fatigue. The patient was ... Read more
The morning after the vaccine, the patient experience extreme weakness and fatigue. The patient was unable to move herself and had to have 2 people to assist her to the car. The patient's daughter took her to the emergency room.
83 2021-05-23 fatigue Extreme fatigue, lightheadedness, shortness of breath. Initial onset was rather sudden on 4/29/21 a... Read more
Extreme fatigue, lightheadedness, shortness of breath. Initial onset was rather sudden on 4/29/21 and seen at urgent care without definitive dx and DC'd without treatment and somewhat improved. Health did not resume to normal and deteriorated again with same sx on 5/1/21; presented to UC again and transferred to main ED. Again, DC'd without definitive dx or tx ordered and marginally improved at the time of DC. Sx worsened again prompting another visit to the ED on 5/3/21 and again DC'd without definitive dx or tx.
83 2021-05-27 fatigue, chills Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue.
83 2021-05-27 fever, chills, fatigue Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue. We do not kn... Read more
Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue. We do not know why my platelate count dropped so low. I was not ill before I had the vaccine. I only know that after my reaction to the second Moderna Vaccine, I had side effects and never felt well after the vaccine. My bloodwork done for my Wellness Checkup showed low platelet and as time went by my white count went higher and higher above normal. Weekly bloodwork and testing of my blood showed that "something" caused my platelets to fight, thus dropping my count to a low of 21. What caused the platelets to attack? We will never know. Now, with all the study done by my Oncologist, I am beginning to heal. It all started after my Moderna Vaccine. Do you think that the vaccine may have caused my health issues?
83 2021-05-28 fever I experienced a rash on my whole body, with extreme inflammatory, redness, rash. My skin was all red... Read more
I experienced a rash on my whole body, with extreme inflammatory, redness, rash. My skin was all red over my body, my skin got crusty, ran a fever. The rash was very bad. I felt very sick. I went to see a dermatologist who put me on steroids. The steroids calmed the rash down. And 3 weeks later, same thing happened, my dermatologist again put me on steroids again and it was the same thing that occurred. Then my rash cleared up and then it also happened two more times, but not as severe. I was unable to get my second vaccine, advised from two specialists, two allergists and internists and all advised me not to take the second vaccine. All my blood work came back normal except my IEG was off the chart. I do not have the lot # to provide.
83 2021-05-29 fever, lethargy About 24 hrs after 1st Moderna shot, patient presented with fever to 38.9, confusion , lethargy. Ne... Read more
About 24 hrs after 1st Moderna shot, patient presented with fever to 38.9, confusion , lethargy. Negative infectious workup. Defervesced and mental status returned to baseline after another 48 hours.
83 2021-06-03 dehydration, headache drained fluid off her liver; they thought she was dehydrated; Throwing up; Small headache; Not eatin... Read more
drained fluid off her liver; they thought she was dehydrated; Throwing up; Small headache; Not eating; Not drinking; Not peeing; Sore feet; Sepsis; Death; Screwed up kidneys; Fluid overload; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Death), SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (shoulders and knees), Hypertension, Acid reflux (esophageal), Penicillin allergy, Drug allergy (Lyrica), Drug allergy (cymbalta) and Drug allergy (ibuprofen). Concomitant products included AMLODIPINE for Blood pressure management, AMITRIPTYLINE for Sleep disorder, HYDROCODONE, POTASSIUM and PARACETAMOL (TYLENOL) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DECREASED APPETITE (Not eating) (seriousness criterion hospitalization), FLUID INTAKE REDUCED (Not drinking) (seriousness criterion hospitalization), ANURIA (Not peeing) (seriousness criterion hospitalization), VOMITING (Throwing up) (seriousness criterion hospitalization) and HEADACHE (Small headache) (seriousness criterion hospitalization). In April 2021, the patient experienced RENAL DISORDER (Screwed up kidneys) (seriousness criterion hospitalization prolonged), FLUID OVERLOAD (Fluid overload) (seriousness criterion hospitalization prolonged) and PAIN IN EXTREMITY (Sore feet) (seriousness criterion hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion hospitalization prolonged), LIVER DISORDER (drained fluid off her liver) (seriousness criterion hospitalization) and DEHYDRATION (they thought she was dehydrated) (seriousness criterion hospitalization). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) in May 2021 at a dose of UNK dosage form. The patient died on 21-May-2021. It is unknown if an autopsy was performed. At the time of death, SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood potassium: abnormal (abnormal) abnormal. Additional concomitant products used included a non-specific acid reflux pill. Treatment information includes fluids, medications NOS, diuretic NOS, dialysis, a catheter, duloxetine (Cymbalta) and antibiotics NOS. Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received 25-MAY-2021 included no new information.; Sender's Comments: Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected.
83 2021-06-06 chills, sleepiness, fatigue Chills Jun5,Jun6 and Jun7. Fatigue, sleepy with no energy Jun5 and Jun6.Heavy stiffness and joint p... Read more
Chills Jun5,Jun6 and Jun7. Fatigue, sleepy with no energy Jun5 and Jun6.Heavy stiffness and joint pain in lower back waistline,thighs and legs. Swelling increased in leg foot but lower on Jun7. Arm sore but better Jun7.
83 2021-07-05 pneumonia J18.9 - Pneumonia of right middle lobe due to infectious organism E87.1 - Hyponatremia
83 2021-07-05 respiratory tract congestion Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. T... Read more
Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. The following day the patient complained of SOB and the nursing staff found her O2 sat in the 50 so she was brought to the hospital. She was evaluated at the Hospital and discharged back to nursing facility the same day. Patients daughter brought patient back to facility from hospital. On 07/03 patient complained of congestion but "breathing better". On 07/04, patient stayed in bed all day. RN at facility administered tylenol and a soda and right after administration found the patient unresponsive. Nurse started CPR and 911 was called. EMS used defibrillator until the staff alerted EMS that patient was DNR. Patient passed away in room between 3-4pm.
83 2021-07-13 head discomfort, fatigue sharp pain inleft hand fingers; Left shoulder really hurt; Left arm skin on top was crinkled; Interm... Read more
sharp pain inleft hand fingers; Left shoulder really hurt; Left arm skin on top was crinkled; Intermittent pain in entire left side of body; Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful; Stayed in bed; Unable to go back to sleep/did not sleep well; loss of stamina; Shoulder make grinding sound; Anaphylactic shock; Felt terrible/felt miserable; Soreness; Throat started to swell; Left side of her head felt like a balloon; Felt like she had puffiness on the left side; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy (raw pineapple), Fruit allergy (coconut shredded) and Oil allergy (coconut oil). On 06-Feb-2021 at 6:01 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), FEELING ABNORMAL (Felt terrible/felt miserable), ORAL PAIN (Soreness), PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon), SWELLING FACE (Felt like she had puffiness on the left side), ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and FATIGUE (Extremely tired). On 07-Feb-2021, the patient experienced BED REST (Stayed in bed), INSOMNIA (Unable to go back to sleep/did not sleep well) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful). On 10-Feb-2021, the patient experienced PAIN (Intermittent pain in entire left side of body). On 11-Feb-2021, the patient experienced SKIN WRINKLING (Left arm skin on top was crinkled). On 12-Feb-2021, the patient experienced ARTHRALGIA (Left shoulder really hurt). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sharp pain inleft hand fingers). On 06-Feb-2021, PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon) and SWELLING FACE (Felt like she had puffiness on the left side) had resolved. On 07-Feb-2021, BED REST (Stayed in bed) had resolved. On 12-Feb-2021, FEELING ABNORMAL (Felt terrible/felt miserable), INSOMNIA (Unable to go back to sleep/did not sleep well), PAIN (Intermittent pain in entire left side of body), SKIN WRINKLING (Left arm skin on top was crinkled), ARTHRALGIA (Left shoulder really hurt) and FATIGUE (Extremely tired) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), ORAL PAIN (Soreness) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful) outcome was unknown and ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and PAIN IN EXTREMITY (sharp pain inleft hand fingers) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were not provided. Reduced from dance four lessons consecutively to two lessons consecutively. 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-Jun-2021: Updated Reporter address. Updated patient demographic details such as height, weight, race, ethnic group and Allergies(raw pineapple, coconut shredded, coconut oil). Added new Events like Loss of energy, Shoulder make grinding sound, Anaphylactic shock, Sharp pain in left hand fingers and crunchy sound in left upper shoulder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
83 2021-07-24 fatigue Sore arm, tired
83 2021-07-26 fever, pneumonia SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE... Read more
SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE DAY FOLLOWING THIS PARTY, SHE STARTED TO COMPLAIN ABOUT SHORTNESS OF BREATH AND LEFT PLEURITIC PAIN., FEVER AND POOR PO INTAKE. SHE WAS ADMITTED TO THE HOSPITAL UNTIL JULY 7. SHE WAS DIAGNOSED WITH PNEUMONIA , SEPSIS AND MILD PLUERAL EFFUSION. HER D DIMER WAS ELEVATED AND SHE WAS TREATED WITH LOVENOX FOR SUSPECTED PULMONARY EMBOLISM. DUE TO HER POOR KIDNEY FUNCTION, SHE WAS UNABLE TO GET A CT SCAN WITH CONTRAST TO DETERMINE THE THE SEVERITY OF THIS CLOT. SHE HAS SINCE BEEN DISCHARGED HOME FROM HER REHAB DUE TO NOT BEING ABLE TO PARTICIPATE IN CARE, TO HOSPICE CARE.
84 2021-01-04 headache At 1054 patient c/o headache at a 8/10 on the Wong pain scale, dizziness. BP 159/66, P 57, R 20, SpO... Read more
At 1054 patient c/o headache at a 8/10 on the Wong pain scale, dizziness. BP 159/66, P 57, R 20, SpO2 96%. At 1110 headache 2/10 on pain scale, dizziness gone. BP 150/60, P 52, R 20, SpO2 96%. At 1120 PCP here to assess patient, instructions to return next week to clinic for an office visit. Pt. reports headache gone. At 1122 BP 154/59, P 54 with symptoms still gone.
84 2021-01-08 chills, headache, fatigue Headdache Trembling in the Body Tiredness Chills
84 2021-01-10 fever 1-9-21 fever of 101.0 at 10:18pm and fever on 1/10/21 at 12:16 am
84 2021-01-11 fever PT spouse called to report side effects: Fever 100.9, swelling and bright redness at injection site... Read more
PT spouse called to report side effects: Fever 100.9, swelling and bright redness at injection site 20 minutes after receiving the injection, nausea vomiting, body aches, could not get out of bed for 3 days. All resolved now. (7 days later)
84 2021-01-13 fever, chills Pain on Left side, just below the 12th rib on the back part of body. Fever was 99.6 at 1:30pm 1/14/... Read more
Pain on Left side, just below the 12th rib on the back part of body. Fever was 99.6 at 1:30pm 1/14/21. Feeling chills. Body aches. Arms felt sore.
84 2021-01-18 fatigue, headache, chills Tired, slept 6 hours after getting 1st vaccine dose. Woke up at 6:30 pm 1-17-21 with chills, dull,... Read more
Tired, slept 6 hours after getting 1st vaccine dose. Woke up at 6:30 pm 1-17-21 with chills, dull, headache, very painful right arm difficult to lift, achy joints. took extra strength Tylenol . Back to sleep at 7:00 pm 1-7-21 and slept 4 hours til 11:00 pm. Took another extra strnength Tylenol .slept another 6 hours till 5:30 pm 1-18-21. still having aches in joints , dull headache, temp only 97.5. no chills. took another extra strength Tylenol. Ate breakfast and all symptoms left except very sore arm. Did not expect a reaction with 1st dose. Never have reacted to any vaccine before.
84 2021-01-18 fever, chills Fever Chills Bad arm pain Lasted about 8 hours No treatment subsided after taking Tylenol and resti... Read more
Fever Chills Bad arm pain Lasted about 8 hours No treatment subsided after taking Tylenol and resting
84 2021-01-19 headache Vomiting, head ache, weakness
84 2021-01-20 headache Initially, the first night, my feet felt extreme cold. All over soreness the night of the shot and ... Read more
Initially, the first night, my feet felt extreme cold. All over soreness the night of the shot and all the next day and evening. Headache the night of the shot and all the next day and evening. Aspirin does not touch it. Ear ringing, still. Left calf pain and shooting pain into my left foot. Needless to say, all the above seemingly getting worse into evening of the 2nd day.
84 2021-01-20 headache Day 3: Upset stomach, cramps, nausea, terrible headaches; Took Tylenol for headaches, didn?t help; l... Read more
Day 3: Upset stomach, cramps, nausea, terrible headaches; Took Tylenol for headaches, didn?t help; lasting 3 days so far. Resting and praying symptoms will subside as I have had some flu symptoms with ?Flu vaccine for over Age 65 patients previously, but never the Headaches before! Did not notify Doctor For the first 4 days.
84 2021-01-20 sleepiness, headache Given shot on Monday, January 11, 2021 at 10:15 am . Was fine until 7:30 pm that night. Felt like I... Read more
Given shot on Monday, January 11, 2021 at 10:15 am . Was fine until 7:30 pm that night. Felt like I was drugged and couldn't keep my eyes open. Slept (except for bathroom stops) until 7:30 pm on Tuesday night. Very red and large knot on shot arm. Lasted many days. Very sleepy for days, Dull headaches. Stomach upset. Very foggy thought processes for more than a week. Blurry vision for a few days. Joint pain. Spoke with Moderna and they suggested I talk to my doctor. Doctor told me the side effects would go away within ten days. Most of they did.
84 2021-01-21 body temperature increased, lethargy fever of 101, feels lethargic and no energy
84 2021-01-21 malaise Got sick to her stomach, very weak with dizziness and disoriented like in a fog. No headache, fatig... Read more
Got sick to her stomach, very weak with dizziness and disoriented like in a fog. No headache, fatigue. Not as sick to her stomach, but the weakness is still there and not getting better. Shaking hands. Not able to talk right now due to weakness.
84 2021-01-21 throat irritation throat felt funny, she said it felt strange to swallow and that her head felt funny. Administered 25... Read more
throat felt funny, she said it felt strange to swallow and that her head felt funny. Administered 25mg Benadryl and gave patient water.
84 2021-01-22 headache, fatigue, fever very very colds (covered with 3 blankets), weak (afraid to walk for fear of falling),stomach hurt. n... Read more
very very colds (covered with 3 blankets), weak (afraid to walk for fear of falling),stomach hurt. nausea, headache, left arm (injection site hurt - could not even flush toilet) , headache, I felt like I would be short of breath but never needed to use the emgerency inhaler. Highest fever was 100.1; The entire next day I was very tired but the symptoms seemed to gradually go away.
84 2021-01-23 cough Exactly 12 hours after receiving my vaccination, at 1:30 am, I had a horrific coughing spell that la... Read more
Exactly 12 hours after receiving my vaccination, at 1:30 am, I had a horrific coughing spell that lasted for half an hour. In addition, I had wheezing and a feeling of "bubbles" in my chest. My arm was very hot and tender at the injection site. I slept through the rest of the night but awoke feeling extremely weak and confused. As a result, I spent the day in bed. I had no appetite, as well. The next day, I had coughing bouts off and on and still don't feel myself.
84 2021-01-24 fatigue 8th of January got shot. achy right arm and swollen for week. 24th took shower whole shot area was r... Read more
8th of January got shot. achy right arm and swollen for week. 24th took shower whole shot area was red with rash. could see mark where needle went in. felt tired and arm ached.
84 2021-01-24 fever, headache, chills headache, chills, fever for 3 days
84 2021-01-25 body temperature increased Temperature 101.1 degrees Fahrenheit on 1/18/2021 @ 1:28pm. Tylenol 650mg administered. Orders obtai... Read more
Temperature 101.1 degrees Fahrenheit on 1/18/2021 @ 1:28pm. Tylenol 650mg administered. Orders obtained to admnister one liter of normal saline via intravenous route due to resident's poor oral intake. IV fluids initiated. Temperature 98.9 degrees Fahrenheit on 1/18/2021 @ 4:35. Temperature 101.0 degrees Fahrenheit on 1/18/2021 @ 11:54pm. Cold compresses applied. Temperature 98.8 degrees Fahrenheit on 1/19/2021 @ 12:52am.
84 2021-01-25 chills Patient reports that she had a sore arm. However, the adverse reaction started that evening/early mo... Read more
Patient reports that she had a sore arm. However, the adverse reaction started that evening/early morning of the next day. She woke up itching and chills. She continues to have a few chills every now and then. She is covered in a morbilliform rash sparing hands, feet, and face.
84 2021-01-25 fatigue, chills, cough pt stated that she woke up with left arm throbbing, has chills, was extremely thirsty, very fatigued... Read more
pt stated that she woke up with left arm throbbing, has chills, was extremely thirsty, very fatigued, has cough and nausea with no appetite. Pt states she is not sure if she has a temp but took 500 mg Tylenol at 3:00AM. Pt will contact PCP for medical advice.
84 2021-01-27 chills, headache Light headedness & slight headache followed by rash on hands and feet and thighs, then hands and fee... Read more
Light headedness & slight headache followed by rash on hands and feet and thighs, then hands and feet turned beet red and swelled, uncontrolled shaking and chills. Went to emergency clinic and was given a steroid injection. Within an hour symptoms began dissipating.
84 2021-01-27 fatigue, headache fatigue, hot flashes, minor headaches - no treatments
84 2021-01-28 headache 30 minutes after vaccine, headache and dizziness, achy, shortness of breath
84 2021-01-29 fatigue, fever The next day: aches, fatigue, low grade fever. The following day: awoke with red, puffy, itchy eyes,... Read more
The next day: aches, fatigue, low grade fever. The following day: awoke with red, puffy, itchy eyes, extreme itching on both arms.
84 2021-01-30 headache, runny nose, fatigue, sneezing First day, Saturday evening: headache and feeling quite tired by 8:00pm. Sunday evening, Jan 24: ... Read more
First day, Saturday evening: headache and feeling quite tired by 8:00pm. Sunday evening, Jan 24: A strange short period of sneezing with runny nose for about one hour and also left arm shot site was sore and tender. Monday, January 25 lump at shot site that was tender; Tuesday, January 26, lump was gone; Wednesday, January 27 felt chilled to the bone and could not get warm. Thereafter no side affects.
84 2021-01-31 malaise, body temperature increased She developed temperature of 103 degrees, malaise, general weakness, and change in level of consciou... Read more
She developed temperature of 103 degrees, malaise, general weakness, and change in level of consciousness. Physician ordered her to be sent to the ER
84 2021-02-04 chills, nasopharyngitis, sweating, fatigue Cold and shivering, painful arm, tiredness, nauseated, sweating. The next day she felt better but ha... Read more
Cold and shivering, painful arm, tiredness, nauseated, sweating. The next day she felt better but had no appetite.
84 2021-02-04 fatigue, fever, headache Nausea, hadache,low fever (100.9) deep fatigue - Slept 16 hours of last 25 hours. Still have slight... Read more
Nausea, hadache,low fever (100.9) deep fatigue - Slept 16 hours of last 25 hours. Still have slight fever -99.8
84 2021-02-04 headache, fatigue, chills Nausea the next day which persisted with vomiting 48 hours later, nausea resolved Headache, dizzine... Read more
Nausea the next day which persisted with vomiting 48 hours later, nausea resolved Headache, dizziness, fatigue, arthralgia, chills but no fever began approx 16 hours after vaccine and persisted for 4-5 days in "waves" (described by patient) Sore arm for couple days.
84 2021-02-05 fever, fatigue, sleepiness No adverse reactions observed until 12th Day. On 12 th day 1/31/21, Started becoming very Sleepy , ... Read more
No adverse reactions observed until 12th Day. On 12 th day 1/31/21, Started becoming very Sleepy , Tired . Two days later brought attention brought to caregiver for Fever, (showed 99.3) feeling very Cold - 3 blankets. Hello pee. No appetite. Just wanted to sleep like very Fatigued. 2/5/21 - Temps 101.9 - Gave 1 Tylenol 500mg tab. Fever down after 4 hours. Stayed down. 2/6/21 - 99.7 at 3 pm. Should I take to the Urgent Care if temp goes up???? I can't get to her doctor. No RESPONSE
84 2021-02-06 malaise no treatments at present Insomnia, weakness, muscle aches all over, discomfort in left side of chest... Read more
no treatments at present Insomnia, weakness, muscle aches all over, discomfort in left side of chest, just did not feel well, all happened within 48 hours
84 2021-02-07 headache C/o generalized weakness/dizziness/headache after receiving vaccine. Was seen in the ED on 1/6/21. ... Read more
C/o generalized weakness/dizziness/headache after receiving vaccine. Was seen in the ED on 1/6/21. Feeling weak and unable to stand up. ER labs unremarkable. Admitted to hospital. After received Azithromycin and Rocephin patientt reports feeling much better. Following day reports feeling symptom free.
84 2021-02-07 sleepiness I was very weak and I nervous like shaking and very sleepy it just lasted about 1 day. When I woke u... Read more
I was very weak and I nervous like shaking and very sleepy it just lasted about 1 day. When I woke up this morning I was feeling okay.
84 2021-02-08 headache CONFUSED, HEADACHE, PRONOUNCED WEAKNESS--UNABLE TO STAND OR SIT PROPPED UP FOR 5 DAYS, LOW O2 SATURA... Read more
CONFUSED, HEADACHE, PRONOUNCED WEAKNESS--UNABLE TO STAND OR SIT PROPPED UP FOR 5 DAYS, LOW O2 SATURATION, HIGH BLOOD PRESSURE
84 2021-02-09 chills, headache 1/27/21 developed dime sized redness and soreness in arm. the next day was 2 inches the next day was... Read more
1/27/21 developed dime sized redness and soreness in arm. the next day was 2 inches the next day was 4 inches across and swollen and warm. Pt also having difficulty breathing, Went to Doctor and ER due to breathing distress. Was monitored but not admitted. Still continues to experience headaches, chills, and an increase in salivary secretions.
84 2021-02-09 headache, fatigue Started on Jan 24 or 25-Extreme fatigue, sleeping til late in afternoon,, unable to get out of bed,,... Read more
Started on Jan 24 or 25-Extreme fatigue, sleeping til late in afternoon,, unable to get out of bed,, headache, just didn't feel right. Went to primary doctor office on 29th. Ran every blood test, ekg and chest xray-mostly normal except orthostatic hypertension. Told to increase fluids. Felt a little better over the next week then same symptoms again Feb 4 and 5th. Took to ER had a seizure and vomiting. CT showed a Stoke and am currently in hospital.
84 2021-02-12 chills I received my first Moderna Vaccine Dose 1 on Saturday, January 30, 2021 at the Clinic at/or around ... Read more
I received my first Moderna Vaccine Dose 1 on Saturday, January 30, 2021 at the Clinic at/or around seven thirty p.m. Initially there were no after effects. On or about February 4th/5th I began experiencing mild chills. Nothing to go to bed for, but noticeable. And a day or so later I broke out in a mild rash ? from my upper chest, upper arms and pelvic area ? again nothing to go to bed for.
84 2021-02-12 fatigue, malaise, fever, headache Began around 3 am: significant all over joint pains, headache, temp., fatigue and general malaise. B... Read more
Began around 3 am: significant all over joint pains, headache, temp., fatigue and general malaise. Basically couldn't get out of bed for about 28 hours
84 2021-02-15 headache fell & hit head, +HA, lost vision left eye x 20mins, +weak
84 2021-02-15 malaise Patient developed, malaise, dizziness and acute right lower quadrant abdominal pain which is now int... Read more
Patient developed, malaise, dizziness and acute right lower quadrant abdominal pain which is now intermittent.
84 2021-02-16 body temperature increased temp to 102 severe back and hip pain obtunded
84 2021-02-16 fever Patient reports her symptoms started on 2/16/2021 with fevers, generalized weakness, mild disorienta... Read more
Patient reports her symptoms started on 2/16/2021 with fevers, generalized weakness, mild disorientation, and dizziness when she presented to the ER.
84 2021-02-17 fatigue The morning after vaccination, she felt extremely and unusually fatigued. After getting up from bed... Read more
The morning after vaccination, she felt extremely and unusually fatigued. After getting up from bed and eating her usual breakfast, she was returning to her bedroom when she became dizzy and fainted, falling to the floor, hitting her head and suffering other effects, including rhabdomyolysis from being on the floor for a long time after the fall as she was unable to get up. She was transported to the ER and was admitted to the hospital for 3 days. She was treated with IV fluids, Tylenol and a short course of antibiotics. While hospitalized, she had a repeat of a rash/swelling at injection site that began about 48 hours after vaccination. The hospital treated the rash with some barrier cream and within 48, the redness, rash and swelling abated.
84 2021-02-18 chills Chills.aches allover. Vomiting although I had only taken metimucil. Arm extremely sore! Dr. told me ... Read more
Chills.aches allover. Vomiting although I had only taken metimucil. Arm extremely sore! Dr. told me it was because I had covid19 90 days before. This continued for 24 hrs, except for vomiting. That stopped after first day. Arm sore for a week!!
84 2021-02-20 chills, fever, headache, fatigue Chills, low grade fever, body aches, headache, extreme fatigue, nausea
84 2021-02-21 body temperature increased T. 99.8
84 2021-02-21 headache, fatigue Pt stated that the evening of getting 2nd dose of Covid vaccine she began to have "charlie horses" a... Read more
Pt stated that the evening of getting 2nd dose of Covid vaccine she began to have "charlie horses" and stated she had involuntary shaking in her legs. Pt then stated she had a severe HA. Some body aches, upset stomach. Day after episode was "doing much better" and symptoms had resolved except for some mild fatigue.
84 2021-02-21 lethargy : Spoke w/ pt. who stated she recd her 1st covid vaccine 2.5 wks ago, Pharmacy, Moderna. At that ti... Read more
: Spoke w/ pt. who stated she recd her 1st covid vaccine 2.5 wks ago, Pharmacy, Moderna. At that time, she noted lethargy as her only SE, and mild redness at vaccination site. Now, however, there is a "4inch x 2 inch circle" around her left deltoid, and it is "blotchy inside the ring". She denies chills, fever, arthralgias, SOB, palpitations, urticaria. When she contacted pharmacy's she was advised to call her PCP.
84 2021-02-22 chills chills and very achy for about 24 hours
84 2021-02-22 lethargy Hospice patient with multiple comorbidities. Within hours of injection became lethargic and unrespon... Read more
Hospice patient with multiple comorbidities. Within hours of injection became lethargic and unresponsive, she remained in this state for 3 days.
84 2021-02-22 pneumonia patient developed pneumonia day after vaccination
84 2021-02-22 fever fever
84 2021-02-23 fatigue, headache Covid Arm ( itching/red/swollen) after one week. Headache for three days and nausea after shot. Fati... Read more
Covid Arm ( itching/red/swollen) after one week. Headache for three days and nausea after shot. Fatigue. Bizarre dreams
84 2021-02-23 sweating, chills, sleepiness 11PM CHILLS,TEETH CHATTERING, BODY SHAKING, NAUSEA. APPROX 2-3 AM 2/18/21 ON WAY TO THE BATHROOM L... Read more
11PM CHILLS,TEETH CHATTERING, BODY SHAKING, NAUSEA. APPROX 2-3 AM 2/18/21 ON WAY TO THE BATHROOM LOSS OF CONSCIOUNESS-FELL HIT HEAD, PASSED OUT 2 X MORE. PARAMEDICS CALLED ADMITTED TO HOSPITAL EEG, CAT SCAN, NO FEVER, CHILLS 4-5AM SWEATING PROFUSLY, LOW BP, POSTURAL HYPOTENSION, DISCHARGE FRIDAY 2/19/2021 . SATURDAY 2/20/2021 HIGH BP > 170. BP CURRENTLY UNSTABLE HIGH AND LOW
84 2021-02-23 throat pain Face swelling, chest pain, arms and legs swelling and aching, sore throat
84 2021-02-23 fever, malaise Swollen, Itchy arm for three days, first night I kept getting up to Pee and the next day I slept the... Read more
Swollen, Itchy arm for three days, first night I kept getting up to Pee and the next day I slept the entire day. My second shot, same reaction, but still do not feel well. Also had temperature of 100 both shots
84 2021-02-23 fever Fever, loss of appetite, mental confusion, weakness
84 2021-02-24 headache PT RECEIVED THE MODERNA VACCINE FOR COVID19 ON MONDAY FEBRUARY 22. SHE STATED THAT AT NIGHT SHE STAR... Read more
PT RECEIVED THE MODERNA VACCINE FOR COVID19 ON MONDAY FEBRUARY 22. SHE STATED THAT AT NIGHT SHE STARTED WITH NAUSEA AND HEADACHES. TUESDAY MORNING AROUND 3:00AM SHE STARTED WITH RASH THAT STARTED AT FEET AND STARTED GOING UPWARDS THE ENTIRE BODY BY WEDNESDAY.
84 2021-02-26 fatigue Sharp pains in left hip and down leg?can?t step on left leg, dizziness, fatigue
84 2021-02-27 headache, fever, chills shortness of breath and n burning in center of chest. Like Lungs were hot. Call to Nurse Pract. rec... Read more
shortness of breath and n burning in center of chest. Like Lungs were hot. Call to Nurse Pract. recommended I go to Emergency room as could be heart attack. Went to Medical Center Emergency Dept as recommended. Took vitals and waited for additional tests. arrrived at Emergency Room of Medical CEnter
84 2021-03-01 chills, fatigue Extreme fatigue, spinal joint pain, muscle aches, foggy brain and chills but no fever. The spinal jo... Read more
Extreme fatigue, spinal joint pain, muscle aches, foggy brain and chills but no fever. The spinal joint pain began in my sacral area and over the next 4 days migrated up to the low back, then to the rib cage, then to the neck. Muscle relaxants were ineffective. Oral steroid decreased the joint pain over a 5 day period.
84 2021-03-01 fever Had Moderna vaccine dose 1 on 2/18/21. 1 week later on 2/25 she stated her injection site had rednes... Read more
Had Moderna vaccine dose 1 on 2/18/21. 1 week later on 2/25 she stated her injection site had redness, swelling and was feverish. Injection site redness has spread out about 6 inches but is improving now on 3/2/21.
84 2021-03-02 fatigue, headache Day 2 (Saturday)- Dizziness & severe nausea beginning early AM. Other symptoms include arm pain, jo... Read more
Day 2 (Saturday)- Dizziness & severe nausea beginning early AM. Other symptoms include arm pain, joint pain, severe headache, pronounced fatigue. Symptoms persisted 3-4 days. ZOFRAN ordered by PCP on day 2 due to vomiting with 1st shot. 3 doses zofran taken total, day 2 & 3. Tylenol taken for headache, & joint pain x 2 doses on day 2. All symptoms resolved by day 4 except for occasional dizziness. "Patient states does not take medicine well. Patient states symptoms started sooner and were worse than 1st shot." Day 4-6 arm itchy.
84 2021-03-02 fever, fatigue, chills Pt stated that after she received the COVID-19 vax she had pain in her left arm. She started having ... Read more
Pt stated that after she received the COVID-19 vax she had pain in her left arm. She started having swelling, redness, chills, muscle aches, pains, fever (99.3), SOB, and fatigue. Her SOB is requiring her use more O2 than normal. Today she still has swelling, redness and soreness around the injection site that is worse than on the first day. Her PCP came to see her yesterday on 3/2/2021 and they told her that her symptoms meant that her immune system was working. Care giver would recommend her to go to the ER if her symptoms persisted.
84 2021-03-03 fatigue Son/caregiver called to report patient was experiencing a decreased mental acuity accompanied with f... Read more
Son/caregiver called to report patient was experiencing a decreased mental acuity accompanied with fatigue and loss of appetite after receiving her 2nd dose of Moderna Covid 19 vaccine since Febuary 27th, 2021. Son describer the symptoms as progressive starting after receiving the vaccine. It was recommend the patient's primary care provider be contacted to receive further advice.
84 2021-03-04 fatigue, sleepiness I am 84 /received the first vaccine on 2/23/21 about 8 hrs. later I got up to help my husband who ... Read more
I am 84 /received the first vaccine on 2/23/21 about 8 hrs. later I got up to help my husband who had a cramp in his foot. I very suddenly became light-headed and felt like I could pass out . I sat down on a chest and put my head down on the foot of the bed and hoped it would pass. About a minute later I became very nauseated and thought I would vomit. I waited about 15 min and did not do so. I went back to bed and stayed quiet for the rest of the night. The 24th I was extremely tired and slept most of the day. When I did get up briefly I ached all over. This gradually ceased by the next day. These symptoms did not return. I am very active and know no other reasons for the reaction.
84 2021-03-04 headache Woke up at 1:30am feeling weird. Experienced Weakness, body shakiness, inability to move lower extre... Read more
Woke up at 1:30am feeling weird. Experienced Weakness, body shakiness, inability to move lower extremities (legs), super weak as in can?t put one leg in front of the other, headache from 1:30am- 11pm on 3/4/21. ?Feels like a spike being driven into the heels of my feet up to my knees where my legs would jump?, pain persisted off and on for entirety of the night. Loss of appetite. Still experiencing some weakness and shakiness.
84 2021-03-04 fever, chills fever, chills, myalgias
84 2021-03-04 sleepiness, fever fever, unable to get up, incontinence, achy, drowsy, un able to eat.
84 2021-03-04 throat clearing, cough During monitoring period, client started coughing and having to clear throat, then possible itching ... Read more
During monitoring period, client started coughing and having to clear throat, then possible itching in throat, PO benadryl given
84 2021-03-05 fever, chills, fatigue, headache, throat pain Fever at 100.6F, Headache, Chills, Sore throats, tiredness.
84 2021-03-07 chills, fever Had chills, fever, nausea and vomiting for several hours on March 7, 2021 No apetite but did drink w... Read more
Had chills, fever, nausea and vomiting for several hours on March 7, 2021 No apetite but did drink water. No treatment. Recoveered in the evening.
84 2021-03-08 cough Patient recieved her first dose of Moderna vaccine today at 1033 am , Patient start coughing around... Read more
Patient recieved her first dose of Moderna vaccine today at 1033 am , Patient start coughing around 1048 am after her fifteen minutes wait expired. Daughter stated her mother do cough at times because of difficulty swallowing. Patient alert no other symptoms. nurse alert called at 1051 am. Nurse alert team arrived at 105 2am and assessed patient . Plan to monitor for an additional 15 minutes. Observed patient for an additional 15 minutes, no coughing her difficulty of breathing noted or any other reactions. Patient stable upon leaving the department at 1105 am via wheelchair with her daughter.
84 2021-03-08 sweating, chills 2/17/2021-3/7/2021 nighttime shaking, profuse sweating, achiness; daytime chills, shaking, and some... Read more
2/17/2021-3/7/2021 nighttime shaking, profuse sweating, achiness; daytime chills, shaking, and some sweating
84 2021-03-08 fever, fatigue, chills Chills, Feverish and fatigued for 2 days only. Arm hurt from shoulder to wrist, large red spot siz... Read more
Chills, Feverish and fatigued for 2 days only. Arm hurt from shoulder to wrist, large red spot size of a tennis ball at injection site . Slightly swollen and warm to the touch.
84 2021-03-12 fever woke during night with a slight fever (100) achy joints and nausea. got worse as morning wore on.... Read more
woke during night with a slight fever (100) achy joints and nausea. got worse as morning wore on. couldn't eat, but was able to drink fluids. about 6PM was able to eat yougut. Temperature was normal. Slept well that night/ Woke today and feel ok able to eat breakfast.
84 2021-03-14 fatigue, headache Lips and tongue stuck together due to dry mouth; feel like autoimmune disease flared up; Both arms w... Read more
Lips and tongue stuck together due to dry mouth; feel like autoimmune disease flared up; Both arms were sore; The back of her head ached; upper back hurt; Felt wiped out; A Spontaneous report, was received from a consumer concerning a 84-year- old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced fell like autoimmune flared up (autoimmune disorder), back of her head ached (headache), both arms were sore (limb discomfort), her upper back hurt (back pain), wiped out (fatigue) and extreme dry mouth. Patient's medical history included Sjogren's syndrome, Autoimmune thyroiditis. On 04 Feb 2021, the patient got the first dose of mRNA-1273 (Lot number: 016M20A) intramuscular upper arm location injection prophylaxis for COVID-19 infection. After 8 hours of receiving the first dose she felt like her autoimmune disease flared up, both of her arm were sored, the back of her head ached, her upper back hurt. She felt wiped out and went to bed much earlier than she normally does. The next day, her mouth was extremely dry, her lips and tongue was stuck together (due to the dry mouth). She did not take anything to alleviate the symptoms. She has not called her healthcare provider. Consent was given for safety to follow up. The action taken for fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown. The outcome for the events fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme 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 the event (pain in extremity, headache, back pain, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the event-Autoimmune disorder has been provided. The subject's history of Sjogren's syndrome may remain a risk factor for dry mouth. Further information has been requested.
84 2021-03-14 fatigue pt states that 5 days after getting the vax she had brain fog and fatigue. She also developed a 6x4... Read more
pt states that 5 days after getting the vax she had brain fog and fatigue. She also developed a 6x4 red, hot, itchy hives arounds the injection site. She stated she had an AFIB event that started up this same day. She has had this before but has not been a problem until this day. Pt is using Goldbond itching cream and Benadryl. Pt will contact her PCP about the AFIB event. Pt still has some redness and itchiness of the arm. The brain fog and fatigue is gone but she still has some AFIB going on.
84 2021-03-15 fever, chills She received the vaccine and got chills, freezing all the way through her. She could not get warm, ... Read more
She received the vaccine and got chills, freezing all the way through her. She could not get warm, two blankets on her and a heated seat, and a microwave heating thing on her chest and stomach that lasted for about 45 minutes. Later she started to get up and her legs would not work, they gave out. She does use a walker and not able to walk. She called 9-1-1 and they informed her that they felt that it was due to the vaccine, and helped her to get up and made sure she was able to use the walker, and informed her to have somebody check on her periodically to make sure that she was okay. She did have soreness at the injection site, running a small fever, but nothing that was too bad.
84 2021-03-18 headache 2/23/21 84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m... Read more
2/23/21 84 y.o. female who presents with complaint of syncopal episode that happened about 6:30 p.m.. Patient was working with a family member to has across the street for a visit when she started feeling dizzy with unsteady gait and shortly after passed out and was cut by the family member. Family member says she was out for about 10 min and then came around. The patient complained of some headache but denies chest pain, nausea vomiting, abdominal pain, cough or shortness of breath. Patient has not been eating or drinking because she has and lost some. Has some food after this episode but was brought in because of continued dizziness. 3/15/21 84 y.o. female who presents with a skin tear on the left forearm and abrasion on the left temporal area after she tripped at home prior to arrival. Patient states she has mobility issues and normally uses a walker but she did not. Patient is on home oxygen. Patient denies loss of consciousness or neck pain but is on Eliquis due to atrial fibrillation and stroke. She does have a pacemaker. Patient denies any other injuries..
84 2021-03-18 lethargy, malaise 03/02/21 the patient was visited by nurse. No signs of distress. Normal vitals. No GI concerns accor... Read more
03/02/21 the patient was visited by nurse. No signs of distress. Normal vitals. No GI concerns according to staff. Her appetite was her usual described as fair. She received her 2nd Moderna vaccination on 03/08/21. Within hour she because very ill according to facility staff. She began to vomit up to 5 times. Her stools because loose. She became more lethargic. She was started on compazine for the vomiting. Her oral intake was minimal. Her symptoms did not resolve and she was visited by the nurse again on 03/11/2021 where she was not very responsive. Her vitals included an irregular pulse and apnea noted in her breathing up to 15 seconds. She died on 03/12/21
84 2021-03-20 chills, sleepiness Moderna Covid vaccine at 10:30 AM and by 8:30 PM she had chills, and difficulty staying awake. Went ... Read more
Moderna Covid vaccine at 10:30 AM and by 8:30 PM she had chills, and difficulty staying awake. Went to ER the next day. Admitted for 26 hours with orthostatic hypotension, due to COVID vaccine.
84 2021-03-21 sleepiness about an hr or so after inj.....severe hand/arm tremors followed by complete incoherence,,, muscles... Read more
about an hr or so after inj.....severe hand/arm tremors followed by complete incoherence,,, muscles like jelly, no use of anything. this total out of it occurence lasted about 12 hrs followed by days of weakness, achy, sleepiness, off and on foggy. general blah feeling
84 2021-03-23 chills Having prolonged pain in neck- Left- with vertigo whenever I get up falling to the left. Very unsta... Read more
Having prolonged pain in neck- Left- with vertigo whenever I get up falling to the left. Very unstable. Chills every day beginning around noon, lasting until around 5pm. whole body shakes. Wondering if this is going to be lasting for a short time?
84 2021-03-24 fatigue, headache Morning after 2nd shot felt great deal of fatigue, to the point of returning to bed. Spent rest of d... Read more
Morning after 2nd shot felt great deal of fatigue, to the point of returning to bed. Spent rest of day on couch with no strength. Beginning of front of head headache. This headache has continued to this day, also some visual blurring. Fuzzy head thinking feeling. These conditions are on going as of today 03/25/2021.
84 2021-03-24 fatigue Diarrhea, fatigue, and confusion starting 3/24/21 with normal blood sugar levels (132). Morning of 3... Read more
Diarrhea, fatigue, and confusion starting 3/24/21 with normal blood sugar levels (132). Morning of 3/25/21 pt disoriented, confused, fatigued (can't stay awake), dizzy, and has vomiting and diarrhea. No fever.
84 2021-03-26 fatigue I am 84 /received the first vaccine on 2/23/21 about 8 hrs. later I got up to help my husband who ... Read more
I am 84 /received the first vaccine on 2/23/21 about 8 hrs. later I got up to help my husband who had a cramp in his foot. I very suddenly became light-headed and felt like I could pass out . I sat down on a chest and put my head down on the foot of the bed and hoped it would pass. About a minute later I became very nauseated and thought I would vomit. I waited about 15 min and did not do so. I went back to bed and stayed quiet for the rest of the night. The 24th I was extremely tired and slept most of the day. When I did get up briefly I ached all over. This gradually ceased by the next day. These symptoms did not return. I am very active and know no other reasons for the reaction.
84 2021-03-27 fatigue, headache Vomiting (5 episodes), body aches and pains, severe headache, extreme weakness and fatigue. Vomiting... Read more
Vomiting (5 episodes), body aches and pains, severe headache, extreme weakness and fatigue. Vomiting lasted about five hours, body aches and headache for 36 hours. Weakness and fatigue for almost five weeks.
84 2021-03-27 headache, fatigue I noticed significant swelling and increased pain at the injection site when I went to bed. (The del... Read more
I noticed significant swelling and increased pain at the injection site when I went to bed. (The deltoid area had swollen a bit by the first night after injection, so this was the second night. ) I took an OTC sleep aid (50 mg diphenhydramine) and drifted off by 1 am. At 3 am I awoke, whether due to my usual polynocturia or the vaccination reaction I can't say. My upper body, especially my arms and hands, was violently shaking and I had a blinding headache--and likely a fever, too. After that, I awoke at 4, 5, 7 and 8 am, during which time the shaking and headache subsided. I was very tired and my whole body was sore, so I went back to bed and slept until 10 am. By midafternoon, I was back to normal.
84 2021-03-28 fatigue on and off dizziness, brainfog and nausea, continuous weakness and fatigue, sometimes incapacitatin... Read more
on and off dizziness, brainfog and nausea, continuous weakness and fatigue, sometimes incapacitating, varying in duration and severity, continuing to present, 3/29/21
84 2021-03-30 fever Felt like she was paralyzed; Could not move or lift arm; Weak; Fever of 100.4; A spontaneous report ... Read more
Felt like she was paralyzed; Could not move or lift arm; Weak; Fever of 100.4; A spontaneous report was received from a consumer concerning a 84-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt like she was paralyzed, could not move or lift arm, fever of 100.4, and weak. The patient's medical history mentions COVID-19 in Dec 2020 and blood pressure. Concomitant medications provided were blood pressure medicine NOS and vitamins. On 09 Mar 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 030a21a) intramuscularly for prophylaxis of COVID-19 infection. On 09 Mar 2021, patient stated she had a bad reaction. Patient stated it felt like she was paralyzed, and she could not move or lift arm. Patient stated she had a fever of 100.4 and weak . The event, felt like she was paralyzed was deemed medically significant. Treatment information was not provided. Lab tests were not provided. Action taken with respect to mRNA-1273 was not reported. The outcome of the events, felt like she was paralyzed, could not move or lift arm, fever of 100.4 and weak 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.
84 2021-03-30 sleepiness, fatigue Patient felt extremely tired following the COVID-19 vaccine. Patient showed no concerning signs/symp... Read more
Patient felt extremely tired following the COVID-19 vaccine. Patient showed no concerning signs/symptoms until the daughter tried to bring the client out to the car, and the patient exhibited rapid-onset somnolence while walking. Patient was brought back into the vaccination clinic to be monitored further. Juice and water given to the patient, patient able to swallow. EMS called to evaluate the client. EMS determined a need for the patient to seek hospital care, but the patient's daughter refused and signed an AMA waiver. Patient and family left the facility against medical advice.
84 2021-03-31 chills, fever respiratory type thing; dizziness; postpone second shot; fever; chills; A spontaneous report was rec... Read more
respiratory type thing; dizziness; postpone second shot; fever; chills; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizziness, fever, respiratory infection and had to postpone second shot schedule. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date after first dose vaccination, the patient experienced chills, dizziness, fever and respiratoryinfection for which she received antibiotics from ER visit. She had to postpone second shot schedule. Treatment information included as antibiotics. Action taken with mRNA-1273 in response to the events was not reported. The outcome of all events was not recovered and for missed dose recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
84 2021-03-31 fatigue small amount of tireness at 2nd day. Tiredness increassing and then decreasing on 3rd day.Itching a... Read more
small amount of tireness at 2nd day. Tiredness increassing and then decreasing on 3rd day.Itching and swelling on 3rd day. Redness at site and beyond, gradually migrating down upper arm. Still migrating downward but not outward on 7th day. Treated with benydryl, tylenol, added antibiotic 2x day on 7th day.
84 2021-04-04 malaise Patient fully recovered from natural SARS-COV-2 infection in early December 2020. Patient was doing... Read more
Patient fully recovered from natural SARS-COV-2 infection in early December 2020. Patient was doing quite well between mid December and mid January. Patient was hospitalized with congestive heart failure in late January 2021. Received first dose of Moderna COVID19 vaccine shortly before being discharged around February 1 (not sure of exact date). Patient was feeling well at that time. Patient became quite ill within 24 hours of Moderna COVID19 vaccine. Patient steadily worsened during February 2021. Was hospitalized in mid February (unsure of date) and diagnosed with kidney failure and liver disease. Congestive heart failure rapidly worsened and previously stable leukemia flared up. Patient was discharged from hospital February 19 and was placed in quarantine at Care Center. Patient was considered terminal and was to go into hospice care. Patient was administered second COVID19 vaccine on February 25, rapidly deteriorated, and died on March 1.
84 2021-04-04 fever, headache, chills On Saturday March 27,2021 the patient was fine on the actual day of second shot which she received a... Read more
On Saturday March 27,2021 the patient was fine on the actual day of second shot which she received at approximately 11:30am. The next day she had a fever of 102, chills, body aches, and severe headache. Tylenol was given with little relief. Symptoms persisted until Monday morning and she reported feeling ?much better.? On Tuesday 3-30-21 at about 3pm she passed out n was taken to an urgent care center where a CT scan of the head was done and was negative. She was discharged to home. The next morning she felt ok but as the day went on she developed facial drooping and slurred speech. She was taken back to the ER and admitted where she remains. An MRI confirmed an ischemic stroke on 4-1 -2021
84 2021-04-06 respiratory tract congestion, sweating, fever Patient's provider states patient experienced after her first Moderna vaccine, fever, her oxygen lev... Read more
Patient's provider states patient experienced after her first Moderna vaccine, fever, her oxygen levels went down, she sweated profusely, her eyes were rolling out, she was also congested and had gurgling sounds and started foaming at the mouth. Hospice care and Medical workers came through to help. X-rays were performed along CT scans of the brain and lungs at Hospital. X-rays of the chest showed ammonia and with lab work performed showed she also had an UTI infection. A Covid test was done which was negative. She was given Tylenol at Hospice Care. After her second dose she also went through the same symptoms but overall is doing well now and is stabilized.
84 2021-04-07 fatigue 4/8/21 Call from case to the Health Department to report symptoms she believes resulted from first C... Read more
4/8/21 Call from case to the Health Department to report symptoms she believes resulted from first COVID vaccination last week. Case states that she was vaccinated on 4/1/21 with the first dose of Moderna. She states that the next day on 4/2/21 she developed nausea and fatigue. She felt better on 4/3/21. On 4/4/21 she went to a family celebration of a holiday and the fatigue and nausea resumed. The nausea and fatigue have continued to this day. She states she has an appointment made with her PCP for 4/12/21. The case states that she is recently returned home. She flew back home on 3/31/21. RN encouraged case to follow up with physician to report continued symptoms and to see if she can be seen sooner. RN also encouraged her to talk with physician about whether they feel she should be tested for COVID. Case agreed and will follow up with physician.
84 2021-04-08 fever, cough, headache, chills Severe headache, chills and fever, very weak,dizzy, cough, and water diarrhea, nausea no vomiting.
84 2021-04-10 fever Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and... Read more
Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clot in lung) and DYSPNOEA (Difficult breathing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Hypertension. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood clot in lung) (seriousness criteria hospitalization and medically significant) and PYREXIA (fever). At the time of the report, PULMONARY EMBOLISM (Blood clot in lung), DYSPNOEA (Difficult breathing) and PYREXIA (fever) outcome was unknown. Treatment details included Heparin, Xarelto. Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine
84 2021-04-12 body temperature increased Red, sore injection site, large lump forv5 days Nausea for 14 days- helped by ginger tea and chicke... Read more
Red, sore injection site, large lump forv5 days Nausea for 14 days- helped by ginger tea and chicken soup 101.2 Oral temp for 2 days followed by temp 99.4-99.7 for 7 days Back and leg pains in both legs caused great difficulty in walking for v3 days, back pain Weight loss- 4-5 lbs
84 2021-04-12 headache arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,tee... Read more
arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,teeth hurt, tightmess in chest, felt like throat was closing up. That lasted for 4 hours, I took an asperin finally, and it started to subside,
84 2021-04-15 fatigue hemoglobin levels were dropping – it was a 4 when it should be a 14; Body started bruising - starte... Read more
hemoglobin levels were dropping – it was a 4 when it should be a 14; Body started bruising - started on her legs and then spread to other locations; she was bleeding everywhere on her body; experienced a little bit of shortness of breath; got tired very easily; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Scoliosis and Sciatica. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily). On 03-Mar-2021, the patient experienced INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) (seriousness criteria hospitalization and medically significant). On 28-Mar-2021, the patient experienced HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14) (seriousness criterion hospitalization) and HAEMORRHAGE (she was bleeding everywhere on her body) (seriousness criterion medically significant). At the time of the report, HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) had not resolved and DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After a few days, her body started bruising. It started on her legs and then spread to other locations. On 28-Mar-2021, she went into the hospital because of the bruising that kept expanding. The doctor there said that her hemoglobin levels were dropping – it was a 4 when it should be a 14. They did a couple of transfusions and discharge her on 30-Mar-2021. On 02-Apr-2021, she had to go back to the hospital, she had bruising on her hands, feet, and arms. Doctor told them that it was that her blood was thinning and that she was bleeding everywhere on her body. She was still at the hospital. They also said that it looked like her body was fighting the treatments - producing antibodies against them. They gave her plasma and steroids. They also did every test possible, CT scans, and the doctors still dis not know what is causing it. Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-071592 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded.
84 2021-04-17 pneumonia My mother died in the hospital after being in the ICU for a week with severe breathing problems. He... Read more
My mother died in the hospital after being in the ICU for a week with severe breathing problems. Her symptoms matched that of a Covid patient but she tested negative for Covid twice (once was the 24 hour test).
84 2021-04-20 throat pain Extreme sore throat on Saturday (two days after the shot). AS of today (4/21/21) her throat doesn'... Read more
Extreme sore throat on Saturday (two days after the shot). AS of today (4/21/21) her throat doesn't hurt doing the day but hurts at night. Patient has an appointment with her physician on 4/22/21 (was already scheduled).
84 2021-04-20 fever Resident complained of weakness, low grade fever, and tachycardiac which led to a fall with a fractu... Read more
Resident complained of weakness, low grade fever, and tachycardiac which led to a fall with a fracture of her tib/fib. Has not returned to baseline.
84 2021-04-20 sinusitis, headache, malaise Sinus infection got worse; Headache; Lost hearing; Had bothering tinnitus; All her body feels sick; ... Read more
Sinus infection got worse; Headache; Lost hearing; Had bothering tinnitus; All her body feels sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost hearing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Allergy (Allergy to Vaccine NOS). Concurrent medical conditions included Diabetes. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), TINNITUS (Had bothering tinnitus), MALAISE (All her body feels sick) and HEADACHE (Headache). On an unknown date, the patient experienced SINUSITIS (Sinus infection got worse). At the time of the report, DEAFNESS (Lost hearing), TINNITUS (Had bothering tinnitus), MALAISE (All her body feels sick), SINUSITIS (Sinus infection got worse) and HEADACHE (Headache) outcome was unknown. No concomitant medicines reported. Treatment information included unspecified antibiotic, diphenhydramine and prednisone. 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. Action taken with the drug in response to the events was not applicable.; 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.
84 2021-04-21 headache, fever Day aftrer second shot, temp went to 102.5, used cold compresses on forehead and throat to reduce fe... Read more
Day aftrer second shot, temp went to 102.5, used cold compresses on forehead and throat to reduce fever. Few days later, developed shoulder pain. Harsh "hot" pain in shoulder joint, radiating across shoulder blade and up neck to base of skull. Have not reported to doctor, for why bother??? Only pain med I can use is tylenol, and it helps some. Also use ice pax wrapped around neck. Pain at times is disabling. Will not take a booster. Also will not advertise this side effect. But have a friend who is also suffering same pain.
84 2021-04-21 sleepiness, fatigue, pneumonia Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body real... Read more
Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body really aching; Redness on the site of injection; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukemia in 2011. Concurrent medical conditions included Hearing impaired. Concomitant products included LATANOPROST for Glaucoma, DORZOLAMIDE and VITAMINS NOS from an unknown date to 03-Apr-2021 for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness) outcome was unknown. Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
84 2021-04-22 pneumonia Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; Th... Read more
Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history was reported). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and medical history were not reported. The treatment received in response to the events was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
84 2021-05-06 fatigue INPT STATUS 3/16/2021 AS PER EMR: PT RECEIVED HER 2ND MODERNA COVID-19 VACCINATION ON FEB. 2ND. SHE... Read more
INPT STATUS 3/16/2021 AS PER EMR: PT RECEIVED HER 2ND MODERNA COVID-19 VACCINATION ON FEB. 2ND. SHE HAD SIGNIFICANT PAIN AT INJECTION SITE FOLLOWED BY WEAKNESS, FATIGUE AND POOR APPETITE. SHE HAD SYNCOPAL EPISODE AND FELL OFF THE TOILET AND PRESENTED TO ED ON 3/16/21.
84 2021-05-14 cough, chills Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of b... Read more
Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of bilat lower abdomen. COVID test positive (4/28) despite receiving Moderna vaccines (2/4 & 3/3/21). Given drops in her O2 saturation, admitted for medical management of acute hypoxic respiratory failure secondary to COVID-19. Received dexamethasone, tocilizumab during admission and ceftriaxone for catheter-related UTI. Pt recovered and ultimately was discharged on 5/11 with followup.
84 2021-05-21 chills, headache, fatigue pink disscolouration; swelling below cheek bones; missed second dose; Chills; felt tired; headache; ... Read more
pink disscolouration; swelling below cheek bones; missed second dose; Chills; felt tired; headache; gland swelling; pain in lower part of arm; Hard Knot; cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in an 84-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 disorder (heart condition) since an unknown date, Asthma since an unknown date, Drooling (excessive saliva while sleeping) since an unknown date, allergy (allergies-scheduled to have scope to check vocal chords.) since an unknown date, Dysautonomia since an unknown date and Sleep apnea (uses a CPAP machine for sleep apnea,) since an unknown date. Concurrent medical conditions included Throat discomfort. Concomitant products included ERYTHROMYCIN STEARATE (ERITHRIN [ERYTHROMYCIN STEARATE]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard Knot). On an unknown date, the patient experienced LYMPHADENOPATHY (gland swelling), PAIN IN EXTREMITY (pain in lower part of arm), ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, CELLULITIS (cellulitis), LYMPHADENOPATHY (gland swelling) and PAIN IN EXTREMITY (pain in lower part of arm) had not resolved, VACCINATION SITE MASS (Hard Knot) outcome was unknown and ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patients treatment medication included high-power antibiotics, cephalexin (Keflex )for 6 days. Self treated swollen lymph nodes with heat. 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. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: added the event (missed dose) and treatment medication; 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.
84 2021-05-25 fatigue, cough, headache COVID-19 positive 5/23/21 requiring 4-day hospitalization after vaccination in February. COVID antib... Read more
COVID-19 positive 5/23/21 requiring 4-day hospitalization after vaccination in February. COVID antibody test returned negative. Presented to ED with SOB for 3-4 days prior, headache, fatigue, and cough. CTA positive for bilateral pulmonary groundglass opacities and small lung nodules. COVID PCR positive. Was maintained on 1L of NC. Received PO decadron 6 mg daily and lasixs in hospital.
84 2021-06-08 fatigue, malaise member stated she had both doses of covid injection, stated had Moderna injection and after second d... Read more
member stated she had both doses of covid injection, stated had Moderna injection and after second dose did not feel well for several days, stated reported to doctor, was on couch for 2-3 days, had fatigue and aches and upset stomach, injection site left arm, does not have access to the injection dose card, had injection at May
84 2021-06-22 headache Quick headaches of very brief duration with any type of strain.
84 2021-06-23 fatigue High blood pressure, never had previous, shortness of breath , at rest and on exertion, rash, exhaus... Read more
High blood pressure, never had previous, shortness of breath , at rest and on exertion, rash, exhaustion
84 2021-06-29 fatigue Pt.'s daughter states 03/14/2021 reported feeling fatigued, achy, and nauseous. *08:00pm ambulance... Read more
Pt.'s daughter states 03/14/2021 reported feeling fatigued, achy, and nauseous. *08:00pm ambulance called for transport, blood clot seen during Cat Scan/ MRI stroke reported. No change in condition/ total care needed. Currently residing with Daughter for total care.
84 2021-07-15 headache The patient's son said his mother complained of dizziness, headache, confusion and very high blood p... Read more
The patient's son said his mother complained of dizziness, headache, confusion and very high blood pressure. He brought her to the emergency room where her blood pressure was found to be extremely high. The staff told him she was reacting to the Moderna Vaccine.
84 2021-07-15 malaise Patient experienced feeling deathly sick after her 2nd COVID vaccine.
85 2021-01-11 headache In the early morning of Monday, January 11th the patient developed a significant headache with neck ... Read more
In the early morning of Monday, January 11th the patient developed a significant headache with neck pain. She also reported parathesia and tingling in bilateral upper extremities with weakness of the right upper extremity. She reported feeling very anxious and "wound up". Patient presented to the Emergency Department 3 hours later. CT of the head/brain, EKG, CBC,CMP, Magnesium and Cardiac profile were performed with no significant findings. Ativan 0.5mg was administered orally. Patient was admitted to the facility for observation. Symptoms gradually resolved with no additional treatment.
85 2021-01-11 sleepiness, headache 2:33 Patient reports feeling lightheaded, drowsy, and headache. BP 160/98; HR 65; O2 99% on r/a. Vac... Read more
2:33 Patient reports feeling lightheaded, drowsy, and headache. BP 160/98; HR 65; O2 99% on r/a. Vaccine site EMT in attendance. bilateral equal weak hand grasps, no drift noted. Oriented x 3. States she forgot to take her BP meds this morning. Patient refused ambulance per recommendation of EMT. 2:43 Patient states she feels fine and is ready to go home. BP 122/80; HR 64. Remains oriented to person, place, and time.. Client used a w/c to arrive and leave facility. Is accompanied with grandson. Left with grandson.
85 2021-01-13 cough, fatigue, respiratory tract congestion She awakened in the middle of the night feeling much pain in arm where injection was. Felt like she ... Read more
She awakened in the middle of the night feeling much pain in arm where injection was. Felt like she would throw up but couldn't move from the bed. Felt like her face was drawn and tight. This morning, she has been very shaky, sounds like some congestion in her chest (cough), very tired, very dry mouth. She is never sick, so this is alarming to her and to me.
85 2021-01-19 fever, fatigue Moderna COVID-19 Vaccine EUA 1 hour after injection, vomiting ensued and persisted through the eveni... Read more
Moderna COVID-19 Vaccine EUA 1 hour after injection, vomiting ensued and persisted through the evening. Low-grade fever (treated with Tylenol). Also experiencing weakness and fatigue.
85 2021-01-19 throat irritation, cough Patient had an immediate reaction following the 1st Moderna COVID-19 Vaccine administration on 01/18... Read more
Patient had an immediate reaction following the 1st Moderna COVID-19 Vaccine administration on 01/18/2021. S/S began immediately following the injection, and were scratchy, dry throat, dry cough, slight wheezing in upper bilateral lobes. Treated with 50 mg Benadryl, monitored for 30 minutes which included vital signs. Patient recovered- home with husband. Advised patient to follow up immediately with urgent care or primary care physician.
85 2021-01-21 fatigue After 15 minutes of observation and no adverse reactions, patient went to the restroom, and went sho... Read more
After 15 minutes of observation and no adverse reactions, patient went to the restroom, and went shopping. 30 minutes after administration, patient was extremely fatigued, unresponsive, unable to be aroused. Called 911. Blood pressure was 60/Error or blood pressure machine was not working properly. Began to gasp and vomit. Epinephrine was administered at that time. 45 minutes after administration, EMS arrived. Patient was discharged from hospital around 3pm and her diagnosis was syncope.
85 2021-01-21 headache Within 5 mins of vaccination the patient reported tingling tongue and mouth. Headache beginning abou... Read more
Within 5 mins of vaccination the patient reported tingling tongue and mouth. Headache beginning about 11:16 am
85 2021-01-21 nasal congestion, malaise Right eye became slightly numb as well as right side of face apprx. 5 or 10 min after shot. Lasted a... Read more
Right eye became slightly numb as well as right side of face apprx. 5 or 10 min after shot. Lasted about a day and a half. Also felt very bad. No fever. But congested second night. Each day felt better. As of Jan 22, 2021. Due to take second injection Jan 30, 2021. Is it ok? I feel alright.
85 2021-01-24 cough, fever, headache Shooting pains in legs, weakness, fever (101.3) headache, cough
85 2021-01-24 headache MODERNA Vaccine results: Headache on day 2,3,4 after administered on Jan. 14; Itchy and red patch ap... Read more
MODERNA Vaccine results: Headache on day 2,3,4 after administered on Jan. 14; Itchy and red patch appeared on left arm at vaccine site that was about 1 inch square that appeared on day 8 after administerd, on day 9 the red had doubled in size, on day 10 the size had tripled, continuing to be itchy and bright red, with a temp of 99.3 to 99.5. On day 11, the red was diminishing, no fever noted.
85 2021-01-24 sneezing, fever, chills Thursday morning at 5:00 started having chills, started running a fever 101 to 102 all day, arm was ... Read more
Thursday morning at 5:00 started having chills, started running a fever 101 to 102 all day, arm was swollen and real red, shoulder and neck pain, started sneezing, and eyes were watering, had weakness in legs, Friday the fever remained in the 90s. As of today, 01/25/2021 no fever, just arm pain and swelling and red. have taken some Ibuprofen every four hours
85 2021-01-26 pneumonia, fatigue The following day, food did not taste as it should and water tasted like metal. By January 13, 2021... Read more
The following day, food did not taste as it should and water tasted like metal. By January 13, 2021, extreme fatigue set in; lack of appetite; and extreme feelings of hopelessness, depression, etc. On January 14, 2021, I took my Aunt to Hospital ER and she received a positive COVID diagnosis. She was released to return home with instructions to use a pulse oximeter; move about every 2 hours and not sleep throughout the day; and to do breathing exercises. All were done. Symptoms did not abate. On January 17, 2021, I took my Aunt to Hospital to receive an infusion of antibodies. Unfortunately, her pulse ox readings dropped into the 80 percentile and she was admitted for care. Although she experienced pneumonia, she improved her pulse ox and was released on January 22, 2021 to (rehabilitation center) for outpatient care.
85 2021-01-27 chills, fatigue 1/24/21 7:00 p.m. Mild gas 1/25/21 mild to moderate gas pain throughout the day. Later in evening ... Read more
1/24/21 7:00 p.m. Mild gas 1/25/21 mild to moderate gas pain throughout the day. Later in evening occasional severe gas with bloating and abdominal rumbling - 10:00 pm diarrhea continuing throughout the night 1/26/21 1:00a.m. explosive diarrhea 10-12 times - saw blood spotting on TP / chills / no fever / tremors / felt nausous 1/27/21 fatigued - even sitting my neck feels too weak to hold my head up / after diarrhea stopped felt better but exhausted
85 2021-01-31 cough, fever Vomiting the night of vaccine Fever following morning Nausea Developed a cough
85 2021-02-01 chills Chills and body aches
85 2021-02-01 runny nose, headache Headache runny nose itchy on hands right hand was swollen on top of hand
85 2021-02-02 body temperature increased Temperature 99.2 and redness at injection site
85 2021-02-03 chills SEVERE PAIN IN PELVIC JOINTS, UNABLE TO GET OUT OF BED. SEVERE PAIN ENTIRE LEFT ARM FROM NECK TO FIN... Read more
SEVERE PAIN IN PELVIC JOINTS, UNABLE TO GET OUT OF BED. SEVERE PAIN ENTIRE LEFT ARM FROM NECK TO FINGERS, UNUSUALLY SEVERE CHILLS, LIGHTHEADEDNESS/DIZZINESS.
85 2021-02-03 fever, chills, fatigue, headache Fever?101 Chills Body aches Headache Nausea Extreme fatigue
85 2021-02-04 body temperature increased Elevated temp 100.6
85 2021-02-05 fever, chills, fatigue Had first Moderna vaccine on January 6,2021 no side effects at that time maybe a little tired, some ... Read more
Had first Moderna vaccine on January 6,2021 no side effects at that time maybe a little tired, some redness on vaccine site a little pain,had the second dosis on February 3,2021same time after 1 PM,did ok until 3 AM next day lots of itching so took a Claritin allergy pill,but at 8 AM could not get out of bed fever,shaking chills ,so after two hours of chills took two tylenols,the chills,shaking stopped but that day unable to eat no apetite ,same on Friday ate a little felt weak,today Saturday still feel weak but ate some soup bread and cereal.Think I will be okay did not report to Dr thought some side effects are expected did sleep a lot first and second day after the second vaccine.
85 2021-02-07 headache, fatigue 1-2 days after vaccine, pt developed weakness, fatigue, body aches, nausea, headache and poor appeti... Read more
1-2 days after vaccine, pt developed weakness, fatigue, body aches, nausea, headache and poor appetite. Pt was admitted to the hospital on 2/5/21 and death occured on 2/6/21
85 2021-02-07 lethargy, fatigue Within a few days, my mother started reporting profound fatigue and shortness of breath while conduc... Read more
Within a few days, my mother started reporting profound fatigue and shortness of breath while conducting routine household activities. She no longer had to energy for her daily exercise walks and became increasingly lethargic. She died in her sleep while taking an afternoon nap on Thursday, February 4th. I am highly concerned this could be a vaccine related.
85 2021-02-07 fever, headache Fever, aches, headache
85 2021-02-09 body temperature increased Initial temp of 100.4, upon recheck 101.9 with 650mg Tylenol given. IV initiated due to low blood pr... Read more
Initial temp of 100.4, upon recheck 101.9 with 650mg Tylenol given. IV initiated due to low blood pressure - 78/35. 400mL NS given then converted to D5 due to GFT being 55. O2 Sats 64% RA when vitals assessed and quickly climbed, ordered to apply continuous O2 at 2LPM via NC and sats climbed to 96%. Last BP 78/35, Dr. ordered for pt to be sent in to hospital if pressure doesn't come up in the next 30 minutes. Pt in trendelenberg position, responds to verbal stimuli. Denies pain. Only complaint was feeling weak. BS up to 197 after tolerating 120ml cranberry juice. Pressures continue to stay low, last BP 72/27, Discussed with Dr. with orders to send to hospital. Admitted to hospital with Hypoglycemia and Hypokalemia.
85 2021-02-09 chills, fatigue, headache, fever Chills 8 P.M. and sore arm on day vaccine administered 2/2/21 Fatigue, muscle pain, ,headache, loss ... Read more
Chills 8 P.M. and sore arm on day vaccine administered 2/2/21 Fatigue, muscle pain, ,headache, loss of appetite, following day 2/3/2021 All clear 2/3/21 Red spot on arm below injection spot, felt feverish, 2/5/2021 Clear 2/8/21
85 2021-02-09 malaise On 1/31/21 it started with a very sharp pain in her lower back, and not feeling good. Worse than he... Read more
On 1/31/21 it started with a very sharp pain in her lower back, and not feeling good. Worse than her usual back pain. A couple of days later she started breaking out in red spots on her back in the same area where the pain was. She went to the doctor and was told that she has shingles. She has had all of the shingles vaccines. Given medicine for the shingles, Valtrex and the shingles have now dried up. Everything is on the left side of her body where she had the vaccine. She is now recovered from the vaccine and the shingles as of today 2/10/21.
85 2021-02-09 fever On 2/9/21 I started running a fever of 100+. My normal temp is 97.3. Too early to tell yet if I w... Read more
On 2/9/21 I started running a fever of 100+. My normal temp is 97.3. Too early to tell yet if I will run a fever today. I suspect this is a fairly normal reaction.
85 2021-02-10 lethargy Patient had no immediate reaction, vital signs remained stable, resident condition did not change, 4... Read more
Patient had no immediate reaction, vital signs remained stable, resident condition did not change, 4 days later became lethargic, O2 sats dropped and sent to the ER.
85 2021-02-10 fever, headache, chills, malaise Patient reported sore arm shortly after vaccination. Later in the evening a feeling of disorientati... Read more
Patient reported sore arm shortly after vaccination. Later in the evening a feeling of disorientation and dizziness. Overnight experienced extreme nausea, headache, fever, chills, body aches, severe weakness and mental disorientation. On the next day, patient was still unable to eat and was extremely weak with continued nausea and severe headache which was aided by Tylenol. 2/11 patient is still very weak and no appetite and a general feeling of malaise.
85 2021-02-11 chills SHOT WAS RECEIVED AT10:10AM ON FEBRUARY 10, 2021.. 12:30 PM THE FIRST REACTION WAS DIZZINESS TO THE... Read more
SHOT WAS RECEIVED AT10:10AM ON FEBRUARY 10, 2021.. 12:30 PM THE FIRST REACTION WAS DIZZINESS TO THE POINT THAT MOM COULD NOT GET UP ALONE. NEXT SYMPTOM WAS SEVERE CHILLS. PAIN SWELLING AT INJECTION SITE. DAY TWO AFTER SHOT (FEB 11,2021) DIZZINESS CONTINUED AND SEVERE CHILLING. FINGERS TURNED BLUEISH AND WERE EXTREMELY COLD. MOM WAS ALSO NAUSEATED THE 2ND DAY AND KEPT A VOMIT BAG CLOSE TO HER. AT NO POINT DID SHE HAVE A FEVER.
85 2021-02-11 malaise, pneumonia Patients husband called office on February 3rd wanted to let us know his wife was in the hospital an... Read more
Patients husband called office on February 3rd wanted to let us know his wife was in the hospital and my not be out to get her 2nd Moderna COVID-19 vaccine on Monday February 8th. I talked with the husband briefly about why his wife was hospitalized. He reported she got sick 2 days after getting her first COVID-19 vaccine. He states she had pneumonia, had a urinary tract infection and had to have a heart catherization with stent placement. We moved her second vaccine appointment to February 17th. The spouse came in on February 8th for his 2nd dose. He told me the doctors did not believe his wife's hospitalization was related to the first COVID vaccine and he said the doctor's told him that she needed her 2nd dose.
85 2021-02-13 fever During the night became almost paralytic (whole body - which lasted two hours), fever 102.7, no ene... Read more
During the night became almost paralytic (whole body - which lasted two hours), fever 102.7, no energy, nausea, no appetite. Second day, slight fever, slight appetite, more energy.
85 2021-02-15 fatigue, chills Within hours I experienced dizziness, chills, and extreme fatigue, in addition to muscle pains. The ... Read more
Within hours I experienced dizziness, chills, and extreme fatigue, in addition to muscle pains. The worst has been the increasing tremors in my head and hands. This is what I am most concerned about. I have a history of tremors, but since the vaccine, there has been a marked increase in the tremors. I did not report this right away because I thought it would go away, but now on the eve of my second shot I am very nervous that it will get even worst. My physician encourages me to continue and get through the side effects than to get COVID with my underlying lung condition. I want to take the vaccine but am nervous that I am experience so much shakiness even a month after the first shot. Would you advise me to take the second shot? My shot is scheduled for tomorrow, February 17.
85 2021-02-16 body temperature increased, chills Chills, temperature, nausea/vomiting, temperature 100.5, body ache, arm redness/itching.
85 2021-02-16 chills, fever chills,cramps nausea,weakness.low fever 100.7
85 2021-02-16 fatigue fatigue, anorexia, generalized weakness. patient describes as severe
85 2021-02-17 dehydration, malaise Moderna COVID-19 Vaccine given at local health department on 2/1/21. Patient developed nausea and l... Read more
Moderna COVID-19 Vaccine given at local health department on 2/1/21. Patient developed nausea and loss of appetite post vaccine. Became weak and sought care at ED on 2/5/21. Found to have leukopenia, anemia. Hydrated and discharged home. Patient continued to feel unwell, developed vomiting and diarrhea (has chronic diarrhea since partial colectomy for remote colon CA, but symptoms were worse). Sought care at my health center on 2/9/21. In-house CBC revealed pancytopenia and patient was clinically ill-appearing and severely dehydrated. Patient was sent back to ED for further evaluation. Patient admitted and consults made to Hematology and GI. Stool culture and cdiff negative, Patient was hydrated and had electrolytes replaced. Acute renal failure present on admission resolved with IVF. Sepsis was ruled out. Developed epistaxis requiring 1 unit of platelets to which she had a moderate allergic reaction requiring steroids and benadryl. Severe thrombocytopenia treated with Peg Filgrastim. CBC improved and patient was discharged to follow up with heme/onc. Her methotrexate and eliquis was held.
85 2021-02-17 malaise 24 hrs after injection i was hot hot, started getting weak, body weird, , feeling nauseous, went tto... Read more
24 hrs after injection i was hot hot, started getting weak, body weird, , feeling nauseous, went tto bed and woke up feeling sick, unsteady on my feet, hard time breathing. Went to the ER on the 10th but was not able to treat you. im getting better but slight nauseous still
85 2021-02-17 malaise 24 hrs after shot i started feeling sick. my whole body was hot hot. I was stressed so i took someth... Read more
24 hrs after shot i started feeling sick. my whole body was hot hot. I was stressed so i took something for the fever to go away. i went to bed and woke up and i was nauseous, unsteady on my feet, dizziness, Went to ER on the 10th per request from my dr that i called and they didn't treat me. yesterday the vaccine site was very itchy. Today it slightly itchy but not bad but i feel pretty good.
85 2021-02-17 sleepiness paralysis, hallucinations, lack of speech, no bowel control, slept for 2 days straight, no mental re... Read more
paralysis, hallucinations, lack of speech, no bowel control, slept for 2 days straight, no mental reasoning or control of bodily functions
85 2021-02-18 fatigue Patient was very fatigued and incoherent the entire day. She does have some short term memory loss ... Read more
Patient was very fatigued and incoherent the entire day. She does have some short term memory loss normally but yesterday she was not able to track simple commands, she could not complete a sentence, she thought people who had dies years ago where living, she was unable to identify her daughter on the telephone etc. None of these examples are typical for her it was very alarming and I was unable to find anything like this listed in side effects. After a night of sleep last night she woke up "normal" this morning and she is not able to recall any of what happened yesterday.
85 2021-02-18 fatigue Upper back pain, stomach cramps, fatigue
85 2021-02-18 headache Patient experienced pain in her mouth that traveled to her head. Onsite EMS was called vitals were t... Read more
Patient experienced pain in her mouth that traveled to her head. Onsite EMS was called vitals were taken BP 162/73 98% O2 room air HR 86. Throat Clear, patient did not describs an headache, experienced chills with first Moderna shot.
85 2021-02-18 lethargy, headache Lethargic, Head ache, thick tongue, difficulty breathing.
85 2021-02-18 pneumonia Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal... Read more
Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal event. The pt reported 2 episodes of SOB and lightheadedness, with the second one as the more severe. On her second episode, she felt severe shortness of breath, tried to walk quickly to her bed with her walker, and fell into her bed. CT angio demonstrated acute saddle PE, mild right heart strain, RUL pulmonary infarct, and mild multifocal pneumonia with suspicion of COVID; IR was consulted and suggested thrombectomy due to the severity of the embolism. In the ED, she was started on heparin drip and put on low-flow NC oxygen without distress. Upon arrival to the emergency department her vital signs were significant for T 36.4, SBP 120/81, HR 95 bpm, NSR, RR 18, FiO2 94% on room air. Her oxygen increased to 98% on 2 L nasal cannula. Her laboratory values revealed WBCs 15.1, Hb 14.4, HCT 43.4, PLT 321, neutrophils 68.8%, D-dimer 4642, NA 134, K3.4, anion gap 9, BUN 17, creatinine 1.00, glucose 163, troponin elevated 0.12, 0.25, and 0.41, urinalysis is unremarkable, COVID-19 swab is positive. A thrombectomy was performed 2/16/2021. She tested COVID positive on 2/16/2021 and her SpO2 remains in the high 90s with dips to mid 80s while talking, but she does not currently experience any SOB.
85 2021-02-18 fever, chills Pt called this morning stating that she has had a high fever all night, chills, nausea with vomiting... Read more
Pt called this morning stating that she has had a high fever all night, chills, nausea with vomiting and not being able to get out of bed.
85 2021-02-21 chills Client complains of normal vaccine side effects on 2/18 and 2/19 (chills, muscle aches, nausea, vomi... Read more
Client complains of normal vaccine side effects on 2/18 and 2/19 (chills, muscle aches, nausea, vomiting). Client reports extreme arm pain, redness, and swelling of arm. Redness and swelling has now extended down past elbow of right arm. Advised client to seek medical treatment by primary care physician.
85 2021-02-22 body temperature increased, fever Resident developed a 100.2 F temperature and shortness of breath. Fever noted at 7:45 pm, Oxygen le... Read more
Resident developed a 100.2 F temperature and shortness of breath. Fever noted at 7:45 pm, Oxygen level was not above 88%, On-call RN was notified at 7:45 pm. RN advised staff to recheck vitals at 9:30 pm and to continue to monitor resident. Family was notified at 7:45 pm also. At 9:30 pm, check of vitals was done. Temperature was 102.5F, SpO2 was 93%, BP 107/63, pulse 102. At 9:50 pm, Family member requested that resident be sent to Emergency Room. EMS was notified, patient transported to Hospital ER.
85 2021-02-22 fever, chills I had severe chills on Friday and my arm was feverish and sore until this morning. I also had weakne... Read more
I had severe chills on Friday and my arm was feverish and sore until this morning. I also had weakness and dizziness.
85 2021-02-22 fever, chills My mom had a fever, chills, aches all over, sore arm, and had 2 days of memory loss/crazy behavior. ... Read more
My mom had a fever, chills, aches all over, sore arm, and had 2 days of memory loss/crazy behavior. It was almost as if she had dementia - she repeatedly called myself and my daughter claiming that her phone didn't work and she needed help. She was trying to tell me a phone number but kept giving me random words instead. She doesn't remember talking to any one of us who spoke to her Saturday and Sunday. She was repeatedly asking what a specific button did on her TV remote, and would then ask again a few minutes later the exact same question. This went on for 2 days.
85 2021-02-22 fever About 12 hours after the receiving the vaccine, I started running a fever. I had mild body aches. Th... Read more
About 12 hours after the receiving the vaccine, I started running a fever. I had mild body aches. That lasted about 36 hours. I had a lost of appetite. The next day (2/18/2021) my arm became swollen and itchy. As of today it slightly swollen, slightly red in color and itching occasionally around the injection site.
85 2021-02-25 chills within 5-6 hours..extreme reaction..chills..aches all over body..Migraine headache..nausea..loss of ... Read more
within 5-6 hours..extreme reaction..chills..aches all over body..Migraine headache..nausea..loss of appetite Lasted approx 30 hrs..arm still sore on day 4
85 2021-02-27 body temperature increased, fatigue, chills Legs and back pain. Little strength in my legs. Chills and slight temperature. Very tired, slept for... Read more
Legs and back pain. Little strength in my legs. Chills and slight temperature. Very tired, slept for several hours for two days. Upset stomach and vomiting.
85 2021-02-27 fever, chills chills, fever beginning 25 hours after vaccine administration lasting overnight.
85 2021-02-27 fever, fatigue Monday, four days after vaccination, Awoke feeling "off" and about noon after Physical therapy treat... Read more
Monday, four days after vaccination, Awoke feeling "off" and about noon after Physical therapy treatment felt worse, really tired, went home to bed, slept, no appetite; 1:00 PM fever 99.9 about 3:00 PM fever 100.9; general body aches, ate a small supper. Went to bed, Slept well, awoke feeling good. No more problems.
85 2021-02-28 fatigue PATIENT CAME FOR HER FIRST DOSE OF COVID-19 VACCINATION. SHE WAS VACCINATED AT 9:30AM AND OBSERVED F... Read more
PATIENT CAME FOR HER FIRST DOSE OF COVID-19 VACCINATION. SHE WAS VACCINATED AT 9:30AM AND OBSERVED FOR 15 MINUTES. PATIENT HAD NO SIDE EFFECTS WHILE SHE SAT FOR 15 MINUTES AFTER BEING VACCINATED. SHE LEFT THE VACCINATION CLINIC WITH HER DAUGHTER IN LAW. AROUND 10:15AM, THE DAUGTHER IN LAW CAME TO THE PHARMACY AND STATED THE PATIENT WAS HAVING A HARD TIME BREATHING IN THE CAR. ONE PHARMACIST RAN OUT TO THE PATIENT AND CHECKED HER PULSE. PATIENT WAS GIVEN A BENADRYL 25MG TABLET TO TAKE. PATIENT ALSO HAD NITROGLYCERIN TABLETS WITH HER AND TOOK ONE TABLET WHILE THEY WAITED FOR PARAMEDICS TO ARRIVE. I CALLED THE PATIENT AROUND 6PM THAT EVENING AND SHE STATED SHE WAS HOME AND FEELING BETTER. SHE WAS A LITTLE TIRED BUT WAS FEELING BETTER AND HAD NO OTHER SYMPTOMS.
85 2021-02-28 headache Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint... Read more
Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint pain; A Spontaneous report was received from a Health care professional concerning a – 85 Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8-jan-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date or an unknown date, The patient experienced the events atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. with hospitilization and disability Treatment provided Tylenol, Advil, Norvasc, lisinopril, codeine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown; Reporter's Comments: This case concerns an 85-year-old female who had serious expected events of headache and serious unexpected speech disorder, increased blood pressure, renal artery arteriosclerosis and NS expected arthralgia. Event onset was the same day as the first dose of mRNA-1273. Treated with Tylenol, Advil, Norvasc, lisinopril, codeine. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
85 2021-02-28 headache Moderna COVID-19 Vaccine 15 hours after I received the vaccination (3 AM of the morning of February ... Read more
Moderna COVID-19 Vaccine 15 hours after I received the vaccination (3 AM of the morning of February 24) I went to the bathroom to take two Tylenol for a headache. I then used the toilet and started walking back to bed (less than 20 feet away). About halfway there, I I realized something was wrong. The next thing I knew I was lying on the ground right next to my bed. On the way down I think I heard crashing into wood furniture. I don?t know how long I was blacked out; it might have been 10 minutes. I managed to get up onto the bed and felt something wet on my pillow case. It was blood coming from a deep laceration on my chin. My doctor told me to go to urgent care. They sent me to the emergency room. I was kept overnight for observation and give three stitches in my chin. I have felt woozy ever since, but all the tests administered in the hospital showed no damage.
85 2021-03-01 cough pt states that on 2/27/2021 she started getting nervous and dizzy. She fell on 2/27/2021 and 2/28/2... Read more
pt states that on 2/27/2021 she started getting nervous and dizzy. She fell on 2/27/2021 and 2/28/2021. On 2/28/2021 she started coughing and having trouble breathing so she went to Urgent Care. She was tested for flu and covid and then told she needed an EKG so was told to go to the ER. She did not go to the ER but went to a Cardiologist Dr. next morning on 3/1/2021. They took chest XRAY, EKG, Blood Work, and covid test. Dr. changed her prescription Carvedilol 6.25 mg x 2 daily and Furosemide 20mg once a day. Pt is expecting them to call her today w/ test results and will FU w/ regular Cardiologist.
85 2021-03-01 fatigue On 2/22/2021 My mom felt very tired. On 2/23 EMS was called at 530 am to report that my mom could no... Read more
On 2/22/2021 My mom felt very tired. On 2/23 EMS was called at 530 am to report that my mom could not walk or stand. My mother is not incontinence but she had urinate her bed. EMS took her to ER they kept her for 24 hrs released her on 2/24/2021 around 2:00 pm. still could not stand right. On 2/30/2021 EMS called again patient could no longer stand went back to ER there until moved on to Rehab on 2/24/2021. Her Dr reported to the family place her for couple of weeks to get her strong. Patient is still no longer walking.
85 2021-03-02 fever, fatigue approximately 24 hours post vaccine Patient developed a low grade fever of 99.5 and had increased fa... Read more
approximately 24 hours post vaccine Patient developed a low grade fever of 99.5 and had increased fatigue. 48 hours later she had decreased neurological functioning. 02/23 she had difficulty swallowing. 02/23 She was admitted to hospice services. 02/26 she passed just before 10 am.
85 2021-03-03 malaise, headache in evening headache nausea overall sick feeling weak had to get in bed no sleep during night sick... Read more
in evening headache nausea overall sick feeling weak had to get in bed no sleep during night sick all night unable to get out of bed till noon felt better ate drank around 2 pm today
85 2021-03-03 pneumonia, chills Pneumonia; health condition continued to deteriorate; chills; Body aches; She also fell; A spontaneo... Read more
Pneumonia; health condition continued to deteriorate; chills; Body aches; She also fell; A spontaneous report was received from a consumer and physician concerning a 85 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pneumonia, fall, chils, myalgia and general health physical health deterioration. The patient's medical history included diabetes and blood pressure both since an unknown date. Relevant concomitant medications included diabetes medication and blood pressure medication. On Date 11-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date 14-Feb-2021, the patient experienced chills and body aches. On an unknown date the patient fell and her health condition continued to deteriorate. On 18-Feb-2021 the patient was diagnosed with pneumonia due to which the patient was hospitalized on the same day. Laboratory details if provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event(s) chills, body aches, fell, health condition deterioration and pneumonia unknown.; Reporter's Comments: This case concerns an 85 year old, female patient, with medical history of HTN and DM, who experienced a serious unexpected event of pneumonia, among others, 8 days after receiving 2nd dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
85 2021-03-04 fatigue, sleepiness, chills Extreme thirst,Fatigue, sleepy, mild muscle pain,joint pain, chills during night
85 2021-03-04 fatigue Generalized weakness to the extent she could not walk unassisted or speak clearly. Fatigue Incontine... Read more
Generalized weakness to the extent she could not walk unassisted or speak clearly. Fatigue Incontinence (perhaps as result of weakness and fatigue) bowel and bladder not usual in this individual.
85 2021-03-05 chills, malaise sore arm, nausea, chills, general not feeling well
85 2021-03-06 headache Sore arm and tired after injection. Woke up Feb. 20th at 3:00am with severe headache, face ache, pai... Read more
Sore arm and tired after injection. Woke up Feb. 20th at 3:00am with severe headache, face ache, pain in eye socket and teeth, neck ache, left shoulder ache, left arm ache
85 2021-03-07 chills, sinus pain, headache pt stated after she got home from taking the covid vax that she started having severe chills, cold h... Read more
pt stated after she got home from taking the covid vax that she started having severe chills, cold hands and feet. She said she could feel the medicine from the vax moving down her arm and stopping in her fingers with a tingling sensation. She was nauseated, sinus pain and headache. The next day the symptoms seem to be improving. By 3/7/2021 she was feeling back to normal.
85 2021-03-09 fever, fatigue, headache At first, slight headache,that progressed to mild, joint ache, fever of 101.1, fatigue. Took 1 Adv... Read more
At first, slight headache,that progressed to mild, joint ache, fever of 101.1, fatigue. Took 1 Advill at 11:10 P.M. Felt better next morning until 1hr. 30 min after arising. Sudden heavy fatigue. Couldn't finish fixing breakfast. Slept 3 hours, did 1 load of laundry, slept 3hr. 30 min.. No appitite, Did another load of laundry, slept 3 hours. Ate fruit and a sandwich about 6:30 P.M Took 4 Low dose aspirin then,, Took a bath and in bed at 10:25.Headache gone then. Slept til 6:00 Sun. felt fine except for fatigue which lasted into Monday,. Also sore right arm at injection site.
85 2021-03-09 fever, malaise, headache pt stated that the next day after getting the vax she started feeling foggy so went back to bed. Pt... Read more
pt stated that the next day after getting the vax she started feeling foggy so went back to bed. Pt had to take Aleve because she was feeling cruddy and couldn't see straight. Had headache, low fever and body aches. Pt drank some water but it came back up as soon as she drank it. Pt states she feels some better today.
85 2021-03-10 headache, fever Pt stated that she received the vaccine on 02/03/2021 and started having a fever, headache, chest pa... Read more
Pt stated that she received the vaccine on 02/03/2021 and started having a fever, headache, chest pain and heaviness in her left arm on 02/06/2021. She stated that she felt better by 02/09/2021. Pt was seen in the office on 02/09/2021 and she was feeling much better. Patient also stated three to four days after vaccine her left arm turn red and was hot to the touch that lasted about 4 days.
85 2021-03-10 fever, chills #1 the lot # is very hard to read due to handwriting on card I was given so I hope it is correct. I... Read more
#1 the lot # is very hard to read due to handwriting on card I was given so I hope it is correct. It could also be 012620A Received the vaccine and that night around 10 PM I started having chills and my body started shaking for about 1 1/2 hours. The next morning, I had a dry mouth and vomiting with mucous going down the back of my throat, low grade fever of 99.6F loss of appetite and diarrhea which lasted about 17 hours. My arm hurt and later it started itching. A rash formed around the injection site. I went to Urgent Care. They said I got an infection from the needle and gave me an antibiotic and told me to use a heating pad to stop the itch. i got a blister on my arm which my son used a needle to puncture it and water came out. Nothing helped so I went to my primary doctor, Dr. He said I was highly allergic to the vaccine and gave me a script for Prednisone which I took for 7 days (start high with pills and then reduce amount I think 3 of 10 mg ) he advised me not to take the second shot for the vaccine so I cancelled the appointment as the doctor said it would make me sicker.
85 2021-03-10 fever, headache, chills, fatigue Heart racing, Fever, Terrible Headache, Chills, Nausea, Weakness, and Fatigue for first 48 hours or ... Read more
Heart racing, Fever, Terrible Headache, Chills, Nausea, Weakness, and Fatigue for first 48 hours or so; continued fatigue even now.
85 2021-03-11 fatigue Patient received vaccine on 2/25/2021 from local health department clinic and presented to this repo... Read more
Patient received vaccine on 2/25/2021 from local health department clinic and presented to this reporter's facility ED on 02/26/2021 with generalized fatigue and body aches.
85 2021-03-14 chills, fever chills and fever 6:00AM next day, mild sore arm, 8:00PM same day, fever gone 3:AM 2nd day, red ra... Read more
chills and fever 6:00AM next day, mild sore arm, 8:00PM same day, fever gone 3:AM 2nd day, red rash 2nd day, no itching
85 2021-03-14 fatigue Diarrhea & extreme fatigue started the day after the second vaccine. She is experiencing extreme f... Read more
Diarrhea & extreme fatigue started the day after the second vaccine. She is experiencing extreme fatigue as of 03/11.
85 2021-03-14 fatigue Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed... Read more
Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise). The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter. On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided). On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill. On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell. Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication. Action taken with mRNA-1273 in response to the events was unknown. The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
85 2021-03-15 headache, chills, fever Massive hair loss. Fever, temperature, chills, headache.
85 2021-03-15 headache, chills, fever 3/15 9AM started to have expressive aphasia noticed by family, shaking chills and headache. Brought... Read more
3/15 9AM started to have expressive aphasia noticed by family, shaking chills and headache. Brought to ER. CTH completed and negative. Admitted for monitoring. 3/16 early AM (5am) -seizure like activity and right sided facial droop. CTH negative MRI, EEG pending Fever 102 3/16 7AM.
85 2021-03-15 headache Eleven days after the first shot, I developed shingles. The day after the second shot, I developed ... Read more
Eleven days after the first shot, I developed shingles. The day after the second shot, I developed fever, severe headache, vomitine, diarrhea which has lasted four days. I could neither eat nor sleep. It felt like I had been poisoned. This is not a small reaction!
85 2021-03-16 fatigue, chills Loss of feeling in right arm within 10 mins and arm turned white/black. Had chills nausea and fat... Read more
Loss of feeling in right arm within 10 mins and arm turned white/black. Had chills nausea and fatigue **diagnosed a few days later with Atrial Fibrilation with rapid ventricular response
85 2021-03-18 chills, fatigue Significant decrease in visual acuity. Symptoms started 2 days after vaccination (1/15/21). Present ... Read more
Significant decrease in visual acuity. Symptoms started 2 days after vaccination (1/15/21). Present for 2 days at severe levels, then improved partially. Can no longer read test. Patient had macular degeneration at baseline,. She has since seen her vitreoretinal specialist who reports no acute changes identified. Also reported 2 days of chills, fatigue, muscle spasms, diarrhea starting 1/15/21 as well. Those symptoms completely resolved after 2 days.
85 2021-03-18 malaise RECEIVED HER FIRST MODERNA VACCINE ON 2/13/2021 AND THEN HER 2ND MODERNA VACCINE ON 3/13/2021. ON 3... Read more
RECEIVED HER FIRST MODERNA VACCINE ON 2/13/2021 AND THEN HER 2ND MODERNA VACCINE ON 3/13/2021. ON 3/14/2021 SHE STARTED TO BECOME DIZZY, CONFUSED AND DEVELOPED MALAISE AND EVENTUALLY BECAME SO WEAK SHE COULD NOT MOVE. PRIOR TO THIS SHE WAS VERY ACTIVE AND WAS WALKING AROUND FINE AND EVEN CLEANS HORSE STALLS AT HER HORSE BOARDING STABLES. SHE WAS PHYSICALLY VERY ACTIVE PRIOR RECEIVING THIS 2ND VACCINATION. SHE IS CURRENTLY ADMITTED. SHE IS STILL CONFUSED AND AGITATED SHE CONTINUES TO BE WEAK AND CANNOT AMBULATE AT THIS TIME.
85 2021-03-19 throat pain, headache Sore throat, right ear pain and most severe: shooting pains on right rear portion of head that last... Read more
Sore throat, right ear pain and most severe: shooting pains on right rear portion of head that lasted 20 hours and then all symptoms disappeared.
85 2021-03-21 fatigue after vaccine my body got little circles on it, not exactly a spot but I had dark circles on the edg... Read more
after vaccine my body got little circles on it, not exactly a spot but I had dark circles on the edges of the spots, my joints got stiff but there was no pain or aches, and seems like I slept more than usual. On the 4th day it seemed like I'd been drained and dry, by the 4th week my skin seemed dry and I tried to drink water, my eyes seemed a little deeper set. I went to my PCP and he sent me to a dermatologist. The dermatologist and he gave me something to bathe in, and I didn't see any difference. The spots are not like a rash, but the discoloration seems to be under the skin, its not a rash on top of the skin but underneath.
85 2021-03-21 malaise Swollen and red upper left deltoid . Malaise .Nausea
85 2021-03-22 sweating Systemic: Flushed / Sweating-Severe, Additional Details: Pt had excessive sweating, was not able to ... Read more
Systemic: Flushed / Sweating-Severe, Additional Details: Pt had excessive sweating, was not able to hold herself up in her chair. HR and RR were normal. Pt was already non verbal and unable to communicate any issue. 911 came, she was evaluated in ER and discharged with no issues. We called her daughter to follow up the next day.
85 2021-03-23 fever, fatigue The day after the shot--fever, very tired all day. Very tired the second day after the shot.
85 2021-03-25 fatigue, headache, chills headache within hours of vaccine. also had fatigue, chills, weakness, pain at injection site around... Read more
headache within hours of vaccine. also had fatigue, chills, weakness, pain at injection site around that time. was found 4 days afterwards by home health aid in bed, with bowel incontinence, disoriented, weak and unable to speak. Pt states also had diminished sight and hearing. pt is diabetic and had elevated blood glucose readings that have persisted almost a month following the vaccine, per pt report
85 2021-03-26 cough, productive cough Moderna COVID-19 Vaccine EUA 3/12/21: The patient was started on antibitoics outpatient Tuesday f... Read more
Moderna COVID-19 Vaccine EUA 3/12/21: The patient was started on antibitoics outpatient Tuesday for bronchiolitis. Covid test was done, no results yet. Pt daughter stated got better yesterday today confused. 85-year-old woman who presented with 2 days history of cough, chest discomfort and shortness of breath. She reports insidious onset of symptoms 2 days ago cough which was initially dry, then productive of scanty whitish sputum. She also reported associated shortness of breath and pleuritic mid chest discomfort. She denies any fever, chills, nausea or vomiting. She denies any known contact with individual diagnosed with been tested with COVID-19 infection, reports compliance with masking directives. She is up-to-date with her COVID-19 vaccination, 2nd short of COVID-19 vaccine was administered last Saturday. Chest in her primary care physician yesterday and been diagnosed with bronchiolitis, prescribed oral Augmentin and Medrol Dosepak without any improvement in symptoms. She presented to emergency department today and was found to be hypoxic to 82% on room air. At present she has required supplemental oxygen at 5-8 liters/minute. She will be admitted to the hospitalist service for further treatment and evaluation. 3/20/21: She is s/p plasma, antibiotics (aztreonam, vancomycin), no remdesivir due to poor renal function. She has been on decadron 3/12 to date (to complete 10 day course) She was able to be weaned down to 1 L NC oxygen while on admission with improved symptoms. Plan is to discharge to rehab today.
85 2021-03-28 body temperature increased Right arm red, swollen, warm, nausea, vomiting, diarrhea, elevated temperature, altered mental statu... Read more
Right arm red, swollen, warm, nausea, vomiting, diarrhea, elevated temperature, altered mental status. Sent to ER. Had elevated cardiac enzymes. Admitted to hospital and treated for sepsis and altered mental status.
85 2021-03-28 headache, lethargy Client felt fine for 2 weeks post vaccination. Exactly 14 days later she developed acute onset of le... Read more
Client felt fine for 2 weeks post vaccination. Exactly 14 days later she developed acute onset of lethargy, Weakness, headache, and body aches. All known side effects but they didn't appear until 14 days later.
85 2021-03-29 headache Caller stated that 10 hours after she got her vaccine she started to have a severe headache, nausea,... Read more
Caller stated that 10 hours after she got her vaccine she started to have a severe headache, nausea, abdominal pain, weakness and shortness of breath. Stated all symptoms but the weakness and shortness of breath have resolved
85 2021-03-30 pneumonia Pneumonia after the 1st dose of Modernavaccine; A spontaneous report was received from a Pharmacist ... Read more
Pneumonia after the 1st dose of Modernavaccine; A spontaneous report was received from a Pharmacist concerning an 85-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pneumonia (Pneumonia). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 10 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number-Unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date the patient developed pneumonia after the first dose of Moderna's COVID-19 vaccine (mRNA-1273). On an unknown date, the patient was hospitalized after developing pneumonia. On 11 Mar 2021 patient was discharged from the hospital. No treatment information related event was provided. Patient currently on steroid treatment. No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcome of the event, pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
85 2021-03-30 fever, chills my entire body started screaming in pain, every bone, every nerve, on a scale of 1-10, it was way ou... Read more
my entire body started screaming in pain, every bone, every nerve, on a scale of 1-10, it was way out of 10; My shoulder started hurting; chills; temperature was 101F; A spontaneous report was received from a (Physician ) concerning a – 85 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced my shoulder started hurting/Arthralgia, my entire body started screaming in pain, every bone, every nerve, On a scale of 1-10, it was way out of 10/Pain, Chills and temperature was 101F/Pyrexia The patient's medical history included as she had the virus but was asymptomatic. Her test came positive. No relevant concomitant medications were reported. On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced my shoulder started hurting, my entire body started screaming in pain, every bone-every nerve, On a scale of 1-10, it was way out of 10/Pain, was serious event, Chills and temperature was 101F. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events were Not Resolved/Not Recovered.; Reporter's Comments: This case concerns an 85-year-old female, with PMH of COVID-19, who experienced a serious unexpected event of severe pain along with nonserious expected fever, chills, arthralgia. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
85 2021-03-30 fever Reporter of event is an in home care giver, reports that the day following the vaccination pt had a ... Read more
Reporter of event is an in home care giver, reports that the day following the vaccination pt had a low grade fever with right arm feeling hot to touch and red from just at injection site down to just above elbow. Red only and no rash. Denies any other issues. On Tuesday, 3/30/21, at time this was reported to health department, the reporter explained the right arm in less red but the area of redness was larger than it was on Monday, 3/29/21. They have applied ice packs to area and believes pt symptoms may be improving. Advised health care provider to report this event to pt's primary doctor as well.
85 2021-03-31 fever, fatigue Nausea,diarrhea,fever,rash,fatigue,head squirrels but no headache
85 2021-04-04 fever, lethargy, dehydration Blood sugars running high, fever, dehydration, nausea, vomiting, poor appetite, electrolyte imbalanc... Read more
Blood sugars running high, fever, dehydration, nausea, vomiting, poor appetite, electrolyte imbalance, ?WBC, lethargic about 1 week after.
85 2021-04-06 headache Worsening of hypertension and persistent headache
85 2021-04-09 chills, fever Red, swollen and itchy arm, fever and chills. For several days. In the beginning. After about 2 wee... Read more
Red, swollen and itchy arm, fever and chills. For several days. In the beginning. After about 2 weeks very weak and shaky legs. Varicose veins became very painful/. Blood tests show high amount of inflammation
85 2021-04-13 fatigue, sweating, chills Fatigue, chills, anxiety, morning sweats, no appetite, hives, below normal temperature.
85 2021-04-15 malaise Very sick; had some of the typical symptoms like achy; weak; just threw up; it developed into a horr... Read more
Very sick; had some of the typical symptoms like achy; weak; just threw up; it developed into a horrible, very severe case of shingles/still has shingles; did not feel very well/was not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) in an 85-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 Shingles (Had received the shingles vaccine). Concurrent medical conditions included AFib (She takes a blood thinner). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 19-Mar-2021, the patient experienced HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) (seriousness criterion medically significant) and MALAISE (did not feel very well/was not feeling well). On an unknown date, the patient experienced ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up). At the time of the report, HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles), MALAISE (did not feel very well/was not feeling well), ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up) had not resolved. The patient was taken twice to the emergency room because she developed very severe shingles. The reporter got a message that the patient threw up and patient was taken to the hospital. treatment for the events included antibiotic and pain medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
85 2021-04-15 fever, chills Blah feeling in am, took a 1 hr nap at 1pm, chills and then fever during the early evening, took 2 T... Read more
Blah feeling in am, took a 1 hr nap at 1pm, chills and then fever during the early evening, took 2 Tylenol, went to bed at 9 pm and slept until 6:30 am. Woke up and continued on my day (Sunday) Arm was sore for about 3 or 4 days after the shot and it itched.
85 2021-04-18 fatigue Vaccination was on Wednesday, March 17, 2021 at 3 PM. Symptoms began 8 days later, and Emergency R... Read more
Vaccination was on Wednesday, March 17, 2021 at 3 PM. Symptoms began 8 days later, and Emergency Room admission 3days later on Sunday, March 28, 2021, for Blood Clots in legs and lungs,(critical in Pulmonary Artery). Blood thinner started immediately was Zarelto, and continues daily. Pain, nausea, shortness of breath, and fatigue were the symptoms. The patient was admitted to hospital for 5 days and sent home to recuperate. 3 days later, on Sunday she was back into the emergency department with intestinal bleeding that had gone on for 2 days. She was admitted again and had a colonoscopy. Bleeding stopped and she went home after 3 more days. She is currently getting home health care.
85 2021-04-19 fever, chills, lethargy Patient explains that for the past several days she has weak and lethargic. She is having a difficu... Read more
Patient explains that for the past several days she has weak and lethargic. She is having a difficult time ambulating. she has had intermittent episodes of fevers and chills, frequent episodes of diarrhea (nonbloody) associated with nausea.
85 2021-04-20 headache, fatigue continued sleeplessness since then , fatigue, nightmares ( never had previously, headaches
85 2021-04-21 fatigue fatigue, thirst
85 2021-04-22 malaise Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell... Read more
Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MALAISE (Feeling unwell). On 15-Mar-2021, the patient experienced CHEST PAIN (Chest pain/right upper quadratic thoracic pain). On 15-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion hospitalization), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was hospitalized on 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain/right upper quadratic thoracic pain), MALAISE (Feeling unwell), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17 Mar 2021 the patient had an x-ray and EKG performed because she was not feeling well and had chest pain- no results provided. On15 Apr 2021 the patient went to emergency room and was hospitalized for multiple pulmonary embolisms with parts being infracted. No treatment information was provided. No relevant concomitant medications were reported. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
85 2021-04-22 pneumonia First DVT in an 85-year-old ambulatory female on daily ASA. Also found to have pneumonia at the sam... Read more
First DVT in an 85-year-old ambulatory female on daily ASA. Also found to have pneumonia at the same time. Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours. Normal O2 sat. Pt was evaluated and seen in memory care where she currently lives. Treatment: ASA discontinued, Eliquis and Levaquin started. Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.
85 2021-04-26 cough, headache Patient c/o dry cough and mild, frontal headache after receiving COVID-19 vaccine today. Denies any... Read more
Patient c/o dry cough and mild, frontal headache after receiving COVID-19 vaccine today. Denies any shortness of breath, dizziness, vision blurriness, or swelling or itching.
85 2021-04-27 fatigue, chills Patient reported SOB, chills, fatigue, muscle aches and red site reaction. Patient needed to use he... Read more
Patient reported SOB, chills, fatigue, muscle aches and red site reaction. Patient needed to use her oxygen.
85 2021-05-03 sweating After patient received vaccine, ~20 minutes later patient became difficult to arouse. Patient was di... Read more
After patient received vaccine, ~20 minutes later patient became difficult to arouse. Patient was diaphoretic and drooling, caregiver suspected glucose levels were out of range. Clinic manager called 911, EMS arrived on scene. Blood glucose was checked reading 302. Caregiver noted patient did not eat this morning. After EMS arrived on the scene patient became responsive to everyone. EMS determined no acute concerns.
85 2021-05-03 sleepiness On March 18-slept all day. On March 19 woke up with red, swollen, hot arm (injection side). Contact... Read more
On March 18-slept all day. On March 19 woke up with red, swollen, hot arm (injection side). Contacted doctor and sent picture which did not make it to vaccine coordinator completing this form. Pt states improved. 2 weeks later, April 2 pt was traveling and woke with right wrist swelling. Went to MD while traveling and diagnosed covid arm. Pt also put on course of cephalexin orally. Pt also instructed to go to ER in 2 days if not improved-pt reports arm significantly improved and did not follow up, but did finish antibiotics. Pt was doing well until 5/1 and woke with right foot swelling and pain. Went to PCP and they took xrays which were negative. Pt prescribed prednisone and another course of cephalexin. Advised to contact vaccine clinic over concern these reactions to right side of body were from Moderna. Pt had not problems with first vaccine on 2/17/21. Symptoms only started after second dose.
85 2021-05-09 headache headache, chest discomfort, dyspnea. Symptoms started approximately 18 minutes after her vaccinatio... Read more
headache, chest discomfort, dyspnea. Symptoms started approximately 18 minutes after her vaccination. she has continued to have dyspnea on exertion since. Vomited the first day after.
85 2021-05-12 lethargy very sore & lackadaisical
85 2021-05-25 fatigue, headache, malaise Feeling unwell; Shoulder pain; Joint pain; Unresponsive to stimuli; Could not speak; Felt very shaky... Read more
Feeling unwell; Shoulder pain; Joint pain; Unresponsive to stimuli; Could not speak; Felt very shaky internally; Leg tightening; Burning sensation; Pain in neck; Unable to sleep; Tiredness; Severe head discomfort; Arm hurt after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt after the injection), FATIGUE (Tiredness) and HEADACHE (Severe head discomfort ). On 13-Mar-2021, the patient experienced INSOMNIA (Unable to sleep). On 15-Mar-2021, the patient experienced NECK PAIN (Pain in neck). On 16-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation) and LIMB DISCOMFORT (Leg tightening). On 18-Mar-2021, the patient experienced NERVOUSNESS (Felt very shaky internally). On 20-Mar-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant) and SPEECH DISORDER (Could not speak). On an unknown date, the patient experienced MALAISE (Feeling unwell), ARTHRALGIA (Shoulder pain) and ARTHRALGIA (Joint pain). At the time of the report, UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), SPEECH DISORDER (Could not speak), BURNING SENSATION (Burning sensation), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Arm hurt after the injection), NERVOUSNESS (Felt very shaky internally), LIMB DISCOMFORT (Leg tightening), INSOMNIA (Unable to sleep), MALAISE (Feeling unwell), FATIGUE (Tiredness), HEADACHE (Severe head discomfort ) and ARTHRALGIA (Shoulder pain) had resolved and ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 203 (Inconclusive) 203. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue, headache and arthralgia are consistent with the known safety profile of mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up included updated height, weight and race of patient, outcome, additional lab information, and additional events. Case was upgraded to serious.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue, headache and arthralgia are consistent with the known safety profile of mRNA-1273.
85 2021-05-31 headache Patient received second COVId 19 vaccine on 4/9/21 @ Health Department. Was admitted to hospital on ... Read more
Patient received second COVId 19 vaccine on 4/9/21 @ Health Department. Was admitted to hospital on 5/18/2021 with SOB, Nausea, Vomiting, and Headache. Diagnosed with COVID 19 infection and COVID 19 Pneumonia. Patient expired on 5/19/2021 at hospital.
85 2021-06-08 influenza like illness, cough, fatigue, headache, lethargy Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body t... Read more
Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body tremors and flu-like symptoms including body aches, headaches and lethargy. within 3 days, headaches and body aches subsided however subject remained extremely fatigued and was unable to perform ADL's. Performance status declined. Sitting in chair/laying in bed 24 hours a day. Became short of breath on minimal exertion. On 6/6/21 patient taken to ER for c/o shortness of breath, cough and tachycardia. Was found to have large pulmonary emboli.
85 2021-06-17 headache Massive headache. Began forgetting things. She was asking the same questions over, and over. She nev... Read more
Massive headache. Began forgetting things. She was asking the same questions over, and over. She never showed signs of concern over her memory.
85 2021-07-01 fever Patient with fevers, myalgias, and delirium. Required hospitalization for infectious work up which h... Read more
Patient with fevers, myalgias, and delirium. Required hospitalization for infectious work up which has been negative to date. Now improving and still hospitalized.
85 2021-07-17 malaise, sleepiness, fatigue Afib wt RVR; Tachycardia; General malaise; Refused 2nd covid vax; Fatigue; After the shot I got real... Read more
Afib wt RVR; Tachycardia; General malaise; Refused 2nd covid vax; Fatigue; After the shot I got real real dizzy; I didn't feel sick, but I didn't feel right; I slept most of the day; I didn't have appetite; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib wt RVR) and TACHYCARDIA (Tachycardia) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis in 2010. Concurrent medical conditions included Drug allergy (aspirin), Drug allergy (Avelox), Drug allergy (morphine), Hypertension since 12-Dec-2011 and Hypothyroidism since 24-Sep-2014. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 24-Sep-2014 to an unknown date, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 12-Dec-2011 to an unknown date and LOSARTAN from 17-Mar-2021 to an unknown date for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Afib wt RVR) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite). On an unknown date, the patient experienced MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue). The patient was hospitalized from 15-Mar-2021 to 18-Mar-2021 due to ATRIAL FIBRILLATION and TACHYCARDIA. The patient was treated with CARVEDILOL at a dose of 6.25 mg. On 20-Mar-2021, DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite) had resolved. On 01-Jun-2021, ATRIAL FIBRILLATION (Afib wt RVR) had resolved. At the time of the report, TACHYCARDIA (Tachycardia), MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: high (High) high. On 15-Mar-2021, Heart rate: high (High) 150. On 20-Mar-2021, Blood pressure measurement: 139/79 (normal) 139/79. On 20-Mar-2021, Heart rate: low (Low) 53. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received included: Added medical history, concomitant medications and added new event of Atrial Fib with RVR.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
86 2021-01-06 fatigue Nausea, fatigue hit suddenly the next morning.
86 2021-01-14 fever vomiting, fever
86 2021-01-17 chills extreme chills.... Moderna COVID 19 Vaccine EUA gave patient warm milk and put to bed...will monito... Read more
extreme chills.... Moderna COVID 19 Vaccine EUA gave patient warm milk and put to bed...will monitor throughout the night
86 2021-01-19 fever, fatigue Not only did I get a reaction on the 17th but also the same reaction today on Jan 20th. Fever of 10... Read more
Not only did I get a reaction on the 17th but also the same reaction today on Jan 20th. Fever of 101.3 Cold, and tired. Took 2 tylenol and 2 pm and will take 2 more at 8 PM
86 2021-01-21 headache, cough, fever, chills The following day after vaccination, 1/20/21, the patient experienced injection site reaction (swell... Read more
The following day after vaccination, 1/20/21, the patient experienced injection site reaction (swelling, redness, and tenderness), fever, chills, headache, cough, and nausea. They resolved on 1/21/21, but patient requested to cancel her second dose of the vaccine. She took acetaminophen on 1/20/21 and 1/21/21.
86 2021-01-21 headache headache, right and left upper arm muscle ache, no appetite or energy lasted 24 hours
86 2021-01-21 fever At approx 5:13pm on 1/21/2021, change in status with being unresponsive to conversation, Face flushe... Read more
At approx 5:13pm on 1/21/2021, change in status with being unresponsive to conversation, Face flushed, taken no food for fluids for the day. T-101.5-102.3 pulse 88-100 02 sat 86%. Unable to take anything orally. Dr updated with request to be evaled in ER. Admitted to rule out UTI, Covid test was negative, continued high temp, WBC count high.
86 2021-01-23 chills, runny nose, sneezing, throat pain, nasopharyngitis Had a sore throat & chills second night after receiving vaccine. Today Sunday 1-24-20 woke up with "... Read more
Had a sore throat & chills second night after receiving vaccine. Today Sunday 1-24-20 woke up with "head cold" like symptoms runny nose, constant sneezing, itchy eyes & sore throat
86 2021-01-23 headache, body temperature increased Side effects include Joint aches: knees, neck wrists headache, fatigue and slight elevation in tempe... Read more
Side effects include Joint aches: knees, neck wrists headache, fatigue and slight elevation in temperature. Temp at the time of injection 97.3, during side effects 99.3. Tylenol for temp. My concern is that I had COVID-19 in March of 2020 and tested positive for antibodies in October of 2020. Do I need another injection?
86 2021-01-24 fatigue Diarrhea, Nausea, Arm pain: redness, fatigue. MD contacted. Tylenol given. Symptoms improved. "Fine... Read more
Diarrhea, Nausea, Arm pain: redness, fatigue. MD contacted. Tylenol given. Symptoms improved. "Fine now"
86 2021-01-24 fatigue Nausea, diarrhea, tired moderna COVID-19 vaccine EUA
86 2021-01-24 fever Fever of 103+F, weakness, difficulty walking, joint soreness...patient rested and was given tylenol ... Read more
Fever of 103+F, weakness, difficulty walking, joint soreness...patient rested and was given tylenol doses of 975mg 2X
86 2021-01-25 throat pain Weakness and sore throat / dry throat
86 2021-01-25 fever high fever, severe pain, dizziness, vomitting, internal bleeding, stroke, sepsis
86 2021-01-27 fatigue Pain in Sciatic Nerve, Loss of appetite, Extremely tired, Nauseau
86 2021-01-27 lethargy, fever extreme lethargy, fever, loose stool, some nausea feeling without vomitting
86 2021-01-28 body temperature increased elevated temperature
86 2021-01-28 fatigue Pain in injection site, fatigue
86 2021-01-31 cough Cough and chest congestion today 2/1/21 (REPORT PROVIDED BY DAUGHTER)
86 2021-01-31 fatigue 10days after shot, my arm got hot the spot got swollen. it was about 5 inches in diameter and it was... Read more
10days after shot, my arm got hot the spot got swollen. it was about 5 inches in diameter and it was hot red and swollen. Physically i had all the chronic fatigue attack where my mind is not sharp, I was depressed, and tired, and i was hurting. My hips were hurting, i have paraphasia in my right foot but it went from my toe to my knee and it was painful. lasted for 10days. I woke up Saturday and everything was fine and i was back happy. I am still stressed
86 2021-01-31 fatigue Patient received vaccine on Jan 22nd at 1:42 pm. Patient stated she woke up at 2:00 am with severe s... Read more
Patient received vaccine on Jan 22nd at 1:42 pm. Patient stated she woke up at 2:00 am with severe shortness of breath and felt as if she had a cement brick on her chest. She struggled to breath all night, and paced the house. Patient states she felt as if she was going to die. Patient did not wake anyone up or tell anyone, so vitals or other information could not be obtained during the reaction. Patient felt better Saturday morning, but still very fatigued and very fearful.
86 2021-01-31 sweating Pt received Moderna covid vaccine. Vaccine Placed into Left deltoid. During vaccine administration, ... Read more
Pt received Moderna covid vaccine. Vaccine Placed into Left deltoid. During vaccine administration, pulse ox was placed to Pt's right index finger, HR showed 122-156, 98% RA. Pt stated she was nervous and anxious and was noted to be diaphoretic. Pt stated she got the vaccine because her spouse wanted her to. At approximately 1646 Pt's HR 138. Pt denies chest pain and sob and stated she was feeling anxious because of all the attention she was getting. O2 at 2 lpm placed via nasal cannula. At 1649 HR 141, O2 at 99% @ 2/LPM. 1653- Pt's HR 120, O2 sat 99% @ 2 lpm. At 1655- HR 126, O2 sat 99% @ 2 lpm. 1700-HR 147, 98% O2 @ 2/LPM. BP 138/89, HR 142 at 1704. BP 137/90 HR 142 at 1710. Pt advised that Paramedics will be called. Pt upset and stated she was fine and declined to have paramedics called. Pt signed AMA at left clinic at 1714 with husband. Advised Pt and spouse to call paramedics if Pt becomes SOB, difficulty breathing and/or having CP. Pt and Spouse verbalized understanding.
86 2021-01-31 fever Fever 101 this evening very mild diarrhea.. this is six days after the shot. Took ASA drinking lots ... Read more
Fever 101 this evening very mild diarrhea.. this is six days after the shot. Took ASA drinking lots of water
86 2021-02-02 headache, fatigue Pt rpts h.a., dizziness, nausea, + diarrhea fatigue onset 01/31/2021, progressively worse today. Den... Read more
Pt rpts h.a., dizziness, nausea, + diarrhea fatigue onset 01/31/2021, progressively worse today. Denies rash/hives SOB, diaphoresis, dysphagia, itching confusion, memory loss, wheezing
86 2021-02-03 malaise, headache, fatigue Extreme tiredness Nausea Headache Muscle and joint pain Generally Unwell
86 2021-02-05 fever, fatigue Fever, severe fatigue, very sore arm
86 2021-02-07 chills severe chills for 1-2 hours
86 2021-02-09 headache Top of head to bottom of feet for itching. difficulty breathing, lung pain, headache, dizziness, dis... Read more
Top of head to bottom of feet for itching. difficulty breathing, lung pain, headache, dizziness, disoriented-unable to maintain balance, growly voice, body aches
86 2021-02-09 headache Around noon she got really hot, sick to stomach, fainty, hard to talk and a headache. Call the ambu... Read more
Around noon she got really hot, sick to stomach, fainty, hard to talk and a headache. Call the ambulance and refused transport to the hospital. Lasted approximately 24 hours.
86 2021-02-11 headache, chills, fatigue Symptons started with headache and mild muscle ache. The headache and muscle pain became more sever... Read more
Symptons started with headache and mild muscle ache. The headache and muscle pain became more severe. It was painful to move and walk. I developed chills. These symptoms lasted during the night, but subsided in the morning just leaving fatigue. In addition, the injection site became inflamed, swollen and painful. It has taken 8 days for these to start subsiding, I still have a few sharp pains and some redness
86 2021-02-12 nasopharyngitis Whole body itching, feeling excessively cold all day
86 2021-02-13 malaise Soreness to injection site including redness and minor swelling and feeling of malaise which did n... Read more
Soreness to injection site including redness and minor swelling and feeling of malaise which did not start until more than a week after the injection.
86 2021-02-15 cough, chills 2/6/21 she had a rash the size of a tennis ball that was pink in color not red, cough for one day, a... Read more
2/6/21 she had a rash the size of a tennis ball that was pink in color not red, cough for one day, and chills for one day. The rash was gone as of 2/10/21. Patient states her arm is back to normal and has no questions or concerns.
86 2021-02-15 fatigue, chills, headache, fever Pain. Swelling (hard area, size of lemon), redness, fatigue, headache, muscle pain joint pain , 4 ho... Read more
Pain. Swelling (hard area, size of lemon), redness, fatigue, headache, muscle pain joint pain , 4 hours of chills on and off,) nausea. loss of appetite, fever of low grade, duration, some lasted 1 week small vesicles on R face above R lip and R shoulder sutured area. Took tylenol and Benadryl which decreased pain and curbed itching.
86 2021-02-15 fatigue, cough, chills Resident experienced chills, fatigue, nausea, coughing, weakness, loss of appetite, and tachychardia... Read more
Resident experienced chills, fatigue, nausea, coughing, weakness, loss of appetite, and tachychardia on 2/15/21. She was transferred to the ER and admitted to the hospital (attached to nursing home) for NSTEMI and cholelithiasis/cholecystitis.
86 2021-02-15 fatigue She had her 2nd COVID-19 vaccine 2 days ago. Yesterday she developed sudden onset of weakness and ti... Read more
She had her 2nd COVID-19 vaccine 2 days ago. Yesterday she developed sudden onset of weakness and tiredness. She had a hard time sitting up, trying to lift her arms, had a hard time articulating how she felt and what was wrong, her speech seemed a little slurred, and she felt nauseated. Her daughter denied facial droop and localizing weakness. She continued to be "out of it" and weak until her daughter put her in bed about 7 hours later. She slept well and got up twice during the night to use the bathroom and seemed ok. She is feeling better today. Pt reports she kept hearing the telephone ringing all night and thought she heard someone yelling about the phone.
86 2021-02-15 fever Nausea, Confusion, fever, weakness, SOB, pain
86 2021-02-16 cough overnight non stop Cough (first night) , "out of it feeling" , brain fog,, low blood pressure, leg w... Read more
overnight non stop Cough (first night) , "out of it feeling" , brain fog,, low blood pressure, leg weakness, nausea, dizziness, mouth ulcers outbreak, face flushing , this happened during the week following the Monday vaccination...?.still have some mouth sores and face flushing
86 2021-02-16 fatigue Reports to PCP on 2/12/21 that she has been having fatigue and "ringing in ears" (tinnitus) which st... Read more
Reports to PCP on 2/12/21 that she has been having fatigue and "ringing in ears" (tinnitus) which started 1 day after her vaccination on 2/4/21. Pt was seen in-clinic at urgent care on 2/13/21. Ear exam was normal. Pt was referred for audiology exam and then follow-up with ENT for referral.
86 2021-02-17 fatigue, chills pt stated that her left arm got very sore and she was very fatigued. A couple of days later she ha... Read more
pt stated that her left arm got very sore and she was very fatigued. A couple of days later she had bad body aches, lightheaded with chills. Pt had a virtual appt w/ her PCP and for her to be tested for Covid since she had been exposed. She tested negative. Doctor told her take Tylenol and meloxicam. She kept these symptoms about 6 days before they subsided.
86 2021-02-17 lethargy, fever CONFUSION, WEAKNESS, LETHARGY, FEVER
86 2021-02-17 fever Date and time of vaccination: (list both if they received both shots): 1st: 1/13/2021 @ 1030, 2nd: 2... Read more
Date and time of vaccination: (list both if they received both shots): 1st: 1/13/2021 @ 1030, 2nd: 2/11/2021 @1030 1st: Moderna #012L20A, 2nd #: 012M20A Stomach pain, cramps and diarrhea, nausea began aprox 2 hrs after 2nd vaccine, resolved after about 3hrs. On 2/13, began having a raised welts on left side of neck/back with itching. Called physician on 2/13, applied cream as ordered. On 2/15, saw PCP, who put her on cortisone cream and who recommended oral benadryl as needed. On 2/16, noticed that rash has moved around her neck to front of chest/neck area. In addition, left buttocks began having same rash as well as right arm at injection site. Intermittent low-grade fever throughout. Follow-up call with PCP scheduled for today. Advised to continue using cream/benadryl/tylenol as needed as prescribed by PCP.
86 2021-02-18 headache PAIN TO LOWER BACK AND INTO RIGHT THIGH, MUSCLES ACHES, HEADACHE
86 2021-02-18 respiratory tract congestion, body temperature increased, cough Felt like I had gotten the virus again. Same symptoms, 104 degree temp. muscle ache, congestion, co... Read more
Felt like I had gotten the virus again. Same symptoms, 104 degree temp. muscle ache, congestion, cough, nausea. This time I could not move my left arm without pain. After 3 days I could still not move to 90 degrees. At 5 days can now reach cups on first shelf of upper cabinets. If I tried to move arm received a terrible stabbing pain in my left arm near the injection site,
86 2021-02-19 fatigue, headache, fever Fateague,headache, fever
86 2021-02-19 malaise Patient had general malaise unknown cause. Onsite EMS was called vitals were taken BP 202/74 ... Read more
Patient had general malaise unknown cause. Onsite EMS was called vitals were taken BP 202/74 100% O2 room air HR 74.Patient treated, Left aginst medical advice. .
86 2021-02-21 chills, fever Fever 101.5. Chills body aches
86 2021-02-22 headache, chills, sweating, fever HAD SHOT IN LEFT ARM - AT 6:00PM LEFT HAND WENT NUMB. AT 8:00 HAD SEVERE CHILLS & HIGH TEMPERATURE ... Read more
HAD SHOT IN LEFT ARM - AT 6:00PM LEFT HAND WENT NUMB. AT 8:00 HAD SEVERE CHILLS & HIGH TEMPERATURE WHICH LASTED FOR 24 HOURS. HUGE BODY PAIN & COULD NOT MOVE ANYTHING. NECK & HEAD HURT SO BAD I COULDN'T STAND TO MOVE. I COULDN'T LIFT ARMS TO DRINK WATER. SON TOOK CARE OF ME ALL DAY THE DAY AFTER THE SHOT. HAD BRAIN FOG. COULDN'T THINK WHAT I WANTED TO DO OR WHAT I WAS DOING. LASTED FOR A WEEK. AFTER A WEEK I TRIED TO DO MY USUAL WORKING OUT ROUTINE, BUT WHEN I TRIED TO RIDE THE ELLIPTICAL I BROKE OUT IN A HUGE SWEAT AN ALMOST PASSED OUT. THAT LASTED UNTIL 2/22/21, WHICH WAS YESTERDAY, WHEN I WAS FINALLY ABLE TO RIDE ELLIPTICAL WITHOUT ANY ADVERSE REACTIONS. (I'M 86, BUT A VERY ACTIVE 86. I PLAY TENNIS 2 TIMES A WEEK & WHEN WEATHER IS NICE I RIDE MY BIKE FOR 15 MILES A COUPLE TIMES A WEEK.) LIFT WEIGHTS 3 TIMES A WEEK AFTER RIDING ELLIPTICAL FOR 45 MINUTES. NOT A TYPICAL 86 YEAR OLD PERSON.
86 2021-02-23 pneumonia, influenza like illness, body temperature increased, headache, fever 2.12-fever, flu-like symptoms, confusion and disorientation 2.15 - resident presented with extreme c... Read more
2.12-fever, flu-like symptoms, confusion and disorientation 2.15 - resident presented with extreme confusion and weakness in arms and legs. unable to do usual daily activities. unable to self-transfer. Taken to ER and diagnosed with UTI. 2.18 - resident complained of headache and being unable to sleep previous night. VS: temp 101.8; BP:135/63; P:93; R:20; SP02:79-80%; HOB elevated. Resident send to ER via ambulance. Diagnosed with pneumonia. hospitalized for 5 days.
86 2021-02-24 fatigue Fatigue on Day 1, Day 2 after vaccine Temp 99.1 on Day2 after vaccine
86 2021-02-24 sweating, lethargy Pt had a near syncopal episode where she became lethargic and nauseated at 1200. Pt became pale and... Read more
Pt had a near syncopal episode where she became lethargic and nauseated at 1200. Pt became pale and diaphoretic and was assesed by paramedics. The patient stated she felt better and her skin signs became normal. AMR 235 arrived on scene and was cancelled after pt refused transport. did the AMA. Nurse did the asessment and paperwork. Pt stated she had diarhea in the morning. CAD #2021-00012425.
86 2021-02-24 fever nauseous, diarrhea, body aches, fever, sore arm,
86 2021-02-27 fever Day after second dose decedent had fever and tremors, subsided on day three (less than 72 hours) aft... Read more
Day after second dose decedent had fever and tremors, subsided on day three (less than 72 hours) after dose with exterem wekness followed by death less than 72 hours after second dose
86 2021-02-28 fatigue started as a painful arm, with itchy rash around the injection site accompanied by fatigue. Lasted f... Read more
started as a painful arm, with itchy rash around the injection site accompanied by fatigue. Lasted for 2 days. Day 3 there is a slight rash.
86 2021-02-28 headache Patient waited in parking lot 15-20 minutes . She noted a headache when she got home. About 3 pm s... Read more
Patient waited in parking lot 15-20 minutes . She noted a headache when she got home. About 3 pm she developed tingling in her face and lips (lasted 3-4 hours), increased heartrate (lasted about 3 hours), increased blood pressure (for about 2 hours), The next day she noted dizziness and weakness, lower extremity redness (redness lasted about 3 days).
86 2021-03-02 fatigue, fever, chills Sore arm, at night chills and shaking. Tiredness. Second day a fever of 99, very tired as well.
86 2021-03-02 headache, fatigue head ache. joint ache. fatigue. sore sight of injection
86 2021-03-03 runny nose Received vaccine on Feb 25. One Feb 28 started feeling like coming down with cold with runny nose an... Read more
Received vaccine on Feb 25. One Feb 28 started feeling like coming down with cold with runny nose and by evening mouth was beginning to feel strange. Monday through Wed with sores on lips, gums, tongue. roof of mouth. Sores were red inside and not raised on lips sores were blister like, raised and sore. Sore on tongue also blister like. All sores were painful. Had difficulty eating especially sour things. Gums were very sore. Today, is feeling a little better. Issue not yet resolved. Tried salt water mouth rinse with fair results to decrease pain. Used OTC meds for pain relief.
86 2021-03-04 cough, fever, fatigue, headache Worst headache ever had, fever, sever coughing, red swollen face, felt like a semi truck ran over... Read more
Worst headache ever had, fever, sever coughing, red swollen face, felt like a semi truck ran over ,tired
86 2021-03-04 headache, chills, fever Chills, extreme joint and muscle pain, fever of 101, dizziness, headache, listless, 6;x3: raised kno... Read more
Chills, extreme joint and muscle pain, fever of 101, dizziness, headache, listless, 6;x3: raised knot at injection site, severe itching at injection site.
86 2021-03-07 fatigue extreme fatigue,nausea,some vomiting,loss of appetite.....no treatmene(rest).. mar8..symptoms decli... Read more
extreme fatigue,nausea,some vomiting,loss of appetite.....no treatmene(rest).. mar8..symptoms declining...still some fatigue suggestion; caution patients re, possible side effects to prevent unecessary alarm and calls to mds
86 2021-03-07 malaise, sweating, headache, fatigue, chills, fever Got the vaccine, and later noticed pain in her neck, knees, head. She had dizziness, chills, shake... Read more
Got the vaccine, and later noticed pain in her neck, knees, head. She had dizziness, chills, shakes, nausea and a slight fever. She went to bed that evening and everything was hurting, and felt very nauseous. She had a very bad nights rest, but when she woke up her temp was over 100, normal is 97. She did take her morning meds and an extra-strength Tylenol and went back to bed. She took Tylenol, was feeling better, but still the chills and fatigue and was better. The problem with the headache continued and her temp was about 99. On 2/12/21 had temp over 100 again, no energy, slept a lot. Had difficulty sleeping that night and had sweats, had temp, nausea and was shaking. On Monday felt shaky, chills and difficulty sleeping. On Tuesday she was having headache, not sleeping well and no energy. She also was not sleeping well, had a headache. By 2/17/21 was feeling better, not great as she was still not sleeping well. She did have covid in April of last year, and was not allowed to see her husband who was in a nursing home until 6/3/20. When she had the covid test she was inconclusive and that's why she could not see her doctor. Her doctor did the antibody test that showed she had antibodies. She is feeling back to normal as of today, 3/8/21. She had the malaise from COVID after she got the 1st vaccine. Feels that they should ask people before getting the vaccine if they had COVID.
86 2021-03-07 malaise She developed a severe red rash from her shoulder down to her elbow on the vaccinated arm. The ras... Read more
She developed a severe red rash from her shoulder down to her elbow on the vaccinated arm. The rash appeared approximately 20 hours after the vaccination. She said the rash was itchy, and lasted approximately 24 hours.
86 2021-03-08 pneumonia, fatigue Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of ... Read more
Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of 3/6/21, she awoke short of breath, felt hot, was a little nauseated, and did not take her medication. She has gradually grown more short of breath and distressed since then. She appears weak, distressed with tachycardia and hypoxemia. Bilateral pneumonia seen on xray. She arrived to the ED in A-fib with RVR HR 150's. O2 90% on 12L NRB. After IV access was obtained and labs drawn patient was transitioned to BiPAP setting 10/5 and 30% per MD at 1300. Her saturations were not maintaining above 90% and O2 was titrated up to achieve a O2 % > 90. She was given a loading dose of Diltiazem per protocol and started on a DilIazemt gtt, the drip was titrated up to max 15 to achieve target HR <100. Her BP remained stable during this course. She received a bolus of NS. 1 gram of Tylenol via IV. 1 gram of Rocephin infusing upon transfer. D5LR infusing at 200 upon transfer.During her course in the ED she was able to communicate with staff when asked questions.
86 2021-03-11 chills, headache temporary paralysis in legs and arms, symptoms were first notice at 4:00am , lasted about 5 hours. a... Read more
temporary paralysis in legs and arms, symptoms were first notice at 4:00am , lasted about 5 hours. also felt nausea lasted about 10 minutes, chills and headache a few hours
86 2021-03-14 fatigue Fatigue, whole body aches, tenderness at injection site. Onset within 12 hours, duration approximate... Read more
Fatigue, whole body aches, tenderness at injection site. Onset within 12 hours, duration approximately 36 hours. Treated with rest, fluids, and Aleve (1 dose, 24 hours after injection). All symptoms resolved within 48 hours.
86 2021-03-15 fatigue, chills The second dose was administered, in error, on day 22 (rather than day 28) therefore, given too earl... Read more
The second dose was administered, in error, on day 22 (rather than day 28) therefore, given too early. This individual began to experience severe body aches, fatigue and reported having chills on day 2 following the vaccination and lasting 3 days. She remained in bed most of day 2, only getting up to the bathroom. After day 2, she was able to get out of bed with assistance for meals, however, continued to complain of fatigue and some body aches. At this time, symptoms have resolved with exception of still experiencing some body aches in the mornings, making it difficult for her to her out of bed and to breakfast.
86 2021-03-15 fever, fatigue 2nd day soar arm, 3rd day fatigue no appitite nauseaus. By 9:30 pm vomiting and diarhia once.had 100... Read more
2nd day soar arm, 3rd day fatigue no appitite nauseaus. By 9:30 pm vomiting and diarhia once.had 100.7 fever . Went to bed ,from12:30 am to 4:00 am , vomited every hour on the hour. Slept til 8:00am 4thday . Drank pedialyte, gatorade water slowley. Ate a cracker toast 1/2 bannana. 9:00 pm diareaha again. Slept threw night. Fatigued on 5 th day. Today am monitoring. What should i expect after 2nd shot?,worried.
86 2021-03-16 headache Presents to ED the day after 2nd covid vaccine with syncope,general weakness, nausea, headache, vom... Read more
Presents to ED the day after 2nd covid vaccine with syncope,general weakness, nausea, headache, vomiting. Admitted for 2 days for syncope workup. Improved with IV fluids. d/c'd home in stable condition.
86 2021-03-18 body temperature increased, fatigue JAN. 27, '21- NOTICED SHORTNESS OF BREATH DURING REGULAR EXERCISE ROUTINE FOR STRENGTH & FLEXIBILITY... Read more
JAN. 27, '21- NOTICED SHORTNESS OF BREATH DURING REGULAR EXERCISE ROUTINE FOR STRENGTH & FLEXIBILITY. JAN. 28, '21 WEAR A FITBIT ON WRIST- SAW READING OF REST. HEART DOCTOR. COULD NOT GET APPT. UNTIL FED. 2ND. WENT TO URGENT CARE- DIAGNOSIS OF SINUS BRADYCARDIA, DYSPNEA ELEVATED BP, CALF PAIN. REFERRED TO ER DEPT. WAITED UNTIL NEXT MORN. TO GO TO HOSPITAL.
86 2021-03-18 headache Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weak... Read more
Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg. The patient's medical history included cellulitis in left leg. No concomitant medications were reported. On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not. Patient did not take anything to treat symptoms but contacted her doctor and pharmacist. The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine. Seriousness criteria for the event of swelling and edema was medically important. Action taken with mRNA-1273 was unknown. The outcome for all the events was considered as recovered/resolved. No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
86 2021-03-19 fatigue, fever fever and fatigue for 2 days Rash noticed on 3rd day
86 2021-03-19 headache, fatigue On 3/14/21 pt got up from bed to use BR and didn't know where she was, fell into wall and to floor. ... Read more
On 3/14/21 pt got up from bed to use BR and didn't know where she was, fell into wall and to floor. She had fatigue, headache, and generalize pain, her BP was low 100/44. All she could do was sleep and had no appetite, on the 20th she felt well enough to go for a car ride, her husband drove. She did see her PCP on the 18th who thought she was depressed, seemed unconcerned that she fell to the floor, her Bp was low this day as well, all labs were normal. This was her 2nd Covid-19 Moderna vaccine, she had no symptoms with the first injection. She has never before experienced disorientation, that she did on 3/14/21 @ 3 am.
86 2021-03-21 fatigue Day after vaccine became super tired and lightheaded, then on March 9 noticed difficulty walking bec... Read more
Day after vaccine became super tired and lightheaded, then on March 9 noticed difficulty walking because feeling of numbness in left leg. I called clinic and they told me to call 911.
86 2021-03-21 headache, chills pt states by noon after taking 2nd dose she had developed itching, chills, headache, body pain, and ... Read more
pt states by noon after taking 2nd dose she had developed itching, chills, headache, body pain, and head was foggy. Pt had very odd body aches and pains, itching, and headaches that would come and go for weeks. These symptoms lasted at least 22 days before subsiding. Pt contacted her PCP and was told to take Claritin. Pt also had an annual appt w/ PCP where she did blood work but pt has not received any results. Pt no longer has these symptoms.
86 2021-03-21 headache, cough, chills pt states that by noon she developed horrific itching on her face, neck and shoulders. Pt had sever... Read more
pt states that by noon she developed horrific itching on her face, neck and shoulders. Pt had severe chills by 3:00 she had a persistent cough, headache, and left arm became numb. Her left hand got cold and nailbeds turned blue. Pt had body aches and pains. Pt took cough medicine, She wrapped her arm in heating pad and messaged her hand. She put a topical medication on her skin to help with itching. Pt had these symptoms for 2 days and then they all subsided.
86 2021-03-21 fever Son-in-law left this RN a voicemail stating that his mother-in-law received the vaccine last Tuesday... Read more
Son-in-law left this RN a voicemail stating that his mother-in-law received the vaccine last Tuesday 3/16 and on Thursday 3/18 she went into the hospital via ambulance as she had uncontrollable diarrhea, nausea and fevers. She is now in a nursing home.
86 2021-03-23 chills, influenza like illness pt states that she developed chills. She had shivers and was very achy like she had the flu. After... Read more
pt states that she developed chills. She had shivers and was very achy like she had the flu. After a few hours these symptoms subsided.
86 2021-03-23 fatigue Dementia; Uncontrolled blood sugar; Fatigue; A spontaneous report was received from a consumer conc... Read more
Dementia; Uncontrolled blood sugar; Fatigue; A spontaneous report was received from a consumer concerning her mother an 86-years-old female patient, who received Moderna's COVID-19 vaccine and experienced dementia, fatigue and uncontrolled blood sugar/ blood glucose abnormal. The patient's medical history included Diabetes which was untreated. No relevant concomitant medications were reported On 04 March 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 March 2021, the patient experienced a medically significant event dementia, fatigue and uncontrolled blood sugar. No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, dementia, fatigue and uncontrolled blood sugar was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
86 2021-03-24 fever, fatigue Moderna COVID-19 vaccine EUA Rash from shoulder to elbow 3 inches across, itchy and painful, fever, ... Read more
Moderna COVID-19 vaccine EUA Rash from shoulder to elbow 3 inches across, itchy and painful, fever, 100* 3 days, Fatigue 6 days beginning 3-2-2021 Rested, slept a lot. applied ice pack to arm with rash, daily oral antihistamine. I felt normal and all side affects had disappeared within 10 days.
86 2021-03-26 chills, headache Severe headaches,chills,,aches
86 2021-03-26 chills Rash, chills, temp., loose stool,
86 2021-03-30 fatigue Extreme tiredness, Confusion, Delusions. This was on-set after 2nd vaccination.
86 2021-03-31 fatigue A day after vaccination the recipient became disoriented, had memory issues, developed a rash and wa... Read more
A day after vaccination the recipient became disoriented, had memory issues, developed a rash and was extremely fatigued. This persisted for "several days."
86 2021-04-03 fatigue Nightmares Fatigue all week, itchy and sore arm on day 9 still present
86 2021-04-06 fatigue 2-3 days after #2 vaccine L wrist became swollen, painful, burning and has remained unchanged for 2... Read more
2-3 days after #2 vaccine L wrist became swollen, painful, burning and has remained unchanged for 2 months. Limited range of motion, can't really use her wrist. She is very tired. Has taken ibuprofen but it does not help.
86 2021-04-10 fatigue Orange sized bruised arm Chest pains x6 lasting approx 6minutes over 7 days Very fatiqued
86 2021-04-12 lethargy, fatigue She got sick, pain in the arm and neck the day after the vaccine. I called her doctors office on th... Read more
She got sick, pain in the arm and neck the day after the vaccine. I called her doctors office on the 19th of Feb and I did not get a call back. She was sick to her stomach, really tired and lost her appetite. On the 22nd I called her doctor again... no response, on the 23 I called again. On the 24th finally someone spoke to me.. they stated they had called my mom and spoke with her. They are suppose to call me, my mom could not remember by the time she would hang up. They said to let her rest and give her electrolytes and Vit. B6. On the 26th when I called the doctor and said she is lethargic they said to take her to the ER. She flat lined at the hospital and her body went into shock. She ended up having Kidney, Heart and Liver Failure. She was still driving and doing all of her cooking, banking, shopping, showering, walking every day on Feb 18th. She died on March 5th.
86 2021-04-20 fatigue Fatigue, hypersomnolence, gait instability, anorexia, apathy, urinary urgency/incontinence, "brai... Read more
Fatigue, hypersomnolence, gait instability, anorexia, apathy, urinary urgency/incontinence, "brain fog"
86 2021-05-04 fever, fatigue Extreme fatigue and weakness, swelling of injection site (left arm), elevated temperature, mental c... Read more
Extreme fatigue and weakness, swelling of injection site (left arm), elevated temperature, mental confusion, complete loss of appetite ,cold sore
86 2021-05-06 fatigue Injection site is very red, swollen and tender. Pt felt exhausted and weak. 20X40 induration and ery... Read more
Injection site is very red, swollen and tender. Pt felt exhausted and weak. 20X40 induration and erythema on outer aspect of right upper arm somewhat involving but below main deltoid muscle. Exquisite tenderness is sensed with any movement. Dr. recommends that she does not get the second dose of the Moderna vaccine as it is too great of a risk for the geriatric patient. Probably OK to get a booster when it comes around. Pt instructed to keep her arm still until she is more comfortable moving it. Prednisone 20 mg tablet 1 tab BID for 3 days then 1 tab QD until gone to start on 4/30/2021.
86 2021-05-12 headache, chills, sweating, influenza like illness, nasopharyngitis, fever Stomach pain which ended in diverticulitis attack; Cold; Sweating; Nausea; Stomach pain which ended ... Read more
Stomach pain which ended in diverticulitis attack; Cold; Sweating; Nausea; Stomach pain which ended in diverticulitis attack; COVID arm; COVID Flu Symptoms; Right arm tender; Fever; Body aches/ Achy flu system; Splitting headache; Chills; Doesn't felt great; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Stomach pain which ended in diverticulitis attack) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diverticulitis since 15-Jul-2018, Drug allergy (Allergy to Flagyl (metronidazole).) and Drug allergy (Allergy to Sulfa). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEELING ABNORMAL (Doesn't felt great). On 09-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Splitting headache) and MYALGIA (Body aches/ Achy flu system). On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm tender). 10-Mar-2021, the patient experienced PYREXIA (Fever). On 10-Mar-2021 at 8:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (COVID Flu Symptoms). In March 2021, the patient experienced CHILLS (Chills). On 19-Mar-2021 at 9:00 AM, the patient experienced VACCINATION SITE REACTION (COVID arm). On 12-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain which ended in diverticulitis attack). On 15-Apr-2021 at 10:00 AM, the patient experienced DIVERTICULITIS (Stomach pain which ended in diverticulitis attack) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). The patient was hospitalized from 15-Apr-2021 to 18-Apr-2021 due to DIVERTICULITIS. The patient was treated with Surgery (On 18-may-2021, patient underwent intestinal surgery to remove diseased section.) for Diverticulitis. On 12-Mar-2021, HEADACHE (Splitting headache) and MYALGIA (Body aches/ Achy flu system) had resolved. At the time of the report, DIVERTICULITIS (Stomach pain which ended in diverticulitis attack), PAIN IN EXTREMITY (Right arm tender) and ABDOMINAL PAIN UPPER (Stomach pain which ended in diverticulitis attack) had not resolved, VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (Doesn't felt great), NASOPHARYNGITIS (Cold), HYPERHIDROSIS (Sweating), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown, INFLUENZA LIKE ILLNESS (COVID Flu Symptoms) had resolved with sequelae and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: increased (High) increased. No concomitant medications were reported. Patient reported to have no health issues for the past 18 months, before administration of mRNA-1273. Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. This case was linked to MOD-2021-023857 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional info:updated events after second dose of scheduled two doses of mRNA-1273 - chills, fever, achy flu, tenderness of right arm, hives, stomach pain. Updated Serious event - Diverticulitis, which required hospitalization. Updated No prior history and no treatment received to events - COVID arm and COVID flu. Updated medical history to Allergy to Sulfa and Flaquil, Diverticulitis on 15-7-2018. On 11-May-2021: Additional info:Updated events - cold, sweating, nausea.AE information(merged with other case); Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. MOD-2021-023857:Patient's first dose
86 2021-05-19 fatigue An avid crossword puzzle worker for 50 yrs, suddenly doesn't work them anymore. Short-term memory is... Read more
An avid crossword puzzle worker for 50 yrs, suddenly doesn't work them anymore. Short-term memory is worse than before. Left side of the mouth droops. Weight loss. Confused. Complained about leg weakness, legs and knees hurt, hard to walk, being tired, drooling, dry mouth, mind not right.
86 2021-06-10 headache, fatigue, sleepiness The following morning patient awoke and said she felt very tired and was complaining of severe stoma... Read more
The following morning patient awoke and said she felt very tired and was complaining of severe stomach gas and bloating. She did not have an appetite and just wanted to sleep and or lay down. The following day she complained that she had a canker sore in her mouth and a headache, still extremely fatigued. The stomach discomfort stayed with her for about a week and seems to have subsided.
86 2021-06-10 productive cough, cough Got second dose of Moderna 4/19/21. Was having increasing shortness of breath since 5/24/21. Admitte... Read more
Got second dose of Moderna 4/19/21. Was having increasing shortness of breath since 5/24/21. Admitted 6/8. Increasing lower extremity edema. Is obese. Coughing up phlegm. No fever/chills/chest pain/abdominal pain. COVID negative. Found to have a saddle pulmonary embolism and DVTs in the lower extremities . Appears unprovoked. Started on Eliquis. Still currently admitted 6/11
86 2021-06-23 body temperature increased, malaise Resident developed elevated temp of 101.2 with malaise, nausea and vomitting
86 2021-07-01 headache Within 15 minutes of receiving vaccine, client became dizzy, got a head ache. Client's heart rate wa... Read more
Within 15 minutes of receiving vaccine, client became dizzy, got a head ache. Client's heart rate was 104 bpm and blood pressure was 191/116. Oxygen stat was 95% on room air. EMTs had client lay down. Client was also given a cookie and some juice. Client was with EMTs for an hour. Blood pressure lowered to 175/110, and pulse to 80 bpm. Client refused EMTs taking her to the hospital. Client and client's daughter were advised to take client to hospital. Client stated that her daughter would take her to hospital.
86 2021-07-05 pneumonia death J18.9 - Pneumonia, unspecified organism
86 2021-07-08 fatigue Early April 2021, my mother said she was experiencing pins, needles, numbness and pain in right leg ... Read more
Early April 2021, my mother said she was experiencing pins, needles, numbness and pain in right leg (mild in left leg), her hands, severe back pain, and extreme fatigue. She soon lost the ability to hold items in her left hand. On May 10th she was in extreme pain, barely able to walk or hold herself up, making her mostly immobile up to the present day. She has experienced repeated intense "shock" sensations down her right leg, and localized areas of intense pain in different parts of her body such as the hip bone, wrists, collarbone, and left side of temple that come and go. In recent weeks, she's lost function of two fingers on the right hand. For the past several weeks, she's had an intense itchy scalp.
86 2021-07-19 headache Encephalopathy; Non-convulsive focal status epilepticus; visual hallucinations; acute confusion; lef... Read more
Encephalopathy; Non-convulsive focal status epilepticus; visual hallucinations; acute confusion; left frontal headache; urinary tract infection; This case was reported in a literature article and describes the occurrence of ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion) and HEADACHE (left frontal headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diastolic dysfunction, Type 2 diabetes mellitus, Phacoemulsification and Lens implant. Concurrent medical conditions included Chronic kidney disease stage 3, Glaucoma and Cataracts. Concomitant products included PREDNISOLONE for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization prolonged and medically significant), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus) (seriousness criteria hospitalization prolonged and medically significant), HALLUCINATION, VISUAL (visual hallucinations) (seriousness criteria hospitalization prolonged and medically significant), CONFUSIONAL STATE (acute confusion) (seriousness criterion hospitalization prolonged), HEADACHE (left frontal headache) (seriousness criterion hospitalization prolonged) and URINARY TRACT INFECTION (urinary tract infection). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CONFUSIONAL STATE, ENCEPHALOPATHY, HALLUCINATION, VISUAL, HEADACHE and STATUS EPILEPTICUS. The patient was treated with CEFALEXIN MONOHYDRATE (CEPHALEXIN [CEFALEXIN MONOHYDRATE]) for Urinary tract infection, at an unspecified dose and frequency; CEFTRIAXONE for Adverse event, at an unspecified dose and frequency; LORAZEPAM for Adverse event, at an unspecified dose and frequency and FOSPHENYTOIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion), HEADACHE (left frontal headache) and URINARY TRACT INFECTION (urinary tract infection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: negative (Negative) Negative. In 2021, Blood folate: normal (normal) normal. In 2021, Blood gases: normal (normal) unremarkable. In 2021, Blood glucose: high (High) 394 mg/dL with an osmolality of 308 mOsm/kg.. In 2021, Blood thyroid stimulating hormone: normal (normal) normal. In 2021, C-reactive protein: borderline (Borderline) 1.2 mg/dL and high (High) 4.0 mg/dL. In 2021, CSF culture: negative (Negative) Negative. In 2021, CSF test: negative (Negative) meningitis/encephalitis panel NAAT, oligoclonal bands and Lyme antibody were negative except for West Nile virus IgG but no IgM antibodies with minimal protein elevation. In 2021, Chest X-ray: normal (normal) unremarkable. In 2021, Computerised tomogram: normal (normal) no acute findings. In 2021, Culture urine: negative (Negative) Negative. In 2021, Electroencephalogram: abnormal (abnormal) non-convulsive focal status epilepticus. In 2021, Magnetic resonance imaging head: normal (normal) with and without contrast showed no acute findings.. In 2021, Metabolic function test: normal (normal) normal. In 2021, Physical examination: abnormal (abnormal) Word finding difficulties and slow mentation. however, no focal neurological deficits noted. No suprapubic, abdominal nor costovertebral pain was noted.. In 2021, Procalcitonin: borderline (Borderline) 0.14 ng/ml. In 2021, Red blood cell sedimentation rate: high (High) 107 mm/hr. In 2021, Respiratory tract infection: normal (normal) normal. In 2021, SARS-CoV-2 test: normal (normal) normal. In 2021, Treponema test: negative (Negative) Negative. In 2021, Urine analysis: negative (Negative) Negative. In 2021, Vital signs measurement: borderline (Borderline) Body temperature: afebrile, Pulse 61, respiratory rate 20, oxygen saturation 99% on room air Blood pressure 150-170/66-75. In 2021, Vitamin B1: normal (normal) normal. In 2021, Vitamin B12: elevated (High) above 2000 pg/mL. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ENCEPHALOPATHY (Encephalopathy), STATUS EPILEPTICUS (Non-convulsive focal status epilepticus), HALLUCINATION, VISUAL (visual hallucinations), CONFUSIONAL STATE (acute confusion) and HEADACHE (left frontal headache) to be possibly related. No further causality assessment was provided for URINARY TRACT INFECTION (urinary tract infection). Patient was at baseline neurological function. Patient had no evidence of cognitive dysfunction at baseline and no known neurological or psychiatric history. Patient had never used tobacco, alcohol nor any other illicit drugs. Their was no evidence of giant cell arteritis. Patient had no family history of seizures. Patient was seen in outpatient neurology clinic one month post hospitalization with baseline neurological status. Patient also reported she received 2nd Moderna vaccine 2 weeks post hospitalization and only experienced local injection soreness. 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 is a literature case. This case was linked to MOD-2021-256855, MOD-2021-256858 (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. This is a literature case.
86 2021-07-29 fatigue heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anythin... Read more
heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anything; hard for her to breath; Could hardly walk; Arm pain; Not like herself; felt wipe out; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (heart became inflamed) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDITIS (heart became inflamed) (seriousness criterion medically significant), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated). On 07-Apr-2021, MYOCARDITIS (heart became inflamed), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated) had resolved. Treatment medication were not reported. Concomitant products were not provided. After the second dose, the patient felt wiped out, weak, couldn't do anything, which was described as "not like herself". At the same time, the patient couldn't lay down. These symptoms lasted for about five weeks. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
87 2021-01-05 fever Vaccinated on Wednesday, 12/30/2020 about 1:30PM. The next evening, patient's arm started to swell a... Read more
Vaccinated on Wednesday, 12/30/2020 about 1:30PM. The next evening, patient's arm started to swell and become hot and started to itch. She had a fever as well. She stated this continued until 1/5/2021.
87 2021-01-05 fever Fever 100.3 degrees Ache body ARm swollen with rash
87 2021-01-06 malaise Malaise, diarrhea, nausea
87 2021-01-13 fever 24 hours following vaccination resident experienced emesis X1 & low grade fever.
87 2021-01-18 throat pain, runny nose, fatigue Resident reported shortness of breath, severe fatigue/weakness, new onset confusion, sore throat, bo... Read more
Resident reported shortness of breath, severe fatigue/weakness, new onset confusion, sore throat, body aches, runny nose
87 2021-01-21 fatigue, sleepiness Patient reports tingling in the tip of her tongue since getting the vaccine (for the past 3 days). S... Read more
Patient reports tingling in the tip of her tongue since getting the vaccine (for the past 3 days). She also reported extreme fatigue once she got home (felt fine at the pharmacy during the observation period). She also states she was so fatigued she didn't remember driving home and had to crawl from her front door to her bed and that she was in bed fatigued for 2 days. She has recovered from the fatigue but is still experiencing tingling in the tip of her tongue, which she hasn't experienced before receiving the vaccine.
87 2021-01-22 headache, chills, fatigue Headache Muscle pain Joint pain Chills Nausea Fatigue
87 2021-01-23 fatigue, fever Woke up early (around 2-3 am ) Friday, January 22 feeling muscle and joint pain . Nausea and vomit... Read more
Woke up early (around 2-3 am ) Friday, January 22 feeling muscle and joint pain . Nausea and vomiting followed at 4: am. Severe fatigue, weakness and upper back and shoulder aches, with a fever of 99.7. which climbed to 100. On Friday evening @ 11:00 pm nausea subsided somewhat but other symptoms mentioned continued along with a fever of 100 F. On Saturday @ noon January 23, 2021, Fever reduced to normal. (97.7), But still very fatigued and week.
87 2021-01-25 fatigue Patient is totally wiped-out and is spending most of her time in bed.
87 2021-01-25 fever, headache Day after vaccine patient reported headache, trouble breathing, numbness in hands and feet, and high... Read more
Day after vaccine patient reported headache, trouble breathing, numbness in hands and feet, and high fever. Patient states she does have COPD and it felt more of an exacerbation, but she states her COPD has been controlled for a while and has not had trouble breathing like this in a long time. Patient has recovered from all symptoms besides numbness in hands. Patient did not seek treatment becuase "she didn't want to".
87 2021-01-26 fatigue, lethargy At first didn't feel anything, her arm was puffed up a little bit which did not bother her. Then st... Read more
At first didn't feel anything, her arm was puffed up a little bit which did not bother her. Then started to feel fatigued to the point of falling down. Light headed, dizziness with vertigo which is not getting any better. Has been taking Meclizine which did not help. Still having the same symptoms, lethargic, cannot get any energy. Took some Tylenol and Ibuprofen about once a day but still having symptoms.
87 2021-01-26 fatigue PATIENT CAME IN TO STORE, AFTER OBSERVATION PERIOD PATIENT HAD NO COMPLAINTS. A COUPLE HOURS LATER P... Read more
PATIENT CAME IN TO STORE, AFTER OBSERVATION PERIOD PATIENT HAD NO COMPLAINTS. A COUPLE HOURS LATER PATIENT HAD BEGUN VOMITING AND DID NOT STOP FOR 3 HOURS. AFTER THAT TIME PATIENT WAS FEELING BETTER AND HAD NO OTHER COMPLAINTS BESIDES EXHAUSTION FOR THE REST OF THE DAY.
87 2021-01-30 chills, fever Low grade fever, chills, body aches, nausea, abdominal pain, diarrhea, confsion, weakness. Unable to... Read more
Low grade fever, chills, body aches, nausea, abdominal pain, diarrhea, confsion, weakness. Unable to get out of bed, stand or walk independently per baseline. Onset within 11 hours of dose with resolution except for leg pain 48 hours after administration
87 2021-01-30 headache, body temperature increased temp of 102.4 for two days, sevee headache for three days, vomiting and diarrhea for two days, confu... Read more
temp of 102.4 for two days, sevee headache for three days, vomiting and diarrhea for two days, confusion, aches all over
87 2021-01-31 sweating After receiving vaccine (within 30 minutes), pt began complaining of chest palpations and diaphoresi... Read more
After receiving vaccine (within 30 minutes), pt began complaining of chest palpations and diaphoresis. Rapid response was called and pt was brought to the ER for follow-up.
87 2021-01-31 sweating After receiving vaccine (within 30 minutes), pt presented with diaphoresis and palpitations. Rapid r... Read more
After receiving vaccine (within 30 minutes), pt presented with diaphoresis and palpitations. Rapid response was called and pt was sent to emergency room for further workup.
87 2021-01-31 lethargy, fatigue Injection given Friday morning. On Saturday she was very tired all day. Sunday she was very tired an... Read more
Injection given Friday morning. On Saturday she was very tired all day. Sunday she was very tired and became light-headed around noon. By Sunday evening she was lethargic. Monday morning, still lethargic and light-headedness has increased. Feeling somewhat disoriented. No fever, blood oxygen at 93.
87 2021-01-31 fever, fatigue low grad temp on 1/29/2021. swelling, redness, tenderness to R deltoid 1/31/2021 in AM, later that ... Read more
low grad temp on 1/29/2021. swelling, redness, tenderness to R deltoid 1/31/2021 in AM, later that AM increased redness and fatigue
87 2021-01-31 fever Patient arrives and appears ill but in no distress. Vital signs were concerning for fever. Given h... Read more
Patient arrives and appears ill but in no distress. Vital signs were concerning for fever. Given history of receiving the COVID-19 vaccine yesterday and concerned about an inflammatory response to the vaccine especially given she had COVID-19 infection back in October. Other residents at the nursing home are demonstrating similar symptoms after receiving the vaccine. IV was placed and labs were drawn and sent. The patient was given normal saline bolus as well as a dose of acetaminophen. Lab work is reassuring for a CBC without leukocytosis, stable anemia which is chronic for the patient, no thrombocytopenia. Electrolytes are only significant for borderline low sodium. Kidney function normal, BUN normal
87 2021-02-02 fatigue Just over 24 hours after vaccine patient states she developed systemic itching, racing heart, sob an... Read more
Just over 24 hours after vaccine patient states she developed systemic itching, racing heart, sob and fatigue which resolved in less than 24 hours. She did not seek care and was fine when she reported these symptoms.
87 2021-02-02 headache Patient presented to the emergency department for evaluation of lightheadedness after receiving seco... Read more
Patient presented to the emergency department for evaluation of lightheadedness after receiving second Moderna vaccine the previous day. Patient was eating breakfast when she started feeling lightheaded. Patient subsequently experienced some nausea. She does endorse a minor headache overnight, but none today. No visual changes no numbness or tingling extremity abnormal weakness in extremities. Patient received IVF and zofran with symptom improvement. Able to discharge home without further escalation of care
87 2021-02-04 body temperature increased Elevated temp 101.5
87 2021-02-04 fever Huge red mark on right arm below the vaccination. Began small the next day, has been getting worse e... Read more
Huge red mark on right arm below the vaccination. Began small the next day, has been getting worse every day since. Now, a WEEK later it is even larger, painful and have even begun to get better. (I have pics from Monday and again today.) She had a fever that did go away the next day. She totally lost her appetite for 5 days and would barely drink anything at all.
87 2021-02-07 headache, chills On Saturday while getting your night medicines from the shelf, and started feeling dizzy, tried to r... Read more
On Saturday while getting your night medicines from the shelf, and started feeling dizzy, tried to reach the shelf and said to herself that "i can't do it, I just can't do it". She staggered back and sat down on a towel hamper and apparently fell off of that onto the floor, lost kidney function. Tried to get up and managed to get her phone out and called her husband (he's hard of hearing - was downstairs). She said when he got there her head was towards the bathroom door and felt that he could not get in and could not get her up so she tried to get up. She did not have any strength. Finally she got up to get on her elbow and crawled into the vanity area and raised up and pulled herself up. She did not enough strength to walk to the bed. She got to the bed and then started with chills, turned on her electric blanket. She felt better Sunday, 1/7/21, and is real shaky today. She feels a little stronger but is not back to where she wants to be. Yesterday evening she felt her arm itching a little bit, and looked at it and it was swollen and red, and had an area about the size of her hand. Her husband felt of it and said that he felt she had fever in it. The arm was sore to touch. It is itching a little bit this morning. She had a headache for a couple of days as well, took a Tylenol one night and her head felt real weird. It was not real severe, and it hurt more times than it did others. It would come and go. Has not taken anything else for these symptoms. Her husband checked her BP, Friday was 108/62, and last night 106/67.
87 2021-02-07 malaise Moderna COVID 19 vaccine #1 given 2/4/21 at 130pm. Patient had malaise, confusion on 2/5. She then h... Read more
Moderna COVID 19 vaccine #1 given 2/4/21 at 130pm. Patient had malaise, confusion on 2/5. She then had 3 generalized seizures- status epilepticus- on 2/5 around 4-5pm. MRI brain and labs unremarkable. She recovered 36 hr later - on Keppra.
87 2021-02-08 body temperature increased, malaise Had vaccine at 9 am 02/0821. Today at 3:00 pm noted to have temp of 100.4 and generalized malaise. ... Read more
Had vaccine at 9 am 02/0821. Today at 3:00 pm noted to have temp of 100.4 and generalized malaise. Denies other complaints. Instructed to take medication to reduce temp, take fluids, rest, retake temp in 4 hours notify MD if temp increases or symptoms worsen.
87 2021-02-10 chills Chills, weakness, lack of appetite
87 2021-02-10 chills Chills and achey all over
87 2021-02-10 lethargy temp 101.1 lethargic
87 2021-02-10 throat pain, fatigue She was fine the first day, on Wednesday she noticed her arm was red, and had difficulty breathing, ... Read more
She was fine the first day, on Wednesday she noticed her arm was red, and had difficulty breathing, but has COPD and used her medications. About 5:00 PM her mouth started watering and she got the drive heaves, and then about 15 minutes and then started having them bad. She laid down and after 15 minutes she could not breath, couldn't get any air. When she was able to get some air, her throat was sore and she was really hoarse. Later in the evening she laid down again and the breathing difficulty happened again and it was worse. She was scared to the point that she was afraid to lie down. She is fatigued. She finally fell asleep during the night and didn't sleep much and today is very tired. She called her doctor this morning, and talked to the nurse. They told her if it got worse to go to the ER. Told her to call the CDC.
87 2021-02-11 fatigue, fever, headache Nausea, Headache, 100.3° Fever, fatigue
87 2021-02-11 head discomfort VACCINE GIVEN AT APPROXIMATELY 12:40. AFTER 15 MINUTE MONITORING PERIOD, PATIENT WAS ASKED BY MONITO... Read more
VACCINE GIVEN AT APPROXIMATELY 12:40. AFTER 15 MINUTE MONITORING PERIOD, PATIENT WAS ASKED BY MONITOR IF SHE WAS FEELING OKAY. PATIENT REPORTS SHE DOES NOT FEEL THE SAME AS BEFORE THE VACCINE. MONITOR STATES PATIENT WAS SHAKING AND HAD NOT PLACED ARM BACK IN SLEEVE FROM INJECTION 15 MINUTES PRIOR. MONITOR IMMEDIATELY GETS NURSE TO ASSESS PATIENT. AT 1257 BLOOD PRESSURE IS 122/62 AND HEART RATE IS 62. PATIENT REPORTS TO NURSE THAT HER HEAD FEELS FULL AND HER EYES ARE HEAVY. DENIES ANY OTHER SIGNS OR SYMPTOMS. PATIENT STATES SHE IS READY TO LEAVE. NURSES ADVISE PATIENT RECOMMENDATIONS TO BE EVALUATED BY EMS. PATIENT REFUSES STATING SHE WILL NOT WAIT. SHE STATES SHE IS READY TO GO HOME AND IF SHE FEELS BAD WHILE DRIVING SHE WILL PULL OVER. RISKS OF LEAVING AGAIN DISCUSSED WITH PATIENT. SHE ONCE AGAIN REFUSES TO WAIT ANY LONGER AND LEAVES.
87 2021-02-14 headache, chills The night she received the shot she developed pain, tenderness, redness and swelling at the injectio... Read more
The night she received the shot she developed pain, tenderness, redness and swelling at the injection site. The next morning had headache, chills, heart felt loud and fast, could not think, could not remember even normal things like how to turn on TV, insomnia. Went to store and became weak and breathing hard with minimal activity, had to sit down and rest before leaving. Symptoms lasted about 3-4 days and at this point have resolved.
87 2021-02-14 headache, fatigue Patient stated her arm was very sore, tender and has a knot around the injection site. She develope... Read more
Patient stated her arm was very sore, tender and has a knot around the injection site. She developed a headache and was extremely tired so she slept the next day. She still has a sore arm with a small knot around the injection site but is feeling better.
87 2021-02-15 chills, cough Chills, coughing entire day, then vomiting.
87 2021-02-15 chills, influenza like illness, fever Started with chills approx. 16 or 17 hours after injection, followed by fever and flu like symptoms ... Read more
Started with chills approx. 16 or 17 hours after injection, followed by fever and flu like symptoms . Lasted approx. 24 hours. Soreness at injection site.
87 2021-02-16 headache, fatigue Nausea, fatigue, lightheaded, headache
87 2021-02-17 dehydration morning after the vaccine my mother couldn't walk and fell out of bed, released her bowels, was naus... Read more
morning after the vaccine my mother couldn't walk and fell out of bed, released her bowels, was nauseous and weak. Called EMT and was taken to hospital. Her blood count dropped to 8.0, dehydrated and remains weak. I am awaiting more information from the hospital on her condition.
87 2021-02-17 lethargy, fever fever, lethargy, dizziness, weakness
87 2021-02-17 lethargy, fever Started feeling ?queasy?. After a few hours had dry heaves. Still later had a fever of 100. This ... Read more
Started feeling ?queasy?. After a few hours had dry heaves. Still later had a fever of 100. This happened on Saturday after having the shot on Friday night. Sunday a.m. my temp was 99 and I just felt lethargic. However, I had a large red patch at the injection site - as I did following the first injection. This has itched very much. I had felt fine since Monday until today when I have had some stomach cramping.
87 2021-02-17 fever Had the vaccine, and was fine and had problems after the first vaccine as well, which he prescribed ... Read more
Had the vaccine, and was fine and had problems after the first vaccine as well, which he prescribed benadryl and a Benadryl cream. He then called her back in a couple of days and she told him that she was fine. She saw the nurse at the facility who told her to call the eye doctor after the first vaccine, and this is exactly the same as the first vaccine. Her eye doctor had started her on a 2nd glaucoma drop Ropressor, and then with the reaction told her to stop taking it. Her eye is worse today than it was yesterday, and has been using cold packs which feel good to her eye. Was also running a fever of 99.9 and felt achy.
87 2021-02-17 fever Fever, body aches, giant hives all over entire body - not just injection site
87 2021-02-21 chills, headache, fever No problems after shot until 12 hrs later. Then chills, fever bad headache, nausea for 2 days. Too... Read more
No problems after shot until 12 hrs later. Then chills, fever bad headache, nausea for 2 days. Took Tylenol and stayed in bed
87 2021-02-21 fatigue blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received... Read more
blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection. On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs. Treatment details were unknown. Action taken with mRNA-1273 was unknown. The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
87 2021-02-23 sweating, sleepiness, chills, fatigue, body temperature increased shaking chills, temp of 99.9 Diaphoretic for 48 hours, in bed and slept 48 hours and then fatigue ... Read more
shaking chills, temp of 99.9 Diaphoretic for 48 hours, in bed and slept 48 hours and then fatigue for a few days following Onset of symptoms was 24 hours following the injection - tolerated well at the time of the injection
87 2021-02-25 headache, malaise Mostly it was nausea ad vomiting and weakness came on suddenly and i couldn't get up. and pain from ... Read more
Mostly it was nausea ad vomiting and weakness came on suddenly and i couldn't get up. and pain from my head to toe. head ache felt like i was frying my brain and everything hurt. there was no treatment i just stayed in bed. i was sicker with the reaction then i was when i had covid. I got better after about 2 days
87 2021-02-27 fever, fatigue, headache After injection on Friday, headache, fever, tired, achy. Very tired through weekend. On Monday she... Read more
After injection on Friday, headache, fever, tired, achy. Very tired through weekend. On Monday she developed painful deep breathing , tightness in chest, more achy, extremely low energy, warranted emergency visit for chest x ray and EKG. Still has debilitating exhaustion a week later.
87 2021-02-28 fever, headache, fatigue Friday I started having diarrhea, Friday night I was throwing up many times. It wasn't like I was si... Read more
Friday I started having diarrhea, Friday night I was throwing up many times. It wasn't like I was sick from the the wrong type of food, it was all water. I had a fever and a headache. This lasted all day and night Saturday. I found some Phenergan from 2009 and I took and it helped. I do not have much of appetite and still feel really tired as of today. I did call and speak to the nurse at my doctor's office.
87 2021-02-28 fever, nasal congestion, runny nose, cough pt stated that about 2 days after getting the covid vax her upper left arm was sore and she develope... Read more
pt stated that about 2 days after getting the covid vax her upper left arm was sore and she developed a dry cough. She lost her voice since her throat was hoarse. She had alot of mucus and nasal congestion. On 1/29/2021 pt stated she was very very weak and could hardly function. On 2/1/2021 she was worse and started running 101 temperature. She contacted her PCP where he recommended for her not to take her 2nd covid vax dose but did not give her any medical advice. She is still having periods of weakness at this time.
87 2021-03-02 cough, chills Details of pt. symptoms following her MODERNA Vaccine Note: She has been and was perfectly healthy ... Read more
Details of pt. symptoms following her MODERNA Vaccine Note: She has been and was perfectly healthy no health issues or symptoms of this nature until after receiving the Moderna COVID vaccination (1st dose). 26 Feb 2021 (Friday) 3:00 PM First dose Moderna vaccine given - no issues at time of vaccination. At approximately 7 hours post-dose ? severe whole body shaking, weakness, racing accelerated heart rate, difficulty walking- lasted throughout the night. 27 FEB 2021 (Saturday) Morning ? brain fog- very confused ? NO FEVER or shaking- however weak, unbalanced on her feet and confused in the afternoon we went about normal activities during the day so we thought she made it thru some acute reaction. Evening ? At approximately 9 PM ? whole body shaking, chills, weak, unbalanced. Her heart rate was not as accelerated (serious) as Friday night 28 FEB 2021 (Sunday) -seemed better but still brain fog (confusion), - by afternoon did normal things did a walk to get fresh air but she seemed to have labored breathing ? ?Huffing? and slow-she seemed better after the walk. 5 PM ? sudden and unexpectedly- she started whole body shaking, chills, difficulty walking, unsteady ? lasted about 1 hour ? unsteady on her feet needed assistance to walk. I put her to bed at 7:30 pm to rest and I was afraid she would fall because unsteady and shaking legs ? she had intermittent whole body shaking, chills, weakness 1March 2021 (Monday) ? around 10 am another episode - intermittent whole body shaking & chills, generalized weakness? developed respiratory symptoms, wheezing, deep croup- like coughing, weakness 2 March 2021 (Tuesday) ? respiratory symptoms seemed to be progressing. 3 March 2021 ( Wednesday) 3 PM Doctor evaluation ? fluid in lungs ? tested for Covid & prescribed antibiotics for lungs- 250 mg AZ ( 5 day treatment)
87 2021-03-02 fatigue, chills At 5:30 PM, March 2nd I began severe chills, shaking, and teeth chattering. My hands were shaking, ... Read more
At 5:30 PM, March 2nd I began severe chills, shaking, and teeth chattering. My hands were shaking, whole body trembling. Then around 10 PM I began perspiring. Very uncomfortable for the night. This morning I feel okay, a little tired.
87 2021-03-04 headache Dizziness, headache
87 2021-03-04 headache Received call from patient on 3/3/2021. She reports that approximately 1.5hrs after receiving her CO... Read more
Received call from patient on 3/3/2021. She reports that approximately 1.5hrs after receiving her COVID vaccine, she began having pain in the top of her head, neck, between her shoulder blades, down both arms to her fingertips, and down her spine. Reports also began having swelling in her feet. Reports having nausea and pain in her chest with walking. She reports she already had trouble with ambulation prior to vaccine, but it has been worse since receiving the vaccine. She reports as of 3/3/21, the pain is still occurring and not getting better. She has not seen her primary doctor since being vaccinated. I encouraged her to speak with her doctor or schedule a visit with them as her pain is not improving.
87 2021-03-04 malaise Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after rece... Read more
Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection. Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.
87 2021-03-06 dehydration, malaise Got shot on Wed. 2/10/2021. Started feeling ill within a few hours. Next day, was "sick" and needed ... Read more
Got shot on Wed. 2/10/2021. Started feeling ill within a few hours. Next day, was "sick" and needed to vomit (but didn't). Temperatures for 3 days was less than normal. 95.6 to 96.1. FridayI I started vomiting and had incidents of a pain in my stomach area and by that night became sicker and dehydrated. Was so sick I couldn't get out of bed to get water (I live alone). By midnight Friday (12:00) Feb. 13 I was so sick I called daughter to take me to hospital. Went to ER and then did blood work. Blood work showed liver enzymes were over 500 and eventually reached over 600, when normal is under 100. Was admitted to hospital. My electrolytes were out of "whack" too. My doctor told me in 11 years practice she had never seen a liver enzymes reading over 600. I am scared to take another vaccine shot at this point. Note: I had blood work done Friday, March 5, 2021 and my liver enzymes was 26 -- normal but I am not interested in getting that sick again and I have concerns about my liver.
87 2021-03-07 fever, headache, chills, throat pain Chills, fever, headache, sore thort, myalgia
87 2021-03-08 fatigue, chills, headache, fever Mild fever with chills, soreness at injection site, fatigue, headache
87 2021-03-08 headache headache with nausea 5 h9urs after vaccine given
87 2021-03-11 fatigue, fever 2/15/2021 -8pm - fever, body aches, weakness and fatigue, seemed o resolve after 24 hours, but durin... Read more
2/15/2021 -8pm - fever, body aches, weakness and fatigue, seemed o resolve after 24 hours, but during that following week, had forgetfulness, second week, forgetting was more frequent, by third week, daily and repetitive , can remember meds, Dr. names, whereimportant papers are , why we were going to the Dr. or where his office is.......etc She says she knows something is wrong, id fearful to walk the dog "I might get lost", she cant remember how to lay cards or marjong, which she did weekly for years. Saw PCP 3/10, went to hospital had CBC, CMP,, lipids, CXR, CAT head, UA, EKG, discharged on aricept and told to make an Neuro appt for eval,, First available was mid April, went back to ER next day 3/11, condition worse, "keep an eye on
87 2021-03-20 fatigue pt is here to receive 2nd dose of Moderna vacc. & she stated 1st dose caused some soreness to the a... Read more
pt is here to receive 2nd dose of Moderna vacc. & she stated 1st dose caused some soreness to the arm & slight fatigue but she noticed blood upon urination after 1st dose on that afternoon. It was not bright red blood but was dark/brick red color like menstrual break through bleeding she did not notice pain associated with it . She did not notice any more vaginal bleeding after the incident. She reported to her PMI, & PMP OK'ed for her to get 2nd dose but to call him if the same urination occurs @ 2nd dose pt abn on Estradiol(HRT)
87 2021-03-22 sweating at approximately 10 minutes post injection, pt complained of feeling dizzy. BP was elevated at 200'... Read more
at approximately 10 minutes post injection, pt complained of feeling dizzy. BP was elevated at 200's/110's, pt was diaphoretic, c/o nausea and chest pain. NP on site and Paramedic on site immediately evaluated and sent via ambulance to ER for further evaluation.
87 2021-03-23 malaise, fever Approx onset 24 hrs after vaccination w/ weakness in legs and generalized malaise/myalgia, fell and ... Read more
Approx onset 24 hrs after vaccination w/ weakness in legs and generalized malaise/myalgia, fell and diminished ability to ambulate -- > approx. 48 hrs after vacc was brought by EMS to ED for evaluation (2/19). Admitted to hospitalist service w/generalized weakness/ambulatory arrest, developed new onset urinary retention night of admission requiring straight cath intermittent. Increased weakness of leg, progressed to right arm/leg weakness > left leg weakness, so TELENEURO Consult initiated, hMRI w/o gado (2/21) checked, no CVA; recommendation for possible LP and EMG. Progressed to apparent areflexia ; seen by NEURO consult onsite (2/23) -- > felt to toxic encephalopathy due to COVID vaccination, motor predominant and detrusor involvement. Bladder atony resolved completely over approx. 3-4 days. Leg strength recovered somewhat over 4-5 days, and patient was referred for SNF rehab discharge. Developed low grade fever and pyuria on 2/24, urine cx grew ecoli ; initially treated with empiric ceftriaxone. Then patient developed left elbow and left knee pain/erythema/edema/tenderness (2/25) and was seen by ID in consultation. Got vancomycin empiric, and had aspiration of left knee joint effusion, revealing no crystals, 500cells monocyte predominant consistent with pseudogout. Vanco d/c'd; NSAIDs contraindicated for frail elder so patient was treated with prednisone short course. Ceftriaxone iv transitioned to po Keflex for ecoli uti to complete 7d course. Patient was discharged to SNF for rehab
87 2021-03-24 headache pt states she woke up with a very sore left arm. She was very stiff and sore to where she only coul... Read more
pt states she woke up with a very sore left arm. She was very stiff and sore to where she only could hardly move. She had a bad headache. she hurt from her head down to feet and every bone in her body hurt as well as her feet. She used a heating pad, took aspirin, and Benadryl. pt says by this day her symptoms were better and gone by the next day.
87 2021-03-24 malaise, fatigue Two days following shot. Cellulitis. Severe itching and local pain in right upper arm. Nausea. Extre... Read more
Two days following shot. Cellulitis. Severe itching and local pain in right upper arm. Nausea. Extreme fatigue. General malaise. Loss of appetite. Generalized weakness.
87 2021-03-29 malaise Described patient feeling fine the day after the vaccine (3/4/21), but by 3/5 she wasn't feeling wel... Read more
Described patient feeling fine the day after the vaccine (3/4/21), but by 3/5 she wasn't feeling well and was on the couch all day. By 3/8 she couldn't get out of bed, then was subsequently admitted to the hospital. Patient remained in hospital for ~2 weeks before passing away on 3/29/21.
87 2021-03-30 head discomfort, fatigue great fatigue and then weakness (2 days) Head feels full (1 day), Lower abdomen tenderness, urinary ... Read more
great fatigue and then weakness (2 days) Head feels full (1 day), Lower abdomen tenderness, urinary frequency, less tenderness the next day on the next , No fever at all,
87 2021-03-31 chills, fatigue, malaise Woke up with sore arm,3 inch circular rash around site of vaccine day 1. Developed into tiredness, w... Read more
Woke up with sore arm,3 inch circular rash around site of vaccine day 1. Developed into tiredness, weakness, chills, rash (not itchy) extended to both arms and both legs and feet. No appetite. General feeling unwell for about 10 days. Took tylenol (normally takes).
87 2021-03-31 fatigue syncope/fainted; Dizziness; couldn't eat; Fatigue/ tiredness; Sore arm; A spontaneous report was rec... Read more
syncope/fainted; Dizziness; couldn't eat; Fatigue/ tiredness; Sore arm; A spontaneous report was received from a consumer concerning herself, an 87-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syncope/fainted, sore arm/pain in extremity, dizziness, fatigue/tiredness, and she couldn't eat (decreased appetite). The patient's medical history included COVID-19 in December 2020. Concomitant product use was not provided. On 11 FEB 2021, 1 day prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 FEB 2021, the patient experienced sore arm. On 12 FEB 2021, the patient experienced syncope (she fainted), dizziness, fatigue/tiredness, and she couldn't eat. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The event of syncope/fainted was considered resolved on an unknown date. The outcome of the events of sore arm, dizziness, fatigue/tiredness, and couldn't eat were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
87 2021-04-01 sleepiness I couldn't stay awake the whole day I slept constantly throughout the night, this morning I took a T... Read more
I couldn't stay awake the whole day I slept constantly throughout the night, this morning I took a Tylenol
87 2021-04-06 chills 8 hours after receiving vaccine , patient had c/o chills, rigors, vertigo, lightheadedness, no synco... Read more
8 hours after receiving vaccine , patient had c/o chills, rigors, vertigo, lightheadedness, no syncope , Patient was seen in office 4/6/2021with unstable gait, change in speech pattern , c/o feeling unstable when standing
87 2021-04-07 cough, fatigue 09MAR2021-Patient is a 87 y.o. old female with a history of receiving her second COVID vaccine this ... Read more
09MAR2021-Patient is a 87 y.o. old female with a history of receiving her second COVID vaccine this past Friday. For the previous 2 to 3 days she has had increasing fatigue and generalized weakness. Anorexia and nausea have been noted as well. Apparently has not been eating or drinking well at all. No vomiting or diarrhea. No new medication recently. No fever or chills. Patient was seen and evaluated in the ER tonight by the ER physician. Significant acute renal failure was noted. Urinalysis was unrevealing. Mild hyperkalemia and moderate metabolic acidosis were noted as well. Initial treatment in the emergency room included a 1 L bolus of normal saline and antiemetic therapy. The hospitalist service was then consulted for admission." Discharge Summary Written 20MAR2021-Patient was admitted and started on IV fluids. Nephrology was consulted. She was started on a bicarb drip for metabolic acidosis. Renal US was negative for hydronephrosis but with incidental biliary ductal dilatation which was stable compared to a previous imaging study in 2011. Unfortunately her renal function continued to worsen and require dialysis. She had a temporary dialysis catheter placed on 3/12. She had RRT started on 3/12 and again on 3/13. Her urine output, electrolytes, and azotemia started to improve slowly. Renal function continued to improve and she no longer required any RRT. Her temporary dialysis catheter was removed on 3/19. Her Foley catheter was also removed on 3/19 and she was urinating well prior to discharge. She will go home with oral Lasix. Patient felt much improved and is agreeable for discharge on this date- 20MAR2021 Second Admission- 02APR2021-05APR2021- INDICATION FOR ADMISSION: This is an 87-year-old female with history of COPD, hypertension, and chronic lung disease, who presented to the Emergency Department on April 2, 2021 with a chief complaint of shortness of breath.. Three days prior to this admission the patient had increasing shortness of breath. The patient also had a nonproductive cough but denied any fever or chills. The patient was started on IV Lasix and IV steroids in the ED. She also had elevated BNP. She was admitted to the hospital for further medical management. Discharge Summary Written 05APR2021- She was started on IV steroids, IV Lasix, nebulization, and she was monitored closely. The patient also had HGB dropping to 8.8 from 11.3 back in March 2021. The patient was started on proton pump inhibitor. Gastroenterology and cardiology eventually were consulted to see the patient. She did have an EGD done at this time which showed gastritis. She will continue Protonix for now. She was started on IV Lasix and she improved with the treatment. Now she remains on room air. She denied any respiratory issue. Her renal function still remains at baseline. Today creatinine is 1.5. The patient can be discharged home today and continue oral Lasix at home daily for now. She was instructed to follow up with her primary care physician and also her cardiologist as outpatient in 1 to 2 weeks.
87 2021-04-09 pneumonia pneumonia, illness; missed her 2nd appointment; This spontaneous case was reported by a consumer (su... Read more
pneumonia, illness; missed her 2nd appointment; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia, illness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia, illness) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment). At the time of the report, PNEUMONIA (pneumonia, illness) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant meds: H. blood pressure medicines. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
87 2021-04-12 malaise patient complained of feeling unwell after second covid vaccine (which happened after first one as w... Read more
patient complained of feeling unwell after second covid vaccine (which happened after first one as well)- dizzy, shaky, chest pressure, nausea, resolved with time in clinc
87 2021-04-13 headache severe headache, vomiting, diarrhea requiring ambulance transport to ER and hospitalization
87 2021-04-13 pneumonia Patient presented 3 days after her second DuoNeb vaccine with weakness dizziness chest pain or short... Read more
Patient presented 3 days after her second DuoNeb vaccine with weakness dizziness chest pain or shortness of breath and was initially diagnosed with a pneumonia by chest x-ray obtained with antibiotics without improvement. Subsequently she was hospitalized and CT of the chest showed left lower lobe segmental pulmonary embolism. The patient never had history of venous thromboembolism in the past. She had weakly positive anticardiolipin antibody of IgG type of unknown significance. She was treated initially with antibiotics but after diagnosis of the blood clot she was started on anticoagulation with apixaban with improvement
87 2021-04-14 headache With 1st vaccine on 1-9-21 I had severe chest pain, the NP diagnosed it as pleurisity, told to take ... Read more
With 1st vaccine on 1-9-21 I had severe chest pain, the NP diagnosed it as pleurisity, told to take Tylenol, on second vaccine 2-6-21 I had a very bad headache that went down my neck and right shoulder, and lower back, NP said it was arthritis, go to sports med. since that time the pain has covered all my joints, muscle spasms to the point of not being able to walk, completely bedridden at this time, severe pain, headache, insomnia
87 2021-04-15 fatigue short of breath; a fast heartbeat; dizzy; nauseous; arm was sore at the injection site; fatigue; Thi... Read more
short of breath; a fast heartbeat; dizzy; nauseous; arm was sore at the injection site; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided). On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant), HEART RATE INCREASED (a fast heartbeat), DIZZINESS (dizzy), NAUSEA (nauseous), VACCINATION SITE PAIN (arm was sore at the injection site) and FATIGUE (fatigue). On 05-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, DYSPNOEA (short of breath), HEART RATE INCREASED (a fast heartbeat), DIZZINESS (dizzy), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.
87 2021-04-19 fatigue Extreme fatigue, weakness, elevated blood pressure
87 2021-04-24 chills Chills, nausea, blood sugar remaining high, no appetite, weak, enzymes high
87 2021-05-10 upper respiratory tract infection, cough, nasal congestion, fever, sinus disorder Chief Complaint Patient presents with ? Sinus Problem x week ? Fever on satuday ? Immuniza... Read more
Chief Complaint Patient presents with ? Sinus Problem x week ? Fever on satuday ? Immunizations 1ts covid vaccine was 01/29/2021 Patient is a 87 y.o. female HPI Patient is an 87-year-old female who presents with URI symptoms with her daughter. Patient does have dementia so history is coming from her daughter. Daughter is having similar symptoms for the similar length of time. Over-the-counter Tylenol for her mom on Saturday otherwise no other over-the-counter medications used. Symptoms started suddenly and have been persistent. Patient appeared feverish to her daughter on Saturday (flush in cheeks) but daughter denies any other known fevers and did not check her temperature. Admits to nasal congestion, nonproductive cough Denies rhinorrhea, ear pain, sinus pressure, sore throat Denies chest pain, trouble breathing, abdominal pain, n/v/d.
87 2021-05-12 chills, fatigue passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped o... Read more
passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped out, Fatigue; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRAVASTATIN for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on). 30-Mar-2021, the patient experienced FATIGUE (Wiped out, Fatigue). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown and FATIGUE (Wiped out, Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: result not mentioned (Inconclusive) result not mentioned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included discontinuation of glipizide. Company comment: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-070319 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information On 04-May-2021: Updated outcome of fatigue, added route of administration of suspect drug.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
87 2021-05-16 cough Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center w... Read more
Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center within Health system with weakness and arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health system on 5/2/2021 complaining of SOB. Stated that she has had non-productive cough for months, but felt it had worsened lately. Pt. found to be COVID positive with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not intubated but expired from cardiac arrest/COVID on 5/16/2021.
87 2021-06-01 throat pain, fatigue felt great weight and pressure on my chest; did not get the second dose of Moderna COVID-19 vaccine ... Read more
felt great weight and pressure on my chest; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot; couldn't swallow; antibodies absent; Fatigue/tiredness; Severe sore throat/not just a severe throat; Neck swelling; Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt great weight and pressure on my chest) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Type 2 diabetes mellitus since an unknown date. Concurrent medical conditions included Drug allergy (allergic to medications), Allergy to animals and Perfume sensitivity. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high, ESZOPICLONE (LUNESTA) for Sleep disorder NOS, GLIMEPIRIDE for Type 2 diabetes mellitus. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat), SWELLING (Neck swelling), SWELLING FACE (Facial swelling) and FATIGUE (Fatigue/tiredness). On 15-Apr-2021, the patient experienced DRUG SPECIFIC ANTIBODY (antibodies absent). On an unknown date, the patient experienced CHEST PAIN (felt great weight and pressure on my chest) (seriousness criterion hospitalization), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot) and DYSPHAGIA (couldn't swallow). The patient was hospitalized from 25-Mar-2021 to 26-Mar-2021 due to CHEST PAIN. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHEST PAIN (felt great weight and pressure on my chest) and OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat) had resolved and SWELLING (Neck swelling), SWELLING FACE (Facial swelling), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot), DYSPHAGIA (couldn't swallow), DRUG SPECIFIC ANTIBODY (antibodies absent) and FATIGUE (Fatigue/tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Antibody test: negative (Negative) states that patient does not have any antibodies. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient's HCP advised to wait for two more weeks to receive the second dose of vaccine. Med Info Agent: *Crosslink with MOD21-058959, MOD21-062129, MOD21-076250, MOD21-085519* Call received from consumer who stated she had reported a previous event, but is frustrated because on the form it says if you have a problem, call us, but there is no number to call. Caller provided her address and confirmed contact information, contact information updated. The consumer stated she does not leave her house, and she does not have a fax machine, so it makes it difficult for her to send it back. The caller would like the company to know about this, but did not have any further requests. Consumer stated she will eventually have someone send it out for her. Caller stated it wasn't just a severe throat as the form mentions, she couldn't swallow, but did not elaborate. Consumer stated she is not going to get the second shot per providers direction, and stated she had no antibodies from the first dose. No further information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs. This case was linked to MOD-2021-058039 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: significant: event added On 03-May-2021: Missed dose On 20-May-2021: Significant follow-up received On 21-May-2021: VAER from uploaded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs.
87 2021-06-03 fatigue, sleepiness Pt reports that she has had ongoing fatigue ever since her COVID Vaccines. Initially felt this as si... Read more
Pt reports that she has had ongoing fatigue ever since her COVID Vaccines. Initially felt this as side effect from the first dose, didn't think much of it; Then after the second dose really started to notice that the ongoing fatigue was continuing, very low energy. Now continually feeling low energy, falling asleep more easily than ever before, even in the middle of the day.
87 2021-06-03 pneumonia death Pneumonia heart murmur weight loss
87 2021-06-27 cough Itchy and reddened skin all over, lumps developed on skin. Welts on neck, coughing.
87 2021-07-08 malaise didn't know anyone around her; very weak; not feeling well; failure to survive complications from CO... Read more
didn't know anyone around her; very weak; not feeling well; failure to survive complications from COVID-19; Hospice care; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (failure to survive complications from COVID-19), MALAISE (not feeling well), CONFUSIONAL STATE (didn't know anyone around her) and ASTHENIA (very weak) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criteria death and hospitalization). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (didn't know anyone around her) (seriousness criteria death and hospitalization) and ASTHENIA (very weak) (seriousness criteria death and hospitalization). On 26-Mar-2021, the patient experienced HOSPICE CARE (Hospice care). On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (failure to survive complications from COVID-19) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was failure to survive complications from covid-19 vaccine. It is unknown if an autopsy was performed. At the time of death, HOSPICE CARE (Hospice care) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. Patient was concomitantly taking blood pressure medications. Patient received IV fluids as corrective treatment. Company Comment : Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: failure to survive complications from COVID-19 vaccine
87 2021-07-17 fever Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a c... Read more
Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her lungs) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her lungs) (seriousness criterion medically significant), COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever). At the time of the report, PULMONARY EMBOLISM (Blood clots in her lungs) outcome was unknown and COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 103. On an unknown date, COVID-19: positive (Positive) Positive. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 is a TCR and it is significant. Event outcome updated, Event is added2nd dose information is added.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
88 2020-12-31 chills Chills. They have resolved.
88 2020-12-31 sweating Anaphylactic like reaction started with dizziness sweating increased heart rate wheezing in and out ... Read more
Anaphylactic like reaction started with dizziness sweating increased heart rate wheezing in and out of consciousness. administered 0.3 of epinephrine, O2 via NC at 3L. called EMS. EMS arrived with in 10 minutes and administered additional 0.5 of Epinephrine and transported patient to the ER
88 2021-01-10 cough Resident developed cough, dizziness and increased confusion and was sent out to hospital via EMS.
88 2021-01-10 head discomfort, fatigue Fatigue and tiredness, heaviness in head, elevated blood pressure
88 2021-01-10 fever, chills chills, fevers and hypoxia
88 2021-01-12 chills Had Covid Vaccine AM of 1.8.2021. Woke up with Nausea, Vomiting X 4, Chills the following AM. Prese... Read more
Had Covid Vaccine AM of 1.8.2021. Woke up with Nausea, Vomiting X 4, Chills the following AM. Presented to ED. Found to be hypotensive during ER. Nausea Vomiting resolved. Tx with fluid replacement and dismissed home instructed to monitor BP. B/P dropped again at home returned and admitted to hospital.
88 2021-01-14 dehydration, sweating Became diaphoretic and lost consciousness after vaccine, was unresponsive for approx. one minute. Ch... Read more
Became diaphoretic and lost consciousness after vaccine, was unresponsive for approx. one minute. Checked pulse and opened airway with Jaw lift.
88 2021-01-17 fatigue Though patient was experiencing pain due to her arthritis, soon after the vaccination (1-2 hours) sh... Read more
Though patient was experiencing pain due to her arthritis, soon after the vaccination (1-2 hours) she experienced increased knee pain in both legs. Since the vaccination, she has also had bad diarrhea. Lastly, the worst symptom she experienced was light headedness and fatigue. At around 8:30pm on the day of the vaccination, she got up from dinner to go to bed a bit early. She was feeling tired and started to fade. She fell backwards against the wall, hit her head and landed on her bottom. Thankfully, I was there to help her up and was able to stay up with her to ensure she didn't have a concussion. Admittedly, she did not drink much water that day so it's possible this exacerbated the side effects of the vaccine. Maybe the clinics can offer people water bottles or other hydrating beverages to ensure things like this don't happen?
88 2021-01-18 malaise, fever Resident reported she didn't feel well. She started running a fever of 103. Resident complained her... Read more
Resident reported she didn't feel well. She started running a fever of 103. Resident complained her stomach and genitals were burning and pain in her legs. Resident has been vomiting today and diarrhea. EMS was called and resident transported to Hospital today 1/19/21
88 2021-01-19 fatigue, fever FEVER, AGITATION, BODY ACHES, FATIGUE
88 2021-01-24 fever Systemic: Other- burning of genital area and stomach, high fever
88 2021-01-28 body temperature increased elevated temperature
88 2021-01-31 fatigue, chills Sore arm, red arm, swollen arm, fever to the arm, chills, fatigued, slept a lot, starting to itch
88 2021-01-31 sweating, malaise Observed for 15 minutes without incident but while waiting for appointment scheduling pt began to fe... Read more
Observed for 15 minutes without incident but while waiting for appointment scheduling pt began to feel unwell. right and left upper quadrant ABD pain, N&V, diaphoretic, 30-40 ml emesis. Hypotensive 100/62 (baseline 144/90). No breakfast this AM. Kept under observation for additional 20 minutes. Pain resolving at time of discharge.
88 2021-02-01 headache Pain an swelling around shot area. Weakness, Muscle Pain Headache Leg cramps Lasted about 24 Hour... Read more
Pain an swelling around shot area. Weakness, Muscle Pain Headache Leg cramps Lasted about 24 Hours.After that time it gradually subsided. Tjis was on Friday and It was gone by Monday
88 2021-02-03 headache, sleepiness Sleepy on the evening of shot, sleepy and weakened arm and leg strength , slurred speech, complains ... Read more
Sleepy on the evening of shot, sleepy and weakened arm and leg strength , slurred speech, complains of headache and dizziness (difficult to validate)
88 2021-02-04 fatigue weak, fatigue day after vaccine Went to ER was told it was a reaction to vaccine and sent me home
88 2021-02-04 lethargy, fever 2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of brea... Read more
2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of breath and decreased oxygen sats. temp 101.7, pulse 102, respirations 36, BP 141/92, oxygen 94%. Lung sounds crackles bilaterally with rhonchi on the left. patient worked up for sepsis, CXR shows mild atelectasis. blood pressure dropped, and continued to drop through treatment requiring levophed drop to be initiated. Patient POA determined that this would not be her sister's wishes and made the decision to make patient comfort care status. 2/3/21- patient lethargic throughout night. 0640-patient demise.
88 2021-02-04 pneumonia EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH AND CHEST AND BACK PAIN. SHE ... Read more
EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH AND CHEST AND BACK PAIN. SHE CODED WHEN SHE GOT IN THE ER AND LATER PASSED AWAY THE MONDAY. DIAGNOSIS WAS PNEUMONIA AND HEART FAILURE PER STEP DAUGHTER.
88 2021-02-04 fever Temp. of 99.3, red, elongated area approximately 2x4inches which caused discomfort.
88 2021-02-10 fatigue, headache, fever 02/08/2021 onset headache, fatigue 02/10/21 fever, & diarrhea. Reports "terrible headache" & "just f... Read more
02/08/2021 onset headache, fatigue 02/10/21 fever, & diarrhea. Reports "terrible headache" & "just felt weak & tired". Took Tylenol for headache & went to bed, slept all day & night. Next day onset fever & diarrhea.
88 2021-02-11 sleepiness, fatigue large rash on right upper arm around injection site that has now covered most of upper arm starting ... Read more
large rash on right upper arm around injection site that has now covered most of upper arm starting on 2/7/21; although tired day after, extreme fatigue starting on 2/8/21 and sleeping almost all day, every day including today 2/12/21; all over body pain, especially in upper body and arms; None have resolved as of today 2/12/21, 7 days after 2nd dose date
88 2021-02-14 fever Daughter notinced that her mom has a fever of 99.8. Gave Tylenol but wanted to know was it normal t... Read more
Daughter notinced that her mom has a fever of 99.8. Gave Tylenol but wanted to know was it normal to have a fever after shot.
88 2021-02-16 fatigue Onset approximately 4am Sunday Feb 14 I experienced extreme fatigue, nausea with dry heaves. Stayed... Read more
Onset approximately 4am Sunday Feb 14 I experienced extreme fatigue, nausea with dry heaves. Stayed in bed ll day, only rising to urinate or for dry heaves. Did not eat or drink anything until 5am Feb. 15 when I had 2 cups of tea. Nausea gone, able to eat. However to date Feb. 17 I am extremely weak, shaky. , afraid to shower for fear of falling.
88 2021-02-20 fever Patient called and stated day after receiving her second dose of Moderna she began to have generaliz... Read more
Patient called and stated day after receiving her second dose of Moderna she began to have generalized edema BLE, BUE, and swelling around joints, she states her vision doesn't seem the same, slightly blurry, but she can see, states hard to describe. States she had a fever 101. on day after and took Tylenol - fever resolved. Other symptoms continue.
88 2021-02-24 headache, body temperature increased, fatigue Fatigue, 100*F, felt hot, Headache, Muscle aches lasting from 11am and continues today at 2:26pm.
88 2021-02-25 fever, chills, fatigue on s-2-4-2020 - Low grade fever (100), chills, muscle aches in both legs, from top to bottom of leg.... Read more
on s-2-4-2020 - Low grade fever (100), chills, muscle aches in both legs, from top to bottom of leg. Fever last 1/2 day, chills subsided as day went on but lasted for full day. leg muscle aches until next day. fatigue for 36 hours. As of 2/25 patient is fine.
88 2021-02-25 sleepiness, fever Delirium, started 2-1/2 hours after injection, admitted to the hospital, required IV sedation, Then,... Read more
Delirium, started 2-1/2 hours after injection, admitted to the hospital, required IV sedation, Then, 20 hours after vaccine developed fever up to 100.9, and patient developed somnolence but no longer combative, then about 32 hours after vaccine improved to 50% of normal status, 48 hours after vaccine was 90% normal, and then slowly returned to normal over the next 2 weeks
88 2021-02-27 lethargy Left arm became red, warm, swollen within hours of injection. This continued to spread starting with... Read more
Left arm became red, warm, swollen within hours of injection. This continued to spread starting with a 2 inch circle and spreading down the arm to the elbow and encircling the arm. Warmth, pain, swelling and redness increased. Also had profound weakness and lethargy that lasted three days. No elevated temperature. Contacted Dr. on 2/5/21 via email in MYCHART Main line health. He advised cool compresses, hydrocortizone and Benadryl or Claritin. We continued this regimen with no improvement until 2/16/2021. At that time redness was faint on arm about 2 inches of deep red and painful circling arm near elbow. On 2/18/2021 rash gone but skin peeling from shoulder to midarm. No further pain or redness or warmth after 2/20/2021
88 2021-03-01 fatigue, headache pt states that she woke up 5 days later today on 3/2/201 with extreme fatigue, headache, nausea. Pt... Read more
pt states that she woke up 5 days later today on 3/2/201 with extreme fatigue, headache, nausea. Pt still has these symptoms but has not contacted her PCP at this time.
88 2021-03-02 body temperature increased Pain in right thigh, SOB, O2 SAT 76%, T-100.7
88 2021-03-03 fatigue, chills She had weakness to the point she wasn't able to bear weight on her extremities, confusion, chills, ... Read more
She had weakness to the point she wasn't able to bear weight on her extremities, confusion, chills, emesis,and fatigue. She was sent to ER @ Hospital. Continues with confusion and weakness as of 3/4/2021.
88 2021-03-05 fatigue, chills Vomiting evening of shot, diarrhea for two days after shot, aching, chills, fatigue for two and a h... Read more
Vomiting evening of shot, diarrhea for two days after shot, aching, chills, fatigue for two and a half days following the shot
88 2021-03-09 body temperature increased, fatigue, lethargy 02/25/2021 by 12:30 feeling very tired , did not sleep well as right arm was painful and hot to touc... Read more
02/25/2021 by 12:30 feeling very tired , did not sleep well as right arm was painful and hot to touch. 02/26/2021 weak, lethargic, pain right arm , redness, swelling and warmth 1" x2", Temp 101.7, Tylenol at 12 noon and temp 100.7 @ 6PM Tylenol given, did not get out of bed till 8PM, only drank water during day, finally Jello around 8 PM. 02/27/2021 still lethargic, resting in bed, right arm red 3"x 3" and warm, itchy, took Claritin and did cool compresses and hydrocortisone cream as had been directed by Dr. after first vaccine . On 2/28/2021redness 3"x4" with two painful bright red itchy spots near inside of right arm continued with treatment. On 02/29/2021 area 4x4 but less redness, still sore and itchy. By 03/01/2021 redness , itching, swelling, pain gone.
88 2021-03-10 headache, fatigue Following the vaccine the next day she had the normal discomfort, tiredness and the arm was sore for... Read more
Following the vaccine the next day she had the normal discomfort, tiredness and the arm was sore for about a week. Then on 2/11/21 she had an ocular migraine, and as that ended she was hit with an intense pain in her head that she had never experienced before. It lasted for hours, for the rest of the day. She took Ibuprofen which did not do anything. She looked up online and the clinic had a report on what to do for the migraines, and she took Ibuprofen and strong coffee. She does that and was able to ward it off and stop it some. Then it continued to happen during the day and the pain is so intense. The day before yesterday, 3/9/21 the regimen of coffee and ibuprofen did not improve. It goes from the top of her head, down to her neck and sore to touch behind her ears. It is now a dull headache around her whole upper skull. She lives alone and her children do not live anywhere close to her. She is also having horrendous fatigue and is not able to get much done such as shopping, also shortness of breath and pounding heart beat generally is very active and some days she is not able to get dressed due to the symptoms. She went to UC and she had them do a COVID test, which was negative and sent to the ER at and her BP was 191/75, and was told to FU with her neurologist and internist and had no answers for her headaches.
88 2021-03-10 malaise, fever, chills Activated a BAKERS SYSTS; she could not get up, she could not go to bathroom; Left leg was very sore... Read more
Activated a BAKERS SYSTS; she could not get up, she could not go to bathroom; Left leg was very sore; Left leg very swollen; Chills; Had fever; Inconsistencies to remember; Not feel well; Delirious; A spontaneous report was received from a consumer concerning 88-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad reaction, began to not feel well, had fever, was delirious, inconsistencies with speech, problems with the left leg, left leg was very sore, very swollen, could not get up, had chills, couldn't sit in the bathroom, overreaction and activated a Baker's cyst The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, approximately three hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced to not feel well, had fever, was delirious(considered medically significant event), inconsistencies to remember, problems with the left leg. On Wednesday 17 Feb 2021, the patient experienced left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills. On Thursday 18 Feb 2021, the patient experienced could not sit in the bathroom. On Friday 19 Feb 2021, the patient was still very swollen. On an unknown date, the patient experienced activated a BAKERS SYSTS Laboratory details included, on Saturday 20 Feb 2021, the patient went to the hospital and got an ECO DOPPLER. Treatment for the event included Ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, bad reaction, began to not feel well, she had a fever, she was delirious, said inconsistencies, problems with the left leg, left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills, couldn't sit in the bathroom, overreaction and activated a BAKERS SYSTS was considered recovering(getting better every day).; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship cannot be excluded.
88 2021-03-14 fever, chills Fever - 104 - Chills - body ack - 4 days.
88 2021-03-14 fever, fatigue approx. ten or eleven days after receiving the Moderna vaccine, my mother experienced fatigue, naus... Read more
approx. ten or eleven days after receiving the Moderna vaccine, my mother experienced fatigue, nausea, body aches and a fever. Within hours, her body was inflamed with rashes from head to toe, with hives in certain spots, and she looks sunburned all over her body. She is extremely itchy and in pain and generally very uncomfortable.
88 2021-03-14 fever, headache, malaise pt got to feeling really sick w/ headache, nausea, light headed and fever of 100.9. Pts son called ... Read more
pt got to feeling really sick w/ headache, nausea, light headed and fever of 100.9. Pts son called ambulance. Pt passed out when EMTs were treating her. Pt was taken to hospital ER on 3/12/2021. They did blood work, covid test (negative) and CT. She was given fentanyl then admitted to the 2nd floor room for observation and given an IV. DX was reaction for Covid Vax. She was discharged on 3/14/2021 to FU w/ PCP within 1 week.
88 2021-03-16 lethargy 5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty s... Read more
5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty swallowing. 7 days post-vaccination patient looked "ashen". 12 days after vaccination patient was improving, but 14 days after vaccination patient was found to have (on lab work) critical hypernatremia (sodium level of 180 mmol/L), patient was re-referred back to hospice, and 17 days post-vaccination patient died.
88 2021-03-16 fever severe body aches all over except in legs, unable to sleep, fever, MISERABLE lasted 36 hours
88 2021-03-18 sweating 1538- pt in vaccine observation area after receiving Moderna vaccine dose 2. 1539-Pt was minimally ... Read more
1538- pt in vaccine observation area after receiving Moderna vaccine dose 2. 1539-Pt was minimally responsive and diaphoretic in her sit/walker. BP not reading , perhaps too low, pulse 70, R20,O2 sat 99% RA, No obvious sign of anaphylaxis. Family reported same symptoms previously, last on 3/12/21 and was eval in outside ED for syncope. 1540-Pt now less responsive but responds to simple commands, BP 63/45,P64,R16, O2sat 98% RA, cold compress applied to forehead. 1546- transferred to gurney in Trendelenburg & decision made to call ambulance. 1550- 911 called. Pt was transferred to ED
88 2021-03-22 lethargy, fatigue, malaise About 8 hours after the vaccine, Ppt experience extreme fatigue, dizziness, and loss of appetite. Sh... Read more
About 8 hours after the vaccine, Ppt experience extreme fatigue, dizziness, and loss of appetite. She continued to be lethargic and feeling unwell until about Monday morning (March 22).
88 2021-03-23 malaise she vomited when they got home and was feeling a little sick
88 2021-03-24 nasopharyngitis, cough She's come down with what looks like a bad cold. She's coughing constantly but says she doesn't real... Read more
She's come down with what looks like a bad cold. She's coughing constantly but says she doesn't really feel bad.v
88 2021-03-27 fatigue Patient said she was "tired, [nauseous], and couldn't eat for 3 days" after 1st dose. Then, a week... Read more
Patient said she was "tired, [nauseous], and couldn't eat for 3 days" after 1st dose. Then, a week later she had "chicken bites" on her arms and legs. All of the symptoms have been resolved. No sign & symptoms of anaphylaxis after 2nd dose.
88 2021-03-28 cough, productive cough, nasopharyngitis Cold symptoms (cough with phlegm) Weakness Low oxygenation
88 2021-03-31 cough, fever COVID+ Narrative: Patient administered COVID-19 vaccine (Moderna) dose #1 2/18/2021. On 3/17/2021, ... Read more
COVID+ Narrative: Patient administered COVID-19 vaccine (Moderna) dose #1 2/18/2021. On 3/17/2021, Patient developed a cough and fever and was brought by ambulance to tertiary care facility with diagnosis of COVID-19. Patient on BIPAP as of 3/22/2021. On 3/26/2021, Patient was initiated on morphine drip for comfort care and BIPAP was discontinued. Patient passed away 3/26/2021.
88 2021-04-01 fatigue weakness and fatigue
88 2021-04-05 body temperature increased, malaise, fatigue pt stated she was fine when she got home after she got the vax. she woke up feeling terrible and wa... Read more
pt stated she was fine when she got home after she got the vax. she woke up feeling terrible and was very ill. Her throat tightened up. She was warm, nauseas and shaking from head to toe, aching from head to toe. Her temp was 99.1, she was very fatigued and has loss of appetite. She took Tylenol for her symptoms. She slept for about 12 hours. Her symptoms lasted for days. She is still very weak and fatigued at this time.
88 2021-04-11 fever, fatigue, chills Adverse Event: Death Treatment: Rest & Cold Pack On Arm At Injection Site (Not Effective) Symptoms... Read more
Adverse Event: Death Treatment: Rest & Cold Pack On Arm At Injection Site (Not Effective) Symptoms: Arm Pain At Injection Site, Diarrhea, Fatigue, Dizziness, Low Appetite, Light Headedness, Fever & Chills
88 2021-04-12 fatigue Fatigue, dizziness, weakness. Issues with breathing caused hospitalization 3 days after shot. Blood... Read more
Fatigue, dizziness, weakness. Issues with breathing caused hospitalization 3 days after shot. Blood clot located in lung and 2 in right leg. Hospital stay 11 days, step down facility roughly 2 weeks, PT/OT upon arrival home.
88 2021-04-12 headache The morning after the vaccine injection, I started vomiting, continuing up until just before 6 PM, -... Read more
The morning after the vaccine injection, I started vomiting, continuing up until just before 6 PM, -- which caused severe rib and bone soreness, and severe headache. The next morning, I woke to severe itching over most of my body. After spending the day scratching to the point of bleeding, I finally went to the clinic on Saturday morning. After an exam, the doctor prescribed allergic anti-itch meds, along with a hydrocortisone cream. (one of my concerns was that I am on blood thinner, and the scratching caused some bleeding much to my dismay)
88 2021-04-14 fever Patient presented to the ED on 4/11/21, which was 4 days after her 2nd Moderna COVID-19 Vaccine, wit... Read more
Patient presented to the ED on 4/11/21, which was 4 days after her 2nd Moderna COVID-19 Vaccine, with bilateral hip pain that patient reports started after getting the vaccine. The bilateral hip and thigh pain was very severe and she was unable to ambulate and perform her ADLs like usual. Vaccine received on 4/7/21.
88 2021-04-15 sleepiness unable to stand or walk; tremors in her legs which as the days progressed spread to her whole body, ... Read more
unable to stand or walk; tremors in her legs which as the days progressed spread to her whole body, arms, head, and; reaction may have been a heightened extreme immune response to the second dose of the; lot of sleepiness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (lot of sleepiness), GAIT INABILITY (unable to stand or walk), TREMOR (tremors in her legs which as the days progressed spread to her whole body, arms, head, and) and ADVERSE REACTION (reaction may have been a heightened extreme immune response to the second dose of the) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No Reported Past Medical History.) on 15-Mar-2021. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced SOMNOLENCE (lot of sleepiness) (seriousness criterion hospitalization). On 18-Mar-2021, the patient experienced GAIT INABILITY (unable to stand or walk) (seriousness criterion hospitalization), TREMOR (tremors in her legs which as the days progressed spread to her whole body, arms, head, and) (seriousness criterion hospitalization) and ADVERSE REACTION (reaction may have been a heightened extreme immune response to the second dose of the) (seriousness criterion hospitalization). The patient was hospitalized from 18-Mar-2021 to 25-Mar-2021 due to ADVERSE REACTION, GAIT INABILITY, SOMNOLENCE and TREMOR. At the time of the report, SOMNOLENCE (lot of sleepiness), GAIT INABILITY (unable to stand or walk), TREMOR (tremors in her legs which as the days progressed spread to her whole body, arms, head, and) and ADVERSE REACTION (reaction may have been a heightened extreme immune response to the second dose of the) outcome was unknown. No concomitant medications were reported. No treatments were reported. During hospitalization, patient underwent numerous tests such as MRI and Xrays to rule out other diagnoses. All tests came back negative. Pt has been in rehabilitation facility since 26MAR2021. Her tremors are lessening in frequency and intensity. She is able to walk for short periods of time and use a walker as well.; Sender's Comments: This case concerns an 88-year-old female hospitalized with serious unexpected events of adverse reaction, somnolence, tremor and gait inability. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
88 2021-04-18 malaise Patient came in today (04/19/2021) so that she could let us know that she has been sick ever since s... Read more
Patient came in today (04/19/2021) so that she could let us know that she has been sick ever since she got her shot 2 months ago.
88 2021-04-19 headache headache, mild hypertension, flushing of face. Started 8 hours after receiving shot, patient report... Read more
headache, mild hypertension, flushing of face. Started 8 hours after receiving shot, patient reported to ED. No treatment administered.
88 2021-04-20 chills, throat pain, malaise pt says about 2 days after getting vax she had a very sore throat and swollen lymph nodes. She had ... Read more
pt says about 2 days after getting vax she had a very sore throat and swollen lymph nodes. She had trouble swallowing, no appetite, and had severe chills w/ no fever. She had trouble sleeping and eating. She could only drink water. She said she could only get a couple of hours of sleep a night. Pt developed thrush. She went to her PCP on 3/18/21. She was prescribed meds to take. Pt went to Dr. on 4/2/21 since she was not feeling any better. She was prescribed more medicine. She went to PCP on 4/19/2021 he gave her valium so she could some sleep. He ordered a sleep study. Pt says she is just starting to get her appetite back but is still having trouble sleeping.
88 2021-04-28 pneumonia Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nau... Read more
Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nausea. Admitted to hospital 3 days after shot and quickly developed pnemonia and died 4 days later after blood O2 fell below 80%. Had periods of mild improvements followed by more severe declines each time.
88 2021-05-24 headache, fatigue She got her vaccine, was tired, no energy. No rash or fever, perhaps a reddened area around the vac... Read more
She got her vaccine, was tired, no energy. No rash or fever, perhaps a reddened area around the vaccine site but it went away. About a week later she found a lump by accident under her arm in the armpit but down a little further towards her breast. The lump is painful when she puts pressure on it when she's trying to sleep. She knows it's there. She went to her PCP yesterday, 5/24/21 and he told her that they will watch it and it should dissipate. He did not give her any treatment for it. She did also have a stiff neck on the side of her vaccine and a headache, which have disappeared. She just wishes it would go away as it's a nuisance. Her doctor said that it was swelling of the lymph node. If she wears something tight it hurts her, but otherwise it doesn't, especially if she wears a bra. She just does not have the energy that she had before. She did get a Prolia shot on 2/4/21 but had no reactions from that, and was told that it would not interfere with the vaccine.
88 2021-05-27 pneumonia Patient was hospitalized due to pneumonia 6 days after receiving 1st dose; This spontaneous case was... Read more
Patient was hospitalized due to pneumonia 6 days after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The patient's past medical history included Lung infection NOS. Concomitant products included IMIPRAMINE for an unknown indication. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) (seriousness criteria hospitalization and medically significant). On 01-May-2021, PNEUMONIA (Patient was hospitalized due to pneumonia 6 days after receiving 1st dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included Antibiotics and Steroids. Very limited information regarding this event has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible.
88 2021-06-09 malaise She got her 2nd vaccine, she did not feel good and has not felt well since getting the 2nd vaccine. ... Read more
She got her 2nd vaccine, she did not feel good and has not felt well since getting the 2nd vaccine. Her whole body has felt weak. She did fall about 2 months ago due to the weakness, she hurt her leg and has not healed since then. She did go to the ER due to the weakness and they could not find any reason to keep her. She fell when she tried to get up at night and fell onto a night stand and landed in-between that and the bed and has a bad spot on her leg. The wound is not healing and they are trying to get her into a wound care center as nothing has helped it. She is now having therapy and they have been putting ointment on it and it is not healing. Home health comes to her house and she is on a walker and doing different exercises on them so that she can get back to having her strength back and able to walk. She was not using the walker before having the vaccine. She is now confined to her house and not able to get in the car and go where she wants to go.
88 2021-06-15 headache Reports severe headache, nausea, and weakness. No temperature. Saw MD either on 6-7-21 or 6-4-21. ... Read more
Reports severe headache, nausea, and weakness. No temperature. Saw MD either on 6-7-21 or 6-4-21. She says MD advised a vaccine reaction to covid vax
88 2021-06-16 fatigue My mom had the vaccine on 2/26/2021 and on 2/27/2021 she said she was feeling more tired. On 2/28 s... Read more
My mom had the vaccine on 2/26/2021 and on 2/27/2021 she said she was feeling more tired. On 2/28 she had a fall on her home and I had to take her to the hospital and it was a suspected hip fracture but it turned out to be a severe contusion. She had a subsequent fall within 2 weeks and it was a non injury fall.
88 2021-06-23 fatigue Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill... Read more
Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.
88 2021-07-14 cough Pt who resides in an assisted living facility w/multi comorbidities p/w SOB w/exertion, coughs and b... Read more
Pt who resides in an assisted living facility w/multi comorbidities p/w SOB w/exertion, coughs and bodyaches. Was found to be COVID positive and O2 sats in the 80s. Was admitted for medical management of acute hypoxic respiratory failure 2ndary to COVID-19 viral PNA despite having received Moderna vaccines (1/26 & 2/23). She was initiated on dexamethasone and O2. Showed rapid improvements and was ultimately discharged 2 days later back to her assisted living facility w/follow-up.
88 2021-07-17 fatigue Serious breathing problem; Feeling lousy all over; Upset stomach; Spitting up; Not interested in eat... Read more
Serious breathing problem; Feeling lousy all over; Upset stomach; Spitting up; Not interested in eating; Started having memory issue; Soreness at the injection; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating) and MEMORY IMPAIRMENT (Started having memory issue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Serious breathing problem) (seriousness criterion hospitalization), FEELING ABNORMAL (Feeling lousy all over) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion hospitalization), VOMITING (Spitting up) (seriousness criterion hospitalization), DECREASED APPETITE (Not interested in eating) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Started having memory issue) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating), MEMORY IMPAIRMENT (Started having memory issue), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. The patient went to hospital 7 times in the past 2 months. The smallest time spent in hospital was three days and the longest time was nine days. The patient was scheduled for second dose on 28-FEB-2021. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
89 2021-01-11 malaise, headache, chills upper arm red swollen hot itchy, resident states has felt terrible since receiving the vaccine will ... Read more
upper arm red swollen hot itchy, resident states has felt terrible since receiving the vaccine will not get the 2nd dose, has had chills, body aches, headache, backache, was in bed for days states she would rather die than have the second vaccine still not feeling "right" to this day
89 2021-01-14 fatigue At 9am on 1/14/21, Patient was unable to speak and unable to move her arms. After an undetermined pe... Read more
At 9am on 1/14/21, Patient was unable to speak and unable to move her arms. After an undetermined period of time (likely less than 5 minutes), she was able to call me (her daughter). She could hardly move her mouth but she was able to tell me that she needed help. I arrived about 20 minutes later. She had full movement at that time and was able to speak. Her BP was 140/73, HR 60. She was tired but scared to go to sleep around 5pm so we went to the local ER. Her labs, EKG, and MRI were all normal for her age. Today (1/15/21) at 10:30am, she experience the same thing but only in her face. She was able to move her arms but not able to talk. I was with her and could tell that she was fully conscious and aware, just couldn't move. It happened again but not as severely after she ate lunch around 12pm.
89 2021-01-21 fever RED, FEVERISH, AND ITCHING FROM SHOULDER TO ELBOW. SOLID RED AND ITCHED. HAD PROBLEMS SLEEPING. HYD... Read more
RED, FEVERISH, AND ITCHING FROM SHOULDER TO ELBOW. SOLID RED AND ITCHED. HAD PROBLEMS SLEEPING. HYDROCORTISONE CREAM OTC DID NOT HELP. RUBBING ALCOHOL APPLIED TO AREA PROVIDED RELIEF. PATIENT APPEARED TO SHOW ME AND HER ARM AND ITLOOKED FINE AND SHE SAID SHE WAS NOT HAVING ANY ISSUES AS OF 01/22/21. PATIENT DID NOT SEE A PHYSICIAN.
89 2021-01-25 fatigue nothing until 1 hour later, then increasing arm soreness and stiffness, fatigue and slight nausea. ... Read more
nothing until 1 hour later, then increasing arm soreness and stiffness, fatigue and slight nausea. By nightfall pain in arm severe, Took 2 ibuprofen and felt better and was able to go to sleep. Still sore in morning, trouble pulling clothes over head, but definitely better.
89 2021-01-25 pneumonia Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill fe... Read more
Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot.
89 2021-01-25 throat clearing, cough, headache, nasopharyngitis, sleepiness Had vaccine, didn't feel much at all. Came home, did not feel bad, day and half later started feeli... Read more
Had vaccine, didn't feel much at all. Came home, did not feel bad, day and half later started feeling bad, as well as kind of like a cold with drainage to her throat, a little coughing. Has had diarrhea for the last 3 days, nausea and generally feeling bad. The first week had a lot of drowsiness, had fogginess as far as thinking. The first few days took Tylenol and did not take anymore as her daughter said it contained aspirin for the pain. Still having the headache, feeling like she is not thinking real good. About a month ago had blood work and everything was perfect, no problems. Due to the fact that she is still having these reactions 2 weeks from the injections wanted to report it.
89 2021-01-31 fatigue, chills 1/21/2021 started feeling achy joints and restless at HS, reported feeling chilled 1/22/2021 Reports... Read more
1/21/2021 started feeling achy joints and restless at HS, reported feeling chilled 1/22/2021 Reports fatigue, states "slept all day" 1/23/2021- 1/26/2021 reports face "puffy", continues with muscle aches Reports used Tylenol to treat symptoms. Not able to recall date/time of initial dose.
89 2021-01-31 lethargy, body temperature increased, pneumonia Patient experienced labored breathing, rails bilaterally, and a temp of 99.2. Labwork showed a crit... Read more
Patient experienced labored breathing, rails bilaterally, and a temp of 99.2. Labwork showed a critical sodium level of 163. She was started on D5/NS 2 liters and then sent to the hospital when her fever spiked to 101.3. She was also very lethargic. She was diagnosed with pneumonia / sepsis
89 2021-01-31 lethargy, fatigue, chills chills, lethargic, muscle pain-saturday felt tired, took tylenol,
89 2021-02-04 body temperature increased temp of 100.2
89 2021-02-04 sweating I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14.... Read more
I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14. Nurse noted that she was pale and diaphoretic at 09:20. She stated that she was feeling weak and had lost all her energy. She had no chest pain, SOB, nausea/vomiting, headache. When taken, her BP was elevated, but her other vitals signs and blood sugar were normal. Her heart rate/rhythm was normal and regular. She reported some epigastric pain. Overtime, her symptoms improved without intervention. Her daughter came to drive her home. She was released after a minimum of 45 minutes post-injection. Suspect vasovagal response
89 2021-02-04 sweating I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14.... Read more
I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14. The nurse reports she was pale and diaphoretic while in observation at 09:20. She had no chest pain, SOB, nausea/vomiting, headache. She stated that she was feeling weak and had lost all her energy. When taken, her BP was elevated, but her other vitals signs and blood sugar were normal. Her heart rate/rhythm was normal and regular. She reported some epigastric pain. Overtime, her symptoms improved without intervention. She was given water, and rested under observation. Her daughter came to drive her home. She was released after a minimum of 45 minutes post-injection.
89 2021-02-05 fatigue, headache head ache, fatigue, no appetite
89 2021-02-07 fever I became nauseous, light headed then fainted. Had mild fever. Recovered after reclining.
89 2021-02-14 headache First day , Jan. 27. in the afternoon serious headaches began lasting for several days.. took Tyleno... Read more
First day , Jan. 27. in the afternoon serious headaches began lasting for several days.. took Tylenol to alleviate. Feb. 3. Very serious itching began at the injection site, on my left arm, width of my arm and down to just above the elbow and the area was very red. I used cold pack to alleviate the severe itching and redness. This lasted for approx. three days. Feb. 8. In the early afternoon my entire left arm began to ache, becoming painful as the day wore on. Then also went down into my armpit. The pain was very intense. I started having heart palpitations so totally Rested. Took a Tylenol for the pain. Took another Tylenol before bedtime and was able to sleep through the night. The pain and ache was better the next morning. By later in the afternoon I felt better,
89 2021-02-14 malaise 1335 - Pt arrived to observation feeling dizzy and not well. MD called, no answer. BP 210/109 133... Read more
1335 - Pt arrived to observation feeling dizzy and not well. MD called, no answer. BP 210/109 1336 pt reported chest pain and 911 called. 1345 - care transferred to 911 and transferred to ED.
89 2021-02-15 fatigue periodic rashes over body and all over itchy starting on day 4. also there has been sore joints and ... Read more
periodic rashes over body and all over itchy starting on day 4. also there has been sore joints and muscles and random fatigue.
89 2021-02-16 fatigue Fatigue, unable to tolerate solids or liquids all day, nausea
89 2021-02-17 lethargy difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was po... Read more
difficulty with balance, lethargy, elevated BP, fell in the floor, on 2/16 could not walk and was poorly responsive had to report to the ER, had two seperate ER visits due to lethargy and unable to walk. on 2/17 patient returned to baseline.
89 2021-02-17 lethargy SEVERE RIGHT ARM PAIN, SHORTNESS OF BREATH, LETHARGY, BODY ACHES, WEAKNESS, DIZZINESS
89 2021-02-21 fatigue Fatigue, Diarrhea
89 2021-02-21 sweating, sleepiness One week later it started itching and the next day it was red and hard. i was hurting on my neck and... Read more
One week later it started itching and the next day it was red and hard. i was hurting on my neck and felt bad and couldn't stay away. I think I had a fever because I was sweating but started feeling better by Sunday
89 2021-02-22 headache rt arm swollen, neck pain, headache
89 2021-02-26 fatigue Trouble breathing, severe fatigue, blood clots in lung and leg.
89 2021-02-26 headache, fatigue Dizziness, extreme fatigue, headache, nausea
89 2021-02-27 fatigue, malaise I learned that my mother started feeling ill the day after the shot in the evening and then went to ... Read more
I learned that my mother started feeling ill the day after the shot in the evening and then went to bed. On Saturday, January 23rd, she was exhausted and unable to get up. We learned this from a friend of hers who had called us back after both my brother and I were unable to reach her by phone. This was about 3:15 pm and we drove to her apartment and found her semi conscious in her bed. We awoke her but she was unable to talk or get up. We then called 911 and emergency paramedics came and took her to hospital.
89 2021-03-01 headache, fatigue Slight headache, feeling extreme tiredness fairly suddenly, saying ?I feel like I could pass out? a... Read more
Slight headache, feeling extreme tiredness fairly suddenly, saying ?I feel like I could pass out? and then passing out. Slight movement of mouth for air, some drooling.
89 2021-03-02 fever Did not open eyes (Unresponsive); Not speaking; Fever; Positive COVID Test; UTI; A spontaneous repor... Read more
Did not open eyes (Unresponsive); Not speaking; Fever; Positive COVID Test; UTI; A spontaneous report was received from a consumer concerning an 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: did not open eyes (unresponsive)/unresponsive to stimuli, UTI (urinary tract infection), positive COVID test/SARS-CoV-2 test postive, fever (pyrexia) and not speaking (dysphasia). The patient's medical history included Parkinson's Disease. On 19-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection. Treatment included antibiotics, remdesivir IV (intravenous) and rehabilitation. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events did not open eyes (unresponsive), UTI, positive COVID test, fever, and not speaking was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced serious unexpected events of COVID-19, pyrexia, urinary tract infection, aphasia, unresponsive to stimuli. The events occurred 25 days after the first dose of mRNA-1273. Treated with antibiotics and IV remdesivir. 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.
89 2021-03-03 fever Moderna COVID-19 Vaccine EUA Pt received Moderna COVID vaccine 2/15/21 (per pt, was 2/8/21 but show... Read more
Moderna COVID-19 Vaccine EUA Pt received Moderna COVID vaccine 2/15/21 (per pt, was 2/8/21 but shows 2/15/21). On 2/25/21 patient presented to ED with a complaint of generalized weekness for about 1 week, reporting it was worse that day. Pt reported diarrhea on Sunday 2/21 but none at visit. Denies fever, chills, chest pain, shortness of breath, nausea, vomiting, abdominal pain, vision changes, headache, sore throat, cough, diarrhea since Sunday, constipation, dysuria, hematuria, altered mental status. Low grade fever of 100 F, BP 155/65. Pt was tested for COVID, resulted in positive, and sent home with instructions for care. 2/26: Pt was contacted regarding starting monoclonal antibody bamlanivimab infusion.
89 2021-03-04 fatigue Severe rash and hives that led to an abscess, especially in the groin and crotch area. Severe exhaus... Read more
Severe rash and hives that led to an abscess, especially in the groin and crotch area. Severe exhaustion.
89 2021-03-04 influenza like illness Per patient's daughter the patient had severe flu like symptoms, shaking, extreme pain in wrists/fin... Read more
Per patient's daughter the patient had severe flu like symptoms, shaking, extreme pain in wrists/fingers/feet. Patient collapsed at home and pronounced dead at scene.
89 2021-03-08 headache Writer received call on 3/8/21 from patient stating that the evening she received her vaccine (3/4/2... Read more
Writer received call on 3/8/21 from patient stating that the evening she received her vaccine (3/4/21), she began experiencing a headache and a red, pruritic rash on her abdomen ("looks like roseola"). By the next day the rash had become "full blown" on her abdomen and wrapped around to her back. Unrelieved by any home remedy. Denies SOB, N, V, or other associated symptoms. Rash had not improved at time of call. Writer advised she be evaluated by her PCP for possible treatment of rash and to determine whether she should receive 2nd vaccine in series. Phone call to patient on 3/9/21 to check status. She reports she saw PCP who gave injection of steroid and a steroid taper. He recommends against receiving 2nd vaccine d/t high suspicion of adverse reaction to the vaccine. At time of call, patient is in NAD and notes some improvement in rash.
89 2021-03-10 chills, fatigue Aches and pains, chills, tiredness, weakness, took Tylenol
89 2021-03-10 chills, malaise, headache Presented with chills and headache and general feeling of Blah a few hours after receiving shot. W... Read more
Presented with chills and headache and general feeling of Blah a few hours after receiving shot. Went to bed with these symptoms. Awoke following morning feeling ok.
89 2021-03-10 fatigue, chills Chills / Fatigue / upset stomach / votiming
89 2021-03-11 fatigue was weak and very tired two hours after vaccination slept for 14 hours and recovered. I was concern... Read more
was weak and very tired two hours after vaccination slept for 14 hours and recovered. I was concerned because no one I know has had these effects. I will be 90years old and will get a second shot on the 16th. I would like to know the cause of these effects on me.
89 2021-03-11 headache, fever Felt feverish, fever blisters in and outside of nose and mouth, headache, swollen and sore right arm... Read more
Felt feverish, fever blisters in and outside of nose and mouth, headache, swollen and sore right arm to elbow, severe word finding deficit. Word finding problems subsided in 90 minutes. Arm swollen for 2 weeks. Headache lasted one day. Fever blisters lasted 2 weeks.
89 2021-03-14 malaise, headache headache, malaise, vomiting, right arm pain has subsided 1st vaccination: 1/27/21 0830, 2nd vaccina... Read more
headache, malaise, vomiting, right arm pain has subsided 1st vaccination: 1/27/21 0830, 2nd vaccination: 3/10/21 0830
89 2021-03-14 sleepiness feels sleepy; arm is sensitive; received the second dose 52 days after the first one; A spontaneous ... Read more
feels sleepy; arm is sensitive; received the second dose 52 days after the first one; A spontaneous report was received from a consumer concerning a 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: received the second dose 52 days after the first one (inappropriate schedule of product administration), feels sleepy (somnolence), arm is sensitive (vaccination site pain). The patient's medical history was not provided. No relevant concomitant medications were reported. On 2 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041120A) for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 001A121A) for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient experienced the event received the second dose 52 days after the first one . On 24 Feb 2021, the patient experienced the events feels sleepy and arm is sensitive. 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. On 23 Feb 2021 the outcome of events received the second dose 52 days after the first one was resolved. The outcome of events, feels sleepy and arm is sensitive was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 001A121A for the second dose) with associated AEs reported as sleepy and injection site pain 1 day after vaccination. 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
89 2021-03-15 pneumonia Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemente... Read more
Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemented our plan together. Please see PA's note for details. All relevant procedures supervised. Patient arrived to the emergency department due to respiratory symptoms, hypoxic, reported that Wednesday he received his 2nd dose of COVID vaccine. His initial workup was concern for NSTEMI with elevated troponin and peaked T-waves, his chest x-ray concerning for COVID/pneumonia. Patient initially tolerated oxygen by nasal cannula and sepsis protocol was started including IV fluid resuscitation that was done cautiously due to the concern of COVID with respiratory failure. The biotics were given. PA-C readdressed code status with patient who confirmed that his DNR DNI, she so contacted his daughter. Patient had multiorgan failure including acute kidney injury, and pneumonia with respiratory failure +/- respiratory failure. Due to the concern of NSTEMI patient was initially going to be transfer to was hospital and transfer was started. Patient respiratory status started deteriorating and his blood pressure dropped slightly but improved after 500 cubic centimeters of IV fluid and he was also placed on a NIPPV. Around 6:00 p.m. patient has significantly desaturation and he discontinued himself NIPPV. Due to inability to intubate patient, he was ventilated with BVM, patient is slowly improved saturation levels and was opening his eyes, he was placed on a non-rebreather. At this point there is high concern of ARDS and due to inability to intubate or give for the respiratory support His daughter was at bedside and updated of current medical status and poor prognosis. Patient continued deteriorating and at this point he had agonal breathing. His daughter was at bedside and she was made aware of the futile prognosis of patient due to his respiratory failure. Patient rapidly became bradycardic and went into cardiac arrest. No CPR was done due to the DNI DNR status of the patient. Critical Care Procedure Note Authorized and Performed by: MD Total critical care time: Approximately 30 minutes Due to a high probability of clinically significant, life threatening deterioration, the patient required my highest level of preparedness to intervene emergently and I personally spent this critical care time directly and personally managing the patient. This critical care time included obtaining a history; examining the patient; pulse oximetry; ordering and review of studies; arranging urgent treatment with development of a management plan; evaluation of patient's response to treatment; frequent reassessment; and, discussions with other providers. This critical care time was performed to assess and manage the high probability of imminent, life-threatening deterioration that could result in multi-organ failure. It was exclusive of separately billable procedures and treating other patients and teaching time. Please see MDM section and the rest of the note for further information on patient assessment and treatment. PE: VITAL SIGNS: BP: 126/75 Pulse: (!) 122 Resp: (!) 40 SpO2: (!) 82 % Temp: 98.1 °F (36.7 °C) Height: 5' 8" (172.7 cm) Weight: 152 lb (68.9 kg) General: Alert, nontoxic, in no acute distress. Lungs: Clear to auscultation bilaterally. CLINICAL IMPRESSION: 1. Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism (HCC) 2. Suspected COVID-19 virus infection 3. NSTEMI (non-ST elevated myocardial infarction) (HCC) 4. Multifocal pneumonia 5. ARDS (adult respiratory distress syndrome) (HCC) 6. Acute kidney injury (HCC) Further care and disposition otherwise as outlined by PA. ED on 2/14/2021 Revision & Routing History Detailed Report Note filed date Mon Feb 15, 2021 8:46 AM
89 2021-03-21 chills, fever The night of the vaccine she developed fever and chills. 3/17 she had bowel and urine incontinence a... Read more
The night of the vaccine she developed fever and chills. 3/17 she had bowel and urine incontinence and her daughter told her to rest and then she insisted on getting into the shower because she was upset about the incontinence 9:15 am she had gotten in the shower and her other daughter was close by when she had bowel and urine incontinence again and then lost consciousness and then she came to and had bowel and urine incontinence for a 3rd time. The bowel movements were massive diarrhea. Reporter believes she had a TIA event (Mini stroke). She was cared for at home by her daughter who is a nurse. In the past, when she has high fever and chills she tends to have TIA events.
89 2021-03-23 chills, headache Patient woke up more disoriented than usual, dizzy, short of breath, chills, headache, congestion, a... Read more
Patient woke up more disoriented than usual, dizzy, short of breath, chills, headache, congestion, and blurred vision. She was taken to the ER, but refused a CT scan. She was given a saline bolus. As of 03/19/21 her vision is still blurred and she is more disoriented than her baseline.
89 2021-03-24 fatigue Patient had a COVID vaccine on 3/12/21, this was her Second dose of Mederna vaccine. She states she ... Read more
Patient had a COVID vaccine on 3/12/21, this was her Second dose of Mederna vaccine. She states she had a scrap on her right elbow 4 hours after she states it turned red and swelled up. She then scrapped her left pointer finger and that swelled and turned red and going up just past her wrist. She states these are really improving but the swelling and itching around her left eye is getting worse. She feels her nose feels swollen. She states her eye is matted shut in the AM. She feels fatigued.
89 2021-04-01 dehydration Patient received her second coronavirus vaccination on March 18, 2021. Shortly thereafter she becam... Read more
Patient received her second coronavirus vaccination on March 18, 2021. Shortly thereafter she became confused. Patient developed anorexia and weakness after the second coronavirus vaccination. Patient presented to the emergency department 3/21/21 with confusion and hyponatremia and was discharged home. She represented to ED on 3/24/21 for altered mental status and was admitted with encephalopathy and hyponatremia after several days of confusion. Patient required Haldol as well as lorazepam and received 3% saline. She had an MRI of the brain showing no acute intracranial process and radiograph of the chest showing no acute findings. She was discharged home 3/26/21 but then returned to the ED 3/29/21 for altered mental status, confusion and dehydration and was admitted with toxic metabolic encephalopathy. MD feels toxic metabolic encephalopathy related to second coronavirus vaccination.
89 2021-04-04 headache, fatigue Nausea, headache, fatigue
89 2021-04-07 fatigue, influenza like illness Began with large baseball sized red area at site 24 hours after, then fatigue, flu like symptoms, Bl... Read more
Began with large baseball sized red area at site 24 hours after, then fatigue, flu like symptoms, Blood Pressure uncontrolled , then 3-7-21 squaded for tremor/seizure like episodes and high BP, Hyponatremia/Sodium low 135. Tremors/seizures continued, squaded on 3-14 for seizure/tremor episode, Hyponatremia Sodium 129, NS IV given. 3-17-21 Squaded again for seizure/tremor episode, admitted to hospital, Sodium 129. Calcium 8.2. Diagnosis r/o focal seizures/myoclonic episodes, Hyponatremia, r/o Moderna. Following up with Nephrology and Neurology currently. Still symptomatic.
89 2021-04-11 fatigue, fever On 3/10/2021 around 2 pm reported more fatigue, low-grade fever, and weak; treated w/ Tylenol; 3/13/... Read more
On 3/10/2021 around 2 pm reported more fatigue, low-grade fever, and weak; treated w/ Tylenol; 3/13/2021 refused medications; 3/16/2021 became constipated; 3/20/2021 gait unsteady and reported feeling as though she'd fall; more fatigued; 3/20/2021 refused medications and slept excessively; 3/20/21 vomited in bed; 3/22/2021 restless and exit seeking; 3/25/2021 packed belongings and exhibited exit seeking; 3/26/2021 transported to hospital 5:15 am due to falling while attempting to pick up something off of the floor; 3/29/2021 hospital reported she had a brain bleed and had chosen hospice care at her daughter's home; resident passed away on 3/30/2021.
89 2021-04-11 lethargy profound Lethargy, difficulty ambulating and progression to DVT bilaterally(03/27/2021)
89 2021-04-13 chills, fever Fever Blisters / cold sores broke out all over lips, outer and inner mouth, fever chills
89 2021-04-14 malaise 4/1 son arrived and she got sick - stomach and general feeling of unwell; couldn't eat. Increase in... Read more
4/1 son arrived and she got sick - stomach and general feeling of unwell; couldn't eat. Increase in shortness of breath (she had this with COPD); 4/2 and 4/3 continued to feel sick as described above. 4/5 son drove her to the hospital; she was dx COVID + in the ED. (note that on 3/27 she shopped with her daughter in law and ate in restaurant)
89 2021-04-15 headache While working at my desk @ 10:00 April 1st, felt a severe jaw pain, radiated around to back of neck... Read more
While working at my desk @ 10:00 April 1st, felt a severe jaw pain, radiated around to back of neck, down back, around to chest. Became very SOB. Called 911. Ambulance took me to hospital ER then ICU. Developed exquisite headache. Given pain meds and slept. Dr saw me the next morning. I had not had a heart attack. They had no DX. I think I had a 23 day delayed reaction to shot #2.
89 2021-04-21 chills, fever fever chills ache dizzy a dizzy spell caused her to fall and break her back. still recovering ... Read more
fever chills ache dizzy a dizzy spell caused her to fall and break her back. still recovering after 7 weeks
89 2021-04-22 headache, malaise, fatigue First Day complaint of aching arms, light head ache. on the 19th second day she said she did not fee... Read more
First Day complaint of aching arms, light head ache. on the 19th second day she said she did not feel very well, tired, by the evening noticed she was a little disoriented, by 10pm she was in bed my sister checked on her as she got worst called ambulance and she had a stroke right before paramedics got there.
89 2021-05-03 fever, lethargy Pt w/hx of dementia brought to ED w/fevers and low oxygen saturation and worsening SOB and lethargic... Read more
Pt w/hx of dementia brought to ED w/fevers and low oxygen saturation and worsening SOB and lethargic. CXR showed chronic appearing interstitial prominence and left basilar opacity. Pt was found to be positive of COVID-19 infection. Had received both Moderna vaccines (1/19/21 & 2/16/21). Pt admitted for additional management for acute hypoxemic respiratory failure, COVID-19 pneumonia and treated with dexamethasone, combivent nebs, remdesivir, and azithromycin/ceftriaxone empirically for secondary bacterial pneumonia. Pt ultimately was discharged 3 days later to an assisted living facility where she resides oxygenating well and more alert.
89 2021-05-06 respiratory tract congestion Dizziness, congestion.
89 2021-05-10 influenza like illness, fatigue This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes th... Read more
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), PULMONARY EMBOLISM (blood clots in her lungs) and THROMBOSIS (blood clots everywhere) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIARRHOEA (diarrhea), BLOOD PRESSURE ABNORMAL (no blood pressure), VACCINATION SITE PAIN (arm still hurts from time to time) and FATIGUE (felt tired). On 03-Mar-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion hospitalization), PULMONARY EMBOLISM (blood clots in her lungs) (seriousness criterion hospitalization) and THROMBOSIS (blood clots everywhere) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PULMONARY EMBOLISM (blood clots in her lungs), THROMBOSIS (blood clots everywhere), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), BLOOD PRESSURE ABNORMAL (no blood pressure) and FATIGUE (felt tired) outcome was unknown and DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (arm still hurts from time to time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) haven't found anything. On an unknown date, Endoscopy: normal (normal) haven't found anything. Treatment medication included apixaban. Action taken with mRNA-1273 in response to the events was not Applicable. The patient had an endoscopy and CAT scan where they haven't found anything at when she was at the clinic. Consumer was vaccinated with first dose on 16JAN2021 (was not able to locate lot/expiration on vaccination card). She got her second dose on 17FEB2021 (was not able to locate lot/expiration on vaccination card) and she felt like she was getting the flu, felt tired and on 3MAR2021, she was rushed to the hospital because she had "no blood pressure" and presented atrial fibrillation and blood clots in her lungs and everywhere. Her arm still hurts from time to time and continues to have diarrhea. She states she is a fairly healthy person does not take any medications, only Centrum vitamins. Since then she has gone to the clinic, had an endoscopy and CAT scan where they haven't found anything. She is now on Eliquis. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-101609 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
89 2021-05-20 chills, fever S/P VACCINE, STARTED WITH FEVER OF 101.2, CHILLS, RESPIRATORY WHEEZING, AND BODY ACHES AT 2100. PRN ... Read more
S/P VACCINE, STARTED WITH FEVER OF 101.2, CHILLS, RESPIRATORY WHEEZING, AND BODY ACHES AT 2100. PRN TYLENOL GIVEN AT 2116, TEMP DECREASED TO 100.1. NURSE PRACTIONER MADE AWARE WITH NEW ORDER FOR DUONEBS. TODAY ON 5/21 SHE STATES SHE STILL FEELS ACHES, HAS NOT HAD ANY TYLENOL TODAY- MORNING TEMP WAS 99.1 AND CURRENTLY IT IS 98.4.
89 2021-05-24 malaise, headache Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated b... Read more
Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated blood pressures of "240 and 190/92"; "sick" ever since after first dose; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DILTIAZEM, CILOSTAZOL (CLAUDINE), MONTELUKAST and SITAGLIPTIN PHOSPHATE (JANUVIA). On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") (seriousness criterion medically significant), MALAISE ("sick" ever since after first dose), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92"), MALAISE ("sick" ever since after first dose), SLEEP DISORDER (can't sleep), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that she was likely to travel to the Emergency Room at the time of the call. Her second dose of the vaccine was scheduled to take place on 17May2021. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high
89 2021-05-29 sleepiness To whom it may concern, Nov. 9, 2020: I was taken to hospital to diagnose why I was sleeping (up t... Read more
To whom it may concern, Nov. 9, 2020: I was taken to hospital to diagnose why I was sleeping (up to 20hours a day) and so drained. I was diagnosed with Covid-19, Pneumonia and was hospitalized for a week and half. I was not on respiratory equipment during this time. Jan. 12, 2021: Received First Moderna COVID-19 Vaccine Shot 1:15 p.m. At 10 p.m. I started, uncontrollable, none stop, and full body shaking (not shiver but shaking) that lasted over an hour. I called my son and 911 who sent an ambulance. My son said he thought I looked like I was having a seizure. The EMT said the only way I could find out what was happening would be to go to the hospital which I chose not to because I did not want to be re-exposed to Covid-19. The EMT suggested I take Benadryl. After the initial hour and taking a Benadryl my shaking subsided. I slept almost around the clock for 3 days. Feb. 9, 2021: Received Second Moderna COVID-19 Vaccine Shot 1:30 p.m. At 7 p.m. I was fine and talked to my son on phone. By 7:30 PM I had started shaking as described above. I called my son to the house and he gave me a Benadryl again. He held my head and shoulders during this shaking episode to keep my shaking from hurting my neck. After an hour or so the shaking again subsided. During the time the shaking was waning my son took a video of my shaking, in which I was shaking just not violently. Again, I slept 3 days. We have concluded these episodes are related to the Moderna COVID-19 Vaccine Shot. April 5, 2021: Appointment with Dr. During my doctor?s appointment I told the doctor of my experiences and showed him the video. The doctor said he hadn?t heard of this reaction. I asked him about the advisability of taking a booster shot. The doctor said we would have to wait and see. May 23, 2021 My questions are: Have you heard of this reaction before? If so, can you supply me with the information you have about it? If a booster is recommended, should I take it or how can I evaluate the risks either way? HOW WILL I BE ABLE TO FOLLOW THRU WITH THIS?
89 2021-06-28 pneumonia Death 5/29/2021 Causes of death listed on death certificate: 1. pneumonia 2. COVID 19 3. coronary... Read more
Death 5/29/2021 Causes of death listed on death certificate: 1. pneumonia 2. COVID 19 3. coronary artery disease, hypertensin, Non insulin dependant diabetes
89 2021-06-30 pneumonia pneumonia (had issues with swallowing and some went into her pulmonary area); This spontaneous case ... Read more
pneumonia (had issues with swallowing and some went into her pulmonary area); This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia (had issues with swallowing and some went into her pulmonary area)) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia (had issues with swallowing and some went into her pulmonary area)) (seriousness criteria hospitalization and medically significant). At the time of the report, PNEUMONIA (pneumonia (had issues with swallowing and some went into her pulmonary area)) had resolved. No treatment medication were provided. Action taken with mRNA-1273 in response to the events was not applicable. Reporter reported that his mother in-lawhad pneumonia (had issues with swallowing and some went into her pulmonary area) after getting the 2nd dose of the Moderna Covid-19 vaccine. The vaccine was administered through a vaccination clinic organized by a local healthcare provider.; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
89 2021-07-06 malaise Pancreatitis; When she got back home she wasn't feeling well so went back to the hospital two weeks ... Read more
Pancreatitis; When she got back home she wasn't feeling well so went back to the hospital two weeks after; She got sick and got into the hospital for 3 weeks; She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.; second dose was cancelled due to lack of product; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Pancreatitis), ILLNESS (She got sick and got into the hospital for 3 weeks) and MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (She got sick and got into the hospital for 3 weeks) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criteria hospitalization prolonged and medically significant), MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) (seriousness criterion hospitalization prolonged), PRODUCT AVAILABILITY ISSUE (She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.) and PRODUCT DOSE OMISSION ISSUE (second dose was cancelled due to lack of product). At the time of the report, PANCREATITIS (Pancreatitis), ILLNESS (She got sick and got into the hospital for 3 weeks) and MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) outcome was unknown and PRODUCT AVAILABILITY ISSUE (She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.) and PRODUCT DOSE OMISSION ISSUE (second dose was cancelled due to lack of product) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provide by the reporter. Treatment information was not provided by the reporter. Very limited information regarding the events "pancreatitis" , "illness" and malaise" has been provided at this time. Further information has been requested. For the events, product dose omission, product availability issue causality is assessed as not applicable.; Sender's Comments: Very limited information regarding the events "pancreatitis" , "illness" and malaise" has been provided at this time. Further information has been requested. For the events, product dose omission, product availability issue causality is assessed as not aplicable.
89 2021-07-14 malaise Client admitted to hospital on 7/14/2021 with COVID-19 symptoms, she was not admitted to ICU or intu... Read more
Client admitted to hospital on 7/14/2021 with COVID-19 symptoms, she was not admitted to ICU or intubated. Writer does not have access to any further details on this case. Please contact admitting hospital if further information is needed.
89 2021-07-22 pneumonia Patient hospitalized with pneumonia.
89 2021-07-26 malaise Patient had mild symptoms of COVID19 and came to the hospital to be tested. Patient tested positive ... Read more
Patient had mild symptoms of COVID19 and came to the hospital to be tested. Patient tested positive for COVID on 07/19/2021 after receiving the COVID19 Moderna vaccination on 12/23/2020 and 01/20/2021. Patient was not hospitalized after testing positive.