Moderna

Cardiovascular symptom reports

Male, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 heart rate increased Breathing difficulty-treated with nebulized medication. Received some relief after breathing treatm... Read more
Breathing difficulty-treated with nebulized medication. Received some relief after breathing treatment. I am on day 2 of having to take breathing treatments. Had fever as high as 102 degrees. I have been sweating profusely for 3 days. I had one night of hallucinating dreams and hardly slept at all. I had all of the general side effects, fatigue, headache, muscle pain, joint pain, chills. I had a rapid heartbeat.
40 2021-01-04 heart rate increased At about 1330 on 30DEC, the patient received the 1st dose of the Moderna COVID-19 vaccine. Less tha... Read more
At about 1330 on 30DEC, the patient received the 1st dose of the Moderna COVID-19 vaccine. Less than five minutes after the vaccine was administered, the patient noticed a metallic taste. About two to three minutes afterwards, the patient noticed a ?tingling? sensation mostly on the left side of the face and minimally on the right side. Almost immediately after the ?tingling? sensation, the patient felt the sensation of an increased heart rate and checked his pulse with his watch that had a pulse sensor. The watch indicated that he had a heart rate of 115 bpm. This sensation of an increased heart rate subsided after for one or two minutes and repeat pulse measurement was in the low 90s. Towards the end of the 15 minute post-vaccination observation period, the medical technician did the final check on the patient. The patient admitted to experiencing a metallic taste and a mild tingling sensation on the neck and face area. The service member was immediately brought back to the treatment room were a faint red rash and was noticed on the left side of the neck by the medical providers present. Two doses of Benadryl 25mg were given and the patient was told to continue to be observed in the observation area. After about 20 minutes, the tingling sensation resolved. The patient checked his pulse again and it was in the low 70s. The metallic taste resolved after about one and a half hours after the start of the symptom.
40 2021-01-04 fainting syncope 4 hours after chills 2-5 hours after body aches off and on for 7 days
40 2021-01-05 hypertension Dizziness, HYPERtension, flushing, tingling on one side of the body- opposite side from injection N... Read more
Dizziness, HYPERtension, flushing, tingling on one side of the body- opposite side from injection Narrative: dizziness, tingling, flushing, on left side of head down to left foot immediately after injection at 1148. BP increased to 168/104 with HR of 103 at 1211.
40 2021-01-06 fast heart rate approximately 5 minutes post vaccine pt reported feeling tachycardia and bilateral hands tingling. H... Read more
approximately 5 minutes post vaccine pt reported feeling tachycardia and bilateral hands tingling. HR noted to be 117 -122, BP 125/79 RR 16 NAD, Lungs CTA bilaterally no wheeze, neck: no stridor, no oral changes. Pt HR 92 after 10 minutes, and reported resolve of symptoms. Pt monitoring extended for a total of 1 hour, no recurrence or progression of symptoms. discussed use of Epi, pt has own epi pen on hand. Pt to discuss with allergist tomorrow, will use Epi if needed as discussed, and instructed go to the ED if any progression of symptoms
40 2021-01-07 chest discomfort chills aches cough sore throat chest tightness
40 2021-01-07 loss of consciousness Lethargy 10-15 minutes after vaccination. He said he could not stay awake. He said he felt himself g... Read more
Lethargy 10-15 minutes after vaccination. He said he could not stay awake. He said he felt himself going to sleep (chin going to chest); someone asked if he was ok. He then woke up and put his head back and hit it ("just a bink on the wall."). Brought to ED via w/c from vaccination monitoring room. Assessed by this RN and as he explains it, he had a loss of consciousness. Ambulated to ED with steady gait; denied dizziness. He states he took a Percocet at 10AM on date of vaccination. He said he has taken Percocet in the past for sciatica and has never had this lethargy and what he reports as a loss of consciousness in the past.
40 2021-01-08 pallor PATIENT RECIEVED THE FIRST DOSE OF MODERNA VACCINE AT HOSPITAL, COVID CLINIC. RN OBSERVING NOTICE TH... Read more
PATIENT RECIEVED THE FIRST DOSE OF MODERNA VACCINE AT HOSPITAL, COVID CLINIC. RN OBSERVING NOTICE THE PATIENT STARTED GETTING ANXIOUS AND WANTED TO MOVE AROUND AND LAY ON THE FLOOR. PATIENT STARTED TO TURN PALE AND WAS COMPLAINING OF BEING WARM. RAPID RESPONSE WAS CALLED. PATIENT STARTED TO LEAN BACK IN THE CHAIR BUT WAS CONSCIOUS THE WHOLE TIME. RAPID RESPONSE TOOK THE PATIENT TO THE ER.
40 2021-01-09 fast heart rate, blood pressure increased 1414- 18min after injection Patient stated he was feeling funny. He reported feeling hot and discomf... Read more
1414- 18min after injection Patient stated he was feeling funny. He reported feeling hot and discomfort to Left side of his neck. Upon evaluation he was mildly tachycardic HR 110. Symptoms began to worsen with redness spreading through his hands and upper torso and pt became diaphoretic. by 1420 Pt BP increased to 171/104. Pt was given IM Benadryl and Decadron per Dr. orders. by 1440 redness had completely resolved and Diaphoresis was gone, HR down to 144/82. by 1500 all Pt's symptoms resolved. Pt was able to be discharged from clinic without s/sx of distress.
40 2021-01-11 palpitations Beginning at 6:30 am on 1/8, two days following vaccination, the individual was driving to work and ... Read more
Beginning at 6:30 am on 1/8, two days following vaccination, the individual was driving to work and began to experience nausea while at a traffic light. He pulled over and threw up. Once he got to work he vomited again. He drove to another facility for work and then threw up 3 or 4 more times. He began experiencing hot flashes at this time. He went to the hospital and was seen in the emergency room. He threw up several more times in the ER and stated that his heart was racing and that he had diarrhea. The emergency room gave him medications for the nausea and he stayed there for 2 or 3 hours. He began to feel better and was discharged to home.
40 2021-01-12 blood pressure decreased, fainting After patient received the vaccine while waiting 15 minutes, the patients blood pressure dropped. Th... Read more
After patient received the vaccine while waiting 15 minutes, the patients blood pressure dropped. The patient fainted and hit his head. He was conscious during the event. The EMS was called and they check the patient. The patient was offered and opportunity to go to the hospital but he declined.
40 2021-01-12 pallor Around noon, my fiance doubled over in agonising pain and clutched his right side. We treated it lik... Read more
Around noon, my fiance doubled over in agonising pain and clutched his right side. We treated it like a stomach ache and he went through the rest of the day, even at work, in gut wrenching pain. This morning when I woke up, I noticed he was out on the couch. When I went to check on him, he was as white as a ghost and his lips were greying around the edges. I immediately told him to call into work. I thought he would say no because he has not called in in over 10 years, but to my surprise, he did so. I put him in bed and the abdominal pain is still present and now his fever is over 103!!! I bought Tylenol and Motrin and will be alternating between the two until the fever breaks and if the pain persists by 8 pm, we will be headed to the emergency room...
40 2021-01-13 fainting About 1 minute after receiving vaccine, pt fainted while on the way to recovery area. Pt was standin... Read more
About 1 minute after receiving vaccine, pt fainted while on the way to recovery area. Pt was standing in entryway when he started to fall down but was caught on the way down by a nurse. While on the floor the pt was asked his name and responded with correct answer, EMS was called and then pt was placed in wheelchair and transferred to cot after. the BP and pulse was taken (63/46, pulse 51) Glucose gel was provided orally. EMS arrived shortly after BP was take but pt refused stating that he was feeling better and he waited out the remainder of his recovery time laying in cot with no other incidents.
40 2021-01-17 chest discomfort Beginning night of 1/13 around 9pm, felt cold chills, nausea, headache, body & muscle aches, loss of... Read more
Beginning night of 1/13 around 9pm, felt cold chills, nausea, headache, body & muscle aches, loss of appetite and fever. Tight chest and hard to breathe. Feels like asthma attack was triggered. Has been persistent symptoms since 1/13. Have been alternating Tylenol and Motrin. Using albuterol pump and vicks vaporizer, as needed.
40 2021-01-23 chest pain Shortly after the shot: - Dizziness - Weakness Later: - Sore left arm - Chest pain, left side - Fat... Read more
Shortly after the shot: - Dizziness - Weakness Later: - Sore left arm - Chest pain, left side - Fatigue - Anxiety, perhaps triggered by all of that.
40 2021-01-26 heart rate increased Muscle spasm and tightness in shoulders, neck and back. Dizziness, Diaphoresis, elevate heart rate, ... Read more
Muscle spasm and tightness in shoulders, neck and back. Dizziness, Diaphoresis, elevate heart rate, nausea.
40 2021-01-28 loss of consciousness Patient lost consciousness will seated approx 10 min into the observation period post 1st Moderna va... Read more
Patient lost consciousness will seated approx 10 min into the observation period post 1st Moderna vaccine injection. Medical staff immediately attended to patient by lowering him to the floor in supine position. 911 was called. He began to arouse while his breathing and vital signs were being checked. He was conscious and reclining in his chair when EMS arrived. He then stated that he "passes out" when he gets injections. EMS evaluated patient, who refused EMS transfer to a local hospital and any further treatment. Coworkers of patient agreed to drive him home and shuttle his car. Patient walked out of the clinic at approx 1500hrs. Moderna Lot 028L20A Exp 09JUL21
40 2021-01-31 fast heart rate fever, chills, soreness at injection site, tachycardia, insomnia on and off for 3 days
40 2021-02-03 fibrin d dimer increased, oxygen saturation decreased Patient received the vaccine on 1/18/21. He awoke early on 1/20/21 with nasal congestion. By that ... Read more
Patient received the vaccine on 1/18/21. He awoke early on 1/20/21 with nasal congestion. By that afternoon, he was having difficulty breathing. He was evaluated at Hospital outpatient clinic and sent to the Hospital Emergency Department. On arrival he was placed on oxygen and given a rapid COVID-19 test and COVID-19 PCA test which were both negative. He was also provided pulmonology consult. He was admitted and remained unable to maintain adequate oxygen sats without 10L oxygen until 1/22/21 late in the evening when he abruptly no longer needed oxygen. He was provided steroids initially. Ceftriaxone IV was added. Respiratory therapy provided ipratropium inhalation and vest therapy. He improved rapidly 1/23/21 and was released from the hospital on 1/24/21.
40 2021-02-07 chest discomfort Elevated heart rate (130 at rest for 10+ hours, my normal is 70-80) Elevated blood pressure (150/89 ... Read more
Elevated heart rate (130 at rest for 10+ hours, my normal is 70-80) Elevated blood pressure (150/89 at rest for 10 + hours, my normal is 110/70) Extreme headache, light sensitive Nausea Mild anaphylaxis itching/burning/tingling in lips, tongue and throat Feeling of intoxication, disoriented, slurred speech, dizziness Rash/redness that spread beyond injection site on to back of shoulder Agitation Itchiness Peeling of skin in mouth/cheeks Blisters on roof of mouth Chest tightness with normal breathing Jaw pain Treatment as listed below; continue with Benadryl every 6 hours and ibuprofen; return if symptoms continue or worsen
40 2021-02-25 pallor, loss of consciousness, fainting Within one minute of receiving vaccine, the patient became pale, stated that he felt dizzy and faint... Read more
Within one minute of receiving vaccine, the patient became pale, stated that he felt dizzy and fainted. Patient regained consciousness within one minute. Upon regaining consciousness, patient reported feeling lightheaded and dizzy but was oriented to person, place and time. Skin was warm and dry but pale in color. After regaining consciousness, patient also stated that he has a history of fainting 5-6 years ago after receiving an influenza vaccination. (During screening questions, patient denied having any reactions to vaccines in the past) Patient independently moved from a chair to a laying down position on a cot and expressed an improvement in how he was feeling. Vital signs taken after event as recorded below. When asked patient stated that he does recall times when he thinks he may have been hypoglycemic in the past. Patient also states that he has been very nervous about receiving injections throughout his life. EMS called and assessed patient at the vaccination clinic site. Patient drank a 10 oz bottle of orange juice prior to EMS arriving and when EMS staff obtained his blood sugar the result was 97. EMS stated that patient was stable and all vital signs were stable. Patients skin color improved to pink. Patients wife was called by patient and she provided transportation home for patient. Prior to leaving the vaccination clinic, patient was walking around for several minutes and denied any feelings of being lightheaded or dizzy. VITALS SIGNS: 5:06pm: Heart rate: 50, Oxygen Saturation: 99% on room air 5:15 pm: Blood pressure: 100/78 ; Heart rate: 50; oxygen saturation 99% on room air. 5:20pm: Blood pressure 98/76 Heart rate:52; oxygen saturation 96% on room air. 5:34 pm: Blood pressure 92/68 Heart rate: 53 oxygen saturation 97% on room air. Vital signs taken by EMS staff were not recorded by public health nursing staff.
40 2021-02-25 pallor 10:05 AFTER RECEIVING INJECTION TO L DELTIOD CLIENT C/O MOUTH AND BACK OF TONGUE SWELLING. B/P 150/... Read more
10:05 AFTER RECEIVING INJECTION TO L DELTIOD CLIENT C/O MOUTH AND BACK OF TONGUE SWELLING. B/P 150/112, R-18 EVEN AND UNLABORED, P-86 AND REGULAR. CLIENT ALERT AND ORIENTED. FACE AND TONGUE ASSESSED; NO SIGNS OF SWELLING NOTED. FACIAL SKIN TONE APPEAR PALE AND ASHEN. NO SWEATING OBSERVED. CLIENT REFUSED EPI INJECTION. 911 CALLED. 10:15- B/P 162/128 R- 18 EVEN AND UNLABORED, P-68 AND REGULAR. CLIENT IS SPEAKING WITHOUT DIFFICULTY. ALERT AND ORIENTED. CLIENT CONTINUES TO APPEAR PALE WITH NO SWEATING. CLIENT CONTINUES TO REPORT TONGUE FEELING "NUMB". ADVISED CLIENT TO DISCUSS 2 ND WITH PCP. 10:18-B/P 165/122 BY EMS. CLIENT ALERT AND ORIENTED. SPEAKING. RESPIRATION UNLABORED. 10:25- CLIENT LEFT FACILITY VIA EMS ALERT AND ORIENTED TIMES 5.
40 2021-02-27 blood pressure increased, heart rate increased Uncontrollable shaking; rise in blood pressure; hives; (stomach, back, face, injection site) high he... Read more
Uncontrollable shaking; rise in blood pressure; hives; (stomach, back, face, injection site) high heart rate; swelling in face and neck; shortness of breath.
40 2021-03-02 fast heart rate Symptoms started 14 hours later including Hazy Urine Fever of 105 Tachycardia Body ache
40 2021-03-04 platelet count decreased All symptoms started 6 hours after second moderna vaccine - CC - Fatigue ++, swollen glands, body ac... Read more
All symptoms started 6 hours after second moderna vaccine - CC - Fatigue ++, swollen glands, body aches - back pain, fever. Fever for 5 days. Bad headache. + bleeding gums 3/4/21 with rash to hands, arms today.
40 2021-03-11 chest pain Patient felt to be in distress at the close of his observation time. He was complaining of trouble w... Read more
Patient felt to be in distress at the close of his observation time. He was complaining of trouble with focusing his eyes, left sided chest pain, and was diaphoretic. Pt appeared to be in moderate distress and very anxious. I examined the pt through the car window and listened to his heart and lungs. Pt was not in respiratory distress and heart rate and rhythm were regular. Reassurance was provided to the pt, but he was also told that to be safe I recommended that he be evaluated in the emergency department and that he be transported via ambulance. Pt expressed understanding and agreed to going to the ED but was refusing transport via EMS. Pt was the passenger in the vehicle and he said that the driver could just take him. I expressed that transport via EMS would be the safest but we could not make him go via EMS and that if they wanted to leave via private vehicle then they could but i still recommended that he be evaluated in the ED. He expressed understanding and that he would go directly to the ED via personal car.
40 2021-03-11 chest pain Medical staff was called for patient distress. Upon getting to the car that the pt was in, he report... Read more
Medical staff was called for patient distress. Upon getting to the car that the pt was in, he reported trouble focusing, left sided chest pain, and sweating. Gen: Awake, Alert, Moderate Distress, diaphoretic Cardio: RRR w/o m/g/r Resp: LCAT in all fields, mildly increased work of breathing Skin: no rashes noted, no edema noted of the face or angioedema noted of the lips Psych: anxious Neuro: able to answer questions appropriately, able to follow instructions, CN 2-12 grossly intact Pt instructed that his symptoms were not necessarily consistent with anaphylaxis but with diaphoresis and left sided CP I recommended that he be evaluated in the Emergency Department. Pt agreed to this. Transport to ED via EMS was offered and pt declined as he had a driver. Informed pt that I could not make him go via EMS but I did recommend it. Pt expressed understanding but thought that he would be fine with it being as close as it is and him being the passenger, so he again declined transport via EMS. They were instructed to proceed directly to the ED for further Eval.
40 2021-03-16 heart attack Patient admitted to the hospital w/NSTEMI, possible myocarditis on MRI chest noted.
40 2021-03-17 heart rate increased, chest discomfort 1 hour after shot, felt: Chest tightness Increased heart beat Felt warm in face Difficulty breathing... Read more
1 hour after shot, felt: Chest tightness Increased heart beat Felt warm in face Difficulty breathing Loss of taste Lasted about 1 hour. Chest tightness and difficulty breathing were mild and intermittent. Occasional chest pain. Nothing severe just felt uncomfortable. After symptoms subsided, contacted doctor who recommended I go to urgent care to be checked out.
40 2021-03-18 heart rate increased Patient was waiting for 15 minute after injection. She felt her heart rate was high, checked her wat... Read more
Patient was waiting for 15 minute after injection. She felt her heart rate was high, checked her watch fitbit, heart rate read 120 bpm. Also was lightheaded. Staff was made aware. 0900 RN assessed patient, HR was 86 with regular beats palpated at the wrist, and ausculated at the heart. Respirations were 18 and regular, Oxygens saturations 96%, B/P 142/86, Patient was alert and orientated. Patient reported at 0902 she was feeling better. Rapid response was called at 0900. At 0908 HR 106, slightly lightheaded, rapid response arrived and transferred patient to ER at 0913 by wheelchair. Patient was alert and oriented.
40 2021-03-21 pallor 12:14 Post vaccination reports feeling dizzy, diaphoretic, color flushed and pale; medical monitorin... Read more
12:14 Post vaccination reports feeling dizzy, diaphoretic, color flushed and pale; medical monitoring w/vitals assessed: BP 93/53 P55 O2 sat 96%RA, rest w/feet elevated, po hydration provided, answering questions; 12:30 BP 101/71 P77 02 sat 98% RA , status improving, remains coherent; 1240 BP 107/78 P 72 reports "feeling better", stands w/no dizziness or reports of additional symptoms, color returns to normal; Released from facility w/self.
40 2021-03-22 skin turning blue, pallor Approx1255: Patient stated he was not feeling well, light-headed. Patient pale, sweating. He asked... Read more
Approx1255: Patient stated he was not feeling well, light-headed. Patient pale, sweating. He asked to lie down. Encouraged to take deep breaths. Patient asked to step outside of room, assisted to hallway chair for air. Wife at side, encouraging to take deep breaths. Patient stated he could not see us and slumped in chair with eyes open and glazed. Shallow breathing, unresponsive to sternal rub. Lips noted to turn purple-blue and then gray. Called for assistance and LVN at patient side obtaining VS, patient took deep breath and started to become responsive. VS at approx. 1303: BP104/47, HR 57, 02 Sat 95%. Patient talking, continued pale and diaphoretic. 911 called and EMS arrived at approx. 1305 Transferred to hospital.
40 2021-03-23 fast heart rate Initial symptoms of the first shot included injection site pain, neck soreness, and severe headache ... Read more
Initial symptoms of the first shot included injection site pain, neck soreness, and severe headache that would come and go. The next day I was so exhausted I couldn't work for 2 days. I barely got out of bed until about 40 hours after the shot where I was able to get out and do some gardening. The reason I am filling this out was at right around 72 hours after the vaccine, I was laying down watching a YouTube video feeling quite relaxed. I then experienced a tachycardia event where my heart rate went up to 120 and stayed there for about an hour. I remained calm and was not experiencing anxiety, but the heart rate persisted. I have had this happen before in panic attacks, but it's quite rare and I am in acute, high level stress. Almost 2 weeks later to the day, I had another tachycardia, stronger than any I've had my entire life that only lasted about 7 seconds, but I would estimate my heart rate jumped to over 250. I thought I was going to go into cardiac arrest it was so jarring. I'm not sure if that one was related to the vaccine.
40 2021-03-24 loss of consciousness Pt was leaving after 15 minute waiting period and passed out at the check out. Pt reported feeling f... Read more
Pt was leaving after 15 minute waiting period and passed out at the check out. Pt reported feeling fine and did not remember passing out. Pt BP 113/71 hr 61. Pt BP dropped to 89/56 after 20 minutes. 1 liter of IV fluid given. Pt monitered an additional 30 minutes. Final BP 118/73 HR 69. Pt discharged home with sister.
40 2021-03-25 palpitations Heart racing, shortness of breath. Funny taste in my mouth so far
40 2021-03-28 skin turning blue, pallor At around 6:30 pm patient felt very dizzy, lightheaded, and nauseous. He also felt hot, had cold swe... Read more
At around 6:30 pm patient felt very dizzy, lightheaded, and nauseous. He also felt hot, had cold sweats, pale face, and blue lips. He started shaking as well. At 6:35 pm his blood pressure was 126/78, his heart rate was 69, and his oxygen saturations were 95%. We called EMS and they arrived around 6:45 pm. He was already feeling much better by the time they arrived. They checked him out and said he was good to go and he left at 6:55 pm.
40 2021-03-31 very slow heart rate, hypotension 10 seconds of tonic clonic seizure like activity 6 minutes after administration of the Moderna COVID... Read more
10 seconds of tonic clonic seizure like activity 6 minutes after administration of the Moderna COVID-19 vaccine with associated hypotension, bradycardia, diaphoresis, and visual disturbance (spots in his vision) that self-resolved after being shaken.
40 2021-04-03 chest discomfort, heart rate irregular Felt heavy pressure on my chest, Irregular heart beat, Light Headed, body aches, fever (100-105F), I... Read more
Felt heavy pressure on my chest, Irregular heart beat, Light Headed, body aches, fever (100-105F), I took Tylenol 500mg every 4 hours for 36 hours and symptoms started to go away.
40 2021-04-04 fainting Fainted with cold sweats and chills
40 2021-04-05 loss of consciousness, pallor, blood pressure decreased PATIENT PASSED OUT AND APPEARED TO BE HAVING A SIEZURE WITH EYES ROLLING BACK IN HEAD. HE WAS SLUMP... Read more
PATIENT PASSED OUT AND APPEARED TO BE HAVING A SIEZURE WITH EYES ROLLING BACK IN HEAD. HE WAS SLUMPED IN CHAIR. NON- RESPONSIVE. wAS ABOUT TO ADMINISTER EPINEPHRINE , WHEN HE CAME TO. HIS VOICE WAS WEAK AND SAID NO TO EPI. HE WAS DIAPHORETIC AND VERY PALE. EMS CAME ONTO SCENE AND TOOK OVER. BLOOD PRESSURE WAS 80/53 PER EMS. HE REFUSED FOR THEM TO TAKE HIM. WIFE WAS CALLED AND CAME TO GET HIM BUT HE HAD TROUBLE STANDING AND HAD TO SIT AWAHILE. IT WAS ABOUT 45MINUTES BEFORE HE EXITED WITH ASSISTANCE. ATTEMPTED TO CONTACT HIM LATER AND HAD TO LEAVE MESSAGE
40 2021-04-06 pulse abnormal, hypotension Patient recieved the vaccine in the left arm and was asked to wait in the pharamcy waiting area for... Read more
Patient recieved the vaccine in the left arm and was asked to wait in the pharamcy waiting area for observation for 15 minutes (no previous hx of anaphylaxis). Upon returning to the main pharmacy floor a few minutes later one of the technicians alerted me to the patient had retrurned to the counter and was "feeling something". He was visibly struggling to maintain balance and I asked patient to take a seat to prevent any risk of falls and motioned to a chair. He took a seat on the floor next to the pharmacy counter and I rushed over to him to tend to him. I asked him if was having any other symptoms and he noted he was feeling lightheaded and having chills all over his body. His body was cold and clammy to the touch and had a difficult time locatiing a pulse on the radial artery. While talking to him his responses were shorter and he seemed like was starting to almost lose conciousness. Management had already called 911 and we offered water to the patient while we waited. Prior to the paramedics arriving I was able to get a pulse using a cuff and it was around 53bpm, the patient also seemed hypotensive.
40 2021-04-08 chest pain, cardiac arrest 3 days sustained fever over 102, cardiac arrest Thursday night, back & chest pain, vomiting, difficu... Read more
3 days sustained fever over 102, cardiac arrest Thursday night, back & chest pain, vomiting, difficulty breathing. Went to ER, admitted to ICU, currently in ICU at hospital.
40 2021-04-08 heart rate irregular, blood pressure increased 4/1/2021 1:15 PM T 98F P 72 B/P 180/130, 1:30 PM T 99F P 77 B/P 160/110, 1:45 PM T 97F P 77 B/P 170/... Read more
4/1/2021 1:15 PM T 98F P 72 B/P 180/130, 1:30 PM T 99F P 77 B/P 160/110, 1:45 PM T 97F P 77 B/P 170/110, c/o metallic taste, felt very anxious, lay in supine position on First Aid cot, ice packs to patient's head and neck at request of patient, requested and tolerated water, became dizzy when lifted head, lay back down for 15 minutes, taken via w/c to van for girl friend to drive home, advised to go home and rest, ambulatory without symptoms at time of discharge to home.
40 2021-04-08 pallor Pt extremely pale, diaphoretic, lightheaded. AAOx3. Respect even and unlabored. Reports extensive hx... Read more
Pt extremely pale, diaphoretic, lightheaded. AAOx3. Respect even and unlabored. Reports extensive hx of this rection to medical procedures. With lying down began to gain color in face, less diaphoresis, and lightheadedness. Instructed to request lying down for 2nd vaccine. Left walking without s/s of distress. BP stable 132/82, spO2 97%, HR 70.
40 2021-04-09 chest discomfort Extremely lightheaded, chills, headache, sensitive skin to the touch, dizziness, nausea, aches and p... Read more
Extremely lightheaded, chills, headache, sensitive skin to the touch, dizziness, nausea, aches and pains, chest compression, sleeplessness . It was so bad that I was debating going to the hospital.
40 2021-04-11 nosebleed Historically i have not gotten bloody noses. But on Saturday 4/10/21 Morning when blowing my nose, ... Read more
Historically i have not gotten bloody noses. But on Saturday 4/10/21 Morning when blowing my nose, my nose bleed quite a bit for a good 10-20 minutes. This happened again 4/12/2021 but for a lot less.
40 2021-04-11 hypotension, fainting Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild
40 2021-04-12 fainting Patient experienced lightheadhedness, dizziness, nausea, syncope within the first 15 minutes of mode... Read more
Patient experienced lightheadhedness, dizziness, nausea, syncope within the first 15 minutes of moderna administration. Patient left the observation area prior to the 15 minutes. Paramedics were called and evaluated patient. Determined patient was okay and needed no further medical attention and told patient to stay in the pharmacy waiting area for 15 more minutes for observation. patient left without further incidents.
40 2021-04-14 very slow heart rate, lightheadedness, pallor Immediate vasovagal reaction to the vaccine with bradycardia to 30, pale, quickly improved without a... Read more
Immediate vasovagal reaction to the vaccine with bradycardia to 30, pale, quickly improved without additional intervention. History of fainting reaction to any shots and blood draw. Family at his side. The patient is not driving today.
40 2021-04-15 chest pain Had usual reaction on day two: chills, tired, sore, etc On day 5 I experienced very painful chest p... Read more
Had usual reaction on day two: chills, tired, sore, etc On day 5 I experienced very painful chest pain quite suddenly- went strait to ER, turned out to be lung pleurisy. I?ve never had this, nor have I ever had chest pain or been to the ER before this.
40 2021-04-15 fast heart rate, cerebrovascular accident, heart rate irregular, blood pressure fluctuation Stroke; Gotten very sick from vaccine; Tachycardia; Blood pressure issues; Dizziniess; Heart rate is... Read more
Stroke; Gotten very sick from vaccine; Tachycardia; Blood pressure issues; Dizziniess; Heart rate issues; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (hospitalized for 7 days; treated with Remdesivir; long recovery) from 11-Sep-2020 to October 2020. Concurrent medical conditions included Blood pressure (ongoing issues) and Heart rate (ongoing issues). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced ILLNESS (Gotten very sick from vaccine), TACHYCARDIA (Tachycardia), BLOOD PRESSURE FLUCTUATION (Blood pressure issues), DIZZINESS (Dizziniess) and HEART RATE IRREGULAR (Heart rate issues). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), ILLNESS (Gotten very sick from vaccine), TACHYCARDIA (Tachycardia), BLOOD PRESSURE FLUCTUATION (Blood pressure issues), DIZZINESS (Dizziniess) and HEART RATE IRREGULAR (Heart rate issues) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 antibody test: 9.64 after one round of the vaccine. On an unknown date, SARS-CoV-2 antibody test: 220 natural antibodies after 2 months. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reports that he had worked for an urgent care performing testing and contracted COVID-19 back in 11SEP2020. Patient was hospitalized for 7 days, was administered Remdesivir, and had a long recovery. Patient reports having issues regulating his blood pressure and heart rate so bad that he had almost died during that time. The recovery took up until 1st week of October and did not feel well until then. Patient reports it was advised to defer first dose of vaccination for COVID-19 for 3 months. Patient self-medicated with OTC Tylenol and Advil which did not help. Patient reports that he was hospitalized a second time around last month (03MAR2021 approximately) for experiencing a stroke. Symptoms felt like he was experiencing a mini-COVID-19 episode and was having a relapse of COVID-19. ER professional advised patient to never take the second dose of the vaccine. Patient reports taking an antibody test (after a single dose of the vaccine) for both natural and for the spike protein on 25MAR2021. Patient reports that he had gotten a 9.64 reading from just one round of the vaccine in comparison to the doctors he had worked who had received both doses of the vaccine, never gotten sick with COVID-19, and produced a 9.0 reading. Patient reports his natural antibodies after 2 months was at 220. Patient wishes to report this information to highlight that his natural antibodies were so high from the previous COVID-19 infection that when he had gotten the first round of the vaccine, he believes that his body rejected the vaccine so strongly that he presented with severe side effects from the vaccine. Patient would like to submit his information to show that he is proof that if someone previously had COVID-19, they should only need a single dose of the vaccine. In addition, patient expressed that if a patient's natural antibody is high, then a reduced dose should be provided or the vaccine should be deferred until natural antibodies reduce Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Event details reported; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
40 2021-04-17 heart rate increased What a nightmare. Moderna shot #1 caused rapid hair loss and arm soreness for a week and low grade n... Read more
What a nightmare. Moderna shot #1 caused rapid hair loss and arm soreness for a week and low grade nausea. But shot #2, holy moly... 12 hours post shot, I developed a fever, chills, violent shaking much of the night, weight loss, nausea, kept throwing up, massive migraine, heart rate racing, every cell in my body throbbing in pain, difficulty urinating, simply staying alive was exhausting. It faded a couple days after the shot, and in its place, fatigue, difficulty getting a full breath in. And now I have tinnitus--constant ear ringing. Absolute torture. And of course significantly more hair loss. So let's add anxiety and depression to the list because of this hell. What a regret it was to get injected with this poison. Rather just keep masking and avoiding people than be stuck with these permanent, life debilitating problems. I know it wont change anything, but I figure I'd report it anyway. What a nightmare. This crap should not be given to anyone with an autoimmune disorder.
40 2021-04-19 fainting Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommende... Read more
Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommended per ACIP guidelines. The following reaction signs/symptoms were observed: syncope, vomitting Emergency response notified: EMS (911) EpiPen administered by RN as per JH standing order?: No Required VAERS reporting completed?: No Report given to EMS (911) Patient was given vaccine at 0918, immediately flagged for nurse at 0920. Nurse went to patient and obtained vitals. BP 150/80 HR 56 regular SP02 99% R 18 regular Called EMS, patient was given water and emesis bag. Vital taken again: BP 130/70 HR 60 regular EMS evaluated patient and stayed 10 mins, advised of nurse hotline on COVID packet & further medical evaluation. Patient was then release to go home.
40 2021-04-20 blood pressure decreased, pallor, loss of consciousness patient has a history of passing out during blood draws, he did warn us of this. Once given the cov... Read more
patient has a history of passing out during blood draws, he did warn us of this. Once given the covid vaccine he passed out about 2 minutes after. He came in and out of consciousness a few times. During this time his blood pressure dropped, he turned pale and was sweating. The paramedics were called as he continued having issues staying conscious. His blood pressure started to go back up, his blood sugar was checked by the paramedics and he was taken to Hospital for evaluation. He had later informed us that he had not eaten breakfast in the morning.
40 2021-04-22 platelet count decreased, cardiac arrest, deep vein blood clot, haemoglobin decreased, low platelet count, pulmonary embolism Moderna COVID-19 Vaccine EUA: patient underwent L1-2 corpectomy, pedicle subtraction osteotomy, and ... Read more
Moderna COVID-19 Vaccine EUA: patient underwent L1-2 corpectomy, pedicle subtraction osteotomy, and extension of fusion from T4 to the pelvis two months after vaccination. During surgery patient became thrombocytopenic and required massive transfusion. Thirteen days after surgery found to have bilateral pulmonary embolisms and deep vein thromboses and placed on anticoagulation. Patient subsequently suffered cardiac arrest and was unable to be resuscitated.
40 2021-04-22 fainting syncope
40 2021-04-23 blood pressure decreased Severe drop in blood pressure, dizziness nausea.. 48 hours after tingling in tongue, roof of mouth,g... Read more
Severe drop in blood pressure, dizziness nausea.. 48 hours after tingling in tongue, roof of mouth,gums..itching on back and legs..
40 2021-04-23 heart rate increased, hypertension Reaction to A-Fib medications Metoprolol and flecainide. Rapid heart rate, high blood pressure, body... Read more
Reaction to A-Fib medications Metoprolol and flecainide. Rapid heart rate, high blood pressure, body shaking, loss of apatite. extreme exhaustion.
40 2021-04-24 inflammation of the heart muscle, chest pain Early in the morning 3 days after receiving the vaccine, patient awoke with chest pain that carried ... Read more
Early in the morning 3 days after receiving the vaccine, patient awoke with chest pain that carried down his left arm. He drove himself to the emergency room at 7am because he just wasn't feeling right. After two EKG's, the Dr. at Hospital located in the area decided to air lift patient to another Hospital for an assumed fatal heart attack. Upon arrival, he was given a heart catheter and no blockages were found. They determined the had myocarditis, inflammation of his heart. However, he had not been sick or battling any illness.
40 2021-04-25 loss of consciousness Patient came in for his 2nd Moderna shot today 4/26/21. I administered the vaccine and asked him to ... Read more
Patient came in for his 2nd Moderna shot today 4/26/21. I administered the vaccine and asked him to remain in the store for a 15-minute observation period (just like the 1st dose). After 2-3 minutes he walked to the pharmacy window to let my technician know he was starting to feel dizzy. At the same time my technician was informing me about his complaint, he lost consciousness and fell, hitting the side of his head on the consultation wall. I immediately asked technician to call 911 and rushed to get EpiPen to patient. He immediately regained consciousness. I did not administer any EpiPen doses. I stayed with him and monitored him until paramedics arrived. When paramedics arrived, they asked me which vaccine I administered and started asking patient questions. They measured his blood pressure. Patient was responsive and he called his wife to let her know he was going to the ER. Paramedic informed us that his blood pressure was low. On his way to the hospital he looked at us and said thank you. I will call him tomorrow to check on him.
40 2021-04-26 pallor, loss of consciousness Husband received his second dose at work. The next morning he got up and turned on the shower and p... Read more
Husband received his second dose at work. The next morning he got up and turned on the shower and passed out. I found him in the bathroom after he regained consciousness in a cold sweat, extremely pale, saying that he thought he was going to throw up. He said it felt like food poisoning. I got him back into bed with a cool wash cloth and he slept off and on the rest of the day. He started feeling a bit better but struggled to comprehend simple questions and would just stare at me blankly as if he couldn't understand what I was saying. Even though he slept most of the day he was falling asleep in his chair by about 8pm. The paleness, waves of exhaustion, and inability to stay awake past 8:30/9pm has continued.
40 2021-04-26 pallor Husband received vaccination at work. That evening he was extremely pale and tired. The following ... Read more
Husband received vaccination at work. That evening he was extremely pale and tired. The following day this continued along with significant confusion (he did not recognize the turn onto the major street to our home where we have lived for nearly 2 years, he also forgot the a pizza was still in existence even though there is one down the street for us that we have passed many times and discussed at length in the past 2 years). The week after his injection he would get home from work and be falling asleep in his chair by 7:30pm with no change to his sleep schedule. He has remained pale and still struggles with exhaustion.
40 2021-04-28 loss of consciousness Day 1- Fever, Body Chills, Headache, Lethargic, Joint Aches Day 2- Body Chills, Headache, Lethargic... Read more
Day 1- Fever, Body Chills, Headache, Lethargic, Joint Aches Day 2- Body Chills, Headache, Lethargic. Joint Ache, Loss of Conciousness
40 2021-04-29 lightheadedness prolonged vagal episode, no LOC; BP: 116/72 HR: 62 patient rested lying down, apple juice; resolv... Read more
prolonged vagal episode, no LOC; BP: 116/72 HR: 62 patient rested lying down, apple juice; resolved at 10:15am
40 2021-04-30 pallor Patient reported feeling sweaty and clammy while being observed after vaccine administration. Then h... Read more
Patient reported feeling sweaty and clammy while being observed after vaccine administration. Then he reported a headache and appeared pale. Patient vomited x1 and then reported feeling better after vomiting. Continued to monitor patient until he stated he felt well enough to leave.
40 2021-05-02 very slow heart rate, fainting, low blood pressure Patient became weak . diaphoretic and was observed to have full dilation of pupils. Patient became ... Read more
Patient became weak . diaphoretic and was observed to have full dilation of pupils. Patient became unresponsive, un able to obtain a pulse. Patient lowered to the floor. Patient became responsive but remained disoriented. Paramedics were called. Patient had orthostatic hypotension and became bradycardic.(NR 30 BPM) He was transported to ED of Hospital. Patient indicates that he has a fear of needles and got "woozy" after immunization. Patient had two syncopal episodes. Patient reports having similar episodes in the past with blood draws. BP in ED was 113/61 and 111/60, EKG normal
40 2021-05-05 heart rate increased, palpitations 15 hours after 2nd dose I experienced the following symptoms and I thought I was going to die. I cou... Read more
15 hours after 2nd dose I experienced the following symptoms and I thought I was going to die. I couldnt get out of bed: 1) Extreme heart palpitations, my heart rate monitor was reading an extremely high stress activity for 2 days post shot. 2) Very Hot and Very Cold body chill and temp swings 3) Sweating profusely, I soaked through my pajamas on 3 different occasions when I woke up from napping. 4) My pee was orange and hurt to pee. 5) My entire body hurt the worst I've ever felt 6) All my joints were super painful, it hurt to walk and I couldn't sleep due to the pain. 7) I had the worst headache I've ever had.
40 2021-05-05 loss of consciousness Patient reported experiencing a blacked-out and fell when he was out running.
40 2021-05-06 chest pain Chills Fever Headache Chest pain Delirium Fatigue
40 2021-05-06 chest pain Symptoms: vomiting, shakes, fever, body aches, lethargy, weakness, loss of appetite, migraine, chest... Read more
Symptoms: vomiting, shakes, fever, body aches, lethargy, weakness, loss of appetite, migraine, chest pains, difficulty breathing, wheezing, shortness of breath.
40 2021-05-06 pulmonary embolism He underwent routine monitoring for his testicular cancer and had CT of his lungs on April 6. He wa... Read more
He underwent routine monitoring for his testicular cancer and had CT of his lungs on April 6. He was found to have asymptomatic Pulmonary emboli. He was started on Eliquis 5 mg bid
40 2021-05-06 fainting General malaise on evening of vaccination (29APR2021). Fatigue and malaise increase over next 3 day... Read more
General malaise on evening of vaccination (29APR2021). Fatigue and malaise increase over next 3 days culminating in witnessed syncopal episode while lying supine at home on 2MAY2021. EMS contacted and SM declined transport. Reported to ED on 03MAY2021 by POV and evaluated, tested for COVID-19 which was negative. SM denies any sick contacts in weeks prior to incident
40 2021-05-07 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
40 2021-05-09 excessive bleeding Hives with red itchy painful rash on right leg within 30 minutes of vaccination. Did not resolve wit... Read more
Hives with red itchy painful rash on right leg within 30 minutes of vaccination. Did not resolve with Benadryl or hydrocortisone after 72 hours. Periodic bleeding and difficulty sleeping.
40 2021-05-10 cardiac arrest, fainting #2 Moderna Vaccine given on 4/20/21 On 5/7/21 patient became SOB before syncope to cardiac arrest... Read more
#2 Moderna Vaccine given on 4/20/21 On 5/7/21 patient became SOB before syncope to cardiac arrest, event was witnessed and CPR started immediately. Patient expired 45 min later at Medical Center.
40 2021-05-13 superficial blood clot Lower left ankle became hard & red with swelling in rear calf on 18th day after first dose. PCP susp... Read more
Lower left ankle became hard & red with swelling in rear calf on 18th day after first dose. PCP suspected lymphatic bacterial infection & prescribed Keflex 500mg t.id. for 10 days. After 10 days condition had not changed. I experienced no pain throughout the entire event, only felt tightness in skin on calf from swelling. Bilateral ultrasound performed & results negative for DVT in both legs. Final Dx is Superficial Thrombophlebitis. Treatment plan is to elevate affected left leg & apply warm compress when possible & wear compression stockings when standing for extended periods.
40 2021-05-16 loss of consciousness Patient was fine and was able to answer all questions before the shot. After the shot was given He s... Read more
Patient was fine and was able to answer all questions before the shot. After the shot was given He said he didn't feel well and passed out. His wife said this has happened to him before. He slumped over in the chair and became incontinent. he came to and then said he felt nauseous. he asked for the garbage can and threw up. I monitored his blood pressure that went to 160 over 100 and then came down to normal over the course of a few minutes. The patient stayed seated for about 30 minutes . After the blood pressure was good for 30 minutes his wife said she was going to drive him home. I explained that they should always tell any immunizer of his previous reactions
40 2021-05-16 fainting Systemic: Dizziness / Lightheadness-Medium, Additional Details: PT BECAME DIZZY DURING THE 15 MINUTE... Read more
Systemic: Dizziness / Lightheadness-Medium, Additional Details: PT BECAME DIZZY DURING THE 15 MINUTE OBSERVATION. PT WAS SEATED AND FELT DIZZY AND FELL FORWARD AND HIT HIS HEAD ON THE FLOOR. EMT WAS CALLED. ICE PACK WAS GIVEN TO PATIENT. PT WAS LOWERED TO THE FLOOR, HE SAT ON THE FLOOR UNTIL EMT CAME. EMT ASSESSED NO ISSUES WITH PT. PT REFUSED TO GO THE ER WITH EMT. PT WAS ADVISED TO DRINK GATORATE AND STAY SEATED FOR FEW MORE MINUTES. HE STATED HE FAINTS WITH BLOODWOR/NEEDLE. SPOKTO PT AT THE END OF THE SHIFT AND PT STATED HE WAS DOING WELL WITH NO ISSUES.
40 2021-05-17 heart rate increased That evening I had chills followed by night sweats. My heart beat was racing over 130 beats per min... Read more
That evening I had chills followed by night sweats. My heart beat was racing over 130 beats per minute for over 8 hours. Headache, 104 degree fever, severe fatigue, pain at injection site, cough developed
40 2021-05-18 blood glucose increased Patient observed to become unresponsive and slumped over in chair during observation at appros 15 mi... Read more
Patient observed to become unresponsive and slumped over in chair during observation at appros 15 minutes. He remained unresponsive to verbal and physical stimuli for approx 5 minutes. Once responsive, he c/o pain all over, abdominal pain with curling up as if cramping. no muscle spasms observed. Skin with mild tenting. vitals monitored, NS IV given, ~150 cc given prior to transfer to EMS. Lorazepam 0.5mg IV given for muscle spasms. Diphenhydramine 25mg IV administered Labs drawn. Oxygen saturation 99% initially with NRB, changed to NC and remained >94% on 2 lpm. patient remained somnolent, not answering questions, though conscious.
40 2021-05-18 inflammation of the heart muscle, chest discomfort, troponin increased COVID dose 1: Moderna, Lot# 042B212A, 4/17/21 @ 3:45pm, R arm COVID dose 1: Moderna, Lot# 022C21A, 5... Read more
COVID dose 1: Moderna, Lot# 042B212A, 4/17/21 @ 3:45pm, R arm COVID dose 1: Moderna, Lot# 022C21A, 5/15/21 @ 3:00 pm, R arm Sat 5/15/21 @ 1500: 2nd dose administered. 5/15/21 @ Evening: pt states light fever, took OTC Aleve, fever decreased (symptomatic, temp not measured) Sun 5/16/21 @ 5am: intense chills. Daytime: fevers, pt took Aleve, temp of 102.1 F. Evening time: pt reports having flu-like symptoms, head fog, slept most of day. Mon 5/17/21: felt fine, took morning off from work. Tues 5/18/21 0630am: woke up with chest tightness/pressure, diaphoresis. Pt presented to BI-Milton Hosptial ED, found to have an elevated troponin to 0.35. Cardiac workup for myocarditis.
40 2021-05-19 heart rate decreased, hypotension PATIENT FELT LIGHT HEADED, NAUSEOUS COUPLE MINUTES AFTER VACCINATION. WE GAVE HIM SOME WATER AND WET... Read more
PATIENT FELT LIGHT HEADED, NAUSEOUS COUPLE MINUTES AFTER VACCINATION. WE GAVE HIM SOME WATER AND WET PAPER TOWEL. CHECKED HIS FOREARM BLOOD PRESSURE, IT WAS 78/47 HEART RATE 46. PATIENT SAID HE HAS NEEDLE PHOBIA, HE HADN'T EATEN SINCE 8 IN THE MORNING. HE WAS STILL ABLE TO TALK AND KEPT SAYING HE WAS FEELING MUCH BETTER, HE DIDN'T WANT US TO CALL 911 OR GET EXTRA MEDICAL HELP. WE GAVE HIM SOME GATORADE AND FOOD TO EAT. CHECKED HIS BLOOD PRESSURE AGAIN 30 MINUTES AFTER THE FIRST CHECK IT WAS 126/75 HEART RATE 77.
40 2021-05-22 chest pain, inflammation of the pericardium Fever, chills, chest pain, shoulder pain, short breath. Recommended to see cardiologist and GI doct... Read more
Fever, chills, chest pain, shoulder pain, short breath. Recommended to see cardiologist and GI doctors. Admitted into emergency hospital and found out that my lungs and hearts inflammations. it was pericarditis and treatment given for this and still on medication and still PCR report shows the inflammation high count.
40 2021-05-24 arrhythmia, fast heart rate, palpitations, palpitations missed beats; become sensitive to light and cannot go outside without sunglasses; sweating more espe... Read more
missed beats; become sensitive to light and cannot go outside without sunglasses; sweating more especially acidic and disgusting; splitting headaches; pain in the left arm at the vaccination site; arrhythmias; altered smell; heart rhythm, palpitations; tachycardia; joint pains; chills; mild fever; dizzy.; "feels like my body has been split into 1000 different microclimates; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmias) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic fatigue syndrome, Fibromyalgia and Neurocardiogenic syncope. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy.). On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (mild fever). In February 2021, the patient experienced FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates). On 18-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmias) (seriousness criterion medically significant), PAROSMIA (altered smell), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), HEADACHE (splitting headaches) and VACCINATION SITE PAIN (pain in the left arm at the vaccination site). On an unknown date, the patient experienced EXTRASYSTOLES (missed beats). On 14-Feb-2021, ARTHRALGIA (joint pains) and CHILLS (chills) had resolved. On 24-Feb-2021, HEADACHE (splitting headaches) had resolved. At the time of the report, ARRHYTHMIA (arrhythmias), PAROSMIA (altered smell), FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates), DIZZINESS (dizzy.), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), EXTRASYSTOLES (missed beats), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), VACCINATION SITE PAIN (pain in the left arm at the vaccination site) and PYREXIA (mild fever) outcome was unknown. No concomitant medications were provided. Treatment taken were Diphenhydramine (Benadryl) , Ibuprofen (Advil), Prednisone and acupuncture to alleviate the symptoms experienced. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
40 2021-05-25 heart rate increased Fever, chills, insomnia, high heart rate. Treated with acetaminophen and prescription sleeping pill ... Read more
Fever, chills, insomnia, high heart rate. Treated with acetaminophen and prescription sleeping pill at midnight. Fever broke around hour later but unable to sleep for another 6 hours
40 2021-05-25 palpitations Intense heart palpitations, sweating. Lasted about 5 minutes then stopped.
40 2021-05-25 fainting I got Moderna vaccine #2 at around 11:30 am. That day, I felt tired and my arm was sore and felt rea... Read more
I got Moderna vaccine #2 at around 11:30 am. That day, I felt tired and my arm was sore and felt really hot then really cold. That night, starting at around 11:30 pm, I woke up every hour and was unable to stay asleep, that continued through the morning. Toward the morning, around 3:30 am, I fainted in the bathroom and came to on the floor, luckily, I didnt get hurt on the way down. I felt crummy that next day and back to normal within 3 days.
40 2021-05-26 pulmonary embolism Acute Bilateral PE
40 2021-05-27 heart rate increased Heart rate got up to 214 five hours after the vaccine. Called 911 and they came to get me. When I go... Read more
Heart rate got up to 214 five hours after the vaccine. Called 911 and they came to get me. When I got there, they had me rear down and my heart rate decreased and they took me to the hospital. The hospital ran test and everything was normal. They discharged me after the IV fluid bag was done. I followed up with my cardiologist 2 weeks later and had a stress test and ekg. All tests were normal. The doctor thinks it was an adverse reactions to the vaccine.
40 2021-05-29 heart rate increased, chest pain, chest discomfort Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Body Aches Generalized-M... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient felt faint, had increased heart rate, and a pressure at back of neck. Stated he felt some minor tightness on and off at throat area. No difficulty breathing.-Mild, Systemic: Nausea-Mild
40 2021-06-01 chest pain, troponin increased, inflammation of the pericardium Patient reported left chest pain since 8:30AM 5/31, onset while driving, worse with movement such as... Read more
Patient reported left chest pain since 8:30AM 5/31, onset while driving, worse with movement such as moving his arms or neck. Later around noon he began having numbness in his left pinky and hand, thus presented to the UC. Diagnosed wtih costochondritis and discharged but high-sensitivity troponin came back elevated at 94 and was asked to present to hospital. Repeat trending down. Cardiology consulted, diagnosed with pericarditis.
40 2021-06-03 cardio-respiratory arrest, fluid around the heart, hypotension Received vaccine at on 5/24/2021. Patient is a 40 y/o male with no significant PMH who initially pre... Read more
Received vaccine at on 5/24/2021. Patient is a 40 y/o male with no significant PMH who initially presented to the hospital after being found down at a restaurant. Was found to have ST segment changes on EKG, somnolent, and hypotensive requiring pressors. Taken to the cath lab where he had equalization of diastolic pressures and subsequently received pericardiocentesis due to concern for tamponade from pericardial effusion. 350 ccs of fluid was drained and his hemodynamics immediately improved and he came off vasopressors. Pericardial drain was placed. Over the next several days he had ongoing workup for the etiology of his pericardial effusion. His pericardial drain output dropped off, was clamped 5/31 and repeat echocardiogram 6/1 did not show significant effusion. Unfortunately, patient went into PEA arrest in the afternoon and was coded for ~40 minutes without return of ROSC. Unclear etiology at this time, no evidence of significant effusion on echocardiogram
40 2021-06-05 fainting, loss of consciousness PATIENT EXPERIENCED SYNCOPE, LOSING CONSCIOUSNESS BRIEFLY. FELL OUT OF CHAIR AND REGAINED CONSCIOUSN... Read more
PATIENT EXPERIENCED SYNCOPE, LOSING CONSCIOUSNESS BRIEFLY. FELL OUT OF CHAIR AND REGAINED CONSCIOUSNESS ROUGHLY 15 SECONDS LATER.
40 2021-06-05 fainting ABOUT 5 MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT CAME UP TO COUNTER AND SAID HE WAS LIGHT HEAD... Read more
ABOUT 5 MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT CAME UP TO COUNTER AND SAID HE WAS LIGHT HEADED AND FELL TO THE FLOOR. PATIENT FAINTED FOR A SPLIT SECOND. I ATTENDED TO PATIENT AND HE WAS GIVEN WATER TO DRINK. 911 WAS CALLED WHILE I WAS BY PATIENT. PATIENT STARTED TO FEEL BETTER BY THE TIME THE PARAMEDICS ARRIVED. UPON THEIR ARRIVAL THEY CHECKED THE PATIENTS VITALS AND EVERYTHING WAS OK. PATIENT RETUREND TO STORE AND CONTINUED SHOPPING
40 2021-06-06 chest pain Chest pains (left side only), Shortness of breath, Increasing worse over 3-4 days. Went to the ER be... Read more
Chest pains (left side only), Shortness of breath, Increasing worse over 3-4 days. Went to the ER because I thought I was having a heart attack.
40 2021-06-09 chest discomfort, chest pain tightness, pain in chest, shortness of breath, weakness, pain and tightness in left lower neck and s... Read more
tightness, pain in chest, shortness of breath, weakness, pain and tightness in left lower neck and shoulder and upper inner bicep area. Symptoms were 5-15 min duration at a time coming and going at all times of the day both with physical exertion and without. Resting pulse was around 120 with each event, symptoms came and went over the course of a week and have since subsided on their own.
40 2021-06-10 blood pressure increased, chest pain Chest pain and trouble breathing ending in ER visits on Jan 11 and 16, intermediate cardiologist vis... Read more
Chest pain and trouble breathing ending in ER visits on Jan 11 and 16, intermediate cardiologist visit Jan 14. Significant increase in blood pressure with any exertion (160/100 after 1 flight of stairs with "one sentence" dyspnea, my baseline ~120/80, baseline weekly exercise of 4 - 8 miles running and 1+ hours strength training). Chest pain @ 2/10, some radiation to left arm. Resolved in ER with IV Toradol. Spontaneously resolved after ~2 weeks. Subsequent persistent chostocondritis, no dyspnea.
40 2021-06-10 chest pain Acute pain in left side of chest similar to pericarditis.
40 2021-06-10 hypotension Presented to ER with fever, chills, cough, shortness of breath and diarrhea. Suddenly became hypoten... Read more
Presented to ER with fever, chills, cough, shortness of breath and diarrhea. Suddenly became hypotensive and diaphoretic in ER, which prompted hospital admission. Had 1/2 positive blood cultures during admission of coagulase negative staph, which was thought to be contaminant. Recieved 1 dose of IV vancomycin during stay. Required supplemental oxygen during admission and received 2 doses of dexamethasone while inpatient.
40 2021-06-11 chest pain I developed 3rd degree heart block or Atrioventricular block after my vaccine shot of the 2nd dose c... Read more
I developed 3rd degree heart block or Atrioventricular block after my vaccine shot of the 2nd dose covid19 vaccine. I went to the Emergency room and was admitted for Emergency surgery on my heart. After my surgery I had developed chest pains that lingered for 1 month until the symptoms improved. My surgery was on March 16th, 2021
40 2021-06-14 lightheadedness, fainting THE PATIENT WAS FEELING FAINT AND TRIED TO LAY DOWN AND PASSED OUT ON THE WAY TO THE FLOOR. IT WAS A... Read more
THE PATIENT WAS FEELING FAINT AND TRIED TO LAY DOWN AND PASSED OUT ON THE WAY TO THE FLOOR. IT WAS A VASOVAGAL RESPONSE. WE HAD HIM LAY ON THE FLOOR FOR ABOUT 10 MINUTES. BP WAS 82/71 PULSE WAS 62. WE GAVE HIM A GATORADE AND A WATER. AFTER 30 MINUTES HE WAS FEELING NORMAL AGAIN. HE REFUSED MEDICAL HELP. HIS EMERGENCY CONTACT WAS NOTIFIED. HE LEFT FEELING FINE AT 2:15PM.
40 2021-06-15 chest pain First shot one month prior, no issues at all. Soreness at the injection site. Second shot: Next da... Read more
First shot one month prior, no issues at all. Soreness at the injection site. Second shot: Next day, high fever, chills, severe muscle and joint pain. Two days after, violent vomiting. increased joint pain, fever, trouble thinking clearly. Three days after, numbness in my left hand, and loss of sensation in my entire right foot. As of 6-16, loss of feeling still continues. 1 week after, chest and lung pain, I think my heart is hurting, almost like random stabbing pains through it, random waves of muscle and joint pain. Issues sleeping. Issues with thinking clearly. I have felt run down since receiving my second shot. Loss of appetite and foggy brain.
40 2021-06-17 hypertension, chest pain About a week after the shot I noticed I was a experiencing some hypertension. I was having chest pai... Read more
About a week after the shot I noticed I was a experiencing some hypertension. I was having chest pains on the right side of my chest, as well as pain and numbness in my right arm around my bicep area. The chest pain is intermittent but the arm pain is pretty constant. My PCP ran a blood panel that showed high cholesterol. I also had an EKG, which was normal. He scheduled me for a stress test. I passed but was told that for a male my age and fitness level, I should have done better. I was prescribed aspirin and atorvastatin 10mg 1x/day. I had COVID in 11/2020, I was asymptomatic.
40 2021-06-17 hypertension, palpitations Vivid dreams and cant sleep, Insomnia, hallucinations, numbness, tingling, facial flushes, rashes, g... Read more
Vivid dreams and cant sleep, Insomnia, hallucinations, numbness, tingling, facial flushes, rashes, gut issues, heart racing and palpitations, high blood pressure, weight loss,
40 2021-06-22 loss of consciousness, palpitations I was going to the bathroom and I got really hot. My heart started to race and I ended up passing ou... Read more
I was going to the bathroom and I got really hot. My heart started to race and I ended up passing out. I was transported to the hospital and admitted over the night for observation. Ten days later, I passed out again and was admitted to the hospital again. I've had a couple of mini episodes where I have had to lay down and elevate my legs to keep from passing out
40 2021-06-22 loss of consciousness Passing out; pain; Difficulty breathing; Dizziness; Mental issues; Physical issues; Hypomanic; "Weir... Read more
Passing out; pain; Difficulty breathing; Dizziness; Mental issues; Physical issues; Hypomanic; "Weird"; Weakness; pain in ankle; Gout pain; Feeling ill; Feels like he almost wants to fall asleep; Vaccination site bruising; Fatigue; headache; arm sore(left arm), muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 053621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypoxia (Low oxygen), Mental disorder and Ankle operation. Concurrent medical conditions included Gout. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain) and FATIGUE (Fatigue). On 09-Jun-2021, the patient experienced ILLNESS (Feeling ill) and SOMNOLENCE (Feels like he almost wants to fall asleep). On 13-Jun-2021, the patient experienced GOUT (Gout pain). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), PAIN (pain), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness) and ARTHRALGIA (pain in ankle). The patient was treated with INDOMETHACIN [INDOMETACIN] for Gout, at an unspecified dose and frequency and IBUPROFEN for Gout, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), VACCINATION SITE BRUISING (Vaccination site bruising), PAIN (pain), GOUT (Gout pain), ILLNESS (Feeling ill), DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), MENTAL DISORDER (Mental issues), PHYSICAL DISABILITY (Physical issues), HYPOMANIA (Hypomanic), SOMNOLENCE (Feels like he almost wants to fall asleep), FEELING ABNORMAL ("Weird"), ASTHENIA (Weakness), HEADACHE (headache), MYALGIA (arm sore(left arm), muscle pain), ARTHRALGIA (pain in ankle) and FATIGUE (Fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications include unspecified mental health medications. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-215030 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated new events- Mental issues, physical issues, Loss of Consciousness, Gout, Arthralgia, Hypomania and feeling abnormal. Updated patient history and treatment medications.; 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.
40 2021-06-22 pallor, hypotension, fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotens... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient had some dizziness, pale color, fell out of chair and on to floor after receiving shot. patient was alert and responsive, sat down again and held on to counter for about 30 minutes. patient stated he no longer felt dizzy or strange. I took patient's BP and it was 99/58 with HR of 55 bpm, patient stated he is very fit and this was normal for him. I allowed patient to leave at that point, contacted him on 6/22, he said he was well and had experienced no additional issues after leaving.
40 2021-06-23 inflammation of the heart muscle Myocarditis or pericarditis according to ED Doc.
40 2021-06-29 heart rate increased, blood pressure increased, chest pain, chest discomfort Within 15 minutes of receiving vaccine, patient began to experience severe chest pain/tightness, ele... Read more
Within 15 minutes of receiving vaccine, patient began to experience severe chest pain/tightness, elevated blood pressure and pulse and broke out in a cold sweat. EMS was called. Follow up 30 minutes after leaving facility - EMS was still monitoring the patient Follow up the next day (6/29/21) - patient was unable to be reached to get an update on status
40 2021-06-30 loss of consciousness, fainting, pallor Patient received 1st dose of Moderna, then started his 15 minute wait. 11 minutes into the wait per... Read more
Patient received 1st dose of Moderna, then started his 15 minute wait. 11 minutes into the wait period, patient got up and came to the pharmacy counter and said he was feeling real warm and "funny" to the pharmacy technician. The technician alerted the pharmacist and when the pharmacist looked over at the patient, he looked pail and started slouching. Pharmacist ran to patient and caught him as he started to pass out. Pharmacist laid him on the floor and by the time the pharmacist had him laying down, the patient came back awake. Patient was sweaty and very warm to touch. During this process, EMS was called. When they arrived patient was already back to normal cognition and said he felt fine other than being warm. EMS check stats and cleared him to drive home after another 15 minutes wait period. The pharmacist believes this was a vasovagal syncope reaction to this patient getting the Moderna vaccine. Patient was fully recovered within 30 minutes of the adverse reaction.
40 2021-07-01 blood glucose increased, chest discomfort My adverse events were that I was having trouble breathing, I felt like someone was stepping on my c... Read more
My adverse events were that I was having trouble breathing, I felt like someone was stepping on my chest consistently, I was coughing a lot, I felt depressed, I had no appetite and felt extremely fatigued. I was admitted to The Emergency room because of high blood sugar so I went back on Lantus and everything has normalized. I was admitted on 06/09/2021 and discharged 06/10/2021. I had blood work drawn and a COVID test. My COVID test came back normal and my blood work showed that my blood sugar was very high.
40 2021-07-02 cerebrovascular accident Had stroke; Has loss of vision in right eye; Has headaches; This spontaneous case was reported by a ... Read more
Had stroke; Has loss of vision in right eye; Has headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In June 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 21-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Has loss of vision in right eye) (seriousness criteria hospitalization and medically significant) and HEADACHE (Has headaches) (seriousness criterion hospitalization). The patient was hospitalized on 21-Jun-2021 due to BLINDNESS, CEREBROVASCULAR ACCIDENT and HEADACHE. At the time of the report, CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) outcome was unknown. No concomitant medication information was provided by the reporter. Treatment information was unknown. It was reported that the patient experienced stroke 3 days after receiving the 2nd dose of the vaccine. He was hospitalized on 21Jun2021. Patient also had headaches and loss of vision in right eye, and both started the day of stroke. 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.
40 2021-07-06 heart attack myocardial infarction
40 2021-07-07 deep vein blood clot Blood clots (thrombus) found in my left thigh's vein, hence the swollen leg. I am not 100% sure if ... Read more
Blood clots (thrombus) found in my left thigh's vein, hence the swollen leg. I am not 100% sure if it's related to the vaccine though.
40 2021-07-08 blood clot I have Peripheral Artery disease and have had bypasses done on both legs. It has been managed fairl... Read more
I have Peripheral Artery disease and have had bypasses done on both legs. It has been managed fairly well with a several minor "tune ups" by angio. I was able to walk pretty well with minimal pain. About a week after my second dose I started noticing increased pain in both of my calves which has become considerably worse since then. I cannot walk 1/10 of a mile without taking a break. Also, around July 1st, my fingers went numb in my right hand, then I started getting pain in my right forearm and cramping in my hand. That pain has made it so the way up my arm. I saw my vascular surgeon and an ultrasound revealed a clot in the bend of my elbow. I was asked how I think I could have gotten the clot, the only thing I've done differently was get that vaccine. It's extremely obvious to me that the vaccine has caused a severe reaction in me. I have a surgery scheduled on Wed. July 14 to have the clot removed.
40 2021-07-12 fainting Fever and chills started 16 hours after 2nd Moderna vaccine. Syncope occurred morning after (Appro... Read more
Fever and chills started 16 hours after 2nd Moderna vaccine. Syncope occurred morning after (Approximately 22 hours after vaccine).
40 2021-07-13 chest discomfort Patient called 7/14/2021 to report that on 7/9/2021 at 11PM he experienced heaviness in chest and tr... Read more
Patient called 7/14/2021 to report that on 7/9/2021 at 11PM he experienced heaviness in chest and trouble breathing that lasted 24-25 hours and went away. Stated he did not go to the hospital or talk to his PCP.
40 2021-07-20 fainting seen patient of at this time for syncopal episodes while driving and at work; worsened Bipolar; Decr... Read more
seen patient of at this time for syncopal episodes while driving and at work; worsened Bipolar; Decreased level of consciousness; worsened Depression; Difficulty breathing/issues with breathing; worsened Anxiety; Feeling ill; felt really tired; felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar) and DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (2 surgeries on other leg). Concurrent medical conditions included Bipolar disorder, Gout (In one leg), Penicillin allergy (reaction- nausea), Drug allergy (Revatio (reaction- nausea)), Drug allergy (Vicodin (reaction- nausea)), Seasonal allergy (reaction- congestion), Anxiety (worse with COVID mask use) and Depression (worse with COVID mask use). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 19-Apr-2021 to an unknown date for Depression, INDOMETACIN (INDOCIN [INDOMETACIN]) from 07-Oct-2020 to an unknown date for Gout, NAPROXEN SODIUM (ALEVE) from 24-Sep-2019 to an unknown date for Pain. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), ILLNESS (Feeling ill) and FATIGUE (felt really tired). On 14-Jun-2021, the patient experienced ANXIETY (worsened Anxiety). On an unknown date, the patient experienced SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work) (seriousness criterion medically significant), BIPOLAR DISORDER (worsened Bipolar) (seriousness criterion medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), DEPRESSION (worsened Depression) and DYSPNOEA (Difficulty breathing/issues with breathing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and OLANZAPINE (ZYPREXA) (oral) ongoing from 07-Jul-2021 for Bipolar affective disorder aggravated, at a dose of 10 mg. At the time of the report, SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ANXIETY (worsened Anxiety), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (worsened Anxiety) to be possibly related. No further causality assessments were provided for SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired). After getting the vaccine in the morning, the patient felt really tired. The patient went to the family doctor for a previously scheduled appointment regarding his condition. On the way there he couldn't keep the eyes open, and felt as if he didn't get enough sleep. The patient hadn't realized that he slept. The patient had assistance from his son because he felt like he could catch his train of thought. The patient told his O2 level was fine and was instructed to take Benadryl. The HCP reported that anxiety, depression and bipolar might be psychological and wondered why these had gotten worse. 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, history of bipolar depression and anxiety may remain as risk factors. This case was linked to MOD-2021-215030, MOD-2021-214836 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up contains New event , Medical history On 08-Jul-2021: Follow-up included: Medical history was updated, Patient weight, anatomical location of vaccine administered, Dose 1 details added On 14-Jul-2021: Case has been updated from non-serious to serious due to the addition of Serious events. New non-serious events also have been added. Patient's demographic details and reporter contact details were updated. Patient's medical history including allergies and current conditions, concomitant medications and treatment details were added.; 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, history of bipolar depression and anxiety may remain as risk factors.
40 2021-07-21 heart rate irregular I started to have numbing on my right side especially on the back of my head. After that I had dizzi... Read more
I started to have numbing on my right side especially on the back of my head. After that I had dizziness and confused. I felt like I could not breath. I was finally able to catch my breath. I am still not able to catch my breath. I went to the ER. They checked my pulse and took notes. They were just trying to rule out everything. They monitored me for a while. The did do an MRI. After that I followed up with my PCP, she ran labs, and they came back normal. They did a COVID test which cam back negative. I still experience irregular heartbeat. I am going to follow-up with my cardiologist at the end of month.
40 2021-07-23 increased heart rate, fluid around the heart, inflammation of the pericardium, chest discomfort, chest pain, ejection fraction decreased DX: Pericarditis; S/S Headache, fever/chills, Acute chest pain or pressure, Chest pain made worse by... Read more
DX: Pericarditis; S/S Headache, fever/chills, Acute chest pain or pressure, Chest pain made worse by lying down, deep inspiration, or cough,Chest pain relieved by sitting up or leaning forward-- onset 04/14/2021 "Progressive severe diffuse anterior chest pain radiates towards his anterior neck...describes a pleuritic component to his chest pain."
40 2021-07-23 fast heart rate, heart rate increased 40 year old patient received second dose of Moderna lot number 026A21A. Began to complain of rapid ... Read more
40 year old patient received second dose of Moderna lot number 026A21A. Began to complain of rapid heart beat, tingling, difficulty breathing, difficulty speaking. No physical evidence of allergic reaction. Vitals were normal except mild tachycardia. No rash or wheeze. Normal oxygen sat. Watched longer, offered food, but patient continued to state he did not feel right. At over 1 hour, asked if he would like to drive to ER, but said he could not drive. Called EMS. Gave Bendadryl IM (no po in kit).
40 2021-07-28 chest pain Chest Pains
40 2021-07-28 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had an event of syncope after the injection and fainted in the chair. I assisted the patient to the ground and had them lie flat and elevated their legs using a chair. Patient regained consciousness and was responsive within 1 min. I checked BP and heart rate (BP was 124/82 and Pulse was 76 b/m). Per store Policy EMS was called by store LOD. EMS arrived and took patient to local hospital. Pts was responsive when they left pharmacy.
40 2021-07-28 fainting Patient completed 2nd dose of Moderna 07/29/2021, first dose was given 07/01/2021. After completed ... Read more
Patient completed 2nd dose of Moderna 07/29/2021, first dose was given 07/01/2021. After completed dose, patient was advised to sit and wait (MINUTES). After the timed interval was completed he would be free to leave. A few minutes after vaccination, the patient started experiencing dizziness and fainting. Objectively, the patient displayed fainting and minor seizure like activities. In addition, the patient was sweating all over the body. This happened over a period of 15-30minutes before EMT arrived to provide additional support.
41 2021-01-01 palpitations 5 minutes post vaccine administration I started to feel palpitations, numbness on both arms and went... Read more
5 minutes post vaccine administration I started to feel palpitations, numbness on both arms and went up the nape/head, flushing, tingling in both arms dizziness, then dysphagia but able to talk. Hives at torso after 10 minutes. I was assessed by to physicians working at the site. Epi pen was given to me by a physician and taken by ambulance to hospital by EMTs who were there at the site. At the hospital I was given 40mg steroids by mouth. After observation for 4 hours I was feeling better, and was discharged home. Ordered to take 40mg of steroids for 2 more days. After one day post vaccination, I have significant pain at the site and body ache.
41 2021-01-03 hypertension After receiving 1st Moderna COVID19 vaccine and while waiting during the 15min waiting period, patie... Read more
After receiving 1st Moderna COVID19 vaccine and while waiting during the 15min waiting period, patient saw someone else get anxious and wobbly and need to lay down, then he also got anxious and felt like his vertigo had been triggered... dizzy when turning head to the side, which he gets sometimes, but this started for him after vaccination. Laid down, rested, and felt better-- symptoms resolved and he was discharged to home. Noted to be hypertensive 143/93-- discussed with him and asked him to speak with primary care physician.
41 2021-01-03 lightheadedness, pallor, cardio-respiratory arrest Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated an... Read more
Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated and diaphoretic. Employee assisted to cot to lie down. Skin pale, continued to be diaphoretic, respirations in the 20's, BP 115/82, HR 110, O2 98% on RA, denied any difficulty breathing, no coughing or evidence of throat tightening, no sign of any swelling at vaccination site, no rash. Code called overhead, Code team arrived. No medications given at time in clinic. Near syncopal episode, No anaphylaxis. Employee taken to ED for further evaluation and observation.
41 2021-01-04 chest pain Left sided pleuritic chest pain developed about 24 hours after vaccination and continued to get wors... Read more
Left sided pleuritic chest pain developed about 24 hours after vaccination and continued to get worse for 2 days after which it is now slowly resolving. Used ibuprofen and tylenol PRN to help with pain symptoms.
41 2021-01-08 heart rate increased Sudden onset of a burning sensation radiating from epigastrium to substernal. Rapid heart rate. Vit... Read more
Sudden onset of a burning sensation radiating from epigastrium to substernal. Rapid heart rate. Vitals obtained and patient was observed for 30 minutes. Patient stated symptoms subsided and vitals returned to normal.
41 2021-01-08 heart rate increased DIAPHORESIS Narrative: Felt sweaty, rapid hr which subsided after 30 min. Initial 137/81 HR 119; En... Read more
DIAPHORESIS Narrative: Felt sweaty, rapid hr which subsided after 30 min. Initial 137/81 HR 119; End 123/48 HR 92 O2 SAT 97
41 2021-01-08 lightheadedness Reported numbness in lips and L Malar area; no angioedema Narrative: Employee was taken to facility... Read more
Reported numbness in lips and L Malar area; no angioedema Narrative: Employee was taken to facility in wheelchair, evaluated and stable. Diagnosis vasovagal due to needle anxiety vs mild allergic reaction to MODERNA vaccine. Given 50mg Benadryl and Solumedrol 125mg IM. Monitored for 30 minutes, completely asymptomatic. Release home in care of wife.
41 2021-01-10 palpitations On the date of injection. My right arm was fine. Waited 15 mins. Everything was ok. Until 130 am at ... Read more
On the date of injection. My right arm was fine. Waited 15 mins. Everything was ok. Until 130 am at night. Woke up due to the heart palpitations and nausea that lasted 10-20 mins. Monitor the symptoms and it went away after 20 mins. Symptoms was mild.
41 2021-01-12 chest discomfort About 5 hrs after receiving vaccine muscle ache in shoulder. Next day mild headache and body aches t... Read more
About 5 hrs after receiving vaccine muscle ache in shoulder. Next day mild headache and body aches through day three. Slight sinus drainage on day 2 and 3 and tightness in chest on day 3 morning. Penis reduced in size, length, and circumference is significant since following day and pain in penal area from day 3 and day 5 most noticeable. Shape of penis has changed (noticed on day 4 due to an erection) and the skin has become loose with the size reduction (like baggy pants.)
41 2021-01-14 loss of consciousness Patient was nervous/diaphoretic upon arrival to vaccine appointment. Patient received vaccine, was b... Read more
Patient was nervous/diaphoretic upon arrival to vaccine appointment. Patient received vaccine, was brought to observation area and seated, and within one minute patient lost consciousness and fell to ground from seated position. Patient was log rolled and opened his eyes and responded to name calling immediately after fall. V/S were taken, loaded onto stretcher. MD took HR, was in 40s. Initial full set of vitals 09:10 BP 115/70, HR 66, o2sat 99%. Laid reverse trendelenburg in stretched. Physician on site and EMS was immediately called. Patient was diaphoretic and responsive/speaking. 09:13 121/55, HR 62, O2sat 98%. 09:17 120/57, HR 78, O2sat 98%, 09:25 118/68, HR 69, O2Sat 96%. At 9:31 patient left for ED with EMS. Of note, patient reported after the fact that he has history of nervousness/anxiety with needles.
41 2021-01-16 chest pain, chest discomfort Moderna COVID-19 Vaccine EUA Low grade fever (99.0-100.9) Tightness of chest Soreness in chest Fatig... Read more
Moderna COVID-19 Vaccine EUA Low grade fever (99.0-100.9) Tightness of chest Soreness in chest Fatigue Soreness in injection site
41 2021-01-19 heart rate increased Sweating, increased heart rate,
41 2021-01-20 fainting Started with flu like symptoms, chills, aches, etc. For about 12 hours. Then I rapidly spiked a 102.... Read more
Started with flu like symptoms, chills, aches, etc. For about 12 hours. Then I rapidly spiked a 102.7 fever and became so physically weak I felt paralyzed. Oxygen saturation dropped into the low 90s and I began to have labored breathing. I made an attempt to stand up and urinate, then passed out and collapsed. Ems came to the house and checked me out. I declined their offer to go to the hospital because I broke the fever, was breathing better, and had no concussion signs from the fall.
41 2021-01-21 heart rate increased, chest discomfort Pt was driving down the road 18-24 hours after receiving vaccine when all of a sudden he experience... Read more
Pt was driving down the road 18-24 hours after receiving vaccine when all of a sudden he experienced dizziness, rapid heartrate, headache, blurred vision, hives to chest and arms, edema and redness at injection site. Pt went to Hospital via EMS on 1-21-20 and was given 50mg Benadryl on ambulance. Pt states that he was diagnosed with a "reaction to the vaccine and I was given prednisone, pepcid and Tylenol in ED." Pt was called on 1-22-21 by Public Health nurse and states that he was feeling much better today but still had the redness and swelling at injection site.
41 2021-01-22 heart rate increased Muscle aches, malaise, chills, 120 to 140 bpm heart rate and perfuse sweating which lasted from dinn... Read more
Muscle aches, malaise, chills, 120 to 140 bpm heart rate and perfuse sweating which lasted from dinner, allnight until early morning. Drank a lot of water and stretched to help relax and tried to call back asleep. Heart rate did eventually go back down to 80 to 90 bpm. Still felt clamy and fatigued. Went to work with little energy.
41 2021-01-24 fast heart rate 12 hrs after vaccine experienced typical adverse side effects of arm pain, fatigue, headache, myalgi... Read more
12 hrs after vaccine experienced typical adverse side effects of arm pain, fatigue, headache, myalgias and arthralgias. 24hrs after vaccination the initial symptoms persisted and also developed urticarial macular exanthem from scalp to waist along with decreased urine output, joint swelling, edema, Had intermittent tachycardia. Symptoms lasted for 72 hours.
41 2021-01-26 very slow heart rate, pallor, hypotension, lightheadedness vasovagal episode with him turning pale, hypotension, bradycardia, dizziness, nausea. Watched for 4... Read more
vasovagal episode with him turning pale, hypotension, bradycardia, dizziness, nausea. Watched for 45 min and he was still feeling the same way, so sent to hospital
41 2021-02-01 fast heart rate tachycardic post 1st COVID vaccine. HR 140. History of anxiety. Emesis x 1.
41 2021-02-04 cerebrovascular accident Stroke two days after vaccination, CVA hemorrhage, aneurysm (hospitalized ICU 08 January 2021, curre... Read more
Stroke two days after vaccination, CVA hemorrhage, aneurysm (hospitalized ICU 08 January 2021, currently requires daily physical therapy and has walker to ambulate).
41 2021-02-04 heart rate increased Cold sore inside part of lip, single angiodema type rash/hive on outside part of lip directly oppos... Read more
Cold sore inside part of lip, single angiodema type rash/hive on outside part of lip directly opposite cold sore, elevated resting heart rate at 95-105 (normal 71-80
41 2021-02-04 palpitations Heart palpitations Intense vertigo
41 2021-02-08 heart rate increased, loss of consciousness Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administrat... Read more
Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administration, developed high fever(102), rapid heart rate, low o2 sat, eventually passed out and EMS had to be called. Was not transported to hospital per pt request.
41 2021-02-12 chest pain, blood pressure increased, heart rate decreased Day 1- pain and lack of range of motion at deltoid left arm , existed for about 5 days. Burning in c... Read more
Day 1- pain and lack of range of motion at deltoid left arm , existed for about 5 days. Burning in chest, possibly lung. Shortness of breath, scanty urination/dark urine, problems with bowel movements. Days 2-4: dizziness, disorientation, gait changes, delay thinking, headaches, shortness of breath chest burning, whole body joint pain, neuropathy like sensations in arms, blood pressure spikes/ pulse rates dropped to 42.
41 2021-02-17 blood vessels inflammation, blood pressure decreased, hypertension, bleeding on surface of brain, fast heart rate Patient is a 41 y.o. male on no AC/AP with no pmhx reported presents 1/31 PM initially to Hospital f... Read more
Patient is a 41 y.o. male on no AC/AP with no pmhx reported presents 1/31 PM initially to Hospital for acute onset 10/10 headache refractory to 800mg motrin which started in occipital region then spread to whole head and neck, nausea and vomiting x 3. Symptoms started around 5pm when he was on a conference call and reports he got bad news so was stressed out. Denies any recent trauma. Pt received toradol 30mg, dexamethasone 10mg, benadryl 25mg and reglan 10mg at hospital prior to transfer. CT showed diffuse SAH and CTA showed no signs of obvious aneurysms. He then received 1g IV keppra and was started on Cardene for BP goal <140. He was transferred to NICU for further monitoring. While in the NICU, his exam and imaging remained stable. He underwent CTA which was unrevealing, and DSA which showed evidence of vasculopathy. BPs came down to <160 and he came off of cardene, did not require additional meds. He was transferred to the floor. Upon transfer, he had another thunderclap HA, accompanied by HTN to the 200s systolic, tachycardia to the 120s, diaphoresis, and blotchy macular rash over the anterior shoulders. Imaging was negative for vasospasm or recurrent bleed, and it was felt that patient's presentation was most c/w RCVS. Trigger felt either 2/2 caffeine intake (patient reported drinking 60 oz coffee daily) vs. Sympathetic discharge syndrome such as pheochromocytoma or carcinoid syndrome. LP was performed, which revealed no nucleated cells and protein elevated in proportion to blood, which confirmed the diagnosis of RCVS. Studies were sent off to diagnose carcinoid syndrome and pheo. Patient was started on nimodipine/gabapentin with standing tylenol and PRN oxycodone for breakthrough pain. Within days, the HAs had markedly decreased in intensity. He was taken off of keppra after 1 week with stable exam and no e/o seizures. He was briefly switched from nimodipine to verapamil but switched back prior to discharge. He was discharged with outpatient followup.
41 2021-02-18 loss of consciousness Woke up to use the restroom. Passed out and fell multiple (~5) times while trying to return to bed. ... Read more
Woke up to use the restroom. Passed out and fell multiple (~5) times while trying to return to bed. I have never experienced that before.
41 2021-02-26 hypertension High blood pressure 150/102 High glucose 184 High pulse 115
41 2021-03-01 chest discomfort shortness of breath, tightness in chest feeling for about 12 hours. Started 36 hours after second do... Read more
shortness of breath, tightness in chest feeling for about 12 hours. Started 36 hours after second dose.
41 2021-03-01 loss of consciousness Patient received first dose of Moderna covid-19 vaccine and went to the 15 minute monitoring area. P... Read more
Patient received first dose of Moderna covid-19 vaccine and went to the 15 minute monitoring area. Per the ED notes patient felt dizzy and developed tunnel vision prior to the patient passing out 15 minutes after getting the vaccine. Similar episodes in the past due to fear of needles. Patient was on floor and rapid response called, patient taken to the ED for evaluation and was discharged in stable condition with vasovagal syncope.
41 2021-03-01 pallor, skin turning blue Walking away from vaccination table offender became dizzy. Sat down. BG checked and 107, normal for ... Read more
Walking away from vaccination table offender became dizzy. Sat down. BG checked and 107, normal for patient. Maintained consciousness but became increasingly unsteady. VS checked, P 34, unable to obtain BP, R 20 and shallow, O2 94%. LCTAB. Patient became pale and lips became cyanotic. Unable to obtain P and O2 at this time. Epinephrin 0.3cc administered, P increased to 54, O2 93, transferred to trauma room and IV fluids administered. Patient fully recovered within an hour.
41 2021-03-02 chest pain, loss of consciousness 2 minutes after received 1st dose of Moderna COVID vaccine, patient stated unilateral headache, advi... Read more
2 minutes after received 1st dose of Moderna COVID vaccine, patient stated unilateral headache, advised to drink water. 3 minutes after receiving vaccine, patient stated " I feel funny, I can't breathe" and lost consciousness x 5-10 seconds. Patient airway clear and breathing monitored. Patient regained consciousness, diaphoretic, oriented. Patient A&O x 4 after sternal rub. HR: 52, SPO2: 97% RA. Provided breath coaching, held patient in upright position, monitored breathing, had patient orally drink water. Manual B/P: 95/60, HR: 64. Patient became more coherent and stated prior to loss of consciousness he felt chest pain, denied any current chest pain, SOB, dizziness, headache, confusion, itching, rash, swelling. Consulted with MD on site who advised EMS called and to monitor patient vitals. Patient declined EMS. Patient placed in wheelchair and taken to private room to lay supine and orally drink fluids. 15 minutes later supine vitals: B/P: 117/77 HR: 68, SPO2: 99% RA. Patient rested for additional 15 minutes, sat upright for 5 minutes. Vitals sitting: B/P 117/79, HR: 69, SPO2: 99% RA. Per MD, patient approved to return home but advised not to drive. Patient stated had not eaten or been drinking water and driven 2 hours prior to vaccination. Patient stated all symptoms resolved except feeling fatigued. Advised patient's wife to drive, to eat/drink prior to leaving, if develops chest pain, SOB, facial swelling, hives, loss of consciousness, lethargy, confusion to go to ER or call 911. Patient and wife verbalized understanding. Patient monitored for 1 hour after loss of consciousness. Telephone call to patient 4 hours after vaccination. Patient stated "feeling much better," ate and drank water after leaving clinic, and resting. Patient denied SOB, chest pain, loss of consciousness, confusion, lethargy, HA, dizziness, lightheadedness. Patient advised to inform PCP of symptoms/reaction and discuss plan for when/if 2nd dose. Explained may have been vasovagal response. Patient stated several years ago having similar episode at ER when seeing blood, stated at vaccine clinic today, watched wife receive vaccine, then saw small drop of blood on his arm before loss of consciousness. Patient stated he will discuss with his PCP.
41 2021-03-14 heart rate increased Flair up of tendentious and upper arm pain in my right arm (the opposite arm from the one I had the ... Read more
Flair up of tendentious and upper arm pain in my right arm (the opposite arm from the one I had the shot in). This is still ongoing. (I have had a few limited periods where I have had tendentious/bursitis in the past, but it as not been an issue in over a year and reoccurred immediately after the shot.) Significant fatigue the day after injection with ongoing fatigue following. Elevated heart rate for at least the day following the injection. Pain at injection site for 3 days
41 2021-03-15 platelet count decreased It was the Moderna Vaccine. I had a prescheduled meeting to get some tests done on the Monday, follo... Read more
It was the Moderna Vaccine. I had a prescheduled meeting to get some tests done on the Monday, following my vaccine (02/22/2021). The results of those labs showed a severe inflammatory response. My blood platelet levels were at 27, and my CRP was at 15. I started bruising easily, which I have never done before, and I had serious body aches and fatigue. I met with Dr. on Tuesday, March 16, 2021 to do some follow up tests. At this point, my platelet levels were up to 96, much improved, but still low. He said that it could very likely be connected to the vaccine. I had the first dose on January 23, 2021, and the second dose on February 20, 2021. I now have to get additional tests to see if these levels improve.
41 2021-03-22 loss of consciousness Pt recieved dose one of Moderna COVID19 Vaccine about 1255pm LOT 046A21A, Exp.9/3/21. Within about 3... Read more
Pt recieved dose one of Moderna COVID19 Vaccine about 1255pm LOT 046A21A, Exp.9/3/21. Within about 3 min of entering waiting room, pt felt faint/ passed out, hit his head on end table, tried to get up into a seat and lost consciousness again for 1-2 SEC. Assissted byt wife and NP to the floor. 911 called by PCT, BP 90/52, HR 65, o2 99%. After evaluation per EMS team, pt chooses not to go with EMS to ED for further care, recommended by NP and EMS. Pt chose to go with wife and will go to ED if worsening symptoms. AMA signed for EMS and clinic
41 2021-03-23 ejection fraction decreased, inflammation of the heart muscle, chest pain 41yo male with history of HLD, LBP, and tobacco use who presented to care initially at the with ches... Read more
41yo male with history of HLD, LBP, and tobacco use who presented to care initially at the with chest pain. He received the second dose of the Moderna vaccine on 18MAR21 at clinic and within 14 hours developed chills and myalgias. He denies any immediate onset of symptoms after receiving the vaccine. The following day he reports experiencing chest pain 24 hours after the vaccine was administered that progressively worsened over the subsequent 36 hours that finally prompted him to seek care. He describes the pain as a central non-radiating squeezing pain that worsened with movement and breathing. He waited to seek care because he reports several of the soldiers in his unit have experienced similar chest pain that eventually resolved. He reports being at his baseline health prior to receiving the vaccine and denies any fever, cough, rhinorrhea, congestion, malaise, vomiting, diarrhea, or rash. Upon initial presentation to care at clinic he was noted to have a Tropnon I of 0.9, WBC of 14, elevated CRP (7.3), and temp to 101.4. Patient was given ASA, Plavix, Lovenox, Tylenol, and Ceftriaxone. Since arriving to clinic and EKG was obtained showing ST elevation in lead 1 and avF concerning for ischemia and underwent a left heart catheterization which was clear of obstruction. Serial high sensitivity Tropnonin levels have been trended to peak of 465. Respiratory viral panel to include SARS COV-2 was negative. Cardiac MRI was consistent with myopericarditis, and show mildly reduced EF for 46%. Blood cultures have not grown any organism. His chest pain has resolved since starting Aspirin and Colchicine.
41 2021-03-23 fainting Patient stated that he started to feel itchy, dizzy, and fainted when he bent over. Fell asleep and ... Read more
Patient stated that he started to feel itchy, dizzy, and fainted when he bent over. Fell asleep and said he was dreaming when we woke him up a few seconds later. It started happening around 5 minutes after he received the vaccine. He stated that he felt fine and back to normal after he was woken up. Had him stay until paramedics came to check him out. Was cleared to go home.
41 2021-03-25 hypertension blood pressure was 200/120; felt like it was hard to breathe; felt dread; felt a strange cold rush o... Read more
blood pressure was 200/120; felt like it was hard to breathe; felt dread; felt a strange cold rush over his system; A spontaneous report was received from consumer concerning a 41 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt a strange cold rush over his system/ feeling cold, felt like it was hard to breathe/dyspnoea, felt dread/fear, blood pressure was 200/120/hypertension. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided. On 8 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, less than a minute after receiving vaccine, patient felt a strange cold rush over hissystem felt like it was hard to breathe, he felt dread. Patient reported that the facility had checked and his blood pressure was 200/120. Patient was not sure if it was a panic attack, but he took antianxiety medicine. Treatment activities for event was done with antianxiety medicine. The seriousness criteria for the event hypertension was assessed as medically significant. The seriousness criteria for other event was not reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, and felt a strange cold rush over his system, felt like it was hard to breathe, felt dread, blood pressure was 200/120 were unknown.; Reporter's Comments: Based on the information provided which includes a STRONG temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded
41 2021-03-28 pallor Patient complained of headache, nausea and difficulty expressing self with periods of confusion. vit... Read more
Patient complained of headache, nausea and difficulty expressing self with periods of confusion. vital sighs obtained and stable. patient continues to be monitored for any worsening symptoms. patients skin color pale. patient administered tylenol that he brought with him, with water and orange juice. patient stated that symptoms have subsided and less headache comparing to initial incident.
41 2021-03-29 fainting, hypotension Syncope, hypotension
41 2021-03-30 blood glucose increased Blurred vision; Complete loss vision; Hearing impairment Whoosh; spike in blood sugar; Fatigue; A sp... Read more
Blurred vision; Complete loss vision; Hearing impairment Whoosh; spike in blood sugar; Fatigue; A spontaneous report was received from a consumer who was a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete loss of vision (blindness), fatigue, blurred vision, spike in blood sugar (blood sugar increased), and hearing impairment "whoosh" (hearing impaired). The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications were insulin glargine and insulin lispro. The patient said he was compliant with his insulin injections. On 29 Dec 2020 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient experienced a spike in blood sugar. He tested his blood sugar immediately following the vaccination and it was in the 280-380 range. Prior to the vaccine, it was 100 to 150. On an unspecified date, his hemoglobin A1C was below 7. On 05 Jan 2021, he experienced hearing impairment "whoosh". On 09 Jan 2021, the patient experienced complete vision loss. On 11 Jan 2021, he experienced blurred vision. Action taken with mRNA-1273 in response to the events was not reported. The event of complete vision loss resolved on 11 Jan 2021. The outcomes of the events of fatigue, blurred vision, hearing impairment "whoosh", and blood sugar spike 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. The patient's medical history of diabetes remains a confounding factor. Further information has been requested.
41 2021-03-31 heart rate increased 2/5/2021--Patient came to Center for 2nd dose Moderna COVID-19 vaccine but reports that after his 1s... Read more
2/5/2021--Patient came to Center for 2nd dose Moderna COVID-19 vaccine but reports that after his 1st dose he had reaction (chills, headache which are common reported side effects) but he also had his resting HR elevated for about 12 hours to 102 bpm and his normal HR is usually 60. 2/9/2021 1635--Called to f/u with patient regarding his 2nd dose of Moderna COVID-19 vaccine, no answer, left message. 2/11/2021 0924--Patient called back, he reports he is feeling well now after 2nd dose but did have a similar reaction but feels like it wasn't quite as bad. He received his 2nd dose on Fri 2/5/21 around 1600 and reports the next morning his HR was elevated to about 104 for about 4 hours, he also had chills for
41 2021-03-31 heart rate irregular, heart rate increased About 1 hour after injection I started feeling mild tingling in my face and throat. I then lost my v... Read more
About 1 hour after injection I started feeling mild tingling in my face and throat. I then lost my voice for approximately 5 minutes. As the next few days started to progress I started noticing mild muscle spasms all over my body, mostly in my legs; waking up in the middle of the night, dry mouth, night sweat (1 occurrence), sudden onset of rapid and irregular heart beat (1 occurrence); kidney pain (right and left), upper abdominal pain (right and left). Prior to vaccine I did not experience any of these events.
41 2021-04-03 loss of consciousness Patient c/o dizziness after vaccine was given. The same happened on his first dose. He was diaphoret... Read more
Patient c/o dizziness after vaccine was given. The same happened on his first dose. He was diaphoretic and passed out for few second. He was medically cleared to receive vaccine. He declined to be taken to the hospital.
41 2021-04-03 palpitations Approximately 6 hours after vaccination, experienced high fever (tmax 103.0), took tylenol with decr... Read more
Approximately 6 hours after vaccination, experienced high fever (tmax 103.0), took tylenol with decrease of fever, also felt palpitations described as his heart was racing all night. Woke up this morning with low grade fever 99.4 and some intermittent palpations which are improving.
41 2021-04-04 chest discomfort, palpitations Shortly after receiving his second dose of Covid 19 vaccine, he reported feeling throat and chest t... Read more
Shortly after receiving his second dose of Covid 19 vaccine, he reported feeling throat and chest tightness, SOB and palpitations.
41 2021-04-04 chest discomfort Fatigue Headache Tightness in chest Runny nose Sore arm
41 2021-04-07 loss of consciousness Patient received vaccine and went in the waiting area for the 15 minute observation. He passed out a... Read more
Patient received vaccine and went in the waiting area for the 15 minute observation. He passed out and fell on the floor. He was sweating but was conscious. We put a bag of frozen blueberries on his neck and wiped his face with a damp towel while waiting for EMS to arrive. He did not require CPR.
41 2021-04-07 pulmonary embolism He had second dose of Moderna COVID vaccine on March 13th. He was admitted with progressive SOB and ... Read more
He had second dose of Moderna COVID vaccine on March 13th. He was admitted with progressive SOB and acute right leg limb ischemia 4/7/21. He was found to have massive Bilateral PE and right common femoral artery and right external iliac atery occlusion. He was unstable and required embolectomy, tPA and EKOS for PE and embolectomy for right leg arterial occlusions. He remains sedated in ICU now.
41 2021-04-07 blood vessels inflammation Patient experienced a non-itching, non-blanching petechial rash across bilateral arms, trunk, and ba... Read more
Patient experienced a non-itching, non-blanching petechial rash across bilateral arms, trunk, and back beginning 5 days after vaccination. Biopsy revealed underlying vasculitis with eosinophils. The rash clears up with use of oral prednisone. Patient has also experienced edema and ulcers of the lower extremities believed to be caused by microeboli associated with vasculitis.
41 2021-04-09 fainting Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Med... Read more
Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported not having eaten since previous day in the afternoon, briefly experienced syncope and fell out of chair that he was seated in while waiting 15 min after given first dose of covid shot, patient waited full amount of time and felt fine after 15 min
41 2021-04-10 blood pressure decreased Patient was sweating profusely and dizzy. His blood pressure dropped to the 70's. After some hydrati... Read more
Patient was sweating profusely and dizzy. His blood pressure dropped to the 70's. After some hydration with Gatorade, patient got up and left on his own. He refused when offered to call for more help. After the vaccination, patient said he remembered he had the same reaction in the hospital when he received an anesthesia injection.
41 2021-04-12 chest discomfort Went to ED 3/30/21 Immediately after receiving the second vaccine 2/25 he developed chest tightness... Read more
Went to ED 3/30/21 Immediately after receiving the second vaccine 2/25 he developed chest tightness and joint pain. The chest tightness resolved within a few hours. He then had severe fatigue x36 hours-sleeping most of that time?followed by fever, chills, myalgias x2d. Those resolved but the arthralgias have persisted since then. Within 1 week he developed worsened joint hypermobility and has had multiple subluxations (fingers, ankles, knee, elbow) that has persisted. Within 1 week he developed joint swelling. He had diffuse pain and hyperalgesia with pain to minimal pressure. At 2 weeks he developed a pruritic popular rash on LE. Due to joint swelling and rash he was placed on a 5d prednisone burst that decreased the pain, swelling, and rash, but recurred when prednisone d/c?d. He was restarted on a 2 week taper which helped partially with pain and swelling but did not resolve them and the rash continued to spread. He still has the rash present now diffuse on legs and torso but it seems to have stopped spreading as of this week. The joint swelling has also seemed to plateau but has not resolved. The joint pain and worsened hypermobility is slowly improving but not resolved. 2 weeks ago (4 weeks after vaccine) he developed new neuropathic symptoms?tingling in his extremities with intermittent shock-like pain, followed by itching and burning along S2-S3 dermatomes (into groin) and back pain. The sacral sxs resolved w/in 1 week but the tingling in extremities has persisted.
41 2021-04-12 heart rate decreased 20 minutes after shot, I went from feeling fairly normal to very suddenly had very severe problems i... Read more
20 minutes after shot, I went from feeling fairly normal to very suddenly had very severe problems including dizziness, confusion , significant difficulty breathing, significant difficulty staying conscious, tingling all over, loss of control of some body movements, inability to sit or stand, pulse dropped to 51 according to medic,. I believed I was dying. Medic indicated I turned "white". The symptoms peaked within 1-2 minutes after onset and stayed bad for several minutes. After a few minutes My pulse started to increase and all symptoms started improving. Within 10 minutes I was feeling well enough to sit, and within 30 minutes I was able to drive home.
41 2021-04-13 cerebrovascular accident I suffered a stroke on March 19, 2021 that effected my Occipital and Temporal Lobes on the right si... Read more
I suffered a stroke on March 19, 2021 that effected my Occipital and Temporal Lobes on the right side of my brain. The primary symptom was almost total and complete blindness. Taken to emergency room, made a stroke alert, tPA cleared clot, spent 5 days at the hospital.
41 2021-04-15 fainting Fainting - never lost consciousness Shot given 10:10am. Was in waiting room and reported feeling ... Read more
Fainting - never lost consciousness Shot given 10:10am. Was in waiting room and reported feeling light headed at 10:25am. 10:25am. Faint/dizzy/supine BP 124/77 Pulse 74. Respiration. 16 10:30am Supine BP 135/73. Pulse 63 10:35am. Supine BP. 134/80. Pulse 66 10:40am. Sitting BP 135/72. Pulse 62 ***follow-up call made 12:27pm had to leave message
41 2021-04-18 heart rate increased I?ve been vaccinated for 2 months now. My new symptoms just started to really ramp up 3 weeks ago. O... Read more
I?ve been vaccinated for 2 months now. My new symptoms just started to really ramp up 3 weeks ago. Of course I had the initial symptoms of being sick for 2 and 1/2 days after my second shot?.but recently it started with leg aches and then it matriculated up into my upper body. My legs have since become less achy per say. Now it?s my upper body and mostly in my shoulders (more in the one I received the shots in), back pain, and general fatigue. Currently still dealing with the upper body ache discomfort, cold hands and feet but I noticed that I have a slight headache always and my vision has became a little blurry in one eye. The headache severity is day to day but what?s interesting now is I?m having ear ringing and sensitivity to sound. Headache seems to emulate from the back of my skull and the crown of my head. The other lingering piece is the fatigue after doing activities. I?m an active guy and recently my body gets really achy after I do anything super strenuous and I get tired. Also feeling a little shaky, some rapid heart rate, and some circulation issues in my legs and arms. Note; never experienced these issues before the Vaccine aside from the normal wear and tear of an active lifestyle.
41 2021-04-18 fainting 5-10min after 2nd dose, pt fainted while sitting in waiting room chair. pt fell forward tipping cha... Read more
5-10min after 2nd dose, pt fainted while sitting in waiting room chair. pt fell forward tipping chair and fell into blood pressure machine. head was scraped between the eyes--slight bleed. pt leg was bruised and pant leg torn from falling into machine. i told technician to call 911 while i went to pt and attempted to sit him up. pt was unresponsive for 20-30 seconds. as he came to, he was able to speak. moved to chair and gave him water as paramedics arrived. they did full assessment x 20-30min. pt did not want to be transported to hospital so they asked him to stay for additional 30min. he then said he was ok to go home.
41 2021-04-19 fast heart rate Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he ... Read more
Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: nausea and vomiting. Assessment : Time of assessment 1005. Alert and oriented, Anxious, Tachycardia, Nausea, Emesis and left hand tingling. As soon as patient received vaccine and was getting ready to sit for his 15 minute observation, he started vomiting x 1 in the floor. He says he felt nauseated, lightheaded, and his left hand was tingling. He was assisted in the wheelchair and taken to the triage area. 1012: BP 148/100, P 110, denies nausea, lightheaded, but still has the tingling to the left hand. 1017: BP 138/100, P 102, denies hand tingling or any other symptoms. 1026 standing BP 120/88, P 108. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Ambulated prior to discharge home without symptoms. There were no vitals filed for this visit. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 20 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
41 2021-04-20 lightheadedness Pt developed dizziness and near syncope shortly after injection. He reports a history of vasovagal r... Read more
Pt developed dizziness and near syncope shortly after injection. He reports a history of vasovagal reactions with injections in the past. BP 78/60 and then improved to 102/68. HR improved from 40-58 after several minutes. Over the course of 15-20 minutes, symptoms resolved and pt fully recovered.
41 2021-04-20 fainting patient reported he has previously fainted immediately following vaccine. His wife brought an ice pa... Read more
patient reported he has previously fainted immediately following vaccine. His wife brought an ice pack and water. Aftervaccination i sat with pt a few minutes to make sure he was feeling well and ready to move to a chair in front of the pharmacy to sit for 30 minutes and make sure he is feeling well. I notified my manager that pt in front has fainted before and he kept a close eye on him. I was administering shot to the next pt and heard a sound. I left vaccination booth and saw pt on the ground. I placed his legs/feet in front of him and his wife held his head and ice pack. Our pt reported that he did not hit or hurt his head and did not need other assistance. we monitored the patient an additional 20 minutes and he was feeling well, vital signs good and accompanied by his wife.
41 2021-04-21 chest pain CHILLS, FEVER,SHARP/PIERCING CHEST PAIN, ENTIRE BODY WEAKNESS, ENTIRE BODY ACHES, HEADACHE, DRY THRO... Read more
CHILLS, FEVER,SHARP/PIERCING CHEST PAIN, ENTIRE BODY WEAKNESS, ENTIRE BODY ACHES, HEADACHE, DRY THROAT.
41 2021-04-21 heart rate increased Headache/mental fogginess, elevated heart rate (110-130 at rest).
41 2021-04-23 loss of consciousness head spinning; dizzy; tired; pain at injection site; nauseas; cold sweats; really weak; could barely... Read more
head spinning; dizzy; tired; pain at injection site; nauseas; cold sweats; really weak; could barely stand up; sick to his stomach; Passed out to sleep at 745 pm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Hyperthyroidism. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) (seriousness criterion medically significant). On 19-Apr-2021 at 11:30 PM, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up) and ILLNESS (sick to his stomach). On 20-Apr-2021, the patient experienced VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm), COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up), ILLNESS (sick to his stomach), VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas) had not resolved. Not Provided Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication. Treatment information was not 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. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine. This case was linked to US-MODERNATX, INC.-MOD-2021-081679 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine, US-MODERNATX, INC.-MOD-2021-081679:cross link Dose 1
41 2021-04-23 palpitations Day 1 and 2, injection site soreness/tenderness. Day 4 to present, heart palpitations. Deep heart pu... Read more
Day 1 and 2, injection site soreness/tenderness. Day 4 to present, heart palpitations. Deep heart pump-up through my neck and into ears sometimes. Day 10, injection site redness/rash.
41 2021-04-24 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Detai... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted after administration of vaccine. patient was checked for responsiveness and flipped to the side. paramedics were called. patient regained conciousness upon tapping on shoulder. patient fell and hit the ground and had a few abrasions to the left head. paramedics arrived and patient was alert and oriented and declined ambulance. patient rested and left with cousin without any further issues.
41 2021-04-25 heart rate increased Patient developed itching 10 mins post-vaccination. Itching moved from upper body to head and inside... Read more
Patient developed itching 10 mins post-vaccination. Itching moved from upper body to head and inside mouth. Felt slight soreness in throat 45 mins in. Took diphenhydramine 25mg. Symptoms slowly dissipated. Stayed under observation a total of 1.5 hours. No feeling of obstruction in throat, no shortness of breath or wheezing, no rash or swelling. VS normal, physical exam normal. Slight increase in heart rtate which may have been due to Adderall.
41 2021-04-25 heart attack Fever, chills, headache, and tiredness (2nd day of receiving the 2nd dose) Feeling good on the 3rd ... Read more
Fever, chills, headache, and tiredness (2nd day of receiving the 2nd dose) Feeling good on the 3rd day Headache, stomach burn, throwing up, and heart attack (4th day of receiving the 2nd dose) Passed away on April 2, 2021
41 2021-04-25 fainting patient fainted after becoming hot and sweaty
41 2021-04-26 heart rate increased Periods of sweating and chills, body aches and elevated heart rate for about 24 hours
41 2021-04-26 loss of consciousness, pallor At 11:41 am client said that he thought he blacked out. He looked pale and was sweating. At 11:43 he... Read more
At 11:41 am client said that he thought he blacked out. He looked pale and was sweating. At 11:43 he had crackers and water. At 11:47 his oxygen saturations were 97% and his heart rate was 69. At 11:49 his blood pressure was 122/78. He felt better and left around 12:00 pm.
41 2021-04-26 loss of consciousness Passed out; Sweaty; Slightly feverish; This spontaneous case was reported by a consumer and describe... Read more
Passed out; Sweaty; Slightly feverish; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Sweaty) and PYREXIA (Slightly feverish). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Sweaty) and PYREXIA (Slightly feverish) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Description: The patient felt sweaty and slightly feverish all night on 21 April 2021. When he got up to urinate he actually passed out (medically significant) and was on the floor for a few seconds. Later last night, on the same day, he went to drink some water, and passed out again for a few seconds. The patient did not seek any medical attention, and stated that he felt fine now. No treatment information 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. 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.
41 2021-04-26 pallor Patient felt light headed. Put his head down on table. Responded to his name after repeating name ... Read more
Patient felt light headed. Put his head down on table. Responded to his name after repeating name once. Patient stated he was dizzy, light headed. Gave him a bottle of water and M & M's. Patient had forehead sweating and was pale. Patient drank the water, had a few M &M's, got cold. Patient finished M& M's and his color. Offered to call 911 or someone for patient. Patient refused. Patient remained seated for approximately 12 more minutes and left on his own accord. Patient stated before leaving he felt fine now and refused medical treatment or an offer to call someone again.
41 2021-04-27 ischaemic stroke, cerebrovascular accident Approximately 3 weeks after Moderna Covid-19 vaccine administration, patient began to experience diz... Read more
Approximately 3 weeks after Moderna Covid-19 vaccine administration, patient began to experience dizziness, transferred to Hospital, diagnosed with ischemic stroke, discharged, returned within days with worsening, diagnosed with new ischemic stroke (contralateral side), transferred to Medical Center, patient's condition worsened, presumably additional new ischemic stroke, patient ultimately died on 3/5/2021. Diagnosis was acute infarction of the brainstem/pons as well as acute bilateral cerebellar/occipital infarctions.
41 2021-04-27 pallor, fainting Patient experienced symptoms consistent with vaso-vagal syncope approximately 5 minutes after inject... Read more
Patient experienced symptoms consistent with vaso-vagal syncope approximately 5 minutes after injection: palor, diaphoresis, dizziness. Patient recovered within 30 minutes with rest and water.
41 2021-04-28 fainting, lightheadedness patient fainted and had a vasovagal response ... very clammy and sweaty but ended up being fine afte... Read more
patient fainted and had a vasovagal response ... very clammy and sweaty but ended up being fine after several minutes
41 2021-05-02 blood glucose increased Per PCP visit note 4/28/2021: Patient reports has had some malaise, labile sugars, insulin resistanc... Read more
Per PCP visit note 4/28/2021: Patient reports has had some malaise, labile sugars, insulin resistance for past 2 weeks which he notes began about 2-3 weeks after initial Covid Moderna vaccine. He then reports over past 4-5 days has felt dehydrated, dark urine, and now with some abdominal distension, nausea, and fatigue. Normal bowel movements. Able to eat, no Tylenol or alcohol use. All meds stopped by Endo due to lab results except his insulin. Did find a note that states he received 2nd Moderna vaccine but also noted that his Endo suggested he should not get the 2nd dose. Our Immunization system did not pull in a 2nd dose. Also was some confusion as to whether he got Pfizer or Moderna, but the system did show Moderna given 3/30. Plan: CT scan, stay off all meds except insulin, PharmD review of meds and report to VAERs, schedule f/u with GI (will see in ~ 2months) CT Scan of abdomen/pelvis: no acute findings Will continue to f/u with PCP and watch lab to be sure numbers are improving.
41 2021-05-02 loss of consciousness covid arm yes, expected that, dizzyness lasting 3 days, tired, flu like symptoms. chills, anxiety, t... Read more
covid arm yes, expected that, dizzyness lasting 3 days, tired, flu like symptoms. chills, anxiety, that was no big deal but last night I had severe stomach pain and rushed to the bathroom , then had severe nautious, I had diarrhea, at the same time. I nearly blacked out. I got very hot and had to take off all my clothes, then when I got up to the toilet to diarrhea again I needed to vomit, I blacked out on my bathroom floor. when I woke up I went back to bed. at the time of the occurence I was too delusional to call for help. I barely ate that day because I felt so bad. I did notice the second day I felt worse after drinking 1,000 mg of vitamin C from one of those Emercencey Packets with lots of water. and the next day I took twice as much to (knock out) what ever I was feeling.
41 2021-05-07 chest pain First Shot April 20th of Moderna after facility cancelled my JJ, Second shot J&J in facility after f... Read more
First Shot April 20th of Moderna after facility cancelled my JJ, Second shot J&J in facility after facility cancelled my second appointment of Moderna. Could not make 2nd shot appointment. Going away for work in state and could not get second shot for three months so just got JJ. 102 fever, chills, chest pains, spasams, joint inflammation, no appetite, no bathroom. full body pain and some altered mental state. weakness. Going on 18 hrs now fever continues to rise.
41 2021-05-08 palpitations, troponin increased Went to the ER for heart palpitations/discomfort. Had elevated Troponins from a heart event
41 2021-05-09 ejection fraction decreased, oxygen saturation decreased, heart rate increased, heart failure On April 27th, I went to local ER with acute shortness of breath. X-ray and CT scan showed possible... Read more
On April 27th, I went to local ER with acute shortness of breath. X-ray and CT scan showed possible fluid build up in lungs. I was admitted to hospital on April 28. Echocardiogram diagnosed heart failure, ejection fraction was 25%. Pulse was also quite high (120-135), and blood oxygen was low (88-90%). Cardiac catheterization showed no blockages in coronary arteries. Echocardiogram, EKG, and bloodwork were negative for heart attack. Ultimate diagnosis from doctor was idiopathic cardiomyopathy. Currently taking several medications and under care from primary care physician and cardiologist. At follow up appointment with primary care following discharge, she suggested I report the incident out of an abundance of caution.
41 2021-05-09 lightheadedness, heart rate decreased I was standing at the toilet when I became dizzy and nearly collapsed. I called for help and my son... Read more
I was standing at the toilet when I became dizzy and nearly collapsed. I called for help and my son assisted me to my bed where I collapsed and could hardly move while I broke out in cold sweats and my wife monitored my heart rate and placed an oxygen monitor on my finger. she said my pulse held steady and slow. The event lasted about 10 minutes and I felt I must return to the toilet for a bowl movement. I began having diarrhea and then began to throw up. After that i took a cool shower and laid in bed. I stayed in bed for about 48 hours.
41 2021-05-10 fainting PATIENT FAINTED DURING POST VACCINATION WAITING PERIOD
41 2021-05-11 heart rate increased, hypertension Moderate fever, arm pain, high heart rate, high blood pressure, high WBC, high Absolute Neutrophil
41 2021-05-11 loss of consciousness, fainting Pt fainted after telling wife he feels unwell, then passed out in wheelchair & didn't recall event. ... Read more
Pt fainted after telling wife he feels unwell, then passed out in wheelchair & didn't recall event. BP 99/60. Pt reported feeling nauseous & eye twitching. Given 8oz apple juice & graham crackers & 8oz water. After 25 min pt reported feeling better but tired. 1.5hrs after vaccine given pt was escorted to car with family and informed to follow up with PCP. Per pt's wife, pt had flushing with first dose
41 2021-05-15 pallor Sweating, paleness beginning <10 mins after giving shot, no loss of consciousness, unclear if patien... Read more
Sweating, paleness beginning <10 mins after giving shot, no loss of consciousness, unclear if patient was dizzy/lightheaded. Patient asked to sit in waiting area until symptoms subsided. Blood pressure checked and WNL. Patient given cold pack.
41 2021-05-17 heart rate decreased My resting heart rate was very low for about 20 minutes. This happened almost immediately after my s... Read more
My resting heart rate was very low for about 20 minutes. This happened almost immediately after my second dose and I couldn't find anything about low heart rate. I felt better soon and did not tell a pharmacist.
41 2021-05-17 hypertension member complained of dizziness and headache after vaccine administration. Patient brought to lay do... Read more
member complained of dizziness and headache after vaccine administration. Patient brought to lay down on a gurney. Headache resolved after patient in supine position. Vitals stable with noted hypertension: 194/129 that remained elevated for 30 minutes. Dizziness and headache resolved. Dr encouraged member ED assessment of continued hypertension. Member agreed to have wife (at bedside) drive him immediately to the ED. Per EMR, member went to emergency and was admitted 5/4- 5/6/2021 and placed on antihypertensives and hypothyroid meds.
41 2021-05-19 fibrin d dimer increased, pulmonary embolism After headaches and fatigue following the shot (within 24 hours) I began to notice slight shortness ... Read more
After headaches and fatigue following the shot (within 24 hours) I began to notice slight shortness of breath 3-5 days following. I didn't give it much thought, but, roughly two weeks after my dose I began to experience severe intercostal pain and sharp pain in the lower lobe of my right lung upon inhalation. I thought this was musculoskeletal at first but after it didn't abate within days, I went to the hospital and was diagnosed with several distal pulmonary emboli. Luckily I survived and am currently on blood thinners while trying to determine the cause of this, having no history of blood clots personally or in extended family.
41 2021-05-19 pallor Patient had no previous issues with vaccines in the past. Patient went to the post-vaccination chair... Read more
Patient had no previous issues with vaccines in the past. Patient went to the post-vaccination chairs and about 2 minutes after giving the Moderna COVID-19 vaccine, patient's wife informed me he was not feeling well. Patient was sweating profusely, shaking, light headedness, and difficulty breathing. Site of injection looked normal. I brought him back to the immunizing booth, laid him down, gave him something soft to lay his head on and cover- up with. His sweating and shaking seemed to get worse. He wanted to sit in the chair since the floor was cold. We sat him up, gave him an ice pack, and gave him some orange juice. We called 911 and instructed EMS where to find us and the patient's symptoms. While waiting on EMS, his symptoms improved slightly. They arrived quickly and assessed the patient's blood pressure, heart rate, and blood sugar. He did not feel as if he needed to go to the hospital. I had the patient wait in the immunization booth a bit longer. He felt better, and color came back into his face. He went home with his wife. I gave them the V-Safe info, so he can report any issues while at home.
41 2021-05-20 heart rate increased Patient reported difficulty breathing, dizziness/weakness, numbness/tingling and a fast heartbeat - ... Read more
Patient reported difficulty breathing, dizziness/weakness, numbness/tingling and a fast heartbeat - and suicidal ideation - went to ED. CHIEF COMPLAINT: SUICIDAL IDEATION (pt. reports suicidal thoughts) and FEVER (pt. received 2nd Moderna vaccine approx 1100 yesterday approx 3-4 hours ago developed chills/fever/anxiety/visual hallucinations/generalized body aches) HISTORY OF PRESENT ILLNESS: HPI: Patient is a 41-year-old male who presents to the emergency department from home with his wife for chief complaint of suicidal ideation, anxiety. Nursing noted him to be hyperventilating in triage. Patient states these thoughts started about 4 hours ago after he started feeling unwell. Patient states that he got his 2nd moderna COVID vaccine at 11:00 a.m. yesterday. This evening after trying to go to bed he started getting fevers body aches and myalgias. He took Advil around 8:00 p.m.. After this, he started having increased thoughts of wanting to harm himself. He states he is having "hallucinations of himself cutting his arms and legs off". He called telemedicine who told him he needs to go to the emergency department. Patient originally did not want to wake his wife up and did not want to go in but he eventually woke his wife and she brought him here. Patient does have a history of PTSD and depression. He is on Cymbalta which apparently he has been taking. He has not been able to see a counselor since the beginning of the year because of his insurance. He does see physicians through the hospital. he has never had to be inpatient but has had to come to the ER a few years ago for suicidal ideation. He also tells me that he quit his job yesterday because he doesn't like seeing people be mean to other people. ED Course as of May 19 0613 Wed May 19, 2021 0339 Patient is a 41-year-old male who presents to the emergency department with suicidal thoughts. Patient has PTSD. Suicidal thoughts started about 4 hours ago. He did get his 2nd moderna COVID vaccine at 11:00 a.m. yesterday and now has a fever and generalized body aches and fatigue. I do believe this is a normal immune response to the COVID vaccine. We will give him Toradol. Patient is very tearful and anxious. I will give him some Ativan while we are waiting for lab work to return. Medical social worker will have to evaluate the patient. 0521 MSW is currently talking to the patient. 0611 Medical social worker and wife felt that patient could be discharged home with the safety plan. He will follow up with the hospital for mental health counseling services. Patient feels much better after fever subsided. He will continue to rotate between Motrin and Tylenol. ED Course User Index DO
41 2021-05-20 heart rate increased Shortness of breath, light headed, rapid pulse, fatigue on and off for 3 days.
41 2021-05-21 inflammation of the pericardium Pericarditis
41 2021-05-22 chest pain Chest pain for about 60 minutes until I took Advil. It was extremely uncomfortable as I would rate i... Read more
Chest pain for about 60 minutes until I took Advil. It was extremely uncomfortable as I would rate it at 8/10 on a pain scale for about 20 minutes. Also mild body aches and headache.
41 2021-05-24 atrial fibrillation, heart rate increased Approximately 14 days after first injection I went to ER with Atrial Fibrilation symptoms. Had been ... Read more
Approximately 14 days after first injection I went to ER with Atrial Fibrilation symptoms. Had been feeling weak and tired for about a week before but ignored symptoms. Awoken early March 21st with NEW Apple watch alerting to high heart rate while sleeping over 150 bpm. Ran ECG and stated Atrial Fibrilation was occuring.
41 2021-05-24 chest pain, troponin increased, inflammation of the pericardium Friday after the shot was good, just a sore arm. On Saturday I developed a fever of 101 and chills a... Read more
Friday after the shot was good, just a sore arm. On Saturday I developed a fever of 101 and chills and was very tired. I felt a little better on Saturday night and Sunday morning after some Tylenol 500 mg. My fever would break then come back for a bit By Sunday afternoon my back began to really hurt. I have some chronic back pain so didn't think too much of it just tried to massage it and stretch it out. However it just kept getting worse and the pain radiated into my chest around 9:00 PM Sunday night. It continued to get worse until about midnight, and I ultimately decided to go to the ER. The tylenol helped reduce the pain by the time I got into the ER but I went in anyway because I was concerned about the intensity of the chest pain I'd had earlier. I was tested for heart enzymes and they were slightly elevated, at .12. On this result, I was admitted to the hospital on suspicion of having suffered a heart attack. I was put on a heparin drip and my troponin levels were tested every 3 hours. They continued to rise to a high of .67. More testing was done, and the cardiology department concluded that I had not suffered a heart attack due to the low troponin levels but that instead I was dealing with heart inflammation. Every doctor and nurse there commented that there had been other patients coming in with cardiac inflammation from vaccines as well. Due to my family history of heart issues and my own existing risks, I was moved to the hospital where I was examined in the cath lab via angiogram. This found no blockages in my arteries, further confirming the cardiology suspicion of cardiac inflammation, and I was given a diagnosis of pericarditis and prescribed colchicine to treat the inflammation.
41 2021-05-26 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt recovered in less than 1/2 hr. Checke... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt recovered in less than 1/2 hr. Checked his BP and pulse- normal. Pt and his cousin said he fainted after getting the first dose on 4/24/2021. He promised he'll see his PCP.
41 2021-05-27 pulmonary embolism Blood Clots noted all over lungs; Abdominal pain radiating from right side to left side then to coll... Read more
Blood Clots noted all over lungs; Abdominal pain radiating from right side to left side then to collar bone; Abdominal pain-right side; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Blood Clots noted all over lungs) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037421B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gallbladder pain. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain-right side). On 30-Apr-2021, the patient experienced PAIN (Abdominal pain radiating from right side to left side then to collar bone). On 04-May-2021, the patient experienced PULMONARY EMBOLISM (Blood Clots noted all over lungs) (seriousness criteria hospitalization and medically significant). On 30-Mar-2021, ABDOMINAL PAIN (Abdominal pain-right side) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood Clots noted all over lungs) and PAIN (Abdominal pain radiating from right side to left side then to collar bone) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Computerised tomogram: Blood clot noted on lungs (all over). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was given IV and oral blood thinner medication as a treatment. Company comment: Very limited information regarding this event has been provided at this time. It is not clear if abdominal pain was gallbladder pain and surgery was prior to onset of pulmonary embolism. Details of the events and discharge summary is required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. It is not clear if abdominal pain was gallbladder pain and surgery was prior to onset of pulmonary embolism. Details of the events and discharge summary is required for further evaluation.
41 2021-06-03 heart rate increased Patient started to ?feel his heartbeat more rapidly?, felt lightheaded, and felt some dizziness. Pat... Read more
Patient started to ?feel his heartbeat more rapidly?, felt lightheaded, and felt some dizziness. Patient was given ice to apply to himself and laid down on the ground with limbs in the air to increase circulation to core. Patient was then brought to a room for provider review and given juice. After a short time patient felt normal and was discharged home.
41 2021-06-03 heart attack had another heart attack¨; ¨Had 2 heart attacks¨; ¨Swollen feet¨; ¨Was very fatigued with litt... Read more
had another heart attack¨; ¨Had 2 heart attacks¨; ¨Swollen feet¨; ¨Was very fatigued with little walking¨; ¨A lot of pain in the arm of the injection ¨( left arm); This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) and MYOCARDIAL INFARCTION (had another heart attack¨) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Automated external defibrillator user (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)), Coronary artery bypass graft (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)) and Catheterization cardiac (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)). Concurrent medical conditions included Diabetes, Blood pressure high and Hypertension (not adequately controlled "has high blood pressure levels but it is not constant so he doesn´t take medication for that".). Concomitant products included METFORMIN for an unknown indication. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (¨A lot of pain in the arm of the injection ¨( left arm)). On 07-May-2021, the patient experienced MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) (seriousness criteria hospitalization and medically significant). On 13-May-2021, the patient experienced PERIPHERAL SWELLING (¨Swollen feet¨) and FATIGUE (¨Was very fatigued with little walking¨). On 20-May-2021, the patient experienced MYOCARDIAL INFARCTION (had another heart attack¨) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-May-2021 to 13-May-2021 due to MYOCARDIAL INFARCTIONThe patient was hospitalized from 07-May-2021 to 13-May-2021 due to MYOCARDIAL INFARCTION The patient was treated with TICAGRELOR (BRILINTA) from 07-May-2021 to 13-May-2021 at an unspecified dose and frequency; ATORVASTATIN CALCIUM (LIPITOL) from 07-May-2021 to 13-May-2021 at an unspecified dose and frequency; BROMAZEPAM (LAXYL [BROMAZEPAM]) from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; CARVEDILOL from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; CLOPIDOGREL from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPRIN) from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; VALSARTAN from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency and SPIRONOLACTONE from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency. On 07-May-2021, VACCINATION SITE PAIN (¨A lot of pain in the arm of the injection ¨( left arm)) had resolved. On 20-May-2021, FATIGUE (¨Was very fatigued with little walking¨) had resolved. At the time of the report, MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) and MYOCARDIAL INFARCTION (had another heart attack¨) had resolved and PERIPHERAL SWELLING (¨Swollen feet¨) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient took the 1st dose of the vaccine on 28apr2021 and referred a lot of pain in the arm of the injection. On 07may2021 he was diagnosed with myocardial infarction and was hospitalized. On 13may2021 the patient got discharged to home with oral medication and an external defibrillator. During this period he had swollen feet and extreme fatigue. On 20may2021 the patient had another myocardial infarction, is currently hospitalized receiving Tridil as treatment and is requires a heart transplant. 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 the patient's comorbidities (diabetes and hypertension) are risk factors for myocardial infarction and pose as confounders of this event. Since the most recent event of myocardial infarction is life-threatening further information was requested regarding the event outcome.; 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 comorbidities (diabetes and hypertension) are risk factors for myocardial infarction and pose as confounders of this event. Since the most recent event of myocardial infarction is life-threatening further information was requested regarding the event outcome.
41 2021-06-06 body temperature decreased, very slow heart rate He received a second dose of Moderna covid vaccine on 5/27 and progressed to develop some lethargy ... Read more
He received a second dose of Moderna covid vaccine on 5/27 and progressed to develop some lethargy and decreased oral intake over the following days. When he arrived in the ED on 5/31 his temperature was 30.0?C rectally and bradycardic (HR51), BP 115/81, mentally altered. No evidence of infection or worsening of existing chronic conditions. he was admitted to ICU for hypothermia.
41 2021-06-09 pulmonary embolism, deep vein blood clot A few days after the second vaccination, patient started feeling poorly. Shortness of breath, tiredn... Read more
A few days after the second vaccination, patient started feeling poorly. Shortness of breath, tiredness and could not shake it. Ended up at hospital and after multiple tests he was flown to another hospital with a pulmonary embolism. He is currently in hospital being treated for PE and multiple clots in his legs.
41 2021-06-10 chest pain, heart rate increased, palpitations Heart attack like symptoms. Severe chest pain, shortness of breath, Heart rate elevated around 10 b... Read more
Heart attack like symptoms. Severe chest pain, shortness of breath, Heart rate elevated around 10 bpm from normal, tired, thumping heart beat, occasional murmur. Symptoms start about a week after first vaccine shot.
41 2021-06-15 arrhythmia, inflammation of the heart muscle, heart rate increased Elevated heart rate, led to arrhythmias on Sunday 5/16 - 48 hours after my 2nd dose. Apple Watch ind... Read more
Elevated heart rate, led to arrhythmias on Sunday 5/16 - 48 hours after my 2nd dose. Apple Watch indicated AFib several times that day. Went to sleep and heart arrhythmia woke me out of my sleep at 4am on Monday 5/17/21, so I went to the ER to get checked out. In the hospital, I was diagnosed with myocarditis, was held there for 4 nights for monitoring and am still taking medication to keep it under control.
41 2021-06-15 palpitations The morning after I received the vaccine, I woke with a fever, severe headache and heart palpitation... Read more
The morning after I received the vaccine, I woke with a fever, severe headache and heart palpitations. I previously had COVID before and it felt very similar with my symptoms, but not as bad. I experienced these symptoms for 2 days. I did have a medication, that I was previously taking, replaced with a different medication.
41 2021-06-20 pulmonary embolism Saddle Pulmonary Embolism
41 2021-06-22 atrial fibrillation, chest pain Shortness of breath, with low grade chest pain, and then the onset of symptomatic atrial fibrillatio... Read more
Shortness of breath, with low grade chest pain, and then the onset of symptomatic atrial fibrillation requiring cardioversion.
41 2021-06-23 chest discomfort Discomfort in left side of chest
41 2021-06-28 cerebrovascular accident Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pa... Read more
Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pain; Was a little off; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) in a 41-year-old male 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 reported by the reporter. No treatment information was provided. Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA) for Blood pressure. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FATIGUE (Was a little off). On 08-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) (seriousness criterion medically significant) and REDUCED FACIAL EXPRESSION (Face was tensed). In June 2021, the patient experienced EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain). On an unknown date, the patient experienced DYSARTHRIA (Slur). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. In May 2021, FATIGUE (Was a little off) outcome was unknown. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke), DYSARTHRIA (Slur), REDUCED FACIAL EXPRESSION (Face was tensed), EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Lyme disease: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient face was tensed and his face was seized. The left side of his face was drooping he had trouble closing his left eye. Water was dripping out of his mouth when he tried to drank he felt that something was not right and his eye was watering that morning constantly. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-229259 (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
41 2021-07-04 cardiac failure congestive Congestive HF diagnosis 6/30/2021. Symptoms of SOB beginning 4/15, issues with sleep except when si... Read more
Congestive HF diagnosis 6/30/2021. Symptoms of SOB beginning 4/15, issues with sleep except when sitting upright and anxiety. No history of medical conditions.
41 2021-07-06 loss of consciousness ABOUT 12 HOURS POST VACCINATION THE PATIENT PASSED OUT AT HOME. PATIENT HAD NO FEELINGS IN ARMS OR L... Read more
ABOUT 12 HOURS POST VACCINATION THE PATIENT PASSED OUT AT HOME. PATIENT HAD NO FEELINGS IN ARMS OR LEGS AND THOUGHT HE WAS HAVING A STROKE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND HAD TO BE PUT ON VENTILATOR AND REMAINED IN THE HOSPITAL FOR 3 DAYS. PT HAS MOSTLY RECOVERED BUT HAD SLOWER USE OF ARMS AND LEGS FOR 1-2 WEEKS
41 2021-07-17 inflammation of the heart muscle, palpitations Heart palpitations and inflammation
41 2021-07-19 heart failure, palpitations, heart rate irregular, chest pain, heart attack heart failure; had heart attack; heart palpitation; anxiety; heart was beating like crazy; had a bur... Read more
heart failure; had heart attack; heart palpitation; anxiety; heart was beating like crazy; had a burning sensation in the chest; very difficult for him to perform even a simple task; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (heart failure) and MYOCARDIAL INFARCTION (had heart attack) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (had heart attack) (seriousness criterion medically significant), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task). At the time of the report, CARDIAC FAILURE (heart failure), MYOCARDIAL INFARCTION (had heart attack), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task) outcome was unknown. Concomitant product use was not provided by the reporter. ? No treatment information was provided. Patient reported that he is a healthy person who exercises regularly, never used alcohol and never had a health issue. Patient also insisted that he had been to the emergency Room 3 times in the past two weeks. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
41 2021-07-20 palpitations extreme heart palpitations, dizziness, severe migraine
41 2021-07-21 chest discomfort Guillain-Barré syndrome; orthostatic light headedness; Difficulty in walking; didnot feel great; It... Read more
Guillain-Barré syndrome; orthostatic light headedness; Difficulty in walking; didnot feel great; Itching; short term memory; chest tightness; Brain fog; Numbness; Tingling; Pain; swelling of hands; joint pain; fatigue; swelling at injection site; Injection site pain; headache; Nausea; rash; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome) in a 41-year-old male 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. No medical history information was provided by the reporter. Concurrent medical conditions included Fruit allergy (Strawberries :Anaphylaxis + Angioedema), Seafood allergy (Shrimp) since 2012, Allergy to nuts (Walnuts[unsure]:Oral itching and jaw tightening.), Food allergy (Mushrooms[ nausea and vomiting]) since 1995, Anaphylaxis since 2012, Hay fever, Urticaria, Migraine, Diverticulosis since 2017, Connective tissue disorder NOS (Suspected), Eczema and Allergic rhinitis. Concomitant products included PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for Diverticulosis, SUMATRIPTAN for Migraine, TRAMADOL for Pain, CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication. On 28-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 DIZZINESS POSTURAL (orthostatic light headedness), GAIT DISTURBANCE (Difficulty in walking), GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome) (seriousness criterion medically significant), FEELING ABNORMAL (didnot feel great), PRURITUS (Itching), AMNESIA (short term memory), CHEST DISCOMFORT (chest tightness), FEELING ABNORMAL (Brain fog), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling), ARTHRALGIA (joint pain), FATIGUE (fatigue), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (Injection site pain), HEADACHE (headache), NAUSEA (Nausea) and RASH (rash). At the time of the report, DIZZINESS POSTURAL (orthostatic light headedness), GAIT DISTURBANCE (Difficulty in walking), GUILLAIN-BARRE SYNDROME (Guillain-Barré syndrome), FEELING ABNORMAL (didnot feel great), PRURITUS (Itching), AMNESIA (short term memory), CHEST DISCOMFORT (chest tightness), FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling), ARTHRALGIA (joint pain), FATIGUE (fatigue), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (Injection site pain), HEADACHE (headache), NAUSEA (Nausea) and RASH (rash) outcome was unknown and HYPOAESTHESIA (Numbness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Lab test include: Cardiovascular evaluation include tilt table test, Rheum workup, Ultrasound were known to cause Rheum. No treatment information was provided. This case was linked to MOD-2021-058060 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up Information received contains No New Information. On 14-Jul-2021: Updated Reporter address. Updated Patient demographics[Height, Weight, Race, Ethinicity ] .Added medical history include Allergies, current medical conditions. Added concomitant medications. Added Vaccine facility information. Added new 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.
41 2021-07-26 chest pain Chest Pain. This started occurring about 2 and a half weeks after my second vaccine dose.
41 2021-07-26 deep vein blood clot, pulmonary embolism, blood clot a month and a half after receiving the vaccine, I developed blood clots in legs; I was diagnosed wit... Read more
a month and a half after receiving the vaccine, I developed blood clots in legs; I was diagnosed with DVT; it travelled to the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-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 THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (it travelled to the lungs) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) in March 2021 for Deep vein thrombosis, at a dose of UNK dosage form. At the time of the report, THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: he was diagnosed as having deep vein thrombosis (abnormal) CT scan of his lungs. He was diagnosed as having Deep Vein Thrombosis (DVT). In 2021, Ultrasound Doppler: he was diagnosed as having deep vein thrombosis (abnormal) An ultrasound of his heart and legs. He was diagnosed as having Deep Vein Thrombosis (DVT). Patient reports having to be hospitalized overnight, one month after vaccination. He stated that he was previously a healthy male with no underlying health conditions. Concomitant 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 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.
42 2020-12-31 heart rate increased, fast heart rate tachycardia Heartrate went from 88 to 110 resolved in less than 1 hour
42 2020-12-31 palpitations Palpitations increased drastically, I started increasing at 01:00 1/1/2021 and at it worse by 07:00 ... Read more
Palpitations increased drastically, I started increasing at 01:00 1/1/2021 and at it worse by 07:00 1/1/21 I was having about 1 very 3-5 seconds. I normally take metoprolol ER 50 to control them but I increased the dose to 75 mg and it helped where I was getting one per min or so. I did have a caffeinated drink at approximately 1800 12/31/20 but that?s not new for me.
42 2021-01-02 heart rate decreased Lightheaded with low heart rate 50-60 bpm for 60 minutes post vaccination. Even with hydration and f... Read more
Lightheaded with low heart rate 50-60 bpm for 60 minutes post vaccination. Even with hydration and food, took 60 min to clear. No syncopal episode. Blood pressure measured normal (120-140 systolic).
42 2021-01-06 fast heart rate Dizziness & Tachycardia
42 2021-01-07 chest pain Aches, diarrhea, vomiting, pneumonia, fever, chest pain
42 2021-01-08 palpitations Heart palpitations and shortness of breath starting around 11 this morning. Received vaccine yesterd... Read more
Heart palpitations and shortness of breath starting around 11 this morning. Received vaccine yesterday at 4:30.
42 2021-01-08 fainting, hypotension Vasovagal syncope about 5 minutes after shot. Symptoms lasted about 5-7 minutes. Hypothensive. Diaph... Read more
Vasovagal syncope about 5 minutes after shot. Symptoms lasted about 5-7 minutes. Hypothensive. Diapharetic, Nausea,
42 2021-01-09 blood glucose increased Client reports covid19 symptoms: fever/ chills /headache/elevated Blood glucose/weakness/confusion/i... Read more
Client reports covid19 symptoms: fever/ chills /headache/elevated Blood glucose/weakness/confusion/itching/shortness of breath
42 2021-01-11 chest pain Chills, Headache, Fever, muscle pain, fatigue, joint pain, chest pain, right had numbness
42 2021-01-11 heart rate increased Two hours after vaccine, I had pain in the neck at my thyroid gland and what seems to be the lymph g... Read more
Two hours after vaccine, I had pain in the neck at my thyroid gland and what seems to be the lymph glands behind it on the right hand side. It was tender. I took tylenol to deal with it. That pain persisted all the next day on Friday and again took tylenol and ibuprofen to deal with it. Then Saturday AM I was awaked early with severe throbbing pain in same thyroid/lymph area, it hurt to swallow, turn my head, and the pain was radiating up to my right ear. I was also having cold sweats. I managed to get the pain down again with tylenol and ibuprofen. On Sunday I spiked a temp of 100.8 and was having flu like symptoms, like body aches and more chills. I got the temp down but my heart rate remained elevated and I found it difficult to catch my breath. This went on for hours. I eventually had to go to the ER, where my pulse eventually came down. Nothing like this has ever happened before. The ER staff could not explain what had happened to me. At the time of writing this on Tuesday, 5 days after vaccine, I again had a lot of cold sweats this morning and there is still some tenderness in the lymph gland area near above the right side of my thyroid gland, but I am feeling better overall.
42 2021-01-11 palpitations, heart rate increased Sudden fast heart/pounding rate about 30 min after vaccination. Followed by immediate warm feeling,... Read more
Sudden fast heart/pounding rate about 30 min after vaccination. Followed by immediate warm feeling, light headedness (similar to feeling of passing out). Every 10-15 min after that for the next 90 minutes a similar but less intense increase in heart rate would occur. During this next 90 minutes my hands were very tingly and clammy, my adrenaline seemed high, and my throat was suddenly very dry requiring several cups of water. Overall intensity of the heart pounding sensation decreased with each episode and overall my heart felt normal about 2 hrs past vaccination. A headache then developed along with fogginess and persisted the rest of the day.
42 2021-01-14 fast heart rate Felt hot, Tachycardia, sensation of throat closing
42 2021-01-17 blood pressure increased, heart rate increased Approximately 45 minutes after vaccination felt sensation of mouth becoming completely dry, felt as ... Read more
Approximately 45 minutes after vaccination felt sensation of mouth becoming completely dry, felt as though regular swallowing process interrupted. Had a glass of water and resolved. Evaluated by doctor and had pulse of 92 (high for patient) and elevated blood pressure 148/92. Rest of vitals normal. Felt anxious. Ate lunch, had about 6 more episodes of mouth drying out, last one about 10 hours after vaccine. Resolved with water. Took benedryl 50mg. Next felt fatigue and right arm soreness. Felt normal within 48 hours.
42 2021-01-18 fast heart rate Slight dizziness and tachycardia lasting for about 10 min
42 2021-01-21 fast heart rate, blood pressure increased Approximately 5 minutes after vaccination, while pt was in our waiting area in front of pharmacy, h... Read more
Approximately 5 minutes after vaccination, while pt was in our waiting area in front of pharmacy, he started to feel light headed/dizzy. He stated he was tachycardic. I had pt sit down immediately. We called 911. I took his blood pressure which was considerably elevated (235/107). Pt had no other signs of an allergic rxn. Paramedics arrived and took pt to the nearest hospital.
42 2021-01-23 loss of consciousness States about an hour after the shot went back to work-was sitting there-felt warm & fuzzy-the next t... Read more
States about an hour after the shot went back to work-was sitting there-felt warm & fuzzy-the next thing he woke up-was on the floor-staff called 911-was taken to ER-states had coughing & couldn't catch his breath & apparently passed out.
42 2021-01-25 atrial fibrillation, chest discomfort Approximately 12 hours after vaccination, the patient realized he had a heaviness in his chest and j... Read more
Approximately 12 hours after vaccination, the patient realized he had a heaviness in his chest and just didn?t feel ?right?. His Apple Watch told him he was in afib. So the patient was taken to the ER by his wife where this was confirmed with an EKG. He was cardioverted back to normal sinus rhythm and he was prescribed Eliquis. Patient has no prior heart arrhythmias or medical concerns. Patient is slightly overweight, but has not had any arrhythmia or history of a fib in the past. Patient was discharged to follow up with his family physician. All of his blood work was normal.
42 2021-01-25 heart rate increased At approximately 5 minutes after the injection, I experiences a short period of Rapid Heart Rate and... Read more
At approximately 5 minutes after the injection, I experiences a short period of Rapid Heart Rate and a feeling of "Flush"\Warm. This lasted about 1-2 minutes. I did not receive any treatment for this. There was no further outcome to report. After 2 minutes it passed, I remained in the waiting area for an extra 5 minutes following my initial 15 minute observation period and left without incident.
42 2021-01-26 enlargement of the heart I have existing peptic ulcer and acid reflux I have been dealing with for years. I also have elevate... Read more
I have existing peptic ulcer and acid reflux I have been dealing with for years. I also have elevated cholesterol level for which I am being treated. Within 24 hours of receiving the first dose of the Moderna vaccine, the pain from my peptic ulcer went from 2 to 10 on a scale of 10. It became so severe that I could not sit at work. I had to leave work and went back home. Then on January 13, 2021, I started noticing a back pain that radiates throughout my left back side. On January 15, 2021, I went to the ER because the pain was so severe that I could not not lie down, sit, or breath. I was diagnosed with pleurisy (inflammation of the lung linings). The X-ray also showed enlarged heart but the ER doctor said my heart is fine. They also performed EKG on me. I did not mention receiving the vaccine to the ER doctor because I never thought the vaccine could result in such side effects. I did not mention it to my PCP also because I believe the vaccine is safe. But recently I went through the sequence of events myself and the only thing that happened regarding my health was the vaccine. Nothing else. After vaccination, I went to ER on Jan 15, 2021 at around 11:30PM due to severe back pain and was diagnosed with pleurisy through X-ray. My X-ray also showed an enlarged heart but I suspect that was due to the fact that I could not breath properly when the x-ray was taken. I will repeat the X-ray in a couple of weeks. Never experienced pleurisy or heart enlargement in my life prior to the vaccine. Not sure the vaccine was responsible but the coincidence is suspicious.
42 2021-01-28 arrhythmia, palpitations Arrhythmia; Heart palpitations; A spontaneous report was received from a 42 year-old, male, patient ... Read more
Arrhythmia; Heart palpitations; A spontaneous report was received from a 42 year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart palpitations and arrhythmia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Jan 2021 at 14:30, approximately 2 days 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 09 Jan 2021, the patient went to the emergency room (ER) because he had heart palpitations and an arrhythmia for about 5 hours. Blood tests, electrocardiogram (EKG) and a chest x-ray were normal. On 10 Jan 2021, the patient's heart palpitations came back again. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, heart palpitations and arrhythmia, was not reported.; Reporter's Comments: This case concerns a 42-year old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Arrhythmia and an unexpected non-serious event of Heart palpitations approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
42 2021-01-29 blood pressure increased, fast heart rate, lightheadedness Presyncope Tachycardia elevated blood pressure
42 2021-01-31 fainting, pallor Received vaccine on 1/26/2021. 1/27/21 at 7:30 pm developed diarrhea. GI symptoms continued on 1/28/... Read more
Received vaccine on 1/26/2021. 1/27/21 at 7:30 pm developed diarrhea. GI symptoms continued on 1/28/21 in the morning. At approximately 1:20pm on thursday. employee had a syncopal episode. Pale and diaphoretic. Then had episode of vomiting. Treated for dehydration with IV fluids. Given script for zofran. Treated as outpatient.
42 2021-02-01 hypertension, fast heart rate Within 2 min of injection, I walked out to waiting room felt tachycardic and dizzy. I immediately i... Read more
Within 2 min of injection, I walked out to waiting room felt tachycardic and dizzy. I immediately informed pharmacist who took my BP. BP first reading in left arm was 235/130 with a HR around 130. Second reading was 205/120 with HR in 120's about 4 min later. I requested an ambulance due to the feeling of being very unwell and dizzy. Trouble concentrating. Ambulance ride was 190/112 ish EKG and BP monitoring at hospital. No anaphalaxis diagnosed but unknown cause. ER discharge after benadryl. BP and HR would continue to cycle up and down for the next 18 hours. Red spot formed about 2 inches away from where I was injected. PCP and allergist thin it was an intravascular injection.
42 2021-02-03 fainting Fever of 103 Body aches Syncope
42 2021-02-04 loss of consciousness 3 minutes after vaccination the patient began to feel a tingling and pain in his arm where the vacci... Read more
3 minutes after vaccination the patient began to feel a tingling and pain in his arm where the vaccine was placed. Within minutes the patient began to feel faint and proceeded to faint as he was gently laid to the ground by the healthcare provider to initiate an emergency response. The patient was alert and oriented at 5:30 but felt nausea and a tingling sensation in the tongue. The patient stated that he had been fasting for 2 days and we determined low blood sugar likely played into his response to the vaccine. Glucose gel was placed in mouth and patient felt better within 15 minutes.
42 2021-02-10 platelet count decreased, low blood platelet count Idiopathic Thrombocytopenic Purpura, on 1 February 2021, I noticed significant bruising on my body a... Read more
Idiopathic Thrombocytopenic Purpura, on 1 February 2021, I noticed significant bruising on my body and Petechiae under my eyes. I call the nurse line and requested a CBC. On 2 February, the Emergency Department called me back and stated my platelets were at 6K (over the last 10 years with CLL, they consistently are at 110K-120K). The emergency department directed me to come in and began treatment with Prednisone and platelet transfusion. I was transferred to Hospital where they started IVIG and 40mg of Dexamethasone for four days. I was discharged on 7 February with stable platelets at 42K
42 2021-02-16 blood pressure increased 4 hours after administration of noticed his face had become numb and his lip was not "moving as it s... Read more
4 hours after administration of noticed his face had become numb and his lip was not "moving as it should." Rt side of face was affected, His blood pressure was elevated at 160/110 at noon. Only other symptom was his arm hurt "alittle." States symptoms are improving and minimal over the weekend. He has noticed them getting worse when he needs to talk alot or with his mask rubbing on his face. Does report his BP has remained elevated and he continues to check each day. Today was 120/95. Does report drinking alot of coffee.
42 2021-02-22 hypertension Immediate reaction - "not feeling well", dizzy to the point that he was not safe to walk Blood press... Read more
Immediate reaction - "not feeling well", dizzy to the point that he was not safe to walk Blood pressure had been a little above normal prior to vaccination and remained high during the half hour of observation, but had started to come down a few points by the time he was taken in a wheelchair to family to go home and rest.
42 2021-02-24 pallor, fast heart rate, chest pain Resident became pale with c/o chest pain followed by emesis. Heart rate Tachy at 142/min. Residen... Read more
Resident became pale with c/o chest pain followed by emesis. Heart rate Tachy at 142/min. Resident indicates pain to mid-sternum radiating to right shoulder. States right arm has been sore since #2 COVID vaccine on 2/16/2021. BP 120/88, Pusle 142, Resp 20, Oxygen saturation 99% on room air, Aspirin 325mg given and supplemental Oxygen applied. Resident was subsequently transferred to the local ER.
42 2021-02-24 fainting Syncopal Episode.
42 2021-02-28 troponin increased, blood pressure increased, chest discomfort 2/21/21 had slight chest pressure radiating to shoulder blades. Rested for half hour. Didn?t go awa... Read more
2/21/21 had slight chest pressure radiating to shoulder blades. Rested for half hour. Didn?t go away. Went to Hospital. Normal ekg. Normal bp. E.R. Determined elevated Troponin level of .10, admitted inpatient for observation, Troponin level went up to 6.3 within hours and 10.9 a day later. Was given heparin iv drip. Cardiac cath w dye done. No blockages found. Several more normal ekg?s done. Normal echocardiogram. Level of heart damage unknown because cardiac mri was not available for use (fully booked). Discharged home.
42 2021-03-03 hypertension Approximately 30 minutes after the administration of the dose I began feeling flush. I had intended ... Read more
Approximately 30 minutes after the administration of the dose I began feeling flush. I had intended to go back to work but instead my supervisor insisted on me being evaluated. It was determined that I was hypertensive. I felt a bit off and a bit strange. Even after lying on a bed in a dark room hypertension continued. I was transported by ambulance to the local emergency department where my BP continued to run high. The next day I was in bed the whole day feeling as if I had Covid all over again. I did previously had Covid but waited over 30 days to receive the vaccination.
42 2021-03-04 loss of consciousness, fainting, excessive bleeding, pallor Patient was given vaccine Moderna vaccine at 09:45 and sent to the observation area. As patient was ... Read more
Patient was given vaccine Moderna vaccine at 09:45 and sent to the observation area. As patient was filling out information on sheet and information area he suffered a syncopal episode at 09:50 in which he collapsed and hit his head on the floor. He suffered a small contusion on the left rear of his head with some bleeding. Patient was unconscious for approximately 15 seconds. When he came too, he complained of nausea. Patient was pale anxious and had fixed dilated pupils. Patient reports that he is a stage four cancer survivor and is taking Xarelto. 911 was called and patient was transported to Emergency Department.
42 2021-03-05 chest discomfort Feels like my asthma got worse. My chest feels much tighter and I'm short of breath. When I woke up ... Read more
Feels like my asthma got worse. My chest feels much tighter and I'm short of breath. When I woke up today, it felt worse.
42 2021-03-08 blood pressure increased THIS PATIENT IS A 42 YO MALE WHO STARTED TO COMPLAIN OF LIGHTHEADEDNESS/DIZZINESS/FEELING FLUSHED AB... Read more
THIS PATIENT IS A 42 YO MALE WHO STARTED TO COMPLAIN OF LIGHTHEADEDNESS/DIZZINESS/FEELING FLUSHED ABOUT 30 MINUTES AFTER RECIEVING VACCINE. PATIENT WAS INITIALLYVISUALLY MONITORED FOR 15 MINUTES WITH NO SIDE EFFECTS. PATIENT LEAFT THE CLINIC SITE, AND RETURNED ABOUT 15 MINUTES LATER REPORTING SYMPTOMS ABOVE. PATIENT A&OX4, GCS 15, NOMAL SKINS. PATIENT DENIES HEADACHE, CHEST PAIN, SHORTNESS OF BREATH. EKG COMPLETED, NO STEMI OBSERVED. PATIENT LED INTO QUIET/DARK ROOM TO REST AND FOR CONTINUED MONITORING OF BLOOD PRESSURE. DUE TO NO CHANGE IN ELEVASTED BP, RECOMMENDATION WAS MADE TO TRANSPORT PATIENT TO CLOSEST ED. PATIENT VERBALLY AGREED. PATIENT WAS ABLE TO WALK WITH ASSISTANCE TO AMR UNIT AND PATIENT CARE WAS HANDED OVER TO UNIT PARAMEDIC. PATIENT TRANSFERRED WITHOUT INCIDENT. LAST NOTED BP ON SITE WAS 176/132 IN A SUPINE POSITION.
42 2021-03-13 loss of consciousness Brief seizure, patient came to consciouness within 30 seconds and was coherent and denied ambulance ... Read more
Brief seizure, patient came to consciouness within 30 seconds and was coherent and denied ambulance or any further care . Sat in chair for 30 minutes and said he was fine and apologized for event as he said he had seizures before but did not volunteer the information before shot.
42 2021-03-17 inflammation of the heart muscle, chest pain Chest pain Myocarditis. Admitted to hospital. Diagnosis confirmed by cardiac mri.
42 2021-03-21 fainting syncope
42 2021-03-22 fainting Patient fainted at pharmacy approximately 7 minutes after receiving vaccine. Went to Emergency Ro... Read more
Patient fainted at pharmacy approximately 7 minutes after receiving vaccine. Went to Emergency Room by ambulance. On follow up phone call patient stated he is doing fine. He received iv fluids at Emergency Room.
42 2021-03-23 deep vein blood clot Diagnosed with a DVT of the left Axillary Vein. had received the Moderna vaccine in the same arm 10 ... Read more
Diagnosed with a DVT of the left Axillary Vein. had received the Moderna vaccine in the same arm 10 days prior. Being evaluated for a PE at present.
42 2021-03-25 fainting Dizzy, faint, feeling uncoordinated, weak
42 2021-03-25 fainting Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient indicated a severe phobia of n... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient indicated a severe phobia of needles, has had history of fainting when exposed to needles. RN on staff monitored bp, (was wnl) gave water, cool towels, and apple juice and was monitored for extra time before being taken home by family member
42 2021-03-31 hypotension Female with patient received vaccine and waiting in post vaccine waiting room for 15 minutes. Got t... Read more
Female with patient received vaccine and waiting in post vaccine waiting room for 15 minutes. Got to the car and started to complain of not feeling well. Called back to POD, staff went to talk with patient. Patient stated he had low blood pressure, not feeling well, no other complaints. Female with patient was going to take patient to seek medical attention due to the heart condition.
42 2021-04-01 loss of consciousness, pallor Patient's wife exited from car screaming for help reporting patient passed out. Upon arrival of RN, ... Read more
Patient's wife exited from car screaming for help reporting patient passed out. Upon arrival of RN, patient had regained consciousness and was A&O x 3. He was sweating, pale, with active pilomotor reflex. VS: BP 80/55, temp unable to obtain, HR 67, RR 24 EMS called and repeat vitals at their arrival BP 152/121, HR 67-70, T 96.5, RR 24. Patient's brother is MD and spoke with EMS reporting extensive hx of vasovagal syncopal events at dentist in past as well as with high stress events. Patient decline transport to ER and wife elected to drive home. Patient remained at cognitive baseline without complaints at time of departure from site.
42 2021-04-01 fast heart rate, heart rate increased 11:34. Sudden onset of rapid pulse, anxiety, feeling cold all over. 11:36 - evaluated onsite by NP ... Read more
11:34. Sudden onset of rapid pulse, anxiety, feeling cold all over. 11:36 - evaluated onsite by NP and EMS. EKG showed SVT with rate of 152; BP 183/117 - Vagal manuevers provided some decrease in rate but no appreciable change. EMS called and transported patient to Hospital. 11:45
42 2021-04-06 chest pain Dizziness, vomiting, chest pain, numb arms, dry mouth
42 2021-04-07 excessive bleeding pt states that 6 hours after recieveing the moderna vaccine he developed blisters on his right arm a... Read more
pt states that 6 hours after recieveing the moderna vaccine he developed blisters on his right arm and right torso that were itchy. Blisters bled. Fever of 103. Pt states he took benedryl and blisters resolved with in 15mins. Pt states he has some labored breathing, howver, states it could have been from anxiety. ot denied any swelling of the throat or difficulty swallowing. Pt also stated that the area of the injection site turned black and that it has sinced resolved. Pt went to see his PCP who advised him not to receive the 2nd dose of Moderna, however; to get the J&J vaccine insteasd.
42 2021-04-07 heart rate irregular Dizziness, heart rate up and down between 62-118 while doing nothing physical. Had to sit down numer... Read more
Dizziness, heart rate up and down between 62-118 while doing nothing physical. Had to sit down numerous times because I almost passed out. Heart rate would rave then drop and I'd break out in cold clammy sweat. Did not seek treatment tried to rest and had friends and kids keep an eye on me. Day 2 better but still times heart would race.
42 2021-04-11 fainting Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
42 2021-04-12 arrhythmia Adverse effects 12 hours after 2nd dose: Body pain Fever Skin Rash Eyes irritation Joints pain Heada... Read more
Adverse effects 12 hours after 2nd dose: Body pain Fever Skin Rash Eyes irritation Joints pain Headache Arrhythmia These Symptoms lasted for 12 hours
42 2021-04-12 heart rate increased Woke up at 4am with extreme rapid heartbeat. This subsided after I drank some water. At 6am, I had t... Read more
Woke up at 4am with extreme rapid heartbeat. This subsided after I drank some water. At 6am, I had teeth chattering chills. As the day progressed I had extremely painful body aches and the worst headache of my life! After 4 advils and sleeping all afternoon, I finally felt a little better, but still sluggish. Per CDC, not recommended to have 2nd dose due to bad reaction, and most probably allergic reaction.
42 2021-04-12 loss of consciousness THE PATIENT SLID OUT OF HIS CHAIR TO A SITTING POSITION. HE BLACKED OUT FOR A SECOND, BUT CAUGHT HI... Read more
THE PATIENT SLID OUT OF HIS CHAIR TO A SITTING POSITION. HE BLACKED OUT FOR A SECOND, BUT CAUGHT HIMSELF BEFORE FALLING OVER. HE FELT LIGHT HEADED. HIS BLOOD PRESURE WAS 140/86 AND A HEART RATE OF 73. AFTER 20 MINUTES HE WAS FEELING FINE AND WAS BACK TO NORMAL. HE REFUSED A CALL TO 911 STATING HE WAS FINE AND WAS RELEASED.
42 2021-04-12 fainting Participant fell off chair on his right side at 11:04 AM. He hit his right temple area. He fainted... Read more
Participant fell off chair on his right side at 11:04 AM. He hit his right temple area. He fainted without warning. He has an abrasion on his right temple and left knee. Syncope episode lasted between 15 seconds. He responded to voice. Vital signs were taken immediately and were stable 118/60 pulse 80 respirations 18 chest clear temperature 97, O2 sat was 98% at 11:04 AM. Participant was accompanied by his partner. He denies blurry vision headache or nausea vomiting his skin was clammy and cool pale in color he has a history of fainting. He denied other health conditions. His blood pressure at 11:24 was 120/90 pulse 71 respirations 16 breast sounds clear temperature 97.3 and O2 sat was 99% His vital signs at 11:39 were 119/75 pulse 72 respirations 16 breath sounds clear 97.5 temperature. he was alert and oriented once he recovered from his fainting. We placed a participant flat on the ground allowed him to rest until he felt able to sit up. We dressed his abrasions in right temple and left knee, monitored his vital signs which were stable. participant drank water and Powerade. he declined a snack he rested in cot when able to be moved. we informed to notify his primary care doctor of the fall and inform to tell vaccinator he has a history of fainting when he comes back for vaccine number two. he was accompanied By his partner off the premises once he felt better was able to ambulate safely his partner will drive him home his vital signs were stable
42 2021-04-13 chest pain Several hours after vaccine was given, had arm pain/numbness, intermittent dizziness. Chest pain, sh... Read more
Several hours after vaccine was given, had arm pain/numbness, intermittent dizziness. Chest pain, shortness of breath, anxiety.
42 2021-04-13 loss of consciousness, very slow heart rate, fainting vaccine adm at 2:33, , 2:40pm pt had fainting episode vs:129/67, P44-54, T96.2, R18, O2 sat 98%, EMS... Read more
vaccine adm at 2:33, , 2:40pm pt had fainting episode vs:129/67, P44-54, T96.2, R18, O2 sat 98%, EMS called R/T syncope and bradycardia. 2:44 vs:116/72, T96.2, R18, O2 97%, in and out of consciousness. lowered to ground by clinical staff, turned on side. 2:50 vs: P70, 112/64, R18. 2:53 EMS onsite, 126/79, P66, R18 3pm EMS cleared pt, declined to go to hospital. 3:10 VS 126/79, P66, R 18, A/O x 4, friend present. Medical director informed, ok to leave. Left in no acute distress.
42 2021-04-14 haemoglobin decreased 42 y/o F with a history of uterine prolapse, GERD who is presenting with low back pain x4-5 days, ab... Read more
42 y/o F with a history of uterine prolapse, GERD who is presenting with low back pain x4-5 days, about 2 weeks after receiving the Moderna vaccine on 3/28; she also developed a raised patchy erythematous rash on her L deltoid (site of vaccine injection) a few days prior to onset of the pain. Symptoms began Saturday, 4/10; pt was helping her mother around her house; was not straining excessively; however, later that day had a sudden burning sensation in her lower-mid back, which has since been recurring in paroxysms. At times it spreads into the posterior thighs but not into the feet; sometimes also spreads upward into the upper back and just below the chin. In between attacks, there is no pain or numbness. There has never been weakness. No urinary/bowel incontinence or saddle anesthesia; sphincter tone was normal. NIF/FVC normal -60, 2.3L. Paroxysmal pain controlled w/ 600mg gabapentin q8h since being hospitalized. There has been no development or progression or symptoms, still only pain and normal neurologic and physical exam.
42 2021-04-14 fainting patient was nervous about getting vaccine. Asked him to wait in out waiting area to be checked on. a... Read more
patient was nervous about getting vaccine. Asked him to wait in out waiting area to be checked on. after couple minutes he came upto register and said feeling dizzy. I brought him in consultation room,he sat on chair ,gave him water to drink. then I let him lay down on floor,he passed out,but was talking to me,answering my question,called 911,EMT came in few minutes,checked everything. They said he might got anxious about getting vaccine,checked BP everthing was fine
42 2021-04-15 lightheadedness Patient had a vasovagal response after the COVID vaccine. He was seated, saw his own blood and warne... Read more
Patient had a vasovagal response after the COVID vaccine. He was seated, saw his own blood and warned me. He began to start blacking out. He had full conciousness, only loss of sight and difficulty hearing for about 5 minutes. I took his BP while he was seated, 104/54 (he reports a normal BP around ~110/60). He sat until he regained sight and drank a full bottle of water. I continued to watch him for an additional 15 minutes and retook his BP= 116/58. Patient informed to call the pharmacy at any time for questions, follow up, etc. Full recovery, patient reports being fine and went about his day.
42 2021-04-15 fainting patient had a Moderna vaccine at 11:00 am then at 11:05 am while in the observation area the patient... Read more
patient had a Moderna vaccine at 11:00 am then at 11:05 am while in the observation area the patient had a syncopal episode and then he was arousable approximately 2 min later. was able to transferred to a stretcher and feet elevate . patient was observed for 30 min. patient was able to exit facility without assistance.
42 2021-04-17 heart rate increased Low Grade Fever, Severe aching, violent shivering for hours on end, Lethargic body and cloudy head. ... Read more
Low Grade Fever, Severe aching, violent shivering for hours on end, Lethargic body and cloudy head. Cranial pressure that felt around entire circumference of head. Lasting over 36 hours each time that forced bed-ridden behavior, forced time off of work, and loss of appetite. Spiked heart rate on numerous occasion throughout the following 36+ hours with heart rates spiking as great as 136 bpm. I should of reported it and visited my physician, but there was nothing more they could do besides for me to hydrate, suppress with Tylenol, & ride it out. Anyone with previous decent COVID cases should be advised against receiving the vaccine. But entities are still forcing us to have it for our jobs. I couldn?t endure a third round. It was a violent illness following the vaccine, which was equivalent to one of my first ?bad? days of actual COVID.
42 2021-04-19 atrial fibrillation, troponin increased, fast heart rate, low blood oxigenation, enlargement of the heart Symptoms started around a week after COVID-19 vaccine, when patient started having shortness of brea... Read more
Symptoms started around a week after COVID-19 vaccine, when patient started having shortness of breath cough and nasal congestion. He was having yellow sputum production and he had chills. Upon arrival to the hospital on 4/18 the patient was tachycardic and chest x-ray that showed cardiomegaly with fluid overload. Progressively became severely hypoxemic and had to be emergently intubated and placed on mechanical ventilation. Patient developed cardiogenic shock which may be acute myocarditis and was placed on an Impella device and norepinephrine drip. The patient continued to worsen and developed acute kidney injury and hyperkalemia and was placed on CRRT. LFTs were also elevated. Patient also went into atrial fibrillation and was started on amiodarone drip. All of the above mentioned occurred within a 12 hour period.
42 2021-04-20 blood glucose increased This is a 42-year-old male patient with past medical history of hypertension presented to the emerge... Read more
This is a 42-year-old male patient with past medical history of hypertension presented to the emergency department today with complaints of nausea, vomiting, diarrhea over the last 5 days. Patient also noted having a nonproductive cough. Denies any fever, chills, chest pain, shortness of breath. Patient notes he got his 2nd CoVID vaccination on the 9th. Imaging done in the emergency department showed Left midlung infiltrates and probably also in the middle lobe. Patient's labs sodium 136, potassium 4.2, BUN 21, creatinine 2.87, glucose 154. Patient was started on IV antibiotics in the emergency department.
42 2021-04-20 chest pain Patient developed chest pain after injection no clear fever and pain persisted until arrival at hosp... Read more
Patient developed chest pain after injection no clear fever and pain persisted until arrival at hospital ED Work up included elevated CPK CKMB and TNT blood work EKG revealed early repolirazation pattern He underwent cardiac catheterization revealing normal angiography and Left ventriculagram and Normal Echocardiogram.
42 2021-04-20 fast heart rate Fever > 100 F Chills Tachycardia (130 bpm at rest) O2sat 93% at rest Hallucinations Extreme fatigue... Read more
Fever > 100 F Chills Tachycardia (130 bpm at rest) O2sat 93% at rest Hallucinations Extreme fatigue X 2 days
42 2021-04-22 fast heart rate, heart rate increased Patient received first dose of Moderna COVID-19 vaccine on 1/4 and second dose on 2/1. Pt called the... Read more
Patient received first dose of Moderna COVID-19 vaccine on 1/4 and second dose on 2/1. Pt called the vaccine line the day after his second dose and reported symptoms of fatigue, body aches, low grade fever, dizziness, and elevated heart rate. He was subsequently advised to visit the ED due to his dizziness and tachycardia. Patient had treated himself with acetaminophen 2 hours prior to arrival to the ED and was given ibuprofen 600 mg in the ED. HR and temperature improved in the ED and was advised to use ibuprofen and acetaminophen for further treatment.
42 2021-04-23 fainting The patient fainted (syncope) minutes after receiving the vaccine while waiting in the post-vaccine ... Read more
The patient fainted (syncope) minutes after receiving the vaccine while waiting in the post-vaccine waiting area. He regained consciousness almost instantly. 911 was called and paramedics checked him out. He previously stated he had no history of syncope, but after the event he admitted he sometimes passes out from getting his blood drawn.
42 2021-04-25 heart attack, chest pain As a citizen I took the Moderna vaccine on 15 APR 20201. Four days after taking the vaccine I develo... Read more
As a citizen I took the Moderna vaccine on 15 APR 20201. Four days after taking the vaccine I developed a blood clot in my heart. On the morning of 19 APR 2021 at 0730 I began having chest pain, I thought I had pulled a muscle while exercising the night before. Throughout the morning the pain in my chest got worse until I called emergency services. The EMTs told me I had a blood clot in my heart and rushed me to the hospital. Once at the hospital I had an angioplasty . No stint was inserted. After the surgery the doctors told me I had very large veins and a strong heart after the clot was removed flow returned and no stint was needed. The doctors also told me that they could not rule out the COVID vaccine as the cause of my blood clot as the rest of me heart looked good with no visible plaques or build up. Official Diagnosis Anterior STEMI- POBA ot LAD Integrillin infusion Fit and Well Moderna vaccine 1 week ago Diagnostic Findings -Left Main Stem - Normal LMS Left Anterior Descending- LAD 100 % stenosis restored flow Conclusion -Aspirin 75 mg od for life - prasugrel 10mg of for 1 year - ECHo Sec prevention, Integrillin infusion 24 hrs - Card rehab I work out every day- prior to the blood clot Blood clot left in heart chamber- taking blood thinners to dissolve.
42 2021-04-25 blood pressure increased Patient complained of swelling in his neck. Patient stated that this happens when he takes the flu ... Read more
Patient complained of swelling in his neck. Patient stated that this happens when he takes the flu shot also. Problem: swelling. A 24 /o patient complained of swelling around the neck. Nurse observed patients neck. no redness noted. patient had no distressed. Patient stated that he has swelling in his neck when he takes the flu shot. 1020 am vitals was taken BP 146/102, HR 85, RR 16 Temp - 97.2 02 Sat 98%, no sign of distress. Nurse observed patient for 30 mins. 1040 am vitals sign BP 147/95, HR 80, RR 16, 02 Sat 98% Patient stated that he felt better 1055 am patient was discharged with family. 03/17/21
42 2021-04-25 chest pain On 4/22/21, approximately 1 hr after the Moderna COVID-19 first vaccination injection, I started to ... Read more
On 4/22/21, approximately 1 hr after the Moderna COVID-19 first vaccination injection, I started to encounter allergic reactions that I used to suffer about 20 years ago. My air intake decreased, and my skin began to become irritated. I formerly had environmental allergies that would reduce my air intake, and the first place I noticed the effects were on my skin and I would become irritable. Physicians told me that when my oxygen levels were low, the body would channel the air to where it was most needed, which is generally not the skin, so my skin would become irritated. When this used to occur, I would respond involuntarily with facial twitches and pulling at my face and hair. Physicians explained that these twitches and pulling actions would draw air to the surface of my skin where I was air depleted. When I took the Moderna injection, this happened again -- I found myself with low air, my face was twitching, and I was pulling on my face to draw air to the area. The result when I was 19 and dealing with allergies is that I would remove small patches of hair from my head or eyebrows or eyelashes, and this would happen almost unconsciously as I tried to stimulate the areas and draw air to the surface of my skin. I did the same thing on 4/22/21, and found later, when looking into a mirror, that I had removed a section of my eyebrow unconsciously. It all comes back to oxygen depletion. A different and more intense event occurred in the night of Friday, 4/23/21, and the early morning of Saturday, 4/24/21. I went to bed at about 11 p.m. or 11:30 p.m. Between that time and approximately 1:30 a.m., I had difficulty sleeping, and I dreamed of pain in my chest. I finally woke up about 1:30 a.m. and found the pain in my chest was real. I was having difficulty breathing deeply. It felt as if the lower part of my lungs (at least on one side) was solidifying or inaccessible. What I did was begin forcing myself to breathe as deeply as possible. Over a period of 30 minutes or longer, I was able to gradually reclaim the use of the deepest part of my longs. With every forced deep breath, I was able to chip away at the area that felt like it was freezing up. Finally, I felt that I could access the deepest part of my longs and breath normally. The pain and lack of use in my lower lungs were very concerning.
42 2021-04-25 fainting Syncope
42 2021-04-26 heart rate decreased, blood glucose increased, oxygen saturation decreased, blood pressure decreased, blood pressure increased Per Patient report: Headache started within 1 hour of vaccination. the following day, Blood sugar ... Read more
Per Patient report: Headache started within 1 hour of vaccination. the following day, Blood sugar and Blood Pressure rose to dangerous levels. Nausea and vomiting. Blood pressure 2??/185, Blood sugar so high unreadable >600?; Unresponsive, breathing labored O2 Stat was low and on oxygen, went by EMS to Medical Center. At ER Blood pressure and HR decreased to dangerous levels for approximately 6 hours. Patient stayed in the hospital for 7 days while he was monitored for continued changes in blood sugar and blood pressure as well as severe nausea and vomiting.
42 2021-05-01 fainting The customer just got his first Moderna covid 19 doe #1 around 2:30 pm. About 5 minutes later called... Read more
The customer just got his first Moderna covid 19 doe #1 around 2:30 pm. About 5 minutes later called me to inform me that he felt dizzy. When I came out he looked at me with his lazy eye and sweat. He did not say anything then his eyes rolled back then fainted. He did not remember the event . I pat him on his shoulder and he was awake right a way. I called 911 but he felt better before the emergency people arrived and they checked him out. He refused to go to the hospital.
42 2021-05-03 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: fainted but recovered right away, hit back of he... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: fainted but recovered right away, hit back of head on the floor, ice applied-Medium, Additional Details: waited 45 minutes before leaving, wife picked him up so he would not drive, patient stated he had a history of fainting after vaccines or giving blood, his head felt better after applying ice, temp 94.6 before leaving and felt his breathing normalize after incident
42 2021-05-03 troponin increased, inflammation of the heart muscle, chest pain had chest pain - was admitted to hospital with elevated troponin and was ultimately diagnosed with a... Read more
had chest pain - was admitted to hospital with elevated troponin and was ultimately diagnosed with acute myocarditis. Was admitted on 4/25 and discharged on 4/27 - symptoms resolved within a week.
42 2021-05-04 ischaemic stroke Ischemic Stroke
42 2021-05-04 inflammation of the pericardium, chest pain Seen in ER 4/15 for chest pain felt c/w possible pericarditis
42 2021-05-04 blood vessels inflammation Acute Vasculitis of lower extremities (foot/ankle/shin/calf), steroids and antibiotics, outcome unce... Read more
Acute Vasculitis of lower extremities (foot/ankle/shin/calf), steroids and antibiotics, outcome uncertain.
42 2021-05-05 chest pain Chest pain, headache. Extreme Tiredness. Dizziness.
42 2021-05-05 loss of consciousness Drowsy, AMS, difficulty breathing, clutching at throat, was not moving air Benadryl 12.5 mg IM, pati... Read more
Drowsy, AMS, difficulty breathing, clutching at throat, was not moving air Benadryl 12.5 mg IM, patient lost consciousness, given EPI Pen x 2 Oxygen 5L Foaming at the mouth, suction provided Patient sent to ER
42 2021-05-05 pulmonary embolism Pulmonary Embolism and Pulmonary Infarction
42 2021-05-06 fainting Patient fainted about 3-5 minutes after vaccination. He recovered consciousness in less than a minu... Read more
Patient fainted about 3-5 minutes after vaccination. He recovered consciousness in less than a minute.
42 2021-05-08 heart rate increased Mild fever Extreme weakness and body ache Pounding head ache Mouth ulcer Breathlessness Increased he... Read more
Mild fever Extreme weakness and body ache Pounding head ache Mouth ulcer Breathlessness Increased heart rate (85bpm instead of normal 65bpm resting) Symptoms started about 12 hours after vaccination (this was the second dose) an persisted till 48 hours after vaccination gradually getting better Taking crocin alleviated symptoms
42 2021-05-09 low blood oxigenation Patient received his first dose of COVID vaccine on 4/24/21. Around 4/30/21 (~ 1 week prior to admi... Read more
Patient received his first dose of COVID vaccine on 4/24/21. Around 4/30/21 (~ 1 week prior to admission), pt developed cough, runny nose, lack of appetite, loss of smell, and shortness of breath. Pt's symptoms became progressively worse, and he presented to the ED on 5/7/21, where he tested positive for COVID. Pt was found to be hypoxic (89% SpO2) and was started on supplemental O2. He was also admitted to the hospital for COVID treatment .
42 2021-05-12 palpitations The night I got the vaccine, I had severe heart palpitations that continued for a couple of weeks b... Read more
The night I got the vaccine, I had severe heart palpitations that continued for a couple of weeks but very severe the first night. Since the second night I have had severe insomnia. Tried trazodone, ambien then clonazepam in that order. Clonazepam helped but I weaned myself off after 3 weeks, did not want to get addicted to them and I also started having tinnitus in right year. Not sure if it is from vaccine, lack of sleep or clonazpeam. 9 weeks out since 1st dose and I continue to suffer from severe insomnia. Only get about 4-5 hours of sleep that is fractured. Takes hours to fall asleep. Skipped 2nd dose due to side effect after 1st dose. Never had sleep issues ever.
42 2021-05-12 palpitations I am a pharmacist with 17 years of clinical experience and so medically literate. The night of the v... Read more
I am a pharmacist with 17 years of clinical experience and so medically literate. The night of the vaccine I had severe heart palpitations that woke me every 2 hours, but I managed to get some sleep. The 2nd night I could not fall asleep at all. I stayed up all night. 2nd night tried melatonin and benadryl, and only manged to sleep 2 hours very late in the night. This went on for a week. I saw a doctor and was given trazodone. It helped fall asleep but kept waking up every hour or 2 and then trouble falling asleep afterwards. So only managed 3-4 hours of sleep each night. I had side effects from Trazodone with mood changes so had to stop taking it. I saw another doctor based on a friend's recommendation who was going through the same issue. I was prescribed clonazepam 1mg. I was finally able to sleep a full night. I took it for 7-10 days and tried to taper back since I did not want to be dependent on it and wanted to go back to sleeping without any sleeping aids. Klonopin 0.5mg seemed to be helping so on a follow-up appointment, I was given a months supply of clonazepam 0.5mg. I took that for a week and tried to taper that further and that did not help with sleep. Amidst of this I started having tinnitus in the right ear and I never had tinnitus before. I don' t know if it was triggered by sleep deprivation, the vaccine or the clonazepam. But I stopped taking clonazepam altogether after 3 weeks. 9 weeks out since the 1st dose and I can sleep a little on alternate nights only. And that sleep is fractured. So one night of almost no sleep and one night of 3-4 of hours of sleep if lucky. I tried benadryl and it helps a little but the trouble falling asleep is just as severe and continue to wake up every 2-3 hours. 8 hours in bed and only manage 3-4 hours of sleep. I skipped the 2nd dose due to continued issues with sleep. Looking for answers and guidance on how best to treat this and if/when this will be over for me.
42 2021-05-13 chest pain, increased heart rate Chest pain, left arm pain, numbness. Pt transported to ED with ST changes. ST changes subsequently t... Read more
Chest pain, left arm pain, numbness. Pt transported to ED with ST changes. ST changes subsequently thought to be early repolarization variant and not MI.
42 2021-05-13 nosebleed Nose bleeds, body aches, hair falling off of the exterior part of my lower legs, headaches. All of ... Read more
Nose bleeds, body aches, hair falling off of the exterior part of my lower legs, headaches. All of the adverse events described started after the second Moderna dose, which was administered on 13 April 2021.
42 2021-05-13 palpitations Unable to get out bed for ~18 hours, had 2 incidents where my heart was pounding and I felt like my ... Read more
Unable to get out bed for ~18 hours, had 2 incidents where my heart was pounding and I felt like my blood pressure was very high, attempted to take my own blood pressure, wife brought the tester in but it wouldn?t work. Felt fine the next morning but I think I would take my chances with Covid than do that again.
42 2021-05-13 blood clot Blood clot formed.
42 2021-05-14 palpitations Patient was warm and having a racing heart. Tried relaxation and fan. Ended up receiving one dose of... Read more
Patient was warm and having a racing heart. Tried relaxation and fan. Ended up receiving one dose of diphenhydramine 25mg and bottled water extended observation to 30 minutes. At the end of 30mins patient was feeling much better, no more racing heart.
42 2021-05-15 loss of consciousness Patient states that he felt fine for 30 mins after shot, then blacked out on his ride home and forgo... Read more
Patient states that he felt fine for 30 mins after shot, then blacked out on his ride home and forgot the whole ride which was a bizarre experience. Then he had a horrific cough which he felt may have cracked a rib.
42 2021-05-18 loss of consciousness - sleeplessness, headache and night sweats - 5/17/21 8PM - 6AM - passed out - 5/18/21 6:30AM - light... Read more
- sleeplessness, headache and night sweats - 5/17/21 8PM - 6AM - passed out - 5/18/21 6:30AM - light headed and headache - 5/18/21 7AM - 10PM - shortness of breath when talking - 5/19/21 10AM - 6PM - headache has dissipated - 5/19/21 12PM
42 2021-05-18 fainting Syncopal episode about 15 minutes post vaccination. BP was 76/44. IV fluids started and patient tr... Read more
Syncopal episode about 15 minutes post vaccination. BP was 76/44. IV fluids started and patient transported to ER by EMS.
42 2021-05-19 nosebleed Bloody nose
42 2021-05-22 inflammation of the pericardium Woke up at 600am w/ onset of epigastric discomfort. Patient states discomfort radiated to L flank, ... Read more
Woke up at 600am w/ onset of epigastric discomfort. Patient states discomfort radiated to L flank, intra-scapular region. Final diagnoses Pericarditis. 3 months of colchicine
42 2021-05-23 chest pain, palpitations No more than an hour after receiving the first dose, I began to have chest pain, middle of the chest... Read more
No more than an hour after receiving the first dose, I began to have chest pain, middle of the chest and maybe angled a bit to the right side. More usual symptoms began to appear later that same day.. fatigue about 3 hours after shot, headaches about 5 hours after shot. After the ?usual? symptoms subsided, the chest pain continued. May10, I went to immediate care, had a ekg which showed healthy results. May22, I was feeling much better, but had pressure applied to my chest by my partner? she inadvertently did this twice in a row. Over the next 1-2 hours, chest pain came rushing back and I began coughing a lot. Now May24, I am still having elevated chest pain and have been having a lot of heart palpitations over the past two days. I was scheduled to have the 2nd dose today, but am worried about what it will do to me.
42 2021-05-24 chest discomfort Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heavin... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: pt experienced fatigue diziness minor tingling of the tounge and minor tightness of chest. paramedics were called to the store however after examantion paitent decided he was fine and decided to leave
42 2021-05-24 inflammation of the heart muscle Hospitalized with myocarditis after the second shot
42 2021-05-24 lightheadedness Patient had a vasovagal event approximately 2 minutes after receiving his 1st dose of Moderna at the... Read more
Patient had a vasovagal event approximately 2 minutes after receiving his 1st dose of Moderna at the vaccination table. Charge Nurse was immediately called over and patient was opening his eyes and looked a little confused. Patient was able to communicate and alert and oriented X4. Patient was sweating and said he still felt a "little dizzy". Vitals were taken at 9:24 am B/P 190/131 HR 45 O2 99% Resp. 14. Cot was brought over to patient and patient was able to transer from chair to cot without assistance. After laying down for about 5 minutes vitals were repeated 9:30 AM B/P 114/66 HR 61 O2 100% Resp. 16. Patient then was able to walk to observation area and sat on a chair for the remainder of his observation time. He left without requiring any further treatment.
42 2021-05-28 hypotension Soarness, low blood pressure and then death.
42 2021-05-28 inflammation of the heart muscle Pericarditis or pleurisy. Was better after three days. Had myocarditits in 2019 and the infection ti... Read more
Pericarditis or pleurisy. Was better after three days. Had myocarditits in 2019 and the infection timeline was identical. That one took 6 days to heal.
42 2021-05-28 palpitations Lightheaded, brain fog, spacing out on normal daily stuff. Heart palpitations. I scheduled to see my... Read more
Lightheaded, brain fog, spacing out on normal daily stuff. Heart palpitations. I scheduled to see my doctor the next day. She suggested to see my cardiologist to follow up.
42 2021-05-29 palpitations Fever - 3-4 days, 102.7 degrees when measured a couple of times Chills - 2-3 days Pounding headache ... Read more
Fever - 3-4 days, 102.7 degrees when measured a couple of times Chills - 2-3 days Pounding headache - 2-3 days Pounding heartrate Fatigue - 5 days
42 2021-06-01 chest discomfort, hypertension Patient experienced facial numness/tingling, chest tightness, possible throat swelling, and shortne... Read more
Patient experienced facial numness/tingling, chest tightness, possible throat swelling, and shortness of breath about 10 minutes after administering Moderna Covid vaccine dose 1. Instructed patient to stay in consultation room for observation. I stayed with the patient and called 911. EMS arrived on scene about 5-10 minutes later. Took vitals, oxygen saturation within normal limits, elevated bp, normal heart rate. EMS monitored patient for about 15 minutes after which patient was still conscious and alert. EMS advised patient to go to hospital for further evaluation and patient accepted. EMS took patient to hospital. Patient generally seemed fine when he left the pharmacy which was about 30 minutes after receiving the vaccine.
42 2021-06-02 hypertension Left leg weakness and numbness when woke up at 9 am 5/24. Had venous saggital sinus thrombosis on v... Read more
Left leg weakness and numbness when woke up at 9 am 5/24. Had venous saggital sinus thrombosis on venous mri with contrast . Had bilateral lacunar infarcts acute on mri. Symptoms gradually subsided with lovenox snd warfarin. Residual weakness left leg but milder than initial presentation Bp very high in ED 5/24/2021 controlled with IV cardene
42 2021-06-06 inflammation of the pericardium, inflammation of the heart muscle myocarditis, pericarditis
42 2021-06-07 palpitations Heart palpitations, breathing issues
42 2021-06-07 fainting syncope
42 2021-06-10 chest pain mild/moderate stabbing pain at sternal notch when swallowing starting approx. 3 hours after vaccinat... Read more
mild/moderate stabbing pain at sternal notch when swallowing starting approx. 3 hours after vaccination, lasted approx. 3 weeks, resolved spontaneously. Did not seek eval/care when symptomatic. no dysphagia to liquid/solid. No airway compromise.
42 2021-06-13 pallor Male Patient oriented in space and time at 6 minutes after the moderna vaccine second dose, report t... Read more
Male Patient oriented in space and time at 6 minutes after the moderna vaccine second dose, report to feel dizziness, sweating and pale skin. At this moment we take the vitals; SO2% 98, 81 HR. After evaluation patient report to feel better and take water.
42 2021-06-16 blood clot, heart attack As per wife's account, patient died approximately 9 days after receiving vaccine on 4/21 of massive,... Read more
As per wife's account, patient died approximately 9 days after receiving vaccine on 4/21 of massive, unknown (suspected cardiac) event. Wife explained that patient was diagnosed with Wolff-Parkinson-White (WPW) syndrome prior to being vaccinated. PCP unaware of diagnosis, and patient did not disclose that on vaccine consent form. Patient reported to his wife that he was feeling unwell after receiving vaccine including unable to move legs well. Patient later diagnosed with thrush and supposedly treated by physician. Patient did not discuss concerns regarding vaccine or WPW with physician. Patient called his wife the day of death and asked her to bring him to the doctor the following day. Wife reported that patient experienced seizures but not concerned as it was similar to childhood seizure. Wife was done at work and drove home after phone call, arriving at house approximately 10-15 minutes after call. Patient supposedly dead when wife arrived. Wife performed CPR for ~15 minutes until EMS arrived, and EMS attempted for another 40 minutes for any electrical activity. Wife declined full autopsy from ME, suspecting that it was massive MI or clot. Wife and patient unaware that WCW could place patient at risk of clots and wondering if the vaccine was partially responsible.
42 2021-06-22 heart attack, excessive bleeding Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness... Read more
Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-year-old male 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 Diabetes (was on anti-diabetic medicine.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant medication included was anti-diabetic medicine. The treatment information was not provided. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: heart attack
42 2021-06-28 nosebleed, platelet count decreased, low blood platelet count Patient got bruising and red spots on over his body about 7 days after receiving first dose of Moder... Read more
Patient got bruising and red spots on over his body about 7 days after receiving first dose of Moderna Covid vaccine. He also had bleeding gum and bloody nose. His platelet count dropped significantly to 5000. Patient was diagnosed with immune thrombocytopenia and was admitted to hospital for treatment over 2 days. He got 2 bags of IVIG over 2 days and given Dexamethasone daily for 4 days.
42 2021-07-05 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
42 2021-07-07 chest discomfort, chest pain patient states that the day after the vaccine he developed chest pains feeling like his heart was go... Read more
patient states that the day after the vaccine he developed chest pains feeling like his heart was going to explode. He went to the nearby hospital er and they advised him to seek treatment from a cardiologist
42 2021-07-07 fainting, heart rate increased Patient felt cold and HR was elevating. Appeared clammy with an obtunded look. Head dropped to chest... Read more
Patient felt cold and HR was elevating. Appeared clammy with an obtunded look. Head dropped to chest, diaphoretic. When name called - patient responded. No SOB or throat swelling. HR 105-124, BP 150-160's / 60-70s. Transferred to the ED. ED diagnosed with vasovagal syncope. discharged without complications.
42 2021-07-13 chest discomfort Shortness of breath, chest heaviness and pressure on chest, worse with deep breath.
42 2021-07-15 loss of consciousness APPROXIMATELY 10 MINUTES AFTER RECEIVING VACCINATION THE PATIENT FELT LIGHT HEADED AND PASSED OUT-HE... Read more
APPROXIMATELY 10 MINUTES AFTER RECEIVING VACCINATION THE PATIENT FELT LIGHT HEADED AND PASSED OUT-HE WAS OUT ABOUT 5-6 SECONDS--WE RESPONDED AS HE CAME TO--HE WAS DISORIENTED --WE CALLED AN AMBULANCE--IN ABOUT 10-15 SECONDS HE WAS FULLY ALERT AND DID NOT WANT THE AMBULANCE WHICH WE CANCELED--HE STARTED SWEATING PROFUSELY AND WE HAD HIM REST ON THE FLOOR--WE GAVE HIM A BOTTLE OF WATER WHICH HE DRANK AND IN ABOUT 5 MINUTES HE FELT COMPLETELY BETTER--WE HAD HIM SIT IN A CHAIR FOR A FEW MINUTES THEN HE GOT UP WALKED AND SAID HE WAS COMPLETELY FINE. IT SHOULD BE NOTED THAT HE HAD A DREAD FEAR OF NEEDLES. WE ARE NOT SURE IF THIS PLAYED ANY ROLE IN THIS REACTION
42 2021-07-20 inflammation of the pericardium, chest pain chest pains \ pericarditis
42 2021-07-23 fainting Systemic: Fainting / Unresponsive-Medium
42 2021-07-25 chest discomfort Pinching the inside of arm, pinching and feels as though a movement is in chest, feels weak
42 2021-07-27 chest pain Patient reported that within 7-10 days he could barely move arms and legs, severe pains, extreme che... Read more
Patient reported that within 7-10 days he could barely move arms and legs, severe pains, extreme chest pain and stomach pain
42 2021-07-28 chest pain Severe chest and abdominal pain never felt before in life. Pain caused difficulty breathing lasting ... Read more
Severe chest and abdominal pain never felt before in life. Pain caused difficulty breathing lasting 4-6 hours, fading and remaining uncomfortable for 12-24 hours.
43 2020-12-31 loss of consciousness I received the vaccine at 6:30pm on 12/27. I worked atb7pm and took lunch at 2:00am. After lunch, I... Read more
I received the vaccine at 6:30pm on 12/27. I worked atb7pm and took lunch at 2:00am. After lunch, I immediately felt sick to my stomache and threw up. I went home after my shift and went to bed. After 5 hours, I woke up and went to the couch to lay down while kids watched TV. Next, I woke to several people in my house. I had a seizure and my son had called 911. I was taken to emergency department. I was admitted and stayed 2 nights in the hospital.
43 2021-01-05 heart rate increased Employee received the Moderna vaccine in the left arm and noted numbness in the left finger tips app... Read more
Employee received the Moderna vaccine in the left arm and noted numbness in the left finger tips approximately 20 minutes later. RN assessed patient and patient requested additional assessment by our Medical Assistance Team (MAT). The MAT team transferred the patient to the Emergency Department for further care. Patient released from ED. Contacted the following day and stated he had an elevated heart rate in the ED and when it returned to normal, they released him with instructions to follow up with his PCP if the arm pain and tingling did not subside in 1-2 days. He states his left shoulder is painful today (1/6/21 10:00 am) and his left fingers are still tingling. Patient instructed to call Occupational Health for further guidance.
43 2021-01-06 hypertension H/A, High blood pressure, Nausea, Fatigue
43 2021-01-06 fast heart rate, ischemic chest pain Tachypnea, Angina, Tachycardia, Sore Muscles Narrative: Started feeling ill on the 28th. Drove hims... Read more
Tachypnea, Angina, Tachycardia, Sore Muscles Narrative: Started feeling ill on the 28th. Drove himself to get checked out at the hospital. Hospital sent him home. Called EMS at 12/30/2020 @ 0200 and was hospitalized for 1 day. He is more stable now but still has these symptoms at a moderate level.
43 2021-01-07 oxygen saturation decreased, heart rate increased dizzy. light headed, weak, headache, shortness of breath, low 02, heart rate high.
43 2021-01-09 hypertension Beginning at 11pm - chills, headache, nausea, muscle aches, sleeplessness, anxiety, high blood press... Read more
Beginning at 11pm - chills, headache, nausea, muscle aches, sleeplessness, anxiety, high blood pressure, pulse 100+ . Syptoms lasted until 3pm the following day. Seemed to improve after taking benadryl. Aleve did not help.
43 2021-01-10 chest pain Significant fever for about 48hrs (first fever of my adult life). Aches, pains, chest pains, increa... Read more
Significant fever for about 48hrs (first fever of my adult life). Aches, pains, chest pains, increased secretions and coughing, fatigue. It was like my body thought I was sick with COVID again. But in some ways it was worse. I was afebrile with the real virus.
43 2021-01-13 palpitations, heart rate increased Approximately 30 minutes after the vaccination, I felt a sensation (pressure in my ears and tingling... Read more
Approximately 30 minutes after the vaccination, I felt a sensation (pressure in my ears and tingling throughout my body), then I could feel my heart start to race. My best estimate as the fast heartbeat last for between 60-120 seconds. I experienced the tingling feeling one more time, about 15 minutes later.
43 2021-01-13 low platelet count Minor itching on face, lower back, arms, legs, and belly. Elevated heart rate ranging from 80-95bpm.... Read more
Minor itching on face, lower back, arms, legs, and belly. Elevated heart rate ranging from 80-95bpm. I took a Zyrtec to help with symptoms at 2:00pm. It did help reduce some of the symptoms. It is presently 3:23pm and some of the itching has subsided but my heart rate is still in the 80s.
43 2021-01-19 chest discomfort 1/15/21 vaccine 10:00am 5:00 pm hives itching, chills, diarrhea, chest tightness "took Childs allerg... Read more
1/15/21 vaccine 10:00am 5:00 pm hives itching, chills, diarrhea, chest tightness "took Childs allergy medicine - had no Benadryl in house" 1/20/21 still has hives and itching
43 2021-01-26 heart rate increased Chills (followed by heavy sweating), Aches, Head aches, sore throat, indigestion, fitful sleep/ drea... Read more
Chills (followed by heavy sweating), Aches, Head aches, sore throat, indigestion, fitful sleep/ dreams, increased heart rate. The big change from dose 1 to 2 is muscle twitching. The twitches coincide with the more extreme joint aches. Sore arm All started about 9 hours after vaccine. Sore arm was mitigated with movement and stretching (as compared to the first dose). Other symptoms have lessened since 7am (19 hours after shot), but linger. Ibuprofen seems to lessen, but not end eymptoms.
43 2021-01-27 fainting, very slow heart rate Abdominal pain, diarrhea, syncope, bradycardia, fever
43 2021-01-28 fainting Patient (DOB 09/20/77) had a reaction to the Moderna Covid-19 vaccine given on 1/29/2021. On the scr... Read more
Patient (DOB 09/20/77) had a reaction to the Moderna Covid-19 vaccine given on 1/29/2021. On the screening form, patient indicated she had allergies. She verbally said she had multiple allergies and had an anaphylactic reaction previously to allergy shots received in a doctor?s office. She said she does carry an Epipen. RPh counseled on the cases of anaphylaxis with the Pfizer vaccine and recommended a 30 minute monitoring period following the vaccine in accordance with CDC guidelines. Patient agreed and received the vaccine at approximately 11:30am with instructions to check back in with RPh at 12:00pm. A few minutes later (at least 5 minutes), a friend of Patient alerted RPh that patient had fainted. The friend was able to catch patient before she fell off the chair and lower her to the ground. Patient was awake and answering questions but appeared to be having trouble maintaining consciousness. She denied shortness of breath, itching, swelling, and no rash or wheezing was evident. An Epipen was available and present but not administered due to lack of respiratory symptoms. 911 was called at 11:39am with the patient?s permission. Her symptoms remained the same until EMS arrived and she left in the ambulance at 11:57am.
43 2021-02-01 pallor was vaccinated with Moderna lot#025L20A. At 1355, shortly after arriving to observation area, he re... Read more
was vaccinated with Moderna lot#025L20A. At 1355, shortly after arriving to observation area, he reported nausea, light headedness, and "feeling like he was going to pass out". First vitals were BP 91/53 (65), 36.7, 95% and HR-74 and noted to be pale. Denies allergies or past history of issues with vaccines however does report not liking needles. After laying down for 15mins he was noted to be less pale and better able to have conversations. Repeat vitals while siting up 123/80 (93), 97%, HR-85. Pt able to eat crackers and juice. Stayed in room until 1450 then walked around for 10mins and decided to leave. Last vitals 124/90 (102). Education given to call 911 if symptoms return or anything new happens. He was also educated to let staff know about this before getting second dose.
43 2021-02-01 palpitations Telehealth phone call on 2/2/21 with provider. Patient described having mild palpitations and exerti... Read more
Telehealth phone call on 2/2/21 with provider. Patient described having mild palpitations and exertional dyspnea that is new onset without airway involvement, did not require current treatment, advised to continue to monitor, if progressing airway involvement advised to see ER care. No history of personal prior MI or CAD, not a current tobacco user.
43 2021-02-03 chest discomfort Vaccine received 1229hrs, Symptoms occurred 1247hrs Complained of upper chest tightness. and stated ... Read more
Vaccine received 1229hrs, Symptoms occurred 1247hrs Complained of upper chest tightness. and stated "feeling something in throat, upper chest tightness, flustered feeling in the head." Symptoms occurred during 15 minute post-vaccination period. EMS on-site and alerted. Per EMS, normal EKG results. Chest tightness subsided and flustered feeling subsided by 1320hrs. VSS, lungs clear, all symptoms subsided by 1333hrs - patient released.
43 2021-02-04 chest pain, palpitations tennis ball sized swollen area on left side of the chest very close to the arm pit. There is a gene... Read more
tennis ball sized swollen area on left side of the chest very close to the arm pit. There is a general constant pain which increases with movement and/or palpation. Tylenol PRN has reduced the pain but temporarily and not significantly.
43 2021-02-07 chest discomfort chills,flu like symptoms. PT presents with burning sensation in chest with tightness and SOB x Satu... Read more
chills,flu like symptoms. PT presents with burning sensation in chest with tightness and SOB x Saturday denies cough. Reports receiving 2nd moderna vaccine Tuesday prior to onset with hx of covid 10/2020. 43 yo m c/o acute atraumatic onset of substernal cp 'burning' sensation and difficulty breathing w/dry cough x24hrs states sx's feel similar to when he had COVID19 back in Oct2020; Pt states that then he was successfully tx'd w/hydroxychloriquine+azithromycin+zinc by civilian provider; initially dx'd w/covid and went in for tx after he woke up 'feeling like I was drowning' 48hrs s/p dx; Pt states burning sensation 'somewhat' similar to that episode; Pt recently received covid19 vaccine w/2nd dos
43 2021-02-07 blood clot On Wednesday 1/27 the day after my second dose I felt a minor pinch/discomfort on my lower leg. I ... Read more
On Wednesday 1/27 the day after my second dose I felt a minor pinch/discomfort on my lower leg. I did not think much of that is reason I did not report it right away. Day by day the discomfort and pain got worse. Exactly one week after my second dose I was not able to sleep due to the pain. On Wednesday 2/3 I decided to go urgent care. From there I was referred for an ultra sound a few hours after. After the ultra sound I was contacted by my doctor, letting me know that the results showed I had a blood clot on my left leg. I was put on Eliquis medicine right away. On 2/5 I was able to physically see my doctor who told me that this was caused by the second dose of the moderne vaccine that I took on 1/26.
43 2021-02-08 blood pressure increased, heart rate increased Within 30 minutes after vaccine administration, patient become sweaty, felt like his heart rate and ... Read more
Within 30 minutes after vaccine administration, patient become sweaty, felt like his heart rate and BP were elevated. He was brought to Urgent Care where he was monitored Rested and remained stable for 20 minutes.
43 2021-02-10 palpitations Patient 43 YO Asian male reported adverse reaction with the first dose of COVID Vaccine. He stated t... Read more
Patient 43 YO Asian male reported adverse reaction with the first dose of COVID Vaccine. He stated that he had heart palpitation for days, then specified x 2 days after the first COVID vaccine. He reported that, he was seen by his provider for the palpitation incident. Denied palpitation at this time at time for presenting for 2nd dose. He also was subsequently Dx with new onset hypertension as well.
43 2021-02-14 chest discomfort Baseball sized diameter swelling around injection site, red (like a rash) in color, itchy, painful t... Read more
Baseball sized diameter swelling around injection site, red (like a rash) in color, itchy, painful to touch and warm to touch. Rash looked yellow to black and blue around the edges as it progressed down the arm. Over the course of 5 days spread from injection site, around the elbow and into the forearm. Hip, knee, foot, shoulder and elbow pain on left side only, Body aches, nausea, visual impairment and loss of balance. Difficulty concentrating and relative "brain fog". Severe drowsiness in the sense of falling asleep while talking to someone and then no memory of it. Chest pressure and constant feeling of being out of breath. Cannot catch breath walking across the house from one room to the next. Severity of symptoms subsided within 24 hours, but some linger up to the time of this report. They are shortness of breath, rash with warmth and pain, lack of concentration and brain fog. Elbow still tender to touch.
43 2021-02-15 palpitations C/O panic attack, heart racing vital signs monitored, given juice
43 2021-02-17 heart rate increased Severe Muscle and joint paint started at around 2am, on 2/18. Followed by severe fatigue and troubl... Read more
Severe Muscle and joint paint started at around 2am, on 2/18. Followed by severe fatigue and trouble standing. Fever of 101.2 noted at 6pm, 2/18. Additional a high heart rate ha been noted since about 4pm, 2/18.
43 2021-02-21 chest discomfort, fast heart rate, heart rate increased Around 60 seconds after injection my left arm became heavy and tingly/numb, this then occurred in my... Read more
Around 60 seconds after injection my left arm became heavy and tingly/numb, this then occurred in my right thumb as well. I had a heavy sensation on my chest and my heart rate increased rapidly to over 120. This would then resolve slowly and then the tachycardia would recur with the odd sensation over my whole body every ten-15 minutes. EMS was called to take vitals and monitor me. Very odd feeling. I was monitored over the course of 2 hours and when I finally stood up my legs felt heavy and weak as well. After going home and resting things seemed to resolve and I was even able to go out to dinner that evening. The following week I didn't notice much of anything but new symptoms arose around 6 days later on Friday. I would feel strange feeling in my legs and a heaviness. I had a strange dizziness but not vertigo. I felt like I was in slow motion at times. This worsened and I had weakness/fatigue that reached its peak on 1/20/21 and 1/21/21. I was unable to operate on Wednesday as an orthopedic surgeon and had to cancel cases due to this weakness. I saw my doctor that day and had a battery of tests run. CMP, TSH, T4, T3, COVID, COVID IgG, Epstein Barr, Brain MRI, Neruo Consult, ANA, CK, Flu A/B, Vit B12 level, ESR, CRP, Vit D level, EKG, CXR. The following day when I awoke in the morning I felt extremely lethargic and had to cancel clinic. Over the following weeks things have gradually improved but I occasionally get some dizzy/lightheaded moments.
43 2021-02-22 heart rate increased Patient states he had a typical reaction the day of the vaccine (low fever, chills, aches, injection... Read more
Patient states he had a typical reaction the day of the vaccine (low fever, chills, aches, injection site pain) and when to bed earlier than usual because he was tired. He didn't sleep well, and this morning his sleep app indicated his heart rate during the night was between 100-110. After noticing his heart rate was between 130-140, he called the clinic and was told to go to the ER. Hospital ER administered several tests and did blood work. The MD's determined his heart was fine and it is likely vaccine related. He is home again and is feeling better (no chills, etc.) and his resting heart rate is now in the low-90's.
43 2021-02-23 blood pressure increased, heart rate increased Week after 1st dose 1/2021, Rapid/intense heart beat, severe rise in blood pressure, which contin... Read more
Week after 1st dose 1/2021, Rapid/intense heart beat, severe rise in blood pressure, which continued thru 2nd dose 2/2021 but along with new frequent fatigue/aches that seem to only go away by constantly drinking LARGE amounts of bottled waters, approx. 2 20oz every hour
43 2021-03-01 hypotension Chills @ T+12 to 13 hrs. (from time of injection). Severe nausea and resultant dehydration/dizzines... Read more
Chills @ T+12 to 13 hrs. (from time of injection). Severe nausea and resultant dehydration/dizziness/Low BP @ T+20 hrs. (lasted about 5 hrs.) Fever and body ache in the 102-103*F range throughout March 1. Overall lethargy throughout March 1. Night sweats night of 3/1 into 3/2. Laryngeal tissue damage from stomach fluids due to extremity of nausea/vomiting.
43 2021-03-02 chest discomfort 6-7 hours post injection an abnormal feeling, with chest discomfort/tightening, general malaise, fat... Read more
6-7 hours post injection an abnormal feeling, with chest discomfort/tightening, general malaise, fatigue, and pain at injection site. Took Tylenol twice throughout night and woke up feeling slightly better, but some chest discomfort persists.
43 2021-03-04 pallor Patient became pale, started sweating, got dizzy, blood pressure dropped to 106/68, but patient stat... Read more
Patient became pale, started sweating, got dizzy, blood pressure dropped to 106/68, but patient stated (after getting vaccinated) this happens to him every time he gets a vaccine. He laid down on the ground, legs were raised. He refused to let me check the BP again stating this will only drop it more. When fire rescue arrived he refused to go to the ER
43 2021-03-08 pallor Patient went very pale and limp for about 30 seconds after receiving vaccine 10 minutes prior. patie... Read more
Patient went very pale and limp for about 30 seconds after receiving vaccine 10 minutes prior. patient came to after alcohol prep pads waved under his nose, ice pack placed behind head. patient then ate and drank after coming back, vital signs were normal, B/P was 94/50, pulse 72, respirations 18, @ 850, B/P 104/56, Pulse 71, respirations 18, B/P 110-60. pulse 72 @ 913, patient's significant other called to come drive him home as patient was feeling better but not well enough to drive home. last set of vitals were @ 930 - B/P was 90/58, pulse 72, pulse ox 99%. Patient continued to be perspiring and stated he only felt weird when he looked to the right. S/O did an assessment on patient when he arrived on scene and felt ok to take him home and patient was not critical. patient was advised to go home and rest, go to ER if not feeling better or if he got worse.
43 2021-03-09 hypertension Headache and high blood pressure, symptoms resolved in one week
43 2021-03-09 fast heart rate I experienced two separate adverse reactions. First adverse reaction occurred on 2/11/21 at 5:00 a... Read more
I experienced two separate adverse reactions. First adverse reaction occurred on 2/11/21 at 5:00 am (after receiving my second shot of the Moderna Covid-19 vaccine). I experienced tachycardia with an approximate heart rate of 175 bp for approximately 30 minutes. I was able to lower my heart rate down with 25 mg of quick release metoprolol. Second adverse reaction started on 2/21/21. I developed shingles on my lower left side. It appears the shingles originated from my L1 dermatome. At the current time 2/10/21 I am still recovering from my shingles.
43 2021-03-14 loss of consciousness, pallor Patient complained of dizziness approximately 5 minutes after receiving vaccine. Experienced transie... Read more
Patient complained of dizziness approximately 5 minutes after receiving vaccine. Experienced transient loss of consciousness 2 minutes later while seated. Transferred to the floor and laid flat immediately after episode. Regained consciousness upon laying flat. Allowed to lay flat for about 10 minutes. Nurse practitioner took blood pressure after having patient sit up. Recorded as 120/80. Patient appeared pale. Encouraged to drink water. EMS arrived approx. 15min after episode. Took blood pressure and checked pulse. BP recorded as 118/84. Patient indicated that he has similar episodes prior after receiving a flu shot and having blood taken. Refused to be transported to hospital facility. Allowed to continue to rest for an additional 30 min after which he was picked up by spouse.
43 2021-03-15 fast heart rate Prior to receiving vaccine, patient was nervous and diaphoretic temperature and o2 was within normal... Read more
Prior to receiving vaccine, patient was nervous and diaphoretic temperature and o2 was within normal limits. Tolerated the administration of vaccine well. With in the 15 minutes of waiting after vaccine, became tachycardiac, SOB , and developed tremors. Sent to ED for further evaluation
43 2021-03-16 fainting Client observed kneeling by chair as diaphoretic. immediately post vaccine. I asked client if he w... Read more
Client observed kneeling by chair as diaphoretic. immediately post vaccine. I asked client if he would lie down to be assessed. Client fainted and fell to the floor and hit the back of his head on the floor. Called code team with immediate assistance. Supported head and neck. Vital signs consistent with fainting episode and stabilized within fifteen minutes. Transferred by EMS to hospital for evaluation of head injury. Initial assessment showed no immediate neurological deficits and no superficial bleeding at head impact location.
43 2021-03-16 fainting Client lightheaded post vaccination, brief vasovagal syncope, lasting about 10 seconds. No fall or i... Read more
Client lightheaded post vaccination, brief vasovagal syncope, lasting about 10 seconds. No fall or injuries, vitals stable, fully recovered in about 10 minutes time.
43 2021-03-17 palpitations 1) Started severe palpitation within minutes 2) It followed by severe dizziness and visual haziness... Read more
1) Started severe palpitation within minutes 2) It followed by severe dizziness and visual haziness 3) After doctors made me lying down on the bed, started feeling better
43 2021-03-19 heart rate increased Hives around body , heart rate high .
43 2021-03-22 chest pain Pain in the chest, left side pain reduced over last 3 days, but still there, not gone completely
43 2021-03-23 heart flutter Sore arm; Heart fluttering; Discomfort; More extreme exhaustion; A spontaneous report was received f... Read more
Sore arm; Heart fluttering; Discomfort; More extreme exhaustion; A spontaneous report was received from a consumer, concerning a 39-year old, male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced extreme exhaustion, sore arm, discomfort, and heart fluttering. The patient's medical history was not provided. Concomitant was not provided. On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 015M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient began to experience extreme exhaustion, sore arm, discomfort and heart fluttering. There was no change planned to the dosing schedule of mRNA-1273 in response to the events. The patient received their second dose on 12 Mar 2021. The outcome of the events, extreme exhaustion, sore arm, discomfort, and heart fluttering, were 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.
43 2021-03-23 fainting, loss of consciousness No issues immediately following vaccine. About 11am, mild symptoms like 99.4 degree fever, muscle a... Read more
No issues immediately following vaccine. About 11am, mild symptoms like 99.4 degree fever, muscle aches, joint pain, very mild nausea, fatigue began. Severe nausea began about 7:15pm. At 7:45pm, severe dizziness resulting in loss of consciousness and fall. Seizure Syncope event lasted 2 1/2 to 4minutes. Slow to wake. Trembling/shaking in extremities, cold sweat. Delayed speech. Paramedics were called. Went to ER at approximately 8:30pm.
43 2021-03-24 loss of consciousness About an hour after the shot I felt like I was getting the Flu. body aches, fever, fatigue, cold ch... Read more
About an hour after the shot I felt like I was getting the Flu. body aches, fever, fatigue, cold chills. I woke up the next day to go to my job and as I was standing at my closet to grab a shirt I felt like I was going to pass out. everything went black. The next thing I knew I was laying on the floor with a shirt in my hand but don't remember how I got on the floor or if I even fell. I asked my Girlfriend if she had heard me fall, She said no. I walked into the bedroom and layed back down on the bed still feeling "out of it". after what felt like a few minutes, I began Heaving like I was going to throw up but I felt like it was a dream and was very slow to react until my girlfriend told me to run to the bathroom. the whole time I was coughing up a foam.
43 2021-03-24 fainting Fainted. Denies SOB, chest pain. refused to ER. states he feels much better after 5min. History of s... Read more
Fainted. Denies SOB, chest pain. refused to ER. states he feels much better after 5min. History of same symptom in the past with needle stick. Seen and cleared by EMS
43 2021-03-29 fainting I received a shot around 9:20. About 9:25 I fainted while in the 15 minute waiting period. I was "ou... Read more
I received a shot around 9:20. About 9:25 I fainted while in the 15 minute waiting period. I was "out" long enough for 911 to be called. I "woke" up a little later, in enough time to cancel the 911 call, and regained my composer. I waited another 10 minutes and felt much better. I have had no other side effects since. I want to add that I was not nervous about the vaccination. I did not have any fear or anxiety about the shot.
43 2021-03-30 blood pressure increased Patient received Moderna vaccine #2 Left Deltoid at 1 PM. Notified First medical team at 1:05 PM re... Read more
Patient received Moderna vaccine #2 Left Deltoid at 1 PM. Notified First medical team at 1:05 PM reported left middle finger, left ring finger and left pinky numbness with digits flexed and numbness to left hand at 1:45. Grips = and strong. Has history of a 4 inch screw in the left arm that typically gets numb when the weather is cold. Had Hx Covid-19 positive in December. Had Moderna vaccine number #1 at 1 PM reports he had [pain, fever, numbness in left middle finger, left ring and left pinky when he awoke 4AM and lasted 12 hrs and resolved at 4 PM. Denies neck or shoulder medical problems. DTRs 2+ and = upper extremities. Pain 5/10. FROM neck/shoulders, wrist. Tenderness to olecranon. Arm easily irritated at ulnar groove and radial nerve. BP elevated 148/104 pulse 102. Pulse ox 97. Sensation decreased to light touch left hand and fingers, intact sensation right hand. Motor strength 5/5 b/l UE. He was instructed to take NSAID prn and report if symptoms do not resolve. Discussed Ulnar nerve irritation w/o possibly due to surgery post since he has had some symptoms of nerve irritation s/p 16 yr elbow surgery. Denies Headache, nausea, vomiting, throat swelling or other symptoms. Seen by Dr. and examined patient also with same findings.
43 2021-03-30 fainting Patient developed syncope approx. 10 min after receiving the vaccine and felt like he could vomit. ... Read more
Patient developed syncope approx. 10 min after receiving the vaccine and felt like he could vomit. EMS was called and he refused to go to hospital.
43 2021-04-01 heart flutter Heart fluttering; more extreme exhaustion; Discomfort; sore arm; Heart fluttering; Fever; This case ... Read more
Heart fluttering; more extreme exhaustion; Discomfort; sore arm; Heart fluttering; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CARDIAC FLUTTER (Heart fluttering) and the second episode of CARDIAC FLUTTER (Heart fluttering) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) 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). 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 13-Mar-2020, the patient experienced PYREXIA (Fever). On 12-Feb-2021, the patient experienced the first episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), FATIGUE (more extreme exhaustion), DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm). On 13-Mar-2021, the patient experienced the second episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). At the time of the report, last episode of CARDIAC FLUTTER (Heart fluttering) outcome was unknown, FATIGUE (more extreme exhaustion) had resolved, DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm) was resolving and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 103.3 (High) Fever for 103.3 degree. This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and non-serious expected pyrexia. Event onset on Day 2 after second dose mRNA-1273. 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. Treatment medications included ibuprofen and acetaminophen.; Sender's Comments: This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and nonserious expected pyrexia. Event onset on Day 2 after second dose mRNA-1273. 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.
43 2021-04-01 chest pain Patient complained of dizziness about 15 minutes after vaccine was administered. After another 5 min... Read more
Patient complained of dizziness about 15 minutes after vaccine was administered. After another 5 minutes symptoms progressed to include shortness of breath and chest pains. Was sent to the Emergency Room immediately.
43 2021-04-02 chest pain, heart rate increased Strong pain in left arm and left upper chest. Rapid heartbeat. Mild pain 10 minutes after shot then ... Read more
Strong pain in left arm and left upper chest. Rapid heartbeat. Mild pain 10 minutes after shot then increasing intensity. At 10-12 hours after shot unable to lift arm. At 24 hours post shot pain only present in arm. Difficulty lifting even a cell phone. At 32 hours post shot arm still tender but can lift objects. Heartbeat still elevated but not as fast as day 1. Another side effect is tiredness which began 24 hours after shot.
43 2021-04-04 chest discomfort, palpitations On my first dose vaccine, 01-22-2021, I went to bed at 9:00pm. On 01-23-2021 in the next morning I ... Read more
On my first dose vaccine, 01-22-2021, I went to bed at 9:00pm. On 01-23-2021 in the next morning I woke up with heart racing with chest pressure, felt dizzy with SOB. I called an ambulance and they performed an EKG which was normal. I went to the hospital and they did triponine values, EKG and I was released after 24 hours of monitoring. About five days later I went to see my PCP for a physical I had scheduled. He performed another EKG and this time it looked abnormal, showed I had gone into cardiac arrest and other tests, such as stress test, reactive blockages test and heart test were also performed. I had no blockage nor heart attack. I then drove home and since then I have been going to doctor's appointments. I have also scheduled a second dose of Moderna vaccine in three to four weeks.
43 2021-04-07 loss of consciousness sweating reports ringing in ear passed out for less than a minute Given 1 dose of epi to Right Thigh
43 2021-04-08 heart rate increased, heart rate irregular Two nights in a row, 04/07 and 04/08, woke up with rapid heart rate (fluctuating from 85-110 bpm) an... Read more
Two nights in a row, 04/07 and 04/08, woke up with rapid heart rate (fluctuating from 85-110 bpm) and felt dizzy, fatigued, feverish, sweaty, shaky and about to pass out. Could have been hyperventilating in sleep because of rapid heart rate. Required about 2 hours of attention to reading, yoga and relaxation to get to sleep. On morning of 04/08, heart rate was still high (78-95) for resting, which is usually in the 50s or 60s. GI disturbance led to frequent bowel movements and the whole condition resulted in malaise and feeling of impending doom. A feedback from acute anxiety as a result of symptoms could be involved. Also involved is the diphenhydramine I took at 9 pm on 04/07 to treat hay fever and acute insomnia. Night if 04/08 was more manageable. But it interrupted sleep with strong disturbances that felt like spasms in prefrontal cortex coming out of sleep. More likely it was movement in sinus congestion that triggered a startle response while exhausted from work. It was bad timing to have the shot during a very busy work week.
43 2021-04-08 pallor Client received the COVID vaccine (Moderna, 1st dose, lot #041AB21A, exp. 5/6/2021) at 1527. EMT ob... Read more
Client received the COVID vaccine (Moderna, 1st dose, lot #041AB21A, exp. 5/6/2021) at 1527. EMT observed the client to be pale and diaphoretic; he and RN responded at 1532. The client complained of dizziness, feeling clammy, and ringing in his ears, as well as spotty vision. His vital signs were as follows: blood pressure 96/78, heart rate 50, respiratory rate 20, and O2 99%. The client stated that he has hypertension and he takes losartan. He takes no other medications, has no other medical conditions, and has no allergies that he is aware of. The client was alert and oriented, and his pupils were equal and reactive to light. He stated that he ate breakfast and a snack at 11 am, but nothing for lunch. The client was offered water. At 1536, the client complained of tingling in his arms and numbness in his tongue. His color had returned to normal. No difficulty breathing, no swelling observed around his mouth or tongue, no complaint of metallic taste. Repeat vital signs were as follows: blood pressure 110/80, heart rate 87, O2 99%. He refused benadryl. At 1541, the client stated that his tongue was no longer numb but his arms were still tingling. He was less diaphoretic. His vital signs were as follows: blood pressure of 116/82, heart rate of 92, respiratory rate 14, and O2 97%. At 1545, the client stated he was no longer dizzy and his symptoms had resolved. Education provided regarding, emergency response and AMR activation, and primary care follow up. At 1550, the client was able to stand up and walk without any dizziness or feeling lightheaded. At 1558, the client's repeat vital signs were as follows: blood pressure 140/99, heart rate 99, respiratory rate 16, and O2 97%. The client was escorted outside by the EMT, and stated he was walking across the parking lot to get some food to eat before returning home. The client left the facility ambulating with a steady gate.
43 2021-04-09 blood pressure increased, heart rate increased Elevated BP and Heart Rate. BP was 155/95 and beats per minute was over 120
43 2021-04-10 blood clot Blood clots both times in left leg after each dose. Emergency room visit required
43 2021-04-11 pulmonary embolism on 4-6, developed upper thoracic back pain. went to ED, Dx with pumonary embolism.
43 2021-04-11 troponin increased On the evening of Friday 4/2/2021 around 9:30 PM, I was experiencing what felt like heartburn. It go... Read more
On the evening of Friday 4/2/2021 around 9:30 PM, I was experiencing what felt like heartburn. It got better before I went to bed. At around 9:00 AM on Saturday 4/3/2021, I was awakened by intense pain and pressure that felt like the worst heartburn I'd ever experienced. After OTC heartburn treatments didn't help, at around 11:00 AM I went to the local ER where I was initially diagnosed as having a heart attack. After being given some baby aspirin and a nitro tablet, I started feeling better and was airlifted immediately to a nearby cardiology unit at another hospital. A heart catheterization and EKGs determined that I had not had a heart attack, but instead had takotsubo cardiomyopathy. I was admitted into the cardiac ICU overnight for observation, transferred to a non-critical room the next day (4/4/2021), and released on Monday 4/5/2021.
43 2021-04-12 heart rate decreased, excessive bleeding, loss of consciousness without warning and approximatly 5 minutes after patient recieved vaccine patient passed out and fel... Read more
without warning and approximatly 5 minutes after patient recieved vaccine patient passed out and fell face first onto floor. patient was approached lying face down on floor bleeding and sounds of gurgling coming from patient patient was unreponsive. When patient was brought around and returned to conciousness patient did not know where he was or what had happened. Patients pulse was very low at 58 and dropping to as low as 39. Patient pulse did not stabilize the entire time patient was under our care. Patient had about a inch and a half laceration about eye and possible facial fracture. It was noticed that patients face was swollen when leaving with ambulance to be transported to er.
43 2021-04-12 lightheadedness Vasovagal event, change in level of consciousness, reports feeling tired. Pt transferred to WC to gu... Read more
Vasovagal event, change in level of consciousness, reports feeling tired. Pt transferred to WC to gurney. Pt reported feeling better after laying down for some time.
43 2021-04-12 fainting Fainting for about 30 seconds to a minute in the bathroom; Feeling dizzy; Could not stand for a whil... Read more
Fainting for about 30 seconds to a minute in the bathroom; Feeling dizzy; Could not stand for a while when fell; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 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. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell). On 07-Apr-2021 at 4:00 AM, the patient experienced SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) (seriousness criterion medically significant). On 07-Apr-2021, DIZZINESS (Feeling dizzy) and DYSSTASIA (Could not stand for a while when fell) had resolved. On 07-Apr-2021 at 4:01 AM, SYNCOPE (Fainting for about 30 seconds to a minute in the bathroom) had resolved. No concomitant medications were reported. Treatment included for the events was acetaminophen. Patient reported that he felt dizzy and fainted for about 30 seconds to 1 minute in his bathroom at around 4:00 am this morning after receiving his second dose of the vaccine yesterday on 6 April 2021.Also, he could not stand for a while when fell. The patient took energy drink. Patient confirmed that the symptom was one time and it has not come back.; 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.
43 2021-04-14 chest discomfort, hypertension, fast heart rate Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Medium, Additional Details: OSat: 92 Respiratory Rate: 22 Temperature: 97.5 F Blood Pressure: 135/93 Pulse 117
43 2021-04-14 deep vein blood clot Patient began experiencing pain in his right leg on 4/5, sought treatment at walk-in clinic on 4/12.... Read more
Patient began experiencing pain in his right leg on 4/5, sought treatment at walk-in clinic on 4/12. Healthcare provider he saw sent him to ultrasound at a medical center, who then referred him to the emergency deptartment. Patient was diagnosed with a DVT and prescribed Eliquis 10 mg BID x7 days then 5 mg BID for 6 months.
43 2021-04-14 hypertension SORE THROAT RININGING IN EARS HEADACHE HYPERTENSION PATIENT SELF TRANSPORTED TO EMERGENCY ROOM REF... Read more
SORE THROAT RININGING IN EARS HEADACHE HYPERTENSION PATIENT SELF TRANSPORTED TO EMERGENCY ROOM REFUSED EMS TRANSPORT
43 2021-04-17 fast heart rate symptoms: dizziness, diarrhea, mid epigastric pressure vitals : tachycardia, leukocytosis admitted f... Read more
symptoms: dizziness, diarrhea, mid epigastric pressure vitals : tachycardia, leukocytosis admitted for monitoring and IVF
43 2021-04-18 lightheadedness vasovagal reaction with dyspnea
43 2021-04-20 deep vein blood clot Had first COVID-19 shot on 03/18/2021. 04/06/2021 started to have right lower leg pain. Was seen at ... Read more
Had first COVID-19 shot on 03/18/2021. 04/06/2021 started to have right lower leg pain. Was seen at urgent care were and xray was done that was negative. Urgent care doctor sent him for ultrasound right lower leg on 04/10/2021 which was negative. He was started on antibiotics and Prednisone. Was seen by PCP whom felt he needed to be seen by vascular. He was seen by Dr. on 04/16/2021 who felt it was a pulled muscle, but he want a repeat ultrasound of right lower leg done. 04/19/2021 ultrasound of right lower leg was done and showed a DVT. He was started on low does baby aspirin 81mg. A follow up ultrasound was ordered for 04/26/2021 to check status of DVT.
43 2021-04-22 blood glucose increased SWELLING, PAIN, GRADUALLY WORSENING. DEVELOPED AN ABSCESS OVER LEFT UPPER BACK IN SCAPULAR AREA. C... Read more
SWELLING, PAIN, GRADUALLY WORSENING. DEVELOPED AN ABSCESS OVER LEFT UPPER BACK IN SCAPULAR AREA. CT SCAN, ABSCESS INCISION & DRAINAGE & PACKING, STARTED ON ANTIBIOTICS. DIAGNOSED WITH SEPSIS ALSO. ALSO BLOOD SUGAR FOUND TO BE 400 WITH NO PRIOR HISTORY OF DIABETES
43 2021-04-22 chest pain, pulmonary embolism, coughing up blood Initial reaction after the injection: Sore left shoulder, stiffness that continued for 2 days 04/12/... Read more
Initial reaction after the injection: Sore left shoulder, stiffness that continued for 2 days 04/12/2021 The patient went to the ER for left chest pain 04/15/2021 Chest CT obtained with pleuritic chest pain diagnosis CTA report: several pulmonary emboli in the left lower lung with lingular infiltrates; 04/15/2021 - 04/16/2021 admission to Hospital ER for pulmonary embolism and infarction 04/15/2021 admitted to hospital for observation for pulmonary emboli with hemoptysis He was started on Eliquis which he has tolerated. There was hemoptysis during this time and after admission. He experienced an increase in left-sided pleuritic pain followed by improvement after being on the Eliquis for several days. He continues to have discomfort with deep inspiration however asymptomatic with regular breathing and has been able to return to many of his routine activities. Started Eliquis 10mg twice daily x7 days, followed by 5 mg twice daily
43 2021-04-24 loss of consciousness Client had a loss of consciousness for 2-3 seconds while waiting in observation area after receivin... Read more
Client had a loss of consciousness for 2-3 seconds while waiting in observation area after receiving vaccine. Reported feeling "tightness in jaw" just prior to LOC. Moved via wheelchair to EMS care on clinic site, placed in supine position on cot. 0940-BP-118/71. Reported h/o "passing out after vaccines". Felt fine within a few minutes and departed clinic accompanied by his wife after 30minutes.
43 2021-04-25 loss of consciousness Patient stated feeling dizzy after getting vaccination. than patient felt hot and ice pack and fan s... Read more
Patient stated feeling dizzy after getting vaccination. than patient felt hot and ice pack and fan stated. Patient BP taken 104/68, 55 Pulse, 20 R at 10:08 am. Shortly afterwards patient black out and Nurse to get safely guide patient to floor, raised feet on chair and secured head up and continue to supply ice pack and fanning. Patient stated seizure activity and Nurse administered Epi injection to control seizure that last only 30-45 seconds and stop. BP taken after seizure and EPI injection 171/93, 65 pulse, 20 R, 98% sat. Patient stated talking and color stated coming back and 911 was called and patient remain on floor talking as we fan continue ice packs on him. Pulse ox 98%, R 18 and
43 2021-04-26 chest pain Headache / fever of 102/ joint and muscle ache and fatigue left lung pain and upper left chest pain
43 2021-04-27 chest discomfort Day of shot slight dizziness and weakness, second day minimal adverse reactions; slight chills, 3rd ... Read more
Day of shot slight dizziness and weakness, second day minimal adverse reactions; slight chills, 3rd day (early morning) total body aches and pains, nausea and major dizziness; full body chills, extreme loss of strength; site of shot internal and external pain leading up to the back of neck, 4th day complete incapacitation uncontrollable shacking from chills; bones ached; constipation; nausea without ability to vomit; 5th day same effects if not worse; still unable to vomit but feeling of endless need to stuck in upper chest, 6th day chills begin to break and body pain subsiding; still weak and dizzy with major headaches, 7th day chills are almost completely gone, body (muscles, tendons, etc) ridiculously tight and aching from the constant shaking from chills and restless sleep over 7 days. Lots and lots of liquids from day 1; day 4 started taking minimal acetaminophen to ease pain and feelings of fever. Temperature never went above 96degrees. Small portioned meals to get nutrients, and constant liquids to stay hydrated. This did not relieve any symptoms, until night 7 when pain started to subside. Constant stretching now to release the constricting of all my muscles and tendons over the course of side effects. Still constipated and slight nausea, still weak in strength.
43 2021-04-27 loss of consciousness Vital signs 108/61 pulse 71 pulse ox 100%,; ED Note: 43 y.o. male otherwise healthy presents to the ... Read more
Vital signs 108/61 pulse 71 pulse ox 100%,; ED Note: 43 y.o. male otherwise healthy presents to the ED with syncope s/p second Moderna Vaccine, onset 1530 this afternoon. Patient reports after receiving the shot, he felt a burning sensation to the injection site on his left arm. He then explains that he began losing his peripheral and ended up losing his vision. Patient then initially felt better but notes he got bad real fast. He mentions he ended up losing consciousness but is unsure for how long. He reports a history of syncope following blood draws but never before with vaccinations. Patient states when he woke up, he felt sweaty, clammy, and nauseous. He notes he currently feels fine otherwise and denies any chest pain, shortness of breath, or palpitations. He denies having any symptoms following administration of the first dose of the Moderna Vaccine. evaluated the patient at bedside and the patient has verbalized agreement and understanding to the plan at this time of discharge without further questions. The patient is comfortable with further observation of his symptoms at home. I discussed our workup, answered all questions and made sure there were no other concerns. I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.
43 2021-05-01 fainting, heart flutter, heart rate increased, lightheadedness Rapid heart beat fluttering feeling. Tiredness. Emergency room ECG tested negative. Addition ECG and... Read more
Rapid heart beat fluttering feeling. Tiredness. Emergency room ECG tested negative. Addition ECG and stress testing at a cardiologist revealed an otherwise health heart. ECG and 24 hour heart minor revealed an ?extra heat beat? development never previously experienced.
43 2021-05-02 heart failure, ejection fraction decreased, fainting Patient reported fevers, chills and myalgia after 1st dose of Moderna COVID vaccine 4/22. Poor PO in... Read more
Patient reported fevers, chills and myalgia after 1st dose of Moderna COVID vaccine 4/22. Poor PO intake and had syncopal episode on 4/24 when standing from the recliner. Initially admitted at hospital, and developed fever, leukocytosis, AKI. Transferred to other hospital for further evaluation and eventually developed acute hypoxic respiratory failure requiring intubation and mechanical ventilation, found to have new onsert heart failure with reduced ejection fraction. He is currently being evaluated for auto-immune and underlying infectious causes, with concern for glumerunephritis, cardiomyopathy and coronary artery disease. Patient extubated to NC as of today but remains in the ICU.
43 2021-05-02 chest pain Fever/chills, decreased appetite. ED visit for chest pain day 3 post vaccination
43 2021-05-06 chest discomfort Patient developed shortness of breath/chest tightness ~15 minutes after receiving second shot. Calle... Read more
Patient developed shortness of breath/chest tightness ~15 minutes after receiving second shot. Called paramedics who assessed the patient and referred to urgent care. Patient's blood pressure measured ~15 minutes post vaccination was 134/86 and HR 91.
43 2021-05-08 blood clot 2-3 days after the first injection, I developed a blood clot in my lower right leg.
43 2021-05-10 chest discomfort Patient works third shift, so he sleeps during the day and went to bed after his first dose. He woke... Read more
Patient works third shift, so he sleeps during the day and went to bed after his first dose. He woke up about 4 hours after his first dose with a "chest spasm". He said it lasted about 30-40 minutes before it subsided. (He also experienced chills and sweating around the same time, which subsided after ~8-10 hours.)
43 2021-05-11 chest discomfort, palpitations Patient by 5/8/21 was experiencing fever to 103, lower back pain, palpitaitons, headache, nausea, le... Read more
Patient by 5/8/21 was experiencing fever to 103, lower back pain, palpitaitons, headache, nausea, left arm and neck pain and dizziness. He was taking Advil and Tylenol to assist with symptom managment. Left arm and neck pain persisted. On the morning of 5/11/21 he awoke with central chest tightness, left arm/shoulder/neck achiness, nausea and headache. During ride to hospital, he had palpitations for 30 minutes. He arrived at Medical Center where he was found to have a positive troponin I of 4.2 (ULN of <0.045). Echo done at that time showed EF of 59% with basal inferior, anterolateral hyokinesia, basal inferolateral hyokinesia, mid inferolateral hyokinesia, diastolic LV function normal function for age and trace mitral regurgitation. ECG showed non diagnostic ST elevations in leads II, III, AVF. The patient was transferred to another Medical Center for urgent cardiac cath based on resting chest, arm and neck pain, positive troponin and wall motion abnormalities seen on echo. Cardiac cath found normal coronary arteries that were free of disease. Troponin I at this medical center was positive 0.31 and 0.39. Further testing ordered is a cardiac MRI to assess for possible acute myocarditis.
43 2021-05-11 fainting FELT DIZZY AND FAINTED. CALLED 911. WAS ABLE TO RECOVER BEFORE 911 ARRIVED
43 2021-05-13 heart failure Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in M... Read more
Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center
43 2021-05-18 chest discomfort, pulmonary embolism Pt admitted to facility on 5/18 with shortness of breath, chest tightness and was found to have bila... Read more
Pt admitted to facility on 5/18 with shortness of breath, chest tightness and was found to have bilateral pulmonary embolism and mild patchy scattered groundglass opacities . Pt reportedly received 1st dose of Moderna COVID vaccine '2 weeks ago' (not vaccinated at this facility). Pt reportedly tested positive for COVID 1 week later (also not at this facility) and was also COVID positive on presentation here on 5/18. Admitted to ICU and currently being treated with Remdesivir, dexamethasone and enoxaparin for anticoagulation. Pt reportedly does have history of DVT/PE in past in 2012.
43 2021-05-18 lightheadedness Vasovagal event 5 minutes after administration. Chart note: pt was siting in waiting room and st... Read more
Vasovagal event 5 minutes after administration. Chart note: pt was siting in waiting room and states he started to feel like he was going to pass out, he stood up to talk to receptionist at window and had vagal response and fell back against wall and slid to floor. He was sitting up, diaphoretic but responsive when provider arrived to waiting room. 911 was called; had him sit for a couple minutes then moved him to wheelchair and had him lay down on table with assistance, ice packs applied to neck and head and manual BP taken and was 96/54, pulse of 50, pulse ox 92% placed oxygen 4 L NC and pulse ox raised to 100%, pt felt better, pulse still running 46-52 on pulse ox, EKG machine attached and pt repeat BP 102/62. ekg done and reviewed no acute cardiac concerns.Paramedics came and pt feeling better, they did orthostatic testing and pt BP was consistently over 106/60's, heart rate up to 68 they then walked pt and his wife outside to discuss transportation to ER for evaluation. Patient refused transport to ED and opted to go home.
43 2021-05-18 fainting PATIENT FAINTED FEW MINUTES AFTER RECEIVING VACCINE, HOWEVER REGAINED CONSCIOUSNESS
43 2021-05-21 loss of consciousness PATIENT WAS UNRESPONSIVE ABOUT 5 MINUTES AFTER VACCINATION... PATIENT RED FACED AND NOT RESPONDING ... Read more
PATIENT WAS UNRESPONSIVE ABOUT 5 MINUTES AFTER VACCINATION... PATIENT RED FACED AND NOT RESPONDING TO QUESTIONS... PATIENT THRUST BOTH ARMS DOWN TO HIS SIDE AND TRIED TO GASP IN A BREATH OF AIR... 911 CALLED AND 1 EPIPEN INTRAMUSCULAR INJECTION GIVEN INTO LEFT THIGH. PATIENT WAS TALKING AND ABLE TO DRINK WATER WHEN PARAMEDICS ARRIVED. HE DIDN'T REALIZE THAT HE HAD "PASSED OUT"... AS PARAMEDICS WERE LIFTING PATIENT TO GURNEY, PATIENT LOST CONSCIOUSNESS AGAIN... WHEN HE CAME TO, HE DID NOT KNOW WHERE HE WAS.
43 2021-05-22 cardiac arrest Cardiac arrest
43 2021-05-23 hypotension, fainting patients fainted, low blood pressure, transported for follow up
43 2021-05-23 fainting Patient fainted after receiving first dose of moderna, patient came to immediately with no confusion... Read more
Patient fainted after receiving first dose of moderna, patient came to immediately with no confusion, he was able to answer all questions
43 2021-05-25 fainting Syncope, Dizziness. Pt reported symptoms of dizziness after vaccination that did not improve in obs... Read more
Syncope, Dizziness. Pt reported symptoms of dizziness after vaccination that did not improve in observation. Pt taken to private observation room. BP 133/76, HR 77, RR 16 -- > 133/75, 76, RR 16. Pt laying on bed communicating and resting. Pt symptoms resolved and pt was released from the vaccination site.
43 2021-05-25 blood clot "Moderna COVID-19 Vaccine. Vaccine on 2/25. Took him to an urgent care on 3-7 because of swollen ... Read more
"Moderna COVID-19 Vaccine. Vaccine on 2/25. Took him to an urgent care on 3-7 because of swollen ankle, foot and lower leg. Had xray but nothing was broken. thought he had sprained ankle. Given prednisone. Ankle continued to be swollen for following days so we followed up with family dr. on 3-22 who sent him for ultrasound which showed an extensive blood clot - DVT. Sent to emergency room. Put on blood thinner shots for a week and sent to doctor on 3-24. He did many blood tests. He started eliquis on 3-30. Saw doctor again on 4-13. His blood tests had shown he has Factor 5--Leiden. On May 11 we saw doctor again. Remain on Eliquis. Another ultrasound and more bloodtests show clot is chronic, but blood thinner is doing its job. No active clotting.
43 2021-05-29 pulmonary embolism Hundreds of pulmonary emboli in both lungs. Infarcture in left lung
43 2021-05-30 loss of consciousness Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out a few minutes after... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out a few minutes after receiving the shot, and hit his head when falling over. He quickly came about. First aid was provided. No sign of confusion.
43 2021-05-31 fainting Syncope; Fall; Head injury; Hyperhidrosis; This regulatory authority case was reported by an other... Read more
Syncope; Fall; Head injury; Hyperhidrosis; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 43-year-old male 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 information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), FALL (Fall), HEAD INJURY (Head injury) and HYPERHIDROSIS (Hyperhidrosis). At the time of the report, SYNCOPE (Syncope), FALL (Fall), HEAD INJURY (Head injury) and HYPERHIDROSIS (Hyperhidrosis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Vital signs measurement: consistent with fainting episode (abnormal) Vital signs consistent with fainting episode and stabilized within fifteen minutes.. 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 medication use was reported. Treatment information was not reported. On 17Mar02021, it was noted by the reporter that the patient was observed kneeling by a chair as diaphoretic immediately post vaccine. The reporter asked the patient if he would lie down to be assessed. The patient then fainted and fell to the floor, hitting the back of his head on the floor. The code team was called for immediate assistance. The patient's head and neck were supported. The patient's vital signs were consistent with fainting episode and stabilized within fifteen minutes. The patient was transferred by EMS to the hospital for evaluation of head injury. It was noted by the reporter that the initial assessment showed no immediate neurological deficits and no superficial bleeding at head impact location on the patient. Further clinical course is unknown/not reported at this time.; 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.
43 2021-06-03 oxygen saturation decreased Patient was sent out to the hospital on Wednesday night (June 2) due to a decrease in oxygen saturat... Read more
Patient was sent out to the hospital on Wednesday night (June 2) due to a decrease in oxygen saturation levels. He was admitted into the ER with a diagnosis for recurrent seizures. Patient has a history of seizures, but a facility worker mentioned that the seizures did not look like the ones he would have.
43 2021-06-03 pulmonary embolism Blood clots in both lungs; Feels really tired all the time; Joints hurt; This spontaneous case was r... Read more
Blood clots in both lungs; Feels really tired all the time; Joints hurt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Blood clots in both lungs) in a 43-year-old male 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 Acid reflux (esophageal) and Retinal migraine. Concomitant products included RABEPRAZOLE SODIUM for Acid reflux (esophageal), METOPROLOL for Retinal migraine. 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 03-Mar-2021, the patient experienced FATIGUE (Feels really tired all the time) and ARTHRALGIA (Joints hurt). On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in both lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-Apr-2021 to 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Blood clots in both lungs) and ARTHRALGIA (Joints hurt) outcome was unknown and FATIGUE (Feels really tired all the time) had not resolved. 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. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains no new information.; 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.
43 2021-06-06 ventricular tachycardia Serve flu like symptoms made myself feel very fatigued, tired, didn't want to do anything, had pulsa... Read more
Serve flu like symptoms made myself feel very fatigued, tired, didn't want to do anything, had pulsation in the arteries ( left upper chest ) right lower calve and on right arm ) was seen and chest x-rays were order and a venous doppler was order.
43 2021-06-07 chest pain I received the first shot on 04/20/2021 Moderna 047B21A in the left arm around 04/23/2021 I had serv... Read more
I received the first shot on 04/20/2021 Moderna 047B21A in the left arm around 04/23/2021 I had serve side effects. So much like the flu, I was very tired, nausea, fatigue, In my upper left chest the "vein" or "arteria" was in pain ( sending shocker's like electrodes ) it almost felt like having a stroke or heart attack ( never experienced one before though ) didn't want to move do anything I didn't continue working at restaurant hired part time there as a prep-cook. I didn't even show up. The second shot Moderna 024C21A I received 05/18/2021 it had the same effect and I also had the "veins" and "arteries" on my right arm and right leg calve same effect shockers and electrodes like I was having a heart attack.
43 2021-06-08 loss of consciousness, oxygen saturation decreased ANAPHYLAXIS: Pt received his second Moderna COVID19 shot on 12Apr2021 at approximately 2:30pm. He wa... Read more
ANAPHYLAXIS: Pt received his second Moderna COVID19 shot on 12Apr2021 at approximately 2:30pm. He waited the required 20 minutes to check for any adverse reaction and then left the facility to drive home. On his drive home, at approximately 3:30pm, he started feeling light headed and lost consciousness, striking a telephone pole. He was gasping and struggling to breathe, so the ambulance treated him with oxygen. When he arrived at the ER , the doctor assessed his condition and confirmed that he was experiencing an anaphylactic reaction related to the COVID vaccine and treated him with an epinephrine injection, steroids, benadryl, and nebulized albuterol.to open his airways. He remained at the ER for ~ 6 hours for observation until his blood oxygen levels increased and he was stable to be released. The car accident resulted in PT suffering a fractured sternum as confirmed via Chest CT Scan by his primary doctor. PT has no history of any allergic reaction to any medication or vaccine. Although he does have well-regulated asthma, this incident was not characteristic of any asthma-related reaction he has ever experienced.
43 2021-06-10 heart rate increased, hypertension About 45 mins after getting the shot. I experienced a tightening of the face with hives. It felt li... Read more
About 45 mins after getting the shot. I experienced a tightening of the face with hives. It felt like the last time I got a bee sting and found out I was allergic to bees. My neck musscles where tight but it was not enough for me to take my epi pen I slepped until 5-19. only awake for about 6 hours a day. When I normally sleep that much. Then on 5-19. Around noon time I woke up and was able to stay awake. I was experiencing fast heart rates from time to time. Still very tired. I was drinking about 32 ounces of water an hour. Then on friday 5-21. The heart issues where very severe and I went to the Emergency room. They gave me an iv bag of fluid and I felt better but still had minnor heart fast rates from time to time. I still felt off. and had a follow up with my primary dr. During the visit he observed high blood preasure of around 144/90. Currently i am observation phase and purchased a blood pressure monitor. According to the over the counter blood pressure monitor . I have been as high as 152/106 and slowly over time it has gone down to as low as 79/58. With more of an average currently holding around 122/80. The monitor has detected two irregular hearbeats with bp stat(138/82, 82bp anb 79/58, and bp 76. I will continue to monitor and report these self monitoring finding to my primary DR on 7-6. I left a message today about updates.
43 2021-06-10 loss of consciousness PATIENT PASSED OUT AFTER RECEIVING VACCINATION. EMS WAS CALLED AND TOOK PATIENT TO HOSPITAL VIA AMB... Read more
PATIENT PASSED OUT AFTER RECEIVING VACCINATION. EMS WAS CALLED AND TOOK PATIENT TO HOSPITAL VIA AMBULANCE.
43 2021-06-10 palpitations About 2 weeks after getting my second vaccination, I started to have mild but then severe heart palp... Read more
About 2 weeks after getting my second vaccination, I started to have mild but then severe heart palpitations. I thought it was the anxiety meds I was on, and adjusted the dosage but it wasn't helping. I stopped taking them. After about a month I started gradually feeling better. Palpitations would worsen if I worked out and or stood up too fast. Today my PCP and I scheduled for me to see a Cardiologist at the end of June. My PCP did some tests that included an EKG after first 6 weeks which was normal. She also did a troponin test, which was also normal. A CRP and Sed rate which were also normal. I still struggle with heart palpitations to this day.
43 2021-06-13 pulmonary embolism, deep vein blood clot, loss of consciousness, fainting Pain in leg presented several weeks after second shot. Symptom was dismissed until loss of consciou... Read more
Pain in leg presented several weeks after second shot. Symptom was dismissed until loss of consciousness/fainting occurred. Onlookers called 911 and after being transported to hospital CT scan revealed bilateral pulmonary embolisms and DVT blood clots were present. D-dimer blood test revealed a range 400 times the appropriate range. Number exceeded the scale. The number of clots on imaging were so numerous, the doctor that read the report said they would not even count them. Was treated on heparin IV and placed in cardiac ICU, prescribed Eliquis to thin blood allowing the body to not create additional clots. In process of establishing a medical team to treat.
43 2021-06-14 hypertension Nausea, vomiting, strong headache, muscle pain, fever, chills, high blood pressure (154/87), no high... Read more
Nausea, vomiting, strong headache, muscle pain, fever, chills, high blood pressure (154/87), no high blood pressure history
43 2021-06-15 heart failure, chest pain, inflammation of the pericardium Pericarditis, plural effusion, cardiac tamponade, heart failure, pneumonia.
43 2021-06-15 palpitations, chest pain, chest discomfort Felt lethargic (aprox. 1 hour after shot) went home fell asleep for about 2 hours and woke up severe... Read more
Felt lethargic (aprox. 1 hour after shot) went home fell asleep for about 2 hours and woke up severe pain in chest and tightening of chest and airway and could only get about half at most of a full breath of air every breath. Could only get sufficient O2 it seemed when lying on back and laying down on my side. Was every bit of all my energy to just take a shower and nearly blacked out with heart racing as I tried to breath in the shower but steam in air was too much to breathe. Lasted for 4 days that way. I still feel like I am constantly winded and I as of today have only regained about half the lung capacity I had prior to incident, and that is just over 1 month mark. I also now have been getting these bad facial breakouts particularly on and around my nose and forehead /;eyes area. I never ever had any acne issues to speak of prior, even as a teen and during puberty. Never had any acne ever and now its bad breakouts some appear to may even leave ling term scarring in certain spots. My day to day diet and normal habits have not been added to or altered in any way either. My heart feels like it beats twice as fast and twice as hard now and I am always short of breath now too. I do not have a family doctor to go and see and I was afraid to call for an e.m.t. or go to the e.r. at the early onset of it all. I truly hought I was a gonner a couple of times though throughout the first 4 days.
43 2021-06-16 loss of consciousness I woke up at approx. 3AM to urinate. I began to black out as I was standing and caught myself before... Read more
I woke up at approx. 3AM to urinate. I began to black out as I was standing and caught myself before I fell. I then attempted to walk about 40 feet to get water and food and i proceeded to completely lose consciousness about 5-7 times. I fell from fully standing and hit my face on the ground. for about two or three hours I ran a fever, though I don't know how high seeing as every time I tried to stand I'd lose consciousness. I we
43 2021-06-16 palpitations Heart palpitations started 4/11/21 and have continued consistently to this reporting date.
43 2021-06-17 pulmonary embolism, chest discomfort Patient was seen once in my office complaining of persistent shortness of breath and chest tightness... Read more
Patient was seen once in my office complaining of persistent shortness of breath and chest tightness of sudden onset that happened few days after receiving second dose of covid vaccine. A CT angiogram ordered showing pulmonary embolism. Diagnosis made more than 10 weeks after vaccination. symptoms appeared in less than one week.
43 2021-06-21 troponin increased, inflammation of the heart muscle, chest pain Chest pain/ shortness of breath caused patient to go to the ER and was admitted with elevated tropon... Read more
Chest pain/ shortness of breath caused patient to go to the ER and was admitted with elevated troponin levels, had cardiac cath that was normal, diagnosis was myocarditis. Started on metoprolol and full aspirin with cardiology follow up. Colchicine added and symptoms resolved but then he developed drug reaction rash and it has to be stopped
43 2021-06-24 deep vein blood clot, pulmonary embolism Patient developed a DVT in left calf that resulted in multiple pulmonary embolisms; patient complain... Read more
Patient developed a DVT in left calf that resulted in multiple pulmonary embolisms; patient complained of shortness of breath x 2 weeks and presented with a swollen and discolored lower leg. X-rays and scans confirmed DVT and PE's. Patient underwent thrombectomy and was on Heparin drip followed by Eliquis at home. Patient discharged from ICU after 3 days.
43 2021-06-24 pulmonary embolism Notified on 6/16 /2021 patient died. Death by PE 1 month after prime dose of Moderna-since unexpecte... Read more
Notified on 6/16 /2021 patient died. Death by PE 1 month after prime dose of Moderna-since unexpected- reported to VAERS
43 2021-06-30 deep vein blood clot Pt developed large lower extremity DVT
43 2021-07-01 chest pain Acute chest left side pain, like a pen pushed in left side of upper body towards heart.
43 2021-07-03 heart rate increased MODERNA COVID-19 VACCINE EUA Rapid Heart, Dizziness, Unbalance, Wheezing, Lower Intestinal Bleeding... Read more
MODERNA COVID-19 VACCINE EUA Rapid Heart, Dizziness, Unbalance, Wheezing, Lower Intestinal Bleeding, Constipation, Irritability
43 2021-07-05 chest pain Patient experience sharp jabbing pain in left lower chest below the nipple line after vaccination. P... Read more
Patient experience sharp jabbing pain in left lower chest below the nipple line after vaccination. Patient reported that pain was coming and going
43 2021-07-07 chest pain, chest discomfort Day after pain in the area of my lung scar and under arm , skin rashes as well in chest, they come b... Read more
Day after pain in the area of my lung scar and under arm , skin rashes as well in chest, they come back and then it was fine for a while but recently in June with Heatwave 1 and currently heatwave2- I felt horrible pressure and pain in my chest and could not breath and the nebulizer wasnt helping. I got an xray and the doctor at the City Md refused to believe me that this was related to vaccine and my lung wound from a previous surgery that increases inflammation as I am now experiencing. I am asking to please help me get a cooling airc conditioner in my kitchen/ bathroom area as it is also where I will be teaching virtually hybrid schedule and only feel relieved in cool air. My school that I teach at is in some rooms adding daily heat exhaustion and I would greatly like if possible any help or treatment and or rehabiliation phyical therapy and also reexamining the area where my origial surgery was and how this can be dangerous for people taking the vaccine.
43 2021-07-09 chest pain Mild intermittent chest pain, left and right sides at different times. Started within a day or so o... Read more
Mild intermittent chest pain, left and right sides at different times. Started within a day or so of receiving vaccine, lasted approximately 3 weeks. Advised by clinic to go to ER. EKG, X-ray and blood draw results were all normal.
43 2021-07-10 heart rate increased Rapid Heart Beat Blurry Vision High Fever - Approaching 2 weeks Strong Dizziness/Vertigo Rashes Week... Read more
Rapid Heart Beat Blurry Vision High Fever - Approaching 2 weeks Strong Dizziness/Vertigo Rashes Week long Headaches Hard to breath Ringing in ears Deep ache/pain in leg & arm with leg swelling
43 2021-07-12 heart rate increased Numbness in extremities. Primarily in legs and fee. Also rapid heart rate. Lasted for a few weeks... Read more
Numbness in extremities. Primarily in legs and fee. Also rapid heart rate. Lasted for a few weeks. Some periodic numbness still
43 2021-07-15 palpitations Approximately after one week of my second dose I began having heart palpitations. Over the course of... Read more
Approximately after one week of my second dose I began having heart palpitations. Over the course of the next month the palpitations increased from 1-2 a day to 4-5 in a day. I recently visited my primary care physician and refered myself to a cardiologist which I am waiting at this point to see. (July 16 2021 today). As of the last week I have actually been feeling better and have only had minor episodes but will still see the cardiologist. But there is no doubt that this was brought on by the second shot.
43 2021-07-17 palpitations, ventricular tachycardia, chest discomfort Nonsustained ventricular tachycardia; Chest discomfort; Rash; S.O.B; Palpitations; This spontaneous ... Read more
Nonsustained ventricular tachycardia; Chest discomfort; Rash; S.O.B; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030C20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included COPD (Frequent exacerbation), Hypertension, Diabetes, Shellfish allergy and Allergy to antibiotic (Cipro allergy). Concomitant products included METOPROLOL for Arrhythmia, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for COPD, ATORVASTATIN for Hyperchloremia, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and AMLODIPINE for Hypertension. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 DYSPNOEA (S.O.B) (seriousness criterion hospitalization), PALPITATIONS (Palpitations) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). On 27-Mar-2021 at 12:06 PM, the patient experienced CHEST DISCOMFORT (Chest discomfort) (seriousness criterion hospitalization). On 26-May-2021, the patient experienced VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Feb-2021 due to DYSPNOEA and PALPITATIONS, then on 27-Mar-2021 due to CHEST DISCOMFORT, then on 25-May-2021 due to RASH, and then on 26-May-2021 due to VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) had not resolved. Patient reported that he visited cardiologist, primary care, emergency room multiple more times. He experienced unknown rash from beginning and continues. One of the emergency room visit on 27-May-2021 and went for palpitation, shortness breath and non sustained ventricular tachycardia was present. He admitted to hospital. He experienced rash on arm, then face, torso and now mid section and thighs have rah. Experiencing palpitation/ arrhythmias daily as well shortness of breath. Treatment information was not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes
43 2021-07-22 blood glucose increased Patient began experiencing extreme fatigue, increased frequency of urination, numbness and tingling ... Read more
Patient began experiencing extreme fatigue, increased frequency of urination, numbness and tingling in fingers and toes. He went to a nearby Urgent Care. Labs were drawn on 5/29/2021. When patient returned to that clinic for follow-up on 6/16/2021, he was given his results of glucose level of 300 and hemoglobin A1c of 12.0%. He was started on metformin 500mg twice a day. He was also started on empagliflozin 10mg daily and dose was tapered up to 25mg daily two weeks later. Patient had repeat labs done at our facility on 6/30/2021: glucose 94, A1c 10.2%. Patient purchased a diabetes monitor. His glucose levels from 6/30 to 7/13/2021 showed his average daily glucose was now only 89 and patient had 10 episodes of low glucose (<70). His highest glucose level was 147 and he did not have any levels above 180. Patient was taken of empagliflozin, kept only on metformin, and will be followed up in 2 weeks. Prior to vaccination, patient had no hospitalizations, illnesses, or any steroid treatments. He is a very healthy, patient with a BMI of 26 who works out 6 days per week.
43 2021-07-22 chest pain, palpitations After the first dose heart palpitations worsened, muscle pain, fatigue, chest pain (sharp pains), s... Read more
After the first dose heart palpitations worsened, muscle pain, fatigue, chest pain (sharp pains), shortness of breath, pain and numbness in legs.
44 2021-01-09 heart rate increased Fever, chills, body aches, pain on site, bruise on site after 2nd day. slight dizziness , flushing ... Read more
Fever, chills, body aches, pain on site, bruise on site after 2nd day. slight dizziness , flushing and increased Heart rhythm on day log administration for about a minute and resolved. Have been having mild to moderate pain on right kidney area.
44 2021-01-10 blood pressure increased Patient reported stroke-like symptoms as he was driving to work: started "feeling funny" with dizzin... Read more
Patient reported stroke-like symptoms as he was driving to work: started "feeling funny" with dizziness; progressed to feeling weakness in left side of face with facial drooping; tingling in left hand progressed to numbness and weakness in left arm and leg; difficultly coordinating motor movement in right arm; difficulty/ diminished speech "tongue felt fat." Symptoms resolved within appx 1+ hour from onset. Per patient, he was given an injection at the hospital (unsure for what?) and was discharged with a prescription for chlorthalidone 25mg daily, blood pressure was elevated.
44 2021-01-10 chest discomfort 1/6/21 Vaccine. 1/7/21 fever, severe migraine, aches everywhere, chills, vomiting, sore throat, ti... Read more
1/6/21 Vaccine. 1/7/21 fever, severe migraine, aches everywhere, chills, vomiting, sore throat, tightness in chest
44 2021-01-12 blood glucose increased Blood sugar between 300-400 not able to keep down with insulin
44 2021-01-14 hypotension Was perfectly normal until I laid down for bed. Got very dizzy and took blood pressure with a cuff ... Read more
Was perfectly normal until I laid down for bed. Got very dizzy and took blood pressure with a cuff and it reported 95/47. Hypotension, shakiness and mild nausea. I've never had this symptom in my life and have taken 3mg melatonin before bed for years. (3mg, not 4mg as reported on the previous page). I was back to normal after ~10 minutes and woke up perfectly normal. Also, minor shoulder pain.
44 2021-01-20 chest discomfort chest tightness, hard to take a deep breath. Patient received Benadryl 50mg IM
44 2021-01-24 fast heart rate 10 minutes after vaccination, I was waiting in my car per instructions and began to feel extremely l... Read more
10 minutes after vaccination, I was waiting in my car per instructions and began to feel extremely light headed and dizzy/faint. I began to sweat a little and have minor tachycardia. I never went back into the clinic but instead leaned the seat of my car back and those symptoms went away after about 30 minutes. I never experienced any symptoms after that.
44 2021-01-25 hypotension Felt light headed after vaccine and has continued to have "dizzy spells" and vertigo up to several t... Read more
Felt light headed after vaccine and has continued to have "dizzy spells" and vertigo up to several times a day, especially on arising. Gives a history of "low blood pressure," but unsure of what the numbers typically are. Has had two events of nausea and headache on other days in the past two weeks since vaccine but doesn't believe it's related to the vaccine. States that events have gotten better over time. Encouraged to see his PCP.
44 2021-01-26 chest pain, palpitations pt had brief palpations 20 minutes after vaccine, pain in left arm spreading across the chest to rig... Read more
pt had brief palpations 20 minutes after vaccine, pain in left arm spreading across the chest to right side 5 hrs later. Felt like someone had punched him repeatedly in the chest the next day and that night he was profoundly fatigued and couldn't take a deep breath, was winded with simple physical tasks ie walking across the room. The next day 1/24/21 the pain resolved but was easily winded. Improving since then
44 2021-01-31 blood pressure increased, hypertension Employee complained of feeling hot flashes, sudden body chill and numbness tingling sensation to his... Read more
Employee complained of feeling hot flashes, sudden body chill and numbness tingling sensation to his arm where the injection was given. Blood pressure was elevated and employee says he has hypertension but its not usually that high. Employee takes Lisinopril.
44 2021-01-31 pallor Fever 101, head ache and body pail
44 2021-02-01 chest discomfort Moderna COVID-19 Vaccine EUA 22 min after vax, pt complained of itching, chest tightness, diphenhyd... Read more
Moderna COVID-19 Vaccine EUA 22 min after vax, pt complained of itching, chest tightness, diphenhydramine 25 mg capsule administered. BP 141/91, HR 93, O2 100% 27 min after vax, BP 136/97, HR 83, O2 100% 33 min after vax, BP 143/90, HR 83, O2 100%, pt reported less itching, less chest tightness, but symptoms remain 34 min after vax, RAPID RESPONSE called 40 min after vax, RAPID RESPONSE team arrived 43 min after vax, report given to ER, pt moved to ER by charge RN 90 min after ER, pt discharged
44 2021-02-01 hypertension, chest pain Five minutes after COVID-19 Moderna injection I started to feel chest pains, tingling/numbness on my... Read more
Five minutes after COVID-19 Moderna injection I started to feel chest pains, tingling/numbness on my left hand (injection site limp) my blood pressure was higher than my normal range, pulse ox was 93%. I was observed in ED for over an hour. After wards at approximately 11:AM on Feb 1st 2021 I broke in fever 104.1, chills, severe joint pain relieved only with high dose Advil 800mg around the clock. Unable to get up from bed due to weakness. I was given a doctors note to be off work for 4-days.
44 2021-02-01 loss of consciousness at 30 a.m. patient got sweaty and passed out. As a result he injured himself. Hospital said all labs... Read more
at 30 a.m. patient got sweaty and passed out. As a result he injured himself. Hospital said all labs were good, full work up and no foreseen reason for passing out. Said possible reaction to vaccine.
44 2021-02-02 blood glucose increased Checked sugar when I got home at 5:30pm, sugar was 570. More insulin was used as my sugar is never t... Read more
Checked sugar when I got home at 5:30pm, sugar was 570. More insulin was used as my sugar is never that high. Experienced blurry vision, and not completely oriented
44 2021-02-05 blood pressure increased Patient reported right sided facial drooping on 2/1/2021 stating that it began three days prior to ... Read more
Patient reported right sided facial drooping on 2/1/2021 stating that it began three days prior to him reporting it. MD documentation: Pt unable to blink right eye, lift right brow and right side of mouth is drooping. PERLA. Pt denied right sided weakness/headache. Pt has demonstrated elevated blood pressures since receiving Covid 19 Vaccine not previously demonstrated.
44 2021-02-07 fainting Near vasovagal syncope 5 days after 2nd dose. 5 days after my second COVID vaccine, I was outside in... Read more
Near vasovagal syncope 5 days after 2nd dose. 5 days after my second COVID vaccine, I was outside in snowy, cold weather about a mile from my car. I had stopped moving to rearrange some items. While stopped, I started to feel lightheaded, develop tunnel vision, and feel faint, almost to the point of blacking out. I put my head down and legs up and felt somewhat better. I then attempted to return to my car. I could go 100-200 yards at a stretch, before having to purposefully fall down and elevate my legs. I traveled the mile back to my car like this (slowly). I could not check my pulse because my hands were too cold; my respiration rate was elevated. At the car, I drank fluids and warmed up and began to recover enough to get home.
44 2021-02-15 palpitations Reported palpitations which is a feeling of a single strong heart beat w/ associated catching of his... Read more
Reported palpitations which is a feeling of a single strong heart beat w/ associated catching of his breath and feeling of startle and mild anxiety which started w/ other post COVID vaccine symptoms of f/c, fatigue, and body aches. Other symptoms resolved but not startle symptoms and pt now also having cough and nasal congestion. Normal exam other than congestion. EKG NSR w/ no feeling of the startle while here and no CP or SOB. CXR normal. Full lab eval also normal including neg CRP, Trop, BNP, and D dimer. CBC and CMP also normal. TSH mildly elevated but normal T4 so likely c/w pt's prior minor thyroid abn but unlikely to be source of current symptoms. Given normal exam and w/u do not feel myocarditis, pericarditis, or clots or other significant process associated w/ current symptoms. Pt retested for COVID since not fully immune prior to symptom onset.
44 2021-02-22 body temperature decreased Low body temp on 2/20 followed by elevated temp on 2/21. Normal temp by 2/22. Soreness and lump at... Read more
Low body temp on 2/20 followed by elevated temp on 2/21. Normal temp by 2/22. Soreness and lump at injection site evening of 2/22, with local burning pain. Left arm muscle soreness on 2/23 with red skin patch approx 3cm x 6cm at injection site.
44 2021-02-23 heart rate increased, fast heart rate Fever, fatigue, low grade fever, swollen lymph node in arm pit and neck. Heart SVT, rapid heart beat... Read more
Fever, fatigue, low grade fever, swollen lymph node in arm pit and neck. Heart SVT, rapid heart beat 48 hours later
44 2021-02-23 fast heart rate Patient experienced tachycardia after both the first and second dose about 30-45 minutes after the v... Read more
Patient experienced tachycardia after both the first and second dose about 30-45 minutes after the vaccine. The initial episode lasted about 20 minutes before resolving on its own. Today's reaction lasted about 30-40 minutes before resolving on its own but then returned at 1720 this evening. Patient's symptoms improving on their own and without intervention. HR currently 107
44 2021-02-25 chest pain Patient developed significant chest pain It did not require additional medical care or impede breath... Read more
Patient developed significant chest pain It did not require additional medical care or impede breathing However, pain was significant and unusual
44 2021-02-28 chest discomfort Chest tightness, lightheaded & nervousness; denies chest pain, SOB or difficulty breathing Vitals: 1... Read more
Chest tightness, lightheaded & nervousness; denies chest pain, SOB or difficulty breathing Vitals: 120/65, HR-80, pulse ox- 97% Client reports history of anxiety, PTSD; takes trazadone 50mg & Abilify 1.25mg nightly 0952- client reports feeling better, cleared by site lead
44 2021-03-05 heart rate decreased Patient's wife texted school nurse as he is an employee of school district. She reported after pati... Read more
Patient's wife texted school nurse as he is an employee of school district. She reported after patient left the school from receiving his vaccine, he began feeling lightheaded, low pulse in the 50's, dizzy, and shortness of breath. Patient has a history of bilateral PE and takes blood thinner. Patient was taken to the Emergency Department by his wife.
44 2021-03-06 heart rate increased 5 min after vaccination, patient complained of increase in heart rate to 133 BPM and feeling like hi... Read more
5 min after vaccination, patient complained of increase in heart rate to 133 BPM and feeling like his arm was tingling and numb. We propped his feet up and gave supportive care such as blanket and ice packs. Patients heart rate went back to normal (75-80 bpm) after 10 minutes. However, 35 minutes post vaccination, pt started having chills and shakes. Gave blanket and monitored patient for 45 min after vaccination. Pt declined 911. Wife took patient home 50 min past vaccination stating she felt he was stable and they would monitor at home.
44 2021-03-06 heart rate increased Ive always had a resting heart rate in the upper 70?s innthe past years until the vaccine. I have n... Read more
Ive always had a resting heart rate in the upper 70?s innthe past years until the vaccine. I have noticed that its been staying in upper 90?s to 103 most of the time especially when I stand up or simply walk across the room. I didn?t realize what was going on for sure for two or three days. This on top of being winded easily.
44 2021-03-06 fainting 12/23/20 (Moderna #1) - Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx'd A... Read more
12/23/20 (Moderna #1) - Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx'd Augmentin x14d, Rapid covid negative (and PCR resulted negative). 12/27 slept all day, 12/28 back to work. 1/12/21 metallic taste in mouth, severe GI sx, malaise, aches, headache. 1/14 seen at walk-in and covid swabbed Negative. 1/21/21 exposed to parents who found out they were covid + on 1/22/21. 1/25/21 (Moderna #2) - Continued with persistent cough and GI sx. Then also developed urinary frequency and urgency. Seen at urgent care 2/1 c/o cough, dx URI, rx'd augmenting. Woke up morning of 2/2/21 abruptly, stood up, said something was wrong, and collapsed. CPR attempted immediately, EMS brought him to ER where he was pronounced dead.
44 2021-03-08 heart rate increased, palpitations Five minutes after injection heart rate began increasing and felt like it was racing. Left arm start... Read more
Five minutes after injection heart rate began increasing and felt like it was racing. Left arm started feeling numb and tingling, then overall felt weak and dizzy. Got flushed/red in the face. Remained seated and propped up feet, applied ice packs. Heart rate was elevated again at 30 minutes after injection. Developed chills/shaking. Remained at pharmacy under observation another 30 minutes. Symptoms mainly resolved and felt generally better over the course of 2-3 hours.
44 2021-03-10 blood pressure fluctuation Patient experienced immediate vomiting; throat tightness. Medical Doctor - was on scene and adminis... Read more
Patient experienced immediate vomiting; throat tightness. Medical Doctor - was on scene and administered IM Epinephrine 0.3ml Time line and Vital Signs 14:20 - BP 148/82 HR: 110 Epi administered 14:32 - BP 140/80 14:34 - O2 sat: 99% HR: 110 BP: 155/82 EMS Called 14:39 14:48 BP 146/78 Patient was alert and was able to ambulate.
44 2021-03-10 palpitations Patient states began having "racing heartbeat, feeling of anxiety, sweating from scalp, cold feet, t... Read more
Patient states began having "racing heartbeat, feeling of anxiety, sweating from scalp, cold feet, temperature of 100.1" at 4:30pm on 3/10/21, patient states took Ibuprofen 800mg and began to feel better. Patient states on 3/11/21 at about 4:30pm began having "racing heartbeat, feelings of anxiety" again, denies having temperature at that time, patient states "went away on its own", did not take medication. Patient states had "rapid heartbeat and feeling anxious" at 5am, no fever, no medication taken.
44 2021-03-12 pulmonary embolism sob, dx pulmonary embolism
44 2021-03-14 pallor Sudden onset of severe dizziness (causing nausea), balance/standing/ walking issues. Complete weak... Read more
Sudden onset of severe dizziness (causing nausea), balance/standing/ walking issues. Complete weakness. Total loss of color/hue in complexion. Difficulty communicating. Feeling of things shutting down or not continuing to ?work.? Got to bed and passed out for over 10 hours. Woke up feeling mostly better.
44 2021-03-16 heart rate increased 3/12/2021: Fever 100.1F; lasting from 2:30pm through 3:30pm; elevated temp of 99.2-99.6 until 3/15/... Read more
3/12/2021: Fever 100.1F; lasting from 2:30pm through 3:30pm; elevated temp of 99.2-99.6 until 3/15/2021 3/12/2021: Chills ~8pm until ~2am on 3/13/2021 nasal congestion 3/13/2021 7:30am-11:00am elevated pulse ~115bpm sporadically from 3/13/2021-3/15/2021 swollen neck glands/throat tightness 3/14/2021 8pm-11pm numb lips & tongue 3/15/2021 2pm-3pm
44 2021-03-16 pulmonary embolism pulmonary embolus onset 3 days post 1st dose Moderna vaccine
44 2021-03-17 pallor, heart rate decreased, palpitations I experienced what I would describe as a cardiac event. My heart started racing out of no where. I h... Read more
I experienced what I would describe as a cardiac event. My heart started racing out of no where. I have an activity tracking device and it was pacing me at 184 bbm for thirty minutes then a subsidence to 120 bbm for the next couple hours. By the evening my heart rate had decreased to the 70 - 80 ish range. Sleep time and the following morning it was what I would consider normal. This event made me dizzy and my skin paled. I was also very tired. It was as if I had done an intense cardio workout with no warm up. 0 to max. I didn't seek medical attention but did consider it.
44 2021-03-21 heart rate increased Patient developed elevated heart rate and became lightheaded about 25 minutes after receiving vaccin... Read more
Patient developed elevated heart rate and became lightheaded about 25 minutes after receiving vaccine.
44 2021-03-22 chest pain Pt experienced faintness and dizziness within 15 minute observation time after vaccination. Pt denie... Read more
Pt experienced faintness and dizziness within 15 minute observation time after vaccination. Pt denied c/o difficulty breathing, swelling of tongue or throat, or other symptoms. No localized swelling or redness. Pulse was 92 and blood pressure initially was 152/98. Pt seated and elevated feet. Provided with 2 bottles of water and monitored for 45 minutes. Dizziness resolved after 15 minutes. Blood pressure lowered to 138/98. Patient called girlfriend for ride home. Pt was complaining of back and chest pain during the event, which patient claimed was normal for him since surgery.
44 2021-03-24 fainting, hypotension Patient experienced very low blood pressure and fainted. He came to quickly, but was transported to ... Read more
Patient experienced very low blood pressure and fainted. He came to quickly, but was transported to hospital by ambulance as a precaution
44 2021-03-28 pallor, hypotension, very slow heart rate Patient came to immunization clinic for first dose of vaccine. Directly after receiving vaccination... Read more
Patient came to immunization clinic for first dose of vaccine. Directly after receiving vaccination patient became dizzy, pale, and diaphoretic. Rapid Response called. Vitals obtained. Patient hypotensive and bradycardic. Patient moved to gurney, placed in trendelenburg position. Vitals obtained. Patient moved to observation treatment area. Orthostatic vitals obtained as patient recovered. Patient observed for extended period of time after recovering. Patient went home with instructions to seek medical care if symptoms worsen.
44 2021-03-29 fainting I passed out driving 60mph on the highway. I awoke stopped in the middle lane not really understandi... Read more
I passed out driving 60mph on the highway. I awoke stopped in the middle lane not really understanding what was going on. Sweat was gushing down my head. Luckily nobody was injured. I start to feel better around 4:30pm
44 2021-03-30 chest pain 12 hrs post vaccination on 3/17/21-Pt c/o onset of chest and arm pains, numbness to left arm, sever ... Read more
12 hrs post vaccination on 3/17/21-Pt c/o onset of chest and arm pains, numbness to left arm, sever fatigue and headache. Went to the Hospital. Remained in ER for 10 hrs before released. Dx-cardio-vessel spasms. c/o continued migraines every 3 hrs for 10 days. Presented to ER again on 3/23/21 for the migraines.
44 2021-03-30 oxygen saturation decreased 6-7 days of red rash on back, fever, drop in 02 saturation, headache, fatigue, body soreness, chills
44 2021-04-03 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: After awakening patient said he felt lik... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: After awakening patient said he felt like he couldn't breathe but was. EMS came to take him to the hospital. His parents who were with him said he does have anxiety around needles and may have a hystory of fainting with shots.
44 2021-04-04 palpitations Fast pounding heart beat, insomnia, anxiety.
44 2021-04-06 chest pain Experience chest pain on right side of chest near armpit which spread across chest one week after th... Read more
Experience chest pain on right side of chest near armpit which spread across chest one week after the first vaccine shot given on January 25, 2021. Pain was going away before the second shot. Received second shot on February 22, 2021 and had the chest pain return, extreme fatigue, headaches, rash at injection site and all over back, achy muscles mainly in upper body, dizzy spells, nausea, and abdominal pain. All these symptoms (minus nausea) continued for three weeks and some are still present (fatigue, chest pain and periodic headaches) after six weeks. I was tested for antibodies and the results came back greater than 400, which is the max limit for the test. The doctor has never seen results that high and we have no idea how high my antibodies actually are. Since my symptoms seem to be slightly improving, the doctor did not recommend further treatment. However, I am concerned as to any possible danger of antibody levels this high.
44 2021-04-06 palpitations Patient complained of night sweats, crazy dreams with persistent palpitations, sweating when awaken ... Read more
Patient complained of night sweats, crazy dreams with persistent palpitations, sweating when awaken from bad dreams from vaccine administration through 4/2/21 at doctor's appointment
44 2021-04-07 chest discomfort Left there after 15 minutes and started driving. About 5 minutes down the road started having stabb... Read more
Left there after 15 minutes and started driving. About 5 minutes down the road started having stabbing back pain shooting from the middle of the back up and down the spine. Chest feels like someone bear hugging hard from the back. Chest tingle and neck pain. This has been for the day. I turned around and went home crying because I was and am scared. Still hurts now and it's 9pm. No insurance and the hospital already has me in collections so I can't go.
44 2021-04-07 pallor Blurred vision, "heavy" feeling in the throat, nose became mostly numb, lips had some numbness, extr... Read more
Blurred vision, "heavy" feeling in the throat, nose became mostly numb, lips had some numbness, extreme paleness. No issues with breathing (even while wearing a mask). Reaction started with blurred vision while reading (during the waiting period at the vaccination clinic). Started within 10 minutes of receiving vaccine. Then the throat heaviness started, nose became numb, and lips were somewhat numb. It occurred in waves, with a few minutes of symptoms, then a mild relief of symptoms (but not total relief), then symptoms returned. This continued for 30-45 minutes. Received water and 2 Benadryl at the vaccination clinic from RN. Benadryl didn't seem to have any impact on symptoms.
44 2021-04-08 heart rate decreased, chest pain, blood pressure decreased Pt c/o of chest pain. Works out a lot. Point tenderness, very anxious. Vital signs at 10:45am 160/98... Read more
Pt c/o of chest pain. Works out a lot. Point tenderness, very anxious. Vital signs at 10:45am 160/98, HR 133, RR 22. Rechecked at 11:00am, BP 140/92, HR 90. Refused to allow calling his wife. Pt transported to hosptial. Follow up call made but no answer.
44 2021-04-08 loss of consciousness pt became weak and sweating, passed out. came to, and was sweating and weak and confused.
44 2021-04-09 blood pressure increased, pulse abnormal, chest pain Pulsation, chest pain, elevated B / P, disorientation, vision distortion, and dizziness.
44 2021-04-09 fainting patient got his 2nd covid vaccine and was waiting in the post vaccine waiting area and after about 5... Read more
patient got his 2nd covid vaccine and was waiting in the post vaccine waiting area and after about 5 minutes fainted. He regained consciousness in about 20 seconds. We had paramedics come out and checked all vitals and released him
44 2021-04-09 fast heart rate Pain and burning both arms for last 8 hours. Fatigue and muscle pain. Pain at injection. Tachycar... Read more
Pain and burning both arms for last 8 hours. Fatigue and muscle pain. Pain at injection. Tachycardia
44 2021-04-11 hypertension Patient in observation. Patient complaining of cottonmouth, tongue numbness, difficulty swallowing, ... Read more
Patient in observation. Patient complaining of cottonmouth, tongue numbness, difficulty swallowing, numb lips, and throat swelling. Vital signs BP-153/97, HR-88, RR-18. Benadryl 50mg give orally by EMT. Patient AOx4, lung sounds clear bilaterally, no hives notes, no injuries noted. Patient monitored. Patient reports feeling better after receiving Benadryl. Vital signs BP-164/45, HR-82, RR-16. Patient reports no more symptoms. Patient educated about adverse reactions and when to seek medical attention. Patient verbalizes understanding.
44 2021-04-12 fibrin d dimer increased, chest pain, pulmonary embolism PT EXP SHORTNESS OF BREATH AND CHEST PAIN; SELF REFERRED TO ER. D-DIMER ELEVATED. CHEST CTA SHOWS SO... Read more
PT EXP SHORTNESS OF BREATH AND CHEST PAIN; SELF REFERRED TO ER. D-DIMER ELEVATED. CHEST CTA SHOWS SOLITARY RIGHT UPPER LOBE PULMONARY ARTERY PULMONARY EMBOLISM. BILATERAL LOWER EXTREMITY ULTRA SOUND SHOWS THROMBOSIS FEMURAL ARTERY NO PERSONAL OR FAMILY HISTORY OF BLOOD CLOTS AND NO HISTORY OF BLEEDING EPISODES OR LONG TRAVEL OR SEDENTARYNESS.
44 2021-04-13 chest pain, coughing up blood, pulmonary embolism, deep vein blood clot FINAL DIAGNOSIS: o Acute pulmonary embolism and DVT SECONDARY DIAGNOSIS: Principal Problem: ... Read more
FINAL DIAGNOSIS: o Acute pulmonary embolism and DVT SECONDARY DIAGNOSIS: Principal Problem: Pulmonary embolism and infarction (CMS/HCC) POA: Yes Active Problems: Tobacco abuse POA: Yes Opioid dependence (CMS/HCC) POA: Yes Pulmonary embolism (CMS/HCC) POA: Unknown DVT (deep venous thrombosis) (CMS/HCC) POA: Unknown Chest pain POA: Unknown Hemoptysis POA: Unknown Resolved Problems: * No resolved hospital problems. * PDMP Query Date: 03/24/21 PDMP Comments: 03/22/21 suboxone 8mg/2mg #14/14 days multiple fills ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- BRIEF HOSPITAL COURSE: a 44 year old male with h/o of anxiety, depression, substance use on Suboxone, history of alcohol abuse, admitted 3/24/2021 with pleuritic chest pain and shortness of breath. Evaluation was positive for bilateral DVT and pulmonary embolism Bilateral PE, infarction, bilateral DVTs -No obvious precipitating factors -patient underwent first COVID 19 vaccine injection, is actually due for second shot. Unclear if this is contributed, recommended to hold on getting second dose and discuss this with PCP. -Also follow-up with PCP for appropriate cancer screening -patient was treated with therapeutic subcutaneous Lovenox, remained hemodynamically stable and is feeling better today. Upon discharge we'll prescribe Elocon is 10 mg b.i.d. for another 5 days followed by 5 mg b.i.d. maintenance dose. He will be provided with coupon for 1 month supply, he was recommended to follow-up with PCP for further recommendations. He will probably need anticoagulation for at least 6 months or longer depending on further course. -Echocardiogram showed ejection fraction 50-55%, Mild mitral valve prolapse no evidence of RV strain. Hemoptysis -Most likely was related to PE and infarction -resolved. Pleuritic chest pain, h/o Afib -Most likely pain was secondary to PE, improved -Continue Cardizem as prior to admission -Stop aspirin since patient will be on anticoagulation therapy History of opioid dependence, alcohol abuse Continue suboxone Ongoing smoking smoking cessation was advised Disposition: Routine Discharge Home CONSULTS: Consults Ordered during this Encounter Procedures ? Ancillary Service Request - IV Team New IV Start (multiple sticks for labs) ? Ancillary Service Request - Social Services PROCEDURES: Procedures Ordered during this Encounter Procedures ? Patient is currently on therapeutic anticoagulation (warfarin, Pradaxa, IV heparin, Rivaroxaban) - no reassessment RADIOLOGY TESTS: CT CTA Chest Final Result 1. Segmental and subsegmental pulmonary emboli throughout the right lung, most prominent in the right lower lobe. Segmental and subsegmental pulmonary artery the left pleural effusion. 2. Wedge-shaped opacities at both lung bases concerning for small pulmonary infarcts. 3. No findings of right heart strain or pulmonary hypertension. Impression discussed with Dr of the ER at 20:44 on 03/24/2021 by phone. Electronically signed by: MD 3/24/2021 8:46 PM US Legs Bil Venous DVT Final Result Bilateral posterior tibial vein thrombosis. This critical result was called to the clinical team, including by telephone, at 6:00 PM by the sonographer, according to internal Department documentation. Electronically signed by: MD 3/24/2021 6:16 PM XR Chest PA and Lateral Final Result Small bilateral pleural effusions. Streaky left basilar opacity may reflect atelectasis or infiltrate. Small right basilar opacity of uncertain significance. All opacities are new since 2016. No pneumothorax. 4 week follow-up is recommended. If the abnormalities have not resolved by then, chest CT is recommended. Electronically signed by: MD 3/24/2021 5:36 PM ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- PROPOSED MANAGEMENT PLAN: Risk for readmission within 30 days: o Low Pending results: Unresulted Labs . . . Comprehensive Metabolic Panel [124639904] Collected: 03/24/21 1818 Updated: 03/24/21 1823 Specimen Source: Blood, Venous Morphology [124639439] Collected: 03/24/21 1700 Updated: 03/24/21 1715 Specimen Source: Blood, Venous Comprehensive Metabolic Panel [124637329] Collected: 03/24/21 1700 Updated: 03/24/21 1705 Specimen Source: Blood, Venous Troponin, HS [124637342] Collected: 03/24/21 1700 Updated: 03/24/21 1705 Specimen Source: Blood, Venous Recommended Testing: o Refer to Hospital Course DISCHARGE MEDICATIONS: Medication List STOP taking these medications aspirin 81 MG Chew TAKE these medications Dose Ordering Provider Morning Afternoon Evening Bedtime apixaban 5 MG Tabs Commonly known as: ELIQUIS Instructions: Take 2 Tabs (10 mg total) by mouth TWICE A DAY for 5 days, THEN 1 Tab (5 mg total) TWICE A DAY. Start taking on: March 26, 2021 Signed by: MD buprenorphine-naloxone 8-2 MG Film Commonly known as: SUBOXONE Instructions: Dissolve 1 Film under the tongue DAILY for 14 days. Instructions: NADEAN: xe2109242 Dose: 1 Film Signed by: MD diltiazem CR 240 MG Cp24 Commonly known as: DILACOR XR Instructions: Take 240 mg by mouth DAILY. Dose: 240 mg Where to Get Your Medication apixaban 5 MG Tabs High-risk Medication Changes: o Refer to Hospital Course PTA Medication Changes: o Refer to Hospital Course
44 2021-04-13 heart rate irregular Severe chills, vertigo and dizziness, irregular heartbeat
44 2021-04-15 chest discomfort, troponin increased, inflammation of the heart muscle developed chest discomfort presented to hospital ER. ekg w diffuse st elevations, elevated troponin... Read more
developed chest discomfort presented to hospital ER. ekg w diffuse st elevations, elevated troponin. taken for coronary angiogram negative for cad. normal echo. diagnosed w myocarditis. no evident viral prodrome or other inciting cause.
44 2021-04-15 pallor Patient felt dizzyness, cold sweats, nausea, and paleness post vaccination while awaiting the 15 min... Read more
Patient felt dizzyness, cold sweats, nausea, and paleness post vaccination while awaiting the 15 minute monitoring period. Pharmacy staff stayed with patient while ambulance arrived and took patients vitals. All was normal and patient began to feel better 10 minutes later. Patient went home. Followed up with patient later in the day and patient feeling much better/no pain in arm/no redness/etc.
44 2021-04-17 blood glucose increased Noticed significant decrease in insulin sensitivity resulting in high blood sugars. Had to manipulat... Read more
Noticed significant decrease in insulin sensitivity resulting in high blood sugars. Had to manipulate boluses to try and find the right correction bolus. Lasted for approx. 1.5-2 weeks post injection.
44 2021-04-17 fainting Approx 15mins after having the shot administered I sat in my car and felt the medication coming on b... Read more
Approx 15mins after having the shot administered I sat in my car and felt the medication coming on by it clouding my vision then causing me to faint (and by description from my fiancé) I had what appeared to be a mild seizure. I was out for a minute or two and when I was conscious again my vision was blurry and I felt very drunk for the next 45mins - hour. I also felt like I could taste the chemicals from the vaccine when I became conscious again. The drunk/vertigo feeling subsided slowly over time but I was given a Benadryl from the pharmacist so I?m not sure when the dizziness stopped but I definitely could not drive home. My fainting was not due to any anxiety due to having a shot or anything, I was perfectly fine for approx 10-15 mins after the vaccine then I felt a cold feeling coming on from my right shoulder then up my neck then I got foggy and dizzy and passed out
44 2021-04-18 chest pain PT RECEIVED A FIRST DOSE OF THE MODERNA VACCINE IN THE LATE MORNING OF 04/17/2021. PT'S DAUGHTER CAL... Read more
PT RECEIVED A FIRST DOSE OF THE MODERNA VACCINE IN THE LATE MORNING OF 04/17/2021. PT'S DAUGHTER CALLED ON THE MORNING OF 04/19/2021 AND SAID SHE WAS CONCERNED ABOUT HER DAD AS HE HAD BEEN COMPLAINING OF A "VERY BAD FEVER, HEADACHE AND CHEST PAIN." PT'S DAUGHTER WAS ASKED IF HER DAD HAD TROUBLE BREATHING AND SHE SAID YES. WHEN ASKED ABOUT HOW LONG IT HAD BEEN GOING ON, SHE SAID SINCE LAST NIGHT. SHE ALSO SAID THE FEVER HAD REACHED 102 DEGREES. PT'S DAUGHTER SAID HER DAD HAD NOT TRIED TAKING ANYTHING TO HELP TREAT THE FEVER OR HEADACHE. SHE ASKED ABOUT IF SHE SHOULD HAVE HIM TAKE TYLENOL, BUT DUE TO THE COMPLAINT OF "SEVERE CHEST PAIN" AND "DIFFICULTY BREATHING," IT WAS RECOMMENDED THE PT SEEK IMMEDIATE MEDICAL ATTENTION AND GO TO THE ER. PT'S DAUGHTER CONFIRMED THAT SHE WOULD.
44 2021-04-19 heart rate increased, loss of consciousness Lost consciousness, Either a siesure or passed out. Cadiac events - Varied and Rapid Heart rate, Low... Read more
Lost consciousness, Either a siesure or passed out. Cadiac events - Varied and Rapid Heart rate, Low Potassium and Low Magnesium
44 2021-04-19 pulmonary embolism Pulmonary Embolism diagnosed on 4/19/2021
44 2021-04-22 chest pain Sharp pain in the left chest. Pt. given 12 Lead EKG (-) result Pt. refused any further treatment. La... Read more
Sharp pain in the left chest. Pt. given 12 Lead EKG (-) result Pt. refused any further treatment. Language line utilized. Pt. monitored for 30 minutes post vaccination. HR-75 SPO2: 99 RESP: 18 BP: 141/80 Seen by EMT on site. D/C'd at 10:10 am
44 2021-04-22 hypotension 44 yo male pt c/o a rash post vaccination. The rash is localized to the vaccination site in patients... Read more
44 yo male pt c/o a rash post vaccination. The rash is localized to the vaccination site in patients right deltoid region. It is approximately one inch in size, non pruritus, erythematous, and circular with a symmetric border. Patient states that this reaction has never occurred with any previous vaccine. Pt denies SOB, CP, or headache. Pt was given 25mg Benadryl and water. Vitals were stable for patient to leave the observation site. Patient was advised to f/u with PCP. BP- Machine error (pt BP usually low normal) HR- 93 (considering anxiety from vaccination experience) SpO2 96%
44 2021-04-23 hypotension Patient is a 45 year old male A & O x4 complaining of anxiety approximately 5 minutes after receivin... Read more
Patient is a 45 year old male A & O x4 complaining of anxiety approximately 5 minutes after receiving the injection. Patient stated that he became very anxious with slight blurred vision. Patient stated that he has had similar events in the past when he is in a medical environment. Patient was placed in a sitting position in the medical evaluation area with vital signs obtained. Initial blood pressure was low but improved to normal limits quickly once in the sitting position and patient stated that his symptoms completely resolved. Patient has a history of anxiety, and allergy to an unknown antibiotic and takes no medications. Negative chest pain, shortness of breath, weakness, dizziness, blurred vision, anxiety and there were no signs of allergic reaction or stroke. Patient was able to stand with no symptoms and continued to deny any complaint. Patient denied any further care and stated that his wife would drive him home. Patient was advised of risks, consequences and when to seek medical care. Patient was accompanied to his vehicle by (EMT) and left with his wife via private vehicle.
44 2021-04-23 loss of consciousness In early AM hours of Apr 23 I began to feel very weak. At around 3:15am when I got up to use the bat... Read more
In early AM hours of Apr 23 I began to feel very weak. At around 3:15am when I got up to use the bathroom, my eyes clouded over and I passed out on the bat Herron floor. I regained consciousness after almost 10 minutes. Luckily I was not injured. But I was practically bedridden all day Apr 23.
44 2021-04-25 loss of consciousness Patient passed out and look like seizures, Called 911
44 2021-04-26 chest pain Patient is 44-year-old Male, to the emergency department for evaluation of left sided chest/rib pain... Read more
Patient is 44-year-old Male, to the emergency department for evaluation of left sided chest/rib pain. Onset: Last night. Aggravated with movement and deep inspiration. No other associated symptoms. Saw primary doctor today in which she had a chest x-ray notable for trace left pleural effusion. In addition had blood work notable for nonelevated dimer
44 2021-04-26 fainting After 5 minutes of the shot, patient fainted & hit his head on the ground. we called 911 afterwards,... Read more
After 5 minutes of the shot, patient fainted & hit his head on the ground. we called 911 afterwards, then the paramedics took him around 1:15 pm
44 2021-04-27 loss of consciousness, pallor After the vaccination, the patient was asked to wait at the Waiting Area for at least a few minutes.... Read more
After the vaccination, the patient was asked to wait at the Waiting Area for at least a few minutes. He was with his father that time and they were seated at the Waiting Area. After a few minutes, the father saw the patient looking somewhat pale and he asked if he is doing okay and he seemed to become unconscious for a brief moment then he started shaking for a few seconds. While this happened, pharmacy called 911 and attended to the patient. His color came back after maybe 5 to 10 minutes, but still had sweats on his forehead. His palms were warm the whole time, no clamminess. 911 came and they attended to the patient and took him.
44 2021-04-28 hypotension, pulse abnormal Found on floor in office at approx 0900. Was responsive and assisted to chair, minimally responsive.... Read more
Found on floor in office at approx 0900. Was responsive and assisted to chair, minimally responsive. SM did not appear to have fallen, but to have laid down on purpose while feeling weak. Paramedics were notified and arrived at approx 0950. He complained of dizziness and tingling hands. CBG was checked on arrival and pt's blood glucose was 40, then 30 and 29 on rechecks. Was given sugary snack/drinks and iv fluids. Medics reported weak pulse and low BP. After initial treatment, pt was able to stand with minimal assist and transfer to stretcher for transport to ER at Hospital. Upon arrival to hospital CBG was still under 50, but was alert and conversational. However hand tingling
44 2021-04-29 nosebleed Severe to moderate epistaxis for 6 days. Rhino rocket at onset of bleed and removed 36 hours later.... Read more
Severe to moderate epistaxis for 6 days. Rhino rocket at onset of bleed and removed 36 hours later. Various other packings attempted for approximately 60 hours all of which failed to stop recurring bleeding. Rhino rocket inserted and will remain inserted for four days. Scheduled to be removed by an Ear, Nose and Throat specialist at the end of four day period. Continuing treatment unknown at this time.
44 2021-05-03 pulmonary embolism Pulmonary embolism of the distal right main pulmonary artery and right middle lobe pulmonary artery
44 2021-05-03 fainting Got up in night to use bathroom and fainted.
44 2021-05-04 chest pain sharp pain left chest. chest x-ray revealed pulmonary effusion in left lung. CT with radioactive dy... Read more
sharp pain left chest. chest x-ray revealed pulmonary effusion in left lung. CT with radioactive dye ruled out Pulmonary Embolism. Swollen lymph nodes also noted in left armpit
44 2021-05-04 pulmonary embolism, deep vein blood clot Patient received his first dose of COVID vaccine on 4/8 and developed GI symptoms ~ 4/16. Patient te... Read more
Patient received his first dose of COVID vaccine on 4/8 and developed GI symptoms ~ 4/16. Patient tested positive for COVID on 4/25 when he presented to the ED. However, he was sent home at that time since he was stable to go home and was not hypoxic. Pt presented to the ED again on 5/4 due to dyspnea on exertion and pain in the back of his knee. Patient was found to be positive for DVT and PE and was started on therapeutic Lovenox. Patient doesn't have a history of VTE, but he does have a family history of VTE. Since patient wasn't found to be hypoxic, COVID treatment wasn't started in the hospital.
44 2021-05-06 chest pain I felt decent; just some sore muscles and where I was injected up until about 2 pm the day after the... Read more
I felt decent; just some sore muscles and where I was injected up until about 2 pm the day after the 2nd vaccine. Then all of my muscles began to ache badly & by 4 pm I was suffering from on and off chills/ sweating ; this lasted all evening. I checked my temperature & only once was the temperature above 100F. I did have some chest pain at times as well. I drank mint tea, took tylenol at regular intervals & used icy hot on the sore back and neck. Following morning I'm feeling a little better but still quite a bit of soreness but as of 7 am , the chills/hots have subsided. I did pee a lot over night; at one point I went to the bathroom about 5-6 times within an hour to 90 minutes.
44 2021-05-06 fast heart rate Received vaccine at medical center. 5 minutes after initial vaccination felt dizzy. After a few minu... Read more
Received vaccine at medical center. 5 minutes after initial vaccination felt dizzy. After a few minutes he was feeling better so left for car at 15 minutes post vaccination. Once getting to car developed lightheadedness, tachycardia, shortness of breath. Brought back into facility given IM epi 0.3 mg with improvement and send via ambulance to our emergency department. No urticarial lesions or angioedema. Observed for approximately 2 hours. No recurrence. Discharged home. No additional meds after epi given in the field.
44 2021-05-07 loss of consciousness, blood pressure increased 1 or 2 minutes after shot started feeling dizzy. Heart rate felt like it dropped and blood pressure... Read more
1 or 2 minutes after shot started feeling dizzy. Heart rate felt like it dropped and blood pressure felt very low. Vision was dark and I spent most of the time concentrating on breathing. I did not lose consciousness or pass out at any time. I was with my wife and children so they were able to give me the timeline. My wife noted I started sweating after about 5 minutes. The symptoms peaked at about 10 minutes and faded slowly after that. Because I felt like the worst of the event had passed we did not report the event at the time. When we got home I laid down for about an hour. My shoulder started hurting about this time as well. I feel I was recovered from the initial symptoms within 2 days. My shoulder was in pain for about 3 days, with the first two days being much worse than the third.
44 2021-05-10 hypertension Sudden high-blood pressure (potential heart issues) that did not exist prior to vaccine.
44 2021-05-10 fainting Syncopal episode less than 15 minutes postvaccination; BP as low as 86/60. Patient recovered within... Read more
Syncopal episode less than 15 minutes postvaccination; BP as low as 86/60. Patient recovered within 30 minutes and was released to home.
44 2021-05-11 fainting Pt had syncopal episode while walking to seat following vaccination. Heart rate between 25-40 beats... Read more
Pt had syncopal episode while walking to seat following vaccination. Heart rate between 25-40 beats per minute with low blood pressure. IV fluids given and atropine administered to increase heart rate
44 2021-05-13 fainting, pallor Pt experienced syncopal episode approx 15 seconds after receiving IM injection. After syncope occurr... Read more
Pt experienced syncopal episode approx 15 seconds after receiving IM injection. After syncope occurred nurse maintained pt in tripod position, and continued attempting to arouse pt which was successful after 20 seconds. Pt was moved via wheelchair to observation area, where vomiting x2 occurred. Diphenhydramine 50 mg PO was administered. EMS was called when pt being diaphoretic and pallor of the forehead and upper extremities was observed. Pt declined transport to hospital for further evaluation. Pt was observed for 30 minutes and left the clinic ambulatory.
44 2021-05-14 fainting Pt experienced syncopal episode after injection. He fell out of his chair to the floor approx 2 min ... Read more
Pt experienced syncopal episode after injection. He fell out of his chair to the floor approx 2 min after injection. He was disoriented upon first assessment for 15 seconds and then awake, alert, oriented. Pt reported he worked out hard and did not eat prior to injection and that he has a history of fainting. Pt vital signs were monitored. VSS. Pt denies pain or injury. No injury noted upon assessment.
44 2021-05-19 fainting Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: Patient fainte... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: Patient fainted while seated after receiving vaccine. Fell on floor and hit head. Potential seizure may have occurred, patient mouth observed to be slouched and words slurred afterward. 911 called and full assessment performed by EMT.
44 2021-05-20 chest pain, inflammation of the heart muscle The patient presented to the emergency department with chest and back pain. Admitted the hospital an... Read more
The patient presented to the emergency department with chest and back pain. Admitted the hospital and diagnosed with myopericarditis.
44 2021-05-21 chest discomfort Within 8 1/2 hrs. after vaccination (2nd COVID-19 Moderna vaccination): moderate to severe headache,... Read more
Within 8 1/2 hrs. after vaccination (2nd COVID-19 Moderna vaccination): moderate to severe headache, fever 100.3 , body aches and chills, cough, sinus drainage, slight tightness in chest, eyes watering, and sore at injection site (left arm).
44 2021-05-21 fainting Syncopal episode, vital signs stable. Interventions implemented, recovered, and released.
44 2021-05-22 heart attack, inflammation of the heart muscle NSTEMI and myocarditis
44 2021-05-25 fainting Patient fainted 2 minutes after second vaccination.
44 2021-05-26 palpitations, troponin increased, chest pain, inflammation of the heart muscle 5/1/21: Patient woke with chest pain, elevated respiratory rate, nausea, and sweating. Recognizing ... Read more
5/1/21: Patient woke with chest pain, elevated respiratory rate, nausea, and sweating. Recognizing symptoms of a heart attack, the patient presented to the emergency room at 5:30am. ECG normal, Troponin at 2.1 at presentation, continued to increase to 4.6 prior to being taken to Cath Lab. Coronary angiography showed no occlusion; patient admitted to telemetry unit for continued monitoring; discharged following day with order for cardiac MRI. Outpatient cardiac MRI conducted 5/5/21 revealed myocarditis. Treatment with beta blockers (Metopolol Succinate 25MG QID) and anti-inflamatory (indomethacin 25MG TID) with direction to avoid exercise. Light yardwork on 5/22 resulted in patient feeling "racing heart".
44 2021-05-29 chest discomfort Shortness of breath and chest tightness. Hospitalized for fluid volume overload after a couple weeks... Read more
Shortness of breath and chest tightness. Hospitalized for fluid volume overload after a couple weeks of having symptoms. Responded well to iv Lasix and was discharged on PO lasix. Has not had any heart issues since transplant 2009
44 2021-05-30 hypertension, palpitations, fainting, chest pain Initially, the patient had dizziness, lightheadedness and a syncopal episode within 5 minutes of the... Read more
Initially, the patient had dizziness, lightheadedness and a syncopal episode within 5 minutes of the vaccine. He returned to normal fairly quickly and went home by report. He presented to the ER shortly after with palpitations and shortness of breath and required a dose of IM epinephrine. Patient since had intermittent fatigue, dizziness, blurred and vision changes as well as tinnitus. On May 31, 2021, patient presented to the ER with headache, lethargy, weakness, diaphoresis and dizziness. Additionally, noted to have slurred speech by his wife. MRI of the brain done at 4 am on 5/31/21 showed the following "1. Acute bilateral cerebellar infarcts are seen with a right posterior 4.3 mm focus a left middle cerebellar peduncle 3.2 mm focus and a left superior cerebellar 7.9 mm linear focus. 2. Occlusion of the left vertebral artery extending into the basilar artery with reconstitution of the basilar artery via bilateral posterior communicating arteries. Findings are concerning for acute dissection occlusion. Consider further evaluation with MRA head and neck. 3. Question subtle area of restricted diffusion seen within the left dorsal medulla better appreciated on the maps measuring approximately 4.9 mm. Left lateral pontine 7.3 mm focus of restricted diffusion versus artifact. These infarcts are not definite and could be artifactual asymmetry.'. He required admission, heparin drip and neurology consult at that time, as well as permissive hypertension. shortly after 1 pm on May 31, he developed chest pain with ischemic changes on EKG requiring cardiology consult with possible intervention, though this was being coordinated with interventional neurology, as he also required basilar angiogram for his MRI findings. as cardiology and interventional neurology were coordinating taking patient for intervention, he became further unresponsive, though maintained his pulse, and required intubation and transfer to ICU, as well as repeat CT of the head to evaluate for continued thrombosis of his basilar system. Work up is still on going
44 2021-05-30 platelet count decreased, haemoglobin decreased, fibrin d dimer increased, low platelet count Pt presented to the hospital with abdominal pain and shortness of breath May 28, 2021 Noted to be t... Read more
Pt presented to the hospital with abdominal pain and shortness of breath May 28, 2021 Noted to be thrombocytopenic - had normal platelet 20 days prior Had bruising, melena
44 2021-06-02 fibrin d dimer increased, deep vein blood clot, heart attack, excessive bleeding, coughing up blood, pulmonary embolism, fast heart rate, superficial blood clot, troponin increased, ejection fraction decreased Patient developed episode of diarrhea shortly after 1st shot in series, this was followed by lowe... Read more
Patient developed episode of diarrhea shortly after 1st shot in series, this was followed by lower extremity swelling and mild dyspnea on exertion, that quickly exacerbated after the 2nd shot on 5/15/2021, that resulted in severe dyspnea on exertion, severe lower extremity swelling with approximately 25 lb weight gain, orthopnea and hemoptysis. Patient reported temperatures of 99.2 F to 99.8 F. Outside CT chest abdomen pelvis angiogram showed moderate to large acute segmental/subsegmental pulmonary emboli with trace right heart strain and right lower lobe pulmonary infarction, moderate right pleural effusion, acute splenic vein thrombosis with extension to the proximal portal vein and associated splenic infarcts, bilateral renal infarcts, and evidence of portal hypertension. He was transferred to the Hospital for further management. Upon presentation here he was tachycardic but with stable blood pressures and requiring up to 5 L by nasal cannula. Initial laboratory studies were notable for WBC 21.0, INR 1.8, D-dimer 11653, NT pro-BNP 17684, troponins 603 to 579 to 574, CRP 127. He was started on a heparin infusion. He was admitted to the MICU for further management. Bedside ultrasound demonstrated reduced biventricular contractility. He was given two doses of 40 mg intravenous furosemide with about 3.5 L of urine output since admission (net negative 3.1 L). His oxygen was weaned to 1 L by nasal cannula. Lower extremity venous and arterial Dopplers were negative. Subsequent imaging demonstrated a transperineal inferior infarct with akinesis of the inferior septum, inferior and inferior lateral walls with apical and mid ventricle akinesis secondary to a complete occluded RCA. moderate pericardial effusion without tamponade noted. Upper extremity ultrasound demonstrated acute DVT in the lower right IJ, innominate, subclavian and proximal axillary veins. MRI venogram was negative for clots, but multiple acute and subacute enhancing infarcts within all 3 vasculature distributions consistent with embolic etiology were noted. TTE showed of mural thrombus along the septal and inferior walls of the LV apex, severely enlarged left ventricle with EF of 20%, severe hypokinesis. Patient was aggressively IV diuresis, with improvement in respiratory status. Maintained on high-intensity heparin for pulmonary emboli, DVT, and diffuse arterial and venous thrombosis. He was bridged to warfarin. Patient was prescribed LifeVest for primary prevention. Started on beta-blocker and ACE-inhibitor given EF. Patient planning on discharge 6/5-6/07, outcome pending.
44 2021-06-03 heart rate increased A fast heartbeat Dizziness and weakness Injection site pain Tiredness Helada che Muscle pain Chilla ... Read more
A fast heartbeat Dizziness and weakness Injection site pain Tiredness Helada che Muscle pain Chilla Joint pain Náusea Feeling unwell SEOLLEIM lymph nodes
44 2021-06-05 oxygen saturation decreased, low blood oxigenation The day after getting the vaccine he began to feel like he had the flu. He progressed each day to b... Read more
The day after getting the vaccine he began to feel like he had the flu. He progressed each day to become weak and dyspneic. He became hypoxic with a pulse ox of 80%.
44 2021-06-09 pulmonary embolism On June 3rd, 2021 I was admitted to the hospital with multiple pulmonary embolisms in both lungs in ... Read more
On June 3rd, 2021 I was admitted to the hospital with multiple pulmonary embolisms in both lungs in multiple spots. No family history or any other medical history that would cause this.
44 2021-06-13 hypertension Patient stated loss of feeling in left traveling up arm to wrist and EMS was called. BP- 150/100 an... Read more
Patient stated loss of feeling in left traveling up arm to wrist and EMS was called. BP- 150/100 and oxygen sat 97% and Pulse 86
44 2021-06-13 heart attack, heart attack, chest discomfort, chest pain anterior STEMI admitted on 5/11/21 with left chest and arm pain. Underwent stent to LAD pt stated he... Read more
anterior STEMI admitted on 5/11/21 with left chest and arm pain. Underwent stent to LAD pt stated he developed chest discomfort and SOB a few days after his 1st moderna vaccine in Mid April
44 2021-06-16 loss of consciousness worst asthma attack he had ever had; unable to breathe; passed out/unconscious; cannot walk; lost we... Read more
worst asthma attack he had ever had; unable to breathe; passed out/unconscious; cannot walk; lost weight; has no muscle left; teeth chattering; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe) and LOSS OF CONSCIOUSNESS (passed out/unconscious) in a 44-year-old male 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 Intubation (The doctor told him that he would have died if they had not intubated him.) from 14-May-2021 to 21-May-2021. Concurrent medical conditions included Asthma (The patient had asthma since childhood.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALBUTEROL [SALBUTAMOL] for Asthma. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced ASTHMA (worst asthma attack he had ever had) (seriousness criteria hospitalization prolonged and life threatening), DYSPNOEA (unable to breathe) (seriousness criteria hospitalization prolonged and life threatening), LOSS OF CONSCIOUSNESS (passed out/unconscious) (seriousness criteria hospitalization prolonged, medically significant and life threatening), TREMOR (shaking) and CHILLS (teeth chattering). On an unknown date, the patient experienced GAIT DISTURBANCE (cannot walk), WEIGHT DECREASED (lost weight) and MUSCULAR WEAKNESS (has no muscle left). The patient was hospitalized from 14-May-2021 to 31-May-2021 due to ASTHMA, DYSPNOEA and LOSS OF CONSCIOUSNESS. The patient was treated with Physical therapy for Gait disturbance. On 21-May-2021, LOSS OF CONSCIOUSNESS (passed out/unconscious) had resolved. At the time of the report, ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe), GAIT DISTURBANCE (cannot walk), TREMOR (shaking), WEIGHT DECREASED (lost weight), MUSCULAR WEAKNESS (has no muscle left) and CHILLS (teeth chattering) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment information included many medications and physical therapy. 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
44 2021-06-17 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
44 2021-06-20 blood glucose increased, fast heart rate I felt my body ache initially then fever sometimes. Headache. I was developing Rashes on my body I ... Read more
I felt my body ache initially then fever sometimes. Headache. I was developing Rashes on my body I went to urgent care and they took a blood sample. At 8:30 PM I got a call from Dr the I have to visit urgent care immediately for a few more tests. Skin: Positive for rash (noticed rash on the trunk and abdomen yesterday. papular rash ). Neurological: Positive for weakness (feels tired and fatigued for last 2-3 days.). Negative for dizziness, tingling, numbness and loss of balance. Psychiatric/Behavioral: The patient does not have insomnia.
44 2021-06-20 chest pain Chest pains with cough, lasted a few days. No treatment, thought was normal until heard it was not.
44 2021-06-20 pallor Pt w/ no known drug allergies and no known medications. Pt has a hx of getting lightheaded w/ shots... Read more
Pt w/ no known drug allergies and no known medications. Pt has a hx of getting lightheaded w/ shots or blood draw. Pt was tingly, pale, and lightheaded immediately after vaccination. @ 13:20 BP 90/49, HR 66, RR 14 -- > @ 13:34 109/72, 61, 16 -- > @13:37 (sitting) 109/75, 60 & (standing) 126/85, 64. Pt stable and released from the vaccination site.
44 2021-06-21 loss of consciousness, chest discomfort Went to bed with the chills, never checked temperature. Woke up in the middle of the night with ches... Read more
Went to bed with the chills, never checked temperature. Woke up in the middle of the night with chest feeling heavy , was hard to breath, Sat up on edge of bed and then passed out and fell backwards in bed. Came to and passed out again. Came to again and took temperature and had 101.3 temp. Ran a fever and had chills for most of the day. Fever was gone by the following day and felt back to normal, just a little fatigued.
44 2021-06-22 palpitations, heart flutter Pt states heart fluttering, rush, feeling terrible run down. Still continuing, feels as though heart... Read more
Pt states heart fluttering, rush, feeling terrible run down. Still continuing, feels as though heart skips a beat ever so often, refuses medical care.
44 2021-06-30 chest pain Stomach , chest, side kidney, breathing . After 2nd shot continued feeling bad .
44 2021-07-02 hypertension, fainting Wound up in the ER with High Blood Pressure/Back in the ER with the same; Collapsed; Lupus in his ki... Read more
Wound up in the ER with High Blood Pressure/Back in the ER with the same; Collapsed; Lupus in his kidneys; Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis; Stomach Issues after second dose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed), LUPUS NEPHRITIS (Lupus in his kidneys), RENAL DISORDER (Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis), ABDOMINAL DISCOMFORT (Stomach Issues after second dose), HYPERTENSION (Wound up in the ER with High Blood Pressure/Back in the ER with the same) and HEADACHE (Headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A. and M20A) for COVID-19 vaccination. The patient's past medical history included Autoimmune disorder. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Issues after second dose) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 06-Jun-2021, the patient experienced SYNCOPE (Collapsed) (seriousness criteria hospitalization and medically significant), LUPUS NEPHRITIS (Lupus in his kidneys) (seriousness criteria hospitalization and medically significant) and RENAL DISORDER (Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERTENSION (Wound up in the ER with High Blood Pressure/Back in the ER with the same) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (Collapsed), LUPUS NEPHRITIS (Lupus in his kidneys) and RENAL DISORDER (Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach Issues after second dose), HYPERTENSION (Wound up in the ER with High Blood Pressure/Back in the ER with the same) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased. On an unknown date, Blood test: abnormal (abnormal) Diagnosed kidney malfunction. Concomitant product use was not provided by the reporter. Patient reported that he had hospitalized for 3 weeks with kidney failure and he was on dialysis. he also reported that his son diagnosed with lupus in his kidney. 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 event is not applicable. Company comment: 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.
44 2021-07-10 excessive bleeding It was an hemorrhage with broken veins; He had his right feet hot, swelling and purple; He had his r... Read more
It was an hemorrhage with broken veins; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. In April 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 HAEMORRHAGE (It was an hemorrhage with broken veins) (seriousness criteria hospitalization and medically significant), FEELING HOT (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) outcome was unknown. Concomitant product use was not provided by the reporter. The patient went to the hospital and was told that it was an hemorrhage due to broken veins and did not have clots. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. No treatment information was 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 was not applicable. Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.
44 2021-07-12 deep vein blood clot, pulmonary embolism I developed a DVT in my lower left leg, which I noticed from the swelling, warmth and pain. Then, a ... Read more
I developed a DVT in my lower left leg, which I noticed from the swelling, warmth and pain. Then, a few days later, on a Sunday so my Dr's office was closed, I started having extreme difficulty in my breathing. I went to the ER and, after having multiple testing, was diagnosed with the DVT and a PE in each lung (almost to the point of full blockage). I was kept in the hospital overnight so they could monitor my breathing to be sure I wasn't stopping breathing throughout the night. I'm now on blood thinners for life.
44 2021-07-15 palpitations Heart palpitations, memory loss, difficulty concentrating, shortness of breath, depression, anxiety
44 2021-07-17 fainting to receive the second is to far out from his first dose since he got it on 03Mar2021; chills; Fever;... Read more
to receive the second is to far out from his first dose since he got it on 03Mar2021; chills; Fever; headache; Light headed; Collapsed; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (COVID -19 in December of 2020 but was not hospitalized.) in December 2020. Concomitant products included VALSARTAN for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SYNCOPE (Collapsed) (seriousness criterion medically significant). On 04-Mar-2021, the patient experienced DIZZINESS (Light headed) and HEADACHE (headache). On 05-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (to receive the second is to far out from his first dose since he got it on 03Mar2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SYNCOPE (Collapsed), DIZZINESS (Light headed), PRODUCT DOSE OMISSION ISSUE (to receive the second is to far out from his first dose since he got it on 03Mar2021), HEADACHE (headache), CHILLS (chills) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102-103 (High) fever around 102-103 degrees. In 2021, Blood pressure measurement: low (Low) Low. In 2021, Heart rate: low (Low) Low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient collapsed in a restaurant booth around 6:50pm and had to go to ER and it was found that his pulse and Blodd pressure was low. But the ER could not come to a conclusion of what caused him to collapsed. His primary care doctor referred him to a cardiologist to make sure everything was okay but he determined that his medication needed to be changed. On 04Mar2021 he felt light headed and on 05Mar2021 her had a fever around 102-103 degrees, chills and used Tylenol to break the fever. The patient could only work half a day both days. On Saturday the patient felt fine and the next week would have spells of lightheadedness that would cause him to have to sit down. Company Comment: This report refers to a case of Product dose omission issue with adverse events of syncope, dizziness, pyrexia, headache and chills in a 45-year-old male patient. Reportedly, the patient experienced syncope, dizziness, pyrexia, headache and chills after the administration of the first dose of Moderna COVID-19 Vaccine, and based on the current 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 causality for the product dose omssion issue is not applicable.; Sender's Comments: This report refers to a case of Product dose omission issue with adverse events of syncope, dizziness, pyrexia, headache and chills in a 45-year-old male patient. Reportedly, the patient experienced syncope, dizziness, pyrexia, headache and chills after the administration of the first dose of Moderna COVID-19 Vaccine, and based on the current 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 causality for the product dose omssion issue is not applicable.
44 2021-07-22 hypotension, fainting Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt received first shot setting down. When advised to move to obseration area and pharmacist walked back to pharmacy, pt fainted. Pt was hot, sweaty, and has low BP. EMT was called and pt was resolved and alert after several minutes. Pt was evaluated by EMT and cleared and left on his own.
44 2021-07-27 inflammation of the heart muscle I had an EKG done on Monday, 26 July and when I saw my primary care physician today, July 28 for pr... Read more
I had an EKG done on Monday, 26 July and when I saw my primary care physician today, July 28 for pre-op for a shoulder surgery scheduled for August 10th, the doctor told me my EKG was abnormal and it shows signs of myocarditis (enlargement of heart)
45 2021-01-04 very slow heart rate Patient went unresponsive and bradycardic post vaccine. Regained responsive within 30 seconds.
45 2021-01-04 chest discomfort, blood pressure increased Recipient reported chest tightness on one side then the other. Blood pressure was checked- 162/103. ... Read more
Recipient reported chest tightness on one side then the other. Blood pressure was checked- 162/103. The recipient was escorted to our facility's outpatient clinic. He reports receiving medication for the blood pressure and being monitor for a few hours but his blood pressure did not decrease. He was encouraged to visit his PCP.
45 2021-01-04 nosebleed After my shot Inhad a lot of energy and felt fine during the day. At night I was shaking uncontrolla... Read more
After my shot Inhad a lot of energy and felt fine during the day. At night I was shaking uncontrollably. drank water and took tylenol. Fell asleep and woke up soaking wet. Next day I still had a fever. Had chills and my body got warm. This went off and on throughout the day. I was exhausted. At night I had a bloody nose. Went to bed and woke up wet again but not as bad as the first night. Morning time I felt fine. Went to the gym and the sauna. Started to exercise and felt lighted headed and cloudy. Went home laid down. I still feel weird on and off. Went to the bathroom and had black stool. My right arm is still sore.
45 2021-01-05 chest discomfort Onset of symptoms: 01/04/2021@12:00PM Temperature: 102F Fatigue, muscle ache, diarrhea, nausea, "hea... Read more
Onset of symptoms: 01/04/2021@12:00PM Temperature: 102F Fatigue, muscle ache, diarrhea, nausea, "heaviness in the chest" Individual was tested yesterday to rule out COIVD19 with PCR (molecular test) and the antigen test. Both test came back today: negative.
45 2021-01-06 palpitations, hypertension Palpitations & Hypertension
45 2021-01-07 chest pain Shortness of breath, coughing, some deep chest soreness. Worse when laying down in any position. Be... Read more
Shortness of breath, coughing, some deep chest soreness. Worse when laying down in any position. Began using Albuterol this morning (approx 3 hours ago) with no change in symptoms.
45 2021-01-07 palpitations SkinRash, Rash, NauseaVomiting, Palpitations, Feeling "hot" and "clammy" Narrative: Employee receive... Read more
SkinRash, Rash, NauseaVomiting, Palpitations, Feeling "hot" and "clammy" Narrative: Employee received vaccine around 10:30am. At around 10:45 employee reported palpitations, nausea, headache, and feeling "hot" and "clammy". BP 193/119 with a HR of 95. After 15 mins of rest, employee continued to feel poorly reporting a slight worsening of symptoms. Face appeared very flushed. BP on recheck 193/112 with a HR of 105. Employee escorted to ED for evaluation at this time. In ED, employee developed full body rash. Was given 50mg IVP benadryl and 125mg IVP methylprenisolone in addition to 1L of Lactated Ringers- all with symptom improvement. Allergy/Immunology consulted. Recommend serum tryptase level. If elevated, advised that employee should not receive second vaccine dose. Employee discharged home with RX for epi-pen, prednisone, and cetirizine. Of note, employee reports a history of Thalassemia. Has a hx of hives with PCN and a rash with cipro.
45 2021-01-08 chest discomfort Confusion, Headache, Myalgia, Arthralgia, Swelling and pain at the injection site, fatigue, tingling... Read more
Confusion, Headache, Myalgia, Arthralgia, Swelling and pain at the injection site, fatigue, tingling, feeling of heat in feet, chest tightness, eye pain Narrative:
45 2021-01-08 loss of consciousness, pallor Pt received Covid-19 vaccine at 1300. After no reportable symptoms for approximately 2 hours, report... Read more
Pt received Covid-19 vaccine at 1300. After no reportable symptoms for approximately 2 hours, reported back to immunizations for additional vaccine. After administration of last vaccine, pt leaned head back (pt was seated), eyes rolled in back of head, and appeared pale and diaphoretic. After a few seconds, pt regained consciousness. Pt continued to rest with legs propped up and cold compress on neck. VS were taken following event: BP 115/80. SPO2 93%, T 96.8, R 16. Pt reports hx of "passing out" with blood draws and previous vaccinations. Provider visited with pt and was okay to leave facility.
45 2021-01-10 chest discomfort All symptoms occurred at the 12-24hr mark: metallic taste, chest tightness, limb (needle like) itchi... Read more
All symptoms occurred at the 12-24hr mark: metallic taste, chest tightness, limb (needle like) itching, cold sweats, body ache/pain, chills, nausea. All symptoms resided except for malaise after the 24hr mark. Malaise current through today(11JAN21)
45 2021-01-10 heart rate irregular, chest pain 8JAN21- 1630 - 1730 - light headed, sporadically saw stars every 2 seconds, in wave pattern. 2000-24... Read more
8JAN21- 1630 - 1730 - light headed, sporadically saw stars every 2 seconds, in wave pattern. 2000-2400- Did not sleep well. Felt dizzy, light headed. Loud ringing in ears. Buzzing of head. 9JAN2021 -Cold sweat, nauseous, prickly pin and needles come and go in hands, arms, legs, and feet. Sharp 2 second knife pains in chest and sides come and go. Strong metallic taste in mouth, even water taste metallic. slight numbness feeling in arms and legs. Very fast heart beat when standing up (120). Immediately drops (to 80) when I lay down. Very loud ringing in ears and buzzing in head. Extreme weakness in muscles. Very fatigued. 10JAN2021 Feeling a little better. Still light headed and slight ringing in ears and buzzing in head. 11JAN2021 Even better but still slight buzzing in head. Very tired and fatigued. Injection site on arm was normally sore (like flu shots). NO headache. NO fever.
45 2021-01-12 ischaemic stroke Patient received vaccine in afternoon of 12/28. She works in ER as housekeeper 7pm-7am. The day she... Read more
Patient received vaccine in afternoon of 12/28. She works in ER as housekeeper 7pm-7am. The day she received the vaccine she became ill with fever chills and nausea and left work at 2am. On 12/31 she developed hemianopia. She went to ER and they did CT scan. She was told it was complex migraine. She left and came Home. On 1/1/21 her vision was back to normal. On 1/3 she suffered bilateral cerebellum ischemic stroke. She is currently in medical center. In Trauma.
45 2021-01-13 blood pressure increased, heart rate increased Within 1 minute of receiving vaccination, heart rate increase to over 145 bpm. Blood pressure incre... Read more
Within 1 minute of receiving vaccination, heart rate increase to over 145 bpm. Blood pressure increased significantly. Began sweating profusely. Developed a very dry mouth and high rate of breathing. Lasted for about 20-30 minutes and then returned to normal.
45 2021-01-13 heart rate increased Patient complained of lightheadedness and elevated heart rate. Vital signs taken. No further complai... Read more
Patient complained of lightheadedness and elevated heart rate. Vital signs taken. No further complaint of headache after 10 minutes, heart rate had slowed. Increased wait time and patient left on own accord.
45 2021-01-13 lightheadedness, palpitations, fast heart rate I experienced tachycardia, almost lost consciousness in the early morning of 1/13/21. I had to call ... Read more
I experienced tachycardia, almost lost consciousness in the early morning of 1/13/21. I had to call 911. When EMT's arrived about 10 minutes, my heart rate went down to 100bpm. I decided not to go to hospital and just continue observation. I still have a feeling of increased nervousness and palpitation in my chest today.
45 2021-01-14 blood pressure increased Client complained of dizziness. He reported to have eaten an apple pie before getting vaccinated. H... Read more
Client complained of dizziness. He reported to have eaten an apple pie before getting vaccinated. He stated that he forgot to take his Xanax this morning. BP at 2:40p 144/106 pulse 108, encouraged to rest. BP repeated at 03:05 136/99 pulse 103 . Client felt better. Encouraged to rest at home and contact PCP in case of adverse reactions.
45 2021-01-14 heart rate increased Vaccine was administered to patient in his room at 12:50pm. After the patient finished his lunch in... Read more
Vaccine was administered to patient in his room at 12:50pm. After the patient finished his lunch in his room he was wheeled out to the nursing station for observation. at 1:30pm the nurse wheeled patient into our working/set up area and stated that patient is having a vaccine reaction. I observed that his lips were noticeably swollen. I asked patient to stick out his tongue, it also was noticeably swollen. Only the tip of his tongue extended about 1/2 inch past his lips. I administered 0.3mg of Epinephrine via and epi-pen into his right thigh and instructed the nursing staff to call 911. Patient improved markedly over the next 10 minutes when Fire Department EMT's arrived. Nursing staff monitored his blood pressure, heart rate and pulse and oxygen sat. heart rate was elevated somewhat likely due to epi , BP was 121/73, pulse steady and ox sat good. Fire Department transported patient to a nearby ER for further evaluation and treatment if necessary.
45 2021-01-14 hypotension, pallor I became very clammy in the hands and started to black out just 10 minutes after having the vaccinat... Read more
I became very clammy in the hands and started to black out just 10 minutes after having the vaccination shot. I was in the waiting room. The staff member monitoring saw me going to the floor and called the head doctor over to help. They called EMT's. I was laid onto the floor on my back and legs up onto a chair. The staff took my blood pressure which was low. Approximately, 2 minutes later, they took my blood pressure and it went back up to a more normal level. The EMT's helped me up and took my blood sugar levels and pulse oxygen levels which seemed normal. I was able to feel better, but the color of my skin was yellowish and pale. The EMT's suggested that I talk with my doctor before getting another vaccine and talk about my symptoms.
45 2021-01-23 pallor, fainting At 12:30 i was lying in bed and started getting more and more restless. I could feel something hap... Read more
At 12:30 i was lying in bed and started getting more and more restless. I could feel something happening with my body on the inside like a storm. I got up to use the bathroom and had a syncopal episode about halfway to bathroom. Fell and i came to immediately when my name was called. I got back into bed. My lips were white. I still felt lightheaded but could breathe freely and easily. There was no noticeable swelling impairing my breathing. Initially i could not get a reading on my pulse oximeter. After a few minutes it worked and by then i was at 95%. I suspect the oxygen was quite low prior to that. For the next day i had a fever and farigue. The day after that I had some lingering fatigue but no fever. Right now I am not planning to get the second shot in the series.
45 2021-01-26 chest pain Chills , chest pain , pain on joints , urinary frecuency , pain on testicles
45 2021-01-27 blood pressure increased During the 15 minute post vaccination observation period patient developed a significant headache an... Read more
During the 15 minute post vaccination observation period patient developed a significant headache and did not feel well. His blood pressure was taken - 190/130 - and he was placed on a gurney in the vaccination area for observation. His blood pressure continued to remain elevated with a persistent headache. He was taken to the emergency department for further workup - triaged there at 1317 with a BP of 190/114. Medications given: APAP 1000mg p.o at 1335. Hydralazine 10mg IV at 1335. Hydralazine 25mg p.o. at 1350. Hydralazine 25mg p.o. at 1530. Discharged in stable condition to home at 1553 with a new prescription for Hydralazine 50mg TID (double his previous dose). Dx included non-compliance and anxiety.
45 2021-01-27 fast heart rate Fever 101.8, Tachycardia, dizziness, Severe malaise, Severe Right sided abdominal pain with peritone... Read more
Fever 101.8, Tachycardia, dizziness, Severe malaise, Severe Right sided abdominal pain with peritoneal signs and tenderness in right upper and lower quadrant. Symptoms started approx 12 hrs after the injection and persisted till 50 hrs post injection. Symptoms were so intense that I had to take 3 days off from work
45 2021-02-01 blood clot, fibrin d dimer increased, chest pain, pulmonary embolism On 1/28/2021 at 0545 hours as I was on my way into work when I started to have severe right side che... Read more
On 1/28/2021 at 0545 hours as I was on my way into work when I started to have severe right side chest pain, so much so that I had to pull over. Shortly thereafter ambulance arrived on scene at which time it was determined that I would be transported to the hospital. Once there, a series of tests were conducted, one of which was a D-Dimer blood test to rule out blood clots. That resulted in an elevated count to which a CT scan was ordered. The result of the CT scan revealed that I had 2 Pulmonary Embolisms, one in the upper lobe of my right lung and one in the middle lobe of my right lung. Due to me being what the doctors said was a healthy 45 year old with no underlying conditions or signs of DVT (deep vein thrombosis) they deemed me low risk at that time and advised I was at low risk of dying in the next 30days. However, they advised that at any time, the clot could possibly become dislodged and cause worse problems, possibly death if time is not given to the body to dissolve the clots. Ultimately it was determined that I be discharged and prescribed blood thinning medications to help thin the blood to prevent further clotting should I have a clotting issue (undetermined at this time).
45 2021-02-02 chest discomfort Muscle pain in both legs, joint pain in both legs, chills, tight chest (used my inhaler 2x with 2 sh... Read more
Muscle pain in both legs, joint pain in both legs, chills, tight chest (used my inhaler 2x with 2 shots each time (albuterol sulfate, 90mcg)) Took first dose of 2 Ibuprofen (200mg each) at 1am then second dose of 2 Ibuprofen (200mg each) at 5am. All symptoms subsided accept for the chest tightness by 730 am on 2/3/2021. Chest tightness is fine and not of concern currently and treated with inhaler.
45 2021-02-02 chest pain Pain from injection went to chest, headache, now has cough with runny nose, itchy throat, no tempera... Read more
Pain from injection went to chest, headache, now has cough with runny nose, itchy throat, no temperature.
45 2021-02-03 fainting, loss of consciousness Approximately 12 hours after my 2nd injection of the Moderna COVID19 vaccine, I experienced severe n... Read more
Approximately 12 hours after my 2nd injection of the Moderna COVID19 vaccine, I experienced severe nausea and ended up having an episode of syncope where I passed out on the stairs in my home.
45 2021-02-05 palpitations, heart rate increased I had muscle aches to the point where it felt like the chest and back were caving in at the same tim... Read more
I had muscle aches to the point where it felt like the chest and back were caving in at the same time. I had fast heart palpitations. I got dizzy and felt weak at points. I went to the Doctor and it was also determined that I was wheezing when he checked my lungs. He prescribed me a 30 day usage of the Albuterol Sulfate pump to help with the wheezing 3x a day.I saw the doctor January 23rd.3 days after receiving the Moderna Covid-19 Vaccine EUA.
45 2021-02-08 excessive bleeding, loss of consciousness Patient was in observation post vaccine and pharmacist saw patient looking different and began to ca... Read more
Patient was in observation post vaccine and pharmacist saw patient looking different and began to call out SIr Sir as pharmacist was making way to chair when patient fell forward onto floor and hit his head on a display of cold medicines. Pharmacist and another associate helped patient up who was conscious. He asked what happened and if he were standing. He shared that everything went pitch black. He was placed on chair; pharmacist asked if he wouldl like to lie down and he declined. He stated he had felt nervous and scared about imz before his appointment. Patient did cut his lip in fall and was given napkins for bleeding and a cold compress for face and neck. Patient waited with us for 2 hours. His BP was 154-74 and pulse of 54 ; patient stated he was a runner with low pulse. Patient arranged for a ride from family member since he lived far and was not sure about driving. I recommend that he place a call in with his provider.
45 2021-02-10 cardiac arrhythmia, heart flutter Noticed increase in heart flutter while lying down but patient unsure if he felt flutters before vac... Read more
Noticed increase in heart flutter while lying down but patient unsure if he felt flutters before vaccine
45 2021-02-12 fast heart rate Patient reports squeezing kidney pain x 12 hours, red itchy flat rash on trunk, tachycardia, headach... Read more
Patient reports squeezing kidney pain x 12 hours, red itchy flat rash on trunk, tachycardia, headache and warm red injection site.
45 2021-02-16 chest pain complaint of chest pain, patient sent to ER and hospital admission 2/10/21 to 2/11/21. advanced car... Read more
complaint of chest pain, patient sent to ER and hospital admission 2/10/21 to 2/11/21. advanced cardiac imaging found old arterial occlusion with collateral perfusion,no stent ,no surgical intervention.
45 2021-02-25 fast heart rate, hypotension Diffuse urticarial rash, fevers, tachycardia, transient hypotension, body aches
45 2021-02-28 fainting Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for a brief moment after... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for a brief moment after he received the COVID vaccine. Called 911 to have him checked out.
45 2021-03-06 palpitations, heart rate increased I have had a low grade fever (99.5) for a week now. I have had insomnia since the night of the inj... Read more
I have had a low grade fever (99.5) for a week now. I have had insomnia since the night of the injection. EVERY night I wake up hot 3 hours after I went to sleep. I have never gotten the chills, only hot. I usually need to take a sleep aid to get back to sleep which is NOT normal for me. Many times I wake up again 3 hours later even after the sleep aid hot. My lack of sleep has really been hard on my daytime working and living at this point. When I wake at night hot my temperature is usually 99.5, but has been a bit lower at times too. I also feel that I have rapid heart rate at this time (when I try to fall back asleep) and it seems as if my heart is beating harder than normal. I also feel a buzzing in my head like I drank too much coffee type of feeling. The first couple of days I felt tired and weak and a bit achy throughout the day. The next few days after that I felt dizzy and light headed with a headache. The first few days I also noticed slight muscle spasms throughout my arms and torso particularly when I laid down at night to go to bed and was still and relaxed. I have been taking over the counter pain/fever pills usually for the headache. I contacted my doctor and he said to give it a week. It has been a week yesterday, but Dr is closed for weekends and Fridays. I went to urgent care on Friday and they were not helpful (virtually). They said give it 5 more days!!!!! I am extremely tired of this and worried at how long it has been. NOBODY I know with the first shot has had this reaction. My wife is nervous as well and we would really like to hear something that may ease our minds at this point. Some explanation as to why my body may be reacting this way, or if any others have had this same situation.
45 2021-03-07 chest pain After receiving my shot, I waited the half an hour. I felt a pinch in my head and tightness in shoul... Read more
After receiving my shot, I waited the half an hour. I felt a pinch in my head and tightness in shoulders and neck. Once I reached the parking lot I was belching ridiculously and started feeling like vomiting. Than my chest hurt. Went back to the clinic and said I don't feel right. They had me stand in line and wait to be re-admitted. The nurse starting taking blood pressure and offered me water I could not swallow the tiniest amount. My neck felt like I was being chocked. My fingers on my left arm started tingling and arm was getting slightly red and arm felt heavy. The nurse said my symptoms were happening internally. The doctor had me remove my mask and looked at the back of my mouth. Than used a stethoscope on my chest and the back. Asked if I had asthma , said no. He Than requested epinephrine shot and a steroid. With in a few seconds I started feeling like I could breathe. He prescribed an epinephrine pen incase I had another episode. Two day later I had another visit online with doctor from about redness on left and right arm. Having another allergic reaction and possible site infection. Now I'm taking 10 days antibiotics and allergy medicine.
45 2021-03-10 heart rate increased Starting around 8pm on the day of the injection, I had the chills and was excessively tired. By the... Read more
Starting around 8pm on the day of the injection, I had the chills and was excessively tired. By the time I went to bed, I developed a fast heartbeat (similar to anxiety spells), front temple head ache, body aches, lethargic feeling.
45 2021-03-11 heart rate irregular Irregular heartbeat for 1-2 days beginning the morning after the vaccine. I also ran 15 strenuous mi... Read more
Irregular heartbeat for 1-2 days beginning the morning after the vaccine. I also ran 15 strenuous miles that morning but I run almost every day.
45 2021-03-11 fainting SUBJECT BECAME FAINT, DIAPHORETIC AND NAUSEATED ABOUT 5 MINUTES AFTER RECEIVING THE 2ND DOSE OF THE ... Read more
SUBJECT BECAME FAINT, DIAPHORETIC AND NAUSEATED ABOUT 5 MINUTES AFTER RECEIVING THE 2ND DOSE OF THE VACCINE.
45 2021-03-14 loss of consciousness High fever/ chills to increased 104.6 on 2nd day , not controlled by 400 g of ibuprofen and 500 mf ... Read more
High fever/ chills to increased 104.6 on 2nd day , not controlled by 400 g of ibuprofen and 500 mf of Tylenol. Finally additional 500.mg was taken in 4 hrs span to break the fever. Severe body aches and inability to sleep. Next day was better qith fever only raging to 100 deg. 4rh day, Monday went to work feeling very weak. Passed out suddenly an hour into work, luckily passed out sitting in chair. 911 was called, all things normal , except weakness, aching, dizziness, Declined er transfer.
45 2021-03-14 loss of consciousness Felt extremely warm, started feeling lightheaded, started sweating profusely, vision started blackin... Read more
Felt extremely warm, started feeling lightheaded, started sweating profusely, vision started blacking out, got very close to blacking out and fainting. I was seated at the time, waiting the 15 minutes for observation after the shot, symptoms happened about 10 minutes into the waiting period. I was given some cold water right away, over the next 10 minutes my vision started coming back and I stopped sweating. Was told I looked flush when they first came over but was looking much better after another 10 mins. I stayed an additional 30 minutes for observation after the event and had friends come take me home and get my car. I'm still feeling very slightly light headed and somewhat tired 2 days later, but otherwise feeling great.
45 2021-03-15 loss of consciousness I blacked out after awaking, brushing teeth, and urinating. I had been standing for 3-4 min before p... Read more
I blacked out after awaking, brushing teeth, and urinating. I had been standing for 3-4 min before passing out. Conclusion presumed from symptoms the following day. I also had a welt and abrasion on head, and split upper lip.
45 2021-03-18 nosebleed I had a nosebleed about 1 hour after the shot. I just had an unexpected another nosebleed on 3/19 at... Read more
I had a nosebleed about 1 hour after the shot. I just had an unexpected another nosebleed on 3/19 at 12:00.
45 2021-03-20 heart rate increased Fast heart rate; rash/ redness - chest, neck, face; feeling hot; feeling dizzy; feeling lump in thro... Read more
Fast heart rate; rash/ redness - chest, neck, face; feeling hot; feeling dizzy; feeling lump in throat; feeling stomach nausea
45 2021-03-20 fainting syncope after receiving vaccination
45 2021-03-22 loss of consciousness Body aches in left shoulder, overnight nausea. These adverse reactions are not so concerning becaus... Read more
Body aches in left shoulder, overnight nausea. These adverse reactions are not so concerning because I have heard how commonly these are experienced. What is most concerning is that I woke up at 3:30 AM feeling nauseous and made my way to the bathroom as a result. At some point, once entering the bathroom, I lost consciousness and when regaining consciousness saw that I had pulled the entire toilet off the floor, cracking the large reservoir and breaking the lid into several pieces. Water was spraying and leaking. Fortunately, I did not suffer a bruise or cut. I am, however, concerned whether I should expect to lose consciousness again.
45 2021-03-25 loss of consciousness A spontaneous report was received from a Consumer concerning himself, a 45-years-old male patient wh... Read more
A spontaneous report was received from a Consumer concerning himself, a 45-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced uncontrollable extreme abdominal pain/abdominal pain, cold sweats/cold sweat and passed out/loss of consciousness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) in his left upper arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced uncontrollable extreme abdominal pain, and passed out. He also had cold sweats. Lab data was not provided. No treatment was taken, just rehydrated. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events -uncontrollable extreme abdominal pain, cold sweat and passed out so badly was considered resolved within 24 hours on 16 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
45 2021-03-29 blood pressure decreased, loss of consciousness 10 min after vaccination became diaphoretic, decreased level of consciousness, decreased BP EMS cal... Read more
10 min after vaccination became diaphoretic, decreased level of consciousness, decreased BP EMS called to site, client stabilized and refused transport to hospital.
45 2021-03-29 hypotension 2.5 days post vaccination, patient had a seizure due to extremely low blood pressure. This was most... Read more
2.5 days post vaccination, patient had a seizure due to extremely low blood pressure. This was most likely due to an adverse reaction to the prescriptions that were prescribed to him post surgery. He was taken to the ER and admitted to the hospital for 2 days. All tests - other than blood pressure of 80/38 on a man with high blood pressure, were normal.
45 2021-03-29 fainting Approximately 5 minutes after vaccination, complained of dizziness, without other symptoms. He then... Read more
Approximately 5 minutes after vaccination, complained of dizziness, without other symptoms. He then lost consciousness for approximately 30 seconds. EMS was called. At the time, his pulse oximeter reading was 98 %, his pulse was 55 and his blood pressure was 150/80. Once he became responsive, he was oriented to person, place and time. Once EMS arrived two minutes later, consented to enter ambulance for evaluation. With confirmation of stable vital signs, and his evaluation complete, refused further care and left the parking lot on his own accord.
45 2021-03-29 fainting Anxiety Syncopal episode 2 lasting several minutes apart.
45 2021-03-30 pallor Patient waiting his 15 minutes after receiving 1st dose. Became limp in chair, face pale. He respond... Read more
Patient waiting his 15 minutes after receiving 1st dose. Became limp in chair, face pale. He responded to his name and other simple questions within 30 seconds of onset but continue to appear pale and reported feeling light headed. Stated that he has fainted before after giving blood, etc; His blood pressure then was 110/60 and pulse 68-72. @nd blood pressure a few minutes was 82/40. He continued to feel light headed with nausea. Decision was made to take him to the Emergency department as vaccine clinic was in hospital. Patient was admitted then to the Emergency room.
45 2021-03-31 cerebrovascular accident Stroke
45 2021-03-31 coughing up blood I started coughing up specs of blood out of the blue. Called doctor and they said to watch it. Lat... Read more
I started coughing up specs of blood out of the blue. Called doctor and they said to watch it. Later that night I started coughing up Tablespoons of fresh blood that wouldn't go away. Took ambulance to ER. CAT Scan showed an inflammation in lung and showed source of bleeding. They diagnosed me with pneumonia though I had no other symptoms (no fever or elevated white count, cough, or anything). Gave me IV antibiotics and sent me home with more antibiotics. Following up with a GP next week and asking to see a pulmonary specialist.
45 2021-04-03 brain sinus blood clot The patient is a 45 y/o male prisoner who presented 4/3/2021 with 3 days of headache, neck pain and ... Read more
The patient is a 45 y/o male prisoner who presented 4/3/2021 with 3 days of headache, neck pain and stiffness, sensitivity to light, and nausea. He was found to have extensive dural venous sinus thrombosis causing the symptoms. He has hypothyroidism was taking levothyroxine 150 mcg daily at time of vaccination. On admission on 4/3/2021 his TSH was found to be 12 and levothyroxine dose was increased to 175 mcg on 4/4/2021. He has no prior history of thrombosis and the only family member with thrombosis is his mother who had DVTs associated with lung cancer. He has a history of prior COVID-19 infection in April of 2020 and at that time reported 3-4 days of mild symptoms and was not hospitalized or given anticoagulation. He has not had fevers, chills, or other symptoms of infection. He received his first dose of the Moderna COVID-19 vaccine at the prison on 3/23/2021 which was 9 days prior to symptom on set 12 days prior to presentation at the hospital. He reports 2-3 days of arm soreness at the injection site in his right arm, mild neck soreness, and fatigue after the injection which had resolved prior to his current symptoms starting. He currently remains hospitalized and is being treated with anticoagulation.
45 2021-04-04 lightheadedness, loss of consciousness Moderna COVID-19 Vaccine EUA first dose given at 6pm. Mild pain at injection site within a few hour... Read more
Moderna COVID-19 Vaccine EUA first dose given at 6pm. Mild pain at injection site within a few hours. 3am (9 hours after injection) I went to the bathroom, and while standing got dizzy and lightheaded tried to sit down. Collapsed while trying to sit down and hit head on bathroom floor. Cut right eyebrow on floor. Tried to get back to bed and was in and out of consciousness for 30-60 seconds per spouse. Vasovagal response symptoms. Cold sweats. I was very thirsty and drank a tall glass of water. 5 minutes later I stood up and went back to bed feeling fine. I slept the rest of the night and felt fine the next day, and for the rest of the weekend with no other symptoms.
45 2021-04-05 excessive bleeding, blood clot I had an extensive oral surgery about 36 hours after getting the vaccination. I had non profuse blee... Read more
I had an extensive oral surgery about 36 hours after getting the vaccination. I had non profuse bleeding after the surgery. I experience a condition called Liver Clot (currant jelly clot). This condition and the bleeding continued for over 5 days following the surgery or 6.5 days after the vaccine dose 1.
45 2021-04-07 heart rate increased After first dose I experienced severe L shoulder pain for 2 days. Couldn't move it well, could not s... Read more
After first dose I experienced severe L shoulder pain for 2 days. Couldn't move it well, could not sleep on it. Pain started 4h after injection. After second dose I started experiencing L shoulder pain after 40 minutes. Pain was so severe I could not put my hand into the packet. In the evening the same day I started running temperature 101F that last 3 days non stop. I started experiencing severe chills, could not stop at times shaking! I was hot and cold every so often. I started experiencing same evening severe body ache which was constant and felt like I was squeezed by some machine. I could not sleep, I felt just terrible, couldn't find comfortable position. My heart beat resting was 110 per minute and it stayed like that first night. My normal resting pulse is 60-70 bps. I did not have headaches or nausea. At night everything felt worse. After 3 nights temperature subsided but I was exhausted and my temperature dropped 95.9F my normal temperature is 97.88F. ( 36.6C) . Since April 2nd I have been tired and I want to sleep all the time.
45 2021-04-12 nosebleed Nose bleeds commenced daily in the mornings and evenings 2 days after. Headaches are frequent. Const... Read more
Nose bleeds commenced daily in the mornings and evenings 2 days after. Headaches are frequent. Constant tiredness and fatigue. Second shot if booked for April 20th - need to know if this will be safe No temp, no fever, no loss of taste
45 2021-04-12 loss of consciousness, fainting Soon after injection I developed soreness at injection site, and about an hour later it travelled do... Read more
Soon after injection I developed soreness at injection site, and about an hour later it travelled down my arm and to my hand, with also arm stiffness. On Monday, 4/12/2021 at 12:15am (about 6 hours after injection) I developed chills and body aches. Throughout the night I also developed a headache, muscle aches, nausea and started sweating. At 9am (4/12/2021) when I woke up, all the symptoms continued (chills, body aches, muscle aches, arm soreness and stiffness, headache, nausea) and also felt extreme tiredness. My temperature at 9:15am was 100.4 degrees F. I basically stayed in bed and slept most of the day. I got up at 2:30pm to get something to eat and had a temperature of 101 degrees F. After eating, which made me feel even more nauseous, I went back to bed and continued to sleep. I woke up at 7:30pm to feed the cats. I felt the same as I did at 2:30pm--listed above--and was up and about for 20 minutes. I started to prepare a quick meal and fainted twice (around 8pm) within a minute from each other. The first time I fell to my knees and the second time I felt onto my back. I was unconscious for only a few seconds each time. I went into bed after and placed an ice pack on my forehead. I took my temperature after the ice pack at 8:15am and my temperature was 101.4 degrees F. I ate soup around 8:45am and took Tylenol (1000mg) at 9:30am. I went back to bed and slept all through the night. This morning (4/13/2021--2 days after injection) I feel much better--only have some slight chills and arm soreness. My temperature at 9:15am (4/13/21) was 95.7 degrees F.
45 2021-04-13 heart rate increased, blood pressure increased, palpitations Patient has a history of anxiety. Patient complained of feeling a fast heart rate, stated heart was... Read more
Patient has a history of anxiety. Patient complained of feeling a fast heart rate, stated heart was "racing". Heart rate 110 initially. After 5 minutes of rest, heart rate was 81. Blood pressure was elevated (150/100, 5 minutes later 144/91), with no history of hypertension. Denies any other symptoms. Patient felt better and left the clinic.
45 2021-04-13 loss of consciousness Patient reports feeling dizzy, lightheaded, passed out 3 times, clammy, anxious. EMS assessed patie... Read more
Patient reports feeling dizzy, lightheaded, passed out 3 times, clammy, anxious. EMS assessed patient, BP:84/63, pulse 41, spo2 97-99%, BS 154, second set of v/s; BP: 99/66, pulse: 52, third set of v/s; BP: 105/68, pulse: 63-75. Patient reports he has history of passing out with needles , he reports feeling better, symptoms improved, refused transport to ER, he was cleared by EMS.
45 2021-04-13 pallor, fainting Patient experienced vasovagal syncope x4. Blood pressure 90/60, skin clammy and pale. Patient was la... Read more
Patient experienced vasovagal syncope x4. Blood pressure 90/60, skin clammy and pale. Patient was laid down with feet elevated and provided a cool compress. Patient's blood pressure reached 118/72 and reported feeling better. Patient was transported via ambulance to the Hospital for further evaluation. Patient required no treatment at the hospital and was discharged home to care of self.
45 2021-04-14 cerebrovascular accident Stroke
45 2021-04-14 fast heart rate 1 minutes post inoculation: Tachycardia with HR 160BPM & left arm swelling. Pt states feeling "gene... Read more
1 minutes post inoculation: Tachycardia with HR 160BPM & left arm swelling. Pt states feeling "generally unwell." Anxious mood. Meds administered during ED visit: Sodium Chloride 0.9% bolus 1L IV; famotidine 20mg IV; diphenhydramine 50mg IV During ED visit VS: BP 123/76, Temp 98.2F oral, HR 84, RR 16, SpO2 100% on RA.
45 2021-04-17 palpitations All side effect experienced and severe. Extreme headache starting 12 hours after injection, fever, c... Read more
All side effect experienced and severe. Extreme headache starting 12 hours after injection, fever, chill, sore body, sore arm. Heartbeat start racing once fever started and sustain at 145 beat per minute for over a day, and over 110 over the next day. Heartbeat has not returned to normal after 3 days. Other reactions subsided after 60 hours, with lightheadedness still lingers after 60 hours.
45 2021-04-17 fast heart rate Sudden onset of tachycardia 8 hours following dose #1 of Moderna vaccine
45 2021-04-19 deep vein blood clot DVT - Left leg. Three separate clots in three different veins. Placed on Eliquis for 3-6 months.
45 2021-04-21 deep vein blood clot On 4/21/2021, 45-year-old male presents to urgent care for complaint of constant left lower extremit... Read more
On 4/21/2021, 45-year-old male presents to urgent care for complaint of constant left lower extremity pain centralized in the calf area radiating to left posterior thigh area since April 12, 2021. He denies fevers, chills, chest pain, shortness of breath, palpitations, orthopnea, peripheral edema, claudication, nausea, vomiting or diarrhea. He reports that symptoms started after receiving the 1st dose of the Moderna Covid vaccine. Ultrasound of LLE completed 4/21/2021 results Acute deep vein thrombosis. Patient directed Hospital ED. Patient prescribed Eliquis 5mg.
45 2021-04-21 pallor 10:10am - pt stated he felt like he was going to pass out, appears diaphoretic and pale. Pt laid on ... Read more
10:10am - pt stated he felt like he was going to pass out, appears diaphoretic and pale. Pt laid on floor and raised his legs, then stated he needed to use the restroom. Pt got up and attempted to ambulate towards restroom, but began to fall forward. Pt placed in chair, increased diaphoresis and gasping respirations with "seizure like" activity and moaning. 10:12am - On site EMS assessed and attended pt. HR 45, O2 100%RA, unable to assess BP as pt removed cuff. 10:15am - 911 called, pt informed staff of his history of syncopal episodes and bradycardia 10:25am - EMS arrived 10:32am - Pt transported via Ambulance.
45 2021-04-21 fainting, pallor, very slow heart rate 10:10am - pt stated he felt like he was going to pass out, appears diaphoretic and pale. Pt laid on ... Read more
10:10am - pt stated he felt like he was going to pass out, appears diaphoretic and pale. Pt laid on floor and raised his legs, then stated he needed to use the restroom. Pt got up and attempted to ambulate towards restroom, but began to fall forward. Pt placed in chair, increased diaphoresis and gasping respirations with "seizure like" activity and moaning. 10:12am - On site EMS assessed and attended pt. HR 45, O2 100%RA, unable to assess BP as pt removed cuff. 10:15am - 911 called, pt informed staff of his history of syncopal episodes and bradycardia 10:25am - EMS arrived 10:32am - Pt transported to Hospital via Ambulance.
45 2021-04-21 fainting Patient appeared to have fainted. He fell as he was leaving the building after being observed for 15... Read more
Patient appeared to have fainted. He fell as he was leaving the building after being observed for 15 minutes following his vaccination. He sustained a laceration to the back of his head on the left-side and also to his left elbow. Pressure was applied using sterile gauze to both lacerations. EMS was called, arrived about 10-15 minutes following the incident, loaded him onto a cart and transported him to the ambulance for further evaluation.
45 2021-04-21 low platelet count, platelet count decreased, nosebleed, haemoglobin decreased Previously healthy 46 yoM received moderna dose 1 on 4/9. On 4/13 starts noticing a petechial rash ... Read more
Previously healthy 46 yoM received moderna dose 1 on 4/9. On 4/13 starts noticing a petechial rash on bilateral feet. This spreads up the legs with some involvement in the torso. On 4/15 notices mucosal bleeding with gums while brushing teeth, increasing spontaneous nose bleeds overnight. On 4/21 has a telehealth PCP visit, sent for lab work which shows thrombocytopenia with a platelet count of 2k as well as a hemoglobin of 12.9. Is sent to the ED with repeat platelet count of 1k. Previously platelets were 143k in 2019. Pt admitted for further work-up
45 2021-04-23 pulmonary embolism, blood clot massive blood clot in the right lung; painful knot under the skin on his arm; threw up about 20 time... Read more
massive blood clot in the right lung; painful knot under the skin on his arm; threw up about 20 times in 6 hours, and kept vomiting all the next day; massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him; next day when he got up and could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (massive blood clot in the right lung), PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) and THROMBOSIS (painful knot under the skin on his arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder NOS in September 2020 and Broken bones. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 GAIT DISTURBANCE (next day when he got up and could barely walk). On 26-Mar-2021, the patient experienced PULMONARY EMBOLISM (massive blood clot in the right lung) (seriousness criteria hospitalization, medically significant and life threatening). On 04-Apr-2021, the patient experienced PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (painful knot under the skin on his arm) (seriousness criterion medically significant) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day). On 19-Mar-2021, GAIT DISTURBANCE (next day when he got up and could barely walk) outcome was unknown. On 28-Mar-2021, PULMONARY EMBOLISM (massive blood clot in the right lung) had not resolved. On 04-Apr-2021, PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) had not resolved. At the time of the report, THROMBOSIS (painful knot under the skin on his arm) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day) outcome was unknown. Not Provided Treatment information provided as blood thinners (IV heparin) and antibiotics were used to treat 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. This case was linked to US-MODERNATX, INC.-MOD-2021-081632 (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. US-MODERNATX, INC.-MOD-2021-081632:2nd dose
45 2021-04-25 fainting Giddiness leading to fainting at home
45 2021-04-25 fainting SYNCOPE TX: IVF. TRANSPORTED TO HOSPITAL
45 2021-04-26 pulmonary embolism 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 PULMONARY EMBOLISM (Developed a pulmonary embolism) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (Developed a pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Developed a pulmonary embolism) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications and treatment details were 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.
45 2021-04-29 hypertension Became very dizzy after leaving restaurant , and noticed blood pressure to rise.
45 2021-04-30 blood pressure decreased My blood pressure dropped to 65/47 with a heart rate of 59 and I nearly lost consciousness.
45 2021-04-30 chest discomfort severe pain at injection site, horrible headache, dizzy, blurry vision, sensitivity to light, conges... Read more
severe pain at injection site, horrible headache, dizzy, blurry vision, sensitivity to light, congestion, difficulty breathing, cough, heavy chest, abdomen swollen and tender to touch, nausea, bloating, loose stool, moaning, fever, sweats, chills, severe joint pain full body, restless, unable to sleep, unable to eat or get out of bed or work
45 2021-05-03 heart rate increased, chest pain Rapid pulse, complete weakness on the right side of my body, unable to stand, difficulty gripping ob... Read more
Rapid pulse, complete weakness on the right side of my body, unable to stand, difficulty gripping objects, chest pains
45 2021-05-04 cerebrovascular accident at ER patient was diagnosed with a stroke and now remains hospitalized; fever; bodyache; This sponta... Read more
at ER patient was diagnosed with a stroke and now remains hospitalized; fever; bodyache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (at ER patient was diagnosed with a stroke and now remains hospitalized) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (fever) and MYALGIA (bodyache). On 27-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (at ER patient was diagnosed with a stroke and now remains hospitalized) (seriousness criteria hospitalization and medically significant). On 18-Apr-2021, PYREXIA (fever) and MYALGIA (bodyache) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (at ER patient was diagnosed with a stroke and now remains hospitalized) had not resolved. Not Provided No concomitant medication was provided. Treatment included hospitalization. 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. Company Comment - Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever and myalgia are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever and myalgia are consistent with the product safety profile.
45 2021-05-04 heart rate increased, loss of consciousness Moderna COVID-19 Vaccine EUA: 2nd dose Please see continuation page ... Inside arm and armpit itch... Read more
Moderna COVID-19 Vaccine EUA: 2nd dose Please see continuation page ... Inside arm and armpit itching after 5 minutes Diarrhea after 3 hrs which stopped in an hr Transient Shortness of breath after 15 hrs ( last about half an hr): oxygen level 95-100 Chills starting after 15 hr Slight fever ~99f Hearth beat: 95 (normal rate ~60) Extreme Nausea w/o vomiting for 3 to 4 hrs Extremely sensitive to smells (pleasant or unpleasant) triggering nausea Stomach and esophagus intense cramps for 4 hrs so intense that I had to call 911 (they didn't prescribe anything other than Tylenol or NyQuil which I couldn't take due to nausea) Passed out multiple times Hallucinations and talking gibberish Lack of concentration
45 2021-05-04 hypertension Patient expressed he was nervous about the vaccine and did not like needles. He decided to look away... Read more
Patient expressed he was nervous about the vaccine and did not like needles. He decided to look away when he was administered the vaccine. Approximately 10 minutes after receiving the vaccine the patient notified pharmacy staff that he felt dizzy and nauseous. The patient was given cold compresses for his neck and wrists. After a few minutes the patient said the dizziness went away but he still felt nauseous. He sat on the floor with his feet elevated for 10 minutes then said he felt better and wanted to go to the bathroom. Upon return from the bathroom he said he vomited a small amount and felt better. We had the patient wait another 10 minutes in the pharmacy area before the patient left to go home.
45 2021-05-04 palpitations Shortness of breath, fatigue, chilis and sweats, headache, weight loss, sore arm injection site, rac... Read more
Shortness of breath, fatigue, chilis and sweats, headache, weight loss, sore arm injection site, racing heart, nausea, achiness.
45 2021-05-05 inflammation of the pericardium Pericarditis Medication Treatment ongoing
45 2021-05-05 blood clot, deep vein blood clot Blood clot in calf deep vein thrombosis
45 2021-05-09 chest pain On 5/7 patient (self) had fever of 101.2 and violent chills as side effects. These subsided 5/8. Adv... Read more
On 5/7 patient (self) had fever of 101.2 and violent chills as side effects. These subsided 5/8. Adverse event on 5/10 was an intermittent cough and deep chest pain that continued to worsen, preventing sleep. Patient took Ibuprofen 800mg. Event in progress. Will evaluate on 5/11 and decided if doctor visit is needed.
45 2021-05-09 fainting Fainted approximately 24 hours after receiving vaccine. Prior to fainting felt nauseous and light h... Read more
Fainted approximately 24 hours after receiving vaccine. Prior to fainting felt nauseous and light headed. Fainting lasted very short period of time (minutes or less), felt better afterwards.
45 2021-05-11 bleeding on surface of brain, brain sinus blood clot, cerebral haemorrhage Pt developed a spontaneous superior sagittal venous thrombosis with resultant subarachnoid hemorrha... Read more
Pt developed a spontaneous superior sagittal venous thrombosis with resultant subarachnoid hemorrhage and Frontal IPH and seizure. Pt had a sudden seizure at home and CTA/MRI showed Superior sagittal sinus thrombosis. Pt required intubation secondary to altered mental status. Pt underwent diagnostic cerebral angiogram which confirmed cerebral sagittal sinus thrombosis. Pt tolerated extubation on 5/11.
45 2021-05-12 chest pain Several hours after Covid vaccine pt developed his classic sickle cell crisis symptoms of severe pai... Read more
Several hours after Covid vaccine pt developed his classic sickle cell crisis symptoms of severe pain and was hospitalized 3/ 27 to 3/ 31 with sickle cell crisis. No clinical evidence of thrombosis, treated with IV hydration and oxygen and improved in several days. Had a previous h/o sickle cell crisis and hospitalization while taking oral typhoid vaccine in 2017. After discharge, 5 days later had onset of chest pain, returned to ER, Chest CT negative for embolus, D- Dimer > 18,000. No clinical evidence of clot. pt hydrated again / O2 but was able to go home. Covid negative by PCR during both episodes.
45 2021-05-13 chest discomfort After 15 minutes of administration, pt is saying that he has "tightness around his heart" but no dif... Read more
After 15 minutes of administration, pt is saying that he has "tightness around his heart" but no difficulty breathing. After 5 more minutes, but then, he said he feels chest tightness on his right side. He got his shot on his right arm. I told him it is probably not an allergic rxn since he has no swelling/rash, no problem with breathing. Most likely he is feeling something on his right side because he got the shot on his right arm.
45 2021-05-14 chest pain, inflammation of the heart muscle Diagnosed with Myocarditis. Severe chest pain began at 2:30am. Went to hospital ER at 4am. Was given... Read more
Diagnosed with Myocarditis. Severe chest pain began at 2:30am. Went to hospital ER at 4am. Was given an ekg and blood test which showed a potential heart attack and was treated with Nitroglycerin at 4:30 am. Was given a cardiac catheterization at 6am that showed no heart attack and no arterial obstructions but showed one wall of the heart was not functioning properly. Heart issue was confirmed later in the day by an echocardiogram study. Was admitted to the hospital. Had an additional attack of chest pains at approximately 2:30pm the next day which was treated with 3 tablets of Nitroglycerin. Blood tests showed markers for inflammation.
45 2021-05-15 hypotension, fainting Fainted twice in less than two minutes. Blood pressure was too low to read on an automatic cuff.
45 2021-05-18 chest discomfort Having slight chest tightness coupled with urge to cough.
45 2021-05-18 heart rate increased, pallor, chest discomfort Still having soreness in both upper arms, feel tired and yawning a lot, high or increased heart beat... Read more
Still having soreness in both upper arms, feel tired and yawning a lot, high or increased heart beat that comes and goes without physical exertion, some chest tightness, left leg cramping, occasional pale face that comes and goes as well.
45 2021-05-21 heart rate irregular Powerful pain in the bones, strong headache, irregular heartbeat and nausea.
45 2021-05-23 inflammation of the heart muscle Acute coronary syndrome with normal coronary arteries on coronary angiogram. Clinical presentation s... Read more
Acute coronary syndrome with normal coronary arteries on coronary angiogram. Clinical presentation suggestive of myocarditis.
45 2021-05-24 palpitations, heart rate irregular Irregular heart beat and my heart skips at interval.
45 2021-05-25 heart rate increased Recipient c/o tingling sensation on injection arm and that side of face, increased heart rate. Water... Read more
Recipient c/o tingling sensation on injection arm and that side of face, increased heart rate. Water was provided. At 11:30AM, BP decreased. Recipient denied s/s of allergic reaction, hypertension, or other discomfort.
45 2021-05-25 loss of consciousness, pallor Patient left the pharmacy area following the vaccination and headed to the employee breakroom to wai... Read more
Patient left the pharmacy area following the vaccination and headed to the employee breakroom to wait the required 15 minutes for observation. He reached the breakroom and sat down. He then became pale and passed out for a few seconds.
45 2021-05-25 pulmonary embolism Patient presented to the ED with difficulty breathing and was diagnosed with pulmonary embolism prio... Read more
Patient presented to the ED with difficulty breathing and was diagnosed with pulmonary embolism prior to this visit. He then presented to the ED on 4/19/21 with similar sx and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
45 2021-05-30 heart rate increased, chest discomfort Severe panic / anxiety attacks. Rapid heart beat. Throat and chest tightening. Dizziness
45 2021-05-31 heart attack Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) an... Read more
Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was hospitalized on 14-Apr-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. No treatment information provided. It was reported that three days after vaccination the patient had a heart attack. He was admitted to the ICU for three days, starting on 14-Apr-2021. He had seen his primary care doctor and his cardiologist multiple times since that incident and he was unsure of whether he should get the second vaccine dose or not.. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
45 2021-06-01 fibrin d dimer increased, pulmonary embolism, chest discomfort, chest pain, low blood oxigenation Patient presented on May 15, 2021 with sudden right lateral inferior chest pain that awoke him. He n... Read more
Patient presented on May 15, 2021 with sudden right lateral inferior chest pain that awoke him. He noted a feeling of heaviness and mild dyspnea for two days prior. Worse when flat. Hypoxic. Right upper quadrant guarding and tenderness. Treated with anticoagulation as an outpatient.
45 2021-06-10 chest pain, heart rate increased, inflammation of the pericardium Pericarditis - Hospitalization from May 17-21, 2021, symptoms: shoulder and back pain, rapid heart r... Read more
Pericarditis - Hospitalization from May 17-21, 2021, symptoms: shoulder and back pain, rapid heart rate, fever, shortness of breath, body aches, chest pain, chills. Treatment 2 weeks round of colchicine and lasix, antibiotics. Re-occurring pericarditis symptoms starting on June 9, 2021
45 2021-06-10 chest pain Patient reports on and off "heart pain" that started after receiving the vaccine. He states, "feels ... Read more
Patient reports on and off "heart pain" that started after receiving the vaccine. He states, "feels like it's inflammed". Advised to talk to physician/be seen by physician.
45 2021-06-16 chest pain, chest discomfort Tightness and pain in chest (around heart area).
45 2021-06-16 chest pain, fast heart rate, palpitations February 15, 2021 started around 10:00am short runs of SVT. Intermitten throughout the day. Worseni... Read more
February 15, 2021 started around 10:00am short runs of SVT. Intermitten throughout the day. Worsening in the evening - feeling nauseated, chest pain, palipations and anxiety. Presented to the ER around 9pm.
45 2021-06-16 hypertension The evening of the 2nd dose, I had a fever of 100.4, the next day both my sciatic nerves felt like t... Read more
The evening of the 2nd dose, I had a fever of 100.4, the next day both my sciatic nerves felt like they were on fire. I couldn't even type an email, my hands and fingers hurt so bad. Strong fatigue, nauseous, headaches. On the Feb of 17th, my lymph nodes got swollen and they are still swollen. My head was light headed. Lymph nodes were so swollen in my arm pits that I had to lift my arms above my head to breathe. Experienced high blood pressure
45 2021-06-20 low blood oxigenation, chest pain 16 days after receiving my first Covid vaccine shot (The 1st of the 2 shots required) Around 7pm on... Read more
16 days after receiving my first Covid vaccine shot (The 1st of the 2 shots required) Around 7pm on May 5th I started having a hard time breathing & slight chest pains. I decided to lay down & that seemed to make it worse. I've never had any issues like this before so I figured it would eventually go away on its own & continued to try and lay down on my bed but as each hour passed it continued to get harder and harder to breath & each breath I took became increasingly strained & felt as though my lungs weren't letting me take in large breaths, only short gasps. By 2am May 6th, 2021, I knew something was obviously veryyy wrong! I drove myself to the closest ER (that being Hospital approx 5 minutes away) & was admitted. After running several tests, I was presented with the news that I had ACUTE RESPIRATORY FAILURE, PNEUMONIA, HYPOXIA, PLEURAL EFFUSION & ACUTE SYSTOLIC CONGESTIVE HEART FAILURE...
45 2021-06-20 loss of consciousness A few minutes after pt received vaccine pt fell down was unconscious and started seizing for approx.... Read more
A few minutes after pt received vaccine pt fell down was unconscious and started seizing for approx. 15 to 20 seconds. He remained uncounsious for an additional 30 seconds and woke up 30 seconds later. He awoke very disoriented and tired. He remained lying down until ems was able to come. He was then taken to the ER.
45 2021-06-22 loss of consciousness For my 2nd dose vaccine, the first night I experienced seizures and was trembling a lot; also develo... Read more
For my 2nd dose vaccine, the first night I experienced seizures and was trembling a lot; also developed headaches and fatigue. I also displayed symptoms of dizziness and blacked out. I have trouble breathing and I am now diabetic. I have congestive heart failure. I cannot go outside to the heat because I black out. I am on an albuterol treatment due to coughing spasms. My arms also get stiff, and I feel when I black out, I am out for a couple of minutes. They performed lab work, EKG, stress test and I am following up with a cardiologist. My blood pressure went up to 210/178. I have to follow up with my cardiologist in two months to monitor my heart. For my 1st dose vaccine, I had two seizures the same night. I could not breathe and gurgled. I went to see my PCP who placed me on high blood pressure medications. I lost 67 pounds of fluid in my chest. I swelled up so bad that I could not put on my shoes. I did not have these problems before receiving the MODERNA vaccine, dose 1 and dose 2. I also got lab work down and found out I had type II diabetes.
45 2021-06-23 fluid around the heart, inflammation of the pericardium, chest pain Patient started having intermittent worsening chest pain and shortness of breath starting 5 days aft... Read more
Patient started having intermittent worsening chest pain and shortness of breath starting 5 days after 1st shot.
45 2021-06-26 heart flutter Feeling of fluttering in the heart for several days... felt like heart beats are going out of sync..... Read more
Feeling of fluttering in the heart for several days... felt like heart beats are going out of sync... I did not seek medical help and this feeling went away after about a week or so. At that time I didnt know that this could be related to the 2nd shot of Moderna vaccine that I took.. I have no heart relates issues..
45 2021-06-27 chest pain Having a slight pain in chest didn't thing anything of it , it went away until a few days later on J... Read more
Having a slight pain in chest didn't thing anything of it , it went away until a few days later on June 4th the pain didn't go, went into the bathroom and almost passed out go the ambulance rushed to the hospital where they had to put a stint in the leg and stayed 4 days in the ICU before being able to come home. Has to take medicine everyday now for heart.
45 2021-06-27 fainting Nausea, fainting.
45 2021-07-02 chest pain Patient started feeling ill the evening of the vaccination and called the pharmacy the next day to r... Read more
Patient started feeling ill the evening of the vaccination and called the pharmacy the next day to report symptoms of light-headedness, dizziness, weak legs, shaking, shortness of breath, chills, and chest pain. I called patient back a few hours later and patient said he felt better and the chest pain went away. He later noted that it could have been his anxiety causing the pain. Patient had been taking ibuprofen, acetaminophen, and drink a lot of water for treatment. Patient did not feel is was necessary to see the doctor or emergency department.
45 2021-07-06 heart rate increased 50 days after the 2nd dose of the Moderna Vaccination, I started having panic attacks. With the pan... Read more
50 days after the 2nd dose of the Moderna Vaccination, I started having panic attacks. With the panic attacks, I also experience extreme dizziness, tingling throughout my body and significant spikes in blood pressure. It is now 71 days after my 2nd dose of the Moderna vaccination and I am still experiencing panic attacks, dizziness, rapid heart rate, and body tingling. The episodes are intermittent. Some days I am completely incapacitated and can't leave my bed which means I am out of work on those days. Some days, I am completely fine and can make it through the day. I am being treated by my doctor with Celexa which is an anxiety medication. So far, the medication isn't working. I had no indication of anxiety or panic attacks prior to getting the vaccination.
45 2021-07-07 loss of consciousness Within three to four hours of receiving the Moderna vaccine my stomach started to become uneasy. I t... Read more
Within three to four hours of receiving the Moderna vaccine my stomach started to become uneasy. I thought it might have been what I ate for lunch after the shot but I started to have diarrhea and vomiting. While I was in the bathroom experiencing both I passed out and hit my head on the floor. My wife called 911 and was checked by the responding paramedics; my vitals were good and I did not feel the need to be transported to the hospital. Throughout the night I had chills and continued to throw up and experience diarrhea.
45 2021-07-08 blood clot in the brain, stroke Within days PT complained of headaches that become severe in intensity. No history of migraines or ... Read more
Within days PT complained of headaches that become severe in intensity. No history of migraines or other health issues . Just had a full workup prior for insurance purposes. Pt went to ER as pain would not subside and was sleeping a lot. Was diagnosed with a infarction in the brain x2. Headaches have never really improved and now is currently admitted into hospital with two more blood clots in brain.
45 2021-07-09 inflammation of the heart muscle, ejection fraction decreased, heart failure Acute myocarditis with decompensated heart failure
45 2021-07-11 heart rate increased, arrhythmia, chest discomfort Elevated heart rate (resting heart rate 145), chest pressure, difficulty breathing, arm heaviness
45 2021-07-14 fast heart rate, blood glucose increased, hypertension Jan 15 – Moderna Shot #1 – no side effects. Feb 12 –Moderna Shot #2 – Side effects: fever, mal... Read more
Jan 15 – Moderna Shot #1 – no side effects. Feb 12 –Moderna Shot #2 – Side effects: fever, malaise, fatigue, site injection pain. Feb 13 - Side effects: fevers 99.2-100.4, body aches, lethargy Feb 14 – Side Effects: morning fevers, midday and afternoon felt like all nerves were on fire specifically the sciatic. Pain radiating down arms and it hurt to type email to (professors at ) Feb 14-17 – Side effects: nausea, mental fog, headache, fatigue Feb 18 – Side effects: (added to already listed above) lymphedema and swelling in ankles and feet. Feb 28 – side effects were still persistent, and breathing had worsened, so I sought out medical help.
45 2021-07-17 blood pressure increased Numbness in left side of the face and increased blood pressure.
45 2021-07-19 chest pain 030B21A - the Lot number could also be this; The acute symptoms: I had severe chest pain and it hur... Read more
030B21A - the Lot number could also be this; The acute symptoms: I had severe chest pain and it hurt quite badly (Thursday). I have suffered from heart problems in the past and the pain did not diminish throughout the entire day. I called my endocrinologist at the time. He said it wasn't related to anything he was doing. On the previous Friday, (the 11th) I moved my dosage of .25. to .5 - - Ozempic - Friday previous to the symptoms starting. It seemed related to lesser pain I had been experiencing after the change of the dosage to the increase on that of the severe chest pain - Thursday, then it was my second my dose of the increased Ozempic that I took and I ended up going in to the hospital ER. They assumed it was a heart attack. They had to put me on two different massive pain killers because I couldn't take morphine. I had a follow up with my primary. I have an appt with a gastroenterologist soon.
45 2021-07-24 inflammation of the heart muscle, heart attack, chest pain Patient reported chest discomfort after initial COVID-19 infection in 12/2020 - mild, lasting for 2 ... Read more
Patient reported chest discomfort after initial COVID-19 infection in 12/2020 - mild, lasting for 2 weeks - did not seek medical attention Received first dose of Moderna vaccine in 2/2021 - chest pain occurred and self resolved after 2 days. Received 2nd dose of Moderna vaccine on 3/19/2021 - chest pain start about 48 hours after wards and was constant prompting him to come to ER on 3/23/2021. Troponin-I was borderline elevated but flat (0.065, 0.054, 0.050, 0.045 ng/mL); echocardiogram did not show any regional wall motion abnormalities or pericardial effusion and preserved left ventricular ejection fraction. With no reported events of myocarditis related to the vaccine at the time and lack of cardiac MR imaging at the facility, patient was briefly treated for presumed NSTEMI with dual antiplatelet, high-intensity statin therapy and initiation of beta-blocker and ACE-inhibitor. On 4/19/2021, with inability to arrange for a local cardiac MR, and rule out underlying ischemic heart disease, a treadmill nuclear stress test was performed showing a moderate-sized fixed anterior and mid to apical anterolateral defect (sparing apex) with no evidence of ischemia on myocardial perfusion imaging or stress ECG. With ambiguity regarding the diagnosis and patient's reluctance to take empiric high-dose NSAIDs with colchicine for presumed myopericarditis, he eventually underwent cardiac MRI at a tertiary care facility on 5/5/2021 showing preserved biventricular size and function with myocardial edema and subtle left ventricular mid wall enhancement involving inferoseptal/inferior wall at the inferior RV insertion point consistent with myocarditis. Patient's aspirin and clopidogrel was subsequently discontinued. He was initiated on high-dose ibuprofen for 2 weeks followed by 3 months of colchicine therapy with interval resolution of symptoms.
45 2021-07-25 chest pain, deep vein blood clot Pt had L Upper chest pleuriti pain and DOE did not seek med attention 6 weeks later sought attention... Read more
Pt had L Upper chest pleuriti pain and DOE did not seek med attention 6 weeks later sought attention for R pleuriti pain and DOE - had pul infarct and LLE DVT
46 2021-01-06 palpitations Dizziness, Palpitations, erythema 3 cm area at injection site l arm Narrative: Palpitations intermi... Read more
Dizziness, Palpitations, erythema 3 cm area at injection site l arm Narrative: Palpitations intermittently today, hemodynamically stable on exam, and ekg nsr. Advised to hydrate rest and avoid caffiene alcohol stress rtc or seek er care if persist/worse. denies chest pain. Consulted with attending physician, employee plans to work today
46 2021-01-06 fast heart rate 1.) Redness, pain, and swelling of arm several inches *below* the needle-puncture site (starting wit... Read more
1.) Redness, pain, and swelling of arm several inches *below* the needle-puncture site (starting within hours of injection) 2.) Transient tachycardia with heart rate to the 130s. Lasted a few minutes. Spontaneously resolved (occurred 31 hours after injection)
46 2021-01-09 heart rate increased Fever, Flu like symptoms., chills/sweating for 72 hrs, Body aches and severe joint pain, disorientat... Read more
Fever, Flu like symptoms., chills/sweating for 72 hrs, Body aches and severe joint pain, disorientation, severe anxiety and jittery, rapid heart rate, Resting heart rate was between 130-140 beats per minute. Severe fatigue and weakness. Stayed in bed for 48+ hrs after adverse symptoms began with little relief.
46 2021-01-12 heart rate increased rapid heart rate and headache upon falling asleep, woke 30 minutes later with drenching sweat and fe... Read more
rapid heart rate and headache upon falling asleep, woke 30 minutes later with drenching sweat and feelings of doom. Jumped out of bed due to anxiety and rapid breathing from feelings of doom. paced the halls of house, attempted to go back to bed but feelings of doom would not go away. finally after an hour my breathing settled down, heart rate returned to normal and sweating dissipated. symptoms did not return but did wake with severe headache and nausea.
46 2021-01-13 palpitations, heart rate increased LOSS OF HEARING, TUNNEL VISION, HOT, HEART PALPATIONS, ELEVATED HEART RATE, SWEATING
46 2021-01-13 palpitations LOSS OF HEARING, HEART PALPATATIONS, TUNNEL VISION
46 2021-01-14 pallor, hypotension, very slow heart rate Patient report sudden onset of weakness, dizziness, and feeling like he was going to pass out about ... Read more
Patient report sudden onset of weakness, dizziness, and feeling like he was going to pass out about twenty minutes after receiving his vaccine. Paramedic on-duty observed patient to pale and diaphoretic and immediately brought all equipment to patient's side and began care. Patient was placed on cardiac monitor and was observed to be markedly hypotensive and bradycardic. Peripheral IV established and atropine administered followed by fluid bolus. A transport unit was requested and arrived within minutes. Patient was assisted to EMS stretcher and transported emergently to the hospital for futher treatment and evaluation.
46 2021-01-18 chest discomfort headaches , sometime so severe that wake me up from sleep. happening every night for last three nig... Read more
headaches , sometime so severe that wake me up from sleep. happening every night for last three nights, it started after 30 hours of getting the vaccine. Headache is so severe that I feel like i will collapse. during the day feels like weight on head and eyes feel heavy.
46 2021-01-18 chest discomfort I received the first dose of Moderna vaccination on 01/13/21. On 01/15/21 in the morning, I felt che... Read more
I received the first dose of Moderna vaccination on 01/13/21. On 01/15/21 in the morning, I felt chest compression, chill, bad headaches, muscle pains, shortness of breath and cough. I went to test for Covid 19 and the result came back on 01/16/21 as positive of Covid 19. My initial symptoms were mild without fever, but it is hard to compare my symptoms since no prior reference. The symptoms are getting better, but I noticed my back (between T8 to T6) has pain. I have consulted medical doctors and health care professionals regarding of being tested as positive after vaccination. No one can answer if I should take the second dose of Moderna vaccine in 4 weeks as scheduled, or I should wait for 90 days and start
46 2021-01-18 heart rate increased pt after injection had pain in injection site with tingling down to the fingertips. Pt stated next ... Read more
pt after injection had pain in injection site with tingling down to the fingertips. Pt stated next day he felt nauseas w/ swelling of the right lymph nodes and hot/cold flashes with vomiting. pt also experienced body aches and fatigue w/ rapid heart beat and sore throat, cough and lost his voice.
46 2021-01-23 chest discomfort Itchy mouth, difficulty swallowing, sweating, feeling that tongue was swelling, light chest tightnes... Read more
Itchy mouth, difficulty swallowing, sweating, feeling that tongue was swelling, light chest tightness. Given 50mg Benadryl. Symptoms subsided. Was required to wait additional 30minutes for observation.
46 2021-01-23 heart rate increased, chest discomfort Intolerable full-body pain, severe headache, nausea, fatigue, rapid heartbeat sitting and increased ... Read more
Intolerable full-body pain, severe headache, nausea, fatigue, rapid heartbeat sitting and increased when I stood/walked, chest pressure
46 2021-01-24 hypertension, palpitations Vaccine recipient experienced a bit of headache, nausea and vomiting after vaccination on 1/19/2021.... Read more
Vaccine recipient experienced a bit of headache, nausea and vomiting after vaccination on 1/19/2021. On 1/22/2021, he started having palpitations and also mentioned that his blood pressure was really high.
46 2021-01-31 platelet count decreased, chest discomfort *vaccine lot # same as prior lot number on same individual. Resident seen in medical clinic in follo... Read more
*vaccine lot # same as prior lot number on same individual. Resident seen in medical clinic in follow up to ED visit this weekend, dx with vaccine reaction, likely due to prior COVID-19 infection. He reports that he developed myalgias, chills, nausea, abdominal cramping, and chest discomfort onset about 12 hours after receiving his Moderna COVID-19 vaccination on 1/29/2021. Due to the severity of his s/s that did not resolve with intervention here and chest discomfort, he was transported to the local emergency department per on-call provider. Per record review, CBC and comp met in the ED 1/30/2021 unremarkable with the the exception of t. bili 1.3. Mg. 1.7. CBC: WBC 11.0, platelets 135, abs neut 9.9, abs lymph 0.5. CKnormal 106. unremarkable. No other diagnostic testing was ordered. Resident reports that his symptoms persisted on and off to some degree through the weekend and now have completely resolved. He has noticed a red rash where adhesive tape was at his IV site. No other rashes. At no time did he report oropharyngeal edema, hives, or SOB. He was treated with ketorolac and IVF in the ED. ROS: otherwise neg. PE: Const: NAD. Neck: supple. Resp: CTAB, no increased WOB. Cardiac: HRRR, no murmur. Integumentary: erythematous patches to R AC area. No drainage or bullous lesions. A/P: vaccination reaction, resolved. Resident has been advised that this was not an allergic reaction and that he is still able to take the second dose in the series, though he may have a similar reaction. Report in VAERS. He understands he has the right to refuse the second dose. Contact dermatitis: short course topical hydrocortisone. Routine labs and f/u in clinic. He has been advised to promptly report any new or worsening symptoms.
46 2021-02-01 atrial fibrillation I received my 2nd dose of the moderna vaccine on 1/24/21. On 1/25/21 at approx 2am I had tremmors, f... Read more
I received my 2nd dose of the moderna vaccine on 1/24/21. On 1/25/21 at approx 2am I had tremmors, feeling of intense cold, headache, body pain, fatigue. That lasted until approx 0300am 1/26/21. I slept most of the day 1/25 except for taking kid to school and monitoring another at home. I had read the side effects and I felt as though things were subsiding on 1/26 but I was still weak with body pain. I was not 100%. I was home alone with 2 kids (wife out of town). 1/25 I had a cough and was short of breath but didn't think much of it. The cough persisted. On 1/27/21 I was still short of breath. I went to a nearby fire station and had them put me on a lifepack. I was in atrial fibrillation. I could not do anything because my wife wasn't due back until 3pm. At 3PM she walked in and I walked out and drove myself to Hospital. I was diagnosed with A-Fib w/ RVR. I was in A-fib until I was cardioverted on 2/1/21 and was given a cryo-ablation.
46 2021-02-04 nosebleed Moderna COVID-19 Nose bleed 1/28/21 at 0140 am Nose bleed 1/28/21 at 0430 am Nose bleed 1/30/21 at ... Read more
Moderna COVID-19 Nose bleed 1/28/21 at 0140 am Nose bleed 1/28/21 at 0430 am Nose bleed 1/30/21 at 0330 am Nose bleed only on left side of nose
46 2021-02-05 blood pressure increased 8 days after my first dose, 01/20/2021, around 9am, my eyes started to turn red, and teary and diffi... Read more
8 days after my first dose, 01/20/2021, around 9am, my eyes started to turn red, and teary and difficulty to look on computer screens and TV. Thinking it might be a Conjunctivitis, assuming it was a windy week in my area, I did do some yard work. That night it started to build pressure, pain and headache. I asked my spouse to buy me eyedrops., did used with no relief. I've putting cold packs at the beginning, but it gives me more headache, I changed to warm compress, and had some relief. For 4 days I suffered the same symptoms and discomfort, not until the 4th day (Friday) I can't take it anymore, I went to an urgent care, they check my V/S, BP is elevated, ranging from 140's/92's. They check my eye pressure, it was elevated. The PA prescribed Tobramycin eyedrop(Tobrex) and recommend me to see an Ophthalmologist to do further evaluation. The next day 5th day (Saturday) went to Dr., get evaluated both of my eyes had high pressure,
46 2021-02-08 fast heart rate Note: I had a PCR confirmed SARS-CoV-2 infection in March, 2020. Approximately 12 hours after the ... Read more
Note: I had a PCR confirmed SARS-CoV-2 infection in March, 2020. Approximately 12 hours after the second vaccine dose, I experienced intense soreness at the vaccination site (significantly greater than the first dose). In the middle of the night I awoke with flu-like symptoms. At 9am I took acetominophen for fever, rigors, muscle aches. This brought mild relief from approx. 9:45am to 11:15 am. My condition continued to worsen through the early afternoon with rigors and significant generalized muscle aches. I experienced tachycardia (90-105 bpm vs normal of ~70bpm), SOB, and starting measuring pulse oximetry which read from 89%-94% (my usual does not go below 97%). This persisted until approximately 8pm with no improvement. I took 40 mg prednisone, 600 mg ibuprofen and within 3 hours was starting to have symptom resolution. I am a physician and up to date on all my vaccinations. I have never had anything approaching this type of response. I don't know if prior SARS-CoV-2 infection creates a situation were the very potent mRNA vaccine triggers a large immunologic recall response. I wanted to get this noted as there may be some reason to alter the vaccine schedule for prior SARS-CoV-2 infections
46 2021-02-09 loss of consciousness, blood pressure increased, chest pain Per patient, woke up on the morning after the day following his vaccination (2/9/21) with chest pain... Read more
Per patient, woke up on the morning after the day following his vaccination (2/9/21) with chest pain, shortness of breath, and feeling light-headed. He tried to sit up, saw red dots, and "passed out" momentarily. He had severe headache upon awakening, ringing in ears, and blurry vision. Went back to bed and slept all day. Symptoms worsened every time he tried to get up. Woke up this AM, with symptoms persisting. Came in for OV, BP noted to be elevated at 150/106. Patient was sent to hospital via ambulance for further work-up and management.
46 2021-02-10 hypertension, nosebleed HEADACHE, LETHARGY, SYMPTOMS CONSISTENT WITH HIGH BLOOD PRESSURE, JOINT ACHES, PAIN AT INJECTION SIT... Read more
HEADACHE, LETHARGY, SYMPTOMS CONSISTENT WITH HIGH BLOOD PRESSURE, JOINT ACHES, PAIN AT INJECTION SITE, SWELLING AT INJECTION SITE, BLOODY NOSE IN THE MORNING, NOTICED BLOOD IN SEMEN - NEVER NOTICED THAT BEFORE IN MY LIFE
46 2021-02-12 pallor, blood pressure decreased, heart rate decreased, palpitations Within a few minutes while sitting on the chair after injection, felt my heart suddenly race, a flus... Read more
Within a few minutes while sitting on the chair after injection, felt my heart suddenly race, a flushing sensation occurred, and I tasted something in my mouth (chemical or metallic taste). I started to get dizzy and was sweating. Called over the Fire Dept personnel who were administering the injections and they helped me (fluids, ECG, etc.). During this time they stated that my blood pressure dropped to the low 40's (not sure the exact number) and my heart rate as well. My complexion was pale to them and sweating a lot. After administering IV fluids a few minutes later my BP and HR started to rise. My SpO2 was good. Transported to ER for evaluation and labwork.
46 2021-02-15 chest pain After 14 minutes in observation patient reported itching on the right arm, there was no visible rash... Read more
After 14 minutes in observation patient reported itching on the right arm, there was no visible rashes on the arm or the body at the time or any time later. Took patient to a stretcher for further observation and about 5 minutes later he said felt dizzy, his pulse was 84 and chest was clear but he then complained of chest pain and headache for which I called EMS at 2:31 PM. During the entire time in observation patient appeared well, not pale, no sweating, talking clearly and no visible rashes. Denies itchy throat and did not complained of pruritus again
46 2021-02-18 chest pain On 2/7/2021 approx 8 PM noticed some tightness of the right arm at the injection site. On 2/8/2021 i... Read more
On 2/7/2021 approx 8 PM noticed some tightness of the right arm at the injection site. On 2/8/2021 in the afternoon some swelling and continued "tight skin" of the right bicep was noted. On 2/8/2021 approx 9:30 PM noticed some "flu-like" symptoms and "poor dexterity" of right arm. Flu-like symptoms lasted until 2/9/2021 but "poor dexterity" and pain of right arm continued through 2/10/2021. On 2/9/2021 noticed swelling of the lymph nodes in the right armpit area, described by individual as "golf ball" size. Swelling increased on 2/10/2021 to include right side of chest. Pain was noted in the pectoralis and right side of back. Individual self-treated with motrin and ice for a few days. Individual did not seek medical care. Individual did not require hospitalization or doctor visit. Individual denied that swelling/pain interfered greatly with quality of life or activities of daily living. Individual did not report symptoms to Medical Clinic until >10 days after symptoms began. At the time of report individual states that flu like symptoms and pain have completely resolved. However, individual still reports some mild swelling (reports improvement of 80-90%).
46 2021-02-20 blood glucose increased blood sugar uncontrollable, 300-400ish range taking over 100 units of fast acting insllin and no rea... Read more
blood sugar uncontrollable, 300-400ish range taking over 100 units of fast acting insllin and no real effect on levels
46 2021-03-04 loss of consciousness 10:05am Post 2nd vaccination, c/o of increased dizziness w/ expressed sweaty feeling, noted as well;... Read more
10:05am Post 2nd vaccination, c/o of increased dizziness w/ expressed sweaty feeling, noted as well; then witnessed 2-4 second LOC, thereafter, O2 via FM applied, becomes alert w/ cohesive verbal response to stimuli; 10:10 EMS activated; BP138/78 P79. 10:24am Ox3, transported to hospital via EMS for further evaluation / treatment.
46 2021-03-05 blood pressure increased On 3/3/21, experienced severe headache since morning which got even worse by night accompanied by mu... Read more
On 3/3/21, experienced severe headache since morning which got even worse by night accompanied by multiple times vomiting and nausea. Elevated blood pressure with the reading fluctuating between 147/85 - 129/87. (Normal blood pressure range for me below 120/75). BP monitored daily since 3/4/21 shows increased BP with ongoing headache affecting activities of daily life. PCP notified.
46 2021-03-09 heart rate increased Rapid heart rate = hospitalization.
46 2021-03-11 pallor within 5 minutes of receiving the vaccine patient became light headed, cold clammy skin with cold sw... Read more
within 5 minutes of receiving the vaccine patient became light headed, cold clammy skin with cold sweats, blurry vision, dizzy, pale/gray skin, and short of breath. Pulse was 60 and BP 90/60- epinephrine 0.5 mg given, pt BP 80/60 returned to 129/88. EMS evaluated patient- patient declined to go with EMS to ER or to go to the ER- pt stated 1 hour after onset that he felt fine and declined to go to ER eventhough he was advised to but states that he will go if he feels he needs to but that he feels normal now.
46 2021-03-11 pulmonary embolism, deep vein blood clot Patient went to Emergency Room d/t UTI, C-diff colitis, PE/DVT admitted treated with IV heparin, Van... Read more
Patient went to Emergency Room d/t UTI, C-diff colitis, PE/DVT admitted treated with IV heparin, Vancomycin/flagyl, antibiotics for UTI
46 2021-03-20 deep vein blood clot symptoms left lower leg pain one day after receiving 2nd COVID vaccine, diagnosed with left leg DVT ... Read more
symptoms left lower leg pain one day after receiving 2nd COVID vaccine, diagnosed with left leg DVT 13 March
46 2021-03-20 deep vein blood clot 12 Feb 2021 at 17:00 patient report electrical shoot pain felt from left foot to left knee. Pain las... Read more
12 Feb 2021 at 17:00 patient report electrical shoot pain felt from left foot to left knee. Pain lasted for approximately 10 sec. Pain repeated twice during the night, waking from rest. 13 Feb 2021 painful episode repeated at 7:30 am. Painful episode repeated at 7:00 pm and continued for every 20 minutes. Pt reported to ER on 13 Feb 2021 at 10:30 pm. Facility conducted ultrasound on 14 Feb 2021 and identified left popliteal near occlusive blood clot. Prescribed Eliquis 5 mg and discharged home; f/u with PCP and Hematology. Continued course of treatment: Continue Eliquis as prescribed for 6-8 wks, f/u with PCP and Hematology.
46 2021-03-26 chest discomfort 1. I was completely normal the day of the second dose. 2. The next day, I had quite significant ch... Read more
1. I was completely normal the day of the second dose. 2. The next day, I had quite significant chills, body aches, fatigue, and some nausea. I also had a metallic taste. 3. Fortunately, the chills, body aches, and fatigue went away the second day. However, I continued to have the metallic taste for days. 4. Also, starting the third day and I still have a cough and tightness in my lungs. I went into a doctor at urgent care four days after the second dose (due to a concern about the cough and tightness in my lungs). All of my vitals were normal and they attributed to side effects from the vaccine. Also, they gave me an inhaler. 5. The inhaler has been somewhat helpful, but I had a consistent cough as well as some tightness in my lungs for two weeks after the second dose. On unusually stressful days, it was even worse. 6. The cough has improved, but I still have it occasionally throughout the day as well as the tightness in my lungs. 7. Finally, I continue to have the metallic taste.
46 2021-03-29 chest pain Woke up by epigastric pain, radiating to chest. Associated with nausea. Went to ER with persistent ... Read more
Woke up by epigastric pain, radiating to chest. Associated with nausea. Went to ER with persistent chest pain. Ruled out cardiac cause. Nausea persisted after discharge from ER leading to another ER visit for hydration. Pain and nausea improved 24 hours later.
46 2021-03-30 blood pressure increased About 30 min after Moderna vaccine dose #1, the patient complained of nausea and pounding pressure a... Read more
About 30 min after Moderna vaccine dose #1, the patient complained of nausea and pounding pressure above his left eye. He had not taken his 3 HTN meds that day. Prior history of EMS transport to ER due to severe high BP. Initial BP at time of symptoms was 250/140 left arm. EMS called. Patient advised to relax. No other treatment at vaccine clinic. At time of transport, BP 190/140.
46 2021-03-31 loss of consciousness Patient passed out and hit his head five minutes after receiving the vaccine.
46 2021-03-31 pallor, fainting, hypotension LIKE A SYNCOPE, EXCESSIVE SWEATING, PALE, FAINTED,LOW PRESSURE, NUMB FINGERS HANDS, VOMITS
46 2021-04-01 blood pressure increased, heart rate increased Dizzyness, elevated blood pressure and pulse, confusion, and loss of fine motor skills
46 2021-04-01 fainting Client received vaccine at 12:40 and waited the required 15 minutes for observation. After leaving t... Read more
Client received vaccine at 12:40 and waited the required 15 minutes for observation. After leaving the building, he felt unwell and starting coming back inside where he had multiple episodes of syncope. EMS was called. The client wasn't able to make it to sitting without syncope so he was transported to the hospital via ambulance.
46 2021-04-02 fast heart rate Severe body aches, fever, tachycardia, leukocytosis resulting in admission for observation on 4/3/20... Read more
Severe body aches, fever, tachycardia, leukocytosis resulting in admission for observation on 4/3/2021. Patient just admitted inpatient at the time of report.
46 2021-04-04 loss of consciousness PT became dizzy and had a seizure like response with LOC and tonic/clonic activity only lasting 2-3 ... Read more
PT became dizzy and had a seizure like response with LOC and tonic/clonic activity only lasting 2-3 seconds. PT spontaneously woke up and was mildly confused. BP 143/93 other vitals stable
46 2021-04-04 fast heart rate, atrial fibrillation Injection site soreness (+3 hrs), High fever (+12 hrs), Headache (+12 hrs), AFIB (+22 hrs), Tachycar... Read more
Injection site soreness (+3 hrs), High fever (+12 hrs), Headache (+12 hrs), AFIB (+22 hrs), Tachycardia (+22 hrs)
46 2021-04-06 loss of consciousness Found on floor by EMS nausea, vomiting, diaphoretic. Felt need to have a BM. Patient considered hypo... Read more
Found on floor by EMS nausea, vomiting, diaphoretic. Felt need to have a BM. Patient considered hypovolemic and unable to increase bp with position. Patient transferred by EMS to nearest hospital
46 2021-04-08 blood pressure increased lightheaded increased blood pressure nausea clammy hands sweating a little and tingling in legs an... Read more
lightheaded increased blood pressure nausea clammy hands sweating a little and tingling in legs and a little in arms
46 2021-04-08 lightheadedness Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypervent... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had a vasovagal reaction. He was \"not a big fan of shots\". Hadn't eaten well the day before nor breakfast. Didn't sleep well. Called 911. They did EKG and it was fine. Spoke with patient the next morning and he was good.
46 2021-04-09 pallor, fainting On 4/10/21 around 2:30 pm I gave the patient his first Moderna COVID vaccine and had him sit in the ... Read more
On 4/10/21 around 2:30 pm I gave the patient his first Moderna COVID vaccine and had him sit in the observation area for the standard 15 minutes. Around 2:35 he and his family notified me that he was feeling lightheaded/faint and nauseous; he also appeared pale and diaphoretic. It seemed to be a vasovagal reaction until he said he was starting to have trouble breathing so I called 911 and got the Epipen/emergency kit ready, and monitored vitals. Then his breathing trouble resolved without needing to administer medication. EMS arrived at 2:39 pm and confirmed his HR/BP/O2 sat were normal. EMS cleared the patient to go home with his family. The patient had never had a vaccine reaction or vasovagal reaction before.
46 2021-04-11 blood glucose increased, pallor Patient began to feel real week and sweating just a few minutes in to vaccine. Became very pale. Cal... Read more
Patient began to feel real week and sweating just a few minutes in to vaccine. Became very pale. Called 911. Took his BP before they arrived. It was 105/60. He claimed that was low for him. He said he feels that way when blood sugar gets low. Paramedics arrived and took BP again had come up to 130/90. We were in the process of taking his sugar when they came and did it. It was 139. Patient felt better on his own really with some candy and water. He decided not to go with paramedics. I called and checked on him this evening and he was fine.
46 2021-04-11 pallor Patient c/o SOB, pale and diaphoretic. Administered 02 2L/NC, NS 0.9 200 ml given, Benadryl 50mg IVP... Read more
Patient c/o SOB, pale and diaphoretic. Administered 02 2L/NC, NS 0.9 200 ml given, Benadryl 50mg IVP and Solu Medrol 125mg IVP given. called 911. Pt verbalized he feels better after medication administered but still want to go ER. Patient send to hospital via ambulance. Doctor notified.
46 2021-04-13 hypertension, palpitations After 5 mins of getting the 1st shot I felt an allergic reaction little bit hard to breathe and hot ... Read more
After 5 mins of getting the 1st shot I felt an allergic reaction little bit hard to breathe and hot flash. I told the pharmacist and was advised to stay an extra 10 minutes. I left the Pharmacy and proceeded to the store and then home. Over the next 1.5 days I felt a sort of brain fog, my arm puffed up red about the size of a half dollar. The brain fog went away and then for the next 2-3 days my body felt like I was coming down with a cold. I seemed to feel better after that initial period until 3/24 when while driving a hot flash came over me and the next day I was again in a type of brain fog. For the next two days I tried to just deal with the brain fog but started to notice on the right side of my neck a feeling of constriction, with abnormally high blood pressure. I went to the hospital ER and the completed a CAT scan of my brain and neck, blood work and urine work up with no evidence of why my neck was feeling constricted and high blood pressure. The symptoms continued and on 4/1 my blood pressure spike to 168/93 and I again went back to the hospital ER and spent the night. I was having heart palpitations, anxiety and very high blood pressure. The hospital this time completed more bloodwork, MRI of my brain and neck and an Eco-cardiogram. I am now on 3 blood pressure and heart medications and have no diagnoses of why my blood pressure and heart rate are so abnormal. I am very healthy and exercise daily and have never encountered this and my BP has always been extremely good.
46 2021-04-14 hypertension, chest pain Pt had chest pain and high blood pressure. Blood pressure did not go down medics were called. Pt ca... Read more
Pt had chest pain and high blood pressure. Blood pressure did not go down medics were called. Pt care was turned over to FD. PT was transported to the hospital
46 2021-04-15 pallor On March 20th had headache and dizziness. Had problem walking. On the 21st he turned pale and felt i... Read more
On March 20th had headache and dizziness. Had problem walking. On the 21st he turned pale and felt ill. On the 22nd he couldn?t walk or speak. Lost control of his bladder. Had extreme dizziness and headache. Sobbed uncontrollably. Took patient to primary for evaluation. They sent him bu ambulance to Emergency.
46 2021-04-16 blood clot, pulmonary embolism Bilateral pulmonary embolism, Left Brachial artery clot, abdominal clots
46 2021-04-19 fibrin d dimer increased, deep vein blood clot patient developed DVT shortly after recieving the vaccination. diagnosed on 4/15/2021 symptoms star... Read more
patient developed DVT shortly after recieving the vaccination. diagnosed on 4/15/2021 symptoms started about one week prior to this.
46 2021-04-19 heart rate increased, chest discomfort About 6 minutes after a got first shot of moderna, I had felt fin. Then within 20-30 seconds I reali... Read more
About 6 minutes after a got first shot of moderna, I had felt fin. Then within 20-30 seconds I realized that my chest was heavy/pressure on my sternum, arms and torso went warm and sweaty, a bit light headed and had fast heart rate. I asked medical team for assistance. They took blood pressure/O2 levels and listen to my heart and lungs. Had epi pen ready, but never administered. Watched me like this for about hour and a half until my bp came back down to normal levels.
46 2021-04-19 cardiac arrhythmia, chest pain Started having heart pvc and pac second day after first shot. Then on april 11 went in to er for che... Read more
Started having heart pvc and pac second day after first shot. Then on april 11 went in to er for chect pain turned out to be panic attack. On april 12 developed bumps on left front shoulder. On april 18 read article about vaccine causing shingles. Went to er and they confirmed shingles. At this time still have shingles on front and back left shoulder.
46 2021-04-20 hypotension Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
46 2021-04-20 loss of consciousness Patient reported feeling feverish and reported passing out in the evening after receiving the 2nd do... Read more
Patient reported feeling feverish and reported passing out in the evening after receiving the 2nd dose of vaccine in the morning. He cut his face when he passed out and went to hospital for treatment.
46 2021-04-20 troponin increased, chest pain 3 days after the vaccine patient presented with headache, body ache and chest pain. Found to have el... Read more
3 days after the vaccine patient presented with headache, body ache and chest pain. Found to have elevated troponin, and abnormal EKG
46 2021-04-21 fainting Patient fainted 5 minutes after receiving vaccination. EMTs attended patient. Patient recovered.
46 2021-04-24 chest pain Chills, headache, cold hands, shoulder and chest soreness, muscle ache, joint pain, fatigue, climbi... Read more
Chills, headache, cold hands, shoulder and chest soreness, muscle ache, joint pain, fatigue, climbing temperature.
46 2021-04-25 chest discomfort The day after receiving the moderna Covid vaccine, i came with extreme tightening of the chest, whee... Read more
The day after receiving the moderna Covid vaccine, i came with extreme tightening of the chest, wheezing, and a heavy cough. I received the shout in 4/23 and on 4/26, which is today, I still have tightness of my he shear and wheezing.
46 2021-04-25 fainting "Client awaiting his wife who was was being observed for 30 mins 12:17 Dizziness and 12:18 syncope f... Read more
"Client awaiting his wife who was was being observed for 30 mins 12:17 Dizziness and 12:18 syncope few secs rescue called regained consciousness diaphoretic, Bp 87/50, Hr 63 reg, Sats 95%, resp 15. Placed on stretcher, place on Ekg monitor sinus rhyth"
46 2021-04-26 chest discomfort, oxygen saturation decreased Noticed slight pressure on chest, causing laboured breathing. Noticed a decreased oxygen level for ... Read more
Noticed slight pressure on chest, causing laboured breathing. Noticed a decreased oxygen level for about 1 hours. After that time, I napped and all issues were over. Also slight headache but nothing disturbing just noticeable.
46 2021-04-27 low platelet count lot: 026A21A NDC 80777-273-99.he started with symptoms after vaccine which progressed. SOBOE, N/V, ... Read more
lot: 026A21A NDC 80777-273-99.he started with symptoms after vaccine which progressed. SOBOE, N/V, fever & fatigue x 1 week in setting of recent COVID vaccine. admitted to hospital via ED with pleural effusion, AKI, Labs notable for +ANA, +smith/RNP, SSA/SSB,+Scl-70, dsDNA, low complements, lymphopenia, leucopenia, thrombocytopenia, rhabdo,worseing renal failure (now on dialysis) with PU, kidney biopsy largely unrevealing. Bone marrow biopsy concerning or HLH. DDx HLH 2/2 to new onset SLE with overlap syndrome/MCTD.patient needed to be transferred to a tertiary center, now at another facility in critical condition with encephalopathy.
46 2021-04-28 hypertension, heart rate increased The patient complained about his eyes being blurry, being light headed, and having shortness of brea... Read more
The patient complained about his eyes being blurry, being light headed, and having shortness of breath. His vitals were taken every few minutes with the following results until Fire department EMTs came on site and monitored his vitals and recommended him to be taken to the hospital. He agreed and they took him to one of the near hospitals. 10:00 am 159/108, Pulse 63 10:07 am 164/110, Pulse 61 10:12 am 148/104, Pulse 61 10:16 am 142/103, Pulse 61 10:22 am 150/108, Pulse 60 10:28 am 157/111, Pulse 61 Oxygen when taken by EMT personnel: 97/60 He said he couldn't understand our talks. He said he couldn't make the words to talk.
46 2021-05-01 palpitations, heart rate irregular Heart palpitations, pounding heart that feels irregular, at times. Felt nausea a couple of morning a... Read more
Heart palpitations, pounding heart that feels irregular, at times. Felt nausea a couple of morning along with heart symptoms and a sensation of difficulty breathing. However, I am able to take a deep breath when feeling this way and am able to work out with no difficulty. The symptoms continue intermittently, but do not happen constantly. A Kardia Mobile device purchased and I was unable to detect irregular heart rhythms with it. I considered going to the doctor and possibly the emergency room to get it checked out, but decided against as the symptoms would stop. They still continue off and on to this day.
46 2021-05-02 deep vein blood clot DVT under clavicle . Sudden Swelling, discoloring and numbness of left arm.
46 2021-05-03 fainting Patient had a syncopal event from chair to floor. He fell off the chair prone. Patient had no signs ... Read more
Patient had a syncopal event from chair to floor. He fell off the chair prone. Patient had no signs of distress prior to event. Medical emergency was called and patient was transported to ED for further evaluation and observation.
46 2021-05-05 fibrin d dimer increased The day after the shot I began having severe abdominal pain, muscle and nerve pain, and shortness of... Read more
The day after the shot I began having severe abdominal pain, muscle and nerve pain, and shortness of breath. The abdominal, muscle, and nerve pain began at around 10:00am. The shortness of breath began around 2:00-3:00 in the afternoon and lasted for 30-45 mins (longer than the 20mins listed in the attending ER physician's report), at which point my wife called for an ambulance and I was taken to the emergency room of Hospital. I was prescribed diphenhydrAMINE injection 25 mg, droperidoL injection 1.25 mg, ketorolac injection 15 mg, and another pain killer by the paramedics that I do not see listed in the record. Although not to the same degree, I have continued to have gastrointestinal cramping since the second vaccination. This is a worsening of a condition (IBS) that I had previously, but which had mostly been in remission since beginning Mirtazapine in Fall 2019 subsequent to a heart attack on 8/7/19. I am meeting with my primary physician, Droctor, on 5/10/21 and contacted, my gastroenterologist, on 5/5/21.
46 2021-05-09 hypertension High Blood Pressure
46 2021-05-09 fast heart rate Supraventricular Tachycardia
46 2021-05-11 chest pain, pulmonary embolism Developed L chest pain and headache late in evening 5-4-21 and diagnosed with pulmonary embolis 5-4-... Read more
Developed L chest pain and headache late in evening 5-4-21 and diagnosed with pulmonary embolis 5-4-21. He was treated initially with high-intensity heparin nomogram and converted on 5-5-21 to oral apixaban. He has done well with this therapy. His risk factors for PE include immobility; however, the risk of a thrombotic event in quadriplegic patients should be that of the general population after the first year of disability, and he has been immobile for around 2.5 years. He has no known underlying malignancy, and his recent imaging of his chest and head are reassuring in this regard. The patient received his Moderna COVID-19 vaccine 12-23-20 and 2-2-21 with vascular events having been reported as being more common following this immunization. Without a clear cause for his PE, this will be reported on VAERS.
46 2021-05-12 blood pressure increased Consistent elevated in blood pressure
46 2021-05-13 deep vein blood clot Deep vein thrombosis
46 2021-05-13 loss of consciousness, pallor The patient received the vaccine and within a few minutes, he got sweaty, pale, passed out for a sh... Read more
The patient received the vaccine and within a few minutes, he got sweaty, pale, passed out for a short period and was unresponsive briefly but still breathing. We took off his long sleeve shirt and put a cold compress on his head till EMS arrived. They took is blood pressure and EKG. He refused to get in ambulance.
46 2021-05-17 palpitations Moderna COVID-19 Vaccine EUA: immediately upon receiving injection, heart began racing, and what ha... Read more
Moderna COVID-19 Vaccine EUA: immediately upon receiving injection, heart began racing, and what had been a relatively quite ringing in my ears for the past year or two, also immediately became 2-3x louder (maybe even more?), where it has remained ever since (nearly 2 months). The heart rate settled down within a few second, but the ringing persisted, and has continued. Before the vaccine, the ringing was a very high pitched, constant tone, like the high pitched tone I used to hear on an airplane sometimes, but it was so quiet that I only noticed when I would wake up in the morning or at other random times when everything around me was very quiet. Since the vaccine, however, it has become loud enough that it's impossible not to notice it constantly; not so loud that I can't hear other things around me or people talking, but definitely loud enough that it's unmistakably there and can at times be a real distraction to focus and even conversation.
46 2021-05-17 fainting FOLLOWING THE INJECTION THE PATIENT FAINTED MOMENTARILY. UPON AWAKENING HE WAS DIAPHORETIC AND BREAT... Read more
FOLLOWING THE INJECTION THE PATIENT FAINTED MOMENTARILY. UPON AWAKENING HE WAS DIAPHORETIC AND BREATHING RAPIDLY. HE THEN VOMITED. PHARMACIST CHECKED BP AND IT WAS WITHIN RANGE,. 911 WAS CALLED AND UPON ARRIVING THE PARAMEDICS CHECKED VITALS AND CONCLUDED PATIENT WAS OKAY. PATIENT WAS NOT TRANSPORTED.
46 2021-05-19 stroke Presented to hospital with headache, found to have a large left-sided intracranial hemorrhage and b... Read more
Presented to hospital with headache, found to have a large left-sided intracranial hemorrhage and bilateral occipital intracranial infarcts
46 2021-05-19 chest pain, heart attack Patient presented to the ED on 4/4/21 with viral illness and left sided chest pain. Patient presente... Read more
Patient presented to the ED on 4/4/21 with viral illness and left sided chest pain. Patient presented to the ED on 4/14/21 with chest pain and was subsequently hospitalized for NSTEMI. These visits are within 6 weeks of receiving first COVID vaccination dose.
46 2021-05-20 cerebrovascular accident After 8 days I started feeling a headache I took ibuprofen then I felt numbness of my mouth and my r... Read more
After 8 days I started feeling a headache I took ibuprofen then I felt numbness of my mouth and my right eye would not fully close only half way, my mouth started drooping sideways when I ate and swallowed food, my throat felt strange the liquid like water would come out a little. My eyes burned, predominately my right eye.
46 2021-05-20 pallor Moderna COVID-19 Vaccine EUA I had pain in shoulder at first, then the whole left arm sore then to t... Read more
Moderna COVID-19 Vaccine EUA I had pain in shoulder at first, then the whole left arm sore then to the point I could not use it. The day after shot at 8:30 pm I was feeling fine. Then all of a sudden my face which is usually red turned pale white. My stomach got chills and started to sweat a lot. I could not keep my head up and was very close to passing out. My wife was scared to the point she almost called 911 for me.
46 2021-05-24 low platelet count, platelet count decreased Fatigue. Did Blood counts and had Platelet count of 11,000
46 2021-05-24 transient ischaemic attack, stroke TIA Symptoms: UNS SYM&SIGN,COGNIT FUNC&AWARE(R419).
46 2021-05-25 chest pain Evaluation on Day of Discharge: Stable for discharge Hospital Course: Patient was evaluated for s... Read more
Evaluation on Day of Discharge: Stable for discharge Hospital Course: Patient was evaluated for sharp reproducible chest pain and shortness of breath. He was evaluated by cardiology who suggested MSK in nature. He started lifting weights earlier this week. His cardiac work up included EKG with NSR, CXR no acute process, troponin neg x3, inflammatory markers negative. He did have significant dyslipidemia and was counseled on importantance of healthy lifestyle, diet modification and importance of taking statin. Patient was treated with OMT with moderate improvement of symptoms and was rx'd muscle relaxer for a few days to help with muscle spasm. He is to follow up with cardiology and get a repeat lipid panel in 3 months as well as follow up with PCP for stress echo and EGD if sx persist.
46 2021-05-25 troponin increased Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vacc... Read more
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was elevated troponin, bilateral pleural effusion, hypertensive urgency.
46 2021-05-31 chest discomfort initial soreness at injection site (Left Shoulder) A couple days after the shot that soreness subsid... Read more
initial soreness at injection site (Left Shoulder) A couple days after the shot that soreness subsided but started experiencing tightness in left chest/heart area. Will experience the tightness for a period of time then it will go away. More prevalent with activity, and is accompanied with shortness of breath as well.
46 2021-05-31 pallor, loss of consciousness Patient stated he felt like he was going to faint. Nurse placed cold bottles of water on both corrod... Read more
Patient stated he felt like he was going to faint. Nurse placed cold bottles of water on both corroded arteries. Client did pass out, pale and a little disoriented when woke up. Client was given a bottle of cold water to drink, which he did. Laid client on a cot to rest until felt better and able to drive home. After approximately 45 minutes, client stated he was ready to do go home and had someone there to drive him.
46 2021-06-03 lightheadedness, lightheadedness vasovagal episode following vaccination. Spostaneous resolution when put in supine position. Paramed... Read more
vasovagal episode following vaccination. Spostaneous resolution when put in supine position. Paramedics on site. No treatment required.
46 2021-06-03 lightheadedness Vasovagal episode following the administration of vaccine. Paramedics onsite. Spontanious resolution... Read more
Vasovagal episode following the administration of vaccine. Paramedics onsite. Spontanious resolution with supine position. Paramedics onsite. No treatment required.
46 2021-06-08 palpitations Sickness bedridden for 3-4 days. Symptoms I never had during my actual bout with real covid. heart ... Read more
Sickness bedridden for 3-4 days. Symptoms I never had during my actual bout with real covid. heart palpitations, chest wheeze making breathing more labored. I had the real covid in March 2020 where I never had respiratory symptoms, tested positive for antibodies May 2020
46 2021-06-08 palpitations Condition aggravated; Palpitations; Tinnitus; This case was received on 01-Jun-2021 and was forwarde... Read more
Condition aggravated; Palpitations; Tinnitus; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), PALPITATIONS (Palpitations) and TINNITUS (Tinnitus) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Asthma and Allergy NOS. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and LOSARTAN for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion disability), PALPITATIONS (Palpitations) (seriousness criterion disability) and TINNITUS (Tinnitus) (seriousness criterion disability). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), PALPITATIONS (Palpitations) and TINNITUS (Tinnitus) 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. Immediately upon receiving injection, the patient's heart began racing, and what had been a relatively quite ringing in his ears for the past year or two, also immediately became 2-3x louder (maybe even more), where it had remained ever since (nearly 2 months). The heart rate settled down within a few second, but the ringing persisted, and continued. Before the vaccine, the ringing was a very high pitched, constant tone, like the high pitched tone he used to hear on an airplane sometimes, but it was so quiet that he only noticed when he would wake up in the morning or at other random times when everything around him was very quiet. Since the vaccine, however, it became loud enough that it was impossible not to notice it constantly; not so loud that he could not hear other things around him or people talking, but definitely loud enough that it was unmistakably there and could at times be a real distraction to focus and even conversation. Treatment medications were 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.; 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.
46 2021-06-10 inflammation of the pericardium Pericarditis. Onset 5/30/21
46 2021-06-13 troponin increased, chest pain Within 24 hours, I began experiencing the usual symptoms associated with 2nd dose, including chills,... Read more
Within 24 hours, I began experiencing the usual symptoms associated with 2nd dose, including chills, fever, body aches, etc. Within 72 hours, I began experiencing serious chest pain, radiating pain into back and shoulders, and numbness in left arm--all symptoms associated with a heart attack. I was immediately taken to the emergency department where I was treated with pain killer for chest pain and given a blood thinner and IV fluids. EKG and chest X-ray were normal. Blood work indicated highly elevated troponin levels thereby indicating significant stress to heart muscle. Treatment included prescribing medications including Lopressor, Lipitor, and aspirin. Following stay in the hospital, I was released with no signs of heart complications. I'm continuing the medications for general maintenance and prevention. Prognosis is good with no further complications and no further threat of a future heart attack based on current medical conditions.
46 2021-06-15 inflammation of the heart muscle, inflammation of the pericardium Myocarditis and Pericarditis
46 2021-06-16 palpitations, heart rate increased 3:31 PM. Client complained of increased hear rate within one minute after receiving Covid 19 vaccin... Read more
3:31 PM. Client complained of increased hear rate within one minute after receiving Covid 19 vaccine. Client reports "felt his heart was racing". Client alert and talking without difficulty. Denies difficulty breathing and denies tightness in throat. BP 183/105 and Pulse 100. Client complained of heart racing. Approximately 3:50 PM BP 147/101 and Pulse 92. Discussed calling 911 with client and he stated was not sure he wanted us to call. Client reports "I just feel weird". RN consulted with Nursing Supervisor and Dr. with decision to call 911. RN called 911. Informed client he can decline transport to emergency room if needed. Client reports he does not have insurance. EMT arrived. BP by EMT at 4:10 pm 162/92 Pulse 95. Client declined transport to emergency room for evaluation. Client referred to local Health Department and insurance application started. At 4:36 pm client reports he's feeling better and requests to return home. BP 170/85 Pulse 85. client reports he feel he can drive home without problems. Application for insurance pending at health department. Client released. Addendum: Initially client denied feeling anxious after vaccination but later admitted he was nervous about getting a shot.
46 2021-06-20 loss of consciousness, fainting Patient experienced syncope while he was sitting for his 15 minute post vaccination wait time. Staff... Read more
Patient experienced syncope while he was sitting for his 15 minute post vaccination wait time. Staff member had conversation with patient in vaccine booth and patient mentioned syncope often happens at the MD office when he gives blood/has blood drawn- usually does not occur following vaccinations. Staff member noticed patient was starting to nod off while sitting upright in chair. she went to check on him to see if he felt okay and patient starting falling out of chair and was unconscious with his eyes open. Staff member was able to catch patient from hitting head on the ground. checked blood pressure and heart rate frequently and helped cool patient off due to excessive sweating. patient had readings 58/44 55 bpm, 126/80 83 bpm, 145/93 89 bpm, and 152/95 91 bpm. patient reports last reading is more like his normal readings. patient experienced 2 dizzy spells so he lied down on the ground, flat on his back with his feet propped. patient's father was waiting in parking lot and patient was able to call father priorto event occurring. according to patient and his father, patient's mother experiences same when she has blood drawn and at every MD appointment, he will immediately lay down prior to having blood drawn. 911 was called and EMTs arrived. patient was back to normal and feeling fine. he was able to stand up on own. patient left with father. will call patient before leaving today to check and make sure he is okay.
46 2021-06-23 atrial fibrillation, heart rate increased, heart rate irregular I have underlying Afib which has been controlled on Sotolol for the last five years with occasional ... Read more
I have underlying Afib which has been controlled on Sotolol for the last five years with occasional episodes of arrhythmia but my heart rate stayed controlled. After the vaccine my heart rate shot up to nearly 300 while I was driving home and it eventually came down but I stayed in Afib for nearly 2 months afterwards. I upped my dose to 400 mg daily from 320 mg of sotolol and eventually got some control of the Afib but now goes out of rhythm more frequently and when it goes out I am not rate controlled.
46 2021-06-23 chest pain BODY ACHES, BLURRED VISION, STOMACH CRAMPING, RASH AT INJECTION SITE, CHEST PAINS
46 2021-06-25 inflammation of the heart muscle Myocarditis and associated disrupted sleep (9 hours), heart fatigue and ache (2.5 days following)
46 2021-06-26 pulmonary embolism, cardiac failure congestive, blood clot Pt received moderna vaccine 4/7/21 and 5/5/21, and developed nausea and vomitting about four hours a... Read more
Pt received moderna vaccine 4/7/21 and 5/5/21, and developed nausea and vomitting about four hours after the second shot. These symptoms plus epigastric and RUQ pain and decreased po intake persisted until evaluation on 6/15/21 to medical center when pt was diagnosed with biventricular systolic congestive heart failure complicated by an RV thrombus and subsequent subsegmental LLL pulmonary embolus. FYI - lot number above for 2nd covid shot is either 025B21A or 025821A (the 4th digit is either a 'B'or '8'). shot #1 given at clinic and #2 given at clinic(both VA clinical areas)
46 2021-06-27 chest discomfort Heaviness in the chest, more so then what is normally felt with CHF
46 2021-07-03 palpitations, chest pain I had injection site pain . I woke up the next day with chills, body aches and pain, chest pains, he... Read more
I had injection site pain . I woke up the next day with chills, body aches and pain, chest pains, heart palpitations, shortness of breath, arm soreness and swelling, fatigue, nausea and I could not get out of bed. I called the hospital and left a message. The doctor called me back and advised me to go to the ER. By the time the doctor called me back, my chest pains and heart palpitations had resolved. The other symptoms still persisted- extreme fatigue and headache which lasted another 4 days. I started to feel better and it took about 6 days for all symptoms to resolve. I did not go to the ER since the cardiac symptoms have resolved. I am still having SOB.
46 2021-07-04 chest pain 3 days after receiving vaccine, developed a severe cold which was diagnosed as pneumonia which laste... Read more
3 days after receiving vaccine, developed a severe cold which was diagnosed as pneumonia which lasted 3 weeks. Then when back to the doctor for follow up and was then diagnosed with bronchitis, Consistent trouble breathing , chest pain, left arm pain for 3 months and has been prescribed multiple inhalers, steroids, antibiotics, chest xrays, ultrasounds, stress tests. Has developed allergic reaction to peanut butter and bee stings. Patient was previously a vigorous healthy man with no serious health conditions.
46 2021-07-06 heart flutter Elevated fluttering heart rate 90 BPM while resting blood pressure 135/80. Fever 101°
46 2021-07-06 inflammation of the heart muscle, chest pain Chest pain/shortness of breath/fatigue Myocharditis Ejection Fraction of left ventricle 30% Hospital... Read more
Chest pain/shortness of breath/fatigue Myocharditis Ejection Fraction of left ventricle 30% Hospitalization, Nitro patch/morphine, angiogram, ultrasound, MRI, Heart Failure Clinic Still in recovery
46 2021-07-06 palpitations Shortness of breath started a few days after second shot of vaccine. However it took 2-3 minutes max... Read more
Shortness of breath started a few days after second shot of vaccine. However it took 2-3 minutes maximum. But on 18th June and later 24 june, I was completely out of breathe. I had been hospitalized on mentioned dates. Test result turned out normal including Heart health. But the problem persiste. High palpitation and breathe shortness start around 8 to 9 pm and continue trough night. I go to sleep with sleep pills each night after walking around for hours.
46 2021-07-10 heart rate irregular, hypertension Hypertension stage 3 for one week (used a good pressure cuff to monitor). Dizzy, fuzzy/foggy thinkin... Read more
Hypertension stage 3 for one week (used a good pressure cuff to monitor). Dizzy, fuzzy/foggy thinking. Forgetful. Headache. I couldn't think at all. When walking it felt like I was floating above my body. Anxiousness. Tired. Out of breathe. Irregular heartbeat. Lasted about a week. Then one morning it was gone. Almost like a fever breaking but instead it was my blood pressure.
46 2021-07-20 chest pain Pt received the 1st dose of Moderna and developed severe onset of vertigo 3 days later along with ch... Read more
Pt received the 1st dose of Moderna and developed severe onset of vertigo 3 days later along with chest pain and shortness of breath. Shortness of breath and chest pain resolved but vertigo persisted until improved 7/21/21. Follow up visit 7/21/21 with his PCP. Vertigo has gradually improved.
46 2021-07-21 chest pain Symptoms after and until now are injection site pain, tiredness, headache, shortness of breath when ... Read more
Symptoms after and until now are injection site pain, tiredness, headache, shortness of breath when I move around and I have a habit of running every morning. Since the vaccine I lack of more air. I have dizziness and before I didn't have any, also I have slight chest pains and tiredness which previously I didn't have.
46 2021-07-22 palpitations hyperhydrosis and palpitations that started about 3 days after the last dose of covid vaccine and sy... Read more
hyperhydrosis and palpitations that started about 3 days after the last dose of covid vaccine and symptoms still ongoing.
47 2021-01-08 hypertension, fast heart rate, chest discomfort Dizziness, HYPERtension & Tachycardia Narrative: within 5 minutes after vaccine experienced chest t... Read more
Dizziness, HYPERtension & Tachycardia Narrative: within 5 minutes after vaccine experienced chest tightness, lightheadedness. On examination BP 190/110, pulse 112. Ear flushing. A&O x 3. No cardiac or respiratory distress. 25mg of Benadryl orally was given. Escorted to the ER in wheelchair. Discharged from the ER diagnosed as HTN and Anxiety. Discharged home in stable condition.
47 2021-01-08 hypertension Headache c/o hypertension post vaccination - bp was 165/116 - history of HTN Narrative:
47 2021-01-08 fainting Syncope vasovagal syncope at time of vaccination
47 2021-01-10 fast heart rate, hypertension Tingling/burning down L arm, similar sensation down L leg; urticaria noted on back of neck extending... Read more
Tingling/burning down L arm, similar sensation down L leg; urticaria noted on back of neck extending slightly to L side of neck. Tachycardia and hypertension upon exam.
47 2021-01-13 blood pressure increased 2-3 min after vaccination he started feeling tingling in the right side of his face. About one minut... Read more
2-3 min after vaccination he started feeling tingling in the right side of his face. About one minute later he felt like he could not get a full breath and he felt the need to run away. We connected a heart monitor, did serial vital signs, listen to lung sounds. He symptoms seem to worsen. He did not have hives, his lungs were clear. His HR was normal but his B/P was elevated. We started and IV and gave him 25 mg mg of IV Benadryl. We contacted Dr. via phone. He talked to the patient and he agreed with our assessment and treatment. He began feeling better about 10 min after the Benadryl and he symptoms cleared by 30 min after Benadryl. We kept him on the heart monitor for 1 hour. He reported he felt fine and back to normal when he left to go home. He refused ambulance transport to the hospital. All reports will be filled out by me.
47 2021-01-13 palpitations Dizziness, heart racing, nausea, severe body aches, fever, chills, difficulty breathing, extreme gas... Read more
Dizziness, heart racing, nausea, severe body aches, fever, chills, difficulty breathing, extreme gas, cramps. Was transported the Hospital and received zofran, atavan, morphine and tested negative for COVID 19 and flu and pneumonia. released after four and a half hours but continued to experience pain in muscles and fever even today (01/14/2021).
47 2021-01-14 blood pressure increased, heart rate increased My blood pressure went up to 170/106 and my heart was beating over 100 about 45 minutes or one hour ... Read more
My blood pressure went up to 170/106 and my heart was beating over 100 about 45 minutes or one hour after I was vaccinated, and I also felt nausea. Nurse called 911, and I was transported to emergency. About 1.5 hour later, my heart was even beating more quickly, and I could hardly talked and difficult to breathe. This happened when I walked to the restroom by myself and came back. After they did some medical tests, gave me medication for allergy (the doctor gave me this since he was not sure if it was my allergy reaction to the vaccines), injected 2 IV bags and rest for few hours, my blood pressure went down to about 140/9x and heart beat back to normal. I was released from ER on the next day at 4:00am.
47 2021-01-18 fast heart rate, lightheadedness Initially I felt fine and had no pain. After about 5 minutes I had tachycardia and sweating, which ... Read more
Initially I felt fine and had no pain. After about 5 minutes I had tachycardia and sweating, which resolved and seemed to be a vaso vagal reaction. About 30 minutes after the vaccine I developed ipsilateral facial numbness which lasted about 24 hours. I would like guidance on whether to proceed with the second dose.
47 2021-01-20 pallor, blood pressure increased, heart rate increased Pt started having dizziness, increased HR, extremities became pale, BP increased to 170/94, HR 144 3... Read more
Pt started having dizziness, increased HR, extremities became pale, BP increased to 170/94, HR 144 30 mins after injection. Pt tolerated first vaccine s difficulty, sxs continued and BP and HR fluctuated off and on for 1hr. Pt was given an EPI pen, Solumedrol 125mg, Zyrtec (refused benadryl) , and Pepcid 20mg during the episode. HR and BP continued to increase - EMS was called and pt was take to the ED and released ~10pm at night to home.
47 2021-01-21 chest discomfort left-sided chest discomfort ("pinching") ~2 hours after vaccination; normal vitals and exam
47 2021-01-21 troponin increased, fast heart rate 01/18/2021-Patient became short of breath with c/o throat tightness and difficulty speaking 30min po... Read more
01/18/2021-Patient became short of breath with c/o throat tightness and difficulty speaking 30min post vaccine. Given epi 0.3mg subcutaneous, Benadryl 50mg by mouth, placed on cardiac monitor for 4 hours with mild tachycardia post epi. Solu medrol 125mg given IV. Sent home and then returned 38 hours later with c/o epigastric pain, nausea, vomiting and weakness. Sent to Medical Center
47 2021-01-25 chest discomfort Patient c/o Numbness of the peri-oral numbness within 5 minutes of getting the vaccaine, strange tas... Read more
Patient c/o Numbness of the peri-oral numbness within 5 minutes of getting the vaccaine, strange taste in the mouth soon after the vaccine. Patient had taken Benadryl , pressure in the eyes and tightness in the chest. Patient continues to have mild episodic vertigo since then.
47 2021-01-26 chest discomfort Arm swelling , Soreness, pain. the following day(s) nausea, labored breathing, funny feeling like a... Read more
Arm swelling , Soreness, pain. the following day(s) nausea, labored breathing, funny feeling like a heavy chest. dizziness ( still happens occasionally seven days after vaccination) fatigue still happening to date.
47 2021-01-26 hypertension, fast heart rate Immediate dizziness, flushed sensation, itchy throat and lips, tachycardia, and high blood pressure
47 2021-01-28 hypotension Patient received 2nd dose of vaccine. He had dizziness upon sitting up, flushing all over, and hypo... Read more
Patient received 2nd dose of vaccine. He had dizziness upon sitting up, flushing all over, and hypotensive. Patient was observed 1801-1830 in vaccination observation area. He was placed in the given water and then placed recumbent position. There was no change. He did improve with juice PO. DR was notified and does not think this is an anaphylactic reaction, but should be transferred to the ED for further evaluation. Patient was transferred to the ED.
47 2021-02-04 chest pain feeling faint, chest pains Narrative: patient was advised to seek treatment in nearest ER
47 2021-02-07 hypotension, fainting Nausea, low blood pressure, fainted, body pain, adverse reaction to cosmetic filler.
47 2021-02-15 hypotension 48 hours post vaccine, patient developed low grade fever and respiratory complaints including shortn... Read more
48 hours post vaccine, patient developed low grade fever and respiratory complaints including shortness of breath. chest x ray showed RUL consolidation. when patient wosened over the next 48 hours from respiratory standpoint including new oxygen requirement and hypotension, decision was made to perform chest ct which confirmed presence of RUL pneumonia. the following day, the patient was bronched and the resultant bronchial alveolar lavage that was performed has thus far been completely negative. repeat chest xray four days later showed resolution of RUL consolidation and patient was no longer symptomatic.
47 2021-02-16 platelet count decreased TO ED ON 02/12 WITH KIDNEY STONE. ON LABWORK, PLATELETS NOTED TO BE LOW AT 85,000. I WAS NOTIFIED ... Read more
TO ED ON 02/12 WITH KIDNEY STONE. ON LABWORK, PLATELETS NOTED TO BE LOW AT 85,000. I WAS NOTIFIED ON 02/16 BY THE UROLOGIST OF LOW PLATELETS WITH NO KNOWN CAUSE AND PATIENT/EMPLOYEE S/P COVID VACCINATION. ADMITTED TO HOSPITAL--DISCHARGED ON 02/14 AND PLATELETS 74,000 AT DISCHARGE. TO FOLLOW-UP OUTPT WITH PROVIDER TO RECHECK LABS.
47 2021-02-18 low blood platelet count Appears that ITP has come back. I have significant bruising on my left triceps, right triceps, and ... Read more
Appears that ITP has come back. I have significant bruising on my left triceps, right triceps, and left hand. I have not sustained any significant trauma that would have caused this type of bruising. In addition, my right foot is very sore around the metatarsals.
47 2021-02-21 chest pain WEAK, CHILLS, JOINT PAIN, SORENESS, AND CHEST PAIN.
47 2021-02-22 lightheadedness Vaccination @ 10:28 am, pre-syncopal, parasthesias episode @ 10:43am. Patient's vitals were monitore... Read more
Vaccination @ 10:28 am, pre-syncopal, parasthesias episode @ 10:43am. Patient's vitals were monitored for an hour, ice packs on chest. Blood pressure monitored and blood sugar check. Patient was alert and stable prior to discharge.
47 2021-02-24 blood pressure increased About 3-5 minutes after getting the vaccine began experiencing a light headedness feeling. Took my b... Read more
About 3-5 minutes after getting the vaccine began experiencing a light headedness feeling. Took my blood pressure and it was a little high (140/95), I attributed this to anxiety but got home and my BP at home was down to about 120/76 about 1 hr. after. I laid down to sleep it off but could not sleep as about 1 hr. after trying to go to sleep I started to get a headache. After about 2 hours of battling it I decided to take a Extra Strength Tylenol which helped with the headache about 2 hrs later is was almost gone but the feeling of lightheadedness/dizziness was still there a bit worse than at the beginning. I slept it off and the next morning it was about 50 % better and by about noon it seemed to be 99% better. Today is Thursday ( on my 3rd day) and still feel a slight dizziness but I also have seasonal allergies which sometimes give me the same symptoms. I expect to be better soon.
47 2021-02-26 chest pain On 2/23/21, about 12 days after the vaccine was received, I felt chest pains in the late afternoon. ... Read more
On 2/23/21, about 12 days after the vaccine was received, I felt chest pains in the late afternoon. At midnight, I woke up with uncontrollable chills and shakes, with a low-grade fever that hovered in the 99.5 -100 range. I attempted to get up and struggled to breathe,; it was as if my abdominal and lower back muscles were seizing. I had to crawl to a kneeling position to urinate. I took several Tylenol then went back to lie down; after a few hours, the fever subsided, and I was able to briefly fall back asleep. At 4:00 a.m. the fever and major chills subsided, with no fevers reported since then, and only occasional chills. However, the muscle fatigue, pain and stiffness have become frighteningly debilitating. On Wednesday - Friday, the three days after I first experienced symptoms, each day it took me between 1.5 - 2 hours to get out of bed and finally get to a standing position. During the day on each day following my first symptoms, I have been able to gradually walk around, go up and down stairs, use the bathroom, and perform basic tasks. However, when the evening comes, it is a different story. 12 midnight - 10 a.m. are the worst hours, as any extended period lying down results in my muscles seizing, freezing and stiffening up. After falling asleep for an hour, it takes 10-20 minutes to mobilize enough (using a crutch and assistance) to get to the bathroom. After falling asleep for 2-3 hours, it takes 30-40 minutes to do the same. And, if I fall asleep for 3+ hours (which is about as long as I've been able to sleep since the adverse reactions began), it will take 1.5 - 2 hours to get completely mobile. This is when I finally wake for the day, and it takes about 10 minutes to raise my head and turn my torso, then another 10-15 minutes to get my legs off the bed and assume a crouching position, then 30-60 minutes to stand on my own.
47 2021-02-27 chest discomfort 1:54 pm Post vaccination, reports feeling episode of chest tightness w/ no additional or associated ... Read more
1:54 pm Post vaccination, reports feeling episode of chest tightness w/ no additional or associated symptoms; Monitor x 30 min w/ po hydration; BP 149/95 P123 RR 19 2:05pm BP 112/ 90 P90, reports "feels better and no longer anxious" ;post monitoring released from facility to home w/self
47 2021-02-27 hypertension Night of 2nd vaccine woke up with a high fever, and severe headache. Fever lasted 36 hours and peake... Read more
Night of 2nd vaccine woke up with a high fever, and severe headache. Fever lasted 36 hours and peaked at 104.8 (with Tylenol). Fever was over 103 degrees for majority of 24 hour period. Fever went away after 36 hours. However, headaches have continued constantly (17 days and counting). Went to the Dr. on 2/19/21. They wanted an CT Scan of head and sinuses. Dr. Prescribed cefuroxime 250 MG tablet in case of sinus infection and ibuprofen 800 MG tablets. Insurance did not approve a STAT CT Scan, so Dr. told me to go to the ER if headache persisted. Went to the ER on 2/23/21. Dr's indicated Blood pressure was very high (180/120). I do not have a history of high blood pressure. They did a CT scan (normal) EKG (normal), and blood work. They inserted an IV with migraine cocktail to alleviate headache. Unfortunately no change. While in the ER they gave me: - Sodium Chloride - Tylenol - Metoclopramide (injection) - DiphenhydrAMINE (Benedryl) (injection) - Dexamethsone - Ketorolac (Toradol) They prescribed methylprednisolone (steroid). Went back to primary doctor on 2/25. Blood pressure remains high (average 158/112 throughout the day), headaches continue (constant). They did more blood work, urine sample, and another EKG. They also ordered a STRESS ECHOCARDIOGRAM. The prescribed lisinopril 10 MG tablet for blood pressure.
47 2021-02-28 palpitations Heart palpitations began 2/25, first shot had SVT about the same amount of time after injection, Wil... Read more
Heart palpitations began 2/25, first shot had SVT about the same amount of time after injection, Will file that as a report also, palpitations continue to today 3/1/21
47 2021-02-28 fast heart rate, hypertension SVT, heart rate at rest was over 200bpm, I laid down for 30 mins and couldn't get it under 180. Fel... Read more
SVT, heart rate at rest was over 200bpm, I laid down for 30 mins and couldn't get it under 180. Felt pressure in head and not very stable. Concerned, sweating, Bp was very high at that point. Don't have the exact number. Called for ambulance, paramedics ruled out WPW and gave me iv drug that brought rate down to 120 fairly quickly, Over the next hours resting rate slowly normalized to around 80 (normal for me is 72). For 2-3 days afterwards had some high resting pulses up to 118 but never as bad and normalized in a few days.
47 2021-03-02 loss of consciousness Patient Started having dizziness, feeling faint at around midnight on 3/3/2021. He then lost conscio... Read more
Patient Started having dizziness, feeling faint at around midnight on 3/3/2021. He then lost consciousness, had seizure-like activity and was taken to hospital via EMS. In the hospital patient was unresponsive and received resuscitation attempts unsuccessfully. Per family, after about 45 minutes, code was called and patient expired.
47 2021-03-04 loss of consciousness A few minutes after the shot i started getting dizzy. it increased with intensity so i flagged down ... Read more
A few minutes after the shot i started getting dizzy. it increased with intensity so i flagged down an attendant for help. I started feeling weak and tired. I went unconscious during which time i was told my breathing was irregular. I think i was unconscious for 2 or 3 minutes. I woke confused, shortly after i woke the medic showed up to my care. He took my heart rate and check my blood sugar. He said my vitals looked ok. He asked if i was feeling better. I was still very dizzy and nauseous. i sat in the parking log for awhile before driving home. I got home and went to bed slept most of the day. I had a fairly bad headache the rest of the evening and a slight nauseous feeling. The next morning i still have a slight headache still feel slight nausea but not bad.
47 2021-03-05 heart rate increased Moderna Covid19 Vaccine EUA: About 12 until 36 hours after shot; slight fever; strong headache; sore... Read more
Moderna Covid19 Vaccine EUA: About 12 until 36 hours after shot; slight fever; strong headache; sore injection site arm; elevated heart rate; insomnia.
47 2021-03-05 heart attack Heart Attacks
47 2021-03-07 heart rate increased I experienced some mild symtoms the night after my first injection. I woke up in sweat and a fast be... Read more
I experienced some mild symtoms the night after my first injection. I woke up in sweat and a fast beating heart, around 110-120 bpm. I felt like I inhaled a bunch of cotten balls in my lungs. These feelings lasted a few hours then went away.
47 2021-03-07 hypertension Around 2:30-3:00 am on March 6, 2021, I woke up to my lips being Swollen and a headache, and High B... Read more
Around 2:30-3:00 am on March 6, 2021, I woke up to my lips being Swollen and a headache, and High Blood Pressure. I have been keeping my lips moist and applying a hot towel to my lips
47 2021-03-14 deep vein blood clot DVT. Symptoms began on 2/19, diagnosed in hospital formally on 2/21.
47 2021-03-14 pallor, hypotension, heart rate decreased 5 minutes after patient received vaccine he started to become lightheaded, dizzy, tingling in bilate... Read more
5 minutes after patient received vaccine he started to become lightheaded, dizzy, tingling in bilateral arms, pale, diaphoretic and hypotensive. Pt leaned forward out of chair and got on the floor, BP 74/46 P 52 O2 sats 96%, pt remained alert and oriented speaking in clear full sentences. Pt remained in this state for approx 20 min, symptoms started to subsided and by approx 1 hour after injection pt BP was 119/74 and all symptoms had resolved and patient was released to home care.
47 2021-03-15 hypertension, heart rate irregular The day after the vaccination, I woke up with atypically cold and discolored red violet hands to wri... Read more
The day after the vaccination, I woke up with atypically cold and discolored red violet hands to wrists, lasting about six days. Irregular heart rhythm and breathing especially during sleep. Intense headaches for roughly 8 days, high blood pressure. Roughly days 4,5,6, being the worst for the headaches, blood pressure and rhythm. Also, day 8 and 9 after the vaccination, sudden red spot on left arm, site of injection appeared, being itchy. Diminished day 10. Day five and six I was very concerned with out of synch breathing, headaches and high blood pressure. Hands still flashes of being cold, and less severe headaches.
47 2021-03-15 loss of consciousness, pallor On 3/16/21 at approximately 12PM a middle-aged male patient came in to get his first dose of Moderna... Read more
On 3/16/21 at approximately 12PM a middle-aged male patient came in to get his first dose of Moderna vaccine. I took in this patient into the IMZ room to give his vaccination and reviewed his form he filled out. On the question related to "have you ever had a reaction to a vaccine (fainting/dizzy)" the patient answered "No". The patient walked outside to the waiting area and sat down to begin his 15mins, at that point another customer yelled for medical attention for him because he passed out in the chair. I ran out with an EpiPen in case it was anaphylaxis. After I got outside the patient regained consciousness in the matter of seconds but was still dazed/confused and I applied a cold compress to the back of his neck and gave the patient some water to drink while feeling for his pulse in the wrist. He began to lose his color/pallor in his face again for a second time at that point I told my technician to call 911, after we dialed them, the patient came back to fully again this time and all color was restored to his face and he was fully conscious this time and able to speak in complete sentences. He wanted me to cancel the 911 call and since he came back to consciousness again in the matter of seconds so we canceled it. I made the patient wait an extra 30 minutes to observe him and he was fine from there on out, his wife was accompanying him and stated he has done this in the past for vaccines (despite answering no in the assessment form) and said she will be driving him home and checking in with his doctor later.
47 2021-03-16 blood glucose increased Woke this AM to elevated blood glucose of 240. I have had to administer additional bolus through da... Read more
Woke this AM to elevated blood glucose of 240. I have had to administer additional bolus through day via insulin pump to manage blood sugar level. This is similar to experience when I am managing blood sugar during sick days, but I do not feel ill.
47 2021-03-17 hypotension Low blood pressure, and to lay down shortly after vaccine while still at urgent care office. Took ,c... Read more
Low blood pressure, and to lay down shortly after vaccine while still at urgent care office. Took ,close an hour to recover.
47 2021-03-17 pulmonary embolism Shortness of breath, Pulmonary embolism
47 2021-03-17 fainting, hypotension Pt with prior vasovagal reactions to blood draws had syncopal episode and noted to be hypotensive sh... Read more
Pt with prior vasovagal reactions to blood draws had syncopal episode and noted to be hypotensive shortly thereafter. placed in trendelenberg, recovered to baseline shortly thereafter.
47 2021-03-19 chest pain, heart attack Pt had COVID in Early January 2021. He had mild symptoms and recoverec. On March 1 2021 had his f... Read more
Pt had COVID in Early January 2021. He had mild symptoms and recoverec. On March 1 2021 had his first Moderna. Covid shot. Next day, ( March 2) headaches. fevers, chills and chest pain. Pt had EKG findings of STEMI myocardial infarction. He was sent to the cath lab from the cath lab he was admitted. Finding of normal coronary arteries. However, he appeared to have developed a cardiomyopathy compared to a prior study. He had a echo on March 3. . Appeared to have a cardiomyopahty with estimated EF or ejection fraction of 40%. He had normal cardiac function three years earlier . On March 3rd his EKG normalizec. He was sent home on March 4
47 2021-03-19 fainting fainted followed by fatigue and continued dizziness
47 2021-03-21 lightheadedness, fainting PATIENT EXPERIENCED VASOVAGAL SYNCOPE, A FEW MINUTES AFTER RECEIVING THE VACCINE. PATIENT REGAINED C... Read more
PATIENT EXPERIENCED VASOVAGAL SYNCOPE, A FEW MINUTES AFTER RECEIVING THE VACCINE. PATIENT REGAINED CONSIOUSNESS IN MATTER OF SECONDS. PATIENT SAT ON FLOOR AND THEN MOVED TO CHAIR. PATIENT REPORTS HE FELT BETTER SEVERAL MINUTES AFTER THE REACTION. PATIENT REMAINED WITHIN PHARMACY AREA FOR DURATION OF ~30 MINUTES. NO OTHER ADVERSE EVENTS OCCURRED .
47 2021-03-23 chest discomfort Patient had trouble breathing and took his inhaler. He continued to have trouble breathing and said ... Read more
Patient had trouble breathing and took his inhaler. He continued to have trouble breathing and said his throat and chest felt tight. EMT gave 20ml of benadryl and assessed patient. Gave another 20ml of Benadryl. EMT asked and reassessed in 5 - 10 minutes. Patient still felt tightness and said it was getting worse. EMT asked if he wanted epi and patient said yes and said his throat was closing more. EMT explained that he would need to go to the hospital then and patient did not want to go to the hospital. Continued assessment and patient stated he was feeling better after EMT had him drink water and do some deep breathing. Patient stated he felt much better and was released from waiting room. Nurse at employer (Clinic was done on site) stated that this is normal for patient to have SOB as he has COPD and commonly has shortness of breath.
47 2021-03-23 blood clot Fever, headache, chills, night sweats. All on same day. 3 days later swollen knees. 10 days later bl... Read more
Fever, headache, chills, night sweats. All on same day. 3 days later swollen knees. 10 days later blood clot in right leg.
47 2021-03-28 blood glucose increased Cannot control blood glucose levels. Extremely high levels since 2nd dose of VACCINE
47 2021-03-29 fainting, pallor Immediately following injection, patient complained new onset headache. Patient then fainted. Pati... Read more
Immediately following injection, patient complained new onset headache. Patient then fainted. Patient came to approximately 30 seconds after passing out. Patient was pale and sweating. Patient able to drink water and chewed a glucose tablet. Patient was also given an ice pack to cool down. Patient rested in pharmacy for 30 minutes then indicated he felt fine, just ?tired.? Patient left the pharmacy approximately 45 min after incident, stating he felt much better. Patient had spouse with him and she drove home.
47 2021-03-29 fainting After 2-3 mins in observation area. I fainted. came too, hot, sweating. had to go to hospital.
47 2021-04-01 heart rate irregular Elevated body temp, 101-102, shivering, body aches, extremely painful injection site, starting aroun... Read more
Elevated body temp, 101-102, shivering, body aches, extremely painful injection site, starting around 6pm and continuing for the following two days. Symptoms mitigated by regular doses of Tylenol. Elevated blood pressure and erratic heartbeat, mitigated by taking benadryl.
47 2021-04-01 lightheadedness vasovagal reaction. patient has a history of similar reactions to procedures and injections.
47 2021-04-05 cardio-respiratory arrest, cardiac arrest, fibrin d dimer increased Cardiopulmonary arrest, D-Dimer 55,000, TNKase administered, ACLS, needle thoracostomy, persistent ... Read more
Cardiopulmonary arrest, D-Dimer 55,000, TNKase administered, ACLS, needle thoracostomy, persistent PEA arrest, decompensated into asystole , pronounced
47 2021-04-05 chest pain, hypertension fever, fatigue, body aches, chills, chest pain and abnormally high blood pressure
47 2021-04-05 pallor Client received his first dose of Covid vaccine in the clinic on 4/1/2021 at approximately 10:25 a.m... Read more
Client received his first dose of Covid vaccine in the clinic on 4/1/2021 at approximately 10:25 a.m. Client was walked to the courtroom for observation for 15 minutes post-vaccination. This is standard procedure. When his 15 minutes was up, Nurse informed him that his time was up and he was free to go, and signed him out. As she was speaking with him, she noticed he was disoriented. She asked if he was all right and fanned his face for a few seconds. 2nd nurse came by at that time, and the women helped pt. back to the clinic and onto a pad on the floor in a nurse?s office. Third person was called. Vitals were taken several successive times (BP ranged from 148/99 to 155/104), Temp was normal and in 97.5 to 98.4 range. Resp 16-18. Pulse was between 78 and 93. Client was disoriented, could not state his name and could not name anyone for us to call. Ammonia salts were employed with no effect. All emergency meds, oral airways, and AED were gathered in case they were needed. No other meds or equipment were used. By standard called for the clerk, and By standard, to call paramedics. She called 911 x 2 and when put through to EMS, was given a disconnect notice. She ran down the hall to the constable?s offices, who placed the call and had paramedics on their way. Then two constables (male and an unknown female constable) came to the Health Dept. Third person got the client to answer with whom to call. Third person called the client?s mother-in-law and employer. Both arrived after the client was transferred via ambulance and left to join him immediately at the hospital. As all this was happening, Nurse, 2nd Nurse, third person, and Bystander were attempting to ensure pt. airway and breathing were patent. He never had difficulty breathing and never had wheezing. There were no other visible signs of anaphylaxis. His color was pale, then improved, but became pallid again at about the time the paramedics arrived. He was never alert or oriented throughout the event. Paramedics arrived at approximately 11:00 a.m. They did an initial assessment and received report on what had occurred and data gathered. They then had to lift pt. onto the stretcher. He was then transported to Hospital.
47 2021-04-06 blood pressure decreased, heart rate decreased Blood pressure and pulse dropped, patient became diaphoretic
47 2021-04-07 chest pain Approx 10 minutes after patient received vaccine, he began to complain of chest pains, dizziness, a... Read more
Approx 10 minutes after patient received vaccine, he began to complain of chest pains, dizziness, and blurry vision. His vitals were stable at BP 133/95, HR 90, Pulse ox 97% on room air. His symptoms persisted so 911 was promptly called. Dr. came and assessed patient and he was found to have clear lungs with no abnormal heart sounds. When EMS arrived, his vitals were very similar and still stable. Patient was taken to Hospital. I spoke with him the following day, 4/7/21, and he reported that his labs were all unremarkable and they treated him for a panic attack and he was feeling well by the time he got home.
47 2021-04-07 pulmonary embolism Patient reported DOE March 4, 2021, was subsequently diagnosed with pulmonary embolism, hospitalized... Read more
Patient reported DOE March 4, 2021, was subsequently diagnosed with pulmonary embolism, hospitalized and treated with Xarelto. He is currently recovering and will continue with Xarelto as an outpatient.
47 2021-04-07 fainting Patient stated he was feeling "heavy", dizzy, nauseated and feeling chills prior to fainting. Once h... Read more
Patient stated he was feeling "heavy", dizzy, nauseated and feeling chills prior to fainting. Once he was attended to, he was evaluated and taken to the local SEARHC ER. He was released a few hours later when his symptoms resolved. This patient had worked over two weeks straight with Herring as a seafood processor with little sleep and exhaustion.
47 2021-04-08 oxygen saturation decreased Injection site soreness 8 hours later, development of flu like symptoms. Next day full flu like symp... Read more
Injection site soreness 8 hours later, development of flu like symptoms. Next day full flu like symptoms, muscle aches, headaches, chills, weakness. Lasted for 4 days. On day 5 lungs really became sore and O2 began dropping into the mid to upper 80s again. Patient is a previous Covid pnuemonia patient with ground glass nodules from Covid 5 months ago. The lung pains and 02 swings felt as bad as Covid pnuemonia back in October and lasted for about 2 weeks. During this time the patient started Symbicort and Abuterol inhalers again for treatment of the lung issues.
47 2021-04-10 palpitations, blood glucose increased Heart Palpitations: ER visit, recommended rest and hydration
47 2021-04-13 fainting Patient fainted, but patient mentioned that he does faint after needle exposure. Patient also ended ... Read more
Patient fainted, but patient mentioned that he does faint after needle exposure. Patient also ended up vomiting. Laid patient on floor and observed for 40 minutes took blood pressure and patient stated that it was normal for him. After 15 more minutes we let patient leave and wife drove him home. Called at 2:40 and confirmed that patient made it home safe.
47 2021-04-14 chest pain Swelling and pain in Right armpit and Right pectoral muscle.
47 2021-04-14 fainting Patient received Moderna vaccine dose 1 at approximately 2:30 pm on 4/14/21. After about 10 minutes,... Read more
Patient received Moderna vaccine dose 1 at approximately 2:30 pm on 4/14/21. After about 10 minutes, the patient had a syncopal event. 2 pharmacists quickly rushed over and aided in laying him on the floor. His feet were lifted off the floor and leaned against a chair. He was sweating profusely and his face was red. He has no prior history of fainting. He stated he only had a power bar to eat all day and has severe anxiety from receiving vaccines. After the patient started to feel better, he sat up on his own on the ground. He given a granola bar, chips, a soda, and some candy. After finishing the snacks, the patient sat in the chair and was advised to stay for at least an additional 15 minutes.
47 2021-04-15 pallor, pulse abnormal Patient received Moderna COVID-19 vaccination. About 10 minutes after injection patient was not look... Read more
Patient received Moderna COVID-19 vaccination. About 10 minutes after injection patient was not looking well. I escorted him to a private area where he continued to be light headed, pale in appearance, and communicated in short sentences. While sitting patients BP was 60/40 and pulse was thready. He was placed on the floor with legs elevated and EMS called. Lungs were clear and normal, heart tones normal as well. No sings of angioedema at any point of his episode. 3 minutes later BP increased to 80/60 with a stronger radial pulse, and a recheck again about 5 minutes later resulted in a BP of 110/72 with regular radial pulse. EMS arrived and assessed patient. He refused transfer to hospital. He was given time, water, and a small meal as he had not eaten or drank much of anything through is night shift. After about 30 minutes he was able to ambulate through the auditorium and stated he was feeling much better. We encouraged him to take the remainder of the day off but he declined and returned to work. He stated he would return if any symptoms were to reoccur or if he had any concerns. He will have his next dose of vaccine in clinic.
47 2021-04-15 blood clot Pt started having headaches on 3/20/21. He was playing golf with a cardiologist and he recommended t... Read more
Pt started having headaches on 3/20/21. He was playing golf with a cardiologist and he recommended that he see his doctor.
47 2021-04-17 blood pressure fluctuation Feel weak, nausea, anxious, blood pressure fluctuating, metallic smell
47 2021-04-17 fainting Patient fainted within 5 min of receiving vaccine
47 2021-04-18 nosebleed Fevers, chills, muscle soreness, nose bleed.
47 2021-04-19 heart rate increased 12 hours after my dose (on Saturday), going to bed at 10:30 and tired, I began to feel a low-grade t... Read more
12 hours after my dose (on Saturday), going to bed at 10:30 and tired, I began to feel a low-grade temperature set in, and I woke up 2 hours later during the night and was having soreness in my lower back as the most pronounced. I had trouble sleeping through most of the night and got up twice to urinate. I could not get comfortable enough to fall asleep - was not necessarily feeling pain, just soreness. During the day Sunday, I tried to rest having lost sleep, and it was mainly my lower back (back strap muscles) which were experiencing soreness. Sunday evening, I went to bed around 9:30, and I woke up around midnight having a sore neck. It felt like I was not necessarily sore in the muscles, but I could feel my heart rate increase and my blood pumping through my neck to my brain. I could not get comfortable at all and lost sleep. During the day Monday, I tried to rest it off, and there was no position I could rest where I was not in pain in my neck. It almost felt like I had some form of encephylitis. I went to bed around 8:30 PM, exhausted. Woke up around midnight again, and I could not get back to sleep until 4 AM. I found a position where my head turned and my shoulder extended away was not painful. I woke up having felt like I had strained that muscle however.
47 2021-04-20 hypertension The night after I took the first Moderna shot, I sweat so much that it went thru my bed matress and ... Read more
The night after I took the first Moderna shot, I sweat so much that it went thru my bed matress and onto the hardwood floors that became warped the next work. I called Moderna to file an insurance claim. And they told me this was a normal side effect. I wish they had told me to put a plastic pee protector sheet on first which would have avoided my warped floors. I have a bid for $3000 to fix the warped floors. Furthermore, my girlfriend left me. Shes and anti-vaxxer and couldn't stand the musty smell of the matress. I have a high blood pressure now. 160/120. I can't tell if that's from the vaccine or the fact that my anti-vaxxine girlfriend left me. Should I go see a doctor or a psychiatrist?
47 2021-04-20 loss of consciousness Patient called 4/21/21 at 2:08 pm and said at 6 AM he woke up in a "pool of sweat" and started vomit... Read more
Patient called 4/21/21 at 2:08 pm and said at 6 AM he woke up in a "pool of sweat" and started vomiting + chills. No fever. He vomited once and has been nauseous since. He feels very dizzy. He was walking down hallway, and he "blacked out" and fell down the stairs. He said he did not hit his head, but the right side of body hurts, as well as chest, after the fall. He said this pain is causing some difficulty breathing. He said his dad witnessed the fall. When asked if the pain is severe, he said "yes". He was told that if he's experiencing "severe" pain after a fall, accompanied with difficulty breathing, he should seek medical attention. He was told he can contact his Dr. for a second opinion first, if desired. Otherwise, it was suggested he check his BP, if possible, sit with head between knees or lay down with feet propped up and NOT walk around if feeling dizzy. He was advised to stay hydrated and introduce bland foods first to see if he can tolerate solid food. He was told he can take whatever oral pain reliever he normally takes that he's allowed to take if needed. Patient will report back to me.
47 2021-04-20 palpitations, fast heart rate 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: rapid heart rate and felt hot.. Assessment : Time of assessment 1042. Alert and oriented, Tachycardia and patient noticed discoloration in his hands. Patient had completed his 10 of his 15 minute observation and reported feeling like his heart is racing and feeling hot. VS taken at 1042: BP 131/91, P 65, Oxygen sat 99%. He was assisted to the wheelchair and taken to the triage area. 1050: BP 130/78, P 56. After additional observation of 15 minutes, he reported no symptoms. 1108: Ambulatory out without any problems observed. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. There were no vitals filed for this visit. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for and additional 15 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
47 2021-04-21 loss of consciousness I woke up on Sat April 17th the day after my 2nd dose of Moderna and went to the bathroom. I was sit... Read more
I woke up on Sat April 17th the day after my 2nd dose of Moderna and went to the bathroom. I was sitting on toilet and next thin i know i'm waking up on the ground looking at the shower. I had blacked out. I then managed to pull myself up and was looking at the mirror in my bathroom and next thing i know i am waking up. I had blacked out again. My wife then discovered me on the floor and helped me up and to bed. There is a cracked tile in my bathroom so i believe i knocked my head pretty good. I felt woozy and had a large scrape on my right shoulder from one of the falls. I was put into concussion protocol by wife; The rest of the day i had the normal side effects of moderna: Fever, chills, headaches, sore left arm, and took tylenol extra strength, rested, hydrated, etc. I felt better later in the day and by the next day Sunday April 18th i felt much better; I was able to drive and get errands done, but felt "Foggy". I felt back to 100% maybe by Tuesday April 20th. My concern is the blackouts not being known. If someone was operating heavy machinery or driving the day after their 2nd shot and blacked out that is a major cause for alarm.
47 2021-04-22 heart attack STEMI heart attack at 6:45pm Transported by ambulance
47 2021-04-22 blood glucose increased Blood sugar spiked to 265 mg/dL during normal side effect period. All other side effects struck me a... Read more
Blood sugar spiked to 265 mg/dL during normal side effect period. All other side effects struck me as normal: aching, chills, very low grade fever, tiredness. Outcome: all good now.
47 2021-04-22 loss of consciousness blacked out twice in the morning; felt like they got a concussion; scraped their shoulder in the pro... Read more
blacked out twice in the morning; felt like they got a concussion; scraped their shoulder in the process; felt weaker than normal and weakness; fever; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice in the morning) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) 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). On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice in the morning) (seriousness criterion medically significant), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous). The patient was treated with Bed rest (Hydration) for Limb injury. At the time of the report, LOSS OF CONSCIOUSNESS (blacked out twice in the morning), CONCUSSION (felt like they got a concussion), LIMB INJURY (scraped their shoulder in the process), ASTHENIA (felt weaker than normal and weakness), PYREXIA (fever), CHILLS (Chills) and NAUSEA (Nauseous) 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. no concomitant medication given patient got hydration and taken rest. 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.
47 2021-04-24 heart rate increased 102 fever Muscles aches 105 heart bpm
47 2021-04-26 loss of consciousness Dizziness, fever, blacked out twice
47 2021-04-27 chest discomfort Extreme fatigue, confusion/"brain fog," and chest tightness which have mostly subsided. Tinnitus: Lo... Read more
Extreme fatigue, confusion/"brain fog," and chest tightness which have mostly subsided. Tinnitus: Loud ringing in ears has not stopped.
47 2021-04-27 loss of consciousness 5 days after shot while riding my bike I appeared to lose consciousness and crashed. (note I had pr... Read more
5 days after shot while riding my bike I appeared to lose consciousness and crashed. (note I had pretty severe fever and body aches 14 hours after injection)
47 2021-04-29 pallor, chest pain S: At 3:40pm, 47yo Male presented for worsening dizziness and vomitting x1 since first dose Moderna ... Read more
S: At 3:40pm, 47yo Male presented for worsening dizziness and vomitting x1 since first dose Moderna COVID vaccine this AM at 10:54am. Patient deteriorating and c/o additional chest pain during intake. Patient getting paler and significantly more dizzy. Per MD, 911 called for patient as he was developing visual disturbances. B: Patient has severe anaphylaxis allergic reaction to penicillin and stated he took 3x Norco this Am. Prior to COVID vaccination, Advised patient that it is safer to consult with his PCP or our doctor here and then receive the COVID vaccine. Patient stated he would rather get the vaccine now and assume all responsibility. Patient observed for 30 mins post-vaccination. At approx. 1110, patient felt dizzy. After crackers and Apple juice, patient stated he felt better. Prior to discharge at 1125, verified with patient that he no longer feels any symptoms. A: At 3:40p, Vitals taken, WNL. Patient immediately assessed by urgent care MD, hemoglobin & Blood glucose WNL. EKG performed per MD. Ambulance called per MD at 3:53pm. 4:00pm EMS arrived. 4:09pm Patient left for Hospital.
47 2021-04-29 fainting Extreme dizziness on first night after receiving 2nd vaccine dose. Stumbled and then fainted, hittin... Read more
Extreme dizziness on first night after receiving 2nd vaccine dose. Stumbled and then fainted, hitting head hard on sink and floor. Awoke to then vomit. Extreme dizziness and vertigo has continued throughout each day and night for 5 days. Additionally, each night I awake every hour having sweat in bed and soaked all sheets.
47 2021-04-30 blood vessels inflammation Vasculitis. 4-5 days after injection red, blood filled, blister-like (burst capillaries and dead tis... Read more
Vasculitis. 4-5 days after injection red, blood filled, blister-like (burst capillaries and dead tissue) swollen areas started to appear on face, ears, mouth and hands followed by significant swelling, pain and stiffness in a number of joints including knees, elbows, hands, fingers and feet. Biopsy pathology came back as vasculitis. Severe symptoms last 2 weeks and lesser symptoms continue following prescribed course of anti-inflammatories. Doctor suggested symptoms may persist until vaccine dissipates in symptoms (approx. 30 days from injection date).
47 2021-05-01 cerebral haemorrhage, platelet count decreased Developed petichiae on 3/20. Labs drawn 3/22 showed Platelets of 20,000. Started 150mg prednisone 3/... Read more
Developed petichiae on 3/20. Labs drawn 3/22 showed Platelets of 20,000. Started 150mg prednisone 3/29. Neurological symptoms that week. Seizure and brain bleed noted on 4/3. Intubated and transferred from local hospital to neuroscience hospital.
47 2021-05-02 deep vein blood clot, pulmonary embolism Leg cramp alerted me to deep vein thrombosis (DVT) and pulmonary embolism (PE) . I had the second d... Read more
Leg cramp alerted me to deep vein thrombosis (DVT) and pulmonary embolism (PE) . I had the second dose of Moderna Monday afternoon. First cramp Tuesday evening. Mild infrequent leg pain Wednesday. Intense morning cramp on Thursday, hospitalized Thursday night with confirmed DVT w/PÉ. Discharged Sunday afternoon. Was fully hidrates at the time, no recent travel by car or plane. No extended period of inactivity such as bed rest or sitting. No evidence I?d internal trauma or injury. No recent surgery. No sign of any form of cancer. Vaccine listed as suspected cause of the DVT
47 2021-05-03 fainting C/O SYNCOPE, SEIZURE ACTIVITY X 20 SECS, NAUSEA, NO HX PRIOR ALLERGIES, PROVIDED WATER AND SNACK, SX... Read more
C/O SYNCOPE, SEIZURE ACTIVITY X 20 SECS, NAUSEA, NO HX PRIOR ALLERGIES, PROVIDED WATER AND SNACK, SX RESOLVED, NO TRANSPORT.
47 2021-05-04 hypertension Approximately 5 minutes after vaccination, patient complained of feeling hot, some fatigue. Initial... Read more
Approximately 5 minutes after vaccination, patient complained of feeling hot, some fatigue. Initial BP: 158/116. O2Sat: 97%; P: 70. BP rechecked at 10 minute intervals. BP: 160/108; 172/ 118, 178/118. BP remained high, denied hx of HTN but reported feeling dizzy or lightheaded last week. Recommended f/u at ER due to elevated BP. EMS activated, care transferred to ambulance crew at 10:55am. Transported to Hospital. Patient spoke another language; wife present to translate.
47 2021-05-04 fainting Patient fainted after shot and hit his head on the floor. patient was transported to hospital.
47 2021-05-05 heart rate increased Moderna COVID-19 Vaccine EUA fatigue, headache, muscle pain, joint pain, chills, fever, difficulty b... Read more
Moderna COVID-19 Vaccine EUA fatigue, headache, muscle pain, joint pain, chills, fever, difficulty breathing, fast heartbeat, weakness
47 2021-05-06 cardiac failure congestive, chest discomfort I received Vaccine on 03/05/2021 and the next day I noticed wheezing and could not take a deep brea... Read more
I received Vaccine on 03/05/2021 and the next day I noticed wheezing and could not take a deep breath.. The following day I felt like something sitting on my chest. On 03/07/2021 I could not walk across the parking lot without giving out of breath. From 03/08/2021 up until now I have been to several Hospitals and Doctors. Diagnosed on 3/16/2021 at A Medical Center with Acute Systolic and Diastolic CHF .
47 2021-05-06 deep vein blood clot DVT of Right lower leg
47 2021-05-09 ischaemic stroke Suffered an ischemic stroke in the pons region of the brain stem
47 2021-05-11 loss of consciousness Patient went unconscious for almost 3 hours; Critical until he wasn't critical; This spontaneous cas... Read more
Patient went unconscious for almost 3 hours; Critical until he wasn't critical; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient went unconscious for almost 3 hours) and CRITICAL ILLNESS (Critical until he wasn't critical) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The patients had neurological workup and cannot drive for 6 months. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient went unconscious for almost 3 hours) (seriousness criterion medically significant) and CRITICAL ILLNESS (Critical until he wasn't critical) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Patient went unconscious for almost 3 hours) and CRITICAL ILLNESS (Critical until he wasn't critical) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood test: blood work clear (normal) Blood work clear. On 24-Apr-2021, Chest X-ray: chest x-ray clear (normal) Chest X-ray clear. On 24-Apr-2021, Computerised tomogram: cat scan clear (normal) CAT scan clear. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The patient went unconscious for almost 3 hours. the patient almost lift flighted to the hospital but could not and ended up calling an ambulance and brought him to the hospital where they kept him from 7:15 AM to 3:30 PM. After the patient woke up he was completely fine. The reporter disclosed that during the wait for the flight, they had to do continuous sternum rub on him. Treatment for the events included IV fluids and NS saline. Based on the current 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
47 2021-05-17 loss of consciousness Administered Moderna vaccine. Patient was sitting in observation and fell face forward out of the ch... Read more
Administered Moderna vaccine. Patient was sitting in observation and fell face forward out of the chair. Patient hit head and chipped tooth. Pt was unconsciousness for less than 10 seconds. Patients glasses cut his forehead. Called management and 911 immediately. 911 arrived and examined and patient refused to go to ER. Said he was okay to drive home. Patient did ask for me to schedule second dose in 4 weeks.
47 2021-05-18 loss of consciousness PATIENT WAS ALERT AT THE TIME OF VACCINATION; HE WAS ABLE TO ANSWER THE VACCINATION QUESTIONAIRES AN... Read more
PATIENT WAS ALERT AT THE TIME OF VACCINATION; HE WAS ABLE TO ANSWER THE VACCINATION QUESTIONAIRES AND QUESTIONS THAT I ASKED PRIOR TO GIVING THE VACCINE. I ASKED THE PATIENT TO WAIT FOR 15 MINUTES FOR MONITORING AFTER THE VACCINATION. ABOUT 5 MINUTES IN, PATIENT FELL OFF CHAIR AND HIT HIS HEAD ON THE GROUND. HEAD WAS BLEEDING. PHARMACY CALLED 911. PARAMEDIC CHECKED ON PATIENT AND OFFERED TO TAKE HIM TO THE HOSPITAL. PATIENT DECLINED. PATIENT'S FIANCE (ALSO CAME TO PHARMACY FOR COVID-19 VACCINE AND WAS BY HIS SIDE AT THE TIME OF INCIDENCE) STATED THAT SHE AND PATIENT HADN'T EATEN ANYTHING SINCE LAST NIGHT. PATIENT WAS ABLE TO ANSWER QUESTIONS BEFORE LEAVING PHARMACY.
47 2021-05-19 chest pain 10/4/21- woke up with chest hurting. chills. whole body hurt including joints. He took blood oxyge... Read more
10/4/21- woke up with chest hurting. chills. whole body hurt including joints. He took blood oxygen and it was low 70's. Dizzy when standing. Considered going to hospital but didn't. Next morning he was fine again.
47 2021-05-19 deep vein blood clot Deep vein Thrombosis in right leg
47 2021-05-20 inflammation of the heart muscle, ejection fraction decreased, heart failure, troponin increased Patient developed myocarditis resulting in hospitalization at medical center. He was treated with m... Read more
Patient developed myocarditis resulting in hospitalization at medical center. He was treated with medications for heart failure, symptoms resolved and he was discharged home with follow up in heart failure clinic.
47 2021-05-20 troponin increased, inflammation of the heart muscle, chest pain MYOCARDITIS: Patient developed chest pain and shortness of breath. He was seen by me in the emergenc... Read more
MYOCARDITIS: Patient developed chest pain and shortness of breath. He was seen by me in the emergency department on 5/16/21 and was found to have an elevated troponin. He was admitted to the hospital and underwent a coronary angiogram which was normal. He has evidence of some global hypokinesis on his echocardiogram and eventually had a cardiac MRI which confirmed that he has myocarditis. He became ill the day after his 2nd Moderna shot and then more ill the next few days and I saw him on Day #3 after his 2nd shot. He is otherwise healthy. He was hospitalized for two days. He was discharged on Losartan and Metoprolol and was not on any medications prior to his presentation.
47 2021-05-24 blood pressure increased, heart rate increased Numbness on top of young and my lips. I had confusion, anxiety headache, lungs were feeling extremel... Read more
Numbness on top of young and my lips. I had confusion, anxiety headache, lungs were feeling extremely hot, nauseous, increase heart rate and elevate blood pressure extreme confusion . I was rushed inside the Er. I received a Ct scan, ,lab work, and a EKG I received IV ,fluids,Ativan,, Diphenhydramine, famotidine and Prednisone.
47 2021-05-24 stroke, brain sinus blood clot Patient is a 47 y.o. pleasant man with history of diabetes, presented to hospital with intractable v... Read more
Patient is a 47 y.o. pleasant man with history of diabetes, presented to hospital with intractable vomiting. He was lethargic and unresponsive. He was found to have bilateral transverse and straight sinus thrombosis, multifocal ischemia consistent with venous infarction. He was treated with heparin drip from diagnosis 5/11 and transitioned to apixaban 5/22. His mentation improved. As of today, he is conversant, disoriented, ambulatory, no longer requiring a feeding tube.
47 2021-05-25 palpitations, palpitations heart palpitations started saturday the 23rd of Jan very subtle on satuday, by monday quite often .... Read more
heart palpitations started saturday the 23rd of Jan very subtle on satuday, by monday quite often . Progressively got worse. by Wednesday night it felt as if my heart was beating upside down. they were probably every 6 beats . went to medical center, where they did chest xray and EKG, along with blood work to see if I was having a heart attack. They diagnosed them as premature beats. Sent me home on a pepcid and magnesium Followed up on Friday the 29th with a cardiologist as they were continuing every 10 beats. He prescribed metoprolol 25mg They subdued after another week. They flared up for second shot but not as bad . I no longer take metoprolol
47 2021-05-26 inflammation of the heart muscle, ejection fraction decreased, chest pain, chest discomfort, heart rate increased, troponin increased HPI/Subjective: is a 47 year old male with minimal past medical history who presents in consultati... Read more
HPI/Subjective: is a 47 year old male with minimal past medical history who presents in consultation. He was hospitalized with myocarditis. The patient presented to PWF 5/16 with CP, fatigue and elevated HR. He had received his second dose of the Moderna COVID-19 vaccine 3 days prior. The initial ECG showed nonspecific ST abnormalities. HS-troponin 1,438 -- > 5,951. Echo showed ejection fraction of 35% with global hypokinesis, akinesis in inferior and inferoapical segments, and mild right ventricular hypokinesis. He was subsequently transferred to to PPMC and underwent coronary angiogram on 5/18/21 which demonstrated normal coronary arteries. In consultation with Dr. , he was discharged on losartan 25 mg/day and metoprolol succinate 50 mg BID for outpatient follow-up. Cardiac MRI 5/19 showed T2 signal abnormality and LGE involving the subepicardium of the lateral wall, inferior wall, as well as septum c/w acute myocarditis. LVEF 53%. Dr. submitted his case to the VAERS site. reports feeling much improved. He denies fatigue, dyspnea, palpitation, or presyncope. He has noted fleeting chest discomfort. No fevers or chills.
47 2021-05-26 fainting Around 2 AM the (approx. 12 hours after he received the vaccine) patient got out of bed to use the r... Read more
Around 2 AM the (approx. 12 hours after he received the vaccine) patient got out of bed to use the restroom, felt dizzy, and fainted.
47 2021-05-27 cardiac arrest 3 days after 2nd dose of moderna patient presented to our er in cardiac arrest; lacking extensive ca... Read more
3 days after 2nd dose of moderna patient presented to our er in cardiac arrest; lacking extensive cardiac history other than a-fib; he had reported anginal like symptoms to his wofe during the day and then collapsed in v-fub and was unrecusitatble; no autopsy or further information; unclear if vaccine is contributory but within 3 days i agreed with patient's wife in that the temporal relation should be reported
47 2021-06-01 loss of consciousness Patient was light headed and sweaty after 10 minutes getting the shot. I was talking to him the who... Read more
Patient was light headed and sweaty after 10 minutes getting the shot. I was talking to him the whole time to make sure he is conscious. It seemed he lost consciousness twice but came back very quickly. Patient said he had lack of sleep the night before so we do not know for sure if the reaction was just because of vaccine or there are other reasons behind his reaction. By the time 911 came patient was ok and could talk and communicate well. they took him to ER for more exams.
47 2021-06-03 loss of consciousness Patient felt dizziness and flushing and then passed out 3 minutes after receiving vaccination and w... Read more
Patient felt dizziness and flushing and then passed out 3 minutes after receiving vaccination and was out for approximately 1 minute.
47 2021-06-03 lightheadedness Vasovagal episode in the observation area folling vaccination. Spontaneous resoulution when placed i... Read more
Vasovagal episode in the observation area folling vaccination. Spontaneous resoulution when placed in the supine position. Paramedics onsite. No treatment required.
47 2021-06-05 cardiac arrest, heart attack STEMI treatment: went into V fib arrest and did CPR and went to cardiac cath and received PCI discha... Read more
STEMI treatment: went into V fib arrest and did CPR and went to cardiac cath and received PCI discharged home
47 2021-06-09 blood pressure increased Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vacc... Read more
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were high pressure injection injury of finger of left hand, diarrhea, elevated BP without diagnosis of hypertension.
47 2021-06-09 inflammation of the heart muscle, ventricular tachycardia, cardiac arrest, palpitations, ejection fraction decreased Ventricular tachycardia and presumed myocarditis. Was feeling well until 4 days after vaccine dev... Read more
Ventricular tachycardia and presumed myocarditis. Was feeling well until 4 days after vaccine developed palpitations found to have monomorphic VT followed by cardiac arrest.
47 2021-06-09 bleeding on surface of brain Vaccine information (brand name, dosage, lot number) Date, time, and location administered: Date: 4... Read more
Vaccine information (brand name, dosage, lot number) Date, time, and location administered: Date: 4/27/2021; Time: ? m; Location: Pharmacy Date and time when adverse event(s) started: Date: 4/28/2021; Time: afternoon Description of the adverse event, including medical treatment and diagnosis: Description: Symptoms include: Worst headache of life Exam Findings include: No focal neurologic findings but given history, CT head ordered.
47 2021-06-09 bleeding on surface of brain The day after the first dose I experienced a subarachnoid hemorrhage. I was hospitalized for 10 day... Read more
The day after the first dose I experienced a subarachnoid hemorrhage. I was hospitalized for 10 days due to the hemorrhage.
47 2021-06-10 heart rate increased, chest pain 32 year endurance athlete with never any issues. Within 2 weeks of second vaccine now have chest pa... Read more
32 year endurance athlete with never any issues. Within 2 weeks of second vaccine now have chest pain, shortness of breath, and high heart rate. Been to listed family doctor. Got EKG, Halter monitor test, and Echocardiogram. Now told I have mild to mid leaky heart valve.
47 2021-06-10 pulmonary embolism, deep vein blood clot DVT, pulmonary embolism
47 2021-06-11 heart attack Heart Attack
47 2021-06-14 inflammation of the pericardium On March 21st Patient received the first dose of Moderna. On April 2nd he was diagnosed with perica... Read more
On March 21st Patient received the first dose of Moderna. On April 2nd he was diagnosed with pericarditis. He continues to require treatment for the pericarditis. He received the second dose on April 11th without any new problems. The vaccines were given at the Vaccine Clinic.
47 2021-06-14 fainting, cardiac arrest Coroner stated that 3 weeks after patient received 2nd dose of COVID-19 Moderna vaccine, patient col... Read more
Coroner stated that 3 weeks after patient received 2nd dose of COVID-19 Moderna vaccine, patient collapsed from cardiac arrest, which lead to death.
47 2021-06-17 chest pain Ache/pain in heart and across chest
47 2021-06-19 heart flutter Patient left work early due to heart fluttering and pain behind eyes. He went home and tried to res... Read more
Patient left work early due to heart fluttering and pain behind eyes. He went home and tried to rest, but ended up feeling worse and went to Emergency Room.
47 2021-06-20 chest pain Upper left Chest Pain with pain radiating to left arm
47 2021-06-21 loss of consciousness patient was found passed out in the parking lot, patient received a laceration above his right eye w... Read more
patient was found passed out in the parking lot, patient received a laceration above his right eye with orbital swelling. we administered first aid to patient and called 911. to my knowledge the patient proceeded to the hospital for additional medical attention. we also gave pt water and crackers as they stated they were dizzy.
47 2021-06-24 heart rate increased Patients appointment was either 2:15 or 2:30. His Apple watch recorded it's last heart beat reading... Read more
Patients appointment was either 2:15 or 2:30. His Apple watch recorded it's last heart beat reading at 3:15 pm, 05/21/2021, within an hour after receiving his second Moderna Covid-19. His heart rate increased rapidly from 3:00 to 3:15, reading 104 - 106 - 108 - 116 bpm. I can provide a photo of these last four readings if you need them. I don't know other symptoms. His body was found by police who were called for a well-check three days later, 05/24/2021. Patient died unattended, at home, alone. I only know for sure the vaccine was administered at a Target store near his home. Patient texted me at 2:48pm saying that Target gave him a $5 coupon for getting his vaccine, and he was going to use it to buy Tylenol.
47 2021-06-27 chest pain Patient reported before vaccine administration that he was bothered by his high blood pressure-LPN c... Read more
Patient reported before vaccine administration that he was bothered by his high blood pressure-LPN checked-150/100-then used automatic BP cuff-was 128/88- within 15 minutes patient complained of chest pain which worsened when laid down. BP-138/88. Requested EMS-was transported to Hospital.
47 2021-06-27 fainting, pallor At 11:30 patient was given Moderna and told to sit for 15 minutes. At around 11:35 patients wife scr... Read more
At 11:30 patient was given Moderna and told to sit for 15 minutes. At around 11:35 patients wife screamed his name and attempted to get his attention by slapping him across the face several time. Patient was unresponsive, pale in color and eyes were open and glazed over. Patient was given an 0.03mg Epipen and was shortly responsive. EMTs promptly arrived 3 minutes later and it was found that he fainted and had a history of fainting with other vaccines. He did not faint with the 1st moderna shot given at our facility.
47 2021-07-08 blood pressure increased After the vaccine, I had regular symptoms from virus that you hear people talk about. Head aches, m... Read more
After the vaccine, I had regular symptoms from virus that you hear people talk about. Head aches, muscle ache and soreness, then I felt better after a few days. Off and on I would have good days and then I would have bad days. I felt sluggish, and would make myself get through the day. Some days I would have headaches and others not so much until month of May following the vaccine. My head hurt almost every day, I was in a busy time in my family owned business as well. I made an appointment with the Doctor and of course had to wait 2 weeks to get in. I couldn't stand it any more and my wife got me in to see Dr. at the walk in clinic. My Blood pressure was high, he did blood work and called and admitted me to hospital. My numbers where all messed up and they told me my kidneys where not filtering. After 3 days at Hospital I was transfered to another hospital. There I met a Nephrologist, who did test, biopsy on my kidneys and started me on dialysis. My Biopsy report is as follows: 1 advanced Glomerular and tubulointerstital fibrosis (Approx. 60%) 2 Focal segemental glomerular sclerosing pattern, likely secondary 3 Moderate arteriolosclerosis 4 Rare neutrophil cast, superimposed pyelonephritis can not be excluded 5 active cellular cresents are not identified in light microscopic material. This basically says that the high blood pressure is what damaged my kidneys. I went from a healthy 48 year old with no blood pressure issues, no health issues until I took the vaccine and with in 6 months it killed the filtration of my kidneys. I am now on dialysis 3 days a week and on the transplant list awaiting a new kidney.
47 2021-07-17 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weak... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: Patient stated he had a fear of needles at the start of the interaction. Was fine right after the injection, then after I completed the immunization for the person he came in with, he fainted. Was out for approx. 30 sec, then awoke. I provided a bottle of water, and ice pack. They sat for 20mins, walked around the store for a bit, then left. He was accompanied by a female who he lived with.
47 2021-07-19 heart attack, blood clot, palpitations I had the vaccine on Saturday and Monday early morning something woke me up, I was sweating and my h... Read more
I had the vaccine on Saturday and Monday early morning something woke me up, I was sweating and my heart was pounding like crazy. I thought it was the side effects of the vaccine. It took 3-4 hours to stop. After 2 weeks at 4AM something woke me up again and I was sweating for no reason. The same symptoms I had after getting the vaccine. On 06/18/2021 again 4AM something woke me up and I had the same sweating and I was throwing up. I thought it was the vaccine so I did not go to the hospital. I did not think this was a heart attack since I am young, healthy, non-smoker, non-drinker. Again, something woke me up. I went upstairs with my neighbor and she took me to urgent care because she thought it was COVID and I thought it was just the vaccine and they said to call ambulance immediately because I was having a heart attack. They took me to the hospital, and they started the procedure. They said it was impossible to open here. By helicopter they took me to another hospital. I was on the doctor on Friday and they told me I still have a blood clot and they try to open but they were not able to open so they left it like clotted. Now they told me they need to do the bypass surgery. No heart attack history in my family. I am not having that surgery because doctors do not care here. I am going to another country to have surgery since they do care over there and it is less expensive. They prescribed a lot of medications for my heart.
47 2021-07-20 deep vein blood clot, blood glucose increased Patient presented to provider office visit 2 days after 2nd dose of Moderna vaccine with testicular ... Read more
Patient presented to provider office visit 2 days after 2nd dose of Moderna vaccine with testicular pain for last 2 days, bluish color on tips of left fingers. Was prescribed levofloxacin x 7 days to cover for possible epididymitis and was told to monitor the finger discoloration and return to PCP next week for recheck. The following day (7/17), he presented to the Emergency Department for evaluation of the fingertip discoloration. He reported that the testicular pain had improved. ED provider noted: Fingertips on 2 or 3 fingers of a few small thin lines that are purplish in color almost as if discoloration of the fingerprint itself. But it is no more than 1 or 2 lines to 2 or 3 fingertips. There is no erythema no swelling no tenderness. There is no muscle soreness. No axillary lymphadenopathy. No ascending lymphangitis. ED Course Differential Dx: Adverse reaction to Covid vaccine, DVT, electrolyte imbalance, coagulopathy, electrolyte imbalance, localized trauma Lab normal white count hemoglobin platelet count mildly elevated hematocrit of 51.3. CMP showed a low CO2 22 I suspect this is due to prior elevated respiratory rate he does admit that he slightly anxious. Glucose was elevated 142 BUN was 6. Liver function studies normal. Coags normal Did do ultrasound of his arm since he recently was vaccinated there is no evidence of DVT or any occlusion. Patient's fingers are warm he has intact sensation I am not sure if this is an adverse reaction to the recent vaccine, some sort of unknown localized trauma. I suggested patient follow-up closely with primary care for reeval this week if no improvement and return if any acute worsening symptoms or problems.
47 2021-07-21 arrhythmia, chest pain I had Covid-19 in January of 2021. I had mild symptoms. One day after the first dose of my vaccine I... Read more
I had Covid-19 in January of 2021. I had mild symptoms. One day after the first dose of my vaccine I had Arrhythmia. I went the ER, and I was admitted for an Angiogram. I was transferred to the Medical Center. I was in the ICU for 3 days. I was transferred to Telemetry for 3 more days. I was discharged and I returned 2 days later because I had Arrhythmia. I was having chest pain and my White Cells were very high. I was in Telemetry for 4 days. I went back to work until a Few days after the second dose when I was hospitalized again.
47 2021-07-24 loss of consciousness After receiving his COVID-19 moderna vaccine, patient sat in waiting area for his 15 minutes. Befo... Read more
After receiving his COVID-19 moderna vaccine, patient sat in waiting area for his 15 minutes. Before his 15 minutes were up, patient felt light-headed and passed out to the floor. Patient hit head on floor.
48 2021-01-03 blood pressure increased Within two or three minutes after receiving vaccine, individual began to complain of feeling light h... Read more
Within two or three minutes after receiving vaccine, individual began to complain of feeling light headed and vertigo. Blood pressure was normal before vaccine and elevated during time of complaint. Reaction lasted about 30 minutes.
48 2021-01-06 blood pressure increased Incident occurred at a COVID19 mass vaccination clinic. Within 5-10 minutes after vaccination, clien... Read more
Incident occurred at a COVID19 mass vaccination clinic. Within 5-10 minutes after vaccination, client complaint of dizziness, nausea, and right eye was twitching and drooping. Client stated that they had a history of penicillin allergy with a hives/rash reaction. Client checked his sugar and it was at 138. EMS that was on-site checked vitals @11:22 BP 160/100 pulse 72 resp 16 pupils NTL , alert and verbal, skin normal, respirations normal; @11:33 BP 160/105. Client initially refusing transport by EMS. After 45 minutes of blood pressure not dropping, client agreed. @11:50 EMS transport by EMS. Hospital has attempted to reach client for follow up of outcome but has not received return call.
48 2021-01-06 heart rate increased Dizziness After 5 minutes after being vaccinated, pt began to feel lightheaded and dizzy and slightl... Read more
Dizziness After 5 minutes after being vaccinated, pt began to feel lightheaded and dizzy and slightly short of breath, heart rate was 160 and BP was 128/90 with 100% O2 sats on 6L. After that her heart rate started to come down two minutes later to 129
48 2021-01-06 fast heart rate Headache & Tachycardia
48 2021-01-10 hypertension, blood pressure increased SkinRash & HYPERtension Narrative: The patient was observed to have elevated blood pressure and was ... Read more
SkinRash & HYPERtension Narrative: The patient was observed to have elevated blood pressure and was subsequently transferred to this facility's emergency department.
48 2021-01-23 chest pain, chest discomfort Substernal center chest tightness x3 days. Chest tightness with small intervals of pain that would i... Read more
Substernal center chest tightness x3 days. Chest tightness with small intervals of pain that would increase when laying on side. Tightness and pain occurred with the first and second injections. Two other co-workers (same vaccine lot #) polled about their symptoms stated the same chest tightness and pain. Tightness described as the "need to belch but unable to".
48 2021-01-24 chest discomfort Approximately 30 minutes after injection, client began to experience shortness of breath, nausea, v... Read more
Approximately 30 minutes after injection, client began to experience shortness of breath, nausea, vomiting, hives on face and chest, tightness in chest and severe anxiety attack.
48 2021-01-24 skin turning blue Hands and feet turn blue periodically and all extremities have a "cold" sensation at all times. Dr ... Read more
Hands and feet turn blue periodically and all extremities have a "cold" sensation at all times. Dr appointment being made this week of Jan 25th and reported to HCP at healthcare facility.
48 2021-01-30 blood pressure increased About 5 days after I received my injection, my blood pressure went to 170/ 100 for about 2 -3 hours.... Read more
About 5 days after I received my injection, my blood pressure went to 170/ 100 for about 2 -3 hours. I was kept one night at the hospital due to an image of my lungs. My blood pressure had been good and it still has not come down. I am not sure if this is due to injection or not.
48 2021-01-30 chest discomfort Chondrocostal junction syndrome--chest discomfort with referred left arm pain, beginning 5-7 days pr... Read more
Chondrocostal junction syndrome--chest discomfort with referred left arm pain, beginning 5-7 days prior to seeking treatment (1/28/21)
48 2021-01-30 platelet count decreased Evening of the vaccine: mild left arm pain at injection site. Day 1 post vaccine: mild left arm pain... Read more
Evening of the vaccine: mild left arm pain at injection site. Day 1 post vaccine: mild left arm pain all day, By 3pm back pain, flank pain , skin over thighs and right arm tender to the touch. 10pm-5:30am uncontrolled rigors and chills with fever up to 100.5. Day 2 post vaccine: moderate left arm pain, moderate muscle aching, moderate fatigue, occasional nausea, some joint pain, had to leave work after 1/2 day. The evening begins with nausea, then diarrhea all night until Day 3 post vaccine: severe left arm pain, now arm is swollen over injection site for 1st time, sob with activities (1 flight of stairs) and pain when taking a deep breath. Diarrhea resolved by mid day. Muscle and joint pain is better today. severe fatigue, left work after 1/2 day. Day 4 post Vaccine: severe left arm pain, swollen over injection site, fatigue is moderate. muscle pain resolved, DOE and pain on deep breaths improving, muscle and joint pain resolved Day 5 post vaccine: moderate left arm pain, swelling improved. fatigue continues, DOE and pain on deep breaths improving Day 6 post vaccine:left arm pain resolved, fatigue continues to improve slowly, was able to work a full day, DOE and pain on deep breaths is mild. Day 7 post vaccine: DOE and pain on deep breaths has resolved, fatigue is mild and improving Day 14 post vaccine: fatigue has resolved and I was able to resume aerobic exercise.
48 2021-01-31 heart rate increased Fever (100.4 degrees F), body aches, chills, fatigue, rapid pulse rate 101.
48 2021-02-01 nosebleed A few days after the vaccination I got a sporatic nose bleed which was stopped by applying pressure.... Read more
A few days after the vaccination I got a sporatic nose bleed which was stopped by applying pressure. A few hours later it happened again but this time because it happened twice within a few hours I reached out to the EH and advised the NP I experienced it and was advised to report if via VSafe. It was handled by applying pressure and it finally stopped.
48 2021-02-03 blood pressure increased, pulse abnormal, blood glucose increased Starting the next day, I had an increased sensitivity to motion sickness. This is unusual as I am a... Read more
Starting the next day, I had an increased sensitivity to motion sickness. This is unusual as I am a paramedic and work in an ambulance for a living. I also suffered 2 nights of insomnia. On the evening of the third day, I developed joint aches, fatigue, and a series of normal bowel movements (five in 2 hours). The next morning I added a lost of balance and a slight right side facial droop around my eye (no numbness). Later that day I developed nausea and vomiting, a single period of cold chills followed by a period of a hot flash. However, I never developed a fever. By day five, all of my symptoms resolved with the balance issue being the last. Also of note, early on, my blood sugar was elevated, blood pressure was elevated, and pulse elevated.
48 2021-02-03 chest pain developed neck pain, some nausea and chest pain; issues interfered with work/ADL?s missed Sat/Sun. ... Read more
developed neck pain, some nausea and chest pain; issues interfered with work/ADL?s missed Sat/Sun. Still with persistent Neck pain with any movement. No other issues as of 2/1 - nausea resolved, chest pain stopped on weekend
48 2021-02-03 heart rate increased, blood pressure increased Rapid Heart rate for about 30 seconds, rise in blood pressure
48 2021-02-04 fast heart rate Two days after having his first COVID 19 vaccination the patient described new onset tachycardia whi... Read more
Two days after having his first COVID 19 vaccination the patient described new onset tachycardia while at rest that did not resolve with rest. He was seen by a cardiologist for an ECG which was negative for arrhythmia, patient has lab work scheduled but has not yet gone to have it drawn. Was still complaining of feeling tachycardia 3 weeks after getting vaccination.
48 2021-02-05 palpitations, blood pressure increased, heart rate increased Been having rapid heart rate and elevated blood pressure on and off for four days. Ten min after th... Read more
Been having rapid heart rate and elevated blood pressure on and off for four days. Ten min after the first and ONLY shot, it felt like a rush and they brought me to the next room, checked my BP and HR. 177/111 and 115 bpm. Got better after a bit, and went home. 28 hours later, my heart started racing at home, drove to the WR and it was 133-145 Beats and BP was 180-120. Went to the ER again tonight for being light headed, did the EKG and it was normal. Tonight I woke up three times with a heart rate of 90
48 2021-02-09 bleeding on surface of brain, cerebral haemorrhage After the first vaccine next day at 9:00am I have shooting headache,severe pounding in my ear. I tol... Read more
After the first vaccine next day at 9:00am I have shooting headache,severe pounding in my ear. I told my wife (physician) what happened she recommended me to go toER. I went to ER they thought I had a stroke,CT scan diagnosed with subarachnoid bleeding. I was transferred to another hospital 1 day had another CT scan, MRI Scan and was seen by a Neurosurgeon. I was told I have a revolving bleeding in my brain, loss sensation right side and double vision. I'm scheduled for Cerebral Angiogram in Feb.
48 2021-02-13 pulmonary embolism Bilateral PE with right heart strain and pulmonary infarct. COVID negative. Symptoms started 2 day... Read more
Bilateral PE with right heart strain and pulmonary infarct. COVID negative. Symptoms started 2 days after the vaccine progressively worsened. Diagnosed to day - 02/13/2021. Unknown whether this is an adverse event, but no history of coagulopathy or risk factors
48 2021-02-16 fainting, loss of consciousness PT received 1st dose 0.5. ML Moderna IM Left Arm at 0900 HRS. PT did not present with any significa... Read more
PT received 1st dose 0.5. ML Moderna IM Left Arm at 0900 HRS. PT did not present with any significant medical history or preexisting symptoms before vaccination. PT ambulated under his own power to observation area. Approx 5 minutes into observation patient walked back to vaccination table, asked for water, then postured and fell to the ground. Patient appeared to have a vasovagal or seizure event. PT did not hit their head when falling. PT regained consciousness, recalled the vents leading to the altered level of consciousness, but does not remember losing consciousness. PT evaluated by EMS and transported to local ED for evaluation and treatment.
48 2021-02-21 chest pain FATIGUE, NAUSEA, LEFT SIDE MUSCLE PAIN, CHILLS, SORENESS, AND CHEST PAIN.
48 2021-02-22 lightheadedness Started with tiredness, then arm got sore and was painful to lift. Later in the day, body and joint ... Read more
Started with tiredness, then arm got sore and was painful to lift. Later in the day, body and joint aches started. 12 hours after dose, started to get very cold and this turned into violent and uncontrollable shaking from chills. Then headache started 13 hours after dose (the headache lasted for 2 days and was the last symptom to go). Fever fluctuated between 101.5 and 102.1. Later felt very nauseous, felt like I had to vomit but didn?t. Went to the bathroom and there I got dizzy and almost passed out but didn?t. Fever up and down all day the next day. Could only eat a little Campbell?s chicken noodle soup and a small can of coke. By the next evening (day 2) I started to feel better just exhausted and a headache. Went to sleep early, next day (day 3) still had the headache and was exhausted. By Day 4 I was about 80 % back to normal and feeling much better. I didn?t take any fever reducers or other medications during this time. It was all worth it to be vaccinated,
48 2021-02-25 fainting client was administered vaccine by IM inj. LD in a semi fowlers in private room at 06:20pm. Client r... Read more
client was administered vaccine by IM inj. LD in a semi fowlers in private room at 06:20pm. Client remained alert and moved to chair in sitting position. client then had an episode of syncope in chair and was held upright. client had reduced consciousness but was able to respond verbally to voice. client was assist of two to a wheel chair and moved back to private room and administered O2 via NRB @ 4lpm. Client responded well and quickly, was more alert and oriented x3. client given orange juice at 06:30 and was fully alert and orientated, talkative and calm. O2 off at 06:35. Continued to monitor symptoms q 5 mins for 30 mins. Client is an athletic runner. His BP remained in the 92/48 range and his HR at 54. Client was released 06:55.
48 2021-03-01 cerebrovascular accident Stroke; A spontaneous report was received from a consumer concerning a 48-year-old, male patient, wh... Read more
Stroke; A spontaneous report was received from a consumer concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke (cerebrovascular accident). The patient's medical history was not provided by the reporter. Concomitant product use was not reported. On 30 Dec 2020, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. The reporter stated that on 10 Jan 2021, the onset of symptoms of stroke began. The patient reports that he was discharged from the hospital on 20 Jan 2021 and was later discharged from patient rehabilitation on 26 Jan 2021. Treatment for the event included apixaban, acetylsalicyclic acid, and atorvastatin as advised by patient's HCP (health care provider). Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, stroke, was unknown.; Reporter's Comments: This case concerns a 48 year old male who experienced stroke 11 days after the vaccine was administered. Very limited information regarding this event has been provided at this time. Further information has been requested.
48 2021-03-07 palpitations, fainting Got up to use bathroom in middle of night, got lightheaded and fainted. Wife woke me up and I was o... Read more
Got up to use bathroom in middle of night, got lightheaded and fainted. Wife woke me up and I was on floor of bathroom. Not sure how long. Wen to bed with racing heart, cold sweats. Symptoms subsided after about 30 minutes in bed. Went back to sleep. Woke up sore all over body, rash on torso. Sore and tired all day. Symptoms persisted for about 36 hours.
48 2021-03-10 fast heart rate Headache, Myalgia, Arthralgia, Tachycardia, CHILLS, FATIGUE, SORE ARM Narrative:
48 2021-03-11 blood glucose increased Patient's sugar levels skyrocketed to 553 from a previous day of 170. Patient generally stays within... Read more
Patient's sugar levels skyrocketed to 553 from a previous day of 170. Patient generally stays within sugar control of 120-170.
48 2021-03-14 fainting, loss of consciousness Patient received first dose of his Moderna COVID 19 vaccine and was seated in the waiting area arou... Read more
Patient received first dose of his Moderna COVID 19 vaccine and was seated in the waiting area around 11:45am. Around 11:49am patient had fainted and fallen to the floor slumped over onto the adjacent chair. 911 was called, and patient regained consciousness after a minute and was responsive and stated no issues other than dizziness. Patients BP was checked and documented, EMS arrived and also did a thorough exam of the patient and found him stable. Patient stayed in seating area to wait for spouse who came to escort him home around 12:40.
48 2021-03-17 chest pain Within 15 minutes I began to feel pain in upper chest and throat along with Difficulty swallowing. ... Read more
Within 15 minutes I began to feel pain in upper chest and throat along with Difficulty swallowing. I took Benadryl but this continued for about 6 hours
48 2021-03-30 excessive bleeding, loss of consciousness Patient passed out 5 minutes after recieveing vaccine and hit his head and start bleeding
48 2021-03-31 fainting, loss of consciousness Patient in waiting room following COVID vaccine - syncope episode, temporary loss of consciousness 1... Read more
Patient in waiting room following COVID vaccine - syncope episode, temporary loss of consciousness 15-20 seconds - woke up and was given water - less than 5 minutes later second syncope episode, temporary loss of consciousness 15-20 seconds - 911 called - woke again - more water given - EMS providers then took over care
48 2021-04-01 chest discomfort Developed high grade fever (105) at 5pm the evening of vaccination date. Overnight fever continued w... Read more
Developed high grade fever (105) at 5pm the evening of vaccination date. Overnight fever continued with increasing myalgia, arthralgia and fatigue. Attempted Tylenol to reduce fever without improvement. Felt things were "settling in his chest". Went to emergency department afternoon of 3/24 and was admitted overnight for observation. Discharged next day, feeling improved.
48 2021-04-02 chest pain Patient received his first Moderna Vaccine today. The dose was given in his right arm and about 10 ... Read more
Patient received his first Moderna Vaccine today. The dose was given in his right arm and about 10 minutes after administration patient reported chest pain on the left side. Patient was monitored and reported no signs of breathing problems, also no swelling, rash or problems with airways. Patients Blood pressure was taken and recorded as 141/91. His pre vaccine temperature was 97.1, and he reported no allergies or health conditions. He is a 48 year old hispanic and smokes. Patient agreed to have ambulance called to check him out as he had no need for Epi-Pen or benadryl. Paramedics arrived at the store approximately 10 minutes after called and released patient with no further treatment and stated that patient possibly had anxiety after the administration as he checked out on all other observations.
48 2021-04-06 fainting Within two minutes of being injected, I had a flush sensation throughout my body and became very nau... Read more
Within two minutes of being injected, I had a flush sensation throughout my body and became very nauseous, faint and got a headache. The symptoms persisted for 30 minutes so the pharmacist called an ambulance to the store. The paramedics checked my vital signs which were stable but recommended that I go to the nearest hospital for further examination and treatment.
48 2021-04-06 low platelet count I began feeling sick with symptoms like fever, chills, nausea, vomiting, rash/spots. Symptoms got w... Read more
I began feeling sick with symptoms like fever, chills, nausea, vomiting, rash/spots. Symptoms got worse over the next few days, and I ended up being admitted in the hospital for thrombocytopenia for 5 days.
48 2021-04-08 chest pain, fainting After second dose, tired, very fatigued, whole body was sore, chest rash, injection site pain, this ... Read more
After second dose, tired, very fatigued, whole body was sore, chest rash, injection site pain, this was the day after the shot and last for about 4 days. Felt bad for weeks after 2nd dose. On 3/23/21, Syncope and collapse, 3 days in hospital. Dr's could not find the cause of syncope and collapse, they ran many tests. On 3/23/21, woke up with severe chest pains and collapsed, large gash on my head, taken to hospital by ambulance. Dr's did not think it was from 2nd dose, but they could not find another reason for Syncope and collapse.
48 2021-04-08 fainting, blood pressure decreased Flu-like symptoms for two day (I don?t consider this an adverse reaction) followed by intermittent d... Read more
Flu-like symptoms for two day (I don?t consider this an adverse reaction) followed by intermittent drops in blood pressure and fainting on days 2 and 4
48 2021-04-08 fainting About 20 seconds after shot patient became dizzy, sweaty and labored breathing. He then told pharma... Read more
About 20 seconds after shot patient became dizzy, sweaty and labored breathing. He then told pharmacist that he had Covid in may of 2020. He then fainted and lost bladder control. The EMT's were called and about 45 minutes later his vital signs were normal and patient left under his own power.
48 2021-04-11 chest pain Symptoms for Moderna's COVID-19 vaccine: Day 1: pain on site of vaccine/feverish/headache/felt delir... Read more
Symptoms for Moderna's COVID-19 vaccine: Day 1: pain on site of vaccine/feverish/headache/felt delirious; Day 2: arm, neck & chest pain on side of vaccine/headache/feverish with chills & body aches/headache persists; Day 3: Much improved; arm still stiff and sore; all other symptoms absence.
48 2021-04-12 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
48 2021-04-14 nosebleed Day after had severe gum bleeding at dentist cleaning, on February 24th had a blood nose hemmorage, ... Read more
Day after had severe gum bleeding at dentist cleaning, on February 24th had a blood nose hemmorage, needed to go to emergency department. They had to insert a nasal balloon because I wouldn't clot for about 4 hrs.
48 2021-04-14 fibrin d dimer increased, blood glucose increased, pulmonary embolism Patient reports around 5 days after receiving Moderna vaccine he experienced fever, diarrhea, n/v an... Read more
Patient reports around 5 days after receiving Moderna vaccine he experienced fever, diarrhea, n/v and SOB. Pt presented 4/07/21 to LGH ED with unremarkable blood work and negative chest x-ray, Covid negative- Pt discharged. 4/12/21 pt represented to LGH ED for some concerns and worsening sob with talking and walking and found to have PE and pneumonia
48 2021-04-15 fainting patient fainted about 7 minutes after his shot at the clinic. he was sitting and fainted in his seat... Read more
patient fainted about 7 minutes after his shot at the clinic. he was sitting and fainted in his seat. The nurse and pharmacists rushed over right away and he was barely responding. his tongue and lips were seen to be swelling. The nurse administered the auvi-q right away and less than a minute, the patient came back and was confused about what happened. he started sweating and his tongue and lips came back to normal. he was monitored for about an hour - he called his doctor because he refused to go to the hospital. his doctor assured he would be okay after being monitored an hour, said to take benadryl around the clock and call 911 if anything happens. patient agreed
48 2021-04-16 hypertension Reported tingling and pins prickles of both arms; SOB; decrease breathe snd at base of lungs; diso... Read more
Reported tingling and pins prickles of both arms; SOB; decrease breathe snd at base of lungs; disoriented; hypertension BP190/100; 186/100; 170/100;Pulse-79; 74; O2 sats 99%.
48 2021-04-17 pulmonary embolism, deep vein blood clot Shortness of breath, pulmonary emboli, deep vein thrombosis (DVT) in leg
48 2021-04-19 blood pressure decreased, fainting About ten minutes after he received his shot he felt dizzy and that he may pass out. He did, in fact... Read more
About ten minutes after he received his shot he felt dizzy and that he may pass out. He did, in fact, faint and was slightly continent. He was diaphoretic, and shaky. His blood pressure was 169/110 to which he says is "his normal", pulse in the 90s, Sp02 was anywhere from 97-98%. When the patient was sat up his blood pressure would drop. He was monitored by paramedic, did not receive treatment other than water and gingerale. He did not want to go to the hospital. Once he was feeling better he went home with his wife.
48 2021-04-19 heart rate increased Pt received second dose moderna vaccine. Did not bring first dose vaccine card, unable to obtain fir... Read more
Pt received second dose moderna vaccine. Did not bring first dose vaccine card, unable to obtain first dose lot number and date of vaccination from patient. Pt left facility and upon approaching stop light in front of building, pt began to experience SOB with fast heart rate and mouth dryness. Pt returned to facility to seek medical attention. Brought to med obs #1 via wheelchair by staff for evaluation. Reports mild improvement of symptoms upon arrival to med obs. No s/s of distress noted upon pt arrival. Pt reports taking prescribed lisinopril PTA this AM. Upon assessment of VS, BP elevated. Pt states he occasionally has SBP 200+/DBP 100+. Denies s/s of anxiety at present and denies headache/vision changes. VS are as follows: 1314: BP 187/107 (RUE), rechecked on LUE 233/134, HR 75, RR 17, O2 sat 98% on RA. 1319: BP 233/118 (LUE), rechecked on RUE 242/122, HR 104, RR 16, O2 sat 99% on RA. Per VS parameters, pt qualifies for EMS transport for ER evaluation of elevated BP. Notified in-house PA of need for assessment and confirmation of EMS need for transport as well as notification to lead supervisor. Constable at employee entrance notified to assist in arriving EMS. Upon assessment of pt by PA, pt disclosed he is non-compliant with prescribed lisinopril at home and will occasionally use medication PRN or double/triple his dosage based on symptoms. PA provided education on proper use of lisinopril and confirmed need for higher level of care. Pt agreeable to EMS transport for further evaluation. 9-1-1 called. While awaiting EMS arrival, pt reported sweating of hands and shallow breathing, stating, "I feel like I have to concentrate on my breathing now." Pt not in distress. EMS arrived to transport pt to Hospital. Pt alert and oriented x4 and ambulatory from stretcher to EMS gurney upon transfer. VS while awaiting EMS arrival are as follows: 1324: BP 249/126, HR 83, RR 17, O2 sat 100% on RA 1329: BP 247/109, HR 85, RR 18, O2 sat 100% on RA 1336: BP 243/112, HR 84, RR 20, O2 sat 100% on RA 1347: BP 245/144, HR 87, RR 18, O2 sat 100% on RA
48 2021-04-20 blood clot PER PATIENT REPORT, PAIN A WEEK LATER MY LEG WAS ACHING. I USED ICY HOT, MASSAGER. STARTED SWELLING... Read more
PER PATIENT REPORT, PAIN A WEEK LATER MY LEG WAS ACHING. I USED ICY HOT, MASSAGER. STARTED SWELLING, WENT TO WALK IN. THEY DID AN ULTRASOUND AND SAID I HAD A BLOOD CLOT IN MY LEG AND IT WAS TRAVELING TO MY LUNGS. THERE WERE A COUPLE SPECKS ON LUNG PER XRAY.
48 2021-04-21 haemoglobin decreased Patient was admitted with Autoimmune hemolytic anemia (Hb 5.3) 4 days after 2nd dose of Morena COVID... Read more
Patient was admitted with Autoimmune hemolytic anemia (Hb 5.3) 4 days after 2nd dose of Morena COVID-19 vaccine. He had elevated reticulocyte count, bilirubin, LDH, positive Coombs test and undetectable haptoglobin at presentation. He required PRBC transfusions and was also treated with steroids and rituximab, after which his anemia started to improve
48 2021-04-21 heart rate increased HEADACHE NECK PAIN ELEVATED HEARTBEAT
48 2021-04-22 cerebrovascular accident, blood pressure increased, hypertension Suspected stroke; Bell's palsy; High BP; A spontaneous report was received from a healthcare profess... Read more
Suspected stroke; Bell's palsy; High BP; A spontaneous report was received from a healthcare professional concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, suspected stroke, and high blood pressure. The patient's medical history, as provided by the reporter, included hypertension. The patient stopped taking hypertension medications since Aug-2020.The concomitant product use was not provided/unknown by the reporter. On 16 Feb 2021, approximately 9 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, approximately 9 hours of receiving vaccine, the patient developed left ear fullness/pain/pressure. On 17 Feb 2021, the patient developed left eye watery and pain behind left ear. On 18 Feb 2021, the patient dribbled when drinking water when working overnight shift. On 19 Feb 2021, upon awakening in the afternoon, patient's speech was "off" and noted left side of face drooped and unable to close left eye. The patient went to Urgent care and referred to ED for suspected stroke due to High blood pressure. The patient was diagnosed with bell's palsy. Treatment for the vent included steroids, eye ointment and metoprolol. Action taken with the drug in response to the event was not provided The outcome of the events, bell's palsy, suspected stroke, and high blood pressure, were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-026086:Same reporter
48 2021-04-23 blood glucose increased Fever, Chills, Body Aches (back), Headaches. High blood sugar readings occurred on day 2 (300+), da... Read more
Fever, Chills, Body Aches (back), Headaches. High blood sugar readings occurred on day 2 (300+), day 3, and day 4. Felt "functional" on day 3 and "normal" on day 4. despite exercise and lowered food intake, sugars did not lower. Visited health care professional to discuss. discussion was over not much known about side affects and that each person reacts differently. course of action to monitor and drink plenty of fluids. used an extra 2 unit shot of lantus on day 3 to lower blood sugars in evening (5PM). on day 4 used a +4 unit shot of lantus to lower sugars in evening (5 PM). This is in addition to my normal lantus shot in the evening at 10 PM. Day 5 sugars returned to normal -- operating in 120-160 range.
48 2021-04-25 blood pressure increased, blood glucose increased Patient received the 2nd Moderna vaccine on 4/19/2021. On 4/20/21, patient had typical side effects ... Read more
Patient received the 2nd Moderna vaccine on 4/19/2021. On 4/20/21, patient had typical side effects such as fever, fatigue, headache, and arm soreness. Patient took Tylenol to treat symptoms. On 4/21/21, patient said he started to develop swelling around base of neck on both sides and had difficulty breathing. He stated that he also had right arm numbness where the injection was given as well as blurry vision. According to patient, his blood pressure was 220/145 and his blood glucose was over 300. Patient went to primary care physician on 4/26/21 about his neck still being swollen after his vaccination. He said his physician gave him diphenhydramine and a steroid shot for the reaction. Patient came to the pharmacy to report his side effects on 4/26/2021.
48 2021-04-27 chest pain, fibrin d dimer increased #1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented after sudden onset of chest pain ear... Read more
#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented after sudden onset of chest pain early in morning and found to be covid +. ECG demonstrated diffuse ST elevation, troponins negative. CT without contrast didn't have much in it. He was found to be COVID rapid test+ and IGG negative. He was admitted into isolation, no oxygen needs. DDIMER was over 2000 and friction rub noted on physical exam. Cardiology ruled out STEMI, thought maybe viral pericarditis - but wanted echo done after out of isolation. CTA was planned for AM on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC was not able to be achieved despite aggressive resuscitation efforts
48 2021-05-02 nosebleed high temperature and body aches leading to rashes and hives, would go away after 1st week after, hi... Read more
high temperature and body aches leading to rashes and hives, would go away after 1st week after, high temperature for a about 5 days, eventually slowed down 2nd week after, then bloody nose for 5 days 3rd week, now still intermittent bloody nose, weakness, and fatigue, occasional high temperature-into the 4th week...
48 2021-05-02 pallor Dizziness, sore throat, pale. He was administered Benadryl 25mg and was treated by paramedics.
48 2021-05-04 nosebleed My husband received the second shot of Moderna vaccine. After 4 hours he started a heavy headache t... Read more
My husband received the second shot of Moderna vaccine. After 4 hours he started a heavy headache that have no better nor with Tylenol . He took 2 tablets at 12:30 and 2 more at 8:00. At 5:30 am he went to the bath with a big headache and start to bleed by nose and mouth. The again at 5:45 am it happen again but in less amount. After that the headache gone but a strong sleepiness started. Actually he feel dizzy and a strong pain in the arm but have no headache. He never have problems of any bleeding before. In the first dosis have no any adverse reaction , just a strong arm pain during two days.
48 2021-05-05 fainting Patient had syncopal episode after receiving vaccine, epinephrine administered via auto injector, pa... Read more
Patient had syncopal episode after receiving vaccine, epinephrine administered via auto injector, patient returned to consciousness. EMS arrived on scene, and walked patient out.
48 2021-05-06 hypotension, fainting This morning I gave Moderna shot to patient. Once I finished giving the shot ask patient to wait 15... Read more
This morning I gave Moderna shot to patient. Once I finished giving the shot ask patient to wait 15 in one of the chairs. The patient came up to the window to tell one of my technician that he didn't feel well before we can go check on him he fainted and fell on floor. He lost conscious for a second by the time I got to him he was speaking with me. One of my technician was on the phone already calling 911. Made sure he didn't have any injuries, checked airway, put his feet up, applied cold compress on face, neck and wrists. Tried checking blood pressure but the paramedics arrived. The paramedics told us his blood pressure was low and didn't want him driving because he was alone in the store. They took him to the hospital.
48 2021-05-11 chest pain Developed symptoms around 4/25, presented to ED with complaints of chest pain and something being st... Read more
Developed symptoms around 4/25, presented to ED with complaints of chest pain and something being stuck in his throat. Subsequently died on 4/27.
48 2021-05-12 deep vein blood clot Was seen in the ER on 04/08/2021 for left calf and leg pain. He stated that symptoms started a few d... Read more
Was seen in the ER on 04/08/2021 for left calf and leg pain. He stated that symptoms started a few days before but worse on the visit date. He has had hx of 3 other DVTs in the past. Denies sob
48 2021-05-12 hypotension, pallor Blood pressure under 40/60; cyst in the brain; lost his vision,; dizzy; turned white; couldn't speak... Read more
Blood pressure under 40/60; cyst in the brain; lost his vision,; dizzy; turned white; couldn't speak; felt something on his back (like a pull on his back); eyes went back; arm hurts towards his chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain) and BLINDNESS (lost his vision,) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C221A) 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 MULTIVITAMIN & MINERAL and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOTENSION (Blood pressure under 40/60) (seriousness criterion hospitalization), CEREBRAL CYST (cyst in the brain) (seriousness criteria hospitalization and medically significant), BLINDNESS (lost his vision,) (seriousness criterion hospitalization), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest). At the time of the report, HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain), BLINDNESS (lost his vision,), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 40/60 (Low) Low, 90/60 (Low) low and 150/69 (normal) normal. On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) They found a cyst in the brain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was specified.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current 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. US-MODERNATX, INC.-MOD-2021-101752:
48 2021-05-12 loss of consciousness Fever and chills with sensation of skin being hot began 15 hours post injection. Took 400mg ibuprofe... Read more
Fever and chills with sensation of skin being hot began 15 hours post injection. Took 400mg ibuprofen every 4-6 hours. Exceeded six hours without ibuprofen and fever returned 27 hours post injection. Took 400 mg ibuprofen and immediately became nauseous. Began walking up stairs and lost consciousness and seized/convulsed briefly (witnessed by my wife). Upon regaining consciousness, I was immediately aware of what happened, date, time, etc., so we did not seek medical attention. Continued ibuprofen every 4-6 hours. On two occasions post loss of consciousness, the first within an hour and the second four hours later, I felt tingly and smelled a strong scent of acetone or ammonia. Both passed quickly. Fever broke soon after second incidence. All symptoms were gone within 48 hours of injection.
48 2021-05-12 fainting, cerebral haemorrhage 5/07 general ill feeling; runny nose, watery eyes. continued until 5/10. Wife denied fever or cough.... Read more
5/07 general ill feeling; runny nose, watery eyes. continued until 5/10. Wife denied fever or cough. continued until 5/10. 5/11 at work, patient collapsed. Was awake but non-responsive, breathing on his own, vomited shortly before EMS arrived. EMS arrived, patient stopped breathing, was bagged until arrival at hospital where he was intubated. 5/12 Patient was extubated and died in early AM 5/13. Medical records state cerebral brain hemorrhage.
48 2021-05-13 heart rate decreased, blood pressure decreased, lightheadedness PATIENT WAS NOT NERVOUS ABOUT RECEIVING HIS FIRST DOSE. OUR IMMUNIZATION CERTIFIED PHARMACY TECH ADM... Read more
PATIENT WAS NOT NERVOUS ABOUT RECEIVING HIS FIRST DOSE. OUR IMMUNIZATION CERTIFIED PHARMACY TECH ADMINISTERED THE DOSE. ABOUT 2 MINUTES LATER HE STATED HE WAS FEELING TINGLY AND HIS EAR TURNED A WHITE COLOR. THE TECHNICIAN CALLED ME INTO THE ROOM WHERE I EXAMINED THE PATIENT. HE WAS NOT RESPONDING AND HIS EYES WERE DILATED. HE WAS TRYING TO BREATH BUT HE WAS HAVING DIFFICULTY. WE MOVED HIM TO THE GROUND AND PLACED HIM ON HIS SIDE TO MAKE SURE HE DID NOT ASPERATE. AFTER ABOUT 20 SECONDS OF BEING ON THE GROUD HE STARTED BREATHING NORMALLY AND WAS CONSCIOUS. THE ENTIRE EPISODE LASTED ABOUT 1 MINUTE (MAYBE SLIGHLY LONGER). EMS ARRIVED A FEW MINUTES LATER. HIS PULSE WAS LOW (ABOUT 50 BPM PER EMS) BUT HIS BLOOD PRESSURE WAS NORMAL (UNSURE OF THE VALUE). HE SAID HE REMEMBERED TALKING TO US AND THE NEXT THING HE KNEW HE WAS LAYING ON THE GROUND. HE WAS VERY NAUSEOUS AFTERWARDS FOR ABOUT 45 MINUTES (HE THREW UP TWICE). WE CONTACTED THE PATIENT THE DAY AFTER AND HE SAID HE WAS FINE AND THAT HE ONLY HAD A SORE ARM. WE BELIEVE THAT HIS BLOOD PRESSURE DROPPED TOO LOW AND CAUSED A VASOVAGAL TYPE RESPONSE.
48 2021-05-18 fast heart rate reported tachycardia and sweating and headache 30 minutes following vaccine, observation time had en... Read more
reported tachycardia and sweating and headache 30 minutes following vaccine, observation time had ended patient stated it came and went quickly but was not observed at facility
48 2021-05-20 chest discomfort Client presented to Healthcare Hospital at approximately 2300, overtly anxious and hyperventilating,... Read more
Client presented to Healthcare Hospital at approximately 2300, overtly anxious and hyperventilating, c/o shortness of breath and chest ; daughter translating. C/o numerous complaints after having 1st Moderna dose today. She had onset of muscle cramping, weakness in legs, then diffuse myalgias, feeling prickling and poking sensations body-wide, chest discomfort sharp and pressure, feels anxious and short of breath. Also c/o increased itching without rash present on examination by MD., Hx non-ischemic cardiomyopathy, normal coronaries by agency at in Jan., managed with metoprolol and lisinopril, EF 30-35%. Cardiomyopathy attributed to thyroid disease.
48 2021-05-22 heart attack Multiple mini heart attacks, with a three day stay in the hospital
48 2021-05-23 loss of consciousness Patient received MODERNA COVID-19 vaccine, waited about 15 min afterwards with no reaction and was s... Read more
Patient received MODERNA COVID-19 vaccine, waited about 15 min afterwards with no reaction and was seen leaving pharmacy area. About 30 minutes afterwards, patient was found laying on floor in the aisle by a customer who then notified front store employee. When employee approached patient, he was awake and alert, but was described as having white foam coming out of mouth and sweating. He said he was ok but just needed to lay down and rest for a bit. Then he got up and went to restroom and reportedly vomited. 911 was called and response team ended up walking with him out of store.
48 2021-05-24 deep vein blood clot Pt had Moderna vaccine #1 on 4/7/21 and # 2 on 5/5/21 and developed a LLE DVT on 5/4/21
48 2021-05-25 fibrin d dimer increased Pt. received 2nd Covid vaccine on 05/14/2021. On 05/15/2021 pt. reports not feeling well with s/s of... Read more
Pt. received 2nd Covid vaccine on 05/14/2021. On 05/15/2021 pt. reports not feeling well with s/s of body aches and chills. Pt. reports that on 5/16/21 that he noticed fever, cough and increased SOB. Pt. presents with c/o increase SOB on 05/18/2021. Pt. was admitted with diagnosis of right upper and middle lobe pneumonia on 05/18/2021. Pt. required 2-3 L of O2 per nasal cannula. Pt. was also on antibiotics on Rocephin 1 gm IV every 24 hours. Pt. received a one time dose of Azithromycin 500 mg in ED.
48 2021-05-26 pallor Patient felt faint within 2 minutes of vaccination. His vision went dark. When I walked back into th... Read more
Patient felt faint within 2 minutes of vaccination. His vision went dark. When I walked back into the room he was pale and sweating, but responding to questions from the person he arrived with. His arm twitched a few times and his head rolled to the side for a few seconds. Then he regained consciousness, but momentarily looked confused. The patient has a history of seizures, but has not suffered from one in 10 years. After that, the patient remained alert, but continued to sweat and felt light headed for most of standard wait time post vaccination. After the 15 minute wait period the patient felt more normal and left.
48 2021-05-28 cerebrovascular accident Patient representative, I believe his wife, called and stated he had a stroke about 1 week after his... Read more
Patient representative, I believe his wife, called and stated he had a stroke about 1 week after his second dose. She states he is admitted to Medical center so outcome is unknown.
48 2021-05-29 heart attack ST Elevation Myocardial infarction (I21.3 - STEMI)
48 2021-06-01 chest pain, fainting, atrial fibrillation Started feeling light headed at 4am and had syncope x 2, his wife stated he was talking nonsense dur... Read more
Started feeling light headed at 4am and had syncope x 2, his wife stated he was talking nonsense during this time, at 8am he had a fib, HR went from 40-155s, B/P 116/60, went to ER with chest pain and SOB, temp. 100.2, spent 3-4 hours in ED. He was sedated and converted.
48 2021-06-02 loss of consciousness I had the vaccine and I had fever, chills, achy and weak, I almost felt like I had Covid. Then about... Read more
I had the vaccine and I had fever, chills, achy and weak, I almost felt like I had Covid. Then about 3 or 4 days after I continued to remain sick and I passed out on the kitchen floor, my wife called the ambulance and they took me to the ER. They gave me some fluids and ran an EKG on my heart. I was observed for a few hours and released to go home later. They did not give me any medications.
48 2021-06-03 lightheadedness, chest discomfort patient started feeling numbness in their finger, toes, arms, and legs followed by chest pressure an... Read more
patient started feeling numbness in their finger, toes, arms, and legs followed by chest pressure and near syncopal episode. Blood pressure was taken and was 151/97 with a heart rate of 94. Ambulance arrived, took vitals at pharmacy, after which patient was taken to the nearby hospital.
48 2021-06-12 palpitations, palpitations For four days I had frighteningly strong heart palpitations, racing/pounding heart, shortness of br... Read more
For four days I had frighteningly strong heart palpitations, racing/pounding heart, shortness of breath while doing normal activities, and a sensation of missed heartbeats/difficulty breathing while falling asleep. This was not a psychological response; I had only a minimal reaction to the first shot, and no fear nor concerns with taking the second shot.
48 2021-06-17 platelet count decreased, cerebrovascular accident Patient is 48yo, presented 48h after 2nd Moderna vacccine with an acute right MCA stroke, required I... Read more
Patient is 48yo, presented 48h after 2nd Moderna vacccine with an acute right MCA stroke, required IV tpa and thrombectomy. Only known risk factor is active cigarette smoking.
48 2021-06-20 chest pain The patient did not want to wait the 15 minutes and went out to his truck. A customer brought the pa... Read more
The patient did not want to wait the 15 minutes and went out to his truck. A customer brought the patient back in as he was complaining of chest pain and SOB. After resting 15 minutes pt stated that he was having a panic attack.
48 2021-06-21 fluid around the heart Pericardial Effusion treated with pericardiocentesis
48 2021-06-22 fainting, loss of consciousness Passed out; Fainted; Collapsed on the floor and injured their arm and shoulder; This spontaneous cas... Read more
Passed out; Fainted; Collapsed on the floor and injured their arm and shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SYNCOPE (Fainted) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). 18-May-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), SYNCOPE (Fainted) and LIMB INJURY (Collapsed on the floor and injured their arm and shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported It was reported that, within 15 minutes of receiving the dose the patient passed out and fainted. The patient collapsed on the floor and injured their arm and shoulder. The patient was seen by the doctor who confirmed no bones were broken. No treatment medication 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.
48 2021-06-27 chest pain, palpitations Since about 5 days after the second vaccine shot I have had heart inflammation. Treating with ibupr... Read more
Since about 5 days after the second vaccine shot I have had heart inflammation. Treating with ibuprofen. At this point I have had it for 2 weeks. When the ibuprofen wears off I can feel my heart pounding and I start to have chest pains.
48 2021-06-27 troponin increased Headache, fever, chills, shortness of breath, generalized weakness, decreased appetite. Was seen in ... Read more
Headache, fever, chills, shortness of breath, generalized weakness, decreased appetite. Was seen in ER and labs were done. Troponin was elevated 0.525, CRP 10.2, D-dimer 1.01, WBC 10.02. CT of head was negative and CT angio of chest showed no PE or pneumonia. Has a headache and was given pain medication. Was transferred to Healthcare for admission.
48 2021-06-28 heart attack five days after shot had nonfatal heart attack
48 2021-07-01 palpitations The day of the first dose of the COVID 19 Moderna vaccine I experienced tinnitus in my right ear for... Read more
The day of the first dose of the COVID 19 Moderna vaccine I experienced tinnitus in my right ear for about 2 hours. Thereafter, I started feeling my heartbeat in my ear every time I laid down and intermittent tinnitus . In early June, I started feeling pain in the same affected ear. At that time I went to my primary care physician who prescribed me antibiotics(Amoxilin) infection. After completing the five day treatment of antibiotics symptoms did not improve so I made an appointment with an ENT and went to an urgent care clinic where they prescribed me an antibiotic and steroid drop but that medication did not improve my symptoms. At the appointment with the ENT on June 9th I was diagnosed with a bulging ear drum and ear infection. More oral antibiotics were prescribed with a steroid to reduce swelling. Pain in the ear seemed to subside but I still had ear fullness and redness. At the follow up appointment on 6/30 a hearing test was done where it was discovered that I lost about 50 percent of my hearing on right ear. I still have tinnitus and hearing loss today.
48 2021-07-03 chest discomfort Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest ... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
48 2021-07-05 fainting Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
48 2021-07-06 palpitations, fibrin d dimer increased patient reported rapid palpitations following the first vaccination. sometime between 05/07/21 and 0... Read more
patient reported rapid palpitations following the first vaccination. sometime between 05/07/21 and 05/10/21 he started having muscle pains in various places that kept moving around. winded easily. Came into the ED on 05/21/21 with complaint of left calf pain x2 weeks. no cause found. patient followed up in another facility on 5/26/21 where bloodwork was unremarkable, but was prescribed 6 day course of tapering steroids. symptoms improved, but returned as steroids tapered. patient developed right calf pain on 6/6/21. bloodwork showed elevated d-dimer and was sent to the ED for evaluation. no lower extremity or pulmonary emboli found. suspected that patient has COVID myocarditis and sent for follow up with cardiology. patient was prescribed steroids again on followup. patient presented to ED again on 06/25/21 with headache, chills, SOB and weakness. there was concern for vasculitis and sent to higher level of care.
48 2021-07-07 inflammation of the heart muscle, ejection fraction decreased, cardiac arrest VF arrest 1 week after second Moderna vaccination. Successfully resuscitated, good neurologic outcom... Read more
VF arrest 1 week after second Moderna vaccination. Successfully resuscitated, good neurologic outcome. Initial ejection fraction was low, 25%, currently improving. MRI with late gadolinium enhancement suggesting myocarditis. Troponin normal. Genetics panel without polymorphism predisposing to cardiomnyopathy.
48 2021-07-08 blood pressure increased Raised his sugar and dropped quickly, made his blood pressure spike A week after first vax smell an... Read more
Raised his sugar and dropped quickly, made his blood pressure spike A week after first vax smell and taste has become a problem and after 2nd vax it became more pronounce. Pt is becoming very down and despondent and is in need of help with problems.
48 2021-07-08 cardiac failure congestive After receiving the 2nd Moderna Covid Vacine I noticed shortness of breath, chronic dry coughing and... Read more
After receiving the 2nd Moderna Covid Vacine I noticed shortness of breath, chronic dry coughing and fatigue/tirdness. Each week was progressively getting worse and rapid declining in my ability to fuction. I was gaining weigh and felt very tired, but thought it was respitory infection and tried to rest hoping it would clear up and improve. After several weeks, I noticed that both feet and legs started to swell and wouldnt return to normal. The decline was rapidly getting worse and I was not able to simply tasks. I tried to get an appointment at my primary physisan and was unable to get an appt, they recommeded I visit urgent care, so I went and was told to go to ER, where I was admitted to the hospital for congestive heart failure.
48 2021-07-11 haemoglobin decreased Acute Lymphoblastic Leukemia, Ph- Began feeling tired and noticed becoming slightly out of breath wi... Read more
Acute Lymphoblastic Leukemia, Ph- Began feeling tired and noticed becoming slightly out of breath within 2-3 weeks of 2nd dose. First hospitalized on May 21 after blood work drawn on 5/20 showed hemoglobin below 5. Nurse at BMT clinic on Sunday told him that he was the 2nd patient that day who mentioned getting leukemia after 2nd dose of Covid vaccine, which prompted this report.
48 2021-07-11 low blood oxigenation Patient admitted for sepsis/pyelonephritis/pneumonia/hypoxemia. COVID 19 negative.
48 2021-07-15 inflammation of the pericardium, chest discomfort, chest pain My husband woke up from chest pain around 2:30 am on 7/14/2021. He wasn't able to sleep and struggle... Read more
My husband woke up from chest pain around 2:30 am on 7/14/2021. He wasn't able to sleep and struggled to function the next day. He describes the pain as feeling like his muscles are pushing against his rib cage. He was most comfortable when he would sit upright. Laying down made it worse. He also felt pain in his upper back. I have never seen him in so much pain. He was moaning and had difficulty sustaining eye contact with me. The second night on 7/15/2021 he again barely slept due to the pain. He was able to briefly fall asleep sitting up. On 7/16/2021 I took him to his doctor where we saw a physicians assistant. She advised we go to the ER since he was having chest pain. At medical center Doctor suspected pericarditis after hearing my husband's symptoms. The doctor said it usually occurs after and infection and my husband has not been treated no has had any infection in many years. All of the test they ran came back clear showing no heart issues. My husband was given narco while in the ER for the pain, but it did not help.
48 2021-07-16 fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient experienced flushing then was in and out of consciousness for a few minutes. BP was normal when checked 20 min after experience.
48 2021-07-17 cerebrovascular accident acute stroke admission on 5/19/21
48 2021-07-19 inflammation of the pericardium, chest pain Received 1st Moderna Vaccine on July 3, July 7 started having light chest pains, over the following ... Read more
Received 1st Moderna Vaccine on July 3, July 7 started having light chest pains, over the following days, chest pains increased, July 18, 2021 chest pains increased to severe. Went to Hospital ER, received aspirin and numerous blood test and was admitted into hospital for further testing. Testing revealed inflammation of the chest cavity around the heart. Discharged day later, advised to rest to allow inflammation to decrease.
48 2021-07-21 heart flutter, heart rate increased Increased heartbeat, flutter, difficulty breathing
48 2021-07-21 fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium
48 2021-07-25 chest pain Fever 103, chest pain, body ache, arm pain
48 2021-07-27 pallor Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient reported feeling dizzy/lighthe... Read more
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient reported feeling dizzy/lightheaded approximately 5 minutes after administration of vaccine. Patient looked pale. 911 was called for assessment. Patient was assessed by paramedics. Patient reported feeling better and was not taken to emergency room. Patient stayed around pharmacy area for about 30-45 minutes after the paramedics left. Patient tried walking around to see how he felt and eventually left on his own.
48 2021-07-28 heart rate increased Moderna COVID-19 Vaccine EUA - Dizzy, cold sweating, rapid heart beat, soreness. One week later swe... Read more
Moderna COVID-19 Vaccine EUA - Dizzy, cold sweating, rapid heart beat, soreness. One week later swelling at injection site with red oval (6 inches by 4 inches) with redish and white color and bumps. Under arm of same arm injection site swelling in arm pit area.
49 2020-12-31 hypertension, fast heart rate, chest discomfort Pt. symptoms included: swelling in the eyes, chest tightness, lump in throat, tachycardia, hypertens... Read more
Pt. symptoms included: swelling in the eyes, chest tightness, lump in throat, tachycardia, hypertension, and wheezes. Pt. was treated on scene with .5mg of epinephrine (IM) and albuterol inhaler in route to hospital.
49 2021-01-01 blood pressure increased noted increased BP for 36 hours after vaccine. 162/86, 161/84, 152/79.
49 2021-01-01 fast heart rate Shortness of breath, tachycardia, chills, minor muscle aches, nausea, head ache
49 2021-01-05 hypotension patient was noted to be flushed by residential home staff on 12/30/2020, approximately 2.5hrs after ... Read more
patient was noted to be flushed by residential home staff on 12/30/2020, approximately 2.5hrs after vaccination, fever present at that time. Prior to COVID19 vaccine administration, this patient did have exposure and was close contact with a known case of COVID19 in a residential care employee. Patient was taken to hospital for evaluation of febrile status, had positive COVID19 test at that time, and reported hypotension per residential care staff.
49 2021-01-07 pallor Gave patient vaccine administration, after 20 minutes of monitoring patient stood up to leave and fe... Read more
Gave patient vaccine administration, after 20 minutes of monitoring patient stood up to leave and felt dizzy and light headed. He turned pale as well. I quickly had him sit down and called the provider in. We listened to heart and lungs, obtained vitals which were: P: 57 BP: 130/65 Temp: 97.5 SP02: 100% Continued to monitor, provider got a more advanced medical history from patient and provider felt like patient was stable enough to monitor for 20 more minutes with no interventions and leave. Patient is discharged
49 2021-01-07 fast heart rate, hypertension, fast heart rate, hypertension flushing, hypertension, tachycardia, cold, clammy
49 2021-01-08 cardiac arrhythmia, lightheadedness, pallor Dizziness started within 30 minutes after injection on 01/08/21 and felt "off". On 01/09/21 approx. ... Read more
Dizziness started within 30 minutes after injection on 01/08/21 and felt "off". On 01/09/21 approx. 0800 Patient began feeling body aches, fevers, injection site pain, increased dizziness, and nausea. At approximately 1pm patient began vomiting and having diarrhea. Symptoms worsened over the next couple hours to where patient was unable to walk without stumbling. Wife witnessed patient becoming very pale and almost pass out at approx. 5:30pm. Patient states he feels like he's in slow motion. Patient is unable to maintain balance when walking and reports increasing fatigue and weakness.
49 2021-01-11 cardiac failure congestive, hypertension, fast heart rate Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a ... Read more
Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF
49 2021-01-11 chest discomfort Mold/moderate wheeze and chest tightness. Onset ~20 min after administration. Lasted 30-45 minutes... Read more
Mold/moderate wheeze and chest tightness. Onset ~20 min after administration. Lasted 30-45 minutes.
49 2021-01-11 fast heart rate, hypertension Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a... Read more
Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF
49 2021-01-12 palpitations headache, bodyache, heart palpitations Narrative: Took Tylenol, Motrin, Zyrtec
49 2021-01-14 heart rate increased, deep vein blood clot, fibrin d dimer increased, oxygen saturation decreased, pulmonary embolism Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pn... Read more
Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pneumonia without fever was made, patient started azithromycin on 1/5 and albuterol treatments every 4-6 hrs. Initially he improved, but then worsened. chest xray on 1/6 was negative for pneumonia, PCR covid test was negative, albuterol treatment did not bring much relief. He started respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered thrombolysis and was discharged home from the ICU on 1/12 on oral anticoagulants. He is gradually improving, but very weak. He tires easily and gets a drop in oxygen to 90- 93%, as well as an increase in the heart rate to 120 when walking less than half a mile. He runs out of breath with exertion.
49 2021-01-19 chest discomfort Tingling at the back of tongue and upper chest tightness.
49 2021-01-21 chest pain Received Vaccine on Friday January 15th 2021 at approximately 0715am after my Isolation and having h... Read more
Received Vaccine on Friday January 15th 2021 at approximately 0715am after my Isolation and having had no symptoms for over a week. Received injection, was observed by our Physician staff for approximately 35 minutes with no adverse reactions noted at that time. Approximately 30 hours later on Saturday my left arm began to hurt and a very very strong fatigue came over me and I took a 2 and a half hour nap on the couch. I was still extremely fatigued upon waking, but my arm continued to hurt more and more up to the point it wasn't usable for anything heavy and/or strenuous at all, hurting just to use it for getting up from the couch. I was assisted to get me things like water, food and stuff. The arm pain began to radiate towards my left shoulder and eventually throughout the day the pain was spreading from my shoulder to include my left upper thorax and left rib cage. By Sunday, what had begun as left arm pain had now become stronger an approximate 5/10 pain. It started to present as atypical chest pain having the pain now fully encapsulated within my left upper chest. Felt what appeared to feel like intercostal pain and a general ache all throughout. By Monday the pain was still all throughout and assessed the situation from a cardiac standpoint and found that the pain was mostly positional and I wasn't exhibiting any cardiac symptoms such as shortness of breath, no sub-sternal pain, no jaw pain, no back pain. It hurt more as I would take a deep breath and began to move my left arm around and bringing it up from my side and did a stretch with my crooked elbow of my left arm I raised it to the ceiling and moved my thorax to my right side and found that this would make it hurt more, so I did some twisting of my thorax and abdomen and found that the pain would increase from movement, it was then that I began to think that it might be Pleuritic pain. Tuesday the 19th and Wednesday the 20th I had to call in Sick because I developed a severe muscle ache below my left calf between my calf and left ankle, as if it was in constant spasm and it affected my walking, like a Charley Horse feeling and wondered if it were the same kind of feeling that I had in my chest and I found it quite odd that all my symptoms were on the left side which is the same side I received the vaccine because my right side didn't have any muscle aches. The overall chest pain began to subside over the next couple of days, but the pleuritic pain that I described never decreased in intensity or pain level. I saw my Personal Dr yesterday January 21st 2021 at approximately 5:15pm as he was walking out of his office and we discussed my symptoms and believing that my symptoms seemed to indicate some kind of tentative diagnosis of a pleurisy issue as he had agreed that there didn't seem to be any cardiac involvement and am scheduled to see him again tomorrow Saturday January 23rd at 4pm As I write this the pain continues as before with no seeming end point and is not diminishing. I had phoned and talked yesterday afternoon and felt it best to check with my primary physician because he hadn't had any reports such as mine.
49 2021-01-21 loss of consciousness Upon waking up felt cold sweat, nauseated and became dizzy. Within 5 min from leaving the bed I lost... Read more
Upon waking up felt cold sweat, nauseated and became dizzy. Within 5 min from leaving the bed I lost consciousness for 2-3minutes. Next thing I remember being on the kitchen floor being called by name by my wife, w a sharp pain on back of my skull. Was told I suddenly collapsed onto the floor. I trained to stand up but could not maintain posture. Had to lay down on my left side for 15-20 min. Then I was able to drink water and walk back to bed where I remained for next couple hours.
49 2021-01-26 fainting Headache, Fever, Cough Wheeze, Nausea Vomiting & Syncope Narrative:
49 2021-01-27 pallor Patient had hot flash 12 minutes after receiving 1st Covid vaccine dose. SBP 93 sitting upright in c... Read more
Patient had hot flash 12 minutes after receiving 1st Covid vaccine dose. SBP 93 sitting upright in chair and face pale. Assisted patient to litter to remain in semi-fowlers position. Recheck SBP 120's. Denies further symptoms and stated hot flash no longer present. returned to chair after 5 minutes. SBP rechecked 120's x2 while upright in chair. Denies further symptoms. Patient remained upright for 15 minutes without symptoms prior to leaving covid clinic.
49 2021-01-27 fast heart rate, fast heart rate Pt received dose #2 Moderna COVID vaccine. Reported tachycardia, dizziness which resolved spontaneou... Read more
Pt received dose #2 Moderna COVID vaccine. Reported tachycardia, dizziness which resolved spontaneously and immediately, R eye tightness. Patient reports similar symptoms associated with first vaccine but occurred that evening. Patient reports symptoms resolved quickly. Patient with VSS and no acute distress noted during visit. Discharged home without escalation of care or intervention. Entered by PSS for tracking.
49 2021-02-05 chest discomfort 49 y.o male with a history of DMII, HTN, DVT, and obesity who was admitted for COVID-19 illness 3 mo... Read more
49 y.o male with a history of DMII, HTN, DVT, and obesity who was admitted for COVID-19 illness 3 months ago who developed fatigue, shortness of breath, malaise, and abdominal pain after receiving the Moderna COVID-19 vaccine. The symptoms persisted and two days after receiving the vaccine he developed chest tightness and left arm pain which prompted him to be evaluated in the emergency department.
49 2021-02-08 heart rate irregular Fatigue Chills Irregular heartbeat
49 2021-02-08 hypotension 1. Left arm became red, itchy and swelling. 2. Blood pressure become lower than average 3. Pain at... Read more
1. Left arm became red, itchy and swelling. 2. Blood pressure become lower than average 3. Pain at the muscle of left under arm .
49 2021-02-09 palpitations Temporarily disabling but not life threatening side effects from COVID vaccine (Moderna), including:... Read more
Temporarily disabling but not life threatening side effects from COVID vaccine (Moderna), including: profound fatigue/lethargy; severe diarrhea, leading to dehydration; severe heart palpitations; moderate injection site pain (severe if touched); moderate neck pain; moderate chills; mild nausea; mild headache; mild fever. Symptoms began approximately 24 hours after receiving the second vaccine, and gradually subsided over the following 24 hours, with only moderate diarrhea, heart palpitations, and fatigue remaining. It was by far the worst reaction I've ever had to a vaccine The only side effects after the first vaccine were moderate fatigue the evening of the vaccine and moderate arm pain.
49 2021-02-09 troponin increased, chest pain 02/03-02/04/2021 TEMPERATURE 100.5 *F, TREATMENT WITH TYLENOL. 02/05/2021 FELT WORSE IN THE MORNING,... Read more
02/03-02/04/2021 TEMPERATURE 100.5 *F, TREATMENT WITH TYLENOL. 02/05/2021 FELT WORSE IN THE MORNING, TREATMENT WITH ALEVE, FELT BETTER. EVENING BEGAN TO HAVE CHEST PAIN, BODYACHE, NECK/JAW PAIN - WENT TO EMERGENCY ROOM. CARDIAC LABS ELEVATED ADMITTED TO HOSPITAL. ALL OTHER TESTS CAME BACK WITHIN LIMITS BUT CATH NOT AVAILABLE ON THE SEEKENDS SO HELD. PATIENT CATH WAS CLEAR, RELEASED APPROX 1600 02/08/2021 WITH INSTRUCTIONS TO FOLLOW-UP WITH PCM. PCM APPOINTMENT SCHEDULED FOR 02/12/2021.
49 2021-02-18 heart attack Severe multi system adverse reaction including heart attack within 5 minutes of vaccine.
49 2021-02-27 fainting 2/24/2021 2/26/2021: High Fever and body ache till 2/26 early morning. 2/26/2021: Became very dizzy ... Read more
2/24/2021 2/26/2021: High Fever and body ache till 2/26 early morning. 2/26/2021: Became very dizzy and FAINTED/PASSED OUT in Restaurant after eating dinner and had 1 beer/1 smoke. Went and sat in a chair when dizzy and passed out in the chair. Created panic in the restaurant. Was Fever free since morning. PASSED OUT FOR about 5 minutes. Woke up and profuse sweating for about 3 minutes after which felt normal.
49 2021-03-02 pallor, lightheadedness Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses ... Read more
Administered Moderna vaccination at 1746 and patient stated that he has experienced vagal responses to injections in the past. Patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft]. After being the observation chair patient stood up and took 4-5 steps toward the wall and sat down on the floor. The patient stated he felt dizzy and then became limp & slumped to the right side, eyes remained open with dilation of pupil fixed at 2mm with no blinking noted. Patient's breathing pattern became shallow & snoring sounds noted. Patient did not respond when spoken to nor did he respond to soft shaking of shoulders. Patient began to demonstrate large jerky body movements similar to seizure activity. The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions. BP 120/72, HR 64, O2 sats 99%, RR 20. Patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs. EMS arrived to find the patient regaining stability. Patient reported to EMS that his is familiar with this type of response and declined to be taken to
49 2021-03-04 palpitations Light Headed, trouble breathing, "heart racing"
49 2021-03-04 lightheadedness Near syncopal episode, assessed by site EMS. Patient AMA
49 2021-03-08 loss of consciousness Patient received his first dose of the vaccine and went to the restroom while waiting for the 15 min... Read more
Patient received his first dose of the vaccine and went to the restroom while waiting for the 15 minutes to elapse. Patient returned to waiting area stating that he fell Unconscious and woke up finding himself on the ground. Upon further assessment it was discovered that the patient also bumped his head during his moment of unconsciousness. Patient was further assessed and questioned where it was revealed that he Had not eaten any food all day. He was given something to drink and a blood pressure check was also conducted. patient was in normal range . after another 15 minutes patient relayed that he feels fine. Patient was escorted by a coworker from the facility.
49 2021-03-10 loss of consciousness After about 45 minutes from the initial injection he completely blacked out while driving us home on... Read more
After about 45 minutes from the initial injection he completely blacked out while driving us home on the freeway. I had to grab the wheel to keep from running off the road or into a semi truck. He said she had tingling in the shoulder and felt nauseous. He blacked out before we could switch drivers. Terrifying
49 2021-03-11 chest discomfort Pt developed symptoms of anaphylaxis: nausea, anxiety, chest tightness, throat tightness about 13 mi... Read more
Pt developed symptoms of anaphylaxis: nausea, anxiety, chest tightness, throat tightness about 13 minutes after injection. Was given 0.3 mg epinephrine and sent by ambulance to ER.
49 2021-03-14 loss of consciousness Patient stared off for a minute or two after receiving the vaccination. The wife stated he frequentl... Read more
Patient stared off for a minute or two after receiving the vaccination. The wife stated he frequently has seizures. The patient came-to and waited in a chair for the requested time, then the patient left.
49 2021-03-15 fast heart rate Tachycardia, Dyspnea, Dysarthria, wtihin seconds after receiving the vaccine injection. injection si... Read more
Tachycardia, Dyspnea, Dysarthria, wtihin seconds after receiving the vaccine injection. injection site showed no erythema, edema or tenderness. patient could not verbally describe what he was feeling. patient was given Epinephrine. After epinephrine patient stated improvement, but as patient was being moved the observation room symptoms returned mainly the dysarthria which was accompanied by cogwheel rigidity, petechias and global muscle contraction. EMS was called, benadryl injection was given as EMS arrived. Patient was then taken to ED.
49 2021-03-16 chest discomfort Patient reports feeling pressure to chest, had difficulty breathing, sweating/clammy, and flushing. ... Read more
Patient reports feeling pressure to chest, had difficulty breathing, sweating/clammy, and flushing. Patient reports feeling better after 20 minutes. Reported he only eats once a day for weight loss. Refused transport to ER
49 2021-03-16 pallor Feeling faint, heavy arms, sweaty, and pale. Recovered after about 20 min of observation, drinking ... Read more
Feeling faint, heavy arms, sweaty, and pale. Recovered after about 20 min of observation, drinking some water, and eating small crackers.
49 2021-03-18 ischemic chest pain, palpitations Fast heart rate and severe heart pain.
49 2021-03-19 skin turning blue Severe shaking to the point I could barely walk, talk, or function in general. In fact, had to end w... Read more
Severe shaking to the point I could barely walk, talk, or function in general. In fact, had to end work conference call due to effects. In desperation, I have my wife help me into a hot shower where I continued to shake violently for about 25 minutes. My wife continued to monitor me to make sure I didn't collapse or pass out and continually ask if we should go to the ER. However, after about 25 minutes the shaking subsided and I was left exhausted with some minor muscle pain due to shaking. It was very difficult to breath during the incident, noticed my hands turning blue so I focused on deep breaths and staying calm to eventually stop it.
49 2021-03-20 heart rate increased Fever, chills, tremors, fast hearbeat.
49 2021-03-21 heart rate increased Flushing and diaphoresis beginning 45 minutes after vaccination. Lasted about an hour.
49 2021-03-22 loss of consciousness passed out completely for 15 minutes; fell backwards for about 15 minutes and was fine; sore arm; le... Read more
passed out completely for 15 minutes; fell backwards for about 15 minutes and was fine; sore arm; lethargic; little bit of chill every now and then; low grade fever; felt like he was about to see stars; felt chills up the back of his neck; A spontaneous report was received from a consumer concerning a 49-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, lethargic, little bit of chill every now and then, low grade fever, felt like he was about to see stars, passed out completely for 15 minutes, felt chills up the back of his neck, fell backwards for about 15 minutes and was fine. The patient's medical history was not provided. Concomitant medications reported were Singulair, Zyrtec, Rhinocort nasal spray for drug use for unknown indication. On 8 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event sore arm, lethargic, little bit of chill every now and then, low grade fever, felt like he was about to see stars, passed out completely for 15 minutes, felt chills up the back of his neck, fell backwards for about 15 minutes and was fine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, sore arm, lethargic, little bit of chill every now and then, low grade fever, felt like he was about to see stars, passed out completely for 15 minutes, felt chills up the back of his neck, fell backwards for about 15 minutes and was fine 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.
49 2021-03-25 palpitations DIZZINESS, NAUSEA, BODY TINGLING, HEART RACING, HEADACHE REPORTED RIGHT AFTER INJECTION. SYMPTOMS LA... Read more
DIZZINESS, NAUSEA, BODY TINGLING, HEART RACING, HEADACHE REPORTED RIGHT AFTER INJECTION. SYMPTOMS LASTED FOR ABOUT AN HR
49 2021-03-28 heart rate increased I awoke with a heart rate of 155 BPM, and BP of 131/81 (upper left arm) and the need to urinate. Ove... Read more
I awoke with a heart rate of 155 BPM, and BP of 131/81 (upper left arm) and the need to urinate. Over the next 40 minutes I needed to urinate 6 additional times, and my heart rate peaked out at 195 BPM, and BP of 139/84. My blood oxygen never went below 95. My hands and feet were extremely cold, but normal in color. After approximately an hour after I recorded the peak heart rate, my rate was 138 BPM. By about 8:45 AM, I was very close to mo normal heart rate and BP. I had no other notable symptoms other than the expected soreness at the injection site and a very slight headache.
49 2021-03-30 fainting, pallor Moderna Covid 19 vaccine, he had syncopal/unresponsive episode. Medical emergency called; vitals an... Read more
Moderna Covid 19 vaccine, he had syncopal/unresponsive episode. Medical emergency called; vitals and glucose obtained. RN and Dr. to vacccine clinic. Pt brady at 40-41, diaphoretic, pale, all other vitals wnl. 911 called. Oxygen applied 2L NC. Pt talking in short sentences, complains of headache and dizziness. No resp distress or chest pain. Has had anxiety (vasovagal) episodes to needles in past.
49 2021-04-01 loss of consciousness Nausea, cold sweats, blacking out, vomiting for 7 hours
49 2021-04-02 ischemic chest pain Fever. Swollen under arm near arm pit. Pains in heart. Headache. Chills.
49 2021-04-02 chest pain, pallor 10 minutes after vaccination patient stated he felt faint and thought he would pass out. We sat pati... Read more
10 minutes after vaccination patient stated he felt faint and thought he would pass out. We sat patient down to monitor and took BP and pulse rate (120/59 and 60). After a few minutes, patient stated he was nauseated and still feeling dizzy. We continued to observe patient and after a few more minutes he stated he was starting to have intermittent chest pain. We then contacted 911 to request assistance. While waiting for EMS to arrive, patient stated the chest pain was becoming more constant. At this time we also observed patient was very pale, sweaty, and his skin was cold to the touch. EMS arrived quickly and took over patient care, stablilizing him and then transporting him to the hospital. We have not received an update on his condition at this time.
49 2021-04-04 blood pressure increased On Friday, 4/2/21, a client (49 yr old male) arrived to the 30 minute Vaccine Recovery lot after COV... Read more
On Friday, 4/2/21, a client (49 yr old male) arrived to the 30 minute Vaccine Recovery lot after COVID 19 Moderna Lot# 020B21A administration at 11:40am. Patient had reported history of rash after taking both Cipro and Penicillin. At 11:55 am while pt was being assessed by vaccine recovery lot, pt reported sudden onset of involuntary movements and mild shortness of breath. The EMT called for the Vaccine Recovery Lot Medical Lead. Began assessing patient at 11:57 am, noting the pt was having involuntary movements of the upper and lower extremities every few seconds. 12:00 pm BP 152/98, pulse 65. Patient was alert and oriented with normal skin color. Pt reported feeling anxious and "maybe it is all in my head". Pt reported the blood pressure on scene was " higher than my normal at 120s/80s. Pt denied any history of recent illness or other vaccines. Pt stated, " I should have known something would happen, I had a premonition about this". Repeat vital signs at 12:32 pm BP 152/98 and pulse 65. Pt continued to have episodes of the involuntary upper and lower extremities lasting approx 3-5 minutes per episode. NP explained to pt that she could not allow him to drive with these movements and pt agreed to evaluation with EMS and transport to local ER for further evaluation. NP instructed to call for EMS. Call was made at 12:48pm and EMS/Fire arrived onsite shortly after. While awaiting Fire Department and EMS, pt reported to NP, "I have a history of Aspergers Syndrome". Also NP spoke with pt's spouse who also agreed pt should be evaluated at local ER. He was transported to the local hospital.
49 2021-04-06 chest discomfort Tightening of chest/difficulty breathing . Broke out in hives on upper arms and arm pits.
49 2021-04-07 pallor, fainting Pt reported feeling dizzy and light headed. He laid down with feet up with cold pack. He felt bett... Read more
Pt reported feeling dizzy and light headed. He laid down with feet up with cold pack. He felt better after about 10 minutes and he sat up. He then fainted within about 5-10 minutes. We again got him safely to the ground with feet up and cold pack. He remained pale and dizzy for about 10 minutes. He then sat up and left after about 20 more minutes after reporting that he felt better.
49 2021-04-08 very slow heart rate, fainting, hypotension Patient reported feeling dizzy. About 5 mins later had syncopal episode w/syncopal seizure. BP 70s/4... Read more
Patient reported feeling dizzy. About 5 mins later had syncopal episode w/syncopal seizure. BP 70s/40s, P 45-47. 911 called. Patient became more alert but was transported to ED based on hypotension and bradycardia.
49 2021-04-09 chest pain Flu like symptoms within 6 hours of being vaccinated, extreme fatigue lasting 4 days - 3 days bedrid... Read more
Flu like symptoms within 6 hours of being vaccinated, extreme fatigue lasting 4 days - 3 days bedridden, chest pain, cough, headache, neck ache, hard to breath, muscular aches, aches in armpits, sore back, stiff legs, face hurts, tingling in head, Still feeling sick on day 4 from vaccine. Would have not gotten the vaccine if I knew I would be this sick
49 2021-04-10 chest discomfort Noticed hives Tonight at around 9pm, It is on upper left arm, Top part of back shoulder, and around ... Read more
Noticed hives Tonight at around 9pm, It is on upper left arm, Top part of back shoulder, and around to upper left chest area. Have had tightness of of chest muscle going to bottom of front left side of neck along with normal achyness around upper left arm.
49 2021-04-10 blood clot very much like a blood clot; R leg swelling; very hematoma; big red patch; warm sensation in the the... Read more
very much like a blood clot; R leg swelling; very hematoma; big red patch; warm sensation in the the leg; pain that he never had; normal pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (very much like a blood clot) in a 49-year-old male 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (normal pain in the injection site). On 04-Apr-2021, the patient experienced THROMBOSIS (very much like a blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg) and PAIN IN EXTREMITY (pain that he never had). At the time of the report, THROMBOSIS (very much like a blood clot), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg), PAIN IN EXTREMITY (pain that he never had) and VACCINATION SITE PAIN (normal pain in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was 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
49 2021-04-11 chest discomfort Body aches, head ache, chest tightness, nausea, fatigue, foggy head
49 2021-04-11 fainting Beyond initial flu-like symptoms, patient initially experienced bouts of light-headedness at around ... Read more
Beyond initial flu-like symptoms, patient initially experienced bouts of light-headedness at around 10:30 a.m. the day after the 2nd shot - which was Apr 9, 2021. After laying down for a couple of hours, the patient tried to have lunch, but experienced syncope at around 12:45 p.m. Patient's spouse could not revive them initially, so called 9-1-1.
49 2021-04-12 chest pain, pulmonary embolism Patient was seen in hospital after receiving 2nd Moderna vaccine at 8am on 1/21/2021. He developed ... Read more
Patient was seen in hospital after receiving 2nd Moderna vaccine at 8am on 1/21/2021. He developed left sided chest pain a few hours earlier. Presented to hospital next day with multiple bilateral pulmonary emboli
49 2021-04-12 deep vein blood clot extensive DVT left LE. diagnosed on 4/10/21, however symptoms started in week prior. Had almost imme... Read more
extensive DVT left LE. diagnosed on 4/10/21, however symptoms started in week prior. Had almost immediate cramping/pains after vaccine that worsened after first week
49 2021-04-13 chest pain Patient was feeling chest pain after receiving the vaccination, patient had previously had a similar... Read more
Patient was feeling chest pain after receiving the vaccination, patient had previously had a similar issue in the past and was told he was having a "pre-heart attack". Patient was taken via ambulance to the ER after the vaccination.
49 2021-04-13 hypertension Difficult to breathe body pain headache nausea higher blood pressure
49 2021-04-13 fainting, platelet count decreased, loss of consciousness, blood glucose increased Nausea and abdominal pain building over several hours leading to syncope. Patient was unconscious fo... Read more
Nausea and abdominal pain building over several hours leading to syncope. Patient was unconscious for at least 10 minutes. Nausea dissipated then built again for several more hours. Observation and lab tests at Emergency room. No treatment. Symptoms resolved.
49 2021-04-15 blood pressure increased THE DAY AFTER HE RECEIVED THE VACCINE HE SAID HIS HEARING FELT LIKE HE WAS IN A WIND TUNNEL, AND THE... Read more
THE DAY AFTER HE RECEIVED THE VACCINE HE SAID HIS HEARING FELT LIKE HE WAS IN A WIND TUNNEL, AND THE VERTIGO STARTED. WITHIN 3 DAYS OF THAT HE LOST ALL HEARING IN HIS LEFT EAR. HE SAW HIS PRIMARY DOCTOR WHO TRIED SOME STEROIDS AND ALLERGY MEDICATIONS. HE WAS REFERRED TO EAR INSTITUTE. The Institute HAS INJECTED STEROIDS INTO HIS LET EAR SEVERAL TIMES, BUT STILL NO HEARING IN HIS LEFT HEAR, AND HE STILL HAS VERTIGO. SINCE THIS HIS BLOOD PRESSURE HAS BEEN INCREASING FROM NORMAL TO THE POINT HIS PROVIDER DID AN EKG ON HIM, WHICH WAS NORMAL SINUS RYTHM. HE KNOW THAT THIS IS GETTING REPORTED, IF YOU HAVE ANY QUESTIONS FOR HIM, HE WOULD BE HAPPY TO ANSWER THEM. NOTE: WHEN HIS PRIMARY REVIEW HIS CHART, HE TOLD patient THAT
49 2021-04-18 chest pain, fluid around the heart, enlargement of the heart 12-18 hours after vaccine had feeling of hot/cold/shivering/myalgia. Few days later started to have... Read more
12-18 hours after vaccine had feeling of hot/cold/shivering/myalgia. Few days later started to have chest pain, shortness of breath that progressed and eventually was severe. seen at ER 2/22/21 and found to have large pericardial effusion on bedside u/s and acute ST changes on EKG. transferred to second hospital and admitted 2/22/21-2/25/21. He was treated with pericardial windows to remove fluid and discharged on ibuprofen and colchicine for presumed viral pericarditis.
49 2021-04-18 fainting Patient received vaccine at 10:29am. Upon walking toward post-vaccination area, patient fainted at 1... Read more
Patient received vaccine at 10:29am. Upon walking toward post-vaccination area, patient fainted at 10:30am. He struck his head on the ground when he passed out. Patient regained groggy consciousness at 10:31am and was able to answer basic questions and seemed somewhat alert. Cold compress was applied to head and neck. EMS was called to assess patient for potential concussion. Patient was taken to local emergency room for follow up assessment/treatment
49 2021-04-19 loss of consciousness, oxygen saturation decreased, heart rate decreased, blood pressure decreased Within 3 minutes after vaccine administration at 11:00am, person had two seizures within 5 minutes o... Read more
Within 3 minutes after vaccine administration at 11:00am, person had two seizures within 5 minutes of each other. Decreased pulse, blood pressure and oxygen saturation. Loss of consciousness for several minutes each time. Emergency measures initiated, including IV and oxygen. Transported by EMS to Emergency Department at 11:25am.
49 2021-04-20 blood pressure increased Dizziness, blurred vision, fatigue, headaches, chills, low grade fever, muscle pain, joint pain, hig... Read more
Dizziness, blurred vision, fatigue, headaches, chills, low grade fever, muscle pain, joint pain, high blood pressure, and swelling of the throat.
49 2021-04-20 blood clot, transient ischaemic attack Memory lapse, difficulty with memory recall; Confused; Blood clots; Cerebral Ischemic Attack; Brain ... Read more
Memory lapse, difficulty with memory recall; Confused; Blood clots; Cerebral Ischemic Attack; Brain Fog; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart valve operation. Concomitant products included WARFARIN SODIUM (COUMADIN) 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confused) (seriousness criterion hospitalization), THROMBOSIS (Blood clots) (seriousness criterion hospitalization) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache). The patient was hospitalized from 10-Apr-2021 to 12-Apr-2021 due to CONFUSIONAL STATE, MEMORY IMPAIRMENT, THROMBOSIS and TRANSIENT ISCHAEMIC ATTACK. At the time of the report, MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache) had not resolved and CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Computerised tomogram: abnormal (abnormal) revealed blood clots. On 10-Apr-2021, International normalised ratio: low (Low) Low. On 10-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) revealed blood clots. On 15-Apr-2021, International normalised ratio: low (Low) Low. It was reported that the patient still has difficulty with memory recall, brain fog, headache, and still having trouble with low INR. The patient did not have any side effects after the first dose. Treatment for the events included Levonox injections and Coumadin (increased dose). Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Headache is consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Headache is consistent with the product known safety profile.
49 2021-04-21 chest pain, blood glucose increased Patient is a personal acquaintance of reporter. Patient contacted reporter on 4/15/21 at 10:18 pm c... Read more
Patient is a personal acquaintance of reporter. Patient contacted reporter on 4/15/21 at 10:18 pm complaining of onset of extreme dizziness, vomiting, "eyes not catching up with my head", extreme fatigue, and feeling like they are "about to pass out". Patient also noted onset of SOB and lower chest pain accompanied by "weird taste" but not metallic taste. Patient was unable to describe the unusual taste. Patient was encouraged to use OTC medications to treat headache and fever, encouraged to use OTC Benadryl/Dramamine. Monitor for worsening and report to ER if symptoms worsened, changed, or failed to improve. Per patient, symptoms lasted through the night and until approximately 3:00 AM on 4/16/21. Patient's wife reported blood sugar of 154 mg/dl, B/P 164/88, and Pulse 70 bpm using home monitors. On 4/16/21, the patient reported onset of fever greater than 101 at approximately 2:00-3:00 AM which lasted approximately 18 hours. Fever onset was accompanied by headache which has persisted from 4/16/21 through 4/22/21. Patient contacted writer on 4/21/21 to state that he still does not feel well, headaches continue and fatigue is persistent. Generally states that he does not feel well.
49 2021-04-21 fainting, loss of consciousness The patient was very nervous prior to getting the immunization and stated that he had a fear of need... Read more
The patient was very nervous prior to getting the immunization and stated that he had a fear of needles. After receiving the immunization the patient went to the waiting area to be observed. Approximately 5-10 minutes later he slid off the chair and hit the back of his head. The observer alerted the staff and 911 was called. He appeared to have fainted and was unconscious for a few seconds. He opened his eyes and appeared to shake a little and sat up and began vomiting while 911 was on the phone. Paramedics arrived and tended to the patient and he refused further treatment.
49 2021-04-22 cerebrovascular accident I had a massive stroke at work a few weeks after the 1st vaccine shot. Rushed to hospital for emerge... Read more
I had a massive stroke at work a few weeks after the 1st vaccine shot. Rushed to hospital for emergency surgery to remove blood clot in right side of brain. My paralysis was reversed after surgery but lingering headaches exist.
49 2021-04-22 hypotension APPROXIMATELY 10 MINUTES AFTER INJECTION, PATIENT BEGAN FEELING DIZZY, SWEATING AND FELL IN THE BACK... Read more
APPROXIMATELY 10 MINUTES AFTER INJECTION, PATIENT BEGAN FEELING DIZZY, SWEATING AND FELL IN THE BACK OF THE AISLE WHILE GRABBING HIS MOTHER TO SIT WITH HIM. I SAT PATIENT DOWN AND ASKED WHAT SYMPTOMS HE WAS EXPERIENCING. HE SAID HE HAD ABSOLUTELY NO TROUBLE BREATHING AND JUST FELT LIGHT HEADED, SOME FLOATERS IN HIS EYES AND SWEATY. I IMMEDIATELY TOOK HIS BLOOD PRESSURE WHICH WAS LOW AND OFFERED HIM WATER, AND GATORADE. PATIENT DID NOT WANT US TO CALL EMS BUT DUE TO LOW BLOOD PRESSURE, EMS WAS CALLED. ALL VITALS WERE CHECKED ABOUT 10-15 MIN LATER BY EMS AND EVERYTHING CHECKED OUT OK. PATIENT DECLINED SERVICES AND TRANSPORATION TO HOSPITAL AND STATED THAT HE FELT MUCH BETTER. FOLLOWED UP WITH PATIENT AN HOUR LATER VIA PHONE AND PATIENT WAS FEELING MUCH BETTER AND WAS JUST RESTING; CALLED AGAIN AT 6:30PM AND PATIENT SAID HE FELT 100% AND I COUNSELED HIM ON VISITING THE ER ASAP IF ANY SYMPTOMS, OR FEELING ILL RETURNED.
49 2021-04-22 fainting, loss of consciousness Pt experienced heavy post vaccination bleeding. Pharmacist applied compression and pt stated that he... Read more
Pt experienced heavy post vaccination bleeding. Pharmacist applied compression and pt stated that he was feeling like he might faint. Pt then layed his head on the table. He blacked out for several seconds at that point. When pt regained consciousness, he was given water and a cool towel. Pt remained in clinic area for 10-15 minutes post vaccination. Pt stated he felt better and remained in pharmacy area for an additional 15 minutes. Pt was called an hour post vaccine to follow up and he stated he felt normal.
49 2021-04-23 heart rate increased Chill, Uncontrollable shaking, fever (101.4), high pulse (130)
49 2021-04-24 heart rate increased My heartbeat has been rapid at times. I can feel it in my chest beating heavy at times. It's not all... Read more
My heartbeat has been rapid at times. I can feel it in my chest beating heavy at times. It's not all the time, but it hasn't gone away. I thought it was caffeine or sugar, so I cut them out of my diet, but it is still happening. I'm going for my physical on 4/29, so I was going to get it checked out then.
49 2021-04-24 fainting After I administered the shot, patient fainted immediately. He did start waking up after 30 seconds... Read more
After I administered the shot, patient fainted immediately. He did start waking up after 30 seconds. I placed an ice pack on his chest and then he started refusing to be placed on the ground. Patient did recover after 30 minutes and was driver home by partner.
49 2021-04-25 chest pain Ongoing- pain under right arm radiating towards chest area. With numbness and tingling. Sharp pain l... Read more
Ongoing- pain under right arm radiating towards chest area. With numbness and tingling. Sharp pain located outside edge of pectoralis major. Also random bumps appearing in different areas of body. Currently 6 bumps all same size shape and appearance. All occurred on different days and different times. Perfectly healthy prior to vaccination.
49 2021-04-27 fainting syncopal event, no loss of consciousness. Fainted from standing position after vaccination. Moved fr... Read more
syncopal event, no loss of consciousness. Fainted from standing position after vaccination. Moved from prone position to wheelchair then to stretcher with EMT care. Neurologically intact. A&Ox3. No signs of head trauma. Evaluated by EMT, stable condition. He declined further care and treatment options. Escorted by EMS with his wife. Left via private vehicle with his wife.
49 2021-04-28 chest pain, pulmonary embolism Chest pain. Positive D-Dimer. Pulmonary Embolism.
49 2021-04-30 blood glucose increased I track my blood sugar 3x per day (morning, an hour after lunch, an hour after dinner). Blood sugar... Read more
I track my blood sugar 3x per day (morning, an hour after lunch, an hour after dinner). Blood sugar is very well controlled using insulin - fasting blood sugar is consistently 115-125, sometimes varying to 110-130. When I got the second Covid shot, my fasting blood sugar the next two days were 147 and 143 - the highest values I have EVER recorded since I started taking insulin (earlier this year). Correspondingly, the values after lunch and dinner yesterday were very elevated. This afternoon and evening, the numbers have returned to normal, and I expect tomorrow morning's fasting value to be back around 120 again. This was not dangerous, but as an engineer, I found it to be a fascinating and statistically significant outlier. The other symptoms I had from the second shot was a fever (over 100 degrees from 11/28 5:30pm through 11/30 8am, and over 102 from 11/28 10pm through 11/29 9am), some general aches and fatigue, and injection site soreness. I had no adverse reaction to the first shot (a month earlier) except for injection site soreness.
49 2021-05-01 fainting, loss of consciousness Patient experienced syncope 1-2 minutes after vaccination. He temporarily lost consciousness. Patien... Read more
Patient experienced syncope 1-2 minutes after vaccination. He temporarily lost consciousness. Patient was sitting and was prevented from falling off the chair.
49 2021-05-02 pallor Client received 2nd dose of COVID-19 vaccine at 3:26pm. At 3:32pm RN was notified that client was no... Read more
Client received 2nd dose of COVID-19 vaccine at 3:26pm. At 3:32pm RN was notified that client was not feeling well and had requested water. Check in with client who reported he was feeling dizzy and nauseous. Took client to cot by wheel chair. Check pulse (92bpm) and pulse ox (95 SpO2). Gave cold compress for neck and forehead. Client vomited small amount of yellow vomitous. Client grey/ashen in color when mask removed. LPN assesed for neck/back, jaw, and shoulder pain. Client became diaphoretic and he removed his vest. Client stated he had jaw pain and pain in back. Also reported arm pain and felling tired a few days before. EMS called. Interpreter used for interaction at cot.
49 2021-05-03 heart rate decreased, hypotension DIZZINESS. LIGHT HEADED. LOW PULSE RATE AND BLOOD PRESSURE
49 2021-05-04 arrhythmia, heart rate increased, atrial fibrillation Patient states he developed fatigue myalgias 8 hours after vaccine, then about two hours later, he b... Read more
Patient states he developed fatigue myalgias 8 hours after vaccine, then about two hours later, he became short of breath. He subsequently reported intermittent shortness of breath and leg swelling. May 5 noted to have atrial fibrillation/ flutter with rapid rate. Unclear if patient had atrial fibrillation at time of initial symptoms and unclear if related to the vaccine at all.
49 2021-05-05 pulmonary embolism, deep vein blood clot Acute bilateral pulmonary embolism and acute right leg deep vein thrombosis, both of unknown etiolog... Read more
Acute bilateral pulmonary embolism and acute right leg deep vein thrombosis, both of unknown etiology
49 2021-05-06 heart rate increased, blood pressure increased Elevated heartrate (approx. 120 bpm) for duration of approx 30 minutes; elevated blood pressure (150... Read more
Elevated heartrate (approx. 120 bpm) for duration of approx 30 minutes; elevated blood pressure (150/90)
49 2021-05-09 skin turning blue The patient was last seen well at 3:30 PM. He was found unresponsive, face down in his own vomit, cy... Read more
The patient was last seen well at 3:30 PM. He was found unresponsive, face down in his own vomit, cyanotic, apneic by family. Patient was unable to be resusitated. He was pronounced dead at 6:51 PM.
49 2021-05-12 hypertension Uncontrolled high blood pressure after second vaccination shot. Have no history of high blood press... Read more
Uncontrolled high blood pressure after second vaccination shot. Have no history of high blood pressure prior.
49 2021-05-17 blood glucose increased I was vaccinated on 01/20/21. On 02/11/21 I started having stiffness in my neck. On 02/15/21 it got ... Read more
I was vaccinated on 01/20/21. On 02/11/21 I started having stiffness in my neck. On 02/15/21 it got worse and could not turn my head as the neck was stiff and swollen. My neck got better after few days and the pain moved to both my biceps. They were also swollen and painful. After few days the pain was gone but I started having pain on both my thighs. They were also swollen and very painful. After few days the pain disappeared and it moved to both legs and feet. At that same time my skin was also getting inflamed and peeling off. I could not even take a shower or bath as the skin was very sensitive and painful. I also started developing some blisters on most parts of my body. It was diagnosed a Bullous Pemphigoid.
49 2021-05-17 chest pain I had the 2nd moderna shot on May 5 the following Monday I had pain right below my chest left side b... Read more
I had the 2nd moderna shot on May 5 the following Monday I had pain right below my chest left side bottom of rib cage Monday May 10th then developed a rash around Wednesday May 12th, this was a couple a bumps on skin left side front bottom of rib cage. Other than pain, I generally feel fine. Pain is severe at times but not consistent. Gradually the rash spread from a coupe of spot into a line of spots from the original point to sternum and then around the back to the spine. Gradually the pain became more consistent and more. I did an E-visit with APNP at 5/16/2021 8:37 AM.
49 2021-05-26 blood pressure decreased Sweating, saw spots, about to pass out, lasted about 2 minutes , checked my blood pressure read 70/5... Read more
Sweating, saw spots, about to pass out, lasted about 2 minutes , checked my blood pressure read 70/50 normal for me in the 120s/80s. Blood pressure started to return normal after two days. Stopped taking my meds on 3/17 restarted on 3/20
49 2021-05-26 chest pain, hypertension, chest discomfort Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: ... Read more
Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypertension-Medium, Additional Details: pt reported L arm pain and also some numbness in lower back right as well as some chest pain after shot. was not dizzy or nauseous. BP elevated at 191/116, then decreased to 180/109 but still elevated. initially offered to call 91 or an ambulance but pt refused. chest pain resolved within minutes as well as the arm and back pain. pt was feeling very anxious before the vaccine which may have precipitated the high bp and chest pain. pt felt fine,referred pt to urgent care for hypertensive urgency.
49 2021-05-28 loss of consciousness Patient received vaccine, came out to the waiting area, and lost consciousness for a very short peri... Read more
Patient received vaccine, came out to the waiting area, and lost consciousness for a very short period of time. He came to and threw up several times. He sat for a while longer said he felt better and under the guidance of his wife left the store. I tried to call him several hours later to see how he was doing but only got an answering machine
49 2021-05-28 lightheadedness, pallor Seizure like phenomena; Breath sounds abnormal; Dizziness; Dyskinesia; Eyelid function disorder; Fal... Read more
Seizure like phenomena; Breath sounds abnormal; Dizziness; Dyskinesia; Eyelid function disorder; Fall; Hyperhidrosis; Hypopnoea; Hypotonia; Muscle twitching; Pallor; Presyncope; Restless legs syndrome; Tremor; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE LIKE PHENOMENA (Seizure like phenomena) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vagal reaction (patient stated he has experienced vagal responses to injections in the past). On 02-Mar-2021 at 5:46 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SEIZURE LIKE PHENOMENA (Seizure like phenomena) (seriousness criterion medically significant). 02-Mar-2021, the patient experienced BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor). At the time of the report, SEIZURE LIKE PHENOMENA (Seizure like phenomena), BREATH SOUNDS ABNORMAL (Breath sounds abnormal), DIZZINESS (Dizziness), DYSKINESIA (Dyskinesia), EYELID FUNCTION DISORDER (Eyelid function disorder), FALL (Fall), HYPERHIDROSIS (Hyperhidrosis), HYPOPNOEA (Hypopnoea), HYPOTONIA (Hypotonia), MUSCLE TWITCHING (Muscle twitching), PALLOR (Pallor), PRESYNCOPE (Presyncope), RESTLESS LEGS SYNDROME (Restless legs syndrome) and TREMOR (Tremor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: 120/72 (normal) 120/72 mmHg. On 02-Mar-2021, Heart rate: 64 (normal) 64 beats per minute. On 02-Mar-2021, Oxygen saturation: 99 (normal) 99%. On 02-Mar-2021, Respiratory rate: 20 (normal) 20 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. No concomitant medications were provided. The patient remained in the vaccination chair for 5 minutes after injection and he reported feeling well and moved to the observation chair without any problems [~10ft]. After being in the observation chair the patient stood up and took 4-5 steps toward the wall and sat down on the floor. The patient stated he felt dizzy and then became limp and slumped to the right side, his eyes remained open with dilation of pupil fixed at 2mm with no blinking noted. The patient's breathing pattern became shallow and snoring sounds were noted. The patient did not respond when spoken to nor did he respond to soft shaking of the shoulders. The patient began to demonstrate large jerky body movements similar to seizure activity. The seizure like activity continued for 3-4 minutes before the patient was able to become aware of surroundings and answer orientation questions. The patient was diaphoretic, pale, shaking of hands and arms, restlessness of lower limbs with frequent repositioning/twitching of legs. EMS (emergency medical services) arrived to find the patient regaining stability. The patient reported to EMS that he is familiar with this type of response and declined to be taken anywhere. Treatment medications were not reported. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. The Company believes the event of Restless leg syndrome is not supported in the source documents and should be delete.
49 2021-05-28 low platelet count, platelet count decreased 12/18/2020: ER visit showing Patient Chief complaint of Left lower leg pain; plt count 243x10^3 WNL;... Read more
12/18/2020: ER visit showing Patient Chief complaint of Left lower leg pain; plt count 243x10^3 WNL; Given Clindamycin 600mg IV in the ER and discharged on Bactrim 800mg PO for Acute Cellulitis diagnosis. 1/2021: Follow-up at PCP office showed plt wnl on routine labs. Resolution of leg symptoms per patient. 3/15/21 & 4/15/21: Received Moderna vaccine one & two at Public health clinic (Additional Information for Item 12: Cigarette smoker 10.5 Pack years, hypertension) Additional information for Item 18: 4/19/2021-4/27/21: Presented to Medical Center ER with complaints of Left leg redness and weakness. Stated he felt weak and tired after receiving the second dose and has been feeling worse since. His friend brought him to the ER stating "he didn't seem like himself." Admitted for acute cellulitis of Left lower extremity, altered mental status, and started on IV Vancomycin (4/19/21-4/22/21) and Levaquin (4/19/21-4/26/21). Baseline plt 74 at admission. Rivaroxaban 10mg PO QD was given 4/19/21 until 4/21/21. Plt count continued to downtrend during admission. Hematology/Oncology service consulted on 4/22/21 who initially suggested thrombocytopenia possibly due to infection or DIC. Yet, worsening thrombocytopenia despite improvement of infection and clinical status was noted. The etiology was then suggested to be Vancomycin induced thrombocytopenia, so Vancomycin was stopped on 4/22/21. Platelet count Patient was discharged with p.o. prednisone and p.o. Levaquin on 4/27/21. Patient stated almost full resolution of LLE pain and redness. Plt count upon discharge was 51. Instructed to stop Rivaroxaban. 5/1/21:Patient presented to ER at Medical Center for Leg pain. US Doppler was negative and patient given Clindamycin IV 600mg in the ER and discharged with Bactrim 800mg qd to be continued until his PCP appointment. May 5, 2021: PCP placed patient on Clindamycin for recurrent cellulitis. 5/14/21-5/22/21: Patient presented to Medical Center ER with worsening left leg cellulitis. Patient was afebrile with a normal wbc count. Upon admission, Plt count was 36. Patient was started on Linezolid 600mg q12h and Ceftriaxone qd. Antibiotics were changed later to Tefalo 600mg Q12Hto be started on 5/15/21. ID consult recommended Daptomycin given patient's thrombocytopenia. Patient was continued on Daptomycin throughout admission and upon discharge, patient's leg was almost back to baseline. Plt count was 138. To rule out other causes of thrombocytopenia, patient medications were reviewed and imaging was done in addition to labs drawn during this admission. See above for the labs. All alternative causes during this admission were ruled out.
49 2021-06-01 chest discomfort PATIENT SAYS HE DEVELOPED CHEST TIGHTNESS THAT IS FELT SOMETIMES ON RIGHT OR LEFT SIDE OF BREASTBONE... Read more
PATIENT SAYS HE DEVELOPED CHEST TIGHTNESS THAT IS FELT SOMETIMES ON RIGHT OR LEFT SIDE OF BREASTBONE. SAYS SYMPTOMS DEVELOPED THE DAY OF THE 2ND VACCINE DOSE. PATIENT ADVICED TO CONTACT CDC AND FAMILY DOCTOR. HAS NOT BEEN EVALUATED BY MEDICAL DOCTOR BEFORE COMING TO PHARMACY
49 2021-06-01 lightheadedness Cannot run more than 1 block. Severe pain & tightness and starting to black out if attempting any lo... Read more
Cannot run more than 1 block. Severe pain & tightness and starting to black out if attempting any longer. Still in effect currently.
49 2021-06-02 cerebrovascular accident received notification that patient was hospitalized 06/02/2021 at Medical Center with COVID-19 infec... Read more
received notification that patient was hospitalized 06/02/2021 at Medical Center with COVID-19 infection and CVA
49 2021-06-02 chest pain heart disorder; Inappropriate schedule of vaccine administered; started feeling short of breath; pai... Read more
heart disorder; Inappropriate schedule of vaccine administered; started feeling short of breath; pain in the back and chest; pain in the back and chest; pain bone; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (heart disorder) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Blood pressure high (Patient was diagnosed at the hospital) on 19-Mar-2021. On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced BONE PAIN (pain bone) and CHILLS (chills). On 16-May-2021, the patient experienced DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest) and BACK PAIN (pain in the back and chest). On 19-May-2021, the patient experienced CARDIAC DISORDER (heart disorder) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered). The patient was hospitalized on 19-Mar-2021 due to CARDIAC DISORDER. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 06-Apr-2021, BONE PAIN (pain bone) and CHILLS (chills) had resolved. At the time of the report, CARDIAC DISORDER (heart disorder), DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest), BACK PAIN (pain in the back and chest) and PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered) 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. Patient received medications for diabetes and high blood pressure however, drug names were not provided. Company comment: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was received.; Sender's Comments: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.
49 2021-06-07 hypertension, heart failure High blood pressure, heart failure, hospitalization
49 2021-06-08 chest discomfort Severe soreness/aches, dizziness, nausea, lightheadedness, tightness in chest, fatigue, followed by ... Read more
Severe soreness/aches, dizziness, nausea, lightheadedness, tightness in chest, fatigue, followed by flu-like symptoms (running nose, sneezing, excessive cough) The flu like symptoms have continued since the shot.
49 2021-06-08 troponin increased, pulmonary embolism Bilateral pulmonary embolism with evidence of R Heart Strain
49 2021-06-09 chest pain, chest discomfort 15 minutes post injection pt complained of chest pain and tightness radiating to left arm and back. ... Read more
15 minutes post injection pt complained of chest pain and tightness radiating to left arm and back. Pt rated pain 8/10. Pt also complained of shortness of breath making it difficult to catch breath. Vital signs checked, PCP notified. Per pcp orders; ASA 81mg administered, O2 administered via nasal cannula, and EKG performed. PCP met with pt. Per PCP orders, pt to be transported to hospital via ambulance. 911 contacted, pt transferred to nearby hospital.
49 2021-06-09 heart attack, blood pressure increased Heart Attack on 4/29/2021, no artery blockage found by doctor. Elevated Blood Pressure.
49 2021-06-10 chest discomfort, troponin increased, chest pain Fever, chills, chest discomfort, minor chest pain.
49 2021-06-10 deep vein blood clot, pulmonary embolism Double pulmonary embolism, and DVT
49 2021-06-12 inflammation of the pericardium, loss of consciousness, inflammation of the heart muscle Myocarditis, Pericarditis, passing out, vomiting
49 2021-06-13 blood clot Developed blood clot in leg.. having lysis surgery today 6/14/2021
49 2021-06-20 atrial fibrillation, cardiac arrhythmia AFib and PCVs.
49 2021-06-20 palpitations, chest discomfort Side effects within first 3 days included extreme sore arm (muscle), temperature, aching, headache, ... Read more
Side effects within first 3 days included extreme sore arm (muscle), temperature, aching, headache, heart palpitations, dizziness, fatigue and difficulty concentrating. However, 5 weeks later I am still experiencing extreme fatigue, tiredness, as well as heaviness in chest.
49 2021-06-20 fainting Patient was in the lobby area of pharmacy when he passed out. The pharmacy manager tried to talk to ... Read more
Patient was in the lobby area of pharmacy when he passed out. The pharmacy manager tried to talk to the patient, but he appeared to be having a seizure (his eyes were rolled up in his head, he was shaking). When the patient came to he seemed confused about where he was. He began sweating profusely. He said he was nauseated and lightheaded. He said he was tingling all over his body. We also noticed that he was bleeding where he hit his head on the ground when he passed out. He stayed seated while the pharmacy manager held a paper towel to the bleeding part on his head. He sipped some water until the EMS arrived and took over. The patient left to go to the ER with the EMS crew after 3:00PM.
49 2021-06-21 deep vein blood clot, fibrin d dimer increased The pt had his first Moderna covid vaccine on 3/19, and after the vaccination, he developed left upp... Read more
The pt had his first Moderna covid vaccine on 3/19, and after the vaccination, he developed left upper lateral calf pain that lasted several weeks. He then had his second Moderna covid vaccine on 4/22, with left knee pain, and again left upper lateral proximal calf pain. He denies any chest pain, heaviness, tightness, pressure, palpitations, or dizziness. He contacted his PCP, and he was advised to come to the ER for evaluation of a possible DVT. This is very suspicious for a direct thrombotic side effect of the pt's Moderna vaccine. The pt has a very high d-dimer, and we can not rule out a mid-distal thigh and left popliteal DVT, so the pt will be covered with Lovenox, and he will present to hospital tomorrow to obtain a venous duplex. They can then, based on clot burden and his subsequent complaints on continuing lovenox bridge to warfarin or a direct acting anticoagulant.
49 2021-06-23 arrhythmia, ventricular tachycardia Patient experienced a major onset of cardiac arrhythmias --Atrial tachycardia, Ventricular tachycard... Read more
Patient experienced a major onset of cardiac arrhythmias --Atrial tachycardia, Ventricular tachycardia and ultimately Ventricular Fibrilation-- he was resuscitated with his internal defibrilator-- this resulted in a 23 day stay in the hospital, most in the ICU to deal with "arrhythmia storms". Alhtough patient has been a cardiac patient for his entire life, he has never expreience the arrhythmia issues of this nature until he was given the vaccine.
49 2021-06-23 cerebrovascular accident After moderna vaccine he having stroke; This spontaneous case was reported by a consumer and describ... Read more
After moderna vaccine he having stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form once. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) had not resolved. 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. Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.
49 2021-06-24 chest discomfort Fever 102 for 2 days, 101 for 3rd day , 100 for the fourth day. Severe headache for 3 days, arm pai... Read more
Fever 102 for 2 days, 101 for 3rd day , 100 for the fourth day. Severe headache for 3 days, arm pain for 4 days, joint pain for 3 days, kidney pain for 2 days, chest pressure, fatigue for weeks - still don?t feel normal. heart discomfort occurred a few days after injection, still having the discomfort and fatigue. Saw doctor today and was referred to cardiologist for evaluation.
49 2021-06-30 cardiac arrest, chest discomfort, blood pressure increased 1. Significant discomfort around the left chest, heart area. Feel null and pain around the armpit, ... Read more
1. Significant discomfort around the left chest, heart area. Feel null and pain around the armpit, upper left arm and left back area. The discomfort and pain reached peak a day after the 2nd shot. When writing this report, 48 hours have passed. The discomfort is not completed gone. 2. Accelerated heart beat rate (90-100 a minute) for 2 nights, with 38.5 deg C fever. 3. Elevated blood pressure (135/95).
49 2021-07-05 palpitations Constant heart racing, on the verge of panic, inability to sleep becoming apparent about a week afte... Read more
Constant heart racing, on the verge of panic, inability to sleep becoming apparent about a week after the vaccination and still ongoing.
49 2021-07-06 blood pressure fluctuation, heart rate increased, chest discomfort Heart beat increase. Chest tight. Short of breath. Blood pressure fluctuate.
49 2021-07-11 stroke, blood pressure increased Patient's last known normal 7/10 at 0300. Presented to ER on 7/11 with symptoms of imbalance, slurre... Read more
Patient's last known normal 7/10 at 0300. Presented to ER on 7/11 with symptoms of imbalance, slurred speech, difficulty swallowing, left side felt week. The previous day, the patient woke up with slurred speech, imbalance, fatigue and slept all day. Patient has no history of stroke, CVD. Does have history of hypertension and hyperlipidemia that is untreated. Patient did not qualify for TPA and was admitted for treatment on the general medical floor. Patient's blood pressure and heart rate continued to rise and was transferred to ICU.
49 2021-07-13 blood clot Developed pain in lower left leg that became so concerning that a doctor appointment was made. Visit... Read more
Developed pain in lower left leg that became so concerning that a doctor appointment was made. Visited doctor on 3/4/21 and doctor thought it might be a blood clot. Ultrasound ordered 3/10/2021, blood clot in left leg confirmed. Second ultrasound done on 3/12/2021 and blood clot was again re-confirmed
49 2021-07-17 cerebrovascular accident Cerebrovascular accident; This case was initially received via another Manufacturer (Reference numbe... Read more
Cerebrovascular accident; This case was initially received via another Manufacturer (Reference number: PVIUS2021001059) on 14-Jun-2021. The most recent information was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. The license partner had received the report from FDA VAERS (Reference number: 1422940). This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Event verbatim Updated. Sender's Comments added. Report type of this case updated from spontaneous to Regulatory Authority.; Sender's Comments: Very limited information regarding this event has been provided at this time. Patient's history of diabetes may be a confounding factor.
49 2021-07-21 chest pain, chest discomfort I have weakness in left arm. Also, feel tightness/burning sensation in Chest all the time
50 2021-01-04 heart rate increased, fast heart rate Injection was painless. Within 5 minutes of vaccine felt dizzy and had heart rate into the 120's. ... Read more
Injection was painless. Within 5 minutes of vaccine felt dizzy and had heart rate into the 120's. Duration approximately 5 minutes then tachycardia and dizziness resolved. Also had a tremor. No angioedema, urticaria or other skin/mucosal findings. Was not anxious. Arrived home and wife and children told me I looked flushed and noticed my pupils were significantly dilated. The flushing and dilated pupils resolved over the next hour. No shortness of breath or hoarse voice of any kind however my mouth felt extremely dry. I did not do anything for treatment. Spontaneous resolution.
50 2021-01-07 lightheadedness patient described feeling lightheaded, near syncope, 'almost passed out' 15 minutes after vaccine ad... Read more
patient described feeling lightheaded, near syncope, 'almost passed out' 15 minutes after vaccine administration
50 2021-01-07 fast heart rate Headache, Myalgia, Tachycardia, Chills, Injection site pain Narrative: Took OTC ibuprofen and tylen... Read more
Headache, Myalgia, Tachycardia, Chills, Injection site pain Narrative: Took OTC ibuprofen and tylenol
50 2021-01-08 blood pressure increased Dizziness, increased blood pressure, dry mouth Narrative: Within 10 minutes of receiving vaccine pa... Read more
Dizziness, increased blood pressure, dry mouth Narrative: Within 10 minutes of receiving vaccine patient complaining of dizziness, increased blood pressure and dry mouth. Sent to urgent care within the building for evaluation. EKG performed. No meds given
50 2021-01-11 hypertension Headache, UrticariaPruritus, HYPERtension, Flushing/Itching of scalp
50 2021-01-13 heart attack Chief Complaint Patient presents with ? Generalized Body Aches     Pt presents via EMS c/o DOE, dr... Read more
Chief Complaint Patient presents with ? Generalized Body Aches     Pt presents via EMS c/o DOE, dry non-productive cough, subjective fevers Tmax 101.9, decreased appetite, aches since testing + for COVID on 1/5.   Patient is a 50 year old male with PMH of Crohns/MS on fingolimod presenting to the Hospital for fevers, shortness of breath and weakness. Patient received COVID vaccine on 12/29. Patient had initial left arm discomfort though has had worsening weakness, cough, shortness of breath and fevers since that time. Patient tested positive for COVID19 on Patient has shortness of breath with exertion that is relieved by rest. Patient denies N/V/D. Patient has taken tylenol at home to attempt to alleviate symptoms.
50 2021-01-16 heart rate increased, increased heart rate, palpitations Received vaccination at approximately 1830 hours on Thursday 01-14-21. Felt ok until approximately ... Read more
Received vaccination at approximately 1830 hours on Thursday 01-14-21. Felt ok until approximately 0900 hours on 01-15-21 when I felt my heart racing and felt hot. Upon EMS arrival I was advised I was sinus tacky and my sugar was 157. Was taken to the hospital where I has a 102.5 fever. Remained in the ER until fever broke and was released at approximately 1800 hours. Off and on fever and rapid heart rate continued at home on 01-16-21.
50 2021-01-18 blood glucose increased, hypertension After COVID vaccine was administered, the patient began to complain of onset headache, and top of he... Read more
After COVID vaccine was administered, the patient began to complain of onset headache, and top of head was tingling. Then the patient began to have a sever deep non productive cough. All vitals were checked and all appeared to be normal for the exception of his blood-pressure which was very high and blood sugar was elevated (he reported to have ate 2 small donuts prior to arriving for the vaccine.) Patient did not have fever, Patient denied throat/airway swelling and his lungs were noted to be clear.
50 2021-01-21 palpitations Lightheaded, dizziness, sweaty, palpitations and nausea lasted for a few minutes. At 08:05 am; Temp... Read more
Lightheaded, dizziness, sweaty, palpitations and nausea lasted for a few minutes. At 08:05 am; Temp= 36.6 C, BP= 127/83, HR= 103, RR= 18, O2 Sats RA= 97%; at 0845: Temp= 36.6 C, BP= 116/82, HR= 106, RR= 18, O2 Sats RA= 98%
50 2021-01-24 pulmonary embolism, oxygen saturation decreased The patient became short of breath and decreased oxygen saturation at home around 2000 on 01/18/2021... Read more
The patient became short of breath and decreased oxygen saturation at home around 2000 on 01/18/2021. He reported to the ED on 01/19/2021 at approximately 0500. The patient was found to have bilateral pulmonary emboli.
50 2021-01-25 fainting, hypotension A few minutes after vaccination while in the 15 minute observation period the patient had a syncopal... Read more
A few minutes after vaccination while in the 15 minute observation period the patient had a syncopal episode lasting 45 seconds with incontinence. On initial ALS assessment patient was found to be hypotensive with a Blood pressure of 60/P. Patient was Transported for further observation.
50 2021-01-28 body temperature decreased Hypothermia - chills and shivering - temperature 91.8 and lasted for at least one hour. Next mornin... Read more
Hypothermia - chills and shivering - temperature 91.8 and lasted for at least one hour. Next morning fever 100.3 lasted for several hours - Rash appeared on abdomen and flanks on 12-19-2020. Rash has disappeared however is till faint at this time.
50 2021-01-29 fast heart rate Starting around 1:00 in the morning, the night of receiving the vaccine, I started with the aches, j... Read more
Starting around 1:00 in the morning, the night of receiving the vaccine, I started with the aches, joint pain, chills, and low-grade fever. I forced myself to go to work. I am a Registered Nurse. The joint pain and aches increased throughout the day along with altered periods of chills and hot flashes. Around 6 PM on the 29th is started feeling worse. I felt like I was tachycardic. I had my wife take my blood pressure. My normal vitals are Pulse-50, BP 110/60. When I took my vitals at 6:00 pm my pulse was 91 and my BP was 85/53. Clearly an allergic reaction. I had no difficulty breathing. Finally, around 1:00 am on 1/30, my fever broke and my heart rate and BP returned to normal ranges. My first vaccination was unremarkable with only a sore arm for three day.
50 2021-02-02 chest discomfort Client phoned with concerns of chest tightness and "just didn't feel right." Client has past med hx ... Read more
Client phoned with concerns of chest tightness and "just didn't feel right." Client has past med hx of a MI. Nurse was unable to establish date of previous MI
50 2021-02-02 transient ischaemic attack, hypertension Narrative: Patient is a 49 year old man with past medical history of hypertension and kidney stones ... Read more
Narrative: Patient is a 49 year old man with past medical history of hypertension and kidney stones who presented with a chief complaint of word finding difficulties and slurred speech. Patient was last seen normal at 1230 pm on 1/21/2021. He got his covid vaccine and shortly after he developed a headache that was on both sides of his head. Felt like 8/10 pain. He then had difficulty with speaking - he didn't know what word to say so he would make a noise. He was on the phone, and that person recommended that he come to the ED to get evaluated.In the ED, a stroke code was called. BP 169/97. NIHSS 0. A CT non con did not show any acute bleed or any signs of a stroke. After the stoke code was ended, the patient has a headache severity 1/10 and did not have any word finding difficulties. Patient was non focal by the time that the stroke code was ended. In the setting of hypertension, a blood pressure of 169/97 on admission and fluctuating symptoms, most concerning on the differential is a TIA. Given his risk factors and episodic presentation, he will need to be worked up for a stroke. The differential also includes post-vaccination reaction vs complex migraine.
50 2021-02-04 loss of consciousness I became extremely ill about 12 hours after vaccination. I slept about (10pm to 6:30 am) 8.5 hours... Read more
I became extremely ill about 12 hours after vaccination. I slept about (10pm to 6:30 am) 8.5 hours, and then I woke for work the next morning. I felt a little off, but I thought I was ok. I entered my shower, and then I was found unconscious on the floor of my shower by my wife about 5 minutes later. I passed out 2 more times while attempting to stand and exit the shower. I was extremely fatigued at this point. I went back to bed and slept until 10 pm that night. I woke for about 2 hours , ate some food and drank some water and soda pop. I then went back to sleep until 7:30 am the next morning. I was awake for 3 hours, and then I slept for 3 more hours. I have been awake for about 2 hours, and I am now typing this adverse event document. The entire time I have had temperature regulation issues, severe headache, muscle and joint aches, and fatigue.
50 2021-02-11 palpitations Had vaccine and had a red spot and sore arm which went away after a couple days. Four days after the... Read more
Had vaccine and had a red spot and sore arm which went away after a couple days. Four days after the vaccine a blood vessel in my hand burst (I don't recall hitting it on anything at all). It puffed up about a centimeter and slowly went away over a few days. Then a little more than a week later the red spot came back and itched very badly and was sore again. It also faded after several days. then yesterday morning I woke up and my arm was sore at the injection site again only I started having the worst headache of my life that lasted 30 hours. I started shaking, sweating massively, I felt hot and cold at the same time, felt as if I had a very high fever but my temperature was 98.4 (totally normal). I was vomiting if I tried to eat or drink. I had severe body aches and EXTREME weakness throughout my body. My heart began to race at 150-160 bpm for several hours and I couldn't sleep. It has gotten about 50% better in the past few hours and will hopefully continue that way. I've never felt anything like it in my life. I need to know if it is safe for me to get the second shot.
50 2021-02-14 heart rate abnormal Unable to feel heart beating in chest, even after heavy exertion. Same thing happened after first do... Read more
Unable to feel heart beating in chest, even after heavy exertion. Same thing happened after first dose, but only lasted 3 weeks. I?m able to visualize my heart rate through an application on my Watch, but do not physically feel tasked, when performing exercises that push my heart rate of over 140 bpm.
50 2021-02-17 blood clot, platelet count decreased, chest pain On January 21, 2021 I started feeling pains in my right shoulder (1st shot was left shoulder) and th... Read more
On January 21, 2021 I started feeling pains in my right shoulder (1st shot was left shoulder) and the following day it had spread across my body, shoulders, chest, arms, legs and calves. I also had a severe headache along with the muscle pains and woke up each day since in a pool of sweat with the sheet soaked to this day. Due to the severe muscle pains, I started taking Tylenol and all the symptoms pointed to the virus itself. I was tested for the virus on Monday, January 25th with negative results on the morning of the 26th. I continued to self-medicate with Advil every four hours to remove the severe muscle pains noted above. To back track slightly, I had a colonoscopy on January 19, 2021 and one large polyp was removed without issue. Due to the full body muscles pains and taking the Advil, it likely caused bleeding from the polyp site of the colonoscopy and went to the ER and they transferred me back the hospital on January 28, 2021, the location of the colonoscopy, and hospital found nothing wrong with the colonoscopy during my 2.5 day stay there. The did an x-ray of my chest to test for the flu and related items and found everything to be clear. They also a CT of my abdomen to look for any abnormalities and found none. Through all this the muscle pains continued when I would move, the muscles would fire up and intense pain persisted until I could calm them down after about 30 mins of intense pain. Hospital also tested me twice for the COVID virus and each turned out negative. Overall, I?ve been tested for the virus nearly 12 times and all were negative. From the visit to Hospital, with the colonoscopy and no additional bleeding occurring, Hospital gave me a steroid called Prednisone to mask the pain on Saturday, January 30, 2021 at about 1pm and by 4pm they fully released me with no idea what was causing the severe muscle pain across my body when I moved. I literally just walked out of the hospital since the steroid masked the muscle pain issue. The steroids worked but I was still walking up in a pool of sweat and very clammy and wet each morning from 1am until I woke up. On February 2, 2021 I had 3 bowel movements that were all dark purple and full of blood clots which led me back to Hospital and the ER could not get in touch with the Hospital Doctors for transfer so they admitted me to the Hospital, thank God. On February 4, 2021 Methodist performed an emergency colonoscopy to clamp the polyp site, took two additional polyps out and did an endoscopy to ensure my upper and lower GI track were clear, and it was and the two additional polyps were benign. Through all this the serve muscle pains persisted and Hospital moved me to a patient room and out of the ER. Over the next several days, February 4 thru the 11th Hospital cleared me of everything they could test for, over 85 different tests were ran based on MyChart. All my blood counts were all over the place, WBC were 19,000, Platelets were nearly 700, my sedimentation rate reached 64+ and the server muscle pains persisted and I was basically incapacitated during my entire stay at Hospital. Hospital had several specialists seem me from Internal Medicine, Infectious Disease, Neurology to Rheumatoid ologist and none of them found anything wrong with me other than my COVID anti-bodies were enormously high with not signs of slowing down. The conclusion by each of the specialist is that my symptoms all point to an Adverse Level 3 Inflammatory Reaction to the first COVID Vaccine shot. The Infectious Disease specialists emphasized that I DO NOT get the second vaccine shot since it would like have killed me. (We had cancelled my 2nd shot, scheduled for February 3, 2021 via Cancer Center the week of January 30, 2021.) Hospital concluded that they could not do anything further for me since all their extensive testing all came up negative other then the COVID antibody levels and started me on the same steroid via IV on February 10, 2021 and on February 11, 2021 I was released from Hospital with a 28-day gradual reduction of the steroid over that timeframe to see if the COVID antibody production would simply stop. They had no other recourse or follow up with for any of the specialists. I?m on my own at this point and scared. To help with the inflammation the only thing my wife and I saw we could do is see a health and well Doctor to try and purge myself of the inflammation and assist my bowel and liver health with trying to rid me of the vaccine and hopefully the antibody production. I?m on a strict diet and taking supplements to assists in the reduction of inflammation and cleaning my system out. Starting today, February 18, 2021 I start stepping back on the steroids prescribed by Hospital and praying that the symptoms and pain simply go away but I?m still having night sweats, weak and shaky.
50 2021-02-18 chest discomfort Started with tightness of chest, (under the lower part of ribcage); sporadic hot flashes and dizzine... Read more
Started with tightness of chest, (under the lower part of ribcage); sporadic hot flashes and dizziness; pulse going up to 95,( when normal is in the 60's). Then sat down an hour later and almost immediately a deep tiredness. got off work early, went home and had no other problems until I attempted to go to sleep. Somewhere around nine o'clock, I started getting muscle cramps so I went to the couch. Shortly after, my right arm, (vaccinated arm) became extremely sore; shortly after, my total body ached; no relief from lying on my left, right, stomach or back; hurt to even sit upright. Then, I started getting cold chills; which alternated with hot flashes and periods of nausea. My mouth went extremely dry, so when I struggled to go use the bathroom, I would wobble my way to the kitchen and want to take a big drink of water, attempted to swallow two tylenol, gagged and started throwing up. Went back to bed and started getting continuous headaches that would move to different places. This happened the rest of the night and most of Thursday when most of the worst symptoms happened. Was able to sleep Thursday night and thought I was feeling better, until I stood up. Today, I was not able to stand longer than one half an hour at any one point; had to lie down and rest while doing any kind of activity. I haven't been able to keep anything down; either vomiting or diarrhea. Have been slowly feeling better with occasional headache.
50 2021-02-26 nosebleed The night following vaccine administration (30 hours post shot), experienced head congestion, foggin... Read more
The night following vaccine administration (30 hours post shot), experienced head congestion, fogginess. (Patient had experienced expected side effects of fatigue and tiredness throughout the day following administration.) Patient took tylenol pm. Approximately 1-2 hours after taking, when patient sat up experienced nose bleed. Nose bled for approximately five minutes. Following putting pressure on nose and cold water, bleeding stopped. No further occurrences of nose bleeding. All other symptoms o fatigue were gone by following morning.
50 2021-02-28 palpitations Within 5 minutes I Became extremely hot. It started from feet up to face, heart palpitations. I co... Read more
Within 5 minutes I Became extremely hot. It started from feet up to face, heart palpitations. I could feel my heart beating in my chest. Uneasy feeling, something was wrong. Dizzy, remained with ice pack and wet towel for 20 minutes. After I left I felt off and dizzy. I had a difficult time driving . That evening I had soreness at injection site for 3 days. Headache and dizziness for 3 days. Chills for 1 day. Back pain and hip pain still to this day.
50 2021-03-02 heart rate decreased C/o dizziness while sitting in monitoring. EMS checked. Client felt hot, dizzy, nausea, increase swe... Read more
C/o dizziness while sitting in monitoring. EMS checked. Client felt hot, dizzy, nausea, increase sweating. Heart monitor showed low pulse rate 30. IV started BS 82. Transported to ER.
50 2021-03-06 nosebleed At 4:30am on Sunday early morning, 3/7/2021, roughly 42 hours after receiving my 2nd dose of the Mod... Read more
At 4:30am on Sunday early morning, 3/7/2021, roughly 42 hours after receiving my 2nd dose of the Moderna COVID-19 vaccine, I was awoken out of sound sleep by a light coughing as something was in my throat. Upon waking, I realized that it was blood that was from a fairly significant bloody nose that I was having. Even though I used facial tissues to deal with the bleed, it took nearly 25 minutes or so to subside as it was quite severe. The situation is/was HIGHLY unusual as I haven't had a bloody nose for at least a decade (or perhaps even 2 decades) and when I earlier did, I was usually able to deal with it and get it to stop within a minute or two. In this case, the bleed was significant, flowing quite heavily, when standing straight up (with blood dripping out of my nose) and even when lying in a prone position, wouldn't stop for 25 minutes. Additionally, in my life, I have never had a bloody nose be the source of being woken out of a sound sleep.
50 2021-03-07 lightheadedness Clammy patient has hx of vaso vagal episodes Vitals: Blood pressure 140/80 HR: 62 O2Sat: 95 Skin sig... Read more
Clammy patient has hx of vaso vagal episodes Vitals: Blood pressure 140/80 HR: 62 O2Sat: 95 Skin signs: warm and dry. Actually clammy warm and dry Circulation: Cap refill <2sec Resp: Breath Sounds Clear Bilaterally Juice given
50 2021-03-08 fast heart rate Dizziness, mild tachycardia, and moderate to severe headache.
50 2021-03-11 fast heart rate Nausea, diarrhea, headache, fever as high as 102, tachycardia, chills, muscle and joint pain
50 2021-03-15 chest discomfort swollen tight sensitive breasts/chest, pain in the middle of the back
50 2021-03-15 loss of consciousness Patient was checked 15 minutes post-vaccination and became unconscious. After one minute, patient wa... Read more
Patient was checked 15 minutes post-vaccination and became unconscious. After one minute, patient was a/o, blood sugar was 119, BP 136/86, RR 18, temp 97.2, Sp02 98%. Patient denied pain. O2 was started at 1.5L. EMS was called and arrived at 1455. Patient declined to go to hospital.
50 2021-03-16 hypotension Pt complained of nausea around 12:14. By 12:38 had hypotension and lightheadedness. Required 2 dos... Read more
Pt complained of nausea around 12:14. By 12:38 had hypotension and lightheadedness. Required 2 doses of epi and IV fluid to raise BP back to normal limits. Taken by 9-1-1 to ED at that time. Never lost consciousness.
50 2021-03-18 heart rate increased Immediately after receiving 1st dose of moderna my arm began to have a burning sensation and become ... Read more
Immediately after receiving 1st dose of moderna my arm began to have a burning sensation and become sore. The burning sensation expanded to my left armpit area over the next few hours and extended to left side of chest. It felt like streaks of burn extending out of armpit area. Approximately 12hrs after receiving the shot (3am) I became extremely nauseated. I alternated between throwing up and diarrhea for the next three hours. During this time i also experienced a fever, chills, sweats, uncontrollable shaking and elevated heart rate. Today (3/19) I am dehydrated, lightheaded and dizzy. fever and chills are gone as well as nausea but heart rate is still elevated.
50 2021-03-19 cardiac arrest UNKNOWN MEDICAL IN THE PARKING LOT AT THE MASS VACCINATION CLINIC. PATIENT WAS FOUND BY A BYSTANDER ... Read more
UNKNOWN MEDICAL IN THE PARKING LOT AT THE MASS VACCINATION CLINIC. PATIENT WAS FOUND BY A BYSTANDER ON THE GROUND AFTER HE RECEIVED HIS SHOT. MEDICAL ON SCENE RESPONDED AND FOUND PATIENT IN CARDIAC ARREST. CPR AND ACTIVATION OF 911 EMERGENCY MEDICAL SERVICES AT 11:59. ON SCENE PATIENT RECEIVED CPR, THEN PLACED ON A LUCAS DEVICE, DEFIBRILLATION X2(VFIB) AND PLACED A KINGS TUBE TO SECURE THE AIRWAY. ROSC ON SCENE, CODE 3 TO CARDIAC CENTER. PATIENT CURRENTLY IN THE ICU AT HOSPITAL.
50 2021-03-21 hypotension, loss of consciousness, pallor diaphoretic Narrative: 3/10/21 50 yr old male received Moderna covid vaccine 0.5ml lot#044A21A exp ... Read more
diaphoretic Narrative: 3/10/21 50 yr old male received Moderna covid vaccine 0.5ml lot#044A21A exp 8/31/21. Within 5 min of receiving vaccine, patient became pale, diaphortic, hypotensive...lost consciousness. Pt has a hx of allergic rhinitis GERD,obese,vit D defi.,chronic leukocytosis,mild emphysema. Pt called prior to arrival, pt was placed in reverse trandeleburg with almost immediate return of consciousness and color. he was given some water and crackers. was observed for 30 minutes in clinic and was cleared and exan by dr to go home. was able to walk to care free of symptoms.
50 2021-03-22 very slow heart rate, fainting dizziness, bradycardia, sweating, fainted & fell. VS taken, observed, juice offered, symptoms resolv... Read more
dizziness, bradycardia, sweating, fainted & fell. VS taken, observed, juice offered, symptoms resolved, pt transfer to ED for abrasion on right side of his forehead
50 2021-03-24 heart rate increased Unexpected high pulse while at rest 180/bpm, sweats, hard mass felt in upper left arm.... occurred ... Read more
Unexpected high pulse while at rest 180/bpm, sweats, hard mass felt in upper left arm.... occurred approx 34 hours after injection... lasted approx 1 hour..... felt normal after full nights rest, but fatigued
50 2021-03-24 palpitations, blood pressure increased No issues day of vaccine. Next day (Monday) started to have racing heartbeat. Tuesday his blood pres... Read more
No issues day of vaccine. Next day (Monday) started to have racing heartbeat. Tuesday his blood pressure shot up (he did not say what it went up to). Wednesday he broke out into a full body itchy rash with large welts.
50 2021-03-24 fainting 1. Right after I got the shot, I got dizzy and felt a little faint but then was fine after that - it... Read more
1. Right after I got the shot, I got dizzy and felt a little faint but then was fine after that - it only lasted a couple of minutes. 2. I had a sore arm for 2 days, but just a dull pain right after the shot. 3. I was fine for the past week but then 8 days after my shot, my arm got a small red rash at the injection site, it was itchy, and a little sore - I got the so called "Covid arm" or "Moderna arm". It came out of nowhere.
50 2021-03-25 hypotension, low blood oxigenation, fainting 50 year old male with history of allergic rhinitis, currently on AIT, presents for follow up. Since ... Read more
50 year old male with history of allergic rhinitis, currently on AIT, presents for follow up. Since last seen he initiated AIT in December 2020 and reports he had tolerated his AIT injections without large local or systemic reactions until yesterday, 16 Mar, when he received his first maintenance dose. Within minutes of receiving his dose he developed shortness of breath, dizziness/altered level of consciousness resulting in collapse, and was noted to be hypoxic. He was treated with IM epinephrine with initial improvement but subsequently again developed shortness of breath, cough and altered level of consciousness. He received his second dose of IM epinephrine and a dose of IM Benadryl with transient improvement, but again developed shortness of breath, cough and altered level of consciousness followed by nausea and vomiting. He was noted to be hypotensive and hypoxic despite these interventions so a third dose of IM epinephrine and IV fluids were administered. He was transferred by ambulance to ER where he was given IV solumedrol, monitored, and admitted to the ICU overnight for observation. He reports fever (Tmax 101 F) last night in the ICU. He endorses he took his Allegra prior to his AIT dose and did not exercise. Of note, on 15 Mar he received his second mRNA COVID19 vaccine.
50 2021-03-25 loss of consciousness Patient was found unresponsive, diaphoretic, but with a pulse. As the clinical supervisor, I checked... Read more
Patient was found unresponsive, diaphoretic, but with a pulse. As the clinical supervisor, I checked his pulse and started to provide a sternal rub. He then started to become responsive. He was able to verbalize who he was and paramedics arrived on the scene. They had him lay on a cot and began to take his blood pressure, pulse, and pulse oximetry. They then checked his blood sugar. Patient was able to sit up and started feeling better.
50 2021-03-26 chest pain, chest discomfort Soreness in arm Tightness/pain in head Pain in chest when taking deep breaths (day 2) General fatigu... Read more
Soreness in arm Tightness/pain in head Pain in chest when taking deep breaths (day 2) General fatigue Diminished appetite Symptoms continued for two days, took a Tylenol at bedtime on day 2. When I woke up on day 3 the symptoms were gone. Symptoms were similar to when I actually had COVID 3 months earlier, but not as numerous, severe, or long lasting.
50 2021-03-27 chest discomfort Fatigue, chest tightness, loss of voice and diarrhea
50 2021-03-28 nosebleed Epistaxis not lasting longer than 5 minutes
50 2021-03-29 body temperature decreased 36 hrs after shot I felt nauseous and dizzy. 20 minutes later I felt hot. 10 minutes later I felt co... Read more
36 hrs after shot I felt nauseous and dizzy. 20 minutes later I felt hot. 10 minutes later I felt cold. Took temperature. It was 65.2 Lasted about 30 minutes. Temp went back to about 90. Then dropped again, but not as bad. Repeated every 30 minutes for about 5 hours. Each episode getting less severe.
50 2021-04-02 chest pain, heart rate increased 2 days after my vaccine, I experiences chest pain, which I would describe as a dull pain in the cent... Read more
2 days after my vaccine, I experiences chest pain, which I would describe as a dull pain in the center of my chest. I thought it was possibly angina. I have no previous history of heart disease. I have had high cholesterol that is managed using Crestor. In addition, my heart would spike throughout the day to as high as 108 bpm, without significant activity. My normal resting heart rate is ~74bpm.
50 2021-04-03 ischaemic stroke Ischemic stroke with aphasia, dysarthria, and right hemiparesis, s/p TPA and thrombectomy with resol... Read more
Ischemic stroke with aphasia, dysarthria, and right hemiparesis, s/p TPA and thrombectomy with resolution of symptoms
50 2021-04-05 atrial fibrillation, heart rate increased 11pm same day as shot. Started having chills, fever (101.6). Tired. Slightly winded. Symptoms laste... Read more
11pm same day as shot. Started having chills, fever (101.6). Tired. Slightly winded. Symptoms lasted until 6PM the next day. fever went back to normal around 4pm next day after shot. * I NEVER had a fever when I had covid. I had an Antibody test completed back in January. It was positive for Antibodies. I had an antibody test back in 2020 BEFORE I had covid. It was negative. A week late after 1st does of vaccine. My heartrate started to increase and had symptoms of Afib again. same symptoms of the Afib and heartrate and breathing, back after I had covid. Exact same feelings and symptoms. The Afib/heart symptoms, stopped last week. I am supposed to get 2nd dose this Thursday, and I am most likely not going to. I don't want the heart rate to increase again. I am having problems making an appointment to ask my doctor. My PCM changed, so it is all confusing and a pain. Its best I just don't it. I had antibodies as of january. I just had the 1st dose last month. I think I am god to go. Not worth the risk for me. I am sick of having covid symptoms, so why force it upon myself again....
50 2021-04-07 pallor At 1314 client receive his first shot of moderna vaccine. At 1319 client complained of feeling faint... Read more
At 1314 client receive his first shot of moderna vaccine. At 1319 client complained of feeling fainting, hot and sweeting. Noted client to be pale and diaphoretic. 1320 BP 60/? HR 46, 02 sat 92% on RA, RR 18, sitting, still diaphoretic. 1324 BP 90/? HR 55, 02 sat 95% on RA lying down. 1329, BP 120/80, HR 55, 02 sat 97% on RA. 1331 HR 60 lying down. 1334 BP 118/88,HR 60, 02 sat 97%on RA lying down. 1335, HR 64, 02 sat 97% on RA. at this time client said he has not eaten all day, worked last night, smooks cigarete and has the same reaction with blood draws. 1339 BP 130/70, HR 62. Client verbalized feeling good and that all symtompts has resolved. No further treatment is needed as standing BP aws 138/70 with no dizziness at this time. Total treatment time was 30min. Client left at 1349. Wife will be driving client home.
50 2021-04-08 blood pressure increased Due to pt's PCN allergy, pt monitored for 30 minutes after receiving the 1st dose of the Covid vacci... Read more
Due to pt's PCN allergy, pt monitored for 30 minutes after receiving the 1st dose of the Covid vaccine. 15 minutes into monitoring, pt developed a throbbing HA and described feeling like his lower extremities had weights tied to them. Pt's BP 140/90. Pt denied any cardiac or neuro. EMS called for further evaluation. While waiting for EMS, pt developed tingling sensation in both hands and had vision changes. Pt transported to hospital upon EMS arrival. Called pt to f/u 4/9. Stated that he was monitored at Hospital ER for several hours. Was given Fioricet for HA and Reglan for stomach. No scans done. Stated that he was feeling much better and was released from the ER the same day. Has a f/u appointment with PCP, on 4/15.
50 2021-04-08 hypertension Chronic Migraine/tension headaches for 9 consecutive day, 3 times daily, hypertension, bp was 173/12... Read more
Chronic Migraine/tension headaches for 9 consecutive day, 3 times daily, hypertension, bp was 173/125, and constipated. Taking large amounts of ibuprofen
50 2021-04-12 chest pain Same day symptoms included Headache, injection site soreness, fatigue and muscle aches and pain thro... Read more
Same day symptoms included Headache, injection site soreness, fatigue and muscle aches and pain through out body. Symptoms lasted 2 days; On 5th day, started feeling nauseous and 8pm started feeling acute abdominal pain with increased intensity. 8:30pm abdominal pain continued with pressure in back and chest. Then wife took me to ER. Exams (CT Scan, bloodwork and vitals) were taken but was all normal. At 2am abdominal pain went away but discomfort in abdominal area continued. I was released at that time. On 7th day had follow up with primary care physician and they reviewed documentation from Hospital and determined that I experienced symptoms from covid vaccine.
50 2021-04-12 palpitations Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, he exper... Read more
Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: difficulty breathing and rapid heart rate. Assessment : Time of assessment 1127. Alert and oriented, Anxious and Unlabored breathing. Patient reported 5-10 minutes after sitting for 15 minute observation, the feeling of his heart beating fast and hard, having SOB. He says he also has a feeling over his legs and arms of feeling "washed out." 1127: BP 139/82, P 77, Sat 100% RA (nurse felt pulse to wrist and it wasn't racing, just beating hard). Patient says his BP is usually not that high. 1129: BP 131/85, P 73 (reports feeling better) 1137: BP 120/85 P 75 (reports this is what his BP is usually running, reports feeling less better, says it's his anxiety kicking in) 1142: BP 121/78 P 72 Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for additional 15 minutes minutes. Discharged home. 1145 ambulatory out.
50 2021-04-12 fainting P.T suffered from a syncope as he was receiving injection. PT states that this is not an uncommon e... Read more
P.T suffered from a syncope as he was receiving injection. PT states that this is not an uncommon event for him when he receives IM injections due to anxiety. PT stated that he began feeling light headed and dizzy just after inection. LOC was less than 30's . Subjects vitals were monitored continuously for 30 minutes. First set of vital were BP- 79/54, HR 45, SPO2 99% on room air. Last set of vitals BP- 112/78, HR 76, SPO2 100 on room air. PT declined transport to a hospital and was advised to follow up with his primary care physician
50 2021-04-12 fast heart rate, chest pain tachycardia, chest pain, shortness of breath, extreme fatigue
50 2021-04-13 chest discomfort Pt. described feeling "bubble in chest." States he has had previous heart attacks in the past. Pt.... Read more
Pt. described feeling "bubble in chest." States he has had previous heart attacks in the past. Pt. sat down for additional 15 min and states he feels better. Pt refused hospital for further evaluation. Pt. D/C 1425
50 2021-04-13 lightheadedness Pt developed dizziness and nearly passed out after injection. BP 100/60, HR 64, SPo2 99%. Symptoms i... Read more
Pt developed dizziness and nearly passed out after injection. BP 100/60, HR 64, SPo2 99%. Symptoms improved without intervention. PT's wife drove him home.
50 2021-04-14 arrhythmia Fever (100-102), chills, pain and stiffness in shoulder, elevated pulse (100-110), arrhythmia, weakn... Read more
Fever (100-102), chills, pain and stiffness in shoulder, elevated pulse (100-110), arrhythmia, weakness, shortness of breath Treated with ibuprofen, acetaminophen, aspirin, electrolytes, multivitamin supplement
50 2021-04-15 deep vein blood clot DVT of right leg post vaccine
50 2021-04-15 pallor, loss of consciousness Patient came in for first Covid shot. After the vaccination, he was instructed to stay for 15 minute... Read more
Patient came in for first Covid shot. After the vaccination, he was instructed to stay for 15 minutes in the "post vaccination" area. He went and sat there and I walked back into the pharmacy to finish the paperwork. I then was alerted by a customer that the patient fell off the chair and hit his head. I ran over to him and by then, he was back in his chair and just realized that he had passed out. While I was with him and talking with him, we paged out for code white. I had instructed one of my techs to call 911 as he was pale and palms were sweaty. I had him walk over to the IMZ area and had him lay on some towels and had his feet propped up on a chair. He was given water and I kept talking with him until EMS arrived. They checked his vitals and were asking standard questions and after about 15-20 mins, he was feeling better and didn't want to go to ER. By then, his coloring was much better and he stated he was feeling a lot better. I asked him if he had a headache and he says that he didn't have a headache and was more embarrassed than anything. He thanked me for my professionalism and care and assured me that he felt back to normal. I called him 2 hours later and he was doing well.
50 2021-04-15 ventricular tachycardia ventricular tachycardia
50 2021-04-17 platelet count decreased, bleeding on surface of brain, cerebral haemorrhage Patient began not feeling well the day following vaccination, with vomiting, diarrhea, and fever. Pa... Read more
Patient began not feeling well the day following vaccination, with vomiting, diarrhea, and fever. Patient became confused today, family called EMS. He was found to have multiple areas of hemorrhage in his brain (SAH) with a critically low platelet count of 24. He is currently in ICU intubated and sedated.
50 2021-04-19 fibrin d dimer increased, pulmonary embolism, fast heart rate CC: patient was watching TV as reported by his mother. started seizing and having difficulty breathi... Read more
CC: patient was watching TV as reported by his mother. started seizing and having difficulty breathing. EMS was called for transport. On arrival to ED, patient was breathing 60-70 BPM, tachy at 135-140 sinus rythym. B/P stable at 140's/90's. his pupils were equal and reactive to light. no response to aggressive sternal rub. slight seizure like activity with arm and leg jerking. Ativan IVP given Patient is on non-rebreather sao2 at 90-100 fluctuating. IV established. he desats to 80-85 on room air. Has frothy sputum from mouth. RSI performed with succs and versed to secure airway and ventilate patient. 7.5 tube placed with one attempt at 27/teeth. verified via direct auscultation and capnography. Tube secured. maintanence medications given to ensure sedation. transfer initiated and airmed launched. Dr. accepted. patient left building at 1940 via airmed. Patients labs (electrolytes WNL) normal wbc. D-dimer at 1500. suspect for PE or flash pulmonary edema although his breathsound are clear bilateral. 18:10 03/27/21. BP: 124/89. MAP: 100. HR: 135. RR: 54. O2 saturation: 94%. Temp: 99.2 F. Pain level now unable to obtain due to patient condition. --20:05 3/27/21 Weight: 81.6 kg estimated
50 2021-04-21 chest pain, pulmonary embolism We have information concerning a member that received the Moderna Vaccine (first dose) on Sunday Apr... Read more
We have information concerning a member that received the Moderna Vaccine (first dose) on Sunday April 11, 2021; Patient denied any side effect immediately following vaccination. However on Sunday April 18, 2021 , patient had complains of shortness of breath, chest pain. At which time presented to the Hospital and was admitted on Sunday April 18, 2021 with a diagnosis of Pulmonary Embolism. Patient remains hospitalized as receiving treatment of blood thinner, and embolectomy procedure.
50 2021-04-21 deep vein blood clot Got his vaccine, that evening he felt as if his face was on fire like a windburn. The next morning ... Read more
Got his vaccine, that evening he felt as if his face was on fire like a windburn. The next morning had an incredible cold chill as soon as air hit him, bone shaking. Then had cold chills/sweating with soaking of his groin area. He can go to sleep with extreme chills and then wake up in a puddle of sweat. He had a headache at first, took Tylenol and it went away. Numbness in his foot like it's falling asleep, left hip hurting, left wrist pain. Today both calves hurt./sore like workout burning pain. Two days ago his father went to have bypass and was at the hospital with him, and walked painfully in but had difficulty hobbling along and was unable to walk back to his truck and had to borrow his dad's cane to be able to walk. Yesterday he was going to cut the grass, knelt down to do something, and when trying to stand up was not able to walk due to the throbbing pain and had to use the cane again. Also having swollen left ankle with discoloration. The calf pain is extreme and throbbing, and the pain when he's not able to walk is in the calf. The ankle has been swollen since Sunday, 4/18/21. He spoke with the ICU nurse in the hospital and he told her about it and she grabbed his ankle and asked if he was sure he didn't have a blood clot. He has not been able to shake the symptoms. The issues with walking are intermittent, some days he can walk fine, the other days he has to use the cane. He still continues with every day hot sweats/cold chills. It's 74 where he is right now and has a sweatshirt on as he is cold. Also the legs hurting, ankle swelling that he ices down at night but the swelling does not go away. Feels like a hard knot in his ankle. He has not sought any treatment for this at this point.
50 2021-04-27 body temperature decreased Generalized muscle soreness, generalized fatigue, low body temperature. Mostly resolved by 24 hr, bu... Read more
Generalized muscle soreness, generalized fatigue, low body temperature. Mostly resolved by 24 hr, but mild muscle weakness and strange sensation in lower body muscles persisted for about a week after.
50 2021-04-27 heart rate increased sitting on couch around 8:30pm and smart watch congratulated him on a good work out. he noticed that... Read more
sitting on couch around 8:30pm and smart watch congratulated him on a good work out. he noticed that his heart rate was up from normal. It indicated that it was around 130 bpm. no other symptoms
50 2021-04-28 hypotension HYPOTENSION (SARASOTA EMS RESPONDED TO PHARMACY); CLAMMY/SOB, EXTREMITY TINGLES; DEATH WITHIN 6-7 HR... Read more
HYPOTENSION (SARASOTA EMS RESPONDED TO PHARMACY); CLAMMY/SOB, EXTREMITY TINGLES; DEATH WITHIN 6-7 HRS
50 2021-04-29 lightheadedness Severe dizziness that presented at 8am on 4/26/21 with sharp intermittent vertigo (like starting to ... Read more
Severe dizziness that presented at 8am on 4/26/21 with sharp intermittent vertigo (like starting to pass out) that subsided quickly approximately 5 times over a 20 minute period. This graduated to constant dizziness and cloudiness and severe shaking while outdoors. Arrived at ER at about 10am and "room spinning" vertigo began shortly after and at about 11am there was about 5 episodes of severe vomiting over about a 2 hour period. Dizziness did not decrease until enough medication was administered to stop the vomiting and allow a dose of Meclizine 25mg PO to be administered and take effect and decrease the dizziness to barely manageable. Left the hospital in this state at about 6PM. Today is 4 days later and dizziness continues as manageable only with Meclizine 25mg every 8 hours.
50 2021-05-01 chest pain On 4/13 Patient underwent aortic root replacement with saphenous vein graft reconstruction of the ri... Read more
On 4/13 Patient underwent aortic root replacement with saphenous vein graft reconstruction of the right coronary artery. He had no prior coronary disease. This operation was done for an enlarging aortic root aneurysm in the setting of Marfan syndrome. The right coronary was anomalous and needed vein extension for reimplantation. He recovered very well and was seen in our clinic on 4/23, with no unusual findings. He had a normal echo, EKG and DVT study performed. On 4/28 he had his first Moderna COVID19 dose. on 5/1, he developed malaise, myalgias, painful lymph nodes, chills, and chest pain. He called my clinic and was instructed to go to the ER, but then felt better and didn't go. He was then found unresponsive later that afternoon and was pronounced dead on arrival of EMS.
50 2021-05-01 chest pain Headache, fever, chest pain, body aches, tiredness, muscle spasms in stomach area.
50 2021-05-02 cerebrovascular accident Stroke
50 2021-05-02 heart rate increased Initially headache followed by mild fever, elevated heart rate(110-130) and diastolic pressure at sl... Read more
Initially headache followed by mild fever, elevated heart rate(110-130) and diastolic pressure at slightest exertion, exhaustion next several days(stayed home next two days into weekend) with any physical activity 3-4 days skin irritations on right arm first now on left arm as well. injection site was hot and felt pressure, then skin irritation that lasted 5-6 days at sight. Tiredness, hot/clammy, skin irritation on both arms and some on front chest slight heart rate elevation still exist at day 12. First shot also in left arm, lot 008B21A tiredness,experienced brief rash underarm area which I believed was heat rash or fiberglass insulation reaction from working in attic at mothers house (Texas freeze repairs). It went away after 5-6 days. Second dose side effects still remain. Taking Tylenol/Ibuprofen to lessen effects and anti-itch cream.
50 2021-05-03 heart attack, chest pain Patient received vaccine on 04/23/21. Four days later developed chest pain. Patient believed this wa... Read more
Patient received vaccine on 04/23/21. Four days later developed chest pain. Patient believed this was related to normal symptoms post vaccination. His pain worsened and patient eventually presented to hospital and found to have inferior infarct, with 100% RCA complicated by VSD and RV failure requiring ECMO support
50 2021-05-04 ischemic chest pain Vertigo , Tinnitus, hearing loss of 10-20 Db?s in my right ear. I feel dizzy daily like I?m sea sick... Read more
Vertigo , Tinnitus, hearing loss of 10-20 Db?s in my right ear. I feel dizzy daily like I?m sea sick. I have ringing in my head 24hrs/ day. Today I visited an ENT & he confirmed hearing loss at every frequency in my right ear. This Friday will be the 4 week mark since my 2nd shot. I have felt terrible for 4 weeks. I have never had any of these issues & before the shot. I have never been on medications. On 4/30/21 I went to ER with a blood pressure of 180/110. That day I had a sharp pain in my heart for 15 min that I have never experienced before. Other joint aches & pains. Hips / back / base of skull
50 2021-05-04 chest pain Significant chest pain. Much difficulty breathing. Most intense for about 4 hours. Soreness when bre... Read more
Significant chest pain. Much difficulty breathing. Most intense for about 4 hours. Soreness when breathing is still persisting, but not as intensely.
50 2021-05-05 atrial fibrillation, fast heart rate, oxygen saturation decreased, fibrin d dimer increased, blood pressure increased Visited ER on 5/3/21 with symptoms of shortness of breath, cough, fatigue, oxygen sats 90-91% on roo... Read more
Visited ER on 5/3/21 with symptoms of shortness of breath, cough, fatigue, oxygen sats 90-91% on room air, tachycardia (HR 114), BP 182/127
50 2021-05-05 heart rate increased Racing mind; accelerated heart rate; outbursts of uncontrollable screaming and anger; trouble stayin... Read more
Racing mind; accelerated heart rate; outbursts of uncontrollable screaming and anger; trouble staying in one place as if I couldn't control my own body movements; severe anxiety with desire to escape. None of these symptoms had been experienced in my past. The events looped in cycles for approximately 5-6 hours. Thought I might be losing my mind. No treatment or medical attention given other than having friends watch over me, and forcing myself to drink plenty of fluids. Outcome: back to normal the next day.
50 2021-05-06 chest discomfort All of the same covid symptoms from when I had the Covid virus in June 2020. I was in the hospital ... Read more
All of the same covid symptoms from when I had the Covid virus in June 2020. I was in the hospital for a bit then. Cold child, all joints ache, headache, can?t breathe, tightness in chest.
50 2021-05-08 palpitations, chest pain, heart attack Dizziness while grocery shopping, next day racing heart beat and minor chest pain, call ambulance th... Read more
Dizziness while grocery shopping, next day racing heart beat and minor chest pain, call ambulance that night. Minor Heart attack. Had cath lab done. No blockage found. Outside of high BP and hormone found in system from heart attack no explainable cause.
50 2021-05-09 heart attack, platelet count decreased Acute ST-elevation myocardial infarction; highly unusual dual artery occlusion including acute prox... Read more
Acute ST-elevation myocardial infarction; highly unusual dual artery occlusion including acute proximal occlusion of the RCA and simultaneous proximal LAD occlusion. At 24 hours later, both arteries re-occluded and required repeat stenting. Patient has critically low platelets and a positive PR4 antibody. Physicians seeing pt feel this is most consistent with vaccine-induced thrombotic thrombocytopenia.
50 2021-05-10 deep vein blood clot pain in rt leg 5 days after vaccine
50 2021-05-10 deep vein blood clot DVT left calf
50 2021-05-10 troponin increased, blood pressure increased, heart attack, chest pain Patient complained of tingling to his hands 15 minutes post-vaccination. Patient had no other s/sx o... Read more
Patient complained of tingling to his hands 15 minutes post-vaccination. Patient had no other s/sx of reaction. Patient observed for another 15 minutes and tingling did not worsen. Patient left observation area and returned to work. Patient returned to observation area around 4:40 p.m. and complained that tingling to hands was still present and he felt tightness in his forearms. Patient is a coach for the children and was outside in the 90+ degree heat during the afternoon. Patient came into observation area to cool down. Patient's blood pressure taken and was elevated, although patient stated that he had HTN. Paramedics called on site to evaluate patient. Patient began to complain of dizziness and was transported to local hospital. On the way to the hospital, the patient developed chest pain and shortness of breath. Patient was diagnosed with a non-STEMI at the hospital and transferred to higher level of care. The patient is currently undergoing observation and tests to determine the cause of the MI. The patient received epinephrine 0.5 ml at the hospital to cover any underlying vaccine reaction.
50 2021-05-11 cardiac arrest Cardiac Arrest, Death
50 2021-05-12 deep vein blood clot Patient developed a DVT 10 days after receiving second dose of Moderna vaccine.
50 2021-05-12 fast heart rate supraventricular tachycardia patient was given adenosine 6mg and 12mg then converted to normal sinus
50 2021-05-18 chest discomfort, troponin increased Information below was sourced from the patient record in the hospital EHR system: Patient presented ... Read more
Information below was sourced from the patient record in the hospital EHR system: Patient presented to ED with PMH of HTN and family history of premature CAD who presented with 2 hours duration of substernal chest discomfort. He had been in his usual state of health prior to this evening. He received the COVID Vaccine on 5/12/21. He went out with his wife for dinner and then upon return, started to have some substernal chest discomfort radiating down his arm. This is associated with some SOB and nausea. No vomiting, no diaphoresis. The pain continued for about 2 hours and then he decided to come to the ED. The EKG was consistent with inferolateral wall MI. States that he has been very active without exertional chest pain or dyspnea. He does have a history of HTN and is currently on lisinopril for this. No known history of hypercholesterolemia. Denies any diabetes. No smoking history. No history of PVD. His mother did have a bypass in her early 60s. At age 37, he did have a catherization following an episode of substernal chest discomfort. The patient states this catherization did not show any abnormalities. Following this, the patient proceeded for PCI stenting with a DES for an occluded OM2 . Patient received Aspirin, Brilinta, Atorvastatin, Metoprolol, and Heparin prior to PCI stenting. Cardiology note confirms acute inferolateral STEMI due to occluded OM@, successfully opened and stented acutely.
50 2021-05-21 chest discomfort Shot area was swollen, pain in right arm- Burning sensation in wrist and up arm. tingling in hands ... Read more
Shot area was swollen, pain in right arm- Burning sensation in wrist and up arm. tingling in hands and feet. Wasn't able to sleep that following night (Wed -Thur). Chest tightness- Slight shortness of breath but not enough to cause me to go to emergency room 5/19 -ongoing . Shot area swelling, burning sensation and tingling stopped the following day (Thurs). Chest tightness, slight shortness of breath is ongoing still today Sat 5/22. I had Chest tightness from first shot that went away after about a week. I just rested 5/19-5/21. somewhat active today 5/22
50 2021-05-22 heart rate increased Elevated heart rate. Started about 12 hours after receiving vaccination and lasting 12+ hours
50 2021-05-22 heart attack Severe swelling and bruising of right arm started on day of injection. Pain and swelling increased f... Read more
Severe swelling and bruising of right arm started on day of injection. Pain and swelling increased following day, Then on Friday evening I had a heartache.
50 2021-05-22 fainting Patient had fainting and blackout post vaccination. Patient has lied on the floor immediately and am... Read more
Patient had fainting and blackout post vaccination. Patient has lied on the floor immediately and ambulance was called. Upon arrival of ambulance it was found patient had low BP 56/36 mm Hg. So, patient was advised to be hospitalised by the ambulance team.
50 2021-05-25 hypotension, loss of consciousness Passed out; Fell from bed; Low systolic blood pressure at 54mmhg; Arm soreness; Felt sick; Diarrhea;... Read more
Passed out; Fell from bed; Low systolic blood pressure at 54mmhg; Arm soreness; Felt sick; Diarrhea; Something was cooking in lung; Productive coughs; Vomiting; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) in a 50-year-old male 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 January 2021. Concurrent medical conditions included Diabetes. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), ILLNESS (Felt sick), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria medically significant and life threatening), FALL (Fell from bed) (seriousness criterion life threatening) and HYPOTENSION (Low systolic blood pressure at 54mmhg) (seriousness criterion life threatening). On 21-Apr-2021, PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea), LUNG DISORDER (Something was cooking in lung), PRODUCTIVE COUGH (Productive coughs), VOMITING (Vomiting) and NAUSEA (Nausea) had resolved, ILLNESS (Felt sick) outcome was unknown. On 22-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell from bed) and HYPOTENSION (Low systolic blood pressure at 54mmhg) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood pressure systolic: 54 mmHg (Low) Low systolic blood pressure at 54mmhg. Physician treated him with fludrocortisone until he felt better for five days.; 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.
50 2021-05-26 palpitations Palpitations occurred right after second moderna vaccine. His EKG was normal. He also reported right... Read more
Palpitations occurred right after second moderna vaccine. His EKG was normal. He also reported right ear tinnitus and left ear hearing exam was abnormal. He will be referred to respective specialists.
50 2021-05-27 blood glucose increased Left upper eye lid swelling Right cheek swelling Developed allergy from Peanuts after for Covid vacc... Read more
Left upper eye lid swelling Right cheek swelling Developed allergy from Peanuts after for Covid vaccine shot - Upper lip swelling stayed over 24 hrs.
50 2021-05-28 oxygen saturation decreased, heart rate increased I had no noticeable issues with my first dose of the Moderna Covid-19 vaccine. I had the following i... Read more
I had no noticeable issues with my first dose of the Moderna Covid-19 vaccine. I had the following issues after my second dose (April 29, 2021): Day 2 (April 30), 28 hours following injection, I experienced an internal feeling of ?jitteriness?, shortness of breath, and accelerated pulse. Pulse oximeter showed my oxygen saturation dropped to 92 percent (my normal is 98-99) and my resting pulse rate increased to 120 bpm (my normal varies from 66 to 75). Aforementioned symptoms subsided after 6 hours. Day 3 (May 1) following injection, local swelling and pain in muscle at site of injection (upper left arm). Arm swelling and pain subsided by Day 7.) Day 4 (May 4), noticed two swollen lymph nodes (size of pea and small marble) near collar bone area of neck (same side as injection). Day 31 (May 29), both lymph node swellings still exists (as of this reporting) though not as prominent.
50 2021-05-29 heart rate increased 4/8/2021 - felt very winded, dizzy and out of breath during physical exertion. Temporary chill dev... Read more
4/8/2021 - felt very winded, dizzy and out of breath during physical exertion. Temporary chill developed. Went away over night. 4/12/2021 - same symptoms during physical exertion. Chills and fever developed shortly after and stayed for 2 weeks ranging from 99.5 to 102. Fever, fatigue, dizziness, headache, sore muscles and joints, rapid heart beat, tingling and burning sensation in hands and feet and increased tinnitus lasted for 3 weeks. Ongoing - sore muscles, joints and tendons, tingling/burning sensation in hands and feet, cold hands and feet, muscle fatigue and tiredness since 4/12/2021 and ongoing today.
50 2021-05-31 heart rate increased Starting on the day of the vaccine (2nd dose), I noticed typical sore arm. At 7pm, had a fever, nau... Read more
Starting on the day of the vaccine (2nd dose), I noticed typical sore arm. At 7pm, had a fever, nausea, ful body pain, and flu-like symptoms. I did take ibuprofen and Benadryl a few hours later around bedtime. I woke up with fatigue, lethargy and Covid fog (decrease mental acuity and lethargic). I had symptoms for 4 days and symptoms started to improve. I noticed my heart rate increased at 120 and would only decrease if I lay down. I went to see a doctor who diagnosed me with POTS (posterial orthostatic tachycardia syndrome). I was prescribed metroprolol 25mg once a day.
50 2021-06-01 chest pain I am a healthy 50 year old male who competes in endurance events including 15 Ironman triathlons and... Read more
I am a healthy 50 year old male who competes in endurance events including 15 Ironman triathlons and many ultra endurance races. I was diagnosed with acute Pericarditis 8 years ago, after 4 days in the hospital and a couple of weeks of rest at home all of my symptoms had subsided and I have had no reoccurrence of this condition since. Approximately one week after receiving my second dose of the Covid 19 Moderna vaccine I began to experience chest pain. 8 days post vaccination the chest pain was radiating into my Left shoulder and arm, I had significant pain on breathing and was extremely uncomfortable lying on my back and could not lie on my left side due to pain. I went to the ER on the evening of May 6th, they performed a chest x-ray, 2 EKG's as well as 2 separate blood work panels. While I did relate my history of having pericarditis and that this pain was very similar to what I had felt before, they, of course, were more concerned on if I was having a coronary event. The EKG and blood work showed I was not so I was simply sent home with a "we don't know why your chest hurts but your are not having a heart attack." After a follow up to a cardiologists almost 2 weeks later it was determined that it was more than likely a flare up of pericarditis but that it had subsided by that time.
50 2021-06-02 heart rate increased, blood pressure increased Approximately 30 hours after 1st Moderna shot, I began to have elevated Blood Pressure and rapid pul... Read more
Approximately 30 hours after 1st Moderna shot, I began to have elevated Blood Pressure and rapid pulse. Day over day, I developed extreme abdominal bloating and elevated blood pressure and rapid pulse. Symptoms have continued for 14 days post shot. Treatment with 4,000mg Simethicone daily to treat bloating. When bloating is reduced - Blood Pressure and Pulse are significantly lowered. Had appointment with PCP on day 13 - currently stopping Metformin - extreme bloating is reducing. Have previously experienced similar (but milder) side effects of extreme abdominal bloating twice (when starting Metformin), but did not have elevated BP or Pulse.
50 2021-06-02 inflammation of the heart muscle, heart attack, chest discomfort Tightness in chest. Shortness of breath. Sore jaw. Pain in left arm. Called 911 and paramedic too... Read more
Tightness in chest. Shortness of breath. Sore jaw. Pain in left arm. Called 911 and paramedic took EKG and informed me I was having a heart attack on the way to the hospital. Once at the hospital they measured my TnT-Gen5 and the baseline was 2658 ng/L with another test taken an hour later showing 2873 ng/L which led to additional tests listed in box 19. Final diagnosis was perimyocarditis and I received a prescription of Colchicine 0.6 MG to be taken twice a day for 6 weeks and then follow up with a cardiologist.
50 2021-06-05 fibrin d dimer increased, pulmonary embolism New onset PE treatment: started on Eliquis 5 mg BID outcome: discharged home after treatment of COVI... Read more
New onset PE treatment: started on Eliquis 5 mg BID outcome: discharged home after treatment of COVID as well
50 2021-06-07 palpitations, chest pain, heart rate irregular Beginning on the 4th day after my second vaccination I had shortness of breath, palpatations, irregu... Read more
Beginning on the 4th day after my second vaccination I had shortness of breath, palpatations, irregular heart beat, hard time walking from chest pain
50 2021-06-07 palpitations The day of my vaccine I started have the same symptoms as I did when I had Covid. I had fever chills... Read more
The day of my vaccine I started have the same symptoms as I did when I had Covid. I had fever chills and a headache. I had the symptoms for about 36 hours and they started decreasing .My heart was palpitating.
50 2021-06-08 cerebrovascular accident temporal stroke presented with left visual field cuts in an otherwise pretty healthy 50 year old wit... Read more
temporal stroke presented with left visual field cuts in an otherwise pretty healthy 50 year old without known vascular or cardiac disease.
50 2021-06-10 chest pain, chest discomfort One week after 2nd dose noticed left ankle and calf area swollen much larger than right ankle. Slig... Read more
One week after 2nd dose noticed left ankle and calf area swollen much larger than right ankle. Slight pain and tightness in left upper chest, upper back, and into left arm occurring often. Symptoms have persisted for over a month. Was checked for a blood clot in left leg but results were negative. Seeing my doctor for additional tests, probably an echo next. Symptoms have persisted daily since about one week after the 2nd dose. Concerned symptoms are consistent with myocarditis.
50 2021-06-14 blood glucose increased, haemoglobin decreased SOUGHT CARE AT ER WITH C/O VOMITING, NOT BEING ABLE TO WALK, CHILLS, FEVER, COUGH, CONGESTION. NEGAT... Read more
SOUGHT CARE AT ER WITH C/O VOMITING, NOT BEING ABLE TO WALK, CHILLS, FEVER, COUGH, CONGESTION. NEGATIVE FOR COVID-19. ADMITTED FOR IV ANTIBIOTICS AND SUPPORTIVE OXYGEN THERAPY. DISCHARGED 2 DAYS LATER. TREATED WITH ZITHROMAX IV, ROCEPHIN IV, O2, ACETAMINOPHEN, HIGH-FLOW NEBULIZERS
50 2021-06-14 loss of consciousness, chest discomfort Around 6:30 p.m. my skin started to burn all over my face begin to swell shortly after that my tongu... Read more
Around 6:30 p.m. my skin started to burn all over my face begin to swell shortly after that my tongue and throat begin to swell I feel pressure on my chest I can barely breathe when I was put into the ambulance I passed out when I woke back up the symptoms seems to have gotten worse the EMT called in a head to the hospital and ask what to do she was told to give me an EpiPen as we got closer to the hospital I begin to shake and tremble uncontrollably that lasted for at least another 30 40 minutes after being admitted to the emergency room my diagnosis was anaphylaxis.
50 2021-06-14 loss of consciousness I had severe weakness, joint pain, and body aches. I could barely get myself out of bed or get up to... Read more
I had severe weakness, joint pain, and body aches. I could barely get myself out of bed or get up to go to the bathroom. The symptoms were reminiscent of having pneumonia. I went to the doctor that following Monday. I continued to use Tylenol. Last month, I've been having cognitive issues and I was blacking out. I went to the hospital and it was discovered that I had an aneurysm. I was hospitalized for 3 days. I am actually going to see a neurologist tomorrow.
50 2021-06-14 palpitations, heart flutter Had a light fluttering; Heart palpitations, flet like he had butterfiles in his chest; This spontane... Read more
Had a light fluttering; Heart palpitations, flet like he had butterfiles in his chest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Had a light fluttering) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Palpitations. Concomitant products included GABAPENTIN, MIRTAZAPINE, CLONAZEPAM and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Had a light fluttering) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations, flet like he had butterfiles in his chest). At the time of the report, CARDIAC FLUTTER (Had a light fluttering) and PALPITATIONS (Heart palpitations, flet like he had butterfiles in his chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the 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; 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
50 2021-06-25 chest pain, palpitations About a week after the second shot I experienced some minor chest pain that would go away some if ... Read more
About a week after the second shot I experienced some minor chest pain that would go away some if I stretched and some heart palpitations that I had never experienced before - for about 3 weeks. The heart palpitations were frightening to me. Reaction to second Moderna shot was quite intense for 2-3 days with chills and fever near 101F - have not had a fever that high in 30 years since I was a kid/teenager (for me it was a high fever). Was wearing a winter jacket while working and it was 70F. EKG was normal when I could get one (mid June) and the conditions seems to have have mostly cleared. Quite strange how it aligned a week after the shot and the fever. I felt this should be made available for metadata review, esp after later hearing of reports in younger males of heart issues the past month. I have routinely gotten flu shots/etc and never had any kind of reaction like this.
50 2021-06-29 heart rate irregular, heart rate increased Rapid heart beat. Heart feeling like it is beating harder than it should.
50 2021-06-29 hypertension, heart rate increased High Fever (102 F), fast heart beat, high blood pressure, body ache including shoulder and right ind... Read more
High Fever (102 F), fast heart beat, high blood pressure, body ache including shoulder and right index finger. Most of the adverse effects were off after taken Ibuprofen twice a day, but the shoulder pain and right index finger pain remains for 3 months and still going on...
50 2021-06-29 blood clot Developed blood clots in left calf leg
50 2021-07-01 blood pressure fluctuation, chest pain 05:02 through 06.30: ? Shortness of breath ? Fluctuating blood pressure. ? Severe chest pain. ? Pain... Read more
05:02 through 06.30: ? Shortness of breath ? Fluctuating blood pressure. ? Severe chest pain. ? Pain in joints. ? Muscle pain. ? Petechiae ? Purpura ? Diziness ? Headaches ? Asthamtic-like phlegm ? Nerve pain in hands ? Numbness in hands
50 2021-07-01 blood clot Blood clot left leg.
50 2021-07-04 heart attack, heart attack Acute MI (Heart Attack) - treatment at Hospital- underwent Cardiac Catheterization and had stent pla... Read more
Acute MI (Heart Attack) - treatment at Hospital- underwent Cardiac Catheterization and had stent placement in LAD, medications prescribed as further treatment, currently living
50 2021-07-05 chest pain Patient called us on 7-6-21 and stated he was experiencing pain in his chest and abdomen for severa... Read more
Patient called us on 7-6-21 and stated he was experiencing pain in his chest and abdomen for several days. He was referred to see his primary care physician. His PCP sent in a prescription for him a few hours after our discussion.
50 2021-07-08 heart attack, chest discomfort "The second shot of Moderna in AM -2 days later had a Non- STEMI- Chest pressure in middle of night ... Read more
"The second shot of Moderna in AM -2 days later had a Non- STEMI- Chest pressure in middle of night around midnight in 24 hours post Second Moderna vaccine Son took him to ER. 5/5- got the second Moderna . 5/6 around Midnight had chest pressure that woke him up - he also had chest pressure .
50 2021-07-08 inflammation of the heart muscle Within an hour of the test, I became extremely ill - chills, 102+ fever, headache, cough, asthma pro... Read more
Within an hour of the test, I became extremely ill - chills, 102+ fever, headache, cough, asthma problems, and loss of appetite/stomach problems. This lasted 5 days and on the 4th, i was hospitalized with myocarditis.
50 2021-07-08 palpitations, chest pain March 18th 2021 he noticed that when he was sitting his lower left leg felt like it was falling asle... Read more
March 18th 2021 he noticed that when he was sitting his lower left leg felt like it was falling asleep; kept happening over a couple of days. On March 24th, 2021 he reports a throbbing in his left thumb that came and went on throughout the day. On March 26th, 2021 he reports having chest pain. He states that when he laid down the chest pain would go away; did not go seek treatment that day. On March 27th 2021 he got his blood drawn and urine sample at the Hospital; results were normal. On March 30th he saw PCP and had EKG; results were normal. April 1st, 2021 had a stress test with normal results. On April 5th, 2021 he went and had ultrasound on left leg and chest x-ray; leg ultrasound showed complex cyst behind left knee and chest x-ray showed heart as normal size with no fluid around heart. Chest pain still continued. On April 21st, 2021 had "heart hiccup" he was working on the computer and felt like his heart stopped and started beating again and then had a headache for a few seconds. On April 22, 2021 reports that he was feeling "mostly better." He reports feeling "gassy" when he has the heart pain/pressure. Reports that when he is moving he feels better. On April 23, 2021 he is walking around Meijer and felt lightheaded and like he could throw up; went home and BP was 155/100 with chest pain and difficulty breathing. He then went to the ER; ran blood tests (normal), leg ultrasound repeat (complex cyst) , chest CT (normal). ER doctor recommended that he see a gastro dr. April 26, 2021 had virtual visit with PCP and he suggested that he take Motrin for the chest pain. Reports that he felt like he was having a "charley horse" in his neck. Leg sleepiness lasted a month and went away. Thumb throbbing lasted a couple weeks and went away. On April 30, 2021 reports bad chest pressure. Chest pain was not consistent, "the pain changes." Would hurt in different locations over his heart and collar bone. May 10, 2021 reports "strange breathing." States that the chest pain and gassy feeling is constant. June 8, 2021 saw gastroenterologist. and was scheduled for an endoscopy. Endoscopy was completed on July 1, 2021; results were normal.
50 2021-07-11 heart rate abnormal abnormally high resting heart rate (102-119beats per minute)
50 2021-07-12 chest pain On June 21, at approximately 8:30 a.m., my husband started with chest pain going thru to his back, h... Read more
On June 21, at approximately 8:30 a.m., my husband started with chest pain going thru to his back, he could not take the pain, saying that he felt very bad, which we had to take him to the nearest hospital to the emergency room. On the way he vomited, having sweats and arriving at the hospital he said that he could not walk, I brought him a wheelchair and he went into the hospital telling me that one foot felt cramp and numb that he could not move it, after the doctors checked him and two hours later he told me that he no longer feel both legs. Since that day he could not move from his stomach down to the tips of his feet, And after a few days and several tests they could not find any reason why he had paralysis, the doctor said that it was a syndrome called Guillen Barré and to date he is still hospitalized without being able to move his feet and waiting for help to receive therapy since we do not have the monetary resources for these services.
50 2021-07-12 heart rate increased Light headed, dizziness. Pain in back of head. Sore throat & difficulty swallowing Numbness in e... Read more
Light headed, dizziness. Pain in back of head. Sore throat & difficulty swallowing Numbness in elbow and wrist. Severe pain in neck, back the upper arm or shoulder Prickling, pins and needles sensations in fingers, toes, ankles, wrists, knees, elbows , joints. Weakness in legs, arms Unsteady walking or standing, balance issues. Double vision, difficulty focusing, heavy eyelids closing randomly Severe pain, achy, shooting or cramps , spasms Difficulty with bladder control Rapid heart rate Difficulty breathing ,weakness, limpness in the muscles of the arm and shoulder Lack of muscle control in the hands, arms Lack of sensation or feeling in hands, feet, legs
50 2021-07-12 platelet count decreased platelet count decreased to 30K on 6/21/21, then 7/9/21 15K, 7/12/21 20K, 7/13/21 21K started on d... Read more
platelet count decreased to 30K on 6/21/21, then 7/9/21 15K, 7/12/21 20K, 7/13/21 21K started on dexamethasone on 7/21
50 2021-07-17 fainting Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
50 2021-07-22 pulmonary embolism, deep vein blood clot acute nephrotic syndrome treating with high dose steroids symptoms included global edema/anasarca c... Read more
acute nephrotic syndrome treating with high dose steroids symptoms included global edema/anasarca complications include pulmonary embolus and DVT
50 2021-07-28 troponin increased, chest pain Patient presented to the ED and was subsequently hospitalized for chest pain, elevated troponin, S/P... Read more
Patient presented to the ED and was subsequently hospitalized for chest pain, elevated troponin, S/P aortic aneurysm repair within 6 weeks of receiving COVID vaccination.
51 2021-01-06 blood pressure decreased, heart rate increased, palpitations 25min after. Rapid heart rate, drop in blood pressure ER visit 1 Day 1-3headache, neck ache Day 4 h... Read more
25min after. Rapid heart rate, drop in blood pressure ER visit 1 Day 1-3headache, neck ache Day 4 heart palpitations/dizziness ER visit 2 Day 5 Heart palpitations/dizziness ER visit 3 Day 6 mild heart palpitations, bone aches in left ankle Day 7 general weakness, aching joints, tired all week, ankle still aches
51 2021-01-06 palpitations, heart rate increased I experienced insidous onset of rapid heart rate with palpitations after approximately 2-3 minutes o... Read more
I experienced insidous onset of rapid heart rate with palpitations after approximately 2-3 minutes of inoculation. This episode lasted about 1-2 minutes. I was not expecting this having no prior history of adverse response to vaccines. I also felt a flushing sensation in my head. My breathing felt slightly more difficult. No sweating, throat closure or itching. I did not measure pulse and instead tried to breathe/meditate to bring it down. I estimate it was about 140 bpm . Breathing/meditation brought it down but it was still elevated when the nurse checked me after 20 minutes. I remained onsite an additional 15 minutes until I felt well enough to leave but my heart rate was still somewhat elevated, about 20 bpm higher than my usual. My heart rate seemed to fluctuate throughout the evening and my sleep was subsequently very poor. I feel much better this morning, just the usual arm soreness after a vaccination. I have reached out to my primary doctor concerning whether she feels this event would warrant my not getting the second dose or perhaps having a prescribed epipen on my person. Having no personal history but a family history of severe heart disease (father had first MI at age 42, second at 44 followed by triple bypass and CHF) this incident with my heart rate certainly raised some anxiety. I had a routine EKG done in June which was normal, I am a physical therapist and in good health. I am hoping to have the next vaccine in a proper medical facility. I have read CDC recommendations to not have the second shot if certain adverse responses are experienced and I am not certain whether this would qualify. I have no history of adverse reactions to vaccines. Considering the role of anxiety versus the insidious and nearly immediate onset of rapid heart rate with palpitations and persistent elevated heart rate for more than 12 hours, I feel this event was primarily driven by the vaccine.
51 2021-01-07 palpitations, fast heart rate, hypertension Agitation, Palpitations, HYPERtension, Tachycardia, Anxiety, clammy skin, nervousness Narrative: ... Read more
Agitation, Palpitations, HYPERtension, Tachycardia, Anxiety, clammy skin, nervousness Narrative: Employee with history of severe anxiety, panic attacks. States this is same symptoms as panic attack.
51 2021-01-10 hypotension, chest pain Numbness in right side of head and right arm (where he received injection). Starting getting confuse... Read more
Numbness in right side of head and right arm (where he received injection). Starting getting confused. Legs started to give out. Continued working. Symptoms got worse. On and off paralysis of legs. Eyes flickered and darted. When he sat down at 1am, he took two nitroglycerin for chest pain. He asked a nurse to take his blood pressure. It was low. He felt he was losing control. He was struggling for breath. Eyes were tearing up real bad and tremors started. He stated he fought to stay conscious. Was started on oxygen. Was assisted in a wheelchair and taken to ER. Waited there for 4 hours. Was delusional. I left without being seen by a doctor after blood work and EKG. Went to sleep and woke up in river of sweat. Went to urgent care at that time. Was given a COVID test and it was negative. Was prescribed zinc and vitamins. He had the same symptoms like he did when he originally got COVID. Today at 9:36am, have fever off and on. Continues to feel pretty bad. Still dizzy.
51 2021-01-13 heart attack, blood pressure fluctuation, heart rate increased, fast heart rate, palpitations Right after the vaccine I just had a slight head ache. I had pretty typical symptoms. Around 8pm my ... Read more
Right after the vaccine I just had a slight head ache. I had pretty typical symptoms. Around 8pm my arm got to 8/10 pain. I have waves of Tachycardia and nausea. I had pretty bad diarrhea the first day and second day, this was also a side effect from the Celexa. The Tachycardia was going up to 130-140 . Very much flu like symptoms, heart pounding, head pounding and very light headed. I was having trouble controlling BP when I stood up. I felt feverish, I kept checking my temp but it was normal. This went on for two day, I wasn't able to eat or drink liquids. I ended up going and getting a Covid test on Tuesday morning, I was feeling somewhat ok. Then in the evening all my same symptoms came back. I spoke with a Dr. who informed me I was probably dehydrated. I almost went into the Emergency Room because my high heart rate and thought I was having a heart attack. I didn't due to high volume of Covid in the ER. I have a follow up meeting with my PA before my second dose to come up with a strategy. The left side of my face started to get numb and the left side of neck. My neck started to get still and went to my jaw.
51 2021-01-13 pallor 10:00 - Patient still at shot table. States he felt lightheaded. Color pale. Encouraged to deep brea... Read more
10:00 - Patient still at shot table. States he felt lightheaded. Color pale. Encouraged to deep breathe, mask removed. States he feels like he is going to pass out. RN (clinic manager) at patient's side. Two additional nurses at patient's side. 10:12- Patient did not lose consciousness. Was able to stand with assist and moved to w/c. Patient taken to private observation accompanied per nursing and EMT. Pt. taken outside for fresh air. HR 130 strong and regular. Unable to obtain BP due morbid obesity. RN recommended to patient to receive second dose of Moderna in a private clinic to be closely monitored and supine. 10:17 - Patient recovered. Declined ambulance. Patient stood, no lightheadedness/vertigo. Patient chose to ambulate to private vehicle, accompanied by wife.
51 2021-01-14 low blood oxigenation 51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic arou... Read more
51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at medical center.
51 2021-01-24 hypertension, chest discomfort, heart rate increased On Friday, I had the second vaccine covid 19, at 9;00 am at the left shoulder and after 12hours at 1... Read more
On Friday, I had the second vaccine covid 19, at 9;00 am at the left shoulder and after 12hours at 10:00 I started to feel the symptoms was light fever ,chills, headaches, body aches. Symptoms that was high concern: shortness of breath, vision discomfort due to the light, high blood pressure, extremities(hand and feet) swelling accelerated pulse ,chest pressure. This lasted on an off proximally 3 to 4 hours. Saturday afternoon at 3pm once again heart rate went up and pulse lasted 1 hour .The entire Saturday was feel the primary symptoms with chest pain . Today Monday I woke up with pain at the left clavicle bone and found a lump that hurts and radiates to the chest and increasing in size .
51 2021-01-24 lightheadedness, blood pressure decreased, fast heart rate severe: chills, ague, fever, organ pain, migraines, random systemic muscle tremors, fatigue, tachyca... Read more
severe: chills, ague, fever, organ pain, migraines, random systemic muscle tremors, fatigue, tachycardia, sudden loss of blood pressure, near syncopy.
51 2021-01-31 chest pain, chest discomfort chest tightness, shortness of breath and chest pain.All this symptoms occur during physical activi... Read more
chest tightness, shortness of breath and chest pain.All this symptoms occur during physical activity.
51 2021-01-31 oxygen saturation decreased Became immediately hot, within 2 hours I was having issues breathing, blood pressure of 202/170. Pu... Read more
Became immediately hot, within 2 hours I was having issues breathing, blood pressure of 202/170. Put on oxygen as my O2 dropped to 90%, Irregular EKG, blood work taken.
51 2021-02-01 low blood oxigenation Fever. Hypoxia. SOB. Hospital admission diagnoses: Aspiration, right lower lobe pneumonia, hypon... Read more
Fever. Hypoxia. SOB. Hospital admission diagnoses: Aspiration, right lower lobe pneumonia, hyponatremia.
51 2021-02-03 chest discomfort Shortness of breath: First noted about 18 hours after the dose, along with body aches, headaches an... Read more
Shortness of breath: First noted about 18 hours after the dose, along with body aches, headaches and fatigue. The latter symptoms resolved after 48 hours, however, the shortness of breath has not resolved as of today (77 hours after the dose). No crackles or wheezes but inhalation and exhalation feels restricted. I had Covid-19 with symptoms beginning on 11/16/2020 and had shortness of breath along with crackles and chest tightness during the second week of illness. The oxygen level declined to 92-93%. I was treated with steroids and azithromycin at that time and the tightness of the chest resolved by about day 17 of illness. I am reporting this adverse effect (chest tightness and shortness of breath) because it may be an autoimmune reaction triggered by the response to the vaccine.
51 2021-02-05 chest pain 1650 patient reports symptoms: lightheadedness, blurry vision, dry and thick throat, thickened tongu... Read more
1650 patient reports symptoms: lightheadedness, blurry vision, dry and thick throat, thickened tongue, left arm weakness and numbness in left hand. 1705 Center chest pain, chin and throat numbness. Twitching in corner of right mouth. Unable to puff out right cheek
51 2021-02-09 loss of consciousness Patient's wife reported shaking for a few seconds and passed out. Patient reports lightheadedness. E... Read more
Patient's wife reported shaking for a few seconds and passed out. Patient reports lightheadedness. EMS performed EKG, HR = 40s to 60s; blood pressure = 99/58. Refused transport to ambulance
51 2021-02-16 cerebrovascular accident For two days after receiving the first vaccination for Covid-19 I ran a temperature of 101.9 and was... Read more
For two days after receiving the first vaccination for Covid-19 I ran a temperature of 101.9 and was not able to go to work. When I returned to work on Friday February 12, 2021 at approximately 8:40am I had a stroke and was rushed by ambulance to the hospital.
51 2021-02-18 low blood oxigenation, hypertension, fibrin d dimer increased, fast heart rate Pneumonia, hypoxemia, Dyspnea, Tachycardia,SIRS, increased lactic acid level, dehydration,fever, HTN... Read more
Pneumonia, hypoxemia, Dyspnea, Tachycardia,SIRS, increased lactic acid level, dehydration,fever, HTN, hypomagnesemia
51 2021-02-20 blood pressure fluctuation, heart rate increased Resting heart rate above 100 and fluctuating blood pressure
51 2021-02-23 hypotension, loss of consciousness Nausea, chills, sweating, loss of consciousness and low blood pressure
51 2021-02-25 fainting 24 hours of flu like symptoms and headache Then fainted and suffered a skull fracture and subdues h... Read more
24 hours of flu like symptoms and headache Then fainted and suffered a skull fracture and subdues hematoma and frontal lobe edema
51 2021-02-28 chest pain Pt. reported back to the HD front window after waiting 15 minutes post vaccination and leaving the H... Read more
Pt. reported back to the HD front window after waiting 15 minutes post vaccination and leaving the HD. He reported that after he was finished with his 15 waiting period he was about to leave and he had a stinging sensation in the middle of his chest. Pt. denies any shortness of breath or any other symptoms. Pt. BP was taken at 10:09 and was 144/88 and again 5 minutes later and it was 137/ 85. Pulse was regular at 61 BPM. Pt. wife came to HD and stayed with husband while he was observed for another 20 minutes. Pt. reported that stinging pain was gone but he was just worried because he had never had a pain like that before. Denies any problems with first Moderna Covid-19 Vaccine EUA. Pt. was advised to contact primary care provider for further evaluation and follow up for his stinging chest pains. Pt left health deparment with wife unassisted and no distress on 03/01/2021 at 10:25 AM.
51 2021-02-28 hypotension After almost 30 hours, after the second injection, And with only a soar arm, I began to experience l... Read more
After almost 30 hours, after the second injection, And with only a soar arm, I began to experience low blood pressure. Over the course of the next 6 hours, my blood pressure plummeted to 82/63. I countered this by intaking large amounts of salt, and ultimately took my Diltiazem and some Tylenol PM. Around 3 am my blood pressure returned to normal and currently holding steady at 118/83, I am monitoring it throughout the day, but it seems stable.
51 2021-03-01 palpitations, blood pressure increased Nightime heart palpitations, Hollow feeling in the diaphragm(difficulty to get deep breaths), blood ... Read more
Nightime heart palpitations, Hollow feeling in the diaphragm(difficulty to get deep breaths), blood pressure spike. Effects lasted about 2 weeks.
51 2021-03-01 low platelet count, lightheadedness fever to 104, thrombocytopenia. Started 2/28/21. had leukocytosis, near syncope and high recurrent f... Read more
fever to 104, thrombocytopenia. Started 2/28/21. had leukocytosis, near syncope and high recurrent fever with all cultures negative. Is improving as of 3/2/21.
51 2021-03-03 bleeding on surface of brain Headache and nausea starting 5:30am 15 Jan with exertion. Same symptoms on 16 Jan, 17, and 21 Jan wi... Read more
Headache and nausea starting 5:30am 15 Jan with exertion. Same symptoms on 16 Jan, 17, and 21 Jan with sexual activity. BP started to be in 150-160/110 range (used home BP cuff) on 19 Jan. No neurological deficits. Presented to ER on 21 Jan with c/o headache an d nausea. BP was 160+/110+. CT scan showed SAH. Transferred to hospital for eval. Was in neurosciences ICU x 1 night and neuro ward x 2 nights. Discharged on 24 Jan. DSA and MRA showed no AVM or aneurysm. LP showed no inflammatory or infectious process. CBC WNL. PT/PTT WNL. Lipids showed hyperlipidemia. Working diagnosis is Reversible Cerebral Vasoconstriction Syndrome.
51 2021-03-04 excessive bleeding Vaccine administered on 01/20/2021 followed by erythema followed by cracking of the skin with bleedi... Read more
Vaccine administered on 01/20/2021 followed by erythema followed by cracking of the skin with bleeding of the palm to the hands and fingers occurring during the next few days following administration of the 2nd dose. These were improved significantly with prednisone taper of 60-40-20 with 5 day dosing. Patient was also placed on betamethasone cream. During prednisone treatment patient had resolution of symptoms, but following discontinuation patient's symptoms have returned to a lesser extent.
51 2021-03-07 low platelet count Initial vaccination January 11, 2021 mild injection site soreness. Second dose vaccine 02/12/2021. ... Read more
Initial vaccination January 11, 2021 mild injection site soreness. Second dose vaccine 02/12/2021. Patient developed myalgias lasting for 1 day. 02/16/2021 patient developed fever chills and body aches. Temperature upwards of 104. Darkening of the urine. Symptoms persistent.
51 2021-03-08 hypotension, oxygen saturation decreased, heart rate decreased Received 2nd Covid shot @ 9:45 a.m. at 10:45 pm. was dizzy, body aches, fever had low blood pressure... Read more
Received 2nd Covid shot @ 9:45 a.m. at 10:45 pm. was dizzy, body aches, fever had low blood pressure, low pulse, low oxygen, cold sweats
51 2021-03-09 chest discomfort Fever of 102.4, treated with ibuprofen and acetaminophen since vaccination. Started on 3/6 Bone, jo... Read more
Fever of 102.4, treated with ibuprofen and acetaminophen since vaccination. Started on 3/6 Bone, joint, and muscle pain. Started on 3/6 Sore throat, swollen lymph nodes in neck, ear ache (left). Started on 3/7 Cough and chest pressure, breathing difficulty. Started on 3/7
51 2021-03-10 blood glucose increased, haemoglobin decreased 51 y.o. male from Facility. The patient was seen at his primary care physician's office for some le... Read more
51 y.o. male from Facility. The patient was seen at his primary care physician's office for some left facial swelling. Apparently, he started getting more short of breath while he was there. He was sent in by EMS. His sats were initially in the upper 80s at his primary care physician's office. He denies any symptoms of URI, but does state he has a long history of COPD. The patient was given some DuoNebs and supplemental oxygen in the emergency room and shortness of breath basically resolved. However, he did have very significant left facial swelling. His CT did show facial cellulitis with possible abscess, but no fluid collection. His white blood cell count was almost 25. He had been having fevers at home. Because of all this the decision was made to admit for IV antibiotics. When I saw the patient, he was willing to stay for IV antibiotics for a few days. 3/11/21 remains hospitalized
51 2021-03-11 palpitations Immediate face redness and swelling. Later in evening no sleep and heart racing, next day no energy... Read more
Immediate face redness and swelling. Later in evening no sleep and heart racing, next day no energy and body soreness. Day 2 heart racing at night and no sleep. Day 3 I was able to sleep through the night.
51 2021-03-14 heart attack Severe Allergic reaction; Heart attack; Neurological issues was unable to think straight; Extreme in... Read more
Severe Allergic reaction; Heart attack; Neurological issues was unable to think straight; Extreme inflammatory response; A spontaneous report was received from a consumer and physician concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight. The patient's medical history was not reported by the reporter. Concomitant medication was not reported. On 22 Jan 2021, 15 minutes prior to the onset of the event, the patient received first of the two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route at right arm for prophylaxis of COVID-19 infection. On 22 Jan 2021, 15 minutes after the vaccination, patient had a severe allergic reaction. Patient had extreme inflammatory response, heart attack, neurological issues was unable to think straight, urinator catheter placed in on sight as fluid build and kept coming out, pulled out 1500ml. Patient was hospitalized 22 Jan 2021 through 24 Jan 2021. Laboratory information at the time of event was not provided. Treatment activities for event was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight 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.
51 2021-03-15 chest discomfort About 15 minutes after my shot, I began to experience symptoms of an allergic reaction, similar to w... Read more
About 15 minutes after my shot, I began to experience symptoms of an allergic reaction, similar to when I accidentally eat tree nuts. There was a tightness in my chest and a tingling of my lips. I brought this to the pharamacists' attention, and they gave me Benadryl and had me wait at the pharmacy, after making me promise to let them know if things got worse. In the next 15 minutes or so, I experienced additional allergic reaction symptoms, including swelling of the tongue and an itchy rash (although these were relatively minor). About an hour after I got the shot, I felt well enough to drive hom.
51 2021-03-16 loss of consciousness Patient feeling dizzy and passing out, lightheaded. EMS started bolus on patient's left arm and tran... Read more
Patient feeling dizzy and passing out, lightheaded. EMS started bolus on patient's left arm and transported to ER
51 2021-03-16 fainting 5 minutes after receiving vaccine patient fainted, pharmacist and Intern got him into where he was g... Read more
5 minutes after receiving vaccine patient fainted, pharmacist and Intern got him into where he was given water and crackers. sat with him for one hour talking and getting updates on symptoms. He continued gradually improving through out the hour. Patient called to come pick him up. informed the pharmacy that he has had fainting spells before with other vaccines and medical procedures. walked them to the car to ensure no fainting spells or other symptoms occurred. Advised patient to call 911 or go to the emergency room if other symptoms arose. Also told them pharmacy will follow up with them later in the evening.
51 2021-03-20 heart rate increased Got the first Moderna dose, 5 minutes later, my heart started raising, I got lightheaded, my hands c... Read more
Got the first Moderna dose, 5 minutes later, my heart started raising, I got lightheaded, my hands cold, my throat narrow. Personnel took me to observation, my blood pressure jumped up to 204, my heart bit to 190, felt like that for 15 minutes, then my BP started to come down. They called an ambulance took me to the hospital, in the ambulance my BP came down to 170. Go to the ER, blood test ok, after two hours there BP came down to 130 they released me. FYI, 51 year old man, very active, I can run a marathon (26.1 miles) in 3:45, Im not diabetic, I dont take any medication, I dont have high blood pressure. Dont know what that happened, no insurance, now waiting for a bill from the hospital, not to mention Im scared to death now taking the second dose.
51 2021-03-21 loss of consciousness Member presented to COVID Vaccination site, received vaccination and approx 10 min after while sitti... Read more
Member presented to COVID Vaccination site, received vaccination and approx 10 min after while sitting in chair, per Member "everything went black" and he unexpectedly fell forward. Knees hit floor first and head hit support wall. No immediate abrasion nor bruising noted, LE elevated, no c/o head pain. Assisted to wheelchair, at which time member again lost consciousness, LE re-elevated, member escorted to exam room. After approx 30 min member evaluated By Physician and determined safe discharge home.
51 2021-03-23 fainting, loss of consciousness Pt was reported to have a high degree of anxiety prior to the Vaccine administration. Reported that ... Read more
Pt was reported to have a high degree of anxiety prior to the Vaccine administration. Reported that pt received #1 vaccination, stood up, walked to observation area and fainted. Was assisted to the ground by staff, pt did not fall or strike head. Pt placed in a chair, in/out of consciousness. Original vitals: 90/60, 37. Pt placed on floor, feet elevated, Vitals:114/69, 63. 911 was called and responded. Pt regained full consciousness, A+Ox3, able to sit in a chair. Pt denied any chest discomfort, other pain, illness before receiving the COVID Vaccine. Pt's girlfriend present. Pt refused ambulance transport.
51 2021-03-23 fainting syncopal event. 911 was then called. Once EMS arrived he was found unresponsive and was in V fib.; t... Read more
syncopal event. 911 was then called. Once EMS arrived he was found unresponsive and was in V fib.; transferred to the cath lab where he was found to have a proximal LAD occlusion deceased 3/17/2021
51 2021-03-24 chest discomfort, heart failure shortness of breath; weakness; diffuse chest tightness; confusion; dizziness; cardiac failure; pulmo... Read more
shortness of breath; weakness; diffuse chest tightness; confusion; dizziness; cardiac failure; pulmonary failure; A spontaneous report was received from a consumer concerning a 51-year-old, male patient who developed cardiac failure, pulmonary failure/respiratory failure and died. The patient's medical history included hypertension, obesity, bee allergy and bipolar disorder. Concomitant product use was not provided by the reporter. Patient received first dose of vaccine prior to two weeks to his death (died on 09 Mar 2021). A week prior to his vaccination as shortness of breath, weakness, diffuse chest tightness, confusion, and dizziness. These symptoms progressed following his vaccination and he was hospitalzed for two days prior to his death on 09 Mar 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 09 Mar 2021 The cause of death was reported as cardio/pulmonary failure with secondary and tertiary causes of hypertension and obesity. Plans for an autopsy were not provided. The outcome of the events, cardiac failure and pulmonary failure were fatal.; Reporter's Comments: This is a case of death in a 51-year-old male subject with a medical history of HTN, obesity, bee allergy and bipolar disorder,who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac failure; pulmonary failure
51 2021-03-25 fainting Systemic: Fainting / Unresponsive-Medium, Additional Details: vax by RN, during pts 15 min wait, fa... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: vax by RN, during pts 15 min wait, fainted to the floor, pt attended to, 911 was called, pt was responsive immideately after fainting, pt reported fainting post other vaccines or blood draws. paramedics evaluated pt, pt viatls were normal, pt decided not to go to hospital, followed up with patient at home and indicated he is doing well.
51 2021-03-28 loss of consciousness Patient received the 1st dose of Moderna and was observed for 15 minutes after the injection. Patien... Read more
Patient received the 1st dose of Moderna and was observed for 15 minutes after the injection. Patient was released and states on their way home they do not know what happened but the woke up and had hit a tree. The airbags did deploy, patient had a gash around 2 inches on the right eyebrow, vital signs were blood pressure of 79/49, oxygen of 99%, and a heart rate of 49. Patient was promptly evaluated by a physician and determined to be more appropriate for the ER, patient was escorted via wheelchair to the emergency room accompanied by a nurse and the physician whom then gave report to the on call physician at Hospital.
51 2021-03-31 cardio-respiratory arrest Cardiopulmonary arrest and death at 0822 4/1/21
51 2021-03-31 chest discomfort Patient was administered Moderna 0.5 mL intramuscularly into right deltoid muscle around 3:30pm. Aro... Read more
Patient was administered Moderna 0.5 mL intramuscularly into right deltoid muscle around 3:30pm. Around 15 minutes later, patient experienced itchy rash on both arms, tingly feeling around stomach area and felt warm over the chest area. Patient also developed feelings of nausea and had pain 7/10 at the right arm of injection site. Patient was given Diphenhydramine 50 mg (1 mL) intramuscularly into left deltoid muscle around 3:50pm.
51 2021-04-01 chest discomfort Approximately 16 hours after receiving his first Moderna COVID 19 vaccine the patient developed ches... Read more
Approximately 16 hours after receiving his first Moderna COVID 19 vaccine the patient developed chest tightness and wheezing, relieved by administration of albuterol by nebulizer given at home. He had no systemic anaphylaxis reaction.
51 2021-04-01 loss of consciousness Flu like symptoms and lost consciousness about 23 hours after vaccination
51 2021-04-02 fainting Patient had syncope at time of injection. Patient reported having syncope with every shot they rece... Read more
Patient had syncope at time of injection. Patient reported having syncope with every shot they receive. Patient slouched in chair, then within 15-30 seconds was conscious and back to normal. No additional care was needed. Patient waited in the pharmacy 30-45 minutes before mother drove home.
51 2021-04-03 palpitations April 2, 2021?-4 to 4 1/2 hours after dose...temperature started to rise?feeling clammy. Chills set... Read more
April 2, 2021?-4 to 4 1/2 hours after dose...temperature started to rise?feeling clammy. Chills set in ?took 1500mg of extra strength Tylenol. In middle of night ?woke up 2-3 times with racing heart?could not get it to slow down on my own(breathing ,etc) eventually slowed down on its own. High fever at the time. At 5:00am took temperature for first time 102.0?took 600mg of ibuprofen. Drinking lots of fluids. Headache and back of neck pain continued to get worse at 11:30am took 1500 mg of extra strength Tylenol and crawled back in bed. Woke up 3:45 burning up/chills took shower to cool body down?could tell temperature way to high?skin very hot to touch. A little disoriented climbing into shower?had to hold the wall in shower to stand steady. Once out of shower?wife and son got home and concerned how I looked. She took temperature at 4:15-4:30 pm and temperature read 107.8.?took 2 more times and both read 107.9 and 107.9...took 600mg of ibuprofen at 4:30 and went toHospital É.R. At 5:30 pm.
51 2021-04-04 fast heart rate Flushing, tachycardia, throat tightness.
51 2021-04-05 palpitations, chest discomfort Allergic reaction type reaction. Heaviness in chest, Tingling in hands and feet, Light headed, Heart... Read more
Allergic reaction type reaction. Heaviness in chest, Tingling in hands and feet, Light headed, Heart racing. Stayed 30 mins gave Benadryl 25mg X2 then patient decided to go to ER.
51 2021-04-06 loss of consciousness Patient passed out and fell out of chair after receiving his second dose. He hit his head when he f... Read more
Patient passed out and fell out of chair after receiving his second dose. He hit his head when he fell. We called 911 and he was transported to our local hospital. I spoke with his brother and he was released and doing ok.
51 2021-04-08 atrial fibrillation Patient with history of AFIB reported a hospitalization due to entering AFIB the morning after recei... Read more
Patient with history of AFIB reported a hospitalization due to entering AFIB the morning after receiving his first dose of Moderna vaccine.
51 2021-04-08 hypertension, heart rate increased Patient reported increased heart rate and anxiety within 15 minutes of vaccination. BP 204/80 P 122... Read more
Patient reported increased heart rate and anxiety within 15 minutes of vaccination. BP 204/80 P 122. BP and pulse decreased slightly while waiting. Patient transported to ER by EMS.
51 2021-04-09 chest discomfort Tightness in the chest on and off, pain the the heart area on and off (I have experienced both of th... Read more
Tightness in the chest on and off, pain the the heart area on and off (I have experienced both of these symptoms on and off throughout my life but it has been worse since I received the shot), headaches almost every day since a week after the shot, lack of energy, tiredness, out of breathe when I climb two flights of stairs at work, and irritability.
51 2021-04-12 very slow heart rate, heart rate decreased, loss of consciousness, pallor Pt was sitting in observation chair after receiving vaccine and became pale, and then loss conscious... Read more
Pt was sitting in observation chair after receiving vaccine and became pale, and then loss consciousness. Pulses were very weak, but thready. Respirations rates were also decreased. when patient awoken, ems was approaching patient. EMS found patient to be bradycardiac. Pulses remained weak, pt remained pale and diaphoretic, very shallow slow respirations but alert and orientated just weak at this time. Pt admitted this happens frequently with injections and blood draws. Pt was asked to see if he could sit up where patient became dizzy, nauseas and then vomited. Pt admitted to not eating today and then refused to go to the hospital. Pt was observed in waiting area for almost 45 minutes, where patient made a full recovery.
51 2021-04-13 heart rate increased had high heart rate after getting covid shot. 158/93, 117. Remained sitting and was fine after.
51 2021-04-14 very slow heart rate s/p 15 minutes after vaccination, patient began experiencing blurry vision, seeing "halos", dizzines... Read more
s/p 15 minutes after vaccination, patient began experiencing blurry vision, seeing "halos", dizziness, bradycardia and diaphoresis. Symptoms worsened when sitting up or standing. BP 110/72 when symptoms first began. Pt placed in supine position with cold compress to back of neck. Given water to drink and stated he ate breakfast prior to his appt. Pt reports no h/o adverse reactions to other vaccines. No improvement in symptoms after 30 minutes, pt reported worsening "halos", so patient taken to ER via EMS.
51 2021-04-14 cerebrovascular accident, transient ischaemic attack Transient Ischemic Attack accute CVA Stroke caused from blood clot to bottom left of the cerebellum.
51 2021-04-17 loss of consciousness Woke up with muscle aches. While walking to get Advil I collapsed on the floor and was conscious bu... Read more
Woke up with muscle aches. While walking to get Advil I collapsed on the floor and was conscious but unresponsive for 15-30 seconds while my wife tried to get me to respond. For the next hour or so I had waves of aches, nausea, dizziness, and muscle weakness. I was then able to get back to sleep and following day, I had mild aches that subsided as the day progressed and was close to feeling normal by evening.
51 2021-04-18 chest discomfort Post covid vaccine, patient is just now complaining of "asthma cough" even with normal or deep breat... Read more
Post covid vaccine, patient is just now complaining of "asthma cough" even with normal or deep breath, slight chest heaviness and flushed face. Denies any numbness and tingling, nausea and vomiting, diaphoresis. Every third breath makes him have a cough. He stated that it's less severe than what he had during the 1st dose of moderna. He already took a benadryl 50 mg 1 hour prior to coming to the clinic today per Dr. Anterior and posterior lunch fields clear without any wheezing.
51 2021-04-18 heart rate increased, fainting, oxygen saturation decreased Syncopal type feeling. Nausea feeling and unsteady on his feet. Light headed when he was standing ... Read more
Syncopal type feeling. Nausea feeling and unsteady on his feet. Light headed when he was standing up.
51 2021-04-20 chest pain chest pain; left arm went numb; GERD; light headed/dizzy; increased in smell; This spontaneous case ... Read more
chest pain; left arm went numb; GERD; light headed/dizzy; increased in smell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history provided). On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (light headed/dizzy) and PAROSMIA (increased in smell). On 10-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD). On 28-Mar-2021, PAROSMIA (increased in smell) had resolved. On 12-Apr-2021, CHEST PAIN (chest pain), DIZZINESS (light headed/dizzy), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. They did a EKG and chemical test, everything normal. More tests were run and everything came back normal. Patient spent two nights in the hospital. 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 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.
51 2021-04-21 chest pain 5 MINUTES AFTER RECEIVING MODERNA (2ND DOSE) PATIENT BEGAN TO FEEL DIZZY. AFTER BEING PLACED ON THE... Read more
5 MINUTES AFTER RECEIVING MODERNA (2ND DOSE) PATIENT BEGAN TO FEEL DIZZY. AFTER BEING PLACED ON THE FLOOR WITH A BLANKET AND PILLOW HE BEGAN TO COMPLAIN OF CHEST PAIN AND WAS COLD. 911 WAS CALLED. PARAMETICS ARRIVED, THEY CHECKED HIS BLOOD PRESSURE WHICH WAS NORMAL. THEY INQUIRED IF HE HAD A REACTION BEFORE AND HE SAID NO. THEY ASKED IF HE HAD MEDICAL CONDITIONS AND HE SAID DIABETIC. THEY ASKED IF HE HAD EATEN AND HE SAID HE HAD BREAKFAST. THEY THEN PUT HIM ON THE STRETCHER AND TOOK HIM TO THE HOSPITAL.
51 2021-04-21 fibrin d dimer increased, chest pain, pulmonary embolism Patient received COVID-19 Moderna vaccine series doses on 2/11/21 and 3/11/21. On 4/12/21, patient p... Read more
Patient received COVID-19 Moderna vaccine series doses on 2/11/21 and 3/11/21. On 4/12/21, patient presented to the ED with chief complaint of left sternal border chest pain. Patient was evaluated by PCP and was found to have elevated D-dimer. Patient was sent to the ED for CTA and was found to have bilateral segmental and subsegmental emboli. Patient was discharged home on Xarelto to treatment of PE.
51 2021-04-21 pallor, loss of consciousness, oxygen saturation decreased PATIENT WAS APPROACHED IN VEHICLE AND ASKED HOW HE WAS FEELING, HE SAID HE DIDNT FEEL WELL AND THOUG... Read more
PATIENT WAS APPROACHED IN VEHICLE AND ASKED HOW HE WAS FEELING, HE SAID HE DIDNT FEEL WELL AND THOUGHT HE MAY OF PASSED OUT. HE WAS ASKED TO PUT HIS CAN IN PARK AND ROLL DOWN HIS WINDOWS. UPON HIM DOING SO HE PASSED OUT AND BECAME UNRESPONSIVE. BP WAS 62/30. 911 WAS CALLED. ICE PACKS WERE PLACED AROUND HIS NECK AS HE WAS CLAMMY AND PALE. HIS LIPS WERE PURPLISH AND OXYGEN WAS 91%. HE CAME TO A SECONDS LATER AND ASKED WHAT HAPPENED. HE THEN WHEN INTO WHAT LOOKED LIKE A SEIZURE THAT LASTED ABOUT 15 SECONDS.HE WAS ASKED IF HE HAD A HISTORY OF SEIZURES AND HE SAID NO. HIS BP WAS TAKEN AGAIN AND IT WAS 90/60.OXYGEN WAS AT 91%. WHEN HE PASSED OUT AGAIN, EPI WAS ADMINISTERED AND PARAMEDICS ARRIVED APPROX 1 MINUTE LATER
51 2021-04-22 blood clot, pulmonary embolism I had a pulmonary embolism on 3/17/2021. Prior to that a blood clot in my left calf.
51 2021-04-23 hypotension Patient experienced hypotension, dizziness, and was diaphoretic. Staff on site provided hydration, c... Read more
Patient experienced hypotension, dizziness, and was diaphoretic. Staff on site provided hydration, checked vitals and blood sugar, elevated patient's legs and called EMS. EMS arrived on site, patient's blood pressure stabilized, and patient was not transported to the ER.
51 2021-04-23 pallor pt start to fill weak after 5 minutes of vaccine. his face was so pale. got tired, and dizzey , swea... Read more
pt start to fill weak after 5 minutes of vaccine. his face was so pale. got tired, and dizzey , sweat. shaking a little bit. pharmacist was monitore him and call 911. after arriving they measure bp and bs. he started feeling better. they left, he stayed for 10 more minutes. after he felt ok he left. pt does't want to go to hospital or emergency department.
51 2021-04-24 pallor Pain at injection site (continued), pallor (continued), excessive diaphoresis (20 hours), nausea (co... Read more
Pain at injection site (continued), pallor (continued), excessive diaphoresis (20 hours), nausea (continued), vomiting (12 hours), diarrhea (12 bours), extreme malaise (lessened after 20 hours but still lingers), gastric pain (20 hours), headache (continued), impaired vision (12 hours), severely weakened gait (18 hours), inability to drive (18 hours), body aches (continued), memory loss and confusion (12 hours), dyspnea (12 hours), fever of 104° F (12 hours with no relief from antipyretics/acetaminophen), fever in excess of 100° F (another 10 hours), fever in excess of 99° F (12 hours), fear of death (36 hours)
51 2021-04-25 heart failure Fever, sweats, chills, headache, burning eyes, loss of taste were expected side effects. Was admitt... Read more
Fever, sweats, chills, headache, burning eyes, loss of taste were expected side effects. Was admitted to the ICU on 3/27/2021 with heart failure. Felt fine before the shot.
51 2021-04-28 fainting, hypotension I fainted while in the bathroom and then again at the ER. Notes from visit said I had 2 syncopal epi... Read more
I fainted while in the bathroom and then again at the ER. Notes from visit said I had 2 syncopal episodes. They cited low blood pressure.
51 2021-04-28 fainting, loss of consciousness patient fainted 5 minutes after transfer to waiting area he fell and I run to see if he is ok He gai... Read more
patient fainted 5 minutes after transfer to waiting area he fell and I run to see if he is ok He gained concious in less than 2 minutes , I applied cold compress to hid neck checked his BP and pulse it was ok but I already told my staff to call 911 once he fell, paramedics came and he was doing well watched him for another 20 minutes make sure he can leave and doing ok, he said he having phobia from needles and he didn't eat
51 2021-05-01 heart rate irregular Burning sensations throughout my body. Irregular heartbeat. Chills. Sweats.
51 2021-05-01 hypertension Pain starting in both legs the day after the vaccine(Tuesday) and fever of 100.6 Later that night th... Read more
Pain starting in both legs the day after the vaccine(Tuesday) and fever of 100.6 Later that night the fever broke and the pain persisted in right leg . He took tylenol to ease pain. Wednesday the pain persisted and he continued with tylenol . Thursday am woke to find the leg was swollen and painful to the point of going to the er.
51 2021-05-02 loss of consciousness patient was under observation post vaccination when he passed out in his chair/slumped over. Patient... Read more
patient was under observation post vaccination when he passed out in his chair/slumped over. Patient was somewhat responsive within 10 seconds. We called 911 immediately. The EMT tested patient's blood pressure and heart rate. Both came back WNL. We monitored the patient for an additional 30 minutes in the pharmacy counseling room. We also got patient an orange Gatorade from the store to help restore his electrolytes as he was profusely sweating. Patient refused the EMS take him to the hospital and wanted to drive himself home from the pharmacy.
51 2021-05-02 palpitations, hypertension anxiety at time of shot, then was on the phone while waiting then came over after about 10min and sa... Read more
anxiety at time of shot, then was on the phone while waiting then came over after about 10min and said was having palpitations, and was nervous. his bp was high and he was concerned so we had him call a ride as he didn't feel he needed an ambulance but wanted to get check out. He went to urgent care and they told him it was anxiety and the my bp machine wasn't big enough for his arm. he is doing fine.
51 2021-05-03 deep vein blood clot Pt with R lower leg pain on 30 Apr 2021. Duplex U/S on 04 May 2021 showed deep venous thrombosis fr... Read more
Pt with R lower leg pain on 30 Apr 2021. Duplex U/S on 04 May 2021 showed deep venous thrombosis from ankle to mid femoral vein. Initiated on rovaroxiban
51 2021-05-03 palpitations Awoke the morning of April 9th with the following: stomach cramps; chest or heart palpitations (left... Read more
Awoke the morning of April 9th with the following: stomach cramps; chest or heart palpitations (left side); significant ringing in both ears (tinnitus). The cramps and palpitations went away within 24-48 hours; the tinnitus has stayed the same for the last 3+ weeks.
51 2021-05-04 blood pressure increased Patient developed a "massive headache" soon after he received his vaccine. He stated his right side... Read more
Patient developed a "massive headache" soon after he received his vaccine. He stated his right side felt weak and numb. His blood pressure at the vaccine clinic was noted to be severely elevated (patient was on blood pressure medication in the past but was taken off of it a while ago). Patient drove himself to the ER and stroke alert was called. Patient needed nicardipine drip and labetalol pushes to bring down blood pressure, and once it was controlled patient was given alteplase.
51 2021-05-05 chest pain After 1St vaccine. Chest pains, difficulty breathing, like breathing through a straw. Saw cardiolo... Read more
After 1St vaccine. Chest pains, difficulty breathing, like breathing through a straw. Saw cardiologist doctor, and was seen at ER. Sent home with Aspirin and colchicine scripts. To this day still having severe chest Pain and difficulty breathing.
51 2021-05-05 loss of consciousness no appetite; cough; feels sick; exhausted; passed out; This spontaneous case was reported by a consu... Read more
no appetite; cough; feels sick; exhausted; passed out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (passed out) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRESYNCOPE (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), COUGH (cough), MALAISE (feels sick) and FATIGUE (exhausted). At the time of the report, PRESYNCOPE (passed out), DECREASED APPETITE (no appetite), COUGH (cough), MALAISE (feels sick) and FATIGUE (exhausted) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication includes naproxen. Patient received the first dose of the Moderna Covid 19 vaccine (Lot:045B21A, expiration:Unknown) on 26APR2021 at a pharmacy. After the administration of the vaccine, patient passed out at a pharmacy and he had to wait there for 45 minutes. Since the administration of the vaccine patient has been exhausted, has no appetite, cough, and overall, just feels sick. Patient took Aleve to help alleviate his symptoms.
51 2021-05-06 cardio-respiratory arrest, cardiac arrest Arrived to emergency department via ambulance from nursing home with complaints of "looking like he ... Read more
Arrived to emergency department via ambulance from nursing home with complaints of "looking like he was about to have a seizure". Patient became unresponsive and a code was called. ACLS performed but the patient did not recover from cardiac arrest.
51 2021-05-07 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
51 2021-05-09 cerebrovascular accident, chest pain it cause him to have more strokes n more sizures n more chest pain n emotially melt done makes bipol... Read more
it cause him to have more strokes n more sizures n more chest pain n emotially melt done makes bipolar worse as well
51 2021-05-09 pallor Nausea and vomiting within 5 minutes of the injection that progress to dizziness, diaphoresis, and ... Read more
Nausea and vomiting within 5 minutes of the injection that progress to dizziness, diaphoresis, and pallor.
51 2021-05-10 chest pain Client reported chest pain radiating to lower back. He originally reported the pain as a 10/10. EMS ... Read more
Client reported chest pain radiating to lower back. He originally reported the pain as a 10/10. EMS were phoned as nurses remained with client obtaining vitals (which all remained within normal limitis). Upon the paramedics arrival, the client was evaluated. He ultimately refused further treatment/transfer to hospital.
51 2021-05-10 loss of consciousness, hypotension patient passed out. when awoken was clammy and sweaty. Lowered him to the floor where he complaine... Read more
patient passed out. when awoken was clammy and sweaty. Lowered him to the floor where he complained about being hot and cold alternatively. BP was usually low 110's over 60 pulse ran about 56. Patient was nauseas. Used ice packs to cool him, and towels to warm him. He did not vomit. He continued to be dizzy and sweaty. BPs and pulses did not improve, after 40 minutes of symptomatic treatment, he consented to an ambulance being called. He was treated by paramedics, I do not know if he was taken to the hospital.
51 2021-05-13 loss of consciousness, atrial fibrillation Headaches, nausea, passed out, EMT administered Narcan, went into afib in the ambulance 160 beats pe... Read more
Headaches, nausea, passed out, EMT administered Narcan, went into afib in the ambulance 160 beats per minute. Toxicology negative. Given eliquis and metoprolol. CT scan, MRI and ECG showed nothing. AFIB resolved itself without a cardioversion or ablation. No AFIB to date.
51 2021-05-13 platelet count decreased Swollen joints that have lasted now for 16 days......numb toes and foot and hands
51 2021-05-15 heart rate increased Headache, muscle ache, joint ache, fever (100 degrees), nausea, increased heart rate, extreme fatigu... Read more
Headache, muscle ache, joint ache, fever (100 degrees), nausea, increased heart rate, extreme fatigue and sleepiness (it was hard to stay awake). I took Tylenol for the headache and the symptoms resolved by 5pm that day except the fatigue and sleepiness. They ended by the morning of the following day.
51 2021-05-16 lightheadedness I occasionally get vaso-vagal episodes that can be related to digestive issues, blood withdrawals, e... Read more
I occasionally get vaso-vagal episodes that can be related to digestive issues, blood withdrawals, etc. I get light-headed, weak, feel like I can vomit and/or have a diarrhea "attack", get hot, feel itchy/burning sensation, turn very pale, get drenched in sweat. These episodes can range from 5-60 minutes. I did not have any reaction on my first dose, ONLY after the 2nd dose was received.
51 2021-05-19 deep vein blood clot Patient presented to PCP office 5/17/2021 for intermittent SOB, pain with breathing, and acute pain ... Read more
Patient presented to PCP office 5/17/2021 for intermittent SOB, pain with breathing, and acute pain to left lower calf. Calf pain began 5/16/2021. SOB had been intermittent and ongoing since after receiving 2nd COVID vaccine per patient. He was dx with acute DVT of LLE. Chest CT was not performed to evaluate for PE as patient reported improvement with SOB/breathing over the prior few days. He was started on Xarelto for blood clot. Blood clot was unprovoked, no prior history of clots/bleeding disorders. He is a generally healthy and active 51 year old male. Unclear if there is a correlation between recent COVID vaccination.
51 2021-05-20 fainting, atrial fibrillation Patient has a syncopal episode and was found to be in new-onset A Fib with RVR
51 2021-05-22 cardiac failure congestive, atrial fibrillation, chest pain Approximately 4 hrs after vaccine administration, dark, red, raised rash appeared on torso, arms, bu... Read more
Approximately 4 hrs after vaccine administration, dark, red, raised rash appeared on torso, arms, buttocks, and legs. So severe that dexamethasone started. Rash did not improve for weeks and steroids continued during that time. Patient noted to then go into congestive heart failure, had 2-3+ pitting edema, "ground glass"/pulmonary congestion in lungs, rapid A-fib with RVR 170-180s. treated at Hospital with admission from 5/15-5/17/2021. Patient complained of chest pain and trouble breathing starting 5/13/2021. Patient has mostly recovered, and is at home now. Now on high dose beta-blockers and eliquis for the new onset A-Fib.
51 2021-05-23 blood pressure increased Approximately 12 hours after receiving the second dose, I spiked a fever of 101, felt body aches and... Read more
Approximately 12 hours after receiving the second dose, I spiked a fever of 101, felt body aches and chills. This lasted for about 1 day. On day 3, I woke with stiff, achy and sore joints in my right hand. On day 4, these symptoms remained in my right hand and moved to my left. Over the next week, stiff joints moved into my toes. EXTREME FATIGUE and mental fogginess also developed as did blood pressure spikes. On week 2, move joints started aching including knees, elbows and shoulder. On week 3, my fingers were so sore and stiff it became difficult to use door knobs. I contacted a virtual doctor to ask for direction. He assumed in was side effects and prescribed me Diclofenance Sodium 75 mg for pain. Two days later, I went to the emergency room as the pain, fatigue and fogginess was becoming very concerning. On week 4, I was finally able to see my family doctor. He assumes it is a overactive immune response to the vaccine and prescribe Prednisone 20 mg to overcome the symptoms. The course of Prednisone has decress the severity of my symptoms but on week 5 I continue to have stiff, painful joints, mental fogginess.
51 2021-05-24 hypertension 24 hours after the second vaccine, I felt so out of breath and my heart rate had gone up to 115 that... Read more
24 hours after the second vaccine, I felt so out of breath and my heart rate had gone up to 115 that I had to go outside and have my daughter drive me home. I did not go to the hospital because I did not believe what was happening and I did not want to worried my daughter on her special day. This was on Saturday May 1 at about 5:00 pm. I went home and went straight to bed. My wife was in disbelief and thought I was faking it. I have been having shortness of breath ever since. I am a teacher and on Monday I spoke to the school nurse and she had told me she had the same reaction and that it would be over in a month or two. I have had the same issues, but over the weekend of the 22 and 23rd of May, I have not been able to sleep as much. On Monday, May 24, I went back to the nurse and she had took my blood pressure. It was 176/99 and that same day I went to the ER . I had all the blood work done and the only thing I had according to the doctor was high blood pressure. I had never had my blood pressure so high before.
51 2021-06-02 heart rate increased, fluid around the heart, fast heart rate adverse events -Shortness of breath, elevated heart rate, hacking cough -... Read more
adverse events -Shortness of breath, elevated heart rate, hacking cough - Found to have be tachycardic, with pericardial effusion treatment - pericardiocentesis performed to drain fluid Outcome - heart rate slowly came down over days
51 2021-06-06 blood clot Patient was first diagnosed with bursitis at his pcp and sent home. Patients elbow was swollen and r... Read more
Patient was first diagnosed with bursitis at his pcp and sent home. Patients elbow was swollen and referred to urgent care by the pharmacist pharmacy. Patient was seen by Dr, and found to have a blood clot when doctor tried to aspirate the elbow. Patient has fully recovered at returned to work
51 2021-06-08 deep vein blood clot, fibrin d dimer increased Blood clot / deep vein thrombosis in left leg developed less than one month after 2nd dose. Acute pa... Read more
Blood clot / deep vein thrombosis in left leg developed less than one month after 2nd dose. Acute pain behind left knee, muscle ache radiating through calf to foot. Swelling. Warm to touch. Felt like a pulled muscle for a week before doctor visit.
51 2021-06-08 pulmonary embolism, deep vein blood clot Pt admitted for L lower extremity DVT and bilateral extensive PE's. No known medical history, family... Read more
Pt admitted for L lower extremity DVT and bilateral extensive PE's. No known medical history, family/personal history of clots, no known clotting risk factors. Pt noted swelling in his leg 2 days after getting second covid vaccine and later developed SOB leading to presentation.
51 2021-06-10 atrial fibrillation AFIB 150 bpm for 23 hours
51 2021-06-10 chest pain, hypertension Inflammation of lymphglands along the neck. Possible myocarditisis. Uncontroled Hypertension , atypi... Read more
Inflammation of lymphglands along the neck. Possible myocarditisis. Uncontroled Hypertension , atypical chest pain.
51 2021-06-12 heart rate irregular, chest pain Ear pain, throat, head and face, eye everywhere the left side, tiredness, the first weeks it increas... Read more
Ear pain, throat, head and face, eye everywhere the left side, tiredness, the first weeks it increased week to week pain in part of the back, difficulty to breath, numbness in legs and arms around all of left side, blurry vision, chest pain, irregular heart beats.
51 2021-06-13 loss of consciousness, blood pressure decreased Received 2nd does of Moderna at approximately 8:30 AM on Wednesday, May 19. At around 8:00PM that ev... Read more
Received 2nd does of Moderna at approximately 8:30 AM on Wednesday, May 19. At around 8:00PM that evening my fever raised to 99.7 degrees. At 1:00 AM on Thursday, May 20 my fever went up to 101.8 at which time I took one adult dose of Nyquil. At 3:00 AM I went to the bathroom to drink more water and I passed out. My wife called 911 and I was taken to a local hospital, for treatment. My blood pressure had dropped to ~90/58. They could not find a vein in the ambulance to administer an IV but the hospital staff was able to. The hospital release me at about 9:00 AM on Thursday, May 20. From about 8:00PM to 3:00AM I had experienced symptoms of severe fever, nausea, muscle chills, severe fatigue.
51 2021-06-15 cerebrovascular accident Suffered minor stroke AM of 1/28/21
51 2021-06-15 chest pain PT EXPERIENCED DIZZINESS, WE CHECKED HIS BLOOD PRESSURE WHICH WAS NORMAL. WE GAVE HIM A TWIZZLER TO ... Read more
PT EXPERIENCED DIZZINESS, WE CHECKED HIS BLOOD PRESSURE WHICH WAS NORMAL. WE GAVE HIM A TWIZZLER TO EAT AND WATER TO DRINK SINCE HE IS A DIABETIC. WE LAID HIM ON THE GROUND, ELEVATED HIS FEET, AND RECHECKED HIS BP 5 MINS LATER. PT STARTED EXPERIENCING CHEST PAIN SO WE CALLED 911 AND AMBULANCE TOOK HIM TO THE ER.
51 2021-06-15 heart rate irregular, atrial fibrillation, heart rate increased Very fast beating heart, irregular heartbeat taken to hospital via Ambulance?. diagnosed with A-fib ... Read more
Very fast beating heart, irregular heartbeat taken to hospital via Ambulance?. diagnosed with A-fib and given cardiac medications
51 2021-06-18 blood pressure increased on 6/19/21 Patient came to store for his 2nd Moderna shot. After the shot was given I had staff obs... Read more
on 6/19/21 Patient came to store for his 2nd Moderna shot. After the shot was given I had staff observe the patient. In a few minutes the patient felt tired and dizzy. His wife said this did not happen with the first shot. I then had staff call for a code white and I went to assist the patient. Immunization cart was brought out and I took the patient's BP 167/122 HR 76. I asked the patient did he have any problems breathing, he said no. I did inform him that his blood pressure was high and that can contribute to him feeling dizzy. I continued to ask the patient if he was breathing ok and he said yes. There was no need for an epi-pen as the patient was conscious and responsive to all my questions. Where his blood pressure was still high I continued to take his blood pressure. Blood Pressure remained high at recorded times: 4:06 pm 176/114 hr 73 4:16 pm 151/110 hr 76 4:18 pm 153/102 hr 76 4:19 pm patient said he tests his sugar twice a day and complains of a headache straight across his forehead 4:26 pm 153/104 HR 74 at this time I was wanting to see if the cuff size played a role in the high blood pressure. Staff was able to find a meter with a larger cuff size 4:30 pm 159/103 HR 79 wife stated that his BP was on the lower end at home 4:34 pm patient stated that he's feeling a bit better . BP still elevated. 4:35 PM 147/103 HR 77 4;36 pm patient said bottom # rarely goes over 100 but has saw top # the same or higher 4:37 pm patient said he's able to walk and go on about his day. I was asking about him eating/drinking anything and this is when he mentioned that he drank 2 monsters and had 2 cups of coffee. I told the patient that this can contribute to him having high blood pressure at this time and asked his wife to monitor his BP when he got home. I will call them in the morning to make sure he is doing ok. Note: patient does not have a PCP verified by his wife. However standing order doctor will be notified.
51 2021-06-21 cardiac arrest, heart attack, pulmonary embolism, chest pain This was very unfortunate 51 years old male with past medical history of hypertension, hyperlipidemi... Read more
This was very unfortunate 51 years old male with past medical history of hypertension, hyperlipidemia, obesity. Patient presented with chief complaint of shortness of breath and chest pain. EMS reported that the patient has been complaining of some shortness of breath and chest pain intermittent for couple of weeks. 12 leads EKG showed evidence of anterior ST elevation myocardial infarction. Code heart was called. Patient developed PEA arrest in the Cath Lab. CPR ACLS was initiated. ROSC was achieved initially after 30 minutes of CPR. Intra-aortic balloon pump was placed. Coronary arteries were essentially clean. Due to high suspicion for massive PE-TPA was given 100 mg without meaningful clinical improvement. CPR was continued for more than an hour. Despite all aggressive measures patient continued to deteriorate. At 3:26 PM patient has no spontaneous breathing, no peripheral pulses, no heartbeats by auscultation or by monitor. Pupils were fixed and dilated. No cough no gag reflexes . patient was pronounced dead.
51 2021-06-21 heart rate increased Fever and high heart rate while resting
51 2021-06-21 loss of consciousness I Experienced a sore arm on day 1 and I experienced vomiting on day 2 and 3 after the 2nd dose. On ... Read more
I Experienced a sore arm on day 1 and I experienced vomiting on day 2 and 3 after the 2nd dose. On day 3 Around 9pm I got extremely hot around 10 pm I went to get something to eat and around 12am I was found outside of the store by the police. An EMT was called they checked my vitals and I declined to go to the hospital because I was feeling fine.
51 2021-06-22 lightheadedness, inflammation of the pericardium chest pain over left side of the sternum when touched the area is very painful...pericarditis; Verti... Read more
chest pain over left side of the sternum when touched the area is very painful...pericarditis; Vertigo symptom/my head was spinning so badly; started to throw up profusely; dizziness was so bad; first time I am experiencing a reaction; about to pass out; This spontaneous case was reported by a dentist and describes the occurrence of PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS for an unknown indication. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (The dizziness was so bad, I thought that, "I am going to die"), VACCINATION COMPLICATION (this was the first time I am experiencing a reaction ) and PRESYNCOPE (about to pass out). On 06-Jun-2021 at 2:00 AM, the patient experienced VERTIGO (Vertigo symptom/my head was spinning so badly) and VOMITING (started to throw up profusely). On 06-Jun-2021 at 4:00 PM, the patient experienced PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (very sick). The patient was treated with IBUPROFEN for Pericarditis, at a dose of 1 dosage form, unknown. On 06-Jun-2021, VERTIGO (Vertigo symptom/my head was spinning so badly), DIZZINESS (The dizziness was so bad, I thought that, "I am going to die"), PRESYNCOPE (about to pass out) and VOMITING (started to throw up profusely) had resolved. At the time of the report, PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) had not resolved and ILLNESS (very sick) outcome was unknown. The outcome of the event of VACCINATION COMPLICATION (this was the first time I am experiencing a reaction ) was resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The reporter noted he never had any adverse reaction after taking any medications before and this was the first time he was experiencing a reaction. He reported to be a healthy person before and now after receiving the Moderna vaccine, he is very sick. The reporter stated that he "will not take the 2nd dose of Moderna vaccine."; 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.
51 2021-06-24 pulmonary embolism, cerebrovascular accident Cerebral venous thrombosis, PE, stroke, left hemiparesis and encephalopathy
51 2021-06-30 cardiac arrhythmia Approximately two days following my second Moderna covid vaccine I began having Premature Ventricula... Read more
Approximately two days following my second Moderna covid vaccine I began having Premature Ventricular Contractions. I would estimate approximately 30-45 per hour. This is below the number required before it is "concerning" however, I had not been having PVCs at all prior to this. In the subsequent weeks, the PVCs have diminished but have not fully subsided. I have had an EKG,ECG, and stress test and all results were normal
51 2021-07-01 heart rate increased, chest discomfort 1. After FIRST dose, I had reaction within 30-40 seconds where I found it difficult to catch my brea... Read more
1. After FIRST dose, I had reaction within 30-40 seconds where I found it difficult to catch my breath, felt like I might pass out, my palms were sweating profusely, & I experienced tingling in my extremities. These symptoms resolved themselves within a few minutes, with the tingling resolving in about an hour or so.(no more noticeable reactions after that) 2. After SECOND dose, ...no immediate reaction like the first time, but arm hurt, as expected for the next couple of days. I didn't notice any side effects until, 06/03, which was about 8-9 days later. So I was running at about mile 4(I am a trail runner), when something just didn't feel right around my heart...some tightness, even some pain across shoulder blades. I continued the run...turned into a run/walk. I continued my day, with something feeling a little off and experienced some night sweats, & poor sleep. I went a couple more days and then on Sunday I went to the local Immediate Care. They did an EKG & sent me to ER. At the ER, they did an EKG, and wanted me to stay to be monitored over nite. At that time, I did NOT feel bad enough to stay, so I left with the agreement that I would return on Monday to do a Stress Echo on my heart. HOWEVER, upon getting home and having a bowl of soup, I experienced what I would call my first episode. Upon getting off the couch, my heart started beating unusually fast, it became VERY difficult to breathe, and I thought I was having a heart attack. Long story short, I drove back to the ER, they checked me in, did another EKG, a chest X-Ray, a chest CT-Scan, admitted me overnite, where they drew blood every 4 hours, and attached me to a heart monitor for roughly 12-16 hours. The next day they also performed a heart stress-echo. Everything came back normal. Since that time, I have had roughly 4-5 of those major episodes, with some smaller ones as well. I went back to Hospital ER on 06/19/2021 with another episode that I felt was worse than the original one. Again, they did an EKG, a chest X-Ray, various blood tests, and everything came back normal. Amongst all of this, I have seen my Family Doctor twice, and a cardiologist once. Hospital performed a heart Calcium test, which came back with a score of six. I believe the range where medium risk of a heart attack comes in is around 100-200. I have also been put on a Holter heart monitor, of which I have a week left of a two week assignment. I haven't had a major episode in about a week and a half now, but I also stopped eating chocolate and given up all caffeine about a week and a half ago. All of that said, I still have tightness in my chest, as well as just an odd feeling there. Other symptoms I am having include being light-headed, dizziness at times, and, more concerning, tingling and numbness in my extremities. The tingling & numbness are primarily in my fingers, hands, and forearms. In addition, twice my index finger on my right hand has turned blue/purple, but ultimately returned to normal color after 24 hours or so. Finally, It is very difficult to get sleep. It seems my heart tries to wake me up every 2-3 hours to let me know something is not right. I can feel an unusual feeling almost immediately after lying down. I really can't even explain the feeling in my chest, but I have never had this feeling before, and have never had sleep issues. In summary, I WAS a 52 year old man with no history of any heart problems, a fairly avid runner with a resting heart rate between 40 and 50, and no history of dizziness, tingling, or numbness in my extremities. After the 2nd dos of Moderna, I now have stopped running, have a myriad of symptoms as mentioned above, and my life has been flipped on its head for a month now,....moreover, I am getting little relief. I need help.
51 2021-07-05 chest discomfort, fibrin d dimer increased, chest pain, pulmonary embolism Patient went to ER 6/28/21 with complaints of chest tightness that began 6/27/21. Discharged home. W... Read more
Patient went to ER 6/28/21 with complaints of chest tightness that began 6/27/21. Discharged home. Went back to ER twice on 7/1/2021 with body aches, fever, chest pain, abdominal pain, diarrhea. Diagnosed with acute pulmonary embolism, enteritis,
51 2021-07-08 blood clot high range d dime test / blood clot; brain fog; breathing issues; Exhaustion; This spontaneous case ... Read more
high range d dime test / blood clot; brain fog; breathing issues; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (high range d dime test / blood clot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011dz1a and 022cz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (high range d dime test / blood clot) (seriousness criterion medically significant), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion). At the time of the report, THROMBOSIS (high range d dime test / blood clot), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: normal (normal) normal and .55 (High) There is concern for patient that there is a blood clot. The patient treatment data was not provided. Patient allergies and medical history was not reported. Patient concomitant medication was not reported. Action taken with m-RNA1273 (moderna COVID-19 Vaccination) (Intramuscular) in response to events was not applicable. In between the doses of vaccine patient had done test (d-dime) and original came back in fine range but after second dose patient test came back in high range .55 so there is concern for patient that there is a blood clot. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-243110 (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.
51 2021-07-11 loss of consciousness, atrial fibrillation Atrial fibrillation; Loss of consciousness; Headache; Nausea; This case was received via FDA VAERS (... Read more
Atrial fibrillation; Loss of consciousness; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1317402) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 51-year-old male 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 Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE and FISH OIL for an unknown indication. On 20-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 27-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), LOSS OF CONSCIOUSNESS (Loss of consciousness), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Computerised tomogram: negative Negative. On 27-Apr-2021, Electrocardiogram: normal normal. On 27-Apr-2021, Heart rate: 160 beats per minute.. On 27-Apr-2021, Toxicologic test: negative (Negative) Diagnosis vasovagal syncope and atrial fibrillation. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Magnetic resonance imaging head and Magnetic resonance imaging heart test was done 27-APR-2021. Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
51 2021-07-11 inflammation of the pericardium Pericarditis
51 2021-07-12 arrhythmia, atrial fibrillation, inflammation of the pericardium, heart flutter, chest pain Chest pains, heart fluttering, dizziness, unusual heart rhythm First admission: Diagnosed with Atr... Read more
Chest pains, heart fluttering, dizziness, unusual heart rhythm First admission: Diagnosed with Atrial fibrillation Second admission: Pericarditis and a pacemaker was administered
51 2021-07-12 cardiac arrhythmia PATIENT HAD PVC'S 3 DAYS POST VACCINATION. POSSIBLE MYOCARDITIS PER PATIENT.
51 2021-07-14 blood clot Blood clot on left leg from knee to the groin area. Never had problems before, not 1 person in my f... Read more
Blood clot on left leg from knee to the groin area. Never had problems before, not 1 person in my family ever had this , not long trips , ground or Arial.
51 2021-07-21 heart rate increased, chest pain, blood pressure fluctuation I'm not certain if these adverse events are due to vaccine want to report what I have experienced. I... Read more
I'm not certain if these adverse events are due to vaccine want to report what I have experienced. I felt run down couple days. My heart rate was elevated, spiking blood pressure changes, mild headaches and chest aches. I'm still exp the symptoms now that I'm on Lisinopril and Metformin.
51 2021-07-23 chest discomfort Pt stated that they were experiencing chest tightness and nausea.
51 2021-07-23 loss of consciousness pt passed out within 5 seconds after receiving the first dose of moderna
51 2021-07-24 blood pressure increased About 10 minutes after injection, patient said he felt high. No rash, swelling or breathing difficul... Read more
About 10 minutes after injection, patient said he felt high. No rash, swelling or breathing difficulty. He confessed he hasn't been taking his blood pressure medication. He had been very nervous about getting the vaccine. I checked his blood pressure and it was elevated. I offered to call medical assistance but he said the blood pressure reading was lower than he has had in the past. He started feeling better fairly quickly and subsequently left the pharmacy area. Follow-up call to patient a little over an hour later and he was feeling good. I do not believe the reaction was from the vaccine but reporting just in case.
51 2021-07-26 platelet count decreased Decreased Platelet Count
51 2021-07-27 loss of consciousness, blood pressure decreased 1-2 weeks after the second vaccination, pt. began experiencing fatigue, headache, muscle aches. He t... Read more
1-2 weeks after the second vaccination, pt. began experiencing fatigue, headache, muscle aches. He then developed a rash all over his body, and sores on his tongue. Then he developed a fever, was unable to leave his bed, passed out multiple times, and was eventually admitted to the hospital with a 105 degree fever and pneumonia on the morning of July 10th. They could not keep his blood pressure up and put him on three different drugs to keep him alive, and by the end of July 10th, just 12 hours after he was admitted, he was put on a ventilator because he was not able to breathe on his own anymore. His white blood cell count was 0.2, and every time they changed the IV bags and momentarily discontinued the BP medicine, he would drop to critical levels. On the second day they were fairly sure he was not going to make it, but he has since gotten a little better. They have been giving him blood transfusions and platelets. He has remained on a ventilator for 18 days now, and has developed fevers every afternoon, up to 102 degrees, which they keep bringing down again with medication and ice. They have tested him for practically ever disease known to man for 18 days. There is no cause they can find. Not cancer, not autoimmune disease, nothing. Pt. has not been to the hospital since he was a child and it was for injury, not illness. He has never had any sort of major disease or cancer or chronic illness. The hospital or me, his mother, can be contacted for any further questions.
51 2021-07-28 blood pressure increased The following morning 7/27/21 I woke with soar arm and a headache that lasted all day. The next m... Read more
The following morning 7/27/21 I woke with soar arm and a headache that lasted all day. The next morning 7/28/21 I got out of bed feeling really dizzy. The dizziness lasted all day and my blood pressure increased 151/99. After speaking to a. On line Dr. I was asked to go to the ER. I went to the ER around 10:30 and as I described what I was dealing with, the receptionist rolled their eyes but took my information. I sat in the waiting room until 2:00am. At that time I felt it would be best to wait to see a Dr in the morning. I will be seeing someone this morning. After getting a little sleep I got up at 8:00am, still suffering from severe dizziness.
52 2021-01-01 palpitations, blood pressure increased Patient received his vaccine at 1600 and began feeling lightheaded with transient palpitations @ 161... Read more
Patient received his vaccine at 1600 and began feeling lightheaded with transient palpitations @ 1615, B/P 154/103 HR 64. 1630 still with lightheadedness B/P 162/106 HR 87 rapid response called. 1700 still lightheaded 175/113 HR 73 O2 99%. Pt. said he still felt dizzy but just wanted to sit for a while longer and did not want to go to ED at that time. 1705 Pt. did end up electing to go to ED because he said he wasn't comfortable going home. Pt. escorted via wheelchair to ED- no further signs of lightheadedness.
52 2021-01-06 chest discomfort LOCAL SORENESS AT SITE DAY 1 DAY 2 SORNESS ON SITE AND UPPER ARM GOING INTO SHOULDER DAY 3 @ 3AM FE... Read more
LOCAL SORENESS AT SITE DAY 1 DAY 2 SORNESS ON SITE AND UPPER ARM GOING INTO SHOULDER DAY 3 @ 3AM FELT HEANEYNESS IN CHEST, SEVER BODY ACHES, PRODUCTIVE COUGH, COUGHING UP ACID TASTE
52 2021-01-06 heart rate increased, palpitations, fast heart rate Patient is a 52 y.o. male. Chief Complaint Patient presents with ? Allergic reaction     Reaction ... Read more
Patient is a 52 y.o. male. Chief Complaint Patient presents with ? Allergic reaction     Reaction to Covid Vaccine       Is patient concerned about a specific cause for the current symptoms? Yes Covid Vaccine Onset of symptoms: 0830. Symptoms include: difficulty breathing and/or wheezing, rapid heart rate or palpitations and generalized redness. Rash distribution: Face. How are symptoms changing over time? improving.   Patient describes symptoms as moderate. Has patient tried any treatment for these symptoms?No What makes the symptoms better? Rest and time What makes the symptoms worse? Nothing   Patient states that the shortness of breath and the increased heart rate started after about 4 minutes - then went away but came back much stronger at 10 minutes post vaccination   No itching, wheezing, cough - just flushed and chilled Increased HR and jittery   Did have surgery recently   Did have Moh's procedure in the fall and had a reaction to the lidocaine - increased heart rate, increased blood pressure   Associated symptoms:   o Fever No   o Sore throat No   o Recent illness No   o Exposure to person(s) with similar rash No   Patient has flu vaccine documented this season.  Patient Active Problem List Diagnosis ? Migraine ? Obstructive sleep apnea syndrome ? Calculus of gallbladder without cholecystitis without obstruction ? Hemiplegic migraine without status migrainosus, not intractable ? Low HDL (under 40) ? History of nonmelanoma skin cancer ? Encounter for screening colonoscopy ? Essential tremor   Medical History Past Medical History: Diagnosis Date ? Acquired hypothyroidism   ? Chronic kidney disease     Stage 2 ? Chronic migraine with aura 01/04/2013 ? Colon polyps   ? Color blind   ? Enlarged prostate   ? GERD (gastroesophageal reflux disease)   ? Hemiplegic migraine   ? Hx of febrile seizure   ? Kidney stones     x 1 - 2001 ? Nodular basal cell carcinoma (BCC) 09/08/2020   bcc nod, rt cheeck and rt medial cheek ? Obstructive sleep apnea syndrome 11/04/2013   Home sleep testing on 10/31/13 with apnea/hypopnea index = 9 and low oxygen saturation = 90%. Auto-PAP titration pending. Surgical History Past Surgical History: Procedure Laterality Date ? Colonoscopy   04/10/2020   ksc ? Hx lap cholecystectomy N/A 12/23/2020   LAPAROSCOPIC CHOLECYSTECTOMY ? Hx of mohs/skin cancer surgery and repair   09/08/2020   bcc nod, rt cheek ? Hx of mohs/skin cancer surgery and repair   09/08/2020   bcc nod, rt medial cheek ? Hx wisdom teeth extraction     ? Upper gi endoscopy   04/10/2020   ksc Objective: BP 116/74 | Pulse 84 | Temp 97.9 °F (36.6 °C) (Oral) | Resp 18 | SpO2 97% General:well-hydrated, well nourished, no acute distress HEENT: ENT exam normal, no neck nodes or sinus tenderness Lung: clear to auscultation bilaterally Heart: regular rhythm, tachycardia noted and no murmurs, clicks, or gallops. Extremities: extremities normal, atraumatic, no cyanosis or edema Skin: flushed (face and neck and chest primarily) , no hives Neuro: alert, orientation normal, speech normal   9:30 AM Improving symptoms Decreased HR, although patient states if feels like it is cycling, flushing is almost resolved No hives or shortness of breath Mild jittery feeling  
52 2021-01-06 palpitations Dizziness, Palpitations & HYPERtension Narrative: Employee received vaccine this AM at approximatel... Read more
Dizziness, Palpitations & HYPERtension Narrative: Employee received vaccine this AM at approximately 0853 this AM, Patient was monitored for 30 minutes after receiving vaccine based on employees verbal report of having a prior reaction to the flu vaccine about 10 years ago. The employee reported having heart palpitations and it felt like "heart was beating out of chest" while on duty after the observation period was complete. The employee returned to the vaccine clinic for further evaluation and was assessed and vitals were taken. Employee was noted to have a heart rate around 105-110s and a BP of 170s/ 90s which the employee stated was "unusual". The employee was then monitored for an additional 30mins, which after 15 mins the employee stated "I'm feeling really bad" , employee reported dizziness and stated "I feel like I'm going to pass out. The employee was started on 2L 02 via face mask and transported to the ER for further evaluation. Vitals were reassessed and found to be within normal limits. Patient verbally reported feeling much better at this time.
52 2021-01-07 hypertension Headache, HYPERtension, congestion Narrative: home to take daily zyrtec for congestion;
52 2021-01-07 fainting Patient had severe nausea/vertigo episode upon awakening on 1/8/21. Patient fainted and collapsed on... Read more
Patient had severe nausea/vertigo episode upon awakening on 1/8/21. Patient fainted and collapsed onto bathroom floor. He hit his head on the wall during the fall. Patient was found barely conscious by his wife right after the fall. Patient temperature, O2 sat and BP all within normal limits measured within 5 minutes of fall. Patient does have history of Meniere's disease x 5 years, but is well-controlled with medication and middle ear steroid injections. Patient has not had severe vertigo episode in 2+ years.
52 2021-01-09 hypertension hypertension (pulse >100), dizziness. Pushed fluids.
52 2021-01-12 hypertension, fast heart rate almost immediately started feeling warm and dizzy, stated I don't feel right. Had him lie down, admi... Read more
almost immediately started feeling warm and dizzy, stated I don't feel right. Had him lie down, administered O2 at 2l/m for feeling of SOB. B/P was elevated at 197/97, O2 sat 98%, heart rate was tachycardia at 140's. Had patient lie down while being monitored. HR slowly came down, B/P systolic dropped 30 points to 160's
52 2021-01-13 atrial fibrillation, cerebral haemorrhage Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable ... Read more
Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter
52 2021-01-14 dilation of blood vessels A day or so after taking the First Merdona immunization 1/6/21 developed warmth in rt arm with redn... Read more
A day or so after taking the First Merdona immunization 1/6/21 developed warmth in rt arm with redness and some pain. Also noted burning on right side under rt arm and back. within 3 days of vaccine had a eruption of an rash on my back and over the weekend 1/11/21 developed vesicles under RT Brest
52 2021-01-16 heart rate increased Patient developed sensation of rapid heart rate followed by urticaria. Vague sensation of dyspnea, ... Read more
Patient developed sensation of rapid heart rate followed by urticaria. Vague sensation of dyspnea, "like running in cold weather" Patient has anaphylactic reaction to shellfish. About 6 hours prior to onset of urticaria and dyspnea, had eaten in a restaurant that does also sever shellfish. Cross contamination cannot be ruled out
52 2021-01-24 chest discomfort CHEST PRESSURE/CONGESTION, HEAD CONGESTION. SYMTOMS SUBSIDED WITHIN 36 HOURS.
52 2021-01-24 fainting 6 episodes of syncope two days after vaccination resulting in hospital admission for what may be an ... Read more
6 episodes of syncope two days after vaccination resulting in hospital admission for what may be an autonomic dysfunction
52 2021-01-30 chest pain, inflammation of the heart muscle, troponin increased The patient had a very severe side effect profile from the second dose of vaccine: "worst I've ever... Read more
The patient had a very severe side effect profile from the second dose of vaccine: "worst I've ever felt" with myalgia, headache, fever and fatigue. This subsided and then on day 3 he developed severe substernal chest pain and came to ER where his hs-cTnI was > 2000 ng/L and peaked at 6700 ng/L. His ECG, echo and cardiac cath were normal but MRI showed evidence of myocarditis with mild left ventricular dysfunction. He is doing well clinically and we are managing expectantly. This appears to be immune mediated myocarditis from the Moderna vaccine
52 2021-02-01 pallor Patient reported feeling foggy, and appeared pale. Patient also reported dry mouth, given water and ... Read more
Patient reported feeling foggy, and appeared pale. Patient also reported dry mouth, given water and that did subside. Fogginess continued but mentation appeared delayed. EMTs brought to evaluate patient. Vital signs taken, full neuro assessment was completed. Gait was weak and unbalance when moving toward stretcher. Patient was sent to Emergency Room via EMT with medic assistance.
52 2021-02-24 chest discomfort Body aches, nausea & chest (lung) discomfort lasting from approximately 4:00am until 12:00pm
52 2021-02-24 chest pain, palpitations heart palpitations, tired, chest pain, anger outbursts, diarrhea , head ache.
52 2021-02-28 fainting, hypotension Fainting twice; Low blood pressure; Sweating like hell; Dizziness; Significant chill; Body was feeli... Read more
Fainting twice; Low blood pressure; Sweating like hell; Dizziness; Significant chill; Body was feeling hot; A spontaneous report was received from a consumer, a 52 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, who experienced fainting twice (syncope), low blood pressure (hypotension), sweating like hell (hyperhidrosis), dizziness, significant chills (chill), and body was feeling hot (pyrexia). The patient's current conditions included epilepsy and slight cholesterol. Historical condition was not reported. Products known to have been used by the patient, within two weeks prior to the event, included eslicarbazepine acetate, simvastatin, atorvastatin, sertraline hydrochloride, acetylsalicylic acid, ubidecarenone, vitamins nos, fish oil and cyanocobalamin. On 13 Feb 2021, prior to the onset of symptoms, the patient received their second planned dose of mRNA-1273, (lot number: 030M20A), intramuscularly into right upper arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, after administering the vaccine, patient stated that everything was normal. The patient stated that he went to bed at 9 pm and at 11 pm, he started feeling significant chill and body was feeling hot. On 14 Feb 2021, at 2 am, the patient woke up to go restroom because he was sweating like hell and felt dizziness. The patient's wife noticed that the patient had fainted, and she stood him up and fainted again. His wife made him sat down on the bed and called 911. Once the paramedics arrived, the patient underwent electrocardiogram (EKG) that was normal and checked his blood pressure (BP) that was at 95/82 (unknow units). The patient stated that his BP was usually normal at 120/80 or 85. The paramedics took him to hospital. In the ambulance, they performed another EKG and BG which came out to be normal. The patient was taken to the hospital and they performed multiple blood test that came out to be normal. The patient stated that the nurse gave him unspecified intravenous (IV) liquid as treatment medication for the events which he does not remember. The patient also informed that the doctors concluded that this may happen due to Moderna COVID-19 vaccine. The patient was discharge from the hospital at 4:14 am of 14 Feb 2021. The patient does have light dizziness but not heavy and no other symptoms. The outcome for the event(s), fainting twice, low blood pressure, sweating like hell, significant chills, and body was feeling hot were considered as resolved/recovered on 14 Feb 2021 and that of event, dizziness, was reported as 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 event, a causal relationship cannot be excluded. Further information has been requested.
52 2021-03-05 hypertension, heart rate increased 5 days after shot, had extreme arm pain and reoccurrence of low grade fever. Also later experienced ... Read more
5 days after shot, had extreme arm pain and reoccurrence of low grade fever. Also later experienced extreme pain in right calf and left thigh. 8 days after shot, saw nurse practitioner who prescribed keflex for the arm and rest/ice for the legs. Arm improved but continued to experience low grade fevers every afternoon/evening. Also showed increase in resting heart rate starting the day after the shot from 55 bpm to 70 bpm 12 days later. Blood pressure also above normal levels
52 2021-03-10 fainting I have taken the 2nd Moderna Shot that morning. During my sleep i felt bad and i was sweaty middle o... Read more
I have taken the 2nd Moderna Shot that morning. During my sleep i felt bad and i was sweaty middle of the night i headed to restroom. And i have fainted. My wife called 9-1-1 when i was awake, i have noticed my sweat. they did EKG and checked my blood pressure 85/95 95 was too low, my tpical is 80/120. EKG was clean. they took me to the ER . Dr . treated me. Two times EKG has conducted all clean, IV connected. Multiple lab tests have been conducted. My diagnosis was poisoning by vaccine.
52 2021-03-16 superficial blood clot No reaction to first shot. Received the second shot the morning of 18 Feb, noticed some minor joint ... Read more
No reaction to first shot. Received the second shot the morning of 18 Feb, noticed some minor joint stiffness, minor pain and tiredness mid morning 19 Feb. Laid down at 16:30 and remained asleep until 0530 the next day. Unusual to sleep 13 hours. Later that weekend I noticed a bruise on my leg. I rarely bruise and had not hit my leg on anything. I ignored the bruise a couple weeks, but as it did not heal, continued to hurt and had swelling I went to my primary doctor on 4 March who thought it was a blood clot and sent me for imaging. They determined it was superficial thrombophlebitis and treated with antibiotics and heat.
52 2021-03-18 fainting, hypotension Patient was nervous due to his shellfish allergy and was apprehensive. He went to get a glass of wat... Read more
Patient was nervous due to his shellfish allergy and was apprehensive. He went to get a glass of water after he was vaccinated and when he sat down, missed his chair and had a syncope episode. Taken back by EMS to secluded area, vitals and glucose checked. Glucose was normal, BP reported as low and EMS decided he should be transported. EMS provided fluids, monitored at ER, BP came back to normal and he was released.
52 2021-03-24 blood pressure increased, heart rate increased, palpitations Lightheadness, racing heartbeat, Face numbness, rolling symptoms throughout body, elevated blood pre... Read more
Lightheadness, racing heartbeat, Face numbness, rolling symptoms throughout body, elevated blood pressure, wrong words being spoken, lower back pain and swelling of arm at injection site.
52 2021-03-28 fainting Patient fainted while sitting at the post-vaccination waiting area about 10 minutes after vaccinatio... Read more
Patient fainted while sitting at the post-vaccination waiting area about 10 minutes after vaccination. Immediately reached out to the patient. Positioned him properly. Other Pharmacist called 911. less than a minute, patient responded. He sat down and meantime the paramedics came in. They took him to the E.R. Called patient after 5 hours, he is still in the ER under observation. but he feels fine
52 2021-03-29 loss of consciousness AFTER RECEIVING THE VACCINATION AND SITTING IN WAITING ROOM FOR 5 MINUTES, PERSON PASSED AND FELL FR... Read more
AFTER RECEIVING THE VACCINATION AND SITTING IN WAITING ROOM FOR 5 MINUTES, PERSON PASSED AND FELL FROM CHAIR, HITTING HIS HEAD ON THE FLOOR. HE WAS HELPED BACK TO HIS CHAIR BY NURSES AND PARAMEDICS, WHO THEN ASSESSED HIS CONDITION. HE STATED HE HAD NOT EATEN ALL DAY. NURSE WHO ASSISTED HIM STATED UN RESPONSIVE TO COMMANDED, DIAPHORETIC PROFUSELY, HOT, HAD VOIDED ON HIMSELF, AND WAS LSLIGHTLY MOANING. HE STATED "MY HANDS FEEL WEIRD," AND THAT HIS VISION WAS BLURRY. PARAMEDICS COMPLETED CHECK UP INCLUDING RUNNING AN EKG ON THE SPOT. PATIENT WAS TAKEN TO THE AMBULANCE ONSITE BUT REFUSED ADDITIONAL TREATMENT.
52 2021-03-30 fainting patient fainted and fell to floor from chair during the waiting period of 15 minutes
52 2021-04-03 hypertension 11:42 patient complained of headache and stiff neck. NP and on site EMS evaluated patient. No medica... Read more
11:42 patient complained of headache and stiff neck. NP and on site EMS evaluated patient. No medications given. VS @11:24 BP 148/100; HR77; SAT 98% on RA VS@11:30 BP 165/111;HR 87; SAT 98% on RA Patient education- recommendation to follow up with PCP regarding HTN, which he states is a new problem for him. Stated his headache is better and less intense. Discharged home @ 11:42
52 2021-04-05 chest pain Generalized and severe joint pain, mainly in lower back, shoulders and thorax
52 2021-04-05 chest pain c/o shortness of breath and chest pain after vaccination. Pt was transported by EMS to Hospital.
52 2021-04-08 loss of consciousness Patient did say before vaccine that he has fainted in the past from previous vaccines. I had a Repre... Read more
Patient did say before vaccine that he has fainted in the past from previous vaccines. I had a Representative administer vaccine while i stood next to patient and talked with him as a distraction from the shot. After Representative gave the vaccine patient asked "did you give vaccine?", he then immediately started to sweat very hard and said he was light headed (he was sitting down), then his eyes rolled back and he slouched down in chair, at which point I held him so he did not fall on floor. He started to jerk and twitch, perhaps was having a seizure, and was sweating very hard. I held him in chair so he would not hit his head or get hurt. After about 30 seconds he regained consciousness and asked how long he was out. His T-shirt was soaked in sweat and he said he felt very dizzy. The Representative got him an ice pack and placed at base of neck, which he said helped alot. I sat with him for 10-15 minutes until he said he felt fine. I asked if he needed medical care and he said he did not, just needed to sit for awhile, and said this has happened before. I gave him a chair to sit in after he was fully alert and he sat for close to half an hour, at which point he said he was back to himself and felt fine. I did offer he could stay as long as needed and I could call anyone if he needed me too, he insisted he was fine and after about 45 minutes he left. I did call him the next day to check on him and he said he was fine.
52 2021-04-13 cerebrovascular accident Patient called to follow up on what may be an adverse effect of the vaccine, according to him and hi... Read more
Patient called to follow up on what may be an adverse effect of the vaccine, according to him and his doctors. After both vaccines patient did not complain any adverse effects. It was on Sunday 4/11/2021 that he suffered from a stroke. At work he was walking around and began to feel his left side of his body and face go numb. This lasted for 4-5 hours. He went to Hospital after a few hours and the ER did many imaging tests to which no abnormal results were revealed. Patient has no damage from stroke, paralysis of face is gone. His current treatment is baby aspirin and he will follow-up with neurology. Patient has not complains as of right now but did make it a point to want to document his experience. Pt has no medical hx, is not a smoker, and lives a healthy lifestyle. Patient was encouraged to call if any new follow-up information occurs.
52 2021-04-13 transient ischaemic attack Transient ischemic Attack; Double vision; Sore injection site; Red injection site; This spontaneous ... Read more
Transient ischemic Attack; Double vision; Sore injection site; Red injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 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 VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site). On 02-Apr-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) (seriousness criterion medically significant). On 01-Apr-2021, VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site) had resolved. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. Treatment of these events included aspirin, Lipitor and Plavix. Based on the current 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.
52 2021-04-14 cardiac failure congestive I started to retain water and eventually gained 26lbs in the next week and ended up in congestive he... Read more
I started to retain water and eventually gained 26lbs in the next week and ended up in congestive heart failure. Doctor was able to get water retention reduced and all is back to normal
52 2021-04-15 pulmonary embolism, fainting, deep vein blood clot Admitted with acute saddle PE with RV strain on 4/13/21, syncope, required TPA. LLE with acute DVT
52 2021-04-16 heart attack REPOERTED BY FAMILY MEMBER THAT THEY FOUND PATIENT DEAD IN SLEEP, NOT BREATHING SUSPECTING HEART ATT... Read more
REPOERTED BY FAMILY MEMBER THAT THEY FOUND PATIENT DEAD IN SLEEP, NOT BREATHING SUSPECTING HEART ATTACK...AUTOPSY WILL BE PERFORMED
52 2021-04-18 transient ischaemic attack Mini-stroke transient ischemic attack; Room spinning; Winking eyelids involuntarily; Felt like he wa... Read more
Mini-stroke transient ischemic attack; Room spinning; Winking eyelids involuntarily; Felt like he was falling to his right side; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included Open heart surgery. Concomitant products included POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), WARFARIN, METOPROLOL SUCCINATE (TOPROL XL), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), VERTIGO (Room spinning) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required) and BLEPHAROSPASM (Winking eyelids involuntarily) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) 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. Patient received vaccine in right non-dominate deltoid muscle to prevent COVID-19. Patient was admitted to hospital from 19Mar2021 to 21Mar2021 for a magnetic resonance imaging (MRI) and computerized tomography (CT) scan, with observation and Low-Dose Aspirin. Patient was feeling much better and his cardiologist recommended that he receives his second Moderna vaccine as soon as required and to take an extra Vitamin D supplement as a precaution. Scheduled second dose was due on 08Apr2021. Treatment included was low dose aspirin.; 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.
52 2021-04-19 excessive bleeding 52 m active alcoholic with lab abnormalities c/w heavy etoh including pancytopenia (anemia to 7s, th... Read more
52 m active alcoholic with lab abnormalities c/w heavy etoh including pancytopenia (anemia to 7s, throbocytopenia to 70s, mild leukopenia-since 12/20); 2 recent admissions (feb march 2021) with likely etoh-induced pre-renal AKI; DM; who received 2nd dose of moderna 4/8/21. After not being in contact with his family for several days, family sought him at his residence where he was found pulsless and apneic on the floor with some scant blood near his face. CPR-- >transported to hospital where upon attempting to intubate profuse bleeding into larynx/pharynx noted. Despite ongoing cpr and mechanical ventilation team in ER was unable to re-establish pulse. He was pronounced dead at about 8 PM 4/9/21.
52 2021-04-20 deep vein blood clot Approximately 3 weeks after 1st Moderna COVID-19 vaccine, patient began experiencing pain and swelli... Read more
Approximately 3 weeks after 1st Moderna COVID-19 vaccine, patient began experiencing pain and swelling below right knee. Patient was diagnosed 10 days later with DVT and prescribed anticoagulant therapy. Patient received 2nd dose of Moderna vaccine after the onset of pain and swelling, but before being diagnosed with DVT.
52 2021-04-20 heart rate increased severe dizziness when physically getting up from bed and when lying down. Mild dizziness throughout... Read more
severe dizziness when physically getting up from bed and when lying down. Mild dizziness throughout the day. Rapid heart beat.
52 2021-04-21 heart rate increased, blood pressure increased For several days a low grade fever got worse each day. Top temperature recorded was 102.8 using dig... Read more
For several days a low grade fever got worse each day. Top temperature recorded was 102.8 using digital thermometer. Pulse rate and blood pressure also increased. On the worst night, April 20, pulse was 105, blood pressure was 150 over 110. Patient also experienced extreme chills, sweating, and hallucinations. The following day the entire body was sore and ached. The following days the symptoms subsided but have yet to completely go away. The other aspect is that these symptoms were not as bad in the day time as they were overnight. The symptoms came in waves.
52 2021-04-21 palpitations 15 minutes after the shot, I became lightheaded in the waiting area and felt like I was going to bla... Read more
15 minutes after the shot, I became lightheaded in the waiting area and felt like I was going to black out. I seemed fine after, and shrugged it off as I sometimes experience this on a rare occasion. Thought it was my anxiety from all the drama hearing about side effects. They kept me for 40 minutes and asked me a few questions and felt that I looked and acted normal. My ride home, my vision seemed "off" and again, I shrugged it off to anxiety. I also had light heart palpitations. I get these sometime when I'm stressed, overly tired, too much coffee, or have anxiety. I wasn't dizzy at all, but my balance felt a tad "off" I was much better in the morning and back to normal within about 24hrs. I am worried about geting my 2nd shot as I read people being dizzy and with super high blood pressures...... Hoping these "symptoms" were just from myself getting worked up about..... possible side effects and allergic reactions.
52 2021-04-21 blood clot Blood clot in mouth on day 2, 9, and 16 from first injection
52 2021-04-22 blood clot 4 days (4/20/2021) post vaccination pain in right calf was experienced. As the pain did not resolve ... Read more
4 days (4/20/2021) post vaccination pain in right calf was experienced. As the pain did not resolve over the next week and felt similar to a DVT experienced post a spinal fusion in 2018 I consulted, on 4/16/2021, with the vascular surgeon, who treated my post surgery DVT in 2018 . He performed an ultrasound and identified a clot in my right calf. On 4/21/2021 he prescribed a course of Eliquis (initial dose 20 mg per day) to resolve the clot. As of today (4/23/2021) the pain has lessened but not resolved. In addition to the DVT I experienced a significant level of fatigue for 3 days post the vaccination. While the fatigue has lessened it has not completely resolved.
52 2021-04-22 transient ischaemic attack TIA; Lips numb; Face numb; Eyes spinning; Right eye winking; Feeling Cloudy vision; Dizziness; CHILL... Read more
TIA; Lips numb; Face numb; Eyes spinning; Right eye winking; Feeling Cloudy vision; Dizziness; CHILLS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (CHILLS). On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization), HYPOAESTHESIA ORAL (Lips numb) (seriousness criterion hospitalization), HYPOAESTHESIA (Face numb) (seriousness criterion hospitalization), EYE MOVEMENT DISORDER (Eyes spinning) (seriousness criterion hospitalization), EXCESSIVE EYE BLINKING (Right eye winking) (seriousness criterion hospitalization), VISION BLURRED (Feeling Cloudy vision) (seriousness criterion hospitalization) and DIZZINESS (Dizziness) (seriousness criterion hospitalization). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to DIZZINESS, EXCESSIVE EYE BLINKING, EYE MOVEMENT DISORDER, HYPOAESTHESIA, HYPOAESTHESIA ORAL, TRANSIENT ISCHAEMIC ATTACK and VISION BLURRED. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHILLS (CHILLS) had resolved. CT scan of the head was done and MRI. Patient said he was discharged on Sunday, March-21st. He said his symptoms were gone after that and he was given baby aspirin. The action taken of all the events with the suspect drug Moderna COVID-19 Vaccine was not applicable. The causality of all events was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's medical history and concomitant medications are necessary for assessment. Further information has been requested.
52 2021-04-23 cerebral haemorrhage Diminished sensation of the right arm and leg with diminished sensation of the left side of face, pa... Read more
Diminished sensation of the right arm and leg with diminished sensation of the left side of face, pain of left occipital extending to temporal area over ear
52 2021-04-24 chest pain patient reported rash and pain in chest, torso and back areas. Instructed patient to see doctor.
52 2021-04-24 loss of consciousness Dizziness that resulted in blacking out for appx 1 min
52 2021-04-25 chest pain Client states he has been having chest pain on and off for 3 days. No strenuous exercises or anythin... Read more
Client states he has been having chest pain on and off for 3 days. No strenuous exercises or anything different. No history of Cardiac issues or elevated BP.
52 2021-04-25 loss of consciousness Shortly after midnight, started in bed with chills for about 2 hours then felt warm then cold and b... Read more
Shortly after midnight, started in bed with chills for about 2 hours then felt warm then cold and back and forth. Woke up around 7:30am with a fever. At 8:45am, walked upstairs to use the bathroom. While in the bathroom, felt dizzy and passed out. My wife and son heard a thud sound. My wife opened the door and I tumbled out still unconscious. I regained consciousness moments later. I was examined by paramedics who arrived at my home.
52 2021-04-26 fainting Patient fainted shortly after getting vaccine. His wife and I helped support him on the chair so tha... Read more
Patient fainted shortly after getting vaccine. His wife and I helped support him on the chair so that he did not fall. We performed supportive measures - drink of water, cold compress.
52 2021-04-27 deep vein blood clot shot on wednesday, on thursday, i began experiencing pain in right leg? by sunday pain in the calve... Read more
shot on wednesday, on thursday, i began experiencing pain in right leg? by sunday pain in the calve muscle? went to ER on Monday afternoon? and was Diagnosed with a DVT? (note, I have no history of blood clots/DVT)
52 2021-04-27 pallor After a few minutes of administering the first Moderna vaccine patient reported to have blurry visio... Read more
After a few minutes of administering the first Moderna vaccine patient reported to have blurry vision with spots, and dizziness. Within a few minutes patient became very sweaty, became pale with mild shakiness. Patient stated he ate every little before getting the vaccine. Pt also stated he was anxious and nervous. Blood pressures were taken at the beginning of the event with a reading of 86/66, heart rate 65. Cold compressions were placed on patient's forehead and arm. after 30 minutes patient felt better and symptoms resolved. Blood pressure upon leaving was 124/76 heart rate 85. Patient walked out without a problem.
52 2021-04-28 heart attack Patient was found unresponsive on 4/15/2021. Patient seemed to pass in his sleep per family member. ... Read more
Patient was found unresponsive on 4/15/2021. Patient seemed to pass in his sleep per family member. The coroner deemed myocardial infarction. No autopsy completed.
52 2021-04-28 palpitations Within 2 minutes after COVID vaccine first shot I felt a flushing sensation and began developing hea... Read more
Within 2 minutes after COVID vaccine first shot I felt a flushing sensation and began developing heart palpitations. It lasted about 5-8 minutes. I sat down for 15 minutes as required by the clinic for all those getting shots. After about 8 minutes heart stopped racing and slowly got back to normal. It did not appear to be caused by anxiety. I did not report it to the clinic staff. In researching this allergic reaction is likely related to Polyethylene Glycol allergy. When I got a colonoscopy a few years ago I used colo prep. Back then my heart was pounding hard the night before and the day of the examination. I did not know it was a side-effect from the solution. Doctors could not explain why my heart rate was high but went ahead with the exam. With the current event it appears is the common link between then and the COVID vaccine.
52 2021-04-30 loss of consciousness Headache; Patient developed a cough on Friday; Patient reports he rarely has an appetite; urinary tr... Read more
Headache; Patient developed a cough on Friday; Patient reports he rarely has an appetite; urinary track infection/felt his urinary track and kidneys were being attacked/urge to urinate; urinary incontinence; patient had projectile vomiting after waking up; violet shaking the next morning; heavy sweat; passed out after vomiting; upper gum was numb; tip of tongue was tingling; feel like having a flu; neck was sore; odd supersmell; testicle started to hurt and are swollen; patient reports having lethargy; Patient reported blood in urine; Patient had fever of 101 F; having joint pain in knees and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out after vomiting) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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 LISINOPRIL for Hypertension. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out after vomiting) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (upper gum was numb), PARAESTHESIA ORAL (tip of tongue was tingling), INFLUENZA LIKE ILLNESS (feel like having a flu), NECK PAIN (neck was sore), PAROSMIA (odd supersmell), TREMOR (violet shaking the next morning), HYPERHIDROSIS (heavy sweat), TESTICULAR PAIN (testicle started to hurt and are swollen), LETHARGY (patient reports having lethargy), HAEMATURIA (Patient reported blood in urine), PYREXIA (Patient had fever of 101 F) and ARTHRALGIA (having joint pain in knees and shoulder). On 21-Apr-2021, the patient experienced URINARY TRACT INFECTION (urinary track infection/felt his urinary track and kidneys were being attacked/urge to urinate), URINARY INCONTINENCE (urinary incontinence) and VOMITING PROJECTILE (patient had projectile vomiting after waking up). On 22-Apr-2021, the patient experienced DECREASED APPETITE (Patient reports he rarely has an appetite). On 23-Apr-2021, the patient experienced COUGH (Patient developed a cough on Friday). On an unknown date, the patient experienced HEADACHE (Headache). On 20-Apr-2021, HYPOAESTHESIA ORAL (upper gum was numb) and PARAESTHESIA ORAL (tip of tongue was tingling) had resolved. On 23-Apr-2021, HAEMATURIA (Patient reported blood in urine) outcome was unknown. On 24-Apr-2021, DECREASED APPETITE (Patient reports he rarely has an appetite) had resolved. On 25-Apr-2021, COUGH (Patient developed a cough on Friday) outcome was unknown. At the time of the report, LOSS OF CONSCIOUSNESS (passed out after vomiting), INFLUENZA LIKE ILLNESS (feel like having a flu), NECK PAIN (neck was sore), PAROSMIA (odd supersmell), URINARY TRACT INFECTION (urinary track infection/felt his urinary track and kidneys were being attacked/urge to urinate), URINARY INCONTINENCE (urinary incontinence), VOMITING PROJECTILE (patient had projectile vomiting after waking up), TREMOR (violet shaking the next morning), HYPERHIDROSIS (heavy sweat), TESTICULAR PAIN (testicle started to hurt and are swollen), LETHARGY (patient reports having lethargy), PYREXIA (Patient had fever of 101 F), ARTHRALGIA (having joint pain in knees and shoulder) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment with ciprofloxacin for urinary tract infection and Flomax for prostate, were 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. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
52 2021-05-04 blood pressure increased 3 hours and 45 min after getting the injection, I had a series of symptoms: -Feeling as if head in ... Read more
3 hours and 45 min after getting the injection, I had a series of symptoms: -Feeling as if head in a vise, crushing pain on all sides. -Blood pressure started rapidly rising to the highest blood pressure I have ever felt. This felt much worse than 250 blood pressure which I have had before. Blood pressure went from normal to 250+ in less than 10 minutes. -Shock symptoms started and I became freezing cold and felt like I would pass out. -I got into bed under many blankets, and I took Benadryl and my blood pressure medicine 3 hours early. I was ready to call an ambulance since I felt I would pass out. The cold sensation lasted all night; each time I got out of bed I started shaking cold. -This morning the symptoms are mainly elevated blood pressure by about 50 points. No one has been able to advise me if I should take the second shot, and that is really bad.
52 2021-05-05 fainting According to facility manager. The patient was on dialysis but found unresponsive 2 hours after rec... Read more
According to facility manager. The patient was on dialysis but found unresponsive 2 hours after receiving the vaccine. CPR was initiated, automated external defibrillator was used (shocked x2)- transported by EMS to hospital
52 2021-05-05 blood vessels inflammation Started breaking out in a rash on feet and lower legs and developed bruising. Red spots went to upp... Read more
Started breaking out in a rash on feet and lower legs and developed bruising. Red spots went to upper thigh and lower back. A few spots on both arms.
52 2021-05-07 pallor Patient experienced nausea, paleness, and sweating. Used an ice pack. Called 911. Paramedics arrived... Read more
Patient experienced nausea, paleness, and sweating. Used an ice pack. Called 911. Paramedics arrived and assessed patient inside and then moved patient outside for further assessment. Called patient after leaving the pharmacy and his wife stated that he was doing fine and back to normal.
52 2021-05-09 palpitations, hypertension large rash on the leg, high fevers, high blood pressure, palpitations, chills, nausua,
52 2021-05-18 pulmonary embolism, chest pain On 5-13-21 the patient began complaining of dizziness, weakness, and left side chest pain. The pati... Read more
On 5-13-21 the patient began complaining of dizziness, weakness, and left side chest pain. The patient was sent to a hospital via 911 ambulance and admitted to the hospital from 5-13-21 to 5-18-21. He was diagnosed with a Pulmonary Embolism, Acute Venous Thrombosis, and a Pulmonary Embolism.
52 2021-05-20 heart attack STEMI happened shortly after Moderna vaccine
52 2021-05-22 hypertension, chest discomfort (5/11) after eating beef jerky & salmon jerky :throat swelling, tightness in chest, indigestion, ton... Read more
(5/11) after eating beef jerky & salmon jerky :throat swelling, tightness in chest, indigestion, tongue burning, dizziness, lightheaded, high bloodpressure ?. (5/12) after eating pistachios, lettuce: throat swelling, tightness in chest, tongue burning, pain in mouth went to urgent care.. did ekg, heart ok , vitals ok initial high reading of blood pressure returned to normal and released (5/14) pain in chest, tightness same as above with throat swelling , went to ER ?. ekg, chest xray, high blood pressure ..nitro glycerine tablets given TWICE ...tightness in chest feeling gone, bp returned to normal .. follow up with primary care and cardiologist was recommended. (5/15) after eating baked potato, same allergic reactions returned in mouth, patient went to urgent care.. was seen and diagnosis food allergy given epi pen, Pepcid, bentyl (5/16) after taking medications : Bentyl and Pepcid was having allergic reaction, discontinue use of those 2 meds
52 2021-05-22 loss of consciousness Possible Vasovagal Syncope: passed out, red, clammy face, confusion, weakness, muscle spasms
52 2021-05-26 palpitations, palpitations Diarrhea for approximately 4 weeks, Heart palpitations and skipping beats starting at vaccine date ... Read more
Diarrhea for approximately 4 weeks, Heart palpitations and skipping beats starting at vaccine date and still currently happening.
52 2021-05-26 fast heart rate, heart attack, fluid around the heart, inflammation of the pericardium, sinus rhythm, increased heart rate 54 days after the first vaccination with Moderna Covid-19 Vaccine, and 25 days after the second vacc... Read more
54 days after the first vaccination with Moderna Covid-19 Vaccine, and 25 days after the second vaccination, at approximately 0730 on Day 1, a 52 year old male, height 175.2cm, weight 95.5kg, without significant medical history or prodrome, had an acute onset of dyspnea manifesting as a small sigh at intervals of 4-6 minutes, which increased in frequency to intervals of 2-3 minutes over the course of the day. At approximately 1400 he had a one minute episode of tachycardia >120 bpm. At 1515, his forehead became diaphoretic. He had neither chest pain nor a pericardial friction rub at any time. He went directly to the local emergency department. Additional information for Item 18: Blood pressure at admission was 155/87, pulse 97, respiratory rate 22/minute, SpO2 98%, and Temperature 37.2. ECG at 1539 interpreted as: "NSR at 85, Lateral ST depressions; ST elevations in aVR, ischemia / Posterior wall MI". ECG at 1541 showed: NSR at 82, unchanged from prior ECG. ECG at 1552 interpreted as: "Sinus tachycardia at 102, ST depressions remain in lateral leads but now also in V3 and V4; persistent ST elevations in aVR CW evolving posterior wall MI". PR depression in leads II and V4-6, and reciprocal PR segment elevation in aVR (pericarditis ECG Stage 1) Atypically for pericarditis, ST depression, rather than ST elevation, was present in leads V3-V6. Owing to a working diagnosis of an evolving posterior wall myocardial infarction, an emergent cardiac catheterization was performed, which demonstrated non-obstructive CAD and a small myocardial bridge. Initial laboratory values were notable for a white blood cell count of 11.89 K/mm3 (4.5 - 11.5), monocytes 1.1 K/mm3 (0.0 -1.0), 9.4% (2.0 - 9.0), neutrophils 7.9 K/mm3 (1.5 - 6.6), 66.9% (40.0 - 75.0). Troponin was negative at admission and 18 hours later. D-Dimer was negative. Viral panels including SARS-CoV-2, Influenza A, Influenza B, and RSV were negative. He was admitted for overnight observation. On Day 2 an echocardiogram was normal with no effusion, and ECG was notable for the absence of PR depression and persistent ST depression in leads (PR segment normalization part of pericarditis ECG Stage 2)Â…... His dyspnea persisted, with a moderate sigh every 1-2 minutes at rest. He was discharged with a presumptive diagnosis of coronary vasospasm or a pulmonary etiology, and told to follow up with his pmd. Over the next several days, his dyspnea was continuous and progressively worsened, and he had diaphoresis of the forehead every morning approximately 0900 until Day 20. Sleep remained normal. On Day 5 he was sighing deeply more than once per minute at rest, causing him distress, and ECG showed (?persistent ST depression in V4-6 with reciprocal changes in aVR). On Day 12, ECG showed T-wave inversion in V1-6 and ST depression in V3-6 (ECG Stage 3); a computed tomography of the chest was normal; and blood tests notable for normal monocyte count .57 K/microliter (0.0 - 0.8), normal CRP 2.15 (1.0-3.0), and an ANA titer of 1:80 (elevated) described as a speckled pattern, which is associated with several autoimmune diseases. Repeat echocardiography on Day 26 showed a small, generalized pericardial effusion and was otherwise normal. Cardiac MRI on Day 29 showed delayed gadolinium uptake. Pulmonary function tests on Day 38 were normal. Stress echocardiography on Day 44 was normal. Cardiac CT angiogram on Day 46was normal. The patient was diagnosed with pericarditis of unknown origin and started on aspirin 650 mg p.o. b.i.d. An ECG on Day 80 showed PR depression in II and V4-6, continued ST depression in II and V3-6, without T wave inversion (T wave normalization c/w ECG Stage 4). Symptoms progressively worsened from onset to nadir around Day 12, on which he had continuous moderate dyspnea upon awakening with severe dyspnea with mild exertion. Symptoms then generally improved until after Day 47, he began to have alternating periods of several days without symptoms followed by several days of mild dyspnea. Clinical symptoms resolved on Day 85.
52 2021-05-30 palpitations Heart Palpitations, Extremely tired for 4 days after each shot.
52 2021-05-31 cardiac arrest ON 3/15/21 patient was found unresponsive by spouse. EMS was called. Patient was found to have card... Read more
ON 3/15/21 patient was found unresponsive by spouse. EMS was called. Patient was found to have cardiac arrest Was given Epinephrine, Amiodarone and External Ventricular defibrillation Patient passed away on 3/15/21
52 2021-06-01 hypertension, cardio-respiratory arrest My brother took the day off work on May 12, 2021 to receive his 2nd dose of the Moderna vaccine. He ... Read more
My brother took the day off work on May 12, 2021 to receive his 2nd dose of the Moderna vaccine. He communicated with friends later that same day saying he was tired and needed to rest. On May 13, 2021, a work colleague followed up with a text message to see how he was doing to which my brother did not respond. This same colleague went to his house a few days later to find him dead lying on his couch.
52 2021-06-02 cardiac arrest Death, cardiac arrest. Patient was found deceased in home, no hospitalization, no autopsy
52 2021-06-03 low platelet count Seizure; Acute kidney failure, unspecified; Hypo-osmolality and hyponatremia; Thrombocytopenia, unsp... Read more
Seizure; Acute kidney failure, unspecified; Hypo-osmolality and hyponatremia; Thrombocytopenia, unspecified
52 2021-06-05 heart rate increased Right after I gave him the shot he said his right hand was tingly. Then the reaction changed to funn... Read more
Right after I gave him the shot he said his right hand was tingly. Then the reaction changed to funny feeling like he was going to faint. With in 15 minutes he had 2 waves of this reaction. The 3rd wave started about 20 minutes after shot and he said it was worse, tingly in both hands , funny feeling like he was going to faint , cold and felt like his pulse rate was up . He never fainted. He kept talking to me. Since the 3rd wave was worse and it lasted the longest, we call 911. They came and checked him out, but he declined to go with them to the hospital. He waited in the store for at least 1 hour. Checked on him at home at 3:05p.m. and he said he felt fine.
52 2021-06-08 chest pain Chest pain developed in the location of the heart. Was persistent but mild. Pain was 2-3 on the 1... Read more
Chest pain developed in the location of the heart. Was persistent but mild. Pain was 2-3 on the 10 scale. I assumed it was caused by work stress, mentioned to family to monitor. I gave up coffee. Pain persisted. Mentioned to sleep Dr at standing appointment April 22 later. He said follow up with primary care. I got into see my PC, April 24. He said my heart sounded OK but decided I should be taken to the emergency room for enzyme test. Also did xray. ER doc ruled out heart attack and said likely inflammation of chest wall or bones in the area. Pain still persists. Got referral to cardiologist and did SPECT test June 8th. results pending.
52 2021-06-09 chest discomfort Chest discomfort. Difficulty breathing. Still have dyspnea. Went to Urgent Care clinic and had neg. ... Read more
Chest discomfort. Difficulty breathing. Still have dyspnea. Went to Urgent Care clinic and had neg. chest X-Ray. Wake up frequently at night due to shortness of breath.
52 2021-06-10 palpitations Racing heart rate, dizziness from this symptoms. Smoke smell, which I continue to smell to even now ... Read more
Racing heart rate, dizziness from this symptoms. Smoke smell, which I continue to smell to even now as I type this note.
52 2021-06-14 loss of consciousness a 52 y.o. male sent for evaluation due to symptoms which have now lasted for months and began occurr... Read more
a 52 y.o. male sent for evaluation due to symptoms which have now lasted for months and began occurring shortly after he received his second Materna vaccine. He had his first Madrona vaccine on 3/26/2021, and his second vaccine on 4/23/2021. Initially he noted headaches, neuralgia, chills and sweats, and just suspected these would dissipate as had been described in the media. His headaches and neuralgia did resolve, but he continued to have significant night sweats and fatigue. He had one episode where he passed out and struck his head. This has not recurred for over a month. He has had 2 episodes of vomiting bilious material these were significantly spread out. He has noted a 20 pound weight loss and difficulty sleeping. He does report that in the last few days his symptoms seem to have improved, and his appetite has improved as well, but he has not noticed any weight gain yet. He did have low-grade fevers the highest being in the 101 range. He had no visual, taste, pulmonary, genitourinary, rheumatological, or dermatological complaints. Apart from the 2 episodes of vomiting he has had no GI issues. His wife is present and concurs with his history. He has had a significant work-up from his primary care provider who included an LDH in late May that was normal, CBC with differential which was benign, a Monospot which was negative, CRP that was elevated at 85 with 0-10 being the reference range, a negative ANA, negative RA, and a sedimentation rate of 42, blood cultures were performed and were negative. Labs earlier in the month noted similar findings. His basic metabolic panel and liver enzymes were also normal. He was also reportedly screened for Lyme and was negative but I do not see this test result. He denies any childhood infections of significance. The also went to a safari in 2019. They traveled recently prior to the onset of his symptoms but he reports no known bites or scratches by ticks, insects, mosquitoes, or other animals. No one else in the household has been sick. He did receive the BCG vaccine as a child. They also report a chest x-ray was performed and was benign. He was given a 10-day course of amoxicillin and reports no significant improvement while on this.
52 2021-06-16 chest pain Pt was admitted to hospital from ED for chest pains on 4/16/21, 15 days after getting first dose of ... Read more
Pt was admitted to hospital from ED for chest pains on 4/16/21, 15 days after getting first dose of vaccine on 4/1/21. Per guidelines, all hospitalizations should be reported.
52 2021-06-18 palpitations, enlargement of the heart, chest discomfort, chest pain Tightness and pain n the chest, shortness of breath, aching feeling in the upper back, lethargy/loss... Read more
Tightness and pain n the chest, shortness of breath, aching feeling in the upper back, lethargy/loss of energy, heart palpitations. cold feet and hands.
52 2021-06-20 cardiac arrest After receiving the 2nd vaccine on 5/15/21, on 5/16 patient had a "stomach ache", on 5/17 he went to... Read more
After receiving the 2nd vaccine on 5/15/21, on 5/16 patient had a "stomach ache", on 5/17 he went to work. At 9:30am, the camera's show him going into the women's restroom to service it, a lady tried to go into the restroom and could not go in, she called the supervisor, when the supervisor arrived there was no pulse. Report source believes he goes into work around 7:00AM. Report sources states she was told " his blood sugar was not elevated". Report source states that the death certificate states he had a cardiac arrest.
52 2021-06-20 deep vein blood clot 06/01/2021 PATIENT EXPERIENCED LEG PAIN AND SWELLING, ON 06/05/2021 PATEINT WENT TO THE ER WITH SEVE... Read more
06/01/2021 PATIENT EXPERIENCED LEG PAIN AND SWELLING, ON 06/05/2021 PATEINT WENT TO THE ER WITH SEVERE LEG PAIN AND WAS ADMITTED TO THE HOSPITAL WITH A DVT. ON 06/07/2021 PATIENT WAS RELEASED FROM THE HOSPITAL AFTER A VASCULAR DOCTOR REMOVED A SUBSTANTIAL CLOT. PATIENT IS CURRENTLY TAKING XARELTO.
52 2021-06-21 heart attack, troponin increased Acute Myocardial Infarction in the setting of nonobstructive coronary artery disease (angiography 3/... Read more
Acute Myocardial Infarction in the setting of nonobstructive coronary artery disease (angiography 3/30/2021) due to Acute MYOCARDITIS proven by cardiac MRI (3/31/2021)
52 2021-06-22 heart flutter, chest pain Chest pain sometimes shooting toward scapula starting about 1 month after second shot. Sometimes a ... Read more
Chest pain sometimes shooting toward scapula starting about 1 month after second shot. Sometimes a fluttery feeling in chest. It stops occasionally if I pinch my left nipple. I looked it up on the internet and it seemed harmless. Then it went away but returned about 2 weeks ago. I didn't think much of it until I saw the reports of myocarditis and pericarditis as side effects today. There has been no treatment as I do not have insurance of any kind. It is still occurring as of today.
52 2021-06-23 chest pain Severe chest pain for 30-40 seconds. Felt like I was having a heart attack. After pain subsided felt... Read more
Severe chest pain for 30-40 seconds. Felt like I was having a heart attack. After pain subsided felt very shakey and light headed. Was hiking at the time. I hike probably over 1,000 miles a year and was on very easy hike.
52 2021-06-23 blood vessels inflammation I was diagnosed with vasculitis (blood vessel disease). It was treated with Prednisone.
52 2021-06-24 cardiac arrest Patient vaccinated on 6/23/2021. Patient later found down by guard in cardiac arrest. Patient revive... Read more
Patient vaccinated on 6/23/2021. Patient later found down by guard in cardiac arrest. Patient revived and transported via EMS to HCF. Patient admitted 6/24/2021 and tested positive for COVID-19 (patient's first known positive in October 2020). Patient currently in the COVID unit on a telemetry monitor.
52 2021-06-24 bleeding on surface of brain Patient developed severe headache 5/9/21, described as squeezing pain as a band around his head. Hea... Read more
Patient developed severe headache 5/9/21, described as squeezing pain as a band around his head. Headache not relieved by meds. Symptoms worsened and 2 weeks later wife noticed abnormal gait then found patient unresponsive. Admitted to hospital and found to have intracranial and subarachnoid hemorrhage.
52 2021-06-28 atrial fibrillation, palpitations, chest pain On 05/30/21 I woke up about 5am with chest pain, shortness of breath, palpitations, heart racing. D... Read more
On 05/30/21 I woke up about 5am with chest pain, shortness of breath, palpitations, heart racing. Drove myself to the ER. Had EKG, labs done, Metoprolol given in ER. Was told I was in Afib. I stayed in ER until shortly after 4pm. I saw Cardiology doctors and then given discharge instructions for a follow up appt for Echo and cardiology doctor appt. Before leaving the ER I returned to normal sinus rhythm.
52 2021-06-29 hypertension Abscess; Skin discolouration; Pimple; Rheumatoid arthritis flare up; Pain; Ingrown hair on right but... Read more
Abscess; Skin discolouration; Pimple; Rheumatoid arthritis flare up; Pain; Ingrown hair on right butocks/grown to size of golf ball; High Blood Pressure; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of ABSCESS (Abscess) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis. The patient's past medical history included Alcoholic (BEER, MARGARITAS, Rarely) in 1988. Concurrent medical conditions included Asthma, Grass allergy, Allergy to animal (cats), Allergy to plants (Trees) and Penicillin allergy. In November 2019, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERTENSION (High Blood Pressure). On 20-May-2021, the patient experienced ABSCESS (Abscess) (seriousness criterion hospitalization) and INGROWN HAIR (Ingrown hair on right butocks/grown to size of golf ball). On 21-May-2021, the patient experienced PAIN (Pain). On 07-Jun-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In 2021, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced SKIN DISCOLOURATION (Skin discolouration) and ACNE (Pimple). The patient was hospitalized from 24-May-2021 to 25-May-2021 due to ABSCESS. The patient was treated with VALSARTAN for Blood pressure high, at a dose of 1 dosage form; ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, at a dose of 1 dosage form; SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of 1 dosage form; METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) at a dose of 1 dosage form and Surgery for Abscess. At the time of the report, ABSCESS (Abscess), INGROWN HAIR (Ingrown hair on right butocks/grown to size of golf ball), PAIN (Pain), HYPERTENSION (High Blood Pressure), SKIN DISCOLOURATION (Skin discolouration), ACNE (Pimple) and FATIGUE (Tiredness) outcome was unknown and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Blood cholesterol: 293 (High) High cholesterol. In April 2021, Blood pressure measurement: 176 / 106 (High) High blood pressure. In April 2021, Cardiac stress test: normal (normal) No Blockage. On 02-Jun-2021, Liver function test: ast:57 alt:147 (High) AST:57, ALT:147 Elevated liver enzymes. On 03-Jun-2021, Blood cholesterol: 128 (normal) Normal cholesterol. 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. Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
52 2021-06-30 blood clot, deep vein blood clot DVT - Cramp and Pain in right calf approximately 2 weeks after the 2nd dose of Moderna. Leg Swe... Read more
DVT - Cramp and Pain in right calf approximately 2 weeks after the 2nd dose of Moderna. Leg Swelling and rash 27 days after 2nd dose with diagnosed blood clot in right leg.
52 2021-07-05 blood clot, chest pain Heart enzyme elevated; Small blood clot; Chest pain; Soreness; Low grade fever; Fatigue; This sponta... Read more
Heart enzyme elevated; Small blood clot; Chest pain; Soreness; Low grade fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) and THROMBOSIS (Small blood clot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history was provided. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) (seriousness criterion medically significant), THROMBOSIS (Small blood clot) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with APIXABAN (ELIQUIS) for Thrombosis, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated), THROMBOSIS (Small blood clot), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) found a clot in his right lung.. On an unknown date, Myocardial necrosis marker increased: increased (High) increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Labs include ultrasound, chest x-ray ,strep tests whose results are not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-237494 (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.
52 2021-07-07 cerebrovascular accident Patient called as part of booster follow up and declined vaccine, shared he was in rehab due to stro... Read more
Patient called as part of booster follow up and declined vaccine, shared he was in rehab due to stroke. No other details shared
52 2021-07-12 haemoglobin decreased, platelet count decreased Patient is a 53 year old male who presented to Medical Center Emergency Department on 5/12/2021 with... Read more
Patient is a 53 year old male who presented to Medical Center Emergency Department on 5/12/2021 with the chief complaint of fever. He is not under the care of a primary care provider and does not take any regular medications. On May 4th patient received his second Moderna COVID vaccine. Several hours later he developed a subjective fever with chills, body aches and a headache. These symptoms have been ongoing since onset. Since this time he has also developed a dry cough, generalized weakness and burning with urination. Denies any shortness of breath, chest pain, nausea, vomiting, or diarrhea. No bloody/dark stools. Wife is at the bedside who states that patient has recently developed "little red bumps" all over his body.
52 2021-07-15 cerebrovascular accident I had an MCA stroke on the Sunday following the administration of the vaccine.
52 2021-07-21 fainting 6/7/2021 DAY 12 POST VACCINE, BOTH ARMS FELT TINGLY AND NUMB ON AND OFF. 6/12/2021 WENT TO URGENT... Read more
6/7/2021 DAY 12 POST VACCINE, BOTH ARMS FELT TINGLY AND NUMB ON AND OFF. 6/12/2021 WENT TO URGENT CARE IN THE MORNING WITH VERY SORE BACK. SENT TO ER. TREATED WITH MUSCLE RELAXER FOR PINCH NERVE IN NECK. A FEW HOURS LATER, HE SUDDENLY COLLAPSED AT HOME UNABLE TO MOVE. TRANSFERED TO ER VIA AMBULANCE. IN ER ALL NIGHT. TRANSFERED 6/13 WHEN AMBULANCE WAS AVAILABLE. NOW HE IS COMPLETELY PARALYZED FROM HIS NECK TO HIS TOES. AFTER MANY TESTS AND EXAMS, HE WAS DIAGNOSED WITH TRANSVERSE MYELITIS. HE REMAINED AT MEDICAL CENTER FOR 3 WEEKS. THEN TRANSFERED TO WHERE IS REMAINS.
52 2021-07-26 blood glucose increased Lightheadedness, brain fog, exhaustion. The main issue is lightheadedness, they come in waves, they... Read more
Lightheadedness, brain fog, exhaustion. The main issue is lightheadedness, they come in waves, they are worse when I am tired, there is no movement or anything that I am doing to cause them. They are worse when I lay down in bed and get up in bed. Balance issues and eye twitching have also become an issue. However, again the feeling like my brain is floating in my head is the main issue
52 2021-07-28 deep vein blood clot Patient developed a DVT in right leg, pain started one week after shot but also on long car ride
53 2021-01-04 chest pain hx of anaphylaxis to MMR. during prolonged observation period developed sensation of heat across che... Read more
hx of anaphylaxis to MMR. during prolonged observation period developed sensation of heat across chest and into throat, and lip felt numb. had taken Benadryl prior to arriving to clinic. Started to improve but with concern of symptoms worsening once Benadryl wears off, he was directed to the ER by private auto. not permitted to drive himself, wife came and picked him up.
53 2021-01-06 hypertension After receiving the shot I walked up to sit down in the bleacher seats, Talked to the doctoer to se... Read more
After receiving the shot I walked up to sit down in the bleacher seats, Talked to the doctoer to set up my reaction site and after he left I felt a wave of panic and felling that my breathing was suffering. Then felt tingleing in my tounge. Just feeling of breath issue. MY blood pressure was high a liitel bit 140-100 and my heart rate was 88.
53 2021-01-07 arrhythmia Moderna COVID-19 Vaccine EUA Patient stated they had the following symptoms -Uncontrolled shaking,... Read more
Moderna COVID-19 Vaccine EUA Patient stated they had the following symptoms -Uncontrolled shaking, fever, Arrhythmia, dizziness, mental status change, nausea, skin reaction
53 2021-01-07 hypertension Dizziness, HYPERtension, Light Headed Narrative: Subjective/Chief Complaint: 'lightheaded' Pt report... Read more
Dizziness, HYPERtension, Light Headed Narrative: Subjective/Chief Complaint: 'lightheaded' Pt reports sudden onset of lightheaded approx. 10 mins after received Covid vaccine injection with SBP of 180 at the time. Currently c/o lightheadedness, denies n/v/cp/sob, pt reports no sickness symptoms before injection.
53 2021-01-07 fast heart rate Fever, NauseaVomiting, Tachycardia, COVID Vaccine administered 12/28 and nausea began pm with fever... Read more
Fever, NauseaVomiting, Tachycardia, COVID Vaccine administered 12/28 and nausea began pm with fever the following day with chills,fatigue,andtachycardia. Tmax102F
53 2021-01-11 hypertension Dizziness, Headache, Myalgia, HYPERtension, Fatigue, Narrative:
53 2021-01-17 heart rate increased numbness in palate day of vaccine, and rapid heart beat and anxiety
53 2021-01-27 pallor, loss of consciousness, blood pressure decreased, fainting He tolerated the injection and went to the waiting room for sit. About 13 minutes after the injecti... Read more
He tolerated the injection and went to the waiting room for sit. About 13 minutes after the injection, the patient walked back to the nurse's station, stating that he did not feel good. He was pale and clammy and started to fall. He was sat in the chair, and he started to lose consciousness. Pulse was faint and the blood pressure was initially 61, pulse about 60. He has no skin rash, stridor, respiratory distress. Respiration was regular and unlabored. Within 10 minutes, he opens his eyes and started responding, his blood pressure improved to 110-120's, pulses 60's, O2 sat 98%, unlabored breathing. He was transferred to a wheelchair and laid down on the exam table. He was observed for another 30 minutes. His vital signs remained stable. He is able to drink water and able to walk around in his own power without difficulty. The patient stated that he does not like needles, and he has not had any vaccination for a long time. Impression: Vasovagal syncope Adverse reaction to the SARS-CoV-2 vaccine, not anaphylactic reaction.
53 2021-02-01 palpitations Developed palpitations and dyspnea about 8 mins after vaccine. Was treated with Benadryl. Seen at my... Read more
Developed palpitations and dyspnea about 8 mins after vaccine. Was treated with Benadryl. Seen at my clinic 45mins later. No symptoms and feeling fine
53 2021-02-03 oxygen saturation decreased axillary adenopathy, fever , chills, flank pain, desaturation of oxygen , lethargy
53 2021-02-04 heart attack Patient died of a heart attack on 1/31/21, 2.5 weeks after vaccination
53 2021-02-05 pallor, very slow heart rate Patient reports feeling lightheaded/dizzy immediately after parking car in the observation lot. EMS... Read more
Patient reports feeling lightheaded/dizzy immediately after parking car in the observation lot. EMS arrived, patient was pale & diaphoretic, fatigued, bradycardic (52) but patient states that was not much lower than his usual resting heart rate. At 1502 patient's color was improving and he stated he was feeling much better. At 1509 patient reports he is feeling back to baseline. At 1515 patient is cleared by EMS. Patient advised to remain on site for an additional 15 minute minimum for monitoring. Advised patient to call his PCP. 911, or go to the nearest emergency room for any further issues. Recommended patient to sign up for on Vsafe. Patient remained until 1530 and left the site.
53 2021-02-07 cerebrovascular accident stroke on 02/02/21, vaccine given on 01/29/21
53 2021-02-08 loss of consciousness, heart rate increased Pt woke near 12AM w/ intense nausea/stomach cramps. No fever - nothing new in diet. Got up to vomit,... Read more
Pt woke near 12AM w/ intense nausea/stomach cramps. No fever - nothing new in diet. Got up to vomit, woke up on bathroom floor later in his own vomit. Intense watery stools after he came to along w/ pain/nausea all night - no other loss of counsciousness. Felt like he should go to ER, had no one to drive him. Felt somewhat better in AM, still intense nausea but no vomiting. No fever, no headache, no pain in neck/sign of head trauma from previous night. Heart rate slightly elevated 91 bpm - 113/73 at time of visit - 3:20 2/9/2021 Referred to primary care physician for a follow-up. Pt had minor issues with the first injection on 1/11/21 - palpable 1" knot around injection site for 1 week, pain & fatigue, night sweats.
53 2021-02-12 heart rate increased, palpitations Patient was asked to move forward in the waiting area, staff noticed he was checking his pulse. Ask... Read more
Patient was asked to move forward in the waiting area, staff noticed he was checking his pulse. Asked if he felt okay and he stated he felt flushed. EMS and clinical lead notified. Patient reports he felt like his heart was racing and had palpitations (hx of palpitations). HR 97, usually in the 80's). Patient cleared by EMS and stated he felt basically back to baseline. Patient asked to wait 15 more minutes before leaving. Instructed patient to call PCP, 911, or go to the nearest emergency room for any further issues. Also advised to sign up for Vsafe.
53 2021-02-16 loss of consciousness Patient was at a gym watching his daughter. He slumped over unconscious. EMS was called. He was foun... Read more
Patient was at a gym watching his daughter. He slumped over unconscious. EMS was called. He was found to be in fine ventricular fibrillation and resuscitation efforts failed. He was brought to Hospital ED where he was pronounced dead. He had underlying cardiac disease but his family requested I report this event as possibly related to the recent COVID vaccination.
53 2021-02-17 chest discomfort, chest pain About 30-45 minutes post dose. Dizziness, lightheadedness, warmth, chest pain/pressure, SOB
53 2021-02-19 fainting Patient felt Syncope / Fainting . Onsite EMS was called vitals BP 92/66 BG 80 98% O2 room air HR 68... Read more
Patient felt Syncope / Fainting . Onsite EMS was called vitals BP 92/66 BG 80 98% O2 room air HR 68. Patient Refused Evaluation/Care, Left aginst medical advice.
53 2021-02-21 chest pain AFTER RECEIVING THE VACCINE HE COMPLAINED OF STABBING CHEST PAIN. ON SITE EMS RESPONDED. HE WAS TAKE... Read more
AFTER RECEIVING THE VACCINE HE COMPLAINED OF STABBING CHEST PAIN. ON SITE EMS RESPONDED. HE WAS TAKEN TO THE AMBULANCE FOR AN EKG. IT WAS RECOMMENDED TO GO TO THE HOSPITAL BY AMBULANCE, BUT HE REFUSED AND LEFT AGAINST MEDICAL ADVISE. I WASN'T ABLE TO GET ANY VITALS FROM EMS.
53 2021-02-22 hypertension I have had a slight headache since 2 days after my Vaccination. I have managed it with low dose ibu... Read more
I have had a slight headache since 2 days after my Vaccination. I have managed it with low dose ibuprofen. Today I had a worse feeling of pressure and checked my BP and it is sky high, both with an Automated Cuff and Manual Cuff. 160's-190's systolic and over 100 diastolic. I have no hx of Hypertension, nor have ever been prescribed meds for it.
53 2021-02-27 chest discomfort Patient complained of having pressure in chest, reports he has history of this before. Refused ER tr... Read more
Patient complained of having pressure in chest, reports he has history of this before. Refused ER transport and cleared by EMS
53 2021-03-01 body temperature decreased aches and pains (headache/hips), fever (101.6), loss of smell, nausea, low temp (95.5)
53 2021-03-03 loss of consciousness In chair immediately following injection, patient completely lost consciousness and slumped against ... Read more
In chair immediately following injection, patient completely lost consciousness and slumped against table. Nurses moved patient into wheelchair, then to gurney where patient was monitored. Patient woke up and returned to being awake, alert and fully oriented in roughly 3 minutes. Patient was seen by Dr and monitored for additional 30 minutes. No medications were given and patient was discharged to home with family member.
53 2021-03-04 blood glucose increased, cardiac arrest, low blood oxigenation Patient is a 53 year old man with a past medical history of follicular lymphoma diagnosed in 2008, m... Read more
Patient is a 53 year old man with a past medical history of follicular lymphoma diagnosed in 2008, more recently with DLBCL with CNS involvement (involving hypothalamus; dx 8/2018; s/p HD MTX, s/p BMT- followed by Dr.), autoimmune hepatitis, obesity, adipic DI, central hypothyroidism and type 2 DM who presented to Hospital via EMS after a fall at home with multisystem organ failure leading to intubation in the ED and subsequent transfer to Oncology ICU for further management. He was in his usual state if health until Sunday. On Saturday he got COVID vaccine at 4pm, that evening he had no issues. Sunday night around 10pm he didn't make complete sense and his wife was concerned because of his history of DM and treated CNS lymphoma. BG was 320-340 at that time. Monday he was good and Monday night he started to have shaking of his left hand. Tuesday he had one episode of diarrhea. Later he was more shaky in the shower and he started to fall and his wife was unable to grab him and he slid down the wall and could not get up. Family was called to help and he was not making sense so they called EMS. Wife reports that he was down approximately 3 hours before EMS was able to get him up. In EMS he was noted to have a large area of skin desquamation from the right posterior knee to the ankle. His GCS was 15. He had stable blood pressure and heart rate. He was hypoxia to the 50s and oxygen was applied. In the ED he was found to be in multisystem organ failure and was intubated and had rapid progression of shock requiring Epinephrine, Levophed and Vasopressin. Crash lines were placed and he was sent to hospital. Upon arrival he was noted to have a cold pulseless right lower extremity and surgery was called. He was evaluated by Trauma Surgery, Orthopedic surgery and Vascular surgery and eventually underwent above the knee amputation. Unfortunately they were not able to remove all nonviable tissue and he continued to deteriorate. He was taken level 1 back to the OR and an additional 10 cm of nonviable tissue was removed. Unfortunately upon arrive he suffered cardiac arrest in the setting of severe lactic acidosis and hyperkalemia.
53 2021-03-04 fainting Syncopal episode
53 2021-03-05 heart rate increased High heart rate, chills, fever, nausea, intense headache
53 2021-03-06 fast heart rate At 5:00 pm on vaccination day I started to experience aching in both legs. By 5:30 pm the aching in... Read more
At 5:00 pm on vaccination day I started to experience aching in both legs. By 5:30 pm the aching in both legs became greater and started a general unwell feeling. By 7:00 pm I had a headache/full body aching/major pain and aching in both legs/rapid heart beat at rest/chills/diarrhea. I suffered from sweats/chills/rapid heart rate/major right and left leg pain and aches/headache for the whole next day. By 11:00pm the day after vaccine, I was only suffering from major head ache and major left and right leg pain and aching and sweating. I woke up the 2nd day after the vaccine symptom free but very fatigued. I took 800mg of Advil every 6 hours from the onset of symptoms. My watch reported my heart rate at a range from 90-121 BPM while at rest for at least 24hours during onset of symptoms.
53 2021-03-16 chest discomfort, pallor Pt stated that he became SOB, had chest tightness, and felt flushed. He then became pale and diapho... Read more
Pt stated that he became SOB, had chest tightness, and felt flushed. He then became pale and diaphoretic. SAO2 98% HR 103
53 2021-03-21 anaemia, haemoglobin decreased Low hemoglobin detected when attempting to donate blood. Completely asymptomatic, but was rejecte... Read more
Low hemoglobin detected when attempting to donate blood. Completely asymptomatic, but was rejected from donating blood today because of a fingerstick Hgb 11.7 gm/dl. This result was duplicated when the fingerstick was redone. I've never been told that I am anemic before.
53 2021-03-21 fast heart rate, low blood oxigenation, troponin increased Shortness of breath Hypoxemia Tachycardia Elevated troponin Pneumonia due to COVID-19 virus Covid-19
53 2021-03-24 atrial fibrillation Patient report to have been in A-fib for three days after receiving first dose of vaccine; Throat cl... Read more
Patient report to have been in A-fib for three days after receiving first dose of vaccine; Throat closure; Felt like anaphylaxis; A spontaneous report was received from a consumer who was a 53-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed atrial fibrillation and an anaphylactic reaction. The patient's medical history included heart failure and allergies to butter and NSAIDS. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, diltiazem, apixaban, lisinopril and loratadine. The patient received their first of two planned doses of mRNA-1273 (Batch number: 040A21A) on 11 Mar 2021 in the left arm for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient reported that he experienced a moderate reaction; throat closure (not complete). He stated that it felt like anaphylaxis. He also reported having a numb tongue. He reported that the reaction was not immediate and that it started about four hours after the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, atrial fibrillation, was considered recovered/resolved. The outcome of the event, anaphylactic reaction, was considered recovering/resolving.; Reporter's Comments: This case concerns a 53-year-old male who experienced a serious anaphylactic reaction with serious unexpected event of atrial fibrillation and throat closure. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Atrial fibrillation resolved, and anaphylaxis resolving. 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.
53 2021-03-26 chest pain Three days after receiving Vaccine in my right arm, I started feeling pain in left side of chest acc... Read more
Three days after receiving Vaccine in my right arm, I started feeling pain in left side of chest accompanied by swelling. Its still the same days later. The pain feels like how a bruise would feel. It feels like a woman who has breast cancer would feel in the chest area.
53 2021-03-26 palpitations 101.4 Temperature/fever, aching joints severe, malaise, no appetite, diarrhea, migraine, nausea, hea... Read more
101.4 Temperature/fever, aching joints severe, malaise, no appetite, diarrhea, migraine, nausea, heart palpitations, breathing difficulty, dizziness, unable to move, unable to sleep regular times, severe exhaustion.
53 2021-03-28 blood glucose increased Became lightheaded & had a mild headache approx. 10minutes after vaccine
53 2021-03-28 nosebleed Epistaxis not lasting longer than 5 minutes
53 2021-03-28 fast heart rate, hypertension After receiving the moderna vaccine, the patient started feeling slight dizziness, high blood pressu... Read more
After receiving the moderna vaccine, the patient started feeling slight dizziness, high blood pressure and tachycardia. Patient was seen by rescue team, vitals did not change, BP kept rising, patient opted for transport at 17:22.
53 2021-03-31 fainting Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
53 2021-04-01 loss of consciousness I TOOK THE SHOT ON 03/20/2021, FELT BREATHLESS WHILST TAKING A WALK ON THE TRAIL ON 03/27/2021. DIZI... Read more
I TOOK THE SHOT ON 03/20/2021, FELT BREATHLESS WHILST TAKING A WALK ON THE TRAIL ON 03/27/2021. DIZINESS ABOUT FOUR TIMES ON 03/27/2021 AND I PASSED OUT MOMENTARILY/CHECKED INTO ER. NOT EXACTLY SURE IF THE VACCINE IS THE CAUSE, BUT IT REQUIRES LOOKING INTO BECAUSE I HAVE NEVER HAD SUCH AN EXPERIENCE IN MY ENTIRE LIFE.
53 2021-04-04 low blood oxigenation, fast heart rate History of Present Illness: This is a 53-year-old male with significant past medical history of cer... Read more
History of Present Illness: This is a 53-year-old male with significant past medical history of cerebral palsy, mental retardation, decubitus ulcer, recent left loculated pleural effusion with empyema status post catheterization line placement by IR at outside hospital. Patient is A&O times 2-3 at baseline. This patient presents with recent fall associated with right shoulder pain, decreased range of movement and minor bruise to forehead. Per report from nursing home patient was also altered and slightly confused. Due to concern for intracranial process patient was transferred to the ED for further workup. In the ED, vitals were remarkable for mild tachycardia. Patient was noted to be hypoxic on room air an Additional information for Item 18: Patient was noted to be hypoxic on room air and placed on 3 L oxygen via nasal cannula. Initial labs show leukocytosis 28.6. For concern for sepsis blood cultures obtained patient initiated on antibiotics vanc and Zosyn. Status post 2 L IV fluid bolus. Inflammatory markers elevated patient tested for COVID-19 infection. CT brain negative for fracture. CT abdomen showed nonspecific thickening of the colonic wall may represent colitis in appropriate clinical setting.
53 2021-04-05 chest pain, heart rate increased, blood pressure increased Patient in observation area, unresponsive to verbal commands, elevated heartrate (120-140), elevated... Read more
Patient in observation area, unresponsive to verbal commands, elevated heartrate (120-140), elevated bp 180's-210/100-105, tachypnea (20-26), normal O2 sat (99-100%). EMS activated. Shaking extremities, able to move all extremities on command. No diaphoresis. At 10 minutes more alert and c/o chest pain 8/10. Transported by EMS to ER.
53 2021-04-05 deep vein blood clot VTE- PE and DVT dx on 4/5/21
53 2021-04-05 hypertension 0915 53 year old male stated that his tongue was tingling after taking his vaccination. Pt has a hi... Read more
0915 53 year old male stated that his tongue was tingling after taking his vaccination. Pt has a history of hypertension. No known allergies. BP, 152/104, HR 71, RR 16. Patient will stay 30 minutes. Will recheck vitals before leaving. 0940 BP 147/100, HR 69, RR 16. Pt stated the tingling on his tongue has stopped. Pt stated he will go visit his doctor today concerning his blood pressure. Pt stated he felt good. Patient was released. LPN
53 2021-04-05 loss of consciousness Started to black out; Trachea collapsed; Swallowed saliva; Could not breathe; This spontaneous case ... Read more
Started to black out; Trachea collapsed; Swallowed saliva; Could not breathe; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Started to black out), TRACHEOMALACIA (Trachea collapsed) and CHOKING (Swallowed saliva) in a 53-year-old male 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Started to black out) (seriousness criterion medically significant), TRACHEOMALACIA (Trachea collapsed) (seriousness criterion medically significant), CHOKING (Swallowed saliva) (seriousness criterion medically significant) and DYSPNOEA (Could not breathe). At the time of the report, LOSS OF CONSCIOUSNESS (Started to black out), TRACHEOMALACIA (Trachea collapsed), CHOKING (Swallowed saliva) and DYSPNOEA (Could not breathe) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information a temporal association between the use of the product and the onset date of the events, a causal relationship with the events cannot be excluded.; 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, a causal relationship with the events cannot be excluded.
53 2021-04-06 cerebrovascular accident Small Right Side Pontine Stroke confirmed by CT and MRI. Treatment includes statin, and anti-platele... Read more
Small Right Side Pontine Stroke confirmed by CT and MRI. Treatment includes statin, and anti-platelet med. Symptoms: Left sided hemiparesis up to 85% loss of function for 10 days with small improvments over days/weeks.
53 2021-04-12 chest pain Headaches, nausea, soreness, aches, tired, weakness. chest hurts. Continuing as of today 4/13/2021
53 2021-04-12 loss of consciousness Blacked out dur to severe dehydration; Felt dizzy tired and went to sleep for a period of 4 - 5 hour... Read more
Blacked out dur to severe dehydration; Felt dizzy tired and went to sleep for a period of 4 - 5 hours; Drenched in sweat; Described his urine been very dark in color, almost black-ish in a way; Projectile vomiting of food; Night sweats; Diarrhea; Given ant nausea medications; Lot of fatigue; Felt pain in his at the injection site; Pain in his lower spine and hips; chills; Blacked out dur to severe dehydration; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration) and DEHYDRATION (Blacked out dur to severe dehydration) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B21A) 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 recorded medical history). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration) (seriousness criterion medically significant), DEHYDRATION (Blacked out dur to severe dehydration) (seriousness criterion hospitalization), DIZZINESS (Felt dizzy tired and went to sleep for a period of 4 - 5 hours), HYPERHIDROSIS (Drenched in sweat), CHROMATURIA (Described his urine been very dark in color, almost black-ish in a way), VOMITING PROJECTILE (Projectile vomiting of food), NIGHT SWEATS (Night sweats), DIARRHOEA (Diarrhea), NAUSEA (Given ant nausea medications), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Felt pain in his at the injection site ), ARTHRALGIA (Pain in his lower spine and hips) and CHILLS (chills). The patient was hospitalized from 05-Apr-2021 to 06-Apr-2021 due to DEHYDRATION. On 06-Apr-2021, LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration), DEHYDRATION (Blacked out dur to severe dehydration), DIZZINESS (Felt dizzy tired and went to sleep for a period of 4 - 5 hours), CHROMATURIA (Described his urine been very dark in color, almost black-ish in a way), VOMITING PROJECTILE (Projectile vomiting of food), DIARRHOEA (Diarrhea), NAUSEA (Given ant nausea medications), FATIGUE (Lot of fatigue), ARTHRALGIA (Pain in his lower spine and hips) and CHILLS (chills) had resolved, VACCINATION SITE PAIN (Felt pain in his at the injection site ) outcome was unknown. At the time of the report, HYPERHIDROSIS (Drenched in sweat) and NIGHT SWEATS (Night sweats) had not resolved. Concomitant product use was not provided by the reporter. On an unspecified date, the patient went to sleep for a period of 4 - 5 hours. Upon waking up, he was drenched in sweat. The patient's mattress, pillow and body were covered in sweat. The patient was only able to stay awake for about 2 hours and the fell back asleep for about 4 -5 hours. This cycle of being up or 2 hours and sleep for 4 - 5 hours continued throughout the weekend. By Monday (05APR2021) morning, the night sweats continued, and contacted his primary care physician, who advised him to go to the nearest emergency room. In emergency room, while diagnostic tests were undergoing. The patient's symptoms began on Friday and ended except of the night sweat which were ongoing. Treatment for the event included anti-nausea medications. 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. 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.
53 2021-04-13 chest pain On the evening of March 16th, pain started down the left side of neck and shoulder On the morning of... Read more
On the evening of March 16th, pain started down the left side of neck and shoulder On the morning of March 17th, pain began to intensify down the neck, shoulder, shoulder blade area, and pectoral area - went to urgent care where an X-Ray was taken. I also given a prescription for a Tizandine, Naproxen, and Gabapentin On March 22nd, I went to my Primary Care Physician so the pain continued, he changed my prescription to Gabapentin and Prednisone. - I stopped taking Tizandine and Naproxen, From March 22 through April 1, the pain continued. On April 2nd, I took an EMG Test The pain continued, on April 7th I went for an MRI Test
53 2021-04-13 pulmonary embolism Pt states he woke up early and couldn't stand due to head spinning, but was okay laying flat. Lasted... Read more
Pt states he woke up early and couldn't stand due to head spinning, but was okay laying flat. Lasted 20 seconds then able to stand slowly. Reports continues to have <5-10 second vertigo episodes 3-4 times a day ever since. Describes vertigo as if riding on a roller coaster and feels room spin in back of head by his neck area behind ears bilaterally. No issues with eyes or ears. Quick position changes or moving from flat to sitting/standing or turn head quickly side to side triggers sensation. No neck pain.
53 2021-04-14 deep vein blood clot Right Lower Extremity DVT confirmed on U/S Presented to our office to rule out hypercoaguable stat... Read more
Right Lower Extremity DVT confirmed on U/S Presented to our office to rule out hypercoaguable state, however previous work up has been negative
53 2021-04-16 chest pain Adverse: Severe Chest, back & should pains. Chest pains come and going all day long on a scale of 3... Read more
Adverse: Severe Chest, back & should pains. Chest pains come and going all day long on a scale of 3-8 in pain. Back pains correlate to the chest pains. Should has always in pain around a 3-4 Been seen by the doctor on April 7th. and they performed two EKGs, two CT Scan and two Ultrasound scans and found nothing wrong with my heart. Since April 4th until today April 17th the chest pains continue. They get much worse when I lay down, so I have to sleep in a chair to lower the pain. Even while sleeping in a chair the pain comes and goes all night long.
53 2021-04-16 hypertension Developed tinnitus after the 1st moderna COVID vaccination. He consider this mild and felt that it ... Read more
Developed tinnitus after the 1st moderna COVID vaccination. He consider this mild and felt that it was subsiding for few days and does decided to get the 2nd moderna COVID vaccination. Within 12 hours he develops severe high-pitched tinnitus that has continued up to now. -here in clinic, he was also found to have high blood pressure (he always had well controlled blood pressures in the past)
53 2021-04-16 pallor, lightheadedness Pt received vaccine immediately complained of being light-headed became pale and diaphoretic. Wheel... Read more
Pt received vaccine immediately complained of being light-headed became pale and diaphoretic. Wheeled to recovery cot to lie down feet elevated, placed ice pack to back of neck. - LOC - SOB - N/V. MD evaluated. Vasovagal response to getting vaccine. VS taken BP 124/80, HR 64 reg strong, resps 14, SpO2 98%. Wife at side stated "this happens all the time after shots giving blood for labwork" Pt stated he didn't eat in morning. After 10 min lying down with feet elevated, sat pt up provided water for hydration, pallor and diaphoresis subsided left deltoid site benign, pt stated "did OK with 1st vaccine". Provided reassurance encouraged to stay 30 min for observation Pt refused to stay for 30. After 20 min. pt left recovery with family. Ok'd to exit, MD aware of pt exiting early OK'd.
53 2021-04-18 deep vein blood clot, fast heart rate, pulmonary embolism Presented to ED with shortness of breath on exertion and tachycardia. Patient reported getting covi... Read more
Presented to ED with shortness of breath on exertion and tachycardia. Patient reported getting covid-19 2nd vaccine 4/11 (moderna) Lot #037B21A. Patient found to have acute saddle pulmonary embolism and right leg femoral DVT. Placed on heparin drip then transferred to hospital on 4/16/2021. Converted from heparin IV to Apixaban PO.
53 2021-04-18 heart rate decreased Shortly after receiving the shot, I had combination of headache/head pressure, which went away after... Read more
Shortly after receiving the shot, I had combination of headache/head pressure, which went away after about 2 hours. Somewhere in 36-48 hours later, I began having headaches (clearly aches, not pressure). These were like my concussion headaches (but I hadn't had been experiencing such strong headaches for a while). These lasted about 2 weeks. Along with the headaches, I got lightheaded very easily. I also noticed my heart rate was lower than normal when I did light exercising (and maybe even at rest, too). I had been experiencing the headaches and lightheadedness when my concussion was worse; I figure some connection / recession brought about by the vaccine. Neurologist attributes the response to inflammation.
53 2021-04-19 chest pain, chest discomfort PATIENT C/O CHEST PAIN AND TIGHTNESS AND HAD SHORTNESS OF BREATH/HOARSENESS/COUGH
53 2021-04-19 loss of consciousness While sitting after receiving his vaccine he patient started to feel dizzy. Then his eyes rolled bac... Read more
While sitting after receiving his vaccine he patient started to feel dizzy. Then his eyes rolled back and he went limp. He was unconscious for under a minute. A police officer came since we called 911 but the patient was already awake and felt better. He declined an ambulance.
53 2021-04-19 fast heart rate, chest discomfort Code Cowboy called around 1610. Went to the parking lot to assess the patient after having a request... Read more
Code Cowboy called around 1610. Went to the parking lot to assess the patient after having a request for help as physician on call for code cowboy was assisting another patient. Patient wheeled inside to collect vitals. He reported that he was having chest tightness and some shortness of breath. Has never had an allergic reaction to anything but latex, and it was not anaphylaxis. Denied swelling of his lips, tongue, throat and trouble swallowing. Denied rash or itching. Patient's BP was 151/75, HR 100. Physical exam: mildly tachycardic, no murmurs. Lungs, CTA bilaterally. No swelling of lips, tongue, face noted. No rashes. EMSA arrived shortly after vitals were taken and he was assessed. He refused to go to the ER via ambulance, but agreed to let his wife take him for evaluation. No medications were given before he left. No major progression of symptoms before he left with wife in car.
53 2021-04-20 blood glucose increased Left Bell's Palsy.
53 2021-04-20 blood pressure fluctuation TWO lower GI tract infections, each one about two weeks after a vaccine shot. Other worries are conf... Read more
TWO lower GI tract infections, each one about two weeks after a vaccine shot. Other worries are confusion and bp oscillation. DETAILS: 1st dose only minor flu like symptoms then 14 days in, big GI tract infection tennis ball size in lower GI followed by UTI and Colo-rectal infections. Gas and no stool passing. 2nd dose down 24-72 hrs later with serious chills and internal fever in main body cavity. Slept it off and hydrated. Then consistent flu like symptoms but stronger and longer than 1st shot. Increasing confusion and maybe dementia? Some 3-D visual dreams too? lots of inflamation feel in body wherever old injuries were. Also blood pressure going high and low even though I cross checked with both electronic wrist version, and mechanical armband version of bp monitors. Consistent frontal lobe head pressure, bp oscillation, and flu like feelings (upset stomach, change in urine and stool color, wooziness, chills, etc.). Thank goodness for coffee! It helps clear up my mind a bit. Then again, 14 days beyond second shot roughly, and the only reason I filed the report, another lower GI tract infection. This time I hit it right away with potassium penicillin 800 mg. This worked the first time too. Just an FYI in case others are showing GI tract version/issues. I believe this was a secondary form of Covid symptoms in early Chinese data if that can be trusted. Still not in good shape but it sounds like second shot causes more issues. I will probably schedule general checkup with my doctor if I dont get better in a week or so.
53 2021-04-20 chest pain, fainting At 3 months post second COVID-19 vaccine (Moderna), developed onset of intermittent left sided chest... Read more
At 3 months post second COVID-19 vaccine (Moderna), developed onset of intermittent left sided chest pain, syncopal episodes, intermittent vertigo, intermittent SOB, and lethargy. All symptoms can be exertional or non-exertional. Have underwent inpatient hospitalization for the above and undergone multiple testing. Have had a CT of the chest, CXR, echocardiogram, cardiac stress testing (chemical), EKGs, multiple labs, and heart catheterization. All testing has been essentially normal including ruling out inflammatory process.
53 2021-04-20 pulmonary embolism Acute bilateral pulmonary emboli without known risk factors for this condition. Onset of symptoms co... Read more
Acute bilateral pulmonary emboli without known risk factors for this condition. Onset of symptoms consistent with acute pulmonary embolism started 2 days after vaccination. Formal diagnosis made on CT chest on 4/13/2021 after worsening symptoms of shortness of breath with exertion prompted evaluation in ER
53 2021-04-21 atrial fibrillation Arrhythmia - burst of a-fib, pain in joints, weakness, chills, inability to sleep continued for 3-4 ... Read more
Arrhythmia - burst of a-fib, pain in joints, weakness, chills, inability to sleep continued for 3-4 days. After consultation with cardiologist returned to normal activities over the course of the following week. Recommended not receiving second dose.
53 2021-04-21 platelet count decreased, low blood platelet count Immune mediated thrombocytopenia. Presented with altered mental status, found to have Platelets at 1... Read more
Immune mediated thrombocytopenia. Presented with altered mental status, found to have Platelets at 10,000.
53 2021-04-22 cardiac arrest Patient reported to onsite health clinic to see nurse at 1930. Complaints of not feeling well. Vomit... Read more
Patient reported to onsite health clinic to see nurse at 1930. Complaints of not feeling well. Vomited then dyspnea. Went into cardiac arrest, AED used x1. EMS called at 1945. CPR, intubation until 2055. Time of death 2055.
53 2021-04-22 excessive bleeding Extreme lethargy, swelling of lymph nodes (neck, armpits), bleeding from mucus membranes
53 2021-04-23 chest pain, fainting pt sat down after 15 minutes of getting imz then left....about 10 minutes after that pt came back an... Read more
pt sat down after 15 minutes of getting imz then left....about 10 minutes after that pt came back and said he was not feeling well and holding his chest he said he had chest pain.....also complained of being hot, faint, and sweaty........we got cold compress for him.......pt was yawning and closed eyes....he wanted to lie down and we allowed him to do that....we got cold compress for him.........after 15 min he sat back up and we gave him water and took bp 123/71 HR 58.......temp 97.4......he said he felt better and left.
53 2021-04-25 chest pain, loss of consciousness Approximately 48 hours after my second Moderna Vaccine I started experiencing breathing difficulty a... Read more
Approximately 48 hours after my second Moderna Vaccine I started experiencing breathing difficulty and shortness of breath. After 58 hours was admitted to emergency room but CT scan of lungs and heart normal. Breathing difficulty continued 24 hours a day until 8 days later in which the breathing difficulty became worse and increased light-headedness occurred On 4/13. A second trip to emergency room happened on 4/13 another CT scan of lungs and heart normal. Breathing difficuly continued until On April 24th I collapsed and blacked out while out for a walk. Was admitted to emergency room on the 24th and remained hospitalized with brain fog, light-headedness, breathing difficulty and sharp pain in right side of chest. Ecco cardio gram test negative. Breathing difficulty, lightleadedness and chest pain have all been steadily increasing since 48 hours after the 2nd Moderna vaccine shot. To date, still no answer as to why this is happening and getting worse.
53 2021-04-28 chest discomfort, troponin increased Patient with no known prior history of coronary artery disease, woke up early morning between 4 and... Read more
Patient with no known prior history of coronary artery disease, woke up early morning between 4 and 5 with severe substernal chest discomfort, associated with some dyspnea. He had the 2nd COVID Moderna shot 2 days prior and has been experiencing mild fever, and chills. He did not get relief with ASA and antacid, and elected to come in . ECG at presentation showed left bundle branch block which was not present on previous ECG done in the hospital and stress test 2 years ago. His initial high sensitivity troponin was markedly elevated around 2500 ng/ml, and second set withint next 60 minutes rose to over 4000 ng/ml, consistent with acute coronary syndrome. Urgent coronary angiography was performed which did not reveal any culprit lesion. A stat echocardiogram showed normal EF and valve function. He was observed for 24 hours and discharged without incident on medical therapy.
53 2021-04-28 transient ischaemic attack Patient had TIA affecting left side of body with symptoms persistent out to 2 hours after onset.
53 2021-04-30 cerebrovascular accident Patient states that he ended up in the ER on 4/7/21 and was diagnosed with a stroke. He states no pr... Read more
Patient states that he ended up in the ER on 4/7/21 and was diagnosed with a stroke. He states no previous health conditions prior to vaccination/stroke. He also states he experienced chills, fatigue, headache, nausea and breathlessness after first dose.
53 2021-05-01 enlargement of the heart I recieved the Covid19 vaccine first shot on March 29th. Approximately 1-2 weeks later, I had a brie... Read more
I recieved the Covid19 vaccine first shot on March 29th. Approximately 1-2 weeks later, I had a brief (<hour) experience of numbness on the left side of my face. Concerned with possible stroke, I examined myself and found nothing of any concern. On May 1st, about 5 days after the second and final Covid19 vaccine shot, I felt the same numbess and did the same check. This time, there was disctinct loss of muscle function on the left side of my face. A call to available urgent-care services indicated it was highly likely that is was -not- a stroke. I went to Urgent Care, which immediately moved me to Emergency Care for a full stroke evaluation (under the -just in case). The diagnosis was Bell's Palsy ("likely triggered by a viral event"). Treatment is oral steroids, antivirals, and lubrications for the affected eye. Expected to clear up between 2 weeks -> 6 months.
53 2021-05-03 fast heart rate, chest pain tachycardia, chest pain, SOB, chills; referred to ED
53 2021-05-04 haemoglobin decreased, low platelet count Chills, fever, muscle pain especially on the legs and the left side of the kidney. Tremors and has v... Read more
Chills, fever, muscle pain especially on the legs and the left side of the kidney. Tremors and has visited several emergency rooms as symptoms get worse. Patient had a prostate biopsy done on 4/26/21 a day before getting vaccinated. Patient is currently admitted to a Medical Center for symptoms related to the prostate. Bloodwork have been done and as of today he is presenting thrombocytopenia and low hemoglobin levels.
53 2021-05-04 oxygen saturation decreased Since my 2nd shot, I have had very painful achy joints and muscles, it has been 2 and a half weeks n... Read more
Since my 2nd shot, I have had very painful achy joints and muscles, it has been 2 and a half weeks now. Flu like symptoms, diarrhea,dizziness, very weak. Short of breath, low pulse o2.
53 2021-05-07 fainting Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Sev... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: He came with his caretaker (sister) and was told side effects after vaccine administration. I also advised to remain seated for 15 minutes. The patient is special needs and got up anyways. I had pharmacy door open to watch patient while sister was in front of him watching him for reactions. I saw him through door standing against the wall. I ran to help him sit back down and he collapsed and hit his head on the floor . Sister said he has seizures. Called 911
53 2021-05-09 nosebleed Intermittent bloody nose that lasted for approximately 8 weeks.
53 2021-05-10 cerebrovascular accident patient's girlfriend stated that patient got the vaccine on Thursday 4-1-21 and that he had to go to... Read more
patient's girlfriend stated that patient got the vaccine on Thursday 4-1-21 and that he had to go to the ER on Friday 4-2-21 because he could not speak or walk. she stated that he had pain behind his right eye and blurred vision. she stated that one week later his doctor ordered a CT scan and determined that he had a stroke. spoke with the Nurse Practitioner at the office. she stated that the patient did have a stroke, but they did not know the cause of the stroke. I am unable to get the lot number of the vaccine because it was entered through the state system and the lot number did not go over. No lot number is associated with the vaccine.
53 2021-05-10 chest pain, blood clot Presents to ED 4/21 with complaints of L side CP starting at approx 2100. Pt reports shooting pain t... Read more
Presents to ED 4/21 with complaints of L side CP starting at approx 2100. Pt reports shooting pain to L side of chest and armpit with palpating area. Pt reports recently diagnosed with LLE blood clot on 4/13, put on eliquis and has been taking for the past 11 days. Pt reports resting makes pain better, palpating makes pain worse and standing makes pain worse in LLE. Pt denies SOB, DOB or cough. Pt denies history of PE, reports multiple bilat lower extrem DVT's. Patient CBC is normal, metabolic panel is normal, troponin is normal. CTA of the chest was obtained and shows no signs of pulmonary embolism. There is some prominence of his pulmonary arteries bilaterally. BNP is also negative. The patient's pain is mostly reproducible on that left chest, doubt ACS in this patient. Patient will be discharged home have him follow-up with his doctor as an outpatient. Patient is stable for discharge.
53 2021-05-11 chest pain, chest discomfort 40 minutes after vaccination, patient reported feeling dizzy and "drunk." Patient ate a granola bar ... Read more
40 minutes after vaccination, patient reported feeling dizzy and "drunk." Patient ate a granola bar and drank a bottle of water as we monitored. 80 minutes after patient reported sharp chest pain and heaviness. He took one of his SQ Nitroglycerin pills, still had chest pain five minutes later and took another. After the second Nitroglycerin we called 911 and he continued to take his third Nitroglycerin tablet.
53 2021-05-12 palpitations, palpitations, heart rate irregular, lightheadedness near syncope episodes, unstable heart rate, palpations, skipped beats. Heart racing more than usua... Read more
near syncope episodes, unstable heart rate, palpations, skipped beats. Heart racing more than usual during excercise
53 2021-05-12 loss of consciousness, pallor PATIENT PASSED OUT 30 SECONDS TO 1 MINUTE AFTER RECEIVING VACCINATION. PATIENT'S BREATHING BECAME A... Read more
PATIENT PASSED OUT 30 SECONDS TO 1 MINUTE AFTER RECEIVING VACCINATION. PATIENT'S BREATHING BECAME ABNORMAL AND STARTING TO SOUND LIKE SNORING. AN EPIPEN WAS ADMINISTERED AT THAT TIME. FACILITY EMERGENCY TEAM WAS CALLED. Upon provider/nursing arrival patient was alert and oriented but very pale. Patient denied complaints of shortness of breath, chest pain, racing heart. Patient complained of feeling hot and sweaty. Patient assisted to exam room and vitals obtained and examined by Dr.. Patient to be monitored for 30 minutes after administration by pharmacy department. Pt's significant other is the driver today. Pt will be monitored and released to go home.
53 2021-05-13 atrial fibrillation, heart rate irregular Eight days after receiving the Moderna shot I woke up in the morning (3/22/2021) with irregular hea... Read more
Eight days after receiving the Moderna shot I woke up in the morning (3/22/2021) with irregular heartbeat. My family doctor confirmed via EKG that I was in Atrial Fibrillation (Afib). Blood samples were taken, test results were normal. Blood thinners were described. Went to see a cardiologist (3/23/2021) where the Afib was confirmed. Following that visit an echocardiogram of the heart was performed, results were normal. Afib turned into persistent mode and I decided to undergo a cardioversion (4/21/2021) to bring my heart back into regular sinus rhythm. Even though the cardioversion turned out to be initially unsuccessful, I experienced the last Afib episode at the end of last month (4/28/2021).
53 2021-05-13 chest discomfort, blood glucose increased, fast heart rate, pulmonary embolism, deep vein blood clot Hospitalized after vaccination with acute submassive PE. ASSESSMENT / PLAN: Patient is a 53-year-ol... Read more
Hospitalized after vaccination with acute submassive PE. ASSESSMENT / PLAN: Patient is a 53-year-old male in no significant past medical history who presented with complaints of progressively worsening shortness of breath, chest pressure and was found to have acute submassive pulmonary embolism for which he underwent successful mechanical thrombectomy per Interventional Radiology. Subsequent bilateral lower extremity DVT ultrasound demonstrated acute DVTs in the left popliteal, posterior tibial, peroneal veins. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (HCC) [I26.99] HOSPITAL COURSE: The patient is a 53-year-old male in no significant past medical history who is admitted for Acute Saddle Pulmonary Embolism. In the ED, the patient was tachycardic, tachypenic requiring 2 L of O2. CT angiogram thorax showed saddle embolus with extensive bilateral pulmonary emboli and evidence for right heart failure. He was immediately started on IV Heparin. PERT Team was activated and the patient underwent a successful mechanical thrombectomy with IR. Dopplers of the lower extremity showed Left lower popliteal, posterior tibial and peroneal DVTs. After 24 hours of hemodynamically stable vitals, the patient was transition to Eliquis. The patient stay was complicated with elevated blood glucose along with Hba1c of 9.7. Endocrinology was consulted and started the patient with Lantus and LDC. The patient will be discharged with diabetic regimen and followed up with PCP/outpatient Endocrine. The patient was stable, AOx4, without complications and discharged safely to his home with his wife.
53 2021-05-13 heart rate increased, blood pressure increased Patient reported rapid heartbeat after vaccine. He also complained of dizziness, and or severe exhau... Read more
Patient reported rapid heartbeat after vaccine. He also complained of dizziness, and or severe exhaustion. His blood pressure was initially 180/103 with a pulse of 85. Patient was given water and and the blood pressure was repeated, it became even more elevated 180/110 with a pulse of 83. EMT was called because patient was not improving and seemed to be deteriorating
53 2021-05-13 fainting Woke up in the middle of the night, felt unwell and then had a syncopal episode. He fell and struck... Read more
Woke up in the middle of the night, felt unwell and then had a syncopal episode. He fell and struck his head and suffered a head laceration. He chose not to seek medical care. Has fully recovered.
53 2021-05-15 deep vein blood clot Deep Vein Thrombosis of right lower extremity 15 days after second vaccination
53 2021-05-17 blood glucose increased Muscular Weakness Right side of Face (Bells Palsy), External Massage/Therapy
53 2021-05-18 blood clot, nosebleed Blood seepage and clot from nose. After expelled blood clot, no blood seepage from nose until after ... Read more
Blood seepage and clot from nose. After expelled blood clot, no blood seepage from nose until after 2nd Moderna vaccine (May 5 to May, 14 2021 #048B21A). Expelled blood clot from nose again. No blood seepage from nose after expelling blood clot.
53 2021-05-21 deep vein blood clot Patient came in for swelling and pain to left calf, he also had a nodule to the medial posterior asp... Read more
Patient came in for swelling and pain to left calf, he also had a nodule to the medial posterior aspect of the calf. He reported the symptoms were since approx the 5/17/21. Pt said it possibly started sooner on the 15th. Pt came in today 5/21/21 because he received an ultrasound at a clinic by referral from his pmd and was dx with a DVT to the left calf. His pmd then referred him to come to ER where I triaged him in the triage department. He mentioned that began feeling bad after the Moderna Shot he received on 4/28/2020 and stated the now he has this new problem that he never had in the past. Only hx was mild htn he said.
53 2021-05-23 atrial fibrillation I was diagnosed with A Fib on 5/13/21. I have never had any history or issue with my heart that I kn... Read more
I was diagnosed with A Fib on 5/13/21. I have never had any history or issue with my heart that I know of before this. It may not even be related
53 2021-05-23 very slow heart rate, arrhythmia Heart arrhythmia followed by Bradycardia. possible heart muscle inflammation.
53 2021-05-23 oxygen saturation decreased, inflammation of the heart muscle, troponin increased, heart rate increased, chest pain Vaccine Received on Wed 3/10/2021. On Saturday - shortness of breath, very elevated resting pulse (b... Read more
Vaccine Received on Wed 3/10/2021. On Saturday - shortness of breath, very elevated resting pulse (by 25 bpm) reduced oxygen saturation (87 on oximeter vs 95), moderate ongoing chest pain. Primary care doctor advised to go to ER. ER visit resulted in misdiagnosis of Heart Attack which was later changed to heart inflammation. Troponin levels elevated and stayed elevated and continue to be elevated 8 weeks later. AFter 8 weeks Troponin levels still elevated and pain occurs upon anything more than modest exercise. Patient has a history as an edurance athlete. All other tests on heart function - stress test/ Ekg, perfusion, echo - show a high peforming heart - no other defects other than heart inflamation.
53 2021-05-24 fainting PT Fainted approximately 17 hours post Covid-19 vaccination. No other health conditions.
53 2021-05-25 heart rate increased Elevated heart rate 108 bps constant with low grade fever on day 1; Severe dizzy spell on day 2 last... Read more
Elevated heart rate 108 bps constant with low grade fever on day 1; Severe dizzy spell on day 2 lasted 20 min
53 2021-05-25 low platelet count, fast heart rate Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness... Read more
Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH. Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.
53 2021-05-26 pulmonary embolism, deep vein blood clot Patient reported signs and symptoms of SOB/right leg pain 1 week after receiving the Moderna vaccine... Read more
Patient reported signs and symptoms of SOB/right leg pain 1 week after receiving the Moderna vaccine. He stated that he was "breathing fire" and woke up with an extremely painful and swollen leg. Upon coming to the ED, it was found to be bilateral PE and right leg DVT.
53 2021-05-30 palpitations From the 3/23 onwards heart palitations. The doctor From the 5/20 to 5/30 i was unable to sleep du... Read more
From the 3/23 onwards heart palitations. The doctor From the 5/20 to 5/30 i was unable to sleep due to the heart palpitations. The doctor at urgent care said it was mycoclonus and prescribed clonazepam and referred me to a cardiologist.
53 2021-05-31 transient ischaemic attack Small stroke.
53 2021-06-01 blood pressure decreased, oxygen saturation decreased They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine; His lungs... Read more
They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine; His lungs were filled with fluid; After 2nd dose, next day morning at 9AM, he didn't feel well while at work; He had upset stomach; He started feeling light headed while driving/very light headed; When he walked in the house, he was short of breath; Turned gray/about a minute and half later, he turned purple and blue; His oxygen was dropped to low 70s; His BP dropped to 80/50; His entire torso was covered in a rash; Very nauseous; On the way home, he started vomiting; He felt little achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) and PULMONARY OEDEMA (His lungs were filled with fluid) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) (seriousness criteria hospitalization and medically significant), PULMONARY OEDEMA (His lungs were filled with fluid) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to ANAPHYLACTIC REACTION and PULMONARY OEDEMA. At the time of the report, ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine), PULMONARY OEDEMA (His lungs were filled with fluid), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 80/50 (Low) 80/50. On 13-May-2021, Oxygen saturation: low 70s (Low) low 70s. Patient's concomitant medication included nasal spray. He was admitted to the hospital. They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine. The patient was discharged from the hospital on 14-May-2021 evening. The patient was treated with Epi-pen and steroids. Based on the current 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.
53 2021-06-01 heart attack heart attack; grand mal seizure episodes "for the first time in over 2 years", he didn't remember th... Read more
heart attack; grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode; he was freezing and was cold; throwing up profusely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by the reporter. Concomitant products included LACOSAMIDE (VIMPAT) for Seizure. On 21-Apr-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-May-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely). The patient was hospitalized on 22-May-2021 due to GENERALISED TONIC-CLONIC SEIZURE and MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (heart attack), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the last time in over 2 years", he didn't remember the episode), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely) outcome was unknown. Patient was admitted to hospital on 22-may-2021.patient lips were purple and had no pulse for 12 minutes, but was resuscitated.The hospital took out patient's breathing tube at on 23May2021, and hospital staff stated he will remain there for a while. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Vomiting is consistent with the known safety profile of the product.; 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 reported events, a causal relationship cannot be excluded. Vomiting is consistent with the known safety profile of the product.
53 2021-06-02 inflammation of the pericardium Pericarditis. Started with pain in right shoulder and trap area on Friday afternoon, started includ... Read more
Pericarditis. Started with pain in right shoulder and trap area on Friday afternoon, started including significant chest pain, pain when breathing. I recognized symptoms from having pericarditis 15 to 20 years earlier. Went to Hospital emergency room, where pericarditis was diagnosed.
53 2021-06-06 palpitations, chest discomfort PATIENT RECEIVED VACCINE ON THURSDAY 5/20/21 IN THE AM. SEEN IN OUR OFFICE ON 5/24/21 AND HE REPORTS... Read more
PATIENT RECEIVED VACCINE ON THURSDAY 5/20/21 IN THE AM. SEEN IN OUR OFFICE ON 5/24/21 AND HE REPORTS SYMPTOMS OF RACING HEART, PALPITATIONS, LEFT CHEST TIGHTNESS, LOW FEVER, AND HEADACHE THAT STARTED THE EVENING OF 5/20/21, SAME DAY HE RECEIVED VACCINE. AT VISIT ON 5/24/21, HE REPORTS NEW LEFT ARM TINGLING IN ADDITION TO CONTINUED SYMPTOMS NAMED ABOVE. EKG OF HEART PERFORMED IN OFFICE 5/24/21, WHICH SHOWED NO CHANGES COMPARED TO PREVIOUS EKG IN HIS RECORD FROM OCTOBER 2020. LAB TESTS ORDERED ON 5/24/21 AND COMPLETED THE SAME DAY WERE WITHIN NORMAL LIMITS AND SHOWED NO CARDIAC CAUSE OF HIS SYMPTOMS. LABS ORDERED WERE: 1) COMPLETE BLOOD COUNT WITH PLATELETS AND AUTO DIFFERENTIAL 2) COMPREHENSIVE METABOLIC PANEL 3) HEMOGLOBIN A1C 4) TROPONIN I ON 5/25/21, PATIENT CALLED OUR OFFICE TO REPORT NEW RASH ON ONE ARM AND HIS BACK. HE REPORTS RASH DOES NOT ITCH OR HURT. ON 6/1/21, SPOKE WITH PATIENT AGAIN TO SEE HOW SYMPTOMS WERE DOING AND HE REPORTED THAT LOW FEVER, RASH, RACHING HEART, CHEST TIGHTNESS, AND LEFT AND RIGHT ARM TINGLING COMES AND GOES FROM DAY TO DAY, BUT HEADACHE HAS CONTINUED DAILY.
53 2021-06-08 hypertension Dermatitis bullous; Erythema; Peripheral swelling; Pruritus; Somnolence; Hypertension; This case was... Read more
Dermatitis bullous; Erythema; Peripheral swelling; Pruritus; Somnolence; Hypertension; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DERMATITIS BULLOUS (Dermatitis bullous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS BULLOUS (Dermatitis bullous) (seriousness criterion medically significant), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension). At the time of the report, DERMATITIS BULLOUS (Dermatitis bullous), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement (120-80): 140/105 (High) BP 140/105mmHg and 155/81 (High) 155/81mmHg. On 29-Mar-2021, Heart rate: 80 (normal) 80 bpm and 82 (normal) pulse 82 bpm. On 29-Mar-2021, Oxygen saturation: 98 % (normal) SpO2 98% and 96 % (normal) SpO2 96%. 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 had red rash and swelling on both arms, mildly itchy. Extended below shot injection site to finger tips. Increased itching under left arm as well as mild itchy on torso. Alert and oriented. No concomitant medication information was provided. No treatment medication 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. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
53 2021-06-09 loss of consciousness I got my second shot of mederna on april 2 at about 130 pm, I got the shot and felt fine for about ... Read more
I got my second shot of mederna on april 2 at about 130 pm, I got the shot and felt fine for about 4 hours at which time I got so tired and dizzy I felt like I was going to pass out, so I stopped what I was doing and went to bed. I slept for 4 hours and woke up in a pool of sweat and was so wet it was like I had just gotten out of the shower. I had the chills and felt cold in 84 Deg F, I went down stairs drank power aid and got out and set up a space heater and sat in front of it with it blowing the hot air on me but had hot and cold flashes, a mild head ach and joint stiffness and pain. I was only able to stay up for 4 hours before I was so exhausted I had to back to sleep and woke up the same way, this continued for the entire weekend. By monday morning my urine was so yellow it was almost black in color, I called my PCP office, they called me back and advised I go to the emergency room asap. I called my parents and got a ride to the hospital emergency room. I told intake what happened and sat down to be called in, they called me in 1 time then had me wait for diagnostic testing, I got vary dizzy just sitting their watching the tv. By the time they called me in for testing I told them I felt vary noxious and ended up passing out on the nurse after they took my blood. They transferred me from that chair to a bed in the blue pod, gave me nausea medication and hooked me up too 2 vary large IV bags and ran them at the same time. Then being up for 4 hours then sleeping for 4 hours and waking up wet in a pool of sweat continued for 6 days in total. the hot and cold flashes and sitting in front of a space heater went on for 12 days in total. waking up in a pool of sweat went on for about 28 - 30 days in total decreasing in severity along the course of time. The only side effect I still have is my sleep is all screwed up now. If I stay up untill 4 am I will sleep to 10;30 then wake up tired and stay in bed untill 11;30 am. if I go to bed at 2 am I wake up at 6;30 am have to use the bath room then can not go back to sleep for at least a hour then do not wake up untill 11 30 am. Normally, I used to goto bed at 2 -3 am and wake up at 9 -10 am every day. on wednesday april 7 th, the doctors office which is part of the same group as the hospital called me to go over the results from the emergency room, but the person calling did not seem to know I had called them on monday morning or they had called me back to tell me to go to the emergency room, so I do not know how much of a help the PCP will be, but I have proof of that in the phone call records. MY PCP is no longer with the practice, so I had to choose a new one
53 2021-06-10 cardiac failure congestive, blood clot Patient had his 2nd Moderna vaccine at pharmacy at 2:00 and was struggling to breathe a few hours la... Read more
Patient had his 2nd Moderna vaccine at pharmacy at 2:00 and was struggling to breathe a few hours later. We were at the emergency room around 6:00pm and he was placed on a ventilator between midnight and 1:00am. He died 10 days later after experiencing clots that led to seizures and congestive heart failure. I have a death certificate if needed.
53 2021-06-12 heart rate increased Experienced chills, frontal headache, fatigue and joint pain for the 3 days following 2nd dose of Mo... Read more
Experienced chills, frontal headache, fatigue and joint pain for the 3 days following 2nd dose of Moderna vaccine (20april2021). Frontal headache lingered for about 10 days along with general fatigue. Also experienced elevated hear rate on runs by +20bpm compared to same runs prior to second dose. Since the second dose dose, I?ve experienced monthly episodic frontal headaches requiring ibuprofen to treat and some issues with blood glucose levels. These events are some what transient in that they resolve within a day. Prior to second dose, I rarely experienced headaches, NMT 1/yr and rarely requiring treatment with NASAID.
53 2021-06-13 heart rate increased convulsive shivering/chills fever up to 102 F Excellerated heart rate, typically resting heart rate ... Read more
convulsive shivering/chills fever up to 102 F Excellerated heart rate, typically resting heart rate approx 75 bpm, during reaction BPM approx. 140, peaking at 190bpm. soreness body aches.
53 2021-06-15 cardiac arrest, blood clot Seizures; Bood clots; Stuggling to breathe; Struggling to walk; ARDS; Acute hypoxic respiratory fail... Read more
Seizures; Bood clots; Stuggling to breathe; Struggling to walk; ARDS; Acute hypoxic respiratory failure; Acute exacerbation of heart failure and sepsis; Acute exacerbation of heart failure and sepsis; Cardiac arrest; Blood infection; Fever; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), SEPSIS (Acute exacerbation of heart failure and sepsis), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis), CARDIAC ARREST (Cardiac arrest), SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe) and GAIT DISTURBANCE (Struggling to walk) in a 53-year-old male 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 Obesity. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) (seriousness criteria death and medically significant), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria death and medically significant), DYSPNOEA (Stuggling to breathe) (seriousness criterion hospitalization prolonged) and GAIT DISTURBANCE (Struggling to walk) (seriousness criterion hospitalization prolonged). In May 2021, the patient experienced SEPSIS (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant), INFECTION (Blood infection) and PYREXIA (Fever). On 17-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization prolonged and medically significant) and THROMBOSIS (Bood clots) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 15-May-2021 to 25-May-2021 due to DYSPNOEA, GAIT DISTURBANCE, SEIZURE and THROMBOSIS. The patient died on 25-May-2021. The reported cause of death was Cardiac arrest, Acute hypoxic respiratory failure, ards and acute exacerbation of heart failure and sepsis. It is unknown if an autopsy was performed. At the time of death, SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe), GAIT DISTURBANCE (Struggling to walk), INFECTION (Blood infection) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Blood pressure measurement: elevated (High) Twice normal. On 15-May-2021, Glycosylated haemoglobin: elevated (High) High. On 15-May-2021, Oxygen saturation: low (Low) Required intubation and was placed on ventilator.. On 15-May-2021, SARS-CoV-2 antibody test: negative (Negative) 1 negative COVID antibody test. On 15-May-2021, SARS-CoV-2 test: negatie (Negative) 3 negative COVID antigen tests. No concomitant medications were provided. It was reported that within few hours after second dose of vaccine patient was struggling to walk and to breathe. The reporter and her husband went to see the patient and took him to an emergency room (ER). In the ER his blood pressure was markedly elevated (twice normal) and his oxygen level was low and by midnight he required intubation and was placed on a ventilator. His HbgA1c was noted to be elevated. Two days after admission (17-May-2021), he developed seizures which the medical team believed to be due to blood clots and he was anti-coagulated. It was determined that he did not have blood clots on his heart valves as the source of the clots. The source of the blood clots was never identified. He later developed fever and was diagnosed with a blood infection and treated with antibiotics. At one point his oxygen requirement on the ventilator went down to 65% but later returned and remained at 100%. He ultimately died on 25-May-2021 and as per copy of his death certificate he had 4 causes of death as cardiac arrest, acute hypoxic respiratory failure, acute respiratory distress syndrome (ARDS) and acute exacerbation of heart failure and sepsis. Treatment included, anticoagulants, antibiotics, intubation and ventilator. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219410 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Cardiac arrest; Acute hypoxic respiratory failure; ARDS; Acute exacerbation of heart failure and sepsis
53 2021-06-20 skin turning blue The pt received his 2nd Moderna covid vaccine on 6/13/21 at 10:45 am (approximately). Starting at 5... Read more
The pt received his 2nd Moderna covid vaccine on 6/13/21 at 10:45 am (approximately). Starting at 5pm he c/o pain, redness and tenderness in the injection site, chills, and lethargy . The next day he did not go to work b/o he felt tired and he stayed home with his 7 y/o daughter while his wife went to work. His wife spoke with him in the am and he reports he was making breakfast for their daughter and he was going to lie down and sleep afterward. He made lunch for daughter about 1 pm and he went to lie down in his chair. His brother called his wife at about 4:30 pm stating he was blue. 911 was called and they were unable to revive him.
53 2021-06-21 chest discomfort, chest pain Fever, chills, achiness, discomfort & pain on my chest or ribcage.
53 2021-06-22 palpitations She had rashes, worsening concentration and "brain fog" after the vaccine. On 4/14/21, she went to t... Read more
She had rashes, worsening concentration and "brain fog" after the vaccine. On 4/14/21, she went to the ED for heart palpitations, shortness of breath, and fatigue for 3 weeks. At that time, she was found to be hyperthyroid.
53 2021-06-22 fainting, deep vein blood clot, pulmonary embolism, chest pain Pt reported syncope and collapse on 6.13.21, onset of LEFT leg swelling, chest pain and dizziness 6.... Read more
Pt reported syncope and collapse on 6.13.21, onset of LEFT leg swelling, chest pain and dizziness 6.17.21. Pt was diagnosed with extensive DVT of LLE and bilateral PE with significant clot burden on 6.22.21
53 2021-06-22 fast heart rate, palpitations, fast heart rate diarrhea, heart palpitations w/ documented tachycardia on fitbit in supraventricular tachycardia ... Read more
diarrhea, heart palpitations w/ documented tachycardia on fitbit in supraventricular tachycardia rhythm on 6/1/2021
53 2021-07-06 chest pain Heqdache severe throwing up fatigue and outvof breathe alot having vision Horroble headache Chest ... Read more
Heqdache severe throwing up fatigue and outvof breathe alot having vision Horroble headache Chest pain Shortness of breathe Pain all over body
53 2021-07-08 lightheadedness, ischemic chest pain, heart rate decreased Three days after first shot I developed purple raised spots on my face which passed after 2-3 weeks.... Read more
Three days after first shot I developed purple raised spots on my face which passed after 2-3 weeks. 4 days after second shot started having trouble with lower heart rate, went to ER when it fell to 37. Since then have been in and out of doctors offices, ER, hospitalization, and dealing with mix of symptoms. Exhaustion/fatigue, sweats, lower heart rate, near fainting, brain fog, pressure or pain in heart area, dizziness, light headed ness.
53 2021-07-17 chest discomfort, loss of consciousness, very slow heart rate patient very nearly loss consciousness and fell on the floor; felt worse; malaise; light headed / di... Read more
patient very nearly loss consciousness and fell on the floor; felt worse; malaise; light headed / dizziness; felt pressure in his chest; weakness; more fatigue/extreme fatigue; bradycardia effect / heart rate was 37 / slower heart rate; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) and BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included GABAPENTIN and SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine, MELOXICAM for Tennis elbow. On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate) (seriousness criterion medically significant), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his chest), ASTHENIA (weakness) and FATIGUE (more fatigue/extreme fatigue). On 01-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt worse). At the time of the report, LOSS OF CONSCIOUSNESS (patient very nearly loss consciousness and fell on the floor), BRADYCARDIA (bradycardia effect / heart rate was 37 / slower heart rate), FEELING ABNORMAL (felt worse), MALAISE (malaise), DIZZINESS (light headed / dizziness), CHEST DISCOMFORT (felt pressure in his chest), ASTHENIA (weakness) and FATIGUE (more fatigue/extreme fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Heart rate: 37 37. On 01-Jul-2021, Blood pressure measurement: Abnormal. On 01-Jul-2021, Echocardiogram: dilation and leaky valve Dilation and leaky valve. On 01-Jul-2021, Heart rate: Normal resting heart rate was 62-64, now its 49-50. Patients standing and walking used to be 75-85, now its 58-57 (standing), 60 (walking). Patient said that over the last two months his sleeping Heart Rate was 42 to 43 and dipped down to 39 sometimes. No treatment drug details was reported. This case was linked to MOD-2021-253997 (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.
53 2021-07-21 chest pain, heart attack I had chest pains. My platelets cell was 543 and white blood cells count was 26000. I went in to the... Read more
I had chest pains. My platelets cell was 543 and white blood cells count was 26000. I went in to the ER after 4 days and was diagnosis as having a heart attack. Cholesterol 203 results. triglycerides was 85.
53 2021-07-21 blood clot Diagnosed with Blood clots; Never received the second dose; Hospitalized for one day; This spontaneo... Read more
Diagnosed with Blood clots; Never received the second dose; Hospitalized for one day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Diagnosed with Blood clots) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced THROMBOSIS (Diagnosed with Blood clots) (seriousness criteria hospitalization and medically significant) and HOSPITALISATION (Hospitalized for one day). On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received the second dose). The patient was hospitalized for 1 day due to THROMBOSIS. At the time of the report, THROMBOSIS (Diagnosed with Blood clots) and HOSPITALISATION (Hospitalized for one day) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that he was currently taking Blood thinners. No concomitant medications were provided by the reporter. This 53 year-old consumer called on 19Jul2021 to report that he received the first dose of Moderna COVID-19 vaccine on 29Mar2021 (Lot#006B21A). On 14Apr2021 patient was diagnosed with Blood clots and was hospitalized for one day. He mentioned that he never received the second dose . Patient is currently taking Blood thinners. No Lab data was provided by the reporter. This report refers to a case of product dose omission for mRNA-1273 (lot # 006B21A) with associated AE reported of thrombosis. Based on the current available information and temporal association between the use of the product and the start date of the event thrombosi, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: This report refers to a case of product dose omission for mRNA-1273 (lot # 006B21A) with associated AE reported of thrombosis. Based on the current available information and temporal association between the use of the product and the start date of the event thrombosi, a causal relationship cannot be excluded. Further information has been requested
53 2021-07-27 blood glucose increased Eyes feel full bulging; Pressure in eyes is different; Vaccine messed up; Headache; This spontaneous... Read more
Eyes feel full bulging; Pressure in eyes is different; Vaccine messed up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EXOPHTHALMOS (Eyes feel full bulging) in a 53-year-old male 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 Glaucoma. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, LISINOPRIL, PREGABALIN (LYRICA), BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) and PILOCARPINE for an unknown indication. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXOPHTHALMOS (Eyes feel full bulging) (seriousness criterion medically significant), OCULAR DISCOMFORT (Pressure in eyes is different), VACCINATION COMPLICATION (Vaccine messed up) and HEADACHE (Headache). At the time of the report, EXOPHTHALMOS (Eyes feel full bulging), OCULAR DISCOMFORT (Pressure in eyes is different), VACCINATION COMPLICATION (Vaccine messed up) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) Dramatic change in blood sugar, close to double.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. On an unknown date, a week after vaccination, the patient had high blood sugar which had a dramatic change and was closer to double. The patient was upset about the referral of the physician regarding the questions of blood sugar and eye pressure. Very limited information regarding these events have been provided. Further information has been requested. Possible confounding factors are the patient's medical history of Glaucoma and Diabetes mellitus.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested. Possible confounding factors are the patient's medical history of Glaucoma and Diabetes mellitus.
53 2021-07-27 cardiac arrhythmia Sudden spike in frequency and intensity of symptoms appearing to be related to my pre-existing eosin... Read more
Sudden spike in frequency and intensity of symptoms appearing to be related to my pre-existing eosinophilic esophagitis and premature ventricular contractions; specifically, coughing triggered by irritated esophagus and feelings of becoming flushed and slightly faint from premature ventricular contraction).
54 2020-12-31 chest discomfort Tightness of chest hard to breathe. Given two shots of morphine
54 2021-01-01 chest discomfort Chest tightness and squeezing sensation; SOB; chills; low grade fever; quivering of legs;
54 2021-01-02 fast heart rate I suffer from lingering SOB with exertion after COVID infection. On the night of 12/31/2020 I began... Read more
I suffer from lingering SOB with exertion after COVID infection. On the night of 12/31/2020 I began to feel more SOB than usual and was unable to correct my SOB with rescue inhaler. Became more SOB with exacerbated tachycardia and tachypnea, My family had to call 911 because I became aphasic and showing signs of possible stroke. I was taken to the ER and admitted for respiratory recovery and to role out stroke. The stroke was ruled out and I recovered with IV prednisone therapy, twice daily and supplemental oxygen. Released after HR, BP, & respiratory effort returned to normal: 01/03/2021
54 2021-01-03 lightheadedness, pallor About an hour after being vaccinated, I got very pale, and almost had a syncope episode at work. I ... Read more
About an hour after being vaccinated, I got very pale, and almost had a syncope episode at work. I felt weak kneed for about 2 hours afterwards, and was still wobbly knees the next day. I also had muscle/joint aches the same day, which went away within 24 hours. In the past 6 days, I have had reoccurring headaches, fatigue, and this morning, had a severe enough headache to bring on nausea. I am med compliant with all my meds and I take care of my Type II diabetes, I am also a volunteer firefighter - advanced EMT, so I know when there is a problem.
54 2021-01-04 hypertension 54yoM presented for a sudden-onset diaphoresis and loss of body strength. Pt had received COVID-19 v... Read more
54yoM presented for a sudden-onset diaphoresis and loss of body strength. Pt had received COVID-19 vaccine this morning at the clinic and noted severe sweating all over the body while lying in bed @ approx 2030. Then pt described severe loss of body strength with dizziness as he was trying to sit up and get to his feet from the floor. Denied palpitation, chest pain, headache, N/V, LOC. His symptoms continued for 20mins until he drank a cup of water. At approx 2050, smoked E-cigarette and arrived at facility at 2100. On arrival, pt denied any symptoms, however, vitals indicated severe hypertension: BP 188/99, HR 56, T 97.6 F. Pt given 81mg ASA x2 and immediately transported to hospital.
54 2021-01-04 loss of consciousness, fainting Pt received vaccination and left after 15 min. observation symptom free. He drove a short distance a... Read more
Pt received vaccination and left after 15 min. observation symptom free. He drove a short distance away from the clinical site when he felt profuse sweating and had syncope (seconds) crashing into curb. He was aroused from impact and was able to stop car. He then developed profuse nausea and sudden urge to defecate. He went to restroom. Given these events he returned to the clinical site in another vehicle. Upon arrival he denied chest pain, shortness of breath or ongoing nausea or abdominal pain. He reported his AM blood sugar was 72 and does not take insulin. No history of coronary disease or syncope. EMS was activated and assumed care.
54 2021-01-05 hypertension High blood pressure. BP went from 146/84 before immunization to 185/90 post immunization. The day ... Read more
High blood pressure. BP went from 146/84 before immunization to 185/90 post immunization. The day after BP is 193/106 and requires medical evaluation.
54 2021-01-08 blood pressure increased Dizziness ABD PAIN Narrative: ARM PAIN DAY 2 AND 3 FATIGUE AND ELEVATED BP DAY 2 AND 3 DAY 4 RESOLVE... Read more
Dizziness ABD PAIN Narrative: ARM PAIN DAY 2 AND 3 FATIGUE AND ELEVATED BP DAY 2 AND 3 DAY 4 RESOLVED
54 2021-01-09 heart rate increased Day 1 Nausea- 4 hrs after Swollen face/neck- 3 to 5 hrs- benadryl Left eye extreme blurry vision- ... Read more
Day 1 Nausea- 4 hrs after Swollen face/neck- 3 to 5 hrs- benadryl Left eye extreme blurry vision- 3 x's 2 to 5 min each Mental fog and confusion- 3 days intense, 4th day trouble with recall without intense focus Headache- 3 days intense, 4th day- moderate Elevated heartrate- sporadic first day until 6 pm Highly irritable- 2 days Incessant talking and moving
54 2021-01-11 heart rate increased elevated heart rate: (100-105) on 01/11/2021 11:00 PM to 11/12/2021 05:00 AM fever: (100 -104) on 01... Read more
elevated heart rate: (100-105) on 01/11/2021 11:00 PM to 11/12/2021 05:00 AM fever: (100 -104) on 01/11/2021 07:00 PM to ongoing
54 2021-01-13 heart rate increased Patient complained of headache and nausea, then dizziness/lightheadedness. All symptoms resolved exc... Read more
Patient complained of headache and nausea, then dizziness/lightheadedness. All symptoms resolved except a fast heart rate. Increased wait time after vaccine. Only complaint remaining was increased heart rate. Heart rate retaken. Patient insisted on driving himself him. Patient called chief nurse upon arrival and did make it home safely.
54 2021-01-20 chest discomfort, blood glucose increased, haemoglobin decreased Vaccinated 12/29/2020 @ ~0845. At ~7 pm same day, experienced extreme chest tightness and squeezing... Read more
Vaccinated 12/29/2020 @ ~0845. At ~7 pm same day, experienced extreme chest tightness and squeezing accompanied by SOB, mostly subsided by 10 pm. Next day, intermittent chest squeezing and SOB. Contacted RN by phone and advised to go to ER. Symptoms minimal to none at time of ER visit on 12/30/2020 @ ~1200. EKG, labs and CXR all negative. Sent home, all symptoms subsided by 12/31/2020.
54 2021-01-21 low blood platelet count, platelet count decreased Petechial hemorrhages, ITP, Platelets extremely low, Borderline dizziness on sudden movements
54 2021-01-26 chest pain As previously recorded, employee reported chest pains, intermittent and recurrent throughout the nig... Read more
As previously recorded, employee reported chest pains, intermittent and recurrent throughout the night of 1/21.
54 2021-01-28 blood glucose increased Glucose levels are elevated as compared to normal after receiving the in 2nd dose of the vaccine. Ad... Read more
Glucose levels are elevated as compared to normal after receiving the in 2nd dose of the vaccine. Additional insulin is required to keep Glucose levels at steady level, which is still above desired target range
54 2021-01-28 palpitations Patient was nervous getting the shot and stated he had a history of severe anxiety. During his obse... Read more
Patient was nervous getting the shot and stated he had a history of severe anxiety. During his observation period he reported that he had a racing heart, shaky hands, and was sweating. Staff monitored him and got him some water. He stated that he had a history of hypoglycemia as well but had not had issues with it in a while. Patient reported that his BG had been 80 that morning and that he had eaten Chick Fil a prior to coming for the vaccine. We offered a snack or glucose tablet but patient refused. We did recommend that the patient remain in our observation are a for an extra 15 minutes and he agreed. After monitoring and water the patient felt better and purchased glucose tablets when he left.
54 2021-01-28 sinus rhythm, chest discomfort Received vaccine at 1615. Within 1 min of receiving vaccine pt c/o "feeling funny", looked flushed. ... Read more
Received vaccine at 1615. Within 1 min of receiving vaccine pt c/o "feeling funny", looked flushed. Developed a mild HA and about a min later complained of chest tightness and shortness of breath (subjective only). VS at 1620: 192/89-hr 84, SaO2 99%. Placed supine, placed on O2 @ 1L/Min via NC. EKG done, NSR w/o acute changes or ectopy. HA worsened (sill only mild-mod) and developed pain to back of neck. BP returning toward normal in 5-10 min. VS @ 1630: 154/89-73 w SaO2 100%. Gradually felt better, discharged about an hour later with mild HA and slightly flushed color. It's worth noting that pt has hx of getting "red" easily on any exertion or emotional changes.
54 2021-01-31 chest discomfort Within 1 min of receiving vaccine pt c/o "feeling funny", looked flushed. Developed a mild HA and ab... Read more
Within 1 min of receiving vaccine pt c/o "feeling funny", looked flushed. Developed a mild HA and about a min later complained of chest tightness and shortness of breath (subjective only). VS at 1620: 192/89-hr 84, SaO2 99%. Placed supine, placed on O2 @ 1L/Min via NC. EKG done, NSR w/o acute changes or ectopy. HA worsened (sill only mild-mod) and developed pain to back of neck. BP returning toward normal in 5-10 min. VS @ 1630: 154/89-73 w SaO2 100%. Gradually felt better, discharged about an hour later with mild HA and slightly flushed color. It's worth noting that pt has hx of getting "red" easily on any exertion or emotional changes.
54 2021-02-04 chest discomfort Patient started having symptoms on 1/4/2021, which was chest pressure. He stated that on day 6 he d... Read more
Patient started having symptoms on 1/4/2021, which was chest pressure. He stated that on day 6 he developed chills, tightness in the chest and headache that lasted 40 hours and then went away. By day 9 he states he was feeling fine. Today he reports a little tightness in the chest but has not had chills and headache since last night. Patient was seen at Urgent care clinic and was evaluated due to his symptoms. Patient received testing for COVID-19 at that time. He did not identify any source of exposure. Although his symptoms have improved he is working from home until his PCR test results come in.
54 2021-02-07 blood glucose increased 21st - swollen big toe and upper part of foot - I had swelling but not as bad as first dose of vacci... Read more
21st - swollen big toe and upper part of foot - I had swelling but not as bad as first dose of vaccine; some of my joints sore, too. On 26th of January, I had shortness of breath and a little dizzy. It was tolerable but was there. Toe/foot symptoms resolved around January 31st but I did still have shortness of breath up until the 2nd of February. Dr put me on Colchesine and Alloepurinal
54 2021-02-13 fast heart rate Moderna COVID?19 Vaccine EUA. Tachycardia day 2
54 2021-02-17 pallor, haemoglobin decreased, anaemia Dizziness, Headache & Anemia Narrative: Received #1 dose of vaccine 12/28/21, noticed dizziness ver... Read more
Dizziness, Headache & Anemia Narrative: Received #1 dose of vaccine 12/28/21, noticed dizziness vertigo headache at the same time period, edema to lower extremities. Received #2 dose 1/20/21, within 4 days noticed headache, continues to have headache to present. Advised to follow up with pmd 2/18/21 as color was pale, Hgb 5.4, admitted and transfused with 2 u prbc.
54 2021-02-17 palpitations as with first shot, my husband experienced heart palpitations after a couple minutes of receiving. ... Read more
as with first shot, my husband experienced heart palpitations after a couple minutes of receiving. Palpitations were transitory. only lasted a few seconds. Shot 1A and 2A. With 2A, he experienced chills, low grade fever and fatigue and sore arm.
54 2021-02-20 chest discomfort I had pain in arm from injection immediately, after injection, which was much different than first d... Read more
I had pain in arm from injection immediately, after injection, which was much different than first dose. But not unexpected. But the adverse symptoms started about 5 hours in or so, i developed a cough, and dyspnea, it was tight in my chest, hard to breathe. the cough was/is (it remains), sometimes hard and raspy, i was a bit wheezy, and I had air hunger, like i could not breathe or get air. if i exhale to strongly i cough, if i talk to much i cough, if i sing i cough, if i inhale too deeply i cough. I also have been very dizzy since the shot and vertigo. I am still coughing and it is 5 days post shot. I started developing headache and severe body pain, pain in my spine, low back and joints. which is expected, but i also had scalp pain and it hurt to be even touched the slightest bit on my scalp and everywhere on my body. I had very stiff neck and eye socket pain as well. I also feel "funny" in my head. LIke dizzy, and vertigo, but also like it is wrapped in a heavy towel and my eyes feel heavy and like i can't see well. my vision is as if it has diminshed. 5 hours after shot cough started, and the dyspnea, i started feeling chills and deep squeezing ache in my arm at jab site, and soon had fever of 100.6, over night it went to 100.8 and i felt terrible, headache, body ache, restless. but next day fever was 102. it remained all day, i had zero energy slept the whole day. no appetite, did not eat anything except a scramble egg which made me nausea. fever remained all day at 101.8. over night. next day temp was 99.8 (my normal is 97.6) and it was 99.8 all day. Cough was persistent and really bad with the dyspnea this whole time and i still have cough 5 days out, just giving a timeline here. by friday, my temp was 98 but i felt extreemly fatigued. I went and got a covid test which was negative. i saw the chiropractor and they helped my back and headache a little bit. went home and rested. cough has lingered, dizzy lingers, chest tight and sob lingers. fatigue lingers. Cough and dyspnea are NOT signs, the sheet i got for V-safe says right on it these are NOT expected.
54 2021-02-23 chest discomfort Vaccine reaction, initial encounter +7 more Dx Medication Problem Reason for Visit Progress Notes ... Read more
Vaccine reaction, initial encounter +7 more Dx Medication Problem Reason for Visit Progress Notes Chief Complaint Patient presents with ? Medication Problem HPI: patient here for COVID vaccine and received at 0923 He states he started feeling lightheaded and hot within 5 minutes Patient appears diaphoretic, flush and unsteady Hx of two COVID infections one in March and second in May 2020, today is first dose of vaccine BG 191, apical pulse 82, LS clear bilateral Patient able to answer all questions After 20 minutes patient still reports feeling off, denies SOB, mouth or throat tingling, headache or CP appointment scheduled two days for PCP Requested patient have his daughter pick up patient and he should avoid driving for today and tomorrow Patient re-evaluated Patient still nauseated Chest tightness-new symptom Cannot stand, unsteady gait Facial flushness Daughter here to give father a ride but decision to transport to ED by provider, discussed with patient and daughter-pt verbalized understanding 121/83 (T50.Z95A) Vaccine reaction, initial encounter (primary encounter diagnosis) Comment: symptomatic treatment discussed Plan: (R42) Light headed Comment: Plan: RANDOM GLUCOSE IN HOUSE, RANDOM GLUCOSE IN HOUSE, OXYGEN 2 LITERS VIA NASAL CANNULA (R61) Diaphoresis Comment: Plan: (R26.81) Unsteady gait Comment: Plan: daughter to drive patient home PLAN: Discussed symptoms requiring immediate provider contact or when to call EMS-pt verbalizes understanding Patient given water, patient able to grasp cup and and drink without difficulty VS retaken 1032 Possible reaction to antibodies due to two COVID inections rtc 2 days as discussed Other Notes All notes Progress Notes from RN (Family Practice) Additional Documentation Vitals: BP 132/89 Pulse 87 Temp 98 °F (36.7 °C) (Non Contact) Resp 12 SpO2 100% Pain Sc 0-None SmartForms: TIME SPENT FOR ENCOUNTER -2021 PHYSICIAN FEE SCHEDULE Encounter Info: Billing Info, History, Allergies, Detailed Report Communications Letter sent to patient
54 2021-02-24 loss of consciousness, fainting Generalized not feeling well the day after vaccine administered then progressed to dizziness, nausea... Read more
Generalized not feeling well the day after vaccine administered then progressed to dizziness, nausea. Approx 20 hours after receiving his second dose of Moderna from Health Department he had a syncope episode with LOC of a few seconds. He sustained head injury that was treated and sutured. No further side effects after day 2 of vaccine.
54 2021-02-25 chest pain Patient received 2nd dose of Moderna Covid Vaccine at 1pm. At 2:30pm he started to develop chest pa... Read more
Patient received 2nd dose of Moderna Covid Vaccine at 1pm. At 2:30pm he started to develop chest pain and left side neck and arm pain. He was admitted to the hospital for further work-up. While in the hospital the patient had relief only from sitting up and forward. The doctor decided to transfer the patient to another facility that had specialist. At the next hospital it was determined that the patient had Viral Pericarditis, associated with the Covid Vaccine.
54 2021-03-01 pallor, fainting PT HAD A SYNCOPLE EPISODE IN HIS CAR WHILE IN OBSERVATION. -12 LEAD. NEGATIVE -BS CHECK -SKINS COLOR... Read more
PT HAD A SYNCOPLE EPISODE IN HIS CAR WHILE IN OBSERVATION. -12 LEAD. NEGATIVE -BS CHECK -SKINS COLOR CHANGE. COOL, PALE, DRY PT AMA. PT WIFE DRIVING PT HOME. MODERNA COVID19 EUA POD VACCINE VACCINE ADVERSE REACTION.
54 2021-03-04 pulmonary embolism, deep vein blood clot Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punk... Read more
Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punky; Arm hurt; A spontaneous report was received from a nurse concerning a 54-year-old, male patient who experienced pulmonary embolism, deep vein thrombosis, vaccination site pain, sluggishness and dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12-Feb-2021, approximately 2 days 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. The patient received his vaccine on 12-Feb-2021 and reported that his arm hurt a little for a few days. On 14-Feb2021, he reported that he started feeling sluggish and on 20-Feb-2021 he began to have difficulty breathing and pain in the right lower base of rib cage. He went to urgent care where he was diagnosed with a pulmonary embolism for which he received treatment. On the evening of the same day, he again started having difficulty breathing with pain upon inhalation. He returned to urgent care and was subsequently admitted at 12:30 AM on 21-Feb-2021. That Monday, 22-Feb-2021, a doppler ultrasound revealed a deep vein thrombosis in the left calf. Patient was treated with heparin intravenously (IV). He was discharged 22-Feb-2021. Treatment for the event included Xarelto 20mg twice per day for two weeks and Heparin IV. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, pulmonary embolism, deep vein thrombosis and dyspnea, was considered recovering/resolving as of discharge on 22-Feb-2021. The outcome of the events, vaccination site pain and sluggishness, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
54 2021-03-05 chest pain Beginning about 16hours after the shot (the next morning) my stomach began to bother me a little, wi... Read more
Beginning about 16hours after the shot (the next morning) my stomach began to bother me a little, within half an hour or so I began to feel a little tingle from the top left arm (shot area) down to my stomach including my sternum area. It got progressively worse. By about hour 17 I was beginning to get cold sweats and stomach bothering me more. By hour 18 I was cold, sweating, nauseous, vomiting, hard tight pain in stomach /and sternum/chest. Stomach / chest pain persisted badly for about 30- 45 minutes then began to subside. By hour 19 most of the sever pain subsided. for the rest of the day (@and still 25 hours later) I still have a lingering miserable stomach and slight headache. I slept most of the afternoon without any medication.
54 2021-03-06 fainting Felt nauseous when trying to urinate, then was sweaty, fainted and fell.
54 2021-03-07 chest discomfort Complained of chest tightness but no angina/pain, left deltoid area "felt warm" after vaccine admini... Read more
Complained of chest tightness but no angina/pain, left deltoid area "felt warm" after vaccine administration. Patient in no apparent distress. Checked vital signs at 1:37 pm and 1:40 pm -- all normal. Patient currently incarcerated. Correctional guards monitored patient for another 20 minutes.
54 2021-03-10 palpitations Aproximately 30 minutes after injection, I felt stimulated as if having drank too many energy drinks... Read more
Aproximately 30 minutes after injection, I felt stimulated as if having drank too many energy drinks, mild diaphoresis, mild trembling, racing heart rate. Suffered uncharateristic insomnia the same night. On 2/23/21, I awoke after 6 hours sleep, with mild body aches and general torpor -malaise. This progressed into the early afternoon to severe body aches 8/10 on pain scale of 10, a moderate headache of 3/10, excessive drowsiness, extreme diaphoresis, chills, and a temperature spike of 1 degree. I had very mild motor trembling in upper extremeties (hands) that seemed unassociated with fever. I took no medications and slept under these general conditions for 80% of the next 48 hours. The headache did reduce after the 10 hours from onset.
54 2021-03-11 atrial fibrillation Atrial fibrillation
54 2021-03-11 oxygen saturation decreased, blood clot, heart rate increased, pulmonary embolism, platelet count decreased After 1st injection (1/11/21) experienced severe shortness of breath with minimal activity with acc... Read more
After 1st injection (1/11/21) experienced severe shortness of breath with minimal activity with accelerated heart rate and drop in O2 stat. within 2 days of injection then developed wheezing cough. Primary MD prescribed Augmentin nd prednisone with eventual success. With normal blood work, chest x-ray and negative Covid test all done by 1/15. On 3/9/21 (28) days after second dose (2/11/21) experienced burning and swelling on right leg. Went to Hospital, ER and found extensive blood clots in right leg and saddle pulmonary embolism . Also had 50% Platelet blood count decrese since the 1/15 bloodwork Admitted for 3 nights on heparin dip. Discharge on home Lovenox injections for 30days.
54 2021-03-14 heart rate decreased, pallor, pulse abnormal pt states he started feeling "funny" around 9-10 minutes after receiving vaccine. Pts wife came and ... Read more
pt states he started feeling "funny" around 9-10 minutes after receiving vaccine. Pts wife came and got clinic staff. Pt became unresponsive, weak thready pulse, clammy, pts color grey/pale. Sternal rub completed- pt unable to state name or follow commands. 911 called by clinic staff. Pharmacy staff also present. HR/pulse ox unable to detect reading, manual pulse in the 50s. Pts neck repositioned and breathing improved. Pts wife standing beside him throughout. Pt became responsive- a & o x3 within 2-3 minutes. Pts color improved, HR in 60s, pulse +2 bilaterally radially. EMS arrived within approximately 5-7 minutes. Pt refused to go with EMS. Pt states "this has happened to me before" "I have an aversion to needles" Discussed this is likely adverse reaction to vaccine. Advised he should not get second dose. Pt was given coke and sat in chair with wife. Pt left store around 727pm.
54 2021-03-14 fainting Patient fainted a few minutes after receiving vaccine. He stated he had a history of doing this wit... Read more
Patient fainted a few minutes after receiving vaccine. He stated he had a history of doing this with past vaccinations. 911 was called. Patient declined treatment and left store approximately 30 minutes later.
54 2021-03-15 chest pain after about 30 minutes, I started having a metallic taste in my mouth. I was also experiencing sore... Read more
after about 30 minutes, I started having a metallic taste in my mouth. I was also experiencing soreness in left arm area. After about an hour, the pain in my arm started to feel as though it was spreading to my left chest cavity area. I then started to get chest pains in the left breast area to the armpit area, but not severe, just concerning. After probably 70-80 minutes, I started feeling drowsy. I continued to feel drowsy all evening and did not sleep well. I woke up and could not return to sleep at 4:45am. My normal waking time is 6:00am. I had/have quite a bit of soreness in my arm, but nothing unbearable. No signs of rash or inflammation around injection sight. I am taking a sick day from work to relax and recover from loss of sleep. The metallic taste persist, but only an annoyance and taste seems to be normal when eating or drinking. A slight achiness in joints, but a cold front was also moving in, which can cause me to have the same effect.
54 2021-03-16 troponin increased, heart attack, chest pain Pt presented to the er on 3/12/2021 with c/o 5 days of worsening chest pain and sob. found to have a... Read more
Pt presented to the er on 3/12/2021 with c/o 5 days of worsening chest pain and sob. found to have a inferior STEMI and transported to different hospital for urgent angiogram. acute lateral MI found on angio resulting in placement of drug eluding stent
54 2021-03-17 cardiac arrest Cardiac Arrest Narrative: Patient received vaccine at 1209 on 3/13/2021, observed for 15min no reac... Read more
Cardiac Arrest Narrative: Patient received vaccine at 1209 on 3/13/2021, observed for 15min no reaction noted. Later that evening patient was not feeling well presented to ER where he was admitted. Had cardiac arrest during hospitalization on 3/16/2021 where patient passed away. Had a Hx of CHF, A-Fib, had a cardiac stent placement in 2020..
54 2021-03-17 heart rate increased Moderna COVID?19 Vaccine Fever with Tmax of 102.5F at 24 hours - resolved after 2 days. Headache (o... Read more
Moderna COVID?19 Vaccine Fever with Tmax of 102.5F at 24 hours - resolved after 2 days. Headache (occipital) - resolved after 2 days. Very mild vertigo and tinnitus - resolved after 2 days. Elevated heart rate for 1-2 days - resting heart rate typically 60-65 increased to 75-90.
54 2021-03-18 pulmonary embolism, fibrin d dimer increased, enlargement of the heart submassive pulmonary embolism R&L lungs
54 2021-03-22 nosebleed Serious very unusual nose bleed. Difficult to stop. Not explainable by any regular or current circu... Read more
Serious very unusual nose bleed. Difficult to stop. Not explainable by any regular or current circumstance or possible cause. Likely combination of factors that vaccination contributed to. Happened again after second dose at roughly same time frame only more severe (30 minutes and sensitivity a couple days before and after)
54 2021-03-26 pallor We waited our 15 minutes then went to the car and drove around the lake area for about 10 minutes t... Read more
We waited our 15 minutes then went to the car and drove around the lake area for about 10 minutes then headed to . As he was driving he wasn't feeling very well, I told him maybe we should go sit in the parking lot of the hospital. We ended up in parking lot. He was pale, nauseated and he thought he was getting a fever (but didn't) and was really getting tired like ran down. So, he said for me to drive him home so he could lay down. I got him home I called Dr. office I knew these symptoms were normal , but didn't think on first dose and that fast... 30 minutes from time of injection to when he got sick feeling. The Doctors office just said to watch him for symptoms if he got worse etc., and I asked if this was normal for how fast this happened. She said there is no normal. He was cold and covered up when we got home and took a 2 hour nap! Afterwards, he helped make dinner and was ok just his arm was really sore.
54 2021-03-26 pulmonary embolism had a Pulmonary Embolism
54 2021-03-27 heart attack My husband died of a sudden massive heart attack. He was one of two teachers who died after the mod... Read more
My husband died of a sudden massive heart attack. He was one of two teachers who died after the moderna vaccine, second dose. A third teacher had a stroke.
54 2021-03-28 chest pain pain and swelling in the left side underarm/chest area
54 2021-03-29 heart attack Heart attack; A spontaneous report was received from a physician assistant, concerning a 54-year-old... Read more
Heart attack; A spontaneous report was received from a physician assistant, concerning a 54-year-old adult male patient who received Moderna's COVID-19 vaccine and experienced heart attack/myocardial infarction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 25 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis. On 07 Mar 2021, after first dose of vaccine, the patient had chest pain and shortness of breath. On 12 Mar 2021, patient had a heart attack and was airlifted to hospital. He was hospitalized from 13 Mar 2021 to 14 Mar 2021. Patient did not have history of heart condition nor was taking any medications prior to having the heart attack. During hospital stay, he had angiogram done, stents were placed. Treatment also included cholesterol lowering medicine, blood pressure medicine and acetylsalicylic acid. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, heart attack was resolved on 14 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of myocardial infarction, a causal relationship cannot be excluded.
54 2021-03-30 very slow heart rate 3/31/21, 0842. 54 yo M complaining of dizziness. Upon observation Pt was diaphoretic, weak, and slow... Read more
3/31/21, 0842. 54 yo M complaining of dizziness. Upon observation Pt was diaphoretic, weak, and slow. EMS evaluation performed. 12-lead.Pt was bradycardic in the 30's. IV established in L ac. Atropine administered. Pt care transferred to responding EMS unit. Pt transported to hospital.
54 2021-03-30 cerebrovascular accident Per mom who called to report- about 2 hrs after vaccine on saturday 03/27/21 pt started to have a he... Read more
Per mom who called to report- about 2 hrs after vaccine on saturday 03/27/21 pt started to have a headache, she gave him some ibuprofen. He was still having headache and sick at stomach she gave him phenegran that evening. States he is paralyzed on left side of body and uses wheelchair but still gets around some on own- he fell 3 times that evening- lost strength in right arm. Monday he slept a lot of the day and when he woke up at 5pm mom states he couldnt talk right- he kept repeating words and trying to smoke a cigarette but had not cigarette in his hand. Was taken to hospital monday evening and at hospital now- mom states some confusion and trying to be combative with nurses. Per mom doctor believed he had a stroke on Saturday.
54 2021-03-31 chest pain Presented to hospital on 3/25 with flank and chest pain after telephone triage referral by PCP offic... Read more
Presented to hospital on 3/25 with flank and chest pain after telephone triage referral by PCP office. ER completed CT scan of abdomen and pelvis which showed evidence of wedge-shaped area of non-perfusion involving upper pole of right kidney (renal infarction). Admitted to telemetry floor. Serial troponins negative. ECHO showed apical septal wall hypokinesis with grade 1 systolic dysfunction. Nuclear stress testing showed high risk study, underwent cardiac cathertization which showed patent grafts. TEE negative for thrombus. Hematology labs pending at time of discharge. Unknown etiology of renal infarction at time of discharge.
54 2021-04-07 blood clot Received 2nd Moderna Covid shot on 03/29/2021 and on 03/31/2021, felt what I thought was a muscle cr... Read more
Received 2nd Moderna Covid shot on 03/29/2021 and on 03/31/2021, felt what I thought was a muscle cramp that never went away. Went to urgent care where the shot was given on unspecified date and they diagnosed what I thought was a muscle cramp area, as a blood clot.
54 2021-04-12 chest pain Muscular pain in arms, chest, and calves. Mild nausea.
54 2021-04-12 deep vein blood clot Patient had a acute occlusive DVT of the left femoral vein from the proximal thigh down to the proxi... Read more
Patient had a acute occlusive DVT of the left femoral vein from the proximal thigh down to the proximal calf involving the femoral vein, popliteal vein, proximal tibial veins on his left lower extremity. He is now being treated with anticoagulant medication p.o. He is currently being evaluated for possible pulmonary embolism as well.
54 2021-04-13 nosebleed Muscle tightness - soreness - at the arm with the injection and it was for about three and five days... Read more
Muscle tightness - soreness - at the arm with the injection and it was for about three and five days. Maybe about 2 weeks from vaccine - I had some congestion (nasal congestion and sneezing) - it was odd (not allergies) and it lasted a solid with heavy heavy drainage and that lasted about two days. I had to use the Mucinex D for it. Then I had the nose bleed - it wouldn't stop bleeding in right nostril. I went to ER - Sunday, the 28th - started at 10:30 pm and after midnight on the 29th it was after 4 hours of bleeding when I went to ED in town. The doctor said my nasal passages were really dry because of the weather. I was using a travel CPAP that doesn't have a humidifier. They cleared a giant clot in the back of my throat - it was the size of a hamburger - it was huge. They used a nasal vasodilator - it looked like nasal spray and they did it and stopped. Vitals were stable and they sent me home. I might have one bloody nose after - a week after and they had given me the nasal vasodilator and that stopped it. They also prescribed a nasal saline spray and I only use the CPAP with the humidifier now.
54 2021-04-15 chest pain Vaccine given to patient at 10:30am 4/14/21 and he called main office and left message that evening ... Read more
Vaccine given to patient at 10:30am 4/14/21 and he called main office and left message that evening on nurse voicemail that he had symptoms starting at 4pm- Severe headache, chest pain, SOB, vomiting and diarrhea. Nurse practitioner called him back the next day when returned to office and retrieved messages and called patient back. He reported he has hx of Cardiac and lung problems and that he had a bad reaction to his flu shot when had in past. He replied no to all these questions on the questionaire, and when asked by staff giving the shot. He was advised by Nurse practitioner to go to ER
54 2021-04-15 pulmonary embolism Acute pulmonary embolism
54 2021-04-15 fainting Patient was returning to unit. When patient reached unit doors, patient collapsed. Health Care calle... Read more
Patient was returning to unit. When patient reached unit doors, patient collapsed. Health Care called, 3 nurses and Mini Ambulance deployed. Upon the Staff's arrival CPR was in progress, AED in place, Narcan administered. Ambulance call, transported to Facility. Patient pronounced 0724 hours
54 2021-04-16 excessive bleeding bleeding from the left ear
54 2021-04-17 blood clot VTE legs, large intestine, & lungs Narrative: Patient reports received his first COVID vaccine dos... Read more
VTE legs, large intestine, & lungs Narrative: Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
54 2021-04-20 excessive bleeding, fainting, pallor Patient was given 2nd Moderna vaccine at about 7:30. Patient was pale and diaphoretic and was lowere... Read more
Patient was given 2nd Moderna vaccine at about 7:30. Patient was pale and diaphoretic and was lowered to the floor by RN and another patient receiving the vaccine who was a cardiologist. He had several beats of clonus and then woke up. He was awake when his first vital signs were obtained. HR 110, BP 190/96, O2 sat 100%. When he was more awake he was assisted in to a reclining chair. BP monitored every few minutes and dropped as low as SBP 104, HR 70-80s. Pt reported that he periodically syncopizes, last 6mo ago. He reported feeling lightheaded after seeing his arm bleed and be swollen after vaccination. After about 1 hours the patient's vital signs were stable but he continued to have symptoms of lightheadedness which worsened when I sat him up (though BP was stable). EMS was called and he was transported to the ED.
54 2021-04-20 heart rate increased PATIENT CALLED THE PHARMACY AT 9:00AM AND SHOWED SIGNS AND SYMPTOMS OF TONGUE SWELLING, BLURRY VISIO... Read more
PATIENT CALLED THE PHARMACY AT 9:00AM AND SHOWED SIGNS AND SYMPTOMS OF TONGUE SWELLING, BLURRY VISION AND RAPID HEART BEAT. I NOTIFIED THE PATIENT TO GO TO THE EMERGENCY ROOM IMMEDIATELY.
54 2021-04-21 blood glucose increased Pt became dizzy and felt cold feet
54 2021-04-21 blood clot Hospitalized for acute blood clot in each leg
54 2021-04-23 heart rate increased, fast heart rate Moderna COVID?19 Vaccine EUA Fever with Tmax of 103.0F at 21 hours - resolved after 2 days. Headache... Read more
Moderna COVID?19 Vaccine EUA Fever with Tmax of 103.0F at 21 hours - resolved after 2 days. Headache (occipital) - resolved after 2 days. Very mild vertigo and tinnitus - resolved after 2 days. Very sore arm and tender for a week. Tachycardia noted at 21 hours with resting heart rate of 110-125 for 1-2 days that normalized over the next 7 days. My resting heart rate is typically 60-65.
54 2021-04-24 bleeding on surface of brain Taken into emergency with sudden onset of seizure at 3 :30am while sleeping at home. Had another sei... Read more
Taken into emergency with sudden onset of seizure at 3 :30am while sleeping at home. Had another seizure when arrived at the hospital. After multiple exams abs tests, diagnosed as subarachnoid hemorrhagic stroke. Don?t know if it?s related to the vaccine received 2 weeks prior
54 2021-04-25 atrial fibrillation 8 days after 2nd moderna covid vaccine kept waking up due to pain upon inhalation. by 2:48 am I co... Read more
8 days after 2nd moderna covid vaccine kept waking up due to pain upon inhalation. by 2:48 am I could only take shallow, open mouth breathes because it hurt too much to take a deep breath. All mucles were sore, but especially the thigh muscles, headache, chills, temp = 100,
54 2021-04-25 cerebrovascular accident A few hours after the shot I felt heat on my right side, face, hands and leg. It progressed and bec... Read more
A few hours after the shot I felt heat on my right side, face, hands and leg. It progressed and became numb and tingling the next day. I thought these were normal side effects from the second shot, but when I had trouble moving my right foot by two days later, I went the emergency room.
54 2021-04-26 deep vein blood clot DVT in left calf
54 2021-04-27 blood pressure decreased, atrial fibrillation AFIB ,bp bottomed out and hospitalized
54 2021-04-27 chest pain, ischemic chest pain, blood pressure increased, heart rate increased, chest discomfort MY THROAT IMMEDIATELY STARTED TO CLOSE AFTER RECEIVING SHOT #1. MY BLOOD PRESSURE (WHICH I HAVE NEVE... Read more
MY THROAT IMMEDIATELY STARTED TO CLOSE AFTER RECEIVING SHOT #1. MY BLOOD PRESSURE (WHICH I HAVE NEVER HAD HIGH BLOOD PRESSURE) SHOT UP TO 215/120 AND MY HEART RATE SHOT UP TO OVER 115. AFTER PARAMEDICS GAVE ME A BENADRYL, AND AFTER WAITING THERE FOR AN HOUR, I WAS RELEASED TO GO HOME WITH INSTRUCTIONS TO TAKE ANOTHER BENADRYL. I ENDED UP TAKING TWO BENEDRYL WHEN I ARRIVED AT HOME AS MY THROAT WAS ABOUT TO CLOSE. SINCE THEN I HAVE HAD HEART ISSUES (PAIN, TIGHTNESS, HIGH BLOOD PRESSURE, ANGINA). I AM SEEING MY CARDIOLOGIST ON A REGULAR BASIS DUE TO NOW HAVING SMALL ARTERY DISEASE AFTER MODERNA'S COVID-19 SHOT #1.
54 2021-04-29 anaemia Patient comes with bilateral burning thigh pain and weakness for 2 weeks that began 1 week after Mod... Read more
Patient comes with bilateral burning thigh pain and weakness for 2 weeks that began 1 week after Moderna COVID vaccine. MRIs of T & L spine are non significant. Inflammatory markers are elevated and he has worsening kidney disease than his baseline. Also with anemia. 4/29 MRI thigh muscles show extensive edema R>L suggestive of myositis from some source. Nephrology considering renal biopsy for his progressive kidney failure. Patient may have autoimmune or inflammatory process affecting both muscle and kidneys. Have sent for autoimmune antibodies as well as other vasculitic markers and requested muscle biopsy by general surgery. He needs to be started on steroids.
54 2021-05-05 nosebleed In the afternoon, I experienced a nosebleed. The weather was not overly dry, I was well-hydrated, a... Read more
In the afternoon, I experienced a nosebleed. The weather was not overly dry, I was well-hydrated, and I was confused why I would experience a nosebleed. The bleed was not excessive, and I considered coincidence. An hour or two later in the late afternoon, my wife noticed that I had a ruptured capillary in my left eye. She was very concerned since it appeared very bloody even though it did not cause me any significant pain. The affected eye was mildly itchy afterward. I was not hit in the eye or scratched it in any way. I associated the capillary bleeding events as related to each other and potentially related to my vaccination. However, both events were minor and passed, cleared up in 72 hours. I have a photo of my eye that is available upon request.
54 2021-05-06 chest pain chest pain head aches limb pain shortness of breath
54 2021-05-06 loss of consciousness PATIENT FAINTED & FELT DIZZY WHILE USING MEN'S URINAL SHORTLY AFTER HE WAS GIVEN HIS 1ST MONDERNA VA... Read more
PATIENT FAINTED & FELT DIZZY WHILE USING MEN'S URINAL SHORTLY AFTER HE WAS GIVEN HIS 1ST MONDERNA VACCINE. WIFE REPORTS HE WAS HISTORY OF FAINTING & ANEMIA, ALTHOUGH THESE CONDITIONS WERE NOT MENTIONED DURING PRE-SCREENING NOR WHEN HE FILLED OUT HIS CONSENT FORM. HE WAS TAKEN BY AMBULANCE AS A PRECAUTION, ALTHOUGH HE WAS ALERT AND RESPONSIVE
54 2021-05-07 bleeding on surface of brain 8 days 9.5 hours after 1st moderna vaccine. emergency room visit for a "thunderclap" headache. diagn... Read more
8 days 9.5 hours after 1st moderna vaccine. emergency room visit for a "thunderclap" headache. diagnosed with a subarachnoid hemorrhage. (brain bleed). no avm, no aneurysm found after 7 days hospitalized with a multitude of scans performed. zero reason for this to have happened?!?!
54 2021-05-09 heart rate increased 5 mins after initial shot, rapid heart rate that subdued in approximately 15 min. About 12 hours af... Read more
5 mins after initial shot, rapid heart rate that subdued in approximately 15 min. About 12 hours after the shot, experienced swelling in face and closure of throat, excessive sweating, fatigue and disorientation/dizziness and muscle paralysis/weakness in the back of neck, needing to use my hand to lift my head up.
54 2021-05-11 pallor Patient presented for first dose of Moderna vaccination at 12:13. Patient stated that when he rose f... Read more
Patient presented for first dose of Moderna vaccination at 12:13. Patient stated that when he rose from the chair, he felt lightheaded. Patient immediately sat down in a chair and subsequently lowered himself to the floor with assistance from a nurse. Patient remained alert and oriented, appeared pale and diaphoretic. Patient denied SOB, C/P, H/A and nausea. BP 160/108, P 69, R 18, O2 96% RA. Respirations are easy and labored, lungs clear on auscultation. Patient on cardiac monitor presenting with normal sinus rhythm. At approximately, 12:20 assisted to a sitting position and patient verbalized feeling better. Patient was then transferred to a wheelchair and continued to be monitored for an additional 15 mins. BP 160/80, P 58, R 18, O2 98%. Patient verbalized that he felt better and his mother was driving him home.
54 2021-05-14 transient ischaemic attack Transient Ischemic attack
54 2021-05-16 pulmonary embolism pulmonary embolism 10 days later.
54 2021-05-17 chest pain Reports his throat was swelled, he had chest pain in which he took nitro for, tired, sweating both m... Read more
Reports his throat was swelled, he had chest pain in which he took nitro for, tired, sweating both morning and night, and had an upset stomach.
54 2021-05-17 platelet count decreased thrombocytopenia platelets 87K foot swelling, and pain petechial rash
54 2021-05-18 chest discomfort Pt received second Moderna vaccine today. During the 15 minute waiting period after the vaccine; he ... Read more
Pt received second Moderna vaccine today. During the 15 minute waiting period after the vaccine; he reported that his chest, back and torso felt tight and almost felt if he were having muscle spasms. We called the squad and had him sit down to rest. He said it felt better to stand and he tried relieving the discomfort by stretching his lower back. We checked his blood pressure (131/90) and asked if he wanted a bottle of water. He said that the feeling was beginning to fade and by the time the squad arrived; he said the felling had passed and he felt fine.
54 2021-05-20 blood clot Patient states that 1-2 hours after receiving vaccine became nausea and had severe headache. Patien... Read more
Patient states that 1-2 hours after receiving vaccine became nausea and had severe headache. Patient stated he sought medical attention and physician stated that " he had developed a blood clot on the right back side of head."
54 2021-05-23 excessive bleeding, fainting About 5 minutes after receiving the vaccination, the patient passed out rolling onto the floor from ... Read more
About 5 minutes after receiving the vaccination, the patient passed out rolling onto the floor from his chair and incurred some cuts to his nose/face. In addition to bleeding from his abrasions, he was vomiting/dry heaving repeatedly. An ambulance was called, and care was taken over by paramedics. He was taken to local hospital to be examined and treated as needed. He received the vaccine at 1;15 pm, passed out at 1:20 pm and was taken away by ambulance about 2:00 pm.
54 2021-05-24 chest pain CHEST PAINS , VOMITING, EXTREME FEVER, MASSIVE HEADACHE BODY PAINS AND ACHES , MINOR CONVULSING , IN... Read more
CHEST PAINS , VOMITING, EXTREME FEVER, MASSIVE HEADACHE BODY PAINS AND ACHES , MINOR CONVULSING , INTERNAL PAIN ALLOVER
54 2021-05-25 cerebral haemorrhage Patient experienced HA on way home from receiviong vaccine. HA persisted on 4-23-21 throughout morn... Read more
Patient experienced HA on way home from receiviong vaccine. HA persisted on 4-23-21 throughout morning and into early afternoon. Patient became catatonic at home, family called 911 and pateint was rushed to hospital via ambulance in hypertensive crisis and seizure activity. Patient diagnosed with brain bleeds in two sepearte areas of brain. Original commentary by neurosurgeon was this was unrelated to Moderna vaccine, current neurologist thinks it could have been related. Patient was in hospital for several days then released on 4-28-21. Patient is healing, going to therapy and compliant with all neurology follow ups. Patient still not released to return to work or to driving as of 5-26-21.
54 2021-05-25 pulmonary embolism, chest pain Per medical record, the patient complained of a productive coughing, difficult breathing, wheezing a... Read more
Per medical record, the patient complained of a productive coughing, difficult breathing, wheezing an chest pain. His discharge diagnosis was noted to be Saddle embolus of pulmonary artery.
54 2021-05-26 fainting Guest experienced a syncopal episode post vaccination and then developed nausea. Guest reports all ... Read more
Guest experienced a syncopal episode post vaccination and then developed nausea. Guest reports all symptoms resolved and refused further medical evalaution.
54 2021-05-27 chest pain Patient is here with left upper abdominal pain and left chest pain that started last night. Patient... Read more
Patient is here with left upper abdominal pain and left chest pain that started last night. Patient had his second MODERNA vaccine on May 20, 7 days ago, has not felt well since then. Initially had muscle aches back pain fever or chills. Reportedly stayed in the hot tub too long and he may have gotten dehydrated. Patient had onset of left upper abdominal pain and left-sided chest pain last night. He took some over-the-counter medications without any relief. He has had a history of some stomach problems and IBS in the past but they usually resolve on their own.
54 2021-05-27 transient ischaemic attack, hypertension First 10 days: High fever, chills, high blood pressure, headache, inability to swallow, entire left ... Read more
First 10 days: High fever, chills, high blood pressure, headache, inability to swallow, entire left side numb (face, head, shoulder, arm), loss of voice Next 28 days and current: loss of voice, swallowing hard, shoulder pain, limited shoulder movement, tight neck in the left side
54 2021-05-29 deep vein blood clot, blood clot Deep Vein Thrombosis (DVT) in right lower leg. Symptoms initially occurred about two days after fee... Read more
Deep Vein Thrombosis (DVT) in right lower leg. Symptoms initially occurred about two days after feeling sick with a high fever. Initially, the pain in the right calf muscle was thought to be a muscle or tendon strain. On May 22nd, during a campout, there was pain along the entire right leg, but at the time I thought it was just related to lower back pain from sleeping on the ground. On May 27 and 28th there was sharp pain at the bottom of my right foot, then on May 29th I noticed sweeling and a hard warm spot just above the inside right ankle. I reported to a local urgent care clinic first then was referred to Medical ER.
54 2021-05-30 fainting, pallor Pt experienced syncope in his chair in the post-vaccine waiting area, fell out of his chair, and hit... Read more
Pt experienced syncope in his chair in the post-vaccine waiting area, fell out of his chair, and hit his head on the ground. Upon assessing the patient, he did not know where he was, but he did know his own name, pt appeared pale and was trembling. Paramedics were called for further assistance and took pt to hospital.
54 2021-05-31 loss of consciousness, blood clot, cerebrovascular accident, cerebral haemorrhage Stroke; Blood clots; Brain bleed; Wife found him on the floor after he collapsed; Still struggling t... Read more
Stroke; Blood clots; Brain bleed; Wife found him on the floor after he collapsed; Still struggling to move left hand; Felt really weird; Acting differently; Kept rubbing his arm and saying it was burning; Wife found him on the floor after he collapsed and fell off the couch; Unable to move or talk; Can't speak / unable to talk; Can not stand up; Arm hurting like crazy / arm was killing him; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Blood clots), CEREBRAL HAEMORRHAGE (Brain bleed), LOSS OF CONSCIOUSNESS (Wife found him on the floor after he collapsed) and HEMIPARESIS (Still struggling to move left hand) in a 54-year-old male 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. No Medical History information was reported. 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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant), CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Wife found him on the floor after he collapsed) (seriousness criterion medically significant), HEMIPARESIS (Still struggling to move left hand) (seriousness criterion medically significant), FEELING ABNORMAL (Felt really weird), ABNORMAL BEHAVIOUR (Acting differently), BURNING SENSATION (Kept rubbing his arm and saying it was burning), FALL (Wife found him on the floor after he collapsed and fell off the couch), HYPOKINESIA (Unable to move or talk), APHONIA (Can't speak / unable to talk), DYSSTASIA (Can not stand up) and MYALGIA (Arm hurting like crazy / arm was killing him). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Blood clots), CEREBRAL HAEMORRHAGE (Brain bleed), LOSS OF CONSCIOUSNESS (Wife found him on the floor after he collapsed), HEMIPARESIS (Still struggling to move left hand), FEELING ABNORMAL (Felt really weird), ABNORMAL BEHAVIOUR (Acting differently), BURNING SENSATION (Kept rubbing his arm and saying it was burning), FALL (Wife found him on the floor after he collapsed and fell off the couch), HYPOKINESIA (Unable to move or talk), APHONIA (Can't speak / unable to talk), DYSSTASIA (Can not stand up) and MYALGIA (Arm hurting like crazy / arm was killing him) 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. It was reported that, the patient felt really weird and was acting differently. Four days after the patient received the vaccine, his wife found him on the floor after he collapsed and fell off the couch and was unable to move or talk. He was taken to hospital and was in ICU for 5-6 days. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
54 2021-06-01 pulmonary embolism SOB started 5/3/21, got worse today at walking. advise ER - Pt was admitted to hospital because bila... Read more
SOB started 5/3/21, got worse today at walking. advise ER - Pt was admitted to hospital because bilat PE.
54 2021-06-02 fainting, loss of consciousness Patient reported feeling funny and then fainted for a couple of minutes. When he regained conscious... Read more
Patient reported feeling funny and then fainted for a couple of minutes. When he regained consciousness he was sweating profusely.
54 2021-06-06 pulmonary embolism Second vaccination received 4/17/21. Leg and knee pain/discomfort and some difficulty walking noted... Read more
Second vaccination received 4/17/21. Leg and knee pain/discomfort and some difficulty walking noted six days after vaccination on 4/23/21. Discomfort continued intermittently for several days. Developed rib/side pain and difficulty taking a deep breath on 5/9/21. Went to ER on 5/10/21. Following extensive blood work, x-Ray and CT scan, was diagnosed with multiple bilateral pulmonary emboli. Started treatment on blood thinner (Eliquis) same day and symptoms have improved. Currently under care of a Hospital.
54 2021-06-08 pallor Patient received vaccine, waited for 15 minutes. Just as patient was getting ready to leave, he repo... Read more
Patient received vaccine, waited for 15 minutes. Just as patient was getting ready to leave, he reported being dizzy and short of breath. Patient reported nausea and became very pale. Vital signs obtained. Epi administered via EPI Pen. Patient reported that he began to feel better. EMS called to transport patient to ED for observation.
54 2021-06-09 inflammation of the pericardium, inflammation of the heart muscle I had pericarditis 2 years ago and 4 days after my 2nd dose of Moderna I felt similar symptoms to wh... Read more
I had pericarditis 2 years ago and 4 days after my 2nd dose of Moderna I felt similar symptoms to when I?d had it. They subsided after a day but came back 3 weeks later. Because of my history of having had Pericarditis I had ultrasound and CT Scan and they showed some inflammation. Blood tests showed C-reactive Protein levels high (70). On my own I googled if pericarditis was a side effect from vaccine as it was odd to me that my symptoms started so soon after. I read that there have been rare cases reported recently but mostly in young people and they?ve subsided. Perhaps because I had it two years ago it triggered a recurrent effect. I was prescribed 600 mg ibuprofen as before by Cardiologist and colchicine as before. My PCP suggested I might want to notify you. I thought I should report this given what I read and that I'm 55, so it?s different than other reports you?ve received. I do not know if I have pericarditis again but the symptoms have been identical to when I did and the CRP level increase would suggest so. I had Echo and EKG and heart alright so it's not Myocarditis. Symptoms included: pain in abdomen chest area, pronounced in URQ this time but it migrated, increased when walking or lying down, difficulty sleeping in side, slightly elevated fever 98.9-95 when I?m usually in 96-98 range, breath hiccups, some nausea. Since taking colchicine and ibuprofen have been feeling better, just concerned that this seemed to have recurred, and started exactly 4 day after my 2nd shot.
54 2021-06-10 inflammation of the heart muscle, chest discomfort Early morning of 5/29/2021, I experienced chills, fever, fatigue. Chills and fever resolved after ab... Read more
Early morning of 5/29/2021, I experienced chills, fever, fatigue. Chills and fever resolved after about 6 hours. Fatigue lasted about 48 hours. Since then, and still continuing as of the time of this report (6/11/2021), I am experiencing periodic chest tightness that comes and goes. It often, but not always, increases with physical exertion, but it sometimes is experienced even at rest. On 6/10/2021, I had a tele-medicine consultation with a doctor who prescribed 600mg ibuprofen 3 times daily for one week to try to resolve suspected myocarditis resulting from the vaccine.
54 2021-06-12 very slow heart rate, loss of consciousness Patient immediately started feeling unwell after being given the Moderna Covid Vaccination. He passe... Read more
Patient immediately started feeling unwell after being given the Moderna Covid Vaccination. He passed out briefly within about 5-10 minutes after the vaccination. He stated that he was not having difficulty breathing but felt light headed and dizzy and needed to lie down. He was placed on the floor and 911 was called. He was not given an Epi injection as he was not having difficulty breathing. Paramedics arrived and stated he was in bradycardia and needed to be transported to the hospital. The man refused to ride with the paramedics in the ambulance, but stated that his wife would drive him to the ER.
54 2021-06-13 loss of consciousness BLACKED OUT WHILE DRIVING THE DAY AFTER VACCINE ADMINISTERED - CAUSED CAR ACCIDENT
54 2021-06-14 chest pain Fatigue, headache, chest pain, muscle ache
54 2021-06-14 chest pain Prolonged pain in chest - shortness of breath - Pain occurs throughout the day - worse at night -
54 2021-06-16 low platelet count VITT: cerebral venous thrombosis and thrombocytopenia with positive PF4 antibody and no heparin expo... Read more
VITT: cerebral venous thrombosis and thrombocytopenia with positive PF4 antibody and no heparin exposure. Symptom onset on 6/4/21 which was 2 days after 2nd dose moderna vaccine (6/2/21) and diagnosed on 6/17/21. Started on bivalrudin. Clinically stable.
54 2021-06-22 loss of consciousness Felt very sick to my stomach, had chills, slight fever, went to bathroom around 2am, and very nause... Read more
Felt very sick to my stomach, had chills, slight fever, went to bathroom around 2am, and very nauseous, next thing I woke up on bathroom floor, not to much time after, then around 6am woke up again to use the bathroom more sick to my stomach, felt very light headed, sweating and I passed out hit the corner of bathroom sink and cut my head, my BP was very low, my wife drove me to ER, I received stitches and many test, I had an allergic reaction, home now, still not feeling well, on Nausea medicine, was able to sleep, but still not feeling great.
54 2021-06-22 pulmonary embolism, palpitations, atrial fibrillation 54 year old male with no known past medical history who received 2nd dose of his Moderna COVID vacc... Read more
54 year old male with no known past medical history who received 2nd dose of his Moderna COVID vaccine at the end of May 2021 (unsure of actual date). The day after he received his second moderna vaccine he developed polydipsia, polyuria and substantial fatigue in addition to muscle aches, nausea, and malaise. His symptoms initially improved but then slowly worsened again, developing shortness of breath, palpitations, heat intolerance, and continued polyuria, polydipsia. Three days prior to presenting to our hospital (which was 3 weeks after his 2nd vaccine dose), pt developed worsening nausea with vomiting and substantial worsening of shortness of breath. On admission to our hospital, he was found to be in Diabetic ketoacidosis (no prior history of Diabetes, auto-immune Diabetes labs pending) as well has having new pulmonary embolism, Atrial fibrillation with RVR, and hyperthyroidism with anti-tpo abs (other's thyroid antibodies still pending). Given the time course of his presentation, it seems to us that he developed these conditions as a complication of his 2nd dose of the Moderna vaccine.
54 2021-06-23 chest pain I had a lot of pain and aches after the second vaccination. I rested in bed for the whole afternoon ... Read more
I had a lot of pain and aches after the second vaccination. I rested in bed for the whole afternoon and night, and I felt better the next day
54 2021-06-27 chest pain Allergy sneezing with body pain. arms L and R, across chest right side of face and neck
54 2021-06-28 ischemic chest pain, chest pain As per patient, next day after he received his 2nd dose of Moderna he had fever and heart pain; he ... Read more
As per patient, next day after he received his 2nd dose of Moderna he had fever and heart pain; he took Tylenol and it relieved the pain; however, today he call us to report it because the chest pain started again; he said he had being coughing since February 2020 after he suspected he had COVID19 but he never was diagnosed because he never got tested. He reported that he had chest pain back in February 2020; he had not seen a doctor and he was strongly recommended to see md ASAP to check his heart and lungs
54 2021-06-29 hypotension, fainting Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness Lig... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe. Additional Details: ER determined patient had a vasovagal syncope episode. At the time of the reaction, patient appeared to have trouble breathing (head back and making noises). I could not find a strong carotid pulse, so 1 dose of epinephrine was given.
54 2021-06-30 cardiac arrest Heart stop and start Beats per min 123 BP 181/117
54 2021-07-06 chest discomfort Have been experiencing headaches and problems with speech. Have a tightening feeling in his chest. W... Read more
Have been experiencing headaches and problems with speech. Have a tightening feeling in his chest. Was giving antibiotics.
54 2021-07-06 heart rate increased, fluid around the heart I had HO Apriitis never had in my life Pericardiocentesis Pericardial effusion Anti-inflammatories ... Read more
I had HO Apriitis never had in my life Pericardiocentesis Pericardial effusion Anti-inflammatories My heart rate was 180 bpm
54 2021-07-06 fluid around the heart I had something that I never had in life. Pericardiocentesis. Pericardial effusion. Anti-inflammator... Read more
I had something that I never had in life. Pericardiocentesis. Pericardial effusion. Anti-inflammatories. My heart rate was 180bpm.
54 2021-07-07 deep vein blood clot, blood clot After the 1st dose vaccine, I had a little bit of a sore arm and mild flu like symptoms of low grade... Read more
After the 1st dose vaccine, I had a little bit of a sore arm and mild flu like symptoms of low grade fever and headache. On 5/2/2021, I started to notice a pain in my leg and went to my normal routine physical and brought that to my doctor's attention. I was sent to get an ultrasound on 5/6/2021 and 2 blood clots were detected. DVT thrombosis on my right calf and another behind my right knee. My 2nd dose of vaccine was schedule for 5/7/2021 and my doctor approved me to go ahead to receive the vaccine (2nd dose Moderna lot #041B21A IM LA). After getting the vaccine, I went to pick up my prescription (Rivaroxaban) for blood thinner for my blood clots. I am going to be on that medication for 6 months. I have also been on Androgel testosterone gel for 10 years which has a warning for blood clots. My doctor have taken me off of the medication for now.
54 2021-07-12 blood pressure decreased reduced blood pressure from 125 to 96 mmHg
54 2021-07-12 chest discomfort, hypertension 5-15 mins after the second dose, I started to feel: shoulder and neck pain (stiff and tight neck) f... Read more
5-15 mins after the second dose, I started to feel: shoulder and neck pain (stiff and tight neck) followed by right side headache that traveled in a straight line to the opposite side then pressure towards the eyes, Chest restriction with breathing difficulty quickly followed The ENT on site took my blood pressure which was high (my normal blood pressure is below normal) I was watched for an hour before i felt good enough to drive home. The headaches continued day and night for 4 weeks after the second dose.
54 2021-07-13 hypertension, palpitations 1. Extreme panic attacks currently persisting 24/7 after second Moderna Covid shot. Xanax helps som... Read more
1. Extreme panic attacks currently persisting 24/7 after second Moderna Covid shot. Xanax helps some but extremeness returns when it wears off. 2. Extreme migraine headaches started two weeks after first Moderna Covid shot. Tapered down to low/moderate headache until second shot a month later when extremeness returned. Has tapered down to chronic (24/7) mild headache. 3. Moderate vertigo/dizziness persisting 24/7. Body feels like it's moving on it's own. 4. Random heart palpitations, random high blood pressure. Typically have low blood pressure due to genetics (so low at times I pass out, Cardiogenic Syncope). 5. Caffeine intake exasperates all the above in extreme manner.
54 2021-07-16 loss of consciousness, fainting Got very dizzy which caused me to collapse. I then had a seizure where my eyes went up in my head a... Read more
Got very dizzy which caused me to collapse. I then had a seizure where my eyes went up in my head and lost consciousness for a few minutes.
54 2021-07-16 fainting, loss of consciousness approximately 24 hours post vaccine fainted. pt's partner describes he was walking toward her and th... Read more
approximately 24 hours post vaccine fainted. pt's partner describes he was walking toward her and then suddenly fell to the ground "passed out cold" She tried to talk to him and at first he did not make sense but after few minutes was able to converse. Call to pharmacy was made about 3 hours after event and pt has recovered, main complaints were weakness and sore (bruised himself when falling).
54 2021-07-17 heart rate increased, arrhythmia, blood pressure increased Extreme fatigue set in about 8-10 days after the second dose of Moderna. A very healthy (exercise 6... Read more
Extreme fatigue set in about 8-10 days after the second dose of Moderna. A very healthy (exercise 6 days a week and carefully watch diet) man who is known for his endless energy suddenly struggled to get out of bed. Fatigue continually got worse from June 8th until July 1st. On July 1st my heart went into arrythmia with bpm reaching 140 at rest. Normal rest is 66 bpm. The arrythmia continued to persist sporadically until I went to the Emergency Room on July 5th. It had progressed to the point that my heart would not stop racing and I thought I was in big trouble. At the ER I learned that my blood pressure had ballooned to 185/125 and my glucose was 152. No previous tests had ever shown any blood work problems in any area. And I have never felt like this in my life. Now my blood pressure is back to normal and eating very low carb to bring the glucose down. But still having an episode of depression and lack of desire to do anything. Totally unlike me at any point in my entire life. Possible delusional thoughts now as well.
54 2021-07-17 inflammation of the pericardium Pericarditis. ICU Anti inflammatory, aspirin
54 2021-07-19 palpitations Heart racing Fever Chills Body aches
54 2021-07-25 heart rate irregular On the 16th of April one week after receiving the vaccine my heart was beating irregularly I was swe... Read more
On the 16th of April one week after receiving the vaccine my heart was beating irregularly I was sweating and becoming light headed. I went to the emergency room. Since that day I have been scheduled to undergo cardio version.
54 2021-07-26 pallor, fainting Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Tingling (sp... Read more
Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt started to not feel well, was sweating/diaphoretic and was pale in color. We called 911 as he was not feeling well. He started snoring and I had tried to wake him. When he came around, he said he was thirsty we gave him water, MS was on the way and we asked who to call and he said his wife-we called her. His O2 sat was 93, pulse was low. He started to revive, color came back and did not want to go w/ ems to hospital. He signed a waiver and was told to call if he continued to have any sympt
54 2021-07-26 fainting, pallor Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sw... Read more
Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient described tingling at injection site after dose given. He became unresponsive within the 15 minute waiting period and was snoring. I was able to awaken him and he said he was thirsty and not feeling well. He was diaphoretic, and very pale. We called 911 and his wife also. EMS arrived, took his vitals and he seemd to be responding. His O2 sat was 93 but his color started to come back and he was starting to feel better. He did not want to go w/ EMS to hospital and signed a waiver.
54 2021-07-27 chest pain I developed severe pain and rushed to ER and after CT Scan, I was found to have blood clot in my lun... Read more
I developed severe pain and rushed to ER and after CT Scan, I was found to have blood clot in my lungs on the right side. I was also told by the lung specialist that I have inflammation all around my lungs. I have been on blood thinner since. However, I continuing to feel pain in my both left and right chest. The pain has continued to increase and I feel it all the time. Sometimes more severe when I lie down on my back. I feel the pain all around my ribs and sometimes going down on my lower back. I have also been having headaches and some coughing, however no blood. I am having pains in my joints in my fingers and ankles.
54 2021-07-28 cerebrovascular accident I63.9 - CVA (cerebral vascular accident) I63.9 - Stroke determined by clinical assessment N17.9 - ... Read more
I63.9 - CVA (cerebral vascular accident) I63.9 - Stroke determined by clinical assessment N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R29.810 - Facial weakness
54 2021-07-28 cerebrovascular accident 12 hours after vaccine I had severe muscle pain, vomiting, severe headaches, and swollen arm, dizzin... Read more
12 hours after vaccine I had severe muscle pain, vomiting, severe headaches, and swollen arm, dizziness and blurry vision and that lasted about 24 hours. 2 days after the vaccine in the morning, I was at work and about 10 am I got very dizzy to the point of losing my balance dizzy. I drove home about a 1/2 hour later. I drove about 90 miles stopped at stop light and experienced vertigo, I went to ER. As, I got out of car, they sent a wheelchair and asked me my symptoms and they immediately told me I was having a stroke. They did cat scan and injected me with TPA. After that they then asked me when did the symptoms started, I told them after my vaccine. They admitted me into the ICU of hospital.
54 2021-07-28 chest pain, heart attack Patient presented to the ED on 3/15/2021 with acute chest pain. Patient presented to the ED on 4/9/2... Read more
Patient presented to the ED on 3/15/2021 with acute chest pain. Patient presented to the ED on 4/9/2021 for NSTEMI and was subsequently hospitalized. These visits were within 6 weeks of receiving COVID vaccination.
55 2020-12-31 chest discomfort, nosebleed, increased heart rate Patient is a 55 year old male with no past medical history who presents with complaint of sudden ons... Read more
Patient is a 55 year old male with no past medical history who presents with complaint of sudden onset of left-sided nonradiating chest discomfort of sudden onset approximately 1 hour prior to presentation while doing administrative work at rest. He describes the pain as a dull heaviness sensation and approximate 3/10 pain severity. Chest discomfort was associated with a feeling of flushing that was quite transient but chest discomfort was persistent. Patient immediately presented to the ED for further evaluation. He denies experiencing any chest pain upon waking up this morning. Does note that he did have a transient episode of epistaxis on his way to work for which he had to pull over and apply pressure to his nose but this subsequently subsided and he attributed this to dry air as he has experienced epistaxis in the past but with less severity previously. In the ER, vital signs noted for BP 133/76, pulse ranging 91-114, respiratory rate 16-20, 96% on room air. Initial laboratory parameters were completely normal including normal CBC, CMP, LFT, lipase, UA, and normal D-dimer. Initial troponin was negative x1. EKG with sinus tachycardia, heart rate of 115. Noted Q waves inferiorly. No acute ST or T wave changes appreciated. Chest x-ray with mild increased density in the left lower lobe. Given this, patient was tested for rapid Covid which was negative but PCR was positive for COVID. CT of the chest noted for focal subsegmental groundglass infiltrate at the superior segment of the LLL, likely infectious versus inflammatory. Also noted small nonspecific groundglass attenuation with focal septal thickening at the right upper lobe which could be infectious or inflammatory, bibasilar atelectasis. Patient was treated with aspirin 324 mg in the ED. Of note, patient actually just received the COVID-19 vaccination on 12/24/20. He denies any shortness of breath, no cough, denies any nausea or vomiting, denies any change in taste or smell nor change in appetite. Does note 1 single episode of loose stool but otherwise denies any diarrhea. Does report that he had approximate 48 to 72-hour period of fatigue and soreness at the site of the left deltoid injection following the vaccination but otherwise no further symptoms. It is also noted that he does have a positive family history of coronary artery disease as his dad had an MI at the age of 49. Patient has never undergone a cardiac catheterization in the past but does report having a negative stress test at the age of 42. He is being admitted under the hospitalist service for further management Patient was initially admitted under observation for chest pain obs. However patient's Covid test came back positive and patient also had dynamic EKG changes concerning for possible unstable angina. Patient was treated with aspirin Plavix full-strength Lovenox along with beta-blocker and a cardiology consult. Serial troponins were negative. Echocardiogram revealed normal EF of 55 to 60% with no hemodynamically significant valvular disease. Cardiology felt that patient likely has underlying coronary artery disease have recommended discharge home with aspirin and Plavix with outpatient stress testing given his positive Covid testing. At the time of discharge patient denied any chest pain or shortness of breath. Patient was borderline diabetic with a hemoglobin A1c of 6.1. Patient was discharged home with Metformin along with glucometer, glucose strip, lancets. Given patient's tachycardia patient's Metformin 25 mg twice daily was changed to Toprol 25 mg daily. (Please note clarification in comparison to discharge home med list. Toprol XL 25 mg daily was called to pharmacy in place of the metoprolol.)
55 2021-01-04 hypertension Myalgia, Fever, NauseaVomiting & HYPERtension
55 2021-01-05 fast heart rate Dizziness, Headache, chills, fatigue, tachycardia
55 2021-01-06 blood pressure decreased, fainting, hypotension Patient received 0.5mL Moderna Covid19 vaccine at mass vaccine clinic on 12/30. This patient was a w... Read more
Patient received 0.5mL Moderna Covid19 vaccine at mass vaccine clinic on 12/30. This patient was a walk thru and not a patient of HP at this time. Daughter reported to ARNP,RN Director Clinical Support on 01/03 the following outcomes: Patient first exhibited the first signs of reaction started about 60 hours after vaccine: hives only (no difficulty breathing, dizziness, lightheadedness); applied hydrocortisone cream, took diphenhydramine. Patient slept for a few hours then woke up for lunch. Around 12:30-1:00 the patient exhibited three episodes of syncope. Emergency services was called after the first. Firefighters couldn't find BP, was in 70s by doppler only. Patient taken to hospital for care. Discharged from ED around 5, suspecting hypotension 2/2 to diphenhydramine use. Monitored vitals at home; became severely hypotensive (BP 70s/40s both with automatic monitor and manual read) and lethargic again about an hour or so after, but normotensive again right before about to call ambulance. Pt claimed to be okay and had some dinner. Fourth episode of syncope, ambulance was called. Patient remains at hospital ED since, still in observation unit. BP's normalized but itching returns periodically. IV steroids and diphenhydramine. Took head CT yesterday; no word on the results. Stable and alert enough since yesterday to communicate with us with his phone. Patient is scheduled for an echo to be done today. No hx of severe allergic reaction. Treated for active TB 30 years ago, shingles x2 in the past few years; otherwise healthy 55 y/o male. Pt discharged 01/04 to home with fatigue and malaise. Not additional symptoms reported since then. Provider doing full cardiac and neurologic work up.
55 2021-01-06 chest pain 1/6/21 received Moderna COVID vaccine. Stated that later in the evening had burning in chest and ext... Read more
1/6/21 received Moderna COVID vaccine. Stated that later in the evening had burning in chest and extreme fatigue. 1/7/21 still feeling fatigued and flu like symptoms.
55 2021-01-08 chest pain arm pain, chest pain,lethargy, headache, swollen lymph glands, throat pain Narrative: Employee stat... Read more
arm pain, chest pain,lethargy, headache, swollen lymph glands, throat pain Narrative: Employee states: day 1: felt injection and symptoms immediately following in arm and left part of chest. Within the first hour, got very tired and could not work. A few hours later a headache persisted and lasted through thenight. day 2: still had headache but it became less persistant over time- would come and go throughout the day. Continued to fall asleep (at least 5 times) and difficulty staying awake. Some stabbing pains in the throat area. day 3: awoke with left underarm pain. Lymph glands are now swollen. two episodes of stabbing pain in my throat today.
55 2021-01-08 fainting Patient fainted and experienced a hard time breathing for 10 mins. Vital signs: BP: uncooperative H... Read more
Patient fainted and experienced a hard time breathing for 10 mins. Vital signs: BP: uncooperative HR: 110 RR: 24 O2: 90% and Temp: 97.5. He received 3 Ls of oxygen and 911 was called. He was sent to the ER.
55 2021-01-15 blood pressure increased, chest pain, palpitations patient experience heart racing, sweating, pain in heart (felt pain to touch) , bp was elevated 150/... Read more
patient experience heart racing, sweating, pain in heart (felt pain to touch) , bp was elevated 150/100 at the highest point. This continued for about 30 minutes after the vaccine
55 2021-01-19 blood glucose increased Within 24 hours, patient reported uncontrolled blood glucose levels above 200. Patient previously ha... Read more
Within 24 hours, patient reported uncontrolled blood glucose levels above 200. Patient previously had blood glucose within normal limits and was well controlled for some time. These elevated blood glucose levels lasted approximately one week. He had no other dietary/medication changes during this timeframe. The only change was that he received the vaccine. He also experienced headache, fatigue and severe injection site pain, peaking at 24 hours post injection.
55 2021-01-20 chest discomfort ON THE 2ND DAY AFTER RECEIVING THE FIRST DOSE OF THE MODERNA COVID 19 VACCINE... I BEGAN TO EXPERIEN... Read more
ON THE 2ND DAY AFTER RECEIVING THE FIRST DOSE OF THE MODERNA COVID 19 VACCINE... I BEGAN TO EXPERIENCE CHEST TIGHTENING THAT RADIATED TO NECK. IT FELT AS IF I WAS BEING SQUEEZED. I DID NOT HAVE A COUGH, FEVER, OR OTHER ASSOCIATED S/SX. IT JUST FEELS AS MY CHEST IS IN A VICE. ON THE 3RD,,4TH AND 5TH DAY POST VACCINE ADMINSTRATION, THE SENSATION OF CHEST SQUEEZING HAS NOT RESOLVED COMPLETELY. THE REASON I AM REPORTING THIS OCCURRENCE IS THAT SEVERAL CO-WORKERS THAT RECEIVED THE SAME MODERNA VACCINE HAVE SIMILAR COMPLAINTS.
55 2021-01-20 fast heart rate Tachycardia x 30 hours >120 (resting HR usually mid 50s), 12 hours of lifetime worst body aches and ... Read more
Tachycardia x 30 hours >120 (resting HR usually mid 50s), 12 hours of lifetime worst body aches and headache and temps >101, extreme fatigue, chills, anorexia and nausea unable to eat for 36 hours, insomnia from pain for 2 nights. Now 48 hours out from vaccine # 2, mild body aches, moderate fatigue, intermittent diaphoresis, mild chills. HA has resolved.
55 2021-01-21 chest pain, inflammation of the pericardium Severe stabbing chest and back pain radiating to the left axilla. Diagnosed with atypical pericardit... Read more
Severe stabbing chest and back pain radiating to the left axilla. Diagnosed with atypical pericarditis with diffuse ST elevation on EKG but no effusion or pericardial thickening on echo/MRI. Treated with ongoing Colchicine and complete resolution of pain. Spent the night under ER observation. Missed 4 days of work.
55 2021-01-24 chest pain About 3 pm on the 21st my arm started to ache, when Ibwoke up on Friday morning my entire arm was so... Read more
About 3 pm on the 21st my arm started to ache, when Ibwoke up on Friday morning my entire arm was sore, the pain persisted all day and Friday evening the pain went into my entire arm to my hand and also to my chest and upper left back and neck.
55 2021-01-25 palpitations ED visit for palpitations, fevers, chills with admission to the hospital for observation.
55 2021-01-26 blood pressure increased Patient reports blood pressure elevation beginning 12/30/2020, approximately 190's/90's, and continu... Read more
Patient reports blood pressure elevation beginning 12/30/2020, approximately 190's/90's, and continues to this current date. Headaches began 1/4/21 and occur approximately 5 times per week along with diminished cognitive ability reported by patient as "brain fog". Patient also reports a "hung over" feeling as well.
55 2021-01-28 blood pressure decreased 48 hours after round 1 of the moderna vaccine, Patient developed severe diarrhea and vomiting. The ... Read more
48 hours after round 1 of the moderna vaccine, Patient developed severe diarrhea and vomiting. The diarrhea and vomiting led to acute dehydration which substantially lowered blood pressure. Patient was then brought to ER and hospitalized for 2 days related to the severe dehydration. Patient has not had similar symptoms in previous 2 years to this incident.
55 2021-02-02 heart rate increased Significant increase in heart rate. From my fitness watch, I had 15 hours and 50 minutes of "fat bu... Read more
Significant increase in heart rate. From my fitness watch, I had 15 hours and 50 minutes of "fat burn" that occurred yesterday (2/2). Today (as of 4 PM )11 hours and 40 minutes. The only time my heart rate returns to normal is when I'm sitting still. I also have chills and heat flashes with some body aches.
55 2021-02-03 chest pain Urticaria and pruritus of both hands and wrists. Denies dyspnea, chest pain, rhinorrhea, nausea, an... Read more
Urticaria and pruritus of both hands and wrists. Denies dyspnea, chest pain, rhinorrhea, nausea, and dizziness.
55 2021-02-03 fast heart rate, increased heart rate, palpitations palpitations, tachycardia, mild dyspnea which lasted several minutes; recurred several hours later t... Read more
palpitations, tachycardia, mild dyspnea which lasted several minutes; recurred several hours later then resolved
55 2021-02-10 deep vein blood clot, pulmonary embolism, fibrin d dimer increased Developed severe pleuritic chest pain x 5 days, went to ER on 2/5/2021, D Dimer over 4000, CT chest ... Read more
Developed severe pleuritic chest pain x 5 days, went to ER on 2/5/2021, D Dimer over 4000, CT chest showed bilateral segmental and sub segmental Pulmonary Emboli. Initial Ultrasound of legs was negative for DVT, follow-up U/S on 2/9/2021 was positive for large Femoral vein DVT. All family history, medical history and other risk factors for coagulation disorder was negative. I was initiated on anticoagulation therapy. (Enoxaparin)
55 2021-02-17 blood glucose increased Injection site pain (not as severe as first dose). Starting approximately 18 hours post injection, e... Read more
Injection site pain (not as severe as first dose). Starting approximately 18 hours post injection, extreme fatigue (slept for 24-30 hours off and on), body aches in lower back and both shoulder joints. Blood sugar was previously well controlled but spiked for several days after injection (levels >300).
55 2021-02-20 lightheadedness injection site soreness, shoulder tightness increased to a shock along nerve to back of thumb within... Read more
injection site soreness, shoulder tightness increased to a shock along nerve to back of thumb within 24hrs. Arm began to pull up with pain through forearm and biceps increasing through 72 hrs. Began meloxicam again at 60 hrs. Woke up at 84hrs with severe arm pain, unable to move arm without pain. Cold sweat and nearly fainted. Pressure/pain in shoulder, biceps, elbow/forearm wrist. Called sibling who is physician and began treating shoulder with ice, tylenol and benedryl. Pain controlled to moderate through day 10 but lifting arm at shoulder or extending results in shock at back of thumb and pain through biceps and forearm. Back base of thumb completely numb. Went to urgent care facility 10 days after injection and
55 2021-02-20 lightheadedness Patient said he had severe arm pain shooting from shoulder to wrist. It was so bad it almost caused... Read more
Patient said he had severe arm pain shooting from shoulder to wrist. It was so bad it almost caused him to faint. Patient"s doctor gave him a steroid taper.
55 2021-02-25 chest pain, deep vein blood clot, pulmonary embolism bilateral pulmonary embolism; multiple areas of infarct; back pain; ateltheisis; chest pain; left le... Read more
bilateral pulmonary embolism; multiple areas of infarct; back pain; ateltheisis; chest pain; left leg pain; deep vein thrombosis; pulmonary effusions; fever; Chills; myalgia; A spontaneous report was received from a physician who was also a 55-year-old, previously healthy male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis. The patient's medical history included daily exercise and no personal or family history of clotting issues and no trauma. Products known to have been used by the patient were not provided. On 02 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039k20-2a) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, approximately 28 days after the first dose, and prior to the onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012m20a) intramuscularly for the prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient reports that for the first 18 hours, he experienced fever, chills and myalgia. On 01 Feb 2021, the patient reports that he thought the myalgia was continuing, as he had pain in his chest and back. The chest pains gradually worsened. On 05 Feb 20221, the patient went to the emergency room and was admitted. He was diagnosed with a pulmonary embolism. He was started on enoxaparin sodium but switched to apixaban. A computerized tomography study of the lungs showed that he had bilateral pulmonary embolism, multiple areas of infarct and atelectasis. His dimer was 4800. COVID-19 test was negative. An echocardiograph was performed, no results were reported. An ultrasound of the legs was performed and ruled out deep vein thrombosis. Date of discharge was not specified. On an unknown date two days after discharge, the patient experienced left leg pain and returned to the emergency department. Patient was diagnosed with deep vein thrombosis that ran the entire length of the femoral artery. Patient was switched back to enoxaparin sodium and taken off the apixaban. A repeat computerized tomography study was done to see if the pulmonary embolism was progressing and it was not, however, it showed pulmonary effusions. All current lab work was reported as normal, except for an increased prothrombin time. COVID-19 test was negative. Patient continues to be followed by a pulmonologist and hematologist. Consent to contact patient, pulmonologist and hematologist was obtained. Action taken with mRNA-1273 was not applicable. The outcome of the events, fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis, was considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
55 2021-02-26 heart rate increased red rash on face and red spotson both palm , difficulty in breathing . increase heart rate. muscle ... Read more
red rash on face and red spotson both palm , difficulty in breathing . increase heart rate. muscle pain in lower extremities, loss of appetite, fever , chills.
55 2021-02-27 heart rate increased "I received the second Moderna vaccine at a Med Com Camp on morning of 6 Feb. As the day progressed... Read more
"I received the second Moderna vaccine at a Med Com Camp on morning of 6 Feb. As the day progressed I began to feel body aches, chills, fatigue, rapid heart rate, shortness of breath, and numbness in my neck, arms, and hands. These symptoms are still persisting. The numbness that has since spread throughout my body (from my head to my feet), body joint and muscle pain and burning sensation, muscle cramps and twitching, and continued fatigue. Additionally, I have had a few of episodes of pressure in my eyes and head resulting in vision issues and issues with my hearing"
55 2021-02-27 heart rate increased I received my second vaccination Moderna COVID-19 Vaccine EUA on 2/26/21 at 4:00, and started feelin... Read more
I received my second vaccination Moderna COVID-19 Vaccine EUA on 2/26/21 at 4:00, and started feeling ill around 11:00 p.m. During the night I developed fever, chills, tremors, rapid heart rate, nausea, body aches, headaches, and fatigue. This lasted about 36 hours. These symptoms were similar to those I experienced when I had Covid-19 in early December of 2020.
55 2021-03-01 troponin increased, chest pain The afternoon following administration of the vaccine he began to experience chest pains. The chest... Read more
The afternoon following administration of the vaccine he began to experience chest pains. The chest pains continued throughout the rest of the day and throughout the night prompting him to present to the Hospital Emergency Department where he was noted to have a mildly elevated troponin and was admitted to the hospital. His troponins returned to normal and he was discharged with an appointment for outpatient coronary angiogram. Of note, he did have a Covid19 infection last fall several months prior to vaccination.
55 2021-03-08 chest discomfort pt stated that after he got the vax on 3/8/2021 his pulse went to 170 and BP went to 170/100. He de... Read more
pt stated that after he got the vax on 3/8/2021 his pulse went to 170 and BP went to 170/100. He developed tremors, rash, and chest tightness. Vax clinic did an EKG w/ abnormal results. Pt was transported to the Medical Center ER. PT had Chest XRAY, 3 EKGs, and lab work. Pt was released after 5 hours. His DX was vaccine and biological substances causing adverse affects. Pt was told to FU w/ PCP.
55 2021-03-10 hypotension On 2/17/2021 patient complained of not feeling well, noted to be hypotensive, was sent to Medical C... Read more
On 2/17/2021 patient complained of not feeling well, noted to be hypotensive, was sent to Medical Center Emergency Department for further evaluation. Diagnosed with COVID-19 infection.
55 2021-03-12 chest discomfort, chest pain On Friday morning I started having chest pains. The pains were sharp and would go away quickly. (Alm... Read more
On Friday morning I started having chest pains. The pains were sharp and would go away quickly. (Almost immediately) They were from the center of my chest to the right of my chest at about the same level as my heart, I could tell that the pains were NOT coming from my heart, or at least, that is how it seemed. I also felt some pains to the left of the center of my chest, but the pains from the left were fewer and not as pronounced. These pains resulted in my leaving work early (I was on the way to work when they started) and I stayed home from work today. The pains did not continue for more than 4 hours or so, and seemed to dissipate later that day. I did feel some discomfort in my chest this morning. This discomfort was extremely mild and did not last much more than an hour and a half. I feel fine this afternoon, as I am writing this note. I have been eating, urinating and have had normal bowl movements today, so I think I am okay. You might be mindful of these chest pains the Moderna vaccine is causing. The pains were sharp and noticeable. I did not call my Doctor because it did not seem necessary. Thank you.
55 2021-03-14 cerebrovascular accident Nursing staff was informed that the patient was having a hard time walking and was not able to speak... Read more
Nursing staff was informed that the patient was having a hard time walking and was not able to speak, just mumble. Presented with rapid eye movement, lip smacking, equal grips bilaterally although difficulty lifting arms. When asked about pain, pointed to R forehead. 136/99, 79, 20, 99.6. Appears uncomfortable and continuous mumbling. To local hospital via ambulance and admitted. Presumed CVA
55 2021-03-14 heart rate increased Pt states heart rate was fast
55 2021-03-16 blood pressure increased Simple My Blood pressure has been spiking , into medically dangerous regions.
55 2021-03-17 very slow heart rate Hospitalization for Bradycardia
55 2021-03-18 blood pressure increased At 2:57 PM S/P Moderna,, vaccination to right deltoid patient repots numbness to throat and lips and... Read more
At 2:57 PM S/P Moderna,, vaccination to right deltoid patient repots numbness to throat and lips and nose. denies difficulty breathing and swollowing. Lungs auscultated and clear lungs. Vital signs within normal range except bp elevated (150/90). Patient continues to report dry throat. Benadryl given as protocol 25 mg (0.5ml) at 3.55pm left deltoid. Patient was continued monitoring maintained. patient reported to live 8 minutes away from the facility so he was asked to call wife to be escorted home. vitals signs were taken times four which were within normal limits.
55 2021-03-18 chest discomfort Patient had a vaccine on 3/19/21, right deltoid at 2:35pm. At 2:45pm, patient experience sternal che... Read more
Patient had a vaccine on 3/19/21, right deltoid at 2:35pm. At 2:45pm, patient experience sternal chest pressure 3 out of 10, headache and diaphoresis. Has a history of heart failure and anxiety. VS#1 160/90, 98% & 62. At 3pm, sternal chest pressure 2 out of 10 & still with headache. VS#2 160/98, 63 & 99%. Advised patient to we need to call EMS to have him check out. Patient is refusing to seek higher level of care. Patient were given education about the sign & symptoms of heart attack and call 911 if any symptoms occur. Patient verbalized understanding.
55 2021-03-18 chest pain 1-2 hours after receiving Moderna vaccination patient began complaining of chest pain to family memb... Read more
1-2 hours after receiving Moderna vaccination patient began complaining of chest pain to family members but refused to seek medical attention. He was found deceased this morning (03/19/21) by his family. Medical Examiner determined time of death was around 8:40pm on 03/18/21.
55 2021-03-18 chest pain after vaccine about 10 min into waiting period patient began to C/O L chest pain. Patient rating pa... Read more
after vaccine about 10 min into waiting period patient began to C/O L chest pain. Patient rating pain @ 1-2. " intermittent stabbing". Vitals 11:10 120/ 70, A-72, 18, 99% lungs clear, HR regular 11:15 120/70, A. - 70, 18, 98% No change in condition 11:20 110/70, A- 70 HR regular. Pain has subsided. Patient states he eat breakfast that consist of 2- BBQ chicken wings and cold cereal. 11:30 120/70, A-70, 18, 99% Patient resting quietly. 11:40 Patient ambulating hallway wo chest pains. Patient reports feeling normal. patient left with work friend. patient has been instructed to seek medical attention if chest pains return. patient states understanding.
55 2021-03-23 fainting Arm hurt 1st like bad tetanus shot for 2 days Chills & sweats started the next day or so Left arm ly... Read more
Arm hurt 1st like bad tetanus shot for 2 days Chills & sweats started the next day or so Left arm lymph node swollen/aching Lightheaded, nauseous, nearly passed out & vomit Thursday night Chills & sweats got worse, very lightheaded, heavy legs, fainted when having seizure Saturday Sunday things seemed to subside * Tinnitus was flaring most of the time **Chronic left jaw ache/pain flaring as well ***Mid back pain spot which has become chronic like jaw wrapped around torso and up/down spine, almost like a cross. This seems to be the lingering issue as of sunday night.
55 2021-03-23 fast heart rate 3/22 Patient had clinic visit for cough, fever and post nasal drip that started 3/20 evening, tested... Read more
3/22 Patient had clinic visit for cough, fever and post nasal drip that started 3/20 evening, tested COVID-19 positive. Patient reported to ER on 3/23 with worsened cough, shortness of breath, fever, myalgias and headache. Noted to be tacycardic with wheezing and rhonchi present, low 90s O2 on room air. Treated with IV fluids, Remdesivir, dexamethasone, oxygen, acetaminophen, duoneb, xopenex, albuterol inhaler
55 2021-03-24 blood pressure increased I woke up the morning of 3/23/2021 approximately 5am with a ringing in my left ear. It has been con... Read more
I woke up the morning of 3/23/2021 approximately 5am with a ringing in my left ear. It has been constant since that time. I should add to the other that my blood pressure has elevated since the vaccine. As part of going on medication on 3/18, it was a concern the medications would elevate my blood pressure. I bought a wrist BP check device and it was averaging 134/95 on 3/22/2021. On 3/23/2021, I was prescribed Losartan. I took one pill at 7:30PM. Today when I woke up and for most of the day the BP has been 124/77-82. The ringing remains persistent
55 2021-03-24 loss of consciousness extreme elevation in bp 195/132 then dropped to 95/55 and an un responsive period of more than... Read more
extreme elevation in bp 195/132 then dropped to 95/55 and an un responsive period of more than 2 minutes. Breathing did not stop, but unable to gain consciousness for 2+ minutes.
55 2021-03-25 loss of consciousness PATIENT HAD VASO SYNCOPE. HE HAD TINKLE IN LEFT HAND. HE WAS ASKED TO SIT FOR 30 MINUTES VS. 15 MINU... Read more
PATIENT HAD VASO SYNCOPE. HE HAD TINKLE IN LEFT HAND. HE WAS ASKED TO SIT FOR 30 MINUTES VS. 15 MINUTES FOR EXTRA OBSERVATION. HE SAID HE WAS FEELING LIGHT HEADED AND SWEATING. AS I WAS WALKING OVER FOR THE 3RD TIME TO CHECK ON HIM I WAS GOING TO ASK HIM TO PUT HIS HEAD IN BETWEEN HIS LEGS HE STARTED TO SLIDE OUT OF CHAIR. WE CALLED 911. WHEN HE CAME TO HE SAID HE PASSES OUT EVERY TIME BLOOD IS TAKEN, AND HE THINKS IT WAS DUE TO THIS ANXIETY.
55 2021-03-26 heart rate increased Elevated heart rate, difficulty swallowing
55 2021-03-28 blood clot Patient had Moderna covid vaccine #1 on 3/21/21. Patient presented to the emergency dept on 3/23/21... Read more
Patient had Moderna covid vaccine #1 on 3/21/21. Patient presented to the emergency dept on 3/23/21 complaining of a discolored right arm (turning purplish) and swollen. Patient had a blood clot in Sept 2020 and was on anticoagulation until Jan 2021. Ultrasound of the RUE found an occlusive thrombus, R subclavian and right axillary vein as well as a nonocclusvie thrombus within the inferior R internal jugular. Patient was initiated on apixaban anticoagulation. Patient was seen back in the office and had a repeat ultrasound due to lack of improvement on 3/26, thrombus was unchanged. Patient continued on apixaban. Patient called the office on 3/29 with no improvement in his arm. Patient to be re-evaluated
55 2021-03-31 heart rate increased Slightly elevated pulse. Lasted 6 to 8 hours. Did not affect breathing.
55 2021-03-31 loss of consciousness, nosebleed Black out; Bloody head; Bloody nose; Very dizzy; Could not walk; felt unusually tired for mid aftern... Read more
Black out; Bloody head; Bloody nose; Very dizzy; Could not walk; felt unusually tired for mid afternoon that day; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt unusually tired for midafternoon/fatigue, experienced a black out/loss of consciousness and woke up face down with a bloody nose/ epistaxis and head/head injury, was very dizzy and couldn't walk/gait inability. The patient's medical history was not provided. Concomitant medications included dolutegravir sodium;lamivudine, pregabalin, and modafinil for unknown indication. On 19 Feb 2021, approximately two days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Feb 2021, after receiving mRNA-1273, the patient felt unusually tired for midafternoon that day. The patient had suffered from chronic fatigue issues but never felt more tired than usual at that point in the day. The patient then experienced a black out and woke up face down with a bloody nose and head. The patient felt very dizzy, was not able to walk and crawled to their mattress and fell asleep. The patient managed to get himself to the Emergency room, a CT scan of the head was performed, and it was revealed that the patient had a fracture that had occurred before the vaccine and was not related to the vaccine. The doctor thought the vaccine however maybe related to the blackout or have exaggerated a concussion and have caused these delayed symptoms. No treatment information was 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 was not applicable. The outcome of the event experienced a black out was resolved at the time of this report and the outcome of the events, felt unusually tired for midafternoon, woke up face down with a bloody nose and head, was very dizzy and couldn't walk was not reported.; Reporter's Comments: Based on reporter's causality and patient's skull fracture that had occurred before the vaccine the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-057947:Second Dose Case
55 2021-03-31 heart attack, cardiac arrest Experienced a heart attack on the evening of March 23, 2021 quickly followed by cardiac arrest. Was... Read more
Experienced a heart attack on the evening of March 23, 2021 quickly followed by cardiac arrest. Was resuscitated during transport to the hospital. The hospital discovered a coronary artery embolism with myocardial infarction. I was taking a blood thinner at the time so the blood clout should not have formed to begin with. No heart disease was found and once clout was removed by heart function returned. I had had my first COVID-19 shot the Thursday before the event so I thought I should report the event in case there's a connection.
55 2021-04-01 heart attack Heart Attack No blockage
55 2021-04-02 atrial fibrillation After 1 hour I started Serious AFIB issues. I had not had serious AFIB since March 2020 That was th... Read more
After 1 hour I started Serious AFIB issues. I had not had serious AFIB since March 2020 That was the time I had surgery to correct it. The time of the shot and the AFIB is NOT a coincidence. I suffered through this attack until Wednesday March 24. On advice through Dr.'s nurse I went to the emergency room at the hospital. After 3 hours and IV's to reduce my heart rate I was okay to go home. This is still happening periodically since the ER visit where it was EXTREMELY rare before. I have decided NOT to get the 2nd dose as I am worried I will have to go to the ER again. Will one dose be enough to combat the virus? Please e-mail an answer if possible.
55 2021-04-04 loss of consciousness, chest pain I had a sharp pain in my chest and told my wife something was wrong.. I sat down and started sweatin... Read more
I had a sharp pain in my chest and told my wife something was wrong.. I sat down and started sweating, after that my wife said she was asking me if I was ok and she said I was staring straight ahead and moaning then my eyes rolled back in my head and I was unconscious. My wife called 911 and was trying to get me to respond but no response. While she was yelling get an ambulance I came to and I asked my wife who are you calling. She told me I was unconscious for several minutes. I went to the ER via ambulance due to the symptoms. The paramedics thought I had a blood clot or heart attack.
55 2021-04-04 palpitations AS SOON AS THE VACCINE WAS ADMINISTERED I WAS WINDED AND FELT TINGLING AROUND MY MOUTH. ON FRIDAY N... Read more
AS SOON AS THE VACCINE WAS ADMINISTERED I WAS WINDED AND FELT TINGLING AROUND MY MOUTH. ON FRIDAY NIGHT I HAD A RACING HEART, WAS HAVING TROUBLE CATCHING MY BREATH AND BLURRY VISION. THAT SETTLED DOWN AFTER 3 HOURS. I WENT TO BED. SATURDAY MORNING AFTER BEING UP FOR ABOUT 1 1/2 HOURS MY HEART STARTED RACING, SHORTNESS OF BREATH AND BLURRY VISION STARTED AGAIN. I WENT TO THE ER . I WAS GIVEN INTRAVENOUS DRUGS TO HELP WITH THE ANXIETY. WAS EXHAUSTED BUT OK FOR SATURDAY AFTERNOON AND EVENING. I DIDN'T TAKE ANY cold medicine OR STEROID MEDICATION ON SATURDAY. SUNDAY MORNING AFTER BEING UP FOR 1 1/2 HOURS IT ALL STARTED AGAIN AND I WENT BACK TO THE ER FOR MORE INTRAVENOUS DRUGS FOR ANXIETY. I WAS GIVEN AN EKG ON BOTH SATURDAY AND SUNDAY TO MAKE SURE I WASN'T HAVING A HEART ATTACK. ON SUNDAY I WAS ALSO GIVEN A CHEST XRAY. SUNDAY I WAS SENT HOME WITH A PRESCRIPTION FOR VALIUM.
55 2021-04-06 chest pain Patient had no reactions immediately after vaccination. Patient presented to the emergency room appr... Read more
Patient had no reactions immediately after vaccination. Patient presented to the emergency room approximately 4 hours after vaccination with left sided chest pain that was radiating down the left arm. The pain was increased with inspiration, movement of his neck, arms, or chest. Patient woke up from a nap with extreme left-sided pain that prevented him from not putting his shoes on or taking his jacket off.
55 2021-04-06 fast heart rate, hypertension Tachycardia, hypertension, flushed, felt vaccine rushed through the body.
55 2021-04-07 blood pressure increased, heart rate increased About 3hrs after shot I had elevated heart rate sitting in my chair it was 124 bpm with bp of 124 ov... Read more
About 3hrs after shot I had elevated heart rate sitting in my chair it was 124 bpm with bp of 124 over 107 I usually have normal bp .this lasted several hours then in the morning I had chills and head acke arm was sore bp normal hand heart rate was 71bpm
55 2021-04-08 chest discomfort tingling in throat, moving into chest. Duration was approximately 15-20 minutes. When presented fo... Read more
tingling in throat, moving into chest. Duration was approximately 15-20 minutes. When presented for second dose described symptoms and dose #2 was not given due to potential allergic reaction.
55 2021-04-08 heart rate increased Fever 102 deg F 4 hours after vaccination broke 4 hours later, Diarrhea and abdominal pain for 3 wee... Read more
Fever 102 deg F 4 hours after vaccination broke 4 hours later, Diarrhea and abdominal pain for 3 weeks after vaccination, elevated heart rate for 2 days after vaccination, loss of weight due to diarrhea 12 lbs.
55 2021-04-09 blood clot experienced blood clot; This spontaneous case was reported by a consumer and describes the occurrenc... Read more
experienced blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (experienced blood clot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Factor V Leiden mutation. Concomitant products included RIVAROXABAN (XARELTO) for Factor V Leiden mutation. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced THROMBOSIS (experienced blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (experienced blood clot) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was treated with blood thinner Xarelto (rivaroxaban) on a daily basis for factor V mutation and was treated with the same for blood clot.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
55 2021-04-11 blood glucose increased Patient presented to ER on 3/27/2021 with c/o right side numbness and facial paralysis, right side. ... Read more
Patient presented to ER on 3/27/2021 with c/o right side numbness and facial paralysis, right side. Dr. attending ER physician, diagnosed him with Bell's palsy. Patient states he received 2nd dose of Covid-19 vaccine (Moderna) on 3-25-21, and woke up the next morning with numbness, weakness of right side of forehead, eye, and mouth. went to ER around 11:00am the next morning (03-27-21). No other significant paralysis or problems with limbs or other mobility problems are noted in ER record. Patient history significant for: Diabetes Mellitus (uncontrolled), and Hypertension (controlled). Was given Clonidine and labs, CT scan was ordered. Labs were signficiant for elevated blood glucose, 321 and elevated HgA1c (10.5). patient was given insulin in the ER. Results of CT (w/o contrast) scan was negative-"no hemorrhage, no mass-effect, no extra-axial fluid collection." "subtle right-sided basal ganglia calcifications."
55 2021-04-11 loss of consciousness I passed out and suffered a concussion. My wife found me on the floor when she heard me hit the grou... Read more
I passed out and suffered a concussion. My wife found me on the floor when she heard me hit the ground. I was taken to the hospital and stayed for two nights while given numerous scans and tests. No indication of stroke or poor heart condition revealed by any of the tests. No other symptoms other than soreness (which could have been attributed to the fall).
55 2021-04-11 palpitations After my second vaccine, I immediately experienced dizziness, light headiness, felt anxious and jitt... Read more
After my second vaccine, I immediately experienced dizziness, light headiness, felt anxious and jittery. I also had heart palpitations and the medic personnel took my heart monitor, it was 80bpm. About 45 minutes of monitoring, my symptoms were slowly going away and I went back to work. That same night I felt fine and by the next morning I was feeling much better.
55 2021-04-12 heart rate increased Bad Chills at night with fever over 102.8 and fatigue. Some nausea and body aches. Elevated Heart ... Read more
Bad Chills at night with fever over 102.8 and fatigue. Some nausea and body aches. Elevated Heart rate up to 110bpm. Fever lasted around 24 hours. 48 hours later mouth sores appeared on lips, roof of mouth and around gums and continue to present. These are painful and blistered.
55 2021-04-12 blood clot I peed a blood clot and had to go to the ER on 03/30/21
55 2021-04-14 stroke, cerebral haemorrhage within 1-2 days of vaccine, he developed confusion/dizziness/myalgia/weakness. He also had intractab... Read more
within 1-2 days of vaccine, he developed confusion/dizziness/myalgia/weakness. He also had intractable headache which had been persistent for the past month. Patient underwent outpatient MRI 4/14 and was found to have new subacute right MCA ischemic infarction with hemorrhagic conversion. Patient continues to be apraxic with continued cognitive effects. He has recovered from the transient weakness and dizziness.
55 2021-04-14 chest pain covid 19 chest pain
55 2021-04-15 heart attack Heart attack; This spontaneous case was reported by a non-health professional (subsequently medicall... Read more
Heart attack; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Heart rate: 209 (High) beats per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
55 2021-04-15 palpitations Feeling like heart racing (>100bpm), could feel with hand to chest; accompanied by some shortness of... Read more
Feeling like heart racing (>100bpm), could feel with hand to chest; accompanied by some shortness of breath. Radial pulse remained normal (70-80bpm) throughout event. Occurred roughly five times over course of three days (4/12-4/14), usually in evenings. Events lasted less than a minute each. Seems to have abated on its own.
55 2021-04-16 fainting Fainted in 3 mts after the vaccine administration. Tech helped the patient to sit.Then he was fine t... Read more
Fainted in 3 mts after the vaccine administration. Tech helped the patient to sit.Then he was fine talking. He did mention that he did not eat anything before coming for the vaccine.Called 911.All vital signs were tested and were good.
55 2021-04-19 low platelet count, platelet count decreased, fibrin d dimer increased 55 y/o male with PMHx of obesity, LLE cellulitis (hospitalized in 2018), and varicose veins seen in ... Read more
55 y/o male with PMHx of obesity, LLE cellulitis (hospitalized in 2018), and varicose veins seen in unit 4/19/21 due to LLE cellulitis not responding to bactrim DS. Patient reports remote history of bilateral cellulitis and hospitalized once for IV abx for 4 days in 2018. He denies DVT history. He was prescribed compression stockings, unsure of compression grade but he isn?t wearing them due to the ongoing pain. He was seen by nursing on 4/2/21 reported leg erythema and swelling starting that day. He was given Rocephin and had Bactrim ordered. The leg swelling/erythema/pain improved minimally with Bactrim DS but still had symptoms so he was seen today. He reports posterior calf tenderness. he denies fevers, chills, sweats, dyspnea, chest pain, SOB, palpitation, abdominal pain, N/V/D/C at this time. exam shows LLE with anterior erythema, tenderness, warmth, and (+) homan sign. 1-2+ BLE edema. He was COVID 19 positive on 11/10/20 and again on 3/15/21. Received moderna on 3/9/21 and 4/6/21. Labs sent to local hospital show D-Dimer >1000 and CBC with thrombocytopenia to 111K per lab with 3+clumping.
55 2021-04-21 blood pressure increased Received vaccine around 10 am, by 2:00 pm headache, by midnight, chills, bad headache, severe body a... Read more
Received vaccine around 10 am, by 2:00 pm headache, by midnight, chills, bad headache, severe body aches, significant sweating, sleeplessness, fever around 100 degrees, ringing in ears, blood pressure up 4-6 points above normal. Chills and fever gone by 9 am 4/21... body aches, head aches, ear ringing last around 36 hours
55 2021-04-22 pulmonary embolism patient received second dose of Moderna vaccine on 4/10/2021, and he developed his first symptoms 7 ... Read more
patient received second dose of Moderna vaccine on 4/10/2021, and he developed his first symptoms 7 days after. He ultimately came to hospital with sob, diagnosed wtih bilateral PTE. no clots noted in his legs bilaterally. He did well, was on Room Air throughout his stay, which was less than 24 hours and went home on Eliquis for Anti-coagulation.
55 2021-04-25 blood pressure increased, heart rate increased Pt went to his PCP, had 105.4 rapid heart rate, diarrhea, elevated b/p 187-85
55 2021-04-25 heart rate increased I received the 2nd dose of the Moderna Vaccine for Covid 19 at 2:15 pm on 4/23/21. I woke up on 4/2... Read more
I received the 2nd dose of the Moderna Vaccine for Covid 19 at 2:15 pm on 4/23/21. I woke up on 4/24/21 around 4:15 am with the following adverse reactions: 103* temperature, extreme body aches and muscle pain, a headache, a fast heartbeat and chills. I took Tylenol every 4-6 hours until the reactions subsided on Sunday afternoon (4/25/21).
55 2021-04-25 fast heart rate, palpitations Vertigo, dizziness, brain fog, tachycardia, pounding heartbeat, nausea, feelings of anxiety
55 2021-04-26 hypertension 3:50 PT C/O EYES BURNING FACE FLUSHED, BP 240/132 HR 112 SKIN MOIST NO SHORTNESS BREATH , PT ASATES... Read more
3:50 PT C/O EYES BURNING FACE FLUSHED, BP 240/132 HR 112 SKIN MOIST NO SHORTNESS BREATH , PT ASATES HX HTN BUT HE STOPPED MEDS A YEAR AGO BECAUSE THEY WERE NOT WORKING. 3:55 HR 104 4:00 PM BP 216/142 REFERRED TO ER- AMBULANCE CALLED 4:05 BP 240/132- TURNED OVER YTO AMBULANCE STAFF = 4:45 AMBULANCE STAFF OBSERV ED PT TIL BP RET'D NORMAL AS PT REFUSED TO GO TO ER
55 2021-04-26 loss of consciousness Patient had a seizure about 5-6 minutes after receiving immunization. They were unconscious for abou... Read more
Patient had a seizure about 5-6 minutes after receiving immunization. They were unconscious for about 1-2 minutes. They regained consciousness and were taken by E,M.T. to be evaluated further.
55 2021-04-28 palpitations 103 deg fever, heart palpitations, achy joints, chills, fatigue
55 2021-04-29 heart rate increased Extreme fatigue. Extreme muscle aches in both arms, both legs, back & torso. Elevated heart rate. He... Read more
Extreme fatigue. Extreme muscle aches in both arms, both legs, back & torso. Elevated heart rate. Headache.
55 2021-04-30 palpitations, lightheadedness hard to think, it has been very disturbing because he has to think for work, and it has been very di... Read more
hard to think, it has been very disturbing because he has to think for work, and it has been very difficult; Continued bad and strange dizziness; vertigo that lasted about 3 weeks and was very disturbing; heart was pounding but heart rate was normal; couldn't sleep; brain fogs; hard to think and remember things; feeling of anxiety; There were times when he feels detached from reality; strange feeling of dizziness and nausea feeling; At some point felt like he was almost going to lose consciousness; felling sick like he had the flu; significant pain in arm; fever; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (hard to think, it has been very disturbing because he has to think for work, and it has been very difficult), DIZZINESS (Continued bad and strange dizziness), VERTIGO (vertigo that lasted about 3 weeks and was very disturbing), PALPITATIONS (heart was pounding but heart rate was normal), INSOMNIA (couldn't sleep), FEELING ABNORMAL (brain fogs), MEMORY IMPAIRMENT (hard to think and remember things), ANXIETY (feeling of anxiety), DISSOCIATION (There were times when he feels detached from reality) and NAUSEA (strange feeling of dizziness and nausea feeling) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy (Respiratory allergies). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felling sick like he had the flu), PAIN IN EXTREMITY (significant pain in arm), PYREXIA (fever) and CHILLS (chills). In April 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENTAL IMPAIRMENT (hard to think, it has been very disturbing because he has to think for work, and it has been very difficult) (seriousness criterion medically significant), DIZZINESS (Continued bad and strange dizziness) (seriousness criterion medically significant), VERTIGO (vertigo that lasted about 3 weeks and was very disturbing) (seriousness criterion medically significant), PALPITATIONS (heart was pounding but heart rate was normal) (seriousness criterion medically significant), INSOMNIA (couldn't sleep) (seriousness criterion medically significant), FEELING ABNORMAL (brain fogs) (seriousness criterion medically significant), MEMORY IMPAIRMENT (hard to think and remember things) (seriousness criterion medically significant), ANXIETY (feeling of anxiety) (seriousness criterion medically significant), DISSOCIATION (There were times when he feels detached from reality) (seriousness criterion medically significant), NAUSEA (strange feeling of dizziness and nausea feeling) (seriousness criterion medically significant) and PRESYNCOPE (At some point felt like he was almost going to lose consciousness). At the time of the report, MENTAL IMPAIRMENT (hard to think, it has been very disturbing because he has to think for work, and it has been very difficult), PALPITATIONS (heart was pounding but heart rate was normal), INSOMNIA (couldn't sleep), FEELING ABNORMAL (brain fogs), MEMORY IMPAIRMENT (hard to think and remember things), ANXIETY (feeling of anxiety), DISSOCIATION (There were times when he feels detached from reality), NAUSEA (strange feeling of dizziness and nausea feeling), PRESYNCOPE (At some point felt like he was almost going to lose consciousness), INFLUENZA LIKE ILLNESS (felling sick like he had the flu), PAIN IN EXTREMITY (significant pain in arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown, DIZZINESS (Continued bad and strange dizziness) had not resolved and VERTIGO (vertigo that lasted about 3 weeks and was very disturbing) had resolved. Patient reports he takes supplements as concomitant medications Patient was prescribed clonazepam for his anxiety and took ibuprofen for his symptoms. Patient went to the ER two weeks after receiving the second dose of the vaccine, he was checked out, ran some tests and everything was within normal limits. Blood work was normal. 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. Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills and pyrexia are consistent with the product safety profile. This case was linked to MOD-2021-090675 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills and pyrexia are consistent with the product safety profile
55 2021-05-03 chest pain, inflammation of the pericardium Two days after second shot, I began experiencing pain in my chest, especially sharp when cough, snee... Read more
Two days after second shot, I began experiencing pain in my chest, especially sharp when cough, sneeze or hiccup. I went to see Dr. on March 10 and he diagnosed as a recurrent pericarditis. I had a case approximately 2 years earlier. He said it would take longer for it to go away this time. I've been under his care ever since, and the pain has never subsided. I am now in an extended timeframe of having the pain and do not believe it to be a coincidence.
55 2021-05-03 nosebleed Patient called into the pharmacy complaining of bloody noses and blood coming out of ears for the pa... Read more
Patient called into the pharmacy complaining of bloody noses and blood coming out of ears for the past 3 days (started around 5/1/21). Patient received Moderna on 4/8/21. Patient is not currently bleeding but was instructed to contact his doctor ASAP. Followed up with patient and he states he did contact his physician and has an appointment scheduled for tomorrow.
55 2021-05-04 deep vein blood clot 5 days after first dose of Moderna Covid-19 vaccine, pt noticed his leg was swelling and told his do... Read more
5 days after first dose of Moderna Covid-19 vaccine, pt noticed his leg was swelling and told his doctor that his leg was swollen at a routine doctor visit that was scheduled ahead of time prior to vaccine. The doctor told the patient to go next door to vascular clinic. They did an ultrasound and found an acute DVT and chronic deep vein thrombosis. Pt was put on Eliquis the same day (4/12/21) to treat the issue. Mild swelling is still present in leg, but pt was cleared by Dr. to receive second dose which he did on 5/5/21.
55 2021-05-05 palpitations, chest pain CHest pain, heart palpitations fatigue - duration 1 month headaches - duration persistent
55 2021-05-07 deep vein blood clot Engorgement/Swelling of lower right extremity from hamstring to foot, significant discomfort in righ... Read more
Engorgement/Swelling of lower right extremity from hamstring to foot, significant discomfort in right calf weight bearing, flexion of right foot/ankle, and to touch (e.g., massage).
55 2021-05-07 hypertension SHORTNESS OF BREATH, HIGH BLOOD PRESSURE, BLURRED VISION, DIZZINESS, AND NUMBNESS
55 2021-05-09 chest pain Starting on 3rd day after the first vaccine shot, I felt sharp pain on my left chest and left back, ... Read more
Starting on 3rd day after the first vaccine shot, I felt sharp pain on my left chest and left back, two days later, rashes appeared, diagnosed as Shingles. Treated with antiviral medication. As today, rashes almost gone, but part of my chest is still sensitive to touch, temperature. The injection site of my left arm still feel mild pain and weak.
55 2021-05-11 pallor, transient ischaemic attack Thursday following vaccing chills, friday headache. saturday through monday well/fine. 5/12/21 woke ... Read more
Thursday following vaccing chills, friday headache. saturday through monday well/fine. 5/12/21 woke up one sided weekness, pale, could not talk, wife, called 911. episode lasted 15-20 minutes per wife. went to ER, was diagnoses with TIA, suspecting vaccine but not confirmed at this time.
55 2021-05-11 superficial blood clot Approximately 17 days after 1 dose administered patient noted chord like feeling in armpit of right ... Read more
Approximately 17 days after 1 dose administered patient noted chord like feeling in armpit of right arm. Followed up with his PCP who stated they could not be sure but thought there may be a correlation between the superficial thrombosis that was discovered and the administration of the COVID-19 vaccine.
55 2021-05-12 deep vein blood clot pt developed right upper leg DVT 2 days after receiving second covid vaccine, first administered on ... Read more
pt developed right upper leg DVT 2 days after receiving second covid vaccine, first administered on 4/7
55 2021-05-15 fainting Pt fainted for a second and hit his head. He immediately got up and was given water and an ice pack... Read more
Pt fainted for a second and hit his head. He immediately got up and was given water and an ice pack. He was asked to sit for a bit until he felt much better. He felt better right away but we had him sit for about 1/2 hour. He had not had anything to eat all day
55 2021-05-16 chest discomfort Client received 1st COVID vaccine of Moderna (Lot# 021C21A) Client reported a headache. EMT responde... Read more
Client received 1st COVID vaccine of Moderna (Lot# 021C21A) Client reported a headache. EMT responded to Client. At 6:03PM, vital signs are blood pressure 141/97, pulse 59, oxygen saturation 98%. RN responded to the event. Client had only a salad to eat today and drank plenty of water. Client has no past medical history, no known allergies, no medications. At 6:10PM vital signs are blood pressure 145/98, pulse 59, oxygen saturation 100%. Client reports no blurred vision, no headache, no shortness of breath, no dizziness, no lightheartedness, no nausea. RN provided education in regards to ED precaution and common adverse effects of the COVID vaccine. At 6:15PM vital signs are blood pressure 141/95, pulse 72, oxygen saturation 98%. Client reports slight chest pressure at 6:16PM, states it can be due to possible high cholesterol client may have. RN offered Client to call paramedics for further evaluation. Client declined. Client reports client has not gone to primary care provider in over a year. RN suggested Client to follow up with primary care provider. Client reports chest pain and headache resolved at 6:18PM. At 6:21PM vital signs are blood pressure 139/97, pulse 67, oxygen saturation 97%. Client is able to stand with a steady gate. Client left at 6:24PM with steady gate.
55 2021-05-17 superficial blood clot He notes acute onset of right antecubital supervicial thrombophlebits 4 days after his second Modern... Read more
He notes acute onset of right antecubital supervicial thrombophlebits 4 days after his second Moderna Covid vaccine. He has not previous SVT/DVT history and no Family History of SVT/DVT.
55 2021-05-18 atrial fibrillation Patient w/h/o afib, but was regular prior to the vaccine, showed up to the hospital approx. 1 mo a... Read more
Patient w/h/o afib, but was regular prior to the vaccine, showed up to the hospital approx. 1 mo after their 2nd moderna vaccine w/afib w/RVR and failed cardioversion.
55 2021-05-18 palpitations, cardiac arrhythmia, chest pain, chest discomfort 3:05 Presented for Moderna Covid Vaccine-1st Dose 3:15 Moderna Lot# 020B21A given in the R deltoid g... Read more
3:05 Presented for Moderna Covid Vaccine-1st Dose 3:15 Moderna Lot# 020B21A given in the R deltoid given 3:36 Began to have ? scratchy throat and racing heart 3:36 O2 sat 97% and HR 84-will continue to monitor for an additional 15 minutes. No history of anaphylaxis reported. 4:00 ? non radiating chest pain. Described as a ?hard? feeling in center of sternum. No diaphoresis or shortness of breath observed, No LOC. BP 180/94 4:05 EMS called 4:15 EMS arrived. BP 195/125. EKG w/ occasional PVC. O2 sat remains in upper 90?s 4:35 Transported to ER
55 2021-05-18 fainting, nosebleed Pt was seated in our observation area and approximately 10 minutes after receiving Moderna dose 1 va... Read more
Pt was seated in our observation area and approximately 10 minutes after receiving Moderna dose 1 vaccination, he fell face first onto the floor. Pt proceeded to have slight tremor and was unresponsive (signs and symptoms of vasovagal syncope) for approximately 1-2 minutes. Once the pt came to, his nose was split and he was bleeding from inside and outside his nose. ED was called. The fire station staff and EMS arrived. Pt was left to be taken care of by emergency response professionals. Pt then left with EMS to the hospital.
55 2021-05-20 brain sinus blood clot Patient presented with on 5/12/21 with headache, nausea and vomiting, malaise, and decreased respons... Read more
Patient presented with on 5/12/21 with headache, nausea and vomiting, malaise, and decreased responsiveness. Headache and malaise had been present on/off since late April after patient had received the second dose of Moderna COVID-19 vaccine. Head CT in ED revealed venous sinus thrombosis. MR venogram with near complete occlusion of the superior sagittal sinus, right transverse and sigmoid sinuses, right internal jugular vein), possible mastoiditis on the right side. Started on heparin drip, unasyn, and transferred to neurosurgical ICU. 5/13/21 underwent mechanical thrombectomy; of the superior sagittal sinus, bilateral transverse and sigmoid sinuses and the right vein of Labbe - flow has been restored. Partial clots remained in right internal jugular vein. Heparin drip was changed to antiXa goal 0.3-0.7. HNS consult - no strong evidence of mastoiditis. 5/14/21 repeat MRI/MRV - thrombus within the right transverse sinus, sigmoid sinus and right jugular bulb, no thrombi in the dominant left transverse sinus or SSS - anticoagulation was changed from heparin to enoxaparin 1 mg/kg every 12 hours 5/15/21 patient was observed in the ICU 5/16/21 discharged home in stable condition
55 2021-05-20 loss of consciousness patient passed out after 10 minutes of taking the vaccine
55 2021-05-21 chest pain Patient came to pharmacy to receive second Moderna covid shot. Patient received shot and asked to ... Read more
Patient came to pharmacy to receive second Moderna covid shot. Patient received shot and asked to stay for 15 minute for observation. While waiting, patient complaint chest pain when he breathe in deeply. Patient waited little longer and felt symptom was getting worse so patient wanted pharmacy to call 911. The paramedics came soon after and patient left with them.
55 2021-05-21 nosebleed Woke up to bloody nose. Stopped by blowing nose (blood plus heavy, dark red mucus), pinching nose, a... Read more
Woke up to bloody nose. Stopped by blowing nose (blood plus heavy, dark red mucus), pinching nose, and leaning forward. Issue built up/recurred every 2 to 3 hours throughout the day. Also, had sinus pressure on left side and maybe post nasal drip (felt it and had the vague taste of iron in my mouth). Issue resolved itself overnight. After clearing my nose in the morning on 04/26, I was good. Also, I had a sore arm around the injection site, starting about 6 hours or so after injection, lasting about 2 days
55 2021-05-23 chest discomfort, inflammation of the heart muscle, inflammation of the pericardium On 4-18-21, 17 days after 1st dose of Moderna, he developed upper abdomen pain, chest discomfort. He... Read more
On 4-18-21, 17 days after 1st dose of Moderna, he developed upper abdomen pain, chest discomfort. He thought it was indigestion and treated it as such. When he got no relief he went to Emergency room where a cardiac alert was initiated. After he died I was told he had developed myocarditis,/pericarditis and they had to remove a liter of blood from the sac around his heart, but that his heart had gone into cardiogenic shock and that he died. They were prepared to insert a stint thinking he had a blocked coronary artery, but his arteries were clear and they had no idea what had caused this to happen. When he died so soon after the vaccine there were people who wanted to blame the vaccine but I checked into it and there were NO links between the vaccine and myocarditis, pericarditis or cardiogenic shock. Within a few weeks of his death, there began to be possible links between the vaccine and myocarditis. I know 55 is older than what is being looked at, but he had absolutely no previous cardiac history prior to this and this case should e looked at as well
55 2021-05-26 low platelet count, anaemia, haemoglobin decreased, platelet count decreased Approximately 9 days after the vaccination, tender left axillary lymphadenopathy, malaise, chills, a... Read more
Approximately 9 days after the vaccination, tender left axillary lymphadenopathy, malaise, chills, and high fever (to 104F) developed; followed several days later by development of marked erythema and warmth over the left chest wall, left axillary region, and onto left back. This presentation required brief hospitalization for treatment of a presumed cellulitis and further diagnostic workup of fevers and lymphadenopathy. The patient was treated with antibiotics for cellulitis and empirically for possible tick-borne illness (early Lyme, glandular tularemia) with notable improvement in the skin erythema and fevers.
55 2021-05-27 atrial fibrillation This is a 55 yo male who contacted his care team on 4/28/21 to report that following his covid vacci... Read more
This is a 55 yo male who contacted his care team on 4/28/21 to report that following his covid vaccine (Moderna dose #2 on 4/24/21), he developed Afib (symptoms = palpitations). Patient does have a history of Afib, diagnosed in 2011, last seen by cardiology in 2017. Patient reports that he will have Afib episodes every few months, they last 6-10 hours (with palpitations), then he self-converts back. In this current episode, it has been persistent. He was advised to report to ED and f/u with his cardiologist. No notes regarding an ED visit. Cardiology visit took place on 5/5/21. BP=134/90, HR=147, Ht=77in, wt=162.8kg; Labs wnl except chol=224, Trig=180, LDL=142. EKG=Afib with RVR, rate 125bpm. Patient was initiated on anticoagulation (apixaban) and completed a cardioversion and TEE on 5/13/21. Patient was managed on diliazem and flecainide. On 5/18, patient called to report he was back in Afib, however he self converted within 24hr. Although patient has a history of Afib and the vaccine is not a clear cause, I will report to VAERS as a potentially clinically significant event.
55 2021-06-02 pulmonary embolism CT of the chest revealed significant bilateral PE with possible heart strain. Was given TPA. Monitor... Read more
CT of the chest revealed significant bilateral PE with possible heart strain. Was given TPA. Monitoring after receiving after TPA and improved
55 2021-06-08 blood glucose increased, very slow heart rate Initial event next morning 9am stye on left eye rash across top of head sever headache, lasted 24 ho... Read more
Initial event next morning 9am stye on left eye rash across top of head sever headache, lasted 24 hours except headache last another 24 hours. On the 24th started around blood sugar spiked to rook on empty stomach, used bathroom constantly, right side of tongue was numb, and continued to run into bathroom, one time noticed facial drooping, weakness right side. Called supervisor to take to ER works as Paramedic, was in brady cardia normally does not have heart problems nor ever had brady cardia. Admitted to hospital, was on prednisone and benzos, for a few days. Was in contact with neuro and endocrinologist. I was very angry with this happened I tried calling Mederna, Mederna read him the info about not being able to sue them. He waited three months before Mederna asked for records, CDC did nothing. Very angry about the fact that nothing was set up to help people with severe reactions to the vaccines. No one wanted to listen to him. Endocrinologist said this is not normal and they continued to push forward and it was proven that it was attributed to the vaccine. Nerve damage underneath the right eye from the Bells Palsy. Completed paperwork back in
55 2021-06-08 chest pain, inflammation of the pericardium Patient brought to ED 6/8 am with substernal chest pain onset 6/7 pm. Tests include EKG, chest xray,... Read more
Patient brought to ED 6/8 am with substernal chest pain onset 6/7 pm. Tests include EKG, chest xray, serial troponin, Chest CT, BNP, d dimer, labs. Patient admitted for further work up which ruled out PE, aortic dissection, pneumothorax. Initial EKG showed ST changes in inferior lead and repeat EKG consistent with pericarditis. CXR showed pulmonary vascular congestion and prominent interstitial markings. WBC showed leukocytosis. Elevated CRP. Patient started on aspirin and colchicine with improvement and discharged home.
55 2021-06-08 inflammation of the pericardium, chest pain Chest pain on left side. Eventually diagnosed as pericarditis after weeks of tests and hospitalizati... Read more
Chest pain on left side. Eventually diagnosed as pericarditis after weeks of tests and hospitalization. Currently on multi-week course of Indomethacin
55 2021-06-09 hypotension, blood pressure decreased Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Mild, Systemic:... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Mild, Systemic: Weakness-Mild, Additional Details: patient was sweating profusely, felt dizzy. We called 911 and they said patient's BP dropped and may not have had a real seizure. patient said he had experience the 'excessive sweating' side effect before when he had allergic reaction (but did not tell the pharmacy staff at check in when we were asking if he had any allergic reaction to something)
55 2021-06-10 chest pain, inflammation of the pericardium Chest pain as a result of Pericarditis. 600 MG of Ibuprofen/3x a day. Mitigare 0.6 MG/2x a day. Both... Read more
Chest pain as a result of Pericarditis. 600 MG of Ibuprofen/3x a day. Mitigare 0.6 MG/2x a day. Both meds were prescribed on May 10th, 2021. I've been taking it since and it certainly has been effective. Unfortunately, when attempting to ween off, the symptoms immediately return.
55 2021-06-10 sinus rhythm, lightheadedness, palpitations, atrial fibrillation Pt received his 2nd vaccine on 4/10/21. he reported that after that he began to experience intermitt... Read more
Pt received his 2nd vaccine on 4/10/21. he reported that after that he began to experience intermittent palpitations which came and went before they persisted with associated near syncope prompting him to come to the emergency room on 6/1/21 where he was diagnosed and admitted with new onset rapid atrial fibrillation. He has no history of sleep apnea, does not drink alcohol, his tsh was normal, troponins were normal, cardiac crp was normal, d dimer was neg and PE was ruled out. he was started on metoprolol and eliquis and broke to sinus rhythm. echo was normal with no atrial enlargement and normal ejection fraction, no valvular disease, chest x ray normal, cmp and cbc normal. He was discharged home on 6/2/21. He will need follow up with cardiology.
55 2021-06-13 heart rate irregular Patient felt faint 5 minutes after being vaccinated. patient says is scared of needles and thinks it... Read more
Patient felt faint 5 minutes after being vaccinated. patient says is scared of needles and thinks it is due to this. He did not want us to call 911 since he does not have an insurance. I nevertheless monitored his vitals until his dauugter who is a nurse arrived .His heart rate varied from 45 to 61.
55 2021-06-13 heart attack, chest pain Heart attack
55 2021-06-15 cerebrovascular accident Acute stroke CT and MRI. MRI showed acute infarction in left cerebellar and occipital lobe started o... Read more
Acute stroke CT and MRI. MRI showed acute infarction in left cerebellar and occipital lobe started on aspirin 81 mg and crestor 40 mg for management.
55 2021-06-17 arrhythmia Patient complains of shortness of breath, very sore arm, inflamed lymph node under left arm, chills,... Read more
Patient complains of shortness of breath, very sore arm, inflamed lymph node under left arm, chills, fever and heart arrhythmias, Patients states he was in perfect health before receiving the Moderna Vaccine. He refuses to go to a doctor for evaluation. The request that I complete VAERS
55 2021-06-20 chest discomfort I had a sharp pain in my back and pressure in my chest. The ER doctor said that I had a small case o... Read more
I had a sharp pain in my back and pressure in my chest. The ER doctor said that I had a small case of pneumonia. I'm not sure if it had anything to do with the vaccine.
55 2021-06-22 arrhythmia, enlargement of the heart Began experiencing heavy heart arrythmia within hours of receiving the 2nd vaccine. Went to urgent ... Read more
Began experiencing heavy heart arrythmia within hours of receiving the 2nd vaccine. Went to urgent care, and was confirmed by EKG. Followed up with Cardiologist, had stress test and Echo cardiogram, confirmed arrythmia and enlarged left ventricle. The arrythmia was heavy for first 2-3 weeks, gradually began to dissipate after 4-6 weeks. No prior history of heart trouble.
55 2021-06-22 inflammation of the heart muscle, chest pain Has not received 2nd dose; Arm pain; Shoulder blade catch sore muscle\ arm pain; Fatigue; Pain at in... Read more
Has not received 2nd dose; Arm pain; Shoulder blade catch sore muscle\ arm pain; Fatigue; Pain at injection site; Myocarditis; Shortness of breath; weakness; Chest pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included DULOXETINE, GLIMEPIRIDE, LISINOPRIL and METFORMIN 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 01-Apr-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ASTHENIA (weakness), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), PAIN (Arm pain), MYALGIA (Shoulder blade catch sore muscle\ arm pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 02-Apr-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), ASTHENIA (weakness), PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose), MYALGIA (Shoulder blade catch sore muscle\ arm pain) and FATIGUE (Fatigue) outcome was unknown and DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and PAIN (Arm pain) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No treatment information was provided. Patient stated that he thinks he may have had COVID in Dec2019 or Jan2020. This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273 product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile. Product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added new event and updated vaccine dose information.; Sender's Comments: This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273 product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile. Product dose omission is not applicable.
55 2021-06-25 chest pain Chronic Chest pain radiates into arms and shoulders, shortness of breath.
55 2021-06-27 heart rate irregular About 24 hours after receiving the vaccination, my heart was beating out of rhythm and had pain, I h... Read more
About 24 hours after receiving the vaccination, my heart was beating out of rhythm and had pain, I have an ICD to keep my heart in rhythm. I didnt sleep for almost 6 days. I could feel when my heart went back into a normal rhythm, It was very painful. My heart is very sensitive. It took about 3 weeks to recover.
55 2021-06-28 atrial fibrillation, heart flutter, cardiac failure congestive Patient called and stated he felt heart fluttering that was diagnosed as a fib that progressed to ac... Read more
Patient called and stated he felt heart fluttering that was diagnosed as a fib that progressed to acute congestive heart failure.
55 2021-06-28 cardiac failure congestive, atrial fibrillation difficulty breathing during a regular exercise time and eventually even walking at all due to severe... Read more
difficulty breathing during a regular exercise time and eventually even walking at all due to severe water retention, after visiting my doctor and having an exam as well as an ekg he determined that i was in afib/congestive heart failure. i was sent to a heart doctor who performed a cardio version which did not convert my heart, later i was hospitalized for the afib and water retention and another cardio version was performed and again it was not successful for more than a day. i am currently scheduled for a cardio ablation on 7-9-21.
55 2021-06-28 pulmonary embolism Severe Pulmonary embolism
55 2021-07-01 blood clot in the brain Starting 03/01/2021, I had a massive headache that lasted 7 or 8 weeks. On 05/20/2021 a MRI was don... Read more
Starting 03/01/2021, I had a massive headache that lasted 7 or 8 weeks. On 05/20/2021 a MRI was done a discovered I had a blood clot in the brain. I'm now on blood thinners, I have to do repeat scan of my brain, frequent doctor visits to monitor clot.
55 2021-07-02 chest pain, inflammation of the pericardium Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1391592) on 22-Jun... Read more
Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1391592) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) in a 55-year-old male 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 Blood pressure high and High cholesterol. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM GENERIC), SILDENAFIL, VARENICLINE TARTRATE (CHANTIX), ZOLPIDEM TARTRATE (ZOLPIDEM TARTATE) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication. On 26-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 15-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant) and CHEST PAIN (Chest pain). The patient was treated with IBUPROFEN on 10-May-2021 at a dose of 600 mg three times a day and COLCHICINE (MITIGARE) at a dose of .6 mg twice a day. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current 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.
55 2021-07-08 blood pressure increased elevated blood pressure of 216/99; received telephone order to administer 0.1 mg clonidine and patie... Read more
elevated blood pressure of 216/99; received telephone order to administer 0.1 mg clonidine and patient to hold next dose of midodrine.
55 2021-07-11 hypertension Blood Pressure was high
55 2021-07-11 pulmonary embolism Acute saddle pulmonary embolism. S/p pulmonary embolectomy. Spent 3 days in ICU + 2 days recovering ... Read more
Acute saddle pulmonary embolism. S/p pulmonary embolectomy. Spent 3 days in ICU + 2 days recovering at the Hospital
55 2021-07-11 blood clot, pulmonary embolism, deep vein blood clot, loss of consciousness, fibrin d dimer increased, troponin increased Received 2nd Moderna COVID-19 dose on 5/8. Experienced sore calf and sore groin around 6/17. Woke ... Read more
Received 2nd Moderna COVID-19 dose on 5/8. Experienced sore calf and sore groin around 6/17. Woke up morning of 6/21 with lower left leg pain and ended up passing out twice in 20 minutes (15 minutes unaccounted for). Experienced extreme sweating and shortness of breath. Called 9-1-1 and was treated by paramedics, then taken to ER.
55 2021-07-14 blood glucose increased 15 minutes after I had the dose, I felt chills, arthritic pain in all my joints, and lethargic. It ... Read more
15 minutes after I had the dose, I felt chills, arthritic pain in all my joints, and lethargic. It got progressively worse and 2 days later, I felt like my blood sugar was high and it was 507 and this was taking Metformin. So I went to the hospital. They were able to get my BS under control. the next day it was high again and they had me come back. I went to the ER 2 days in a roll. For my arthritic pain the hospital prescribed muscle relaxer. My real concern was my blood sugar being so high, but they were able to get it under control. I still have joint pain.
55 2021-07-15 blood glucose increased Moderna COVID-19 Vaccine EUA: patient in clinic for follow-up of left shoulder/arm pain starting ri... Read more
Moderna COVID-19 Vaccine EUA: patient in clinic for follow-up of left shoulder/arm pain starting right after immunization. Patient evaluated that day in the emergency department (ED), administered analgesics, and pain improved. Noted to be hyponatremic and blood glucose increased and was administered intravenous fluids. Patient discharged rom ED stable. On follow-up symptoms have resolved.
55 2021-07-19 blood pressure increased Allergic reaction which came on without a known specific reason. face swelling and elevated blood ... Read more
Allergic reaction which came on without a known specific reason. face swelling and elevated blood pressure,
55 2021-07-20 fainting Patient fainted while waiting 15 minutes, fell over , may have hit head.
55 2021-07-21 heart rate decreased, heart flutter, atrial fibrillation I experienced heart fluttering. I have an app that can check for A-fib. It registered for A-fib. The... Read more
I experienced heart fluttering. I have an app that can check for A-fib. It registered for A-fib. The number one thing that was related to this was low heart rate. Since I've been taken off nabibolol 2.5mg, I haven't had this experience in three days. While I was taking nabibolol 2.5mg, I was having this experience regularly. When I was 45, I learned that I had coronary artery disease and I had 2 stints put in. I have not experienced any other heart issues since then, until now.
55 2021-07-26 chest pain Patient presented to the ED and was subsequently hospitalized for chest pain within 6 weeks of recei... Read more
Patient presented to the ED and was subsequently hospitalized for chest pain within 6 weeks of receiving COVID vaccination.
55 2021-07-28 inflammation of the pericardium Pericarditis, I am now going to have to have a pericardiectomy.
56 2021-01-05 chest discomfort, chest pain 15 hours after shot experianced, dizziness, feeling of fainting, difficulty breathing mild pressure ... Read more
15 hours after shot experianced, dizziness, feeling of fainting, difficulty breathing mild pressure chest pain. Was taken to local Er. Ekg, cat scan chest xrays all negitive. Blood work negitive. No past history of symptoms
56 2021-01-06 chest pain Pt diagnosed with COVID-19 on 12/9/2020 (symptom onset 12/6). Had fully recovered and completed isol... Read more
Pt diagnosed with COVID-19 on 12/9/2020 (symptom onset 12/6). Had fully recovered and completed isolation period. Had vaccine on 12/27, developed fatigue, dry cough and mild SOB after that. Developed chest pain (substernal stabbing discomfort) on 12/28 and presented to ED on 12/29. Work up was benign. Pt discharge home that same night.
56 2021-01-08 chest discomfort light headed for 5 minutes, slight chest tightness Narrative:
56 2021-01-11 lightheadedness After receiving first dose of covid-19 Moderna at 3:27pm, a few minutes later the client felt dizzy ... Read more
After receiving first dose of covid-19 Moderna at 3:27pm, a few minutes later the client felt dizzy and sat on the floor and had a vasovagal response. After inhaling ammonia, he responded and he was AAO x3, paramedics arrived and took vitals all WNLs. Client stayed in observation for 30 more minutes and left the facility feeling ok.
56 2021-01-18 chest pain Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency... Read more
Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.
56 2021-01-19 pallor Approximately 1:10pm began sweating profusely. Complaints of SOB and throat "scratchy". Increased ... Read more
Approximately 1:10pm began sweating profusely. Complaints of SOB and throat "scratchy". Increased respiratory rate noted in the 30's. Breath sounds diminished bilaterally. Gray pallor. Given epi 3mg at approximately 1:15pm with positive response. Transported via ambulance to hospital.
56 2021-01-20 fainting, hypotension Patient was sitting in chair and fainted, would not respond to sternal rub or name. Called rapid res... Read more
Patient was sitting in chair and fainted, would not respond to sternal rub or name. Called rapid response and was taken to ED. Patient was not responding for 2 minutes, proceeded to take vitals and gave him some orange juice in case low sugar. Took vitals and patient had low BP, felt cold, all other vitals were WNL. Taken to ED after about 15 minutes where they ran tests and made sure patient was okay.
56 2021-01-24 chest discomfort, blood pressure increased Feels like onset of pneumonia; Congested; Coughing; Chest is heavy; Increased BP 161/97; A spontaneo... Read more
Feels like onset of pneumonia; Congested; Coughing; Chest is heavy; Increased BP 161/97; A spontaneous report was received from a consumer who was a 56-year-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97. The patient's medical history included post-traumatic stress disorder, depression and asthma. Concomitant product use was not provided by the reporter. On 07-Jan-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 07-Jan-2021 the patient received the Moderna vaccine. On an unknown date, he reported that he felt as if pneumonia was setting in. He stated that he was congested, coughing and had chest heaviness. Additionally, he stated that his blood pressure was elevated to 161/97. Treatment information was not provided. Action taken with mRNA-1273 in response to the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was not provided. The outcome of the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a 56-year-old female patient with medical history of post-traumatic stress disorder, depression and asthma, who experienced events of feels like onset of pneumonia, congested, coughing, heavy chest and increased BP 161/97 after the administration of the first and only dose of mRNA-127 (Lot number unknown, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the events and vaccine administration cannot be excluded. However, the patient has history of asthma and post-traumatic stress disorder which are confounding factors.
56 2021-01-24 chest pain Severe pain that has extended from injection site to chest and shoulder--went to ED for the pain. U... Read more
Severe pain that has extended from injection site to chest and shoulder--went to ED for the pain. Unable to contact employee to get more information.
56 2021-01-27 chest discomfort Moderna COVID vaccine dose 2 received 1/25/21. Started experiencing L arm pain, fatigue, HA, chills,... Read more
Moderna COVID vaccine dose 2 received 1/25/21. Started experiencing L arm pain, fatigue, HA, chills, body aches, chest pressure and SOB on 1/26/21. Could not say whether or not chest pressure and SOB were related to vaccine. Sent to ED same day. ED returned person to work on 1/29/21.
56 2021-01-27 heart rate increased Sudden onset extraordinary sinus congestion (within 4 hours of vaccine). Sinus inflammation and pain... Read more
Sudden onset extraordinary sinus congestion (within 4 hours of vaccine). Sinus inflammation and pain. Increased pulse. Agitated. Difficulty sleeping. Significant decrease in ability to taste and smell.
56 2021-01-27 pallor Patient had left clinic and returned to work. Patient had vertigo episode about 45 min after receiv... Read more
Patient had left clinic and returned to work. Patient had vertigo episode about 45 min after receiving vaccine - became dizzy, multiple episodes of vomiting and diarrhea, pallor. Patient drove back to clinic arrived at 3:10 pm; patient extremely pale, c/o nausea and dizziness, felt anxious and mild fatigue also. Temp upon arrival 97.8 (F). Vital signs as Below: 3:12pm: BP-164/100, P-69, RR-22, PO2-96% 3:16pm: BP-138/96, P-68, RR-22, PO2-95% 3:22pm: BP-144/101, P-74, RR-20, PO2-95% 3:32pm: BP-142/100, P-74, RR-20, P02-97% 3:45pm: BP-117/76, P-70, RR-20, PO2-96% Zofran 1 dose given at 3:25pm, patient laid on side around 3:35pm then seen by in-house provider at 3:54pm. Patient drank small sips of water around 4:00pm and felt better, less nausea and dizziness. Per Dr. patient able to leave with wife as transportation. Patient contacted by Manager that evening and reported feeling better, all symptoms improved. Attempted to contact patient this am - no answer, left message to call back to verify symptoms resolved. Dr. report: Patient was noted to have vertiginous reaction, starting 45 minutes after 1st dose of vaccine with dizziness and nausea. Patient is known to have a history of vertigo. His symptoms resolved within 30 minutes with treatment including rest and Zofran. No further vertigo or other side effects noted. No signs of acute allergic reaction occurred during this period.
56 2021-01-28 oxygen saturation decreased Patient was seen by provider today with symptoms of low oxygenation, malaise, shortness of breath, c... Read more
Patient was seen by provider today with symptoms of low oxygenation, malaise, shortness of breath, cough, congestion, left arm pain where vaccination was received and jaw pain. Patient received Covid vaccine (Moderna) on Tuesday, Jan. 26, 2021. Seen by provider on Friday, Jan. 29, 2021 with symptoms. He was evaluated and it was decided that he be taken to the emergency room for further evaluation and monitoring.
56 2021-02-01 chest pain 22 hours later I got chills, goosebumps, I felt terrible. I felt fatigue, a headache and muscle ache... Read more
22 hours later I got chills, goosebumps, I felt terrible. I felt fatigue, a headache and muscle aches and chest pain. I Went home and laid down. My temp read 102.9. Called a nurse and she was concerned because of my heart condition. come in to the hospital if the chest pain lasts longer than 5 minutes. I didn't go in because I figured I could use a nitroglycerin pill if it got too bad. The following day I had chest pain every few hours or so. the waves of chest pain only lasted about 5 minutes a piece.
56 2021-02-02 fainting Fever, beginning on day after shot, lasted 2 days. The second day after shot he fainted upon standin... Read more
Fever, beginning on day after shot, lasted 2 days. The second day after shot he fainted upon standing up and hit the wall, nausea, fever, fatigue, chills.
56 2021-02-03 heart flutter, palpitations -HEART RACING/HEART FLUTTERS FOR A FEW HOURS DURATION ON JANUARY 29, 1 DAY AFTER VACCINE ADMINISTRAT... Read more
-HEART RACING/HEART FLUTTERS FOR A FEW HOURS DURATION ON JANUARY 29, 1 DAY AFTER VACCINE ADMINISTRATION -FATIGUE LASTING 4 DAYS FOLLOWING COVID-19 VACCINE ADMINISTRATION
56 2021-02-03 palpitations, blood glucose increased Had Expected Sore Arm for 1 Week, Had Flu like Symptoms for 3 Days as expected. Have had Much High... Read more
Had Expected Sore Arm for 1 Week, Had Flu like Symptoms for 3 Days as expected. Have had Much Higher Blood Glucose Readings since Vaccine, On Day 8 Developed extreme GI Issues with Nausea and Watery Diarrhea which is better now at Day 14. Have had Heart Palpations since Vaccine. Then today on Day 14 Developed Rash at Injection Site . My Back Pain has been much more pronounced since Vaccine as well.
56 2021-02-04 cerebrovascular accident Reports that he had pain at the site of injection X2 days; Noted chills and body aches for 2 days
56 2021-02-04 palpitations First dose (Moderna) received 12/30/2020 - reaction 12/31 - 1/1. " Flu like sx: severe fatigue, chi... Read more
First dose (Moderna) received 12/30/2020 - reaction 12/31 - 1/1. " Flu like sx: severe fatigue, chills, SOB, felt like hear racing" : was tested for COVID on 1/6 , reportedly negative & for Flu B . F/u with PCP, who dx'd with 'atypical flu' - sx su,bsequChills,Fatigue
56 2021-02-08 chest discomfort I got the shot at 3pm. I started feeling "off" in stomach/chest around 7-8pm. By 3am, my stomach/che... Read more
I got the shot at 3pm. I started feeling "off" in stomach/chest around 7-8pm. By 3am, my stomach/chest did not feel good at all and I had trouble sleeping. It was definitely not heart related. By 8am I felt chills coming on. By 9am I was fully dressed, with two blankets on, and lying on couch shaking for 20-30 minutes. Later a fever started and it reached about 102.3 before subsiding late afternoon. By 8pm, I felt blah but fever was gone. During that entire time I felt achy overall (similar to what I felt like 2 hours after running a marathon). I didn't have headaches (and rarely do), but area around my eyes were heavy and tired. Weirdly, at times, the top 1/2 of both ears hurt. I experience about every symptom I had as when I had Covid and went to hospital for 26 days except for the breathing issues.
56 2021-02-08 heart attack Died of a heart attack; A spontaneous report was received from a consumer concerning a 56-year-old m... Read more
Died of a heart attack; A spontaneous report was received from a consumer concerning a 56-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died due to a heart attack. 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 additional medications. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. - On an unknown date, the reporter stated the patient received Moderna's COVID-19 vaccine and sometime after he was found dead by his bedside around 02:30 am. The patient died on an unknown date. The cause of death was due to a heart attack. Plans for autopsy were not provided.; Reporter's Comments: This case concerns a 56 year old, male patient, who experienced fatal unexpected event of myocardial infarction. The event occurred on an unspecified date after mRNA-1273 (Lot# Unknown). Treatment details not provided. 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.; Reported Cause(s) of Death: Unknown cause of death
56 2021-02-09 chest discomfort January 31-Feb1 Fever to 102.7, muscle rigidity, spasm and pain, bone pain over entire body lasting ... Read more
January 31-Feb1 Fever to 102.7, muscle rigidity, spasm and pain, bone pain over entire body lasting 7 hours overnight, tylenol 1000mg fever broke and pain subsided. Wanted to call 911. Feb 1st muscle pain increased during the morning and by noon fever of 102.5 with extreme fatigue, tylenol 1000 mg, unable to work. Injection site intense pain radiating down to wrist. Feb1st overnight sweats and bone pain, muscle pain tylenol 1000mg, injection site pain and redness appearing similar to a sunburn near injection site, swelling of lymph nodes under right arm with pain. Headache, moderate to intense. Feb 2nd fever to 100.5 with moderation of the above symptoms. Asthma chest tightness, asthma related productive cough. Tylenol 500mg every 3-4 hours, working from home. Headache continues moderate level. Feb 3rd, no fever all symptoms continue with injection site pain, new increased asthma related wheezing. Tylenol 500 mg every 4 hours. Headache continues with fatigue. Feb 4th, no fever, symptoms moderating, asthma and allergy symptoms increasing. Fatigue increasing. Itching of injection site. Feb 5-current. No fever pain in injection site and lymph node area is moderating, still with Fatigue, Headache, Asthma and allergy symptoms staying steady with period of increased levels. Tylenol 500 mg 6-8 times a day.
56 2021-02-10 heart rate decreased Heart rate dropped to 30; A spontaneous report was received from consumer concerning a 56 year old m... Read more
Heart rate dropped to 30; A spontaneous report was received from consumer concerning a 56 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient's heart rate had dropped to 30. The patient's medical history was organ transplant. Concomitant product use was not provided. On 22-Jan-2021, the patient received the first of two planned doses of mRNA-1273, Batch number 011J20A, intramuscularly for prophylaxis of Covid-19 infection. On an unknown date, the patient's "heart rate was dropped to 30". He was hospitalized for 6 days. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.; Reporter's Comments: This case concerns a 56 year old male patient with relevant medical history of organ transplant who received the first of two planned doses of mRNA-1273 (Batch number 011J20A) intramuscularly for prophylaxis of Covid-19 infection and experienced a serious unlisted event of decreased heart to 30 and was hospitalized for six days. Treatment details not provided. Very limited information regarding this event has been provided at this time which precludes a proper medical assessment and in addition, patient's history of organ transplant may provide an alternative explanation and the event is unlikely related to the vaccine. Further follow has been requested.
56 2021-02-11 heart rate increased Moderna Covid-19 vaccine EUA. Rapid heartbeat, tingling and numbness in extremities, face, tongue, d... Read more
Moderna Covid-19 vaccine EUA. Rapid heartbeat, tingling and numbness in extremities, face, tongue, dizziness, swollen lymph node, blood taste in mouth. I?ve been to the ER three times and they can find nothing wrong with me but I am not well.
56 2021-02-15 ventricular tachycardia, chest discomfort, pallor 1/26/2021: Fatigue, Soreness & headache; Severe chills (0120 a.m.); Body aches, joint pain, nausea/... Read more
1/26/2021: Fatigue, Soreness & headache; Severe chills (0120 a.m.); Body aches, joint pain, nausea/vomiting, pale/cool/diaphoretic skin, chest tightness and lightheaded/Dizziness. Bed rest for remainder of day. 1/27/2021: Continued fatigue, soreness, more lightheaded/dizziness, onset of sustained Ventricular Tachycardia around 1400 hours,Tx at work with Advanced Cardiac Life Support, Emergency Transport to Emergency Room, Amiodarone Drip/Oxygen/IV-TKO,EKG. Emergency Room-Continue Cardiac Care with continued IV drip and Amiodarone. Echo-Cardiogram and admit to Hospital. 1/28/2021: Cont. Hospitalization-Cardiac Cath,monitoring on ICC floor. Hospitalization stay 1/27/2021-02/03/2021. Transfer to another hosp by ambulance. Transferred to Hospital (1/30/21). Further treatment and monitoring. Cardiology tests and procedures (Cardiac MRI, Electro-Physiological Study and defibrillator insertion). Discharged on 2/3/2021. Still under doctor's care during recovery for next 5 weeks and ongoing into the future.
56 2021-02-19 transient ischaemic attack "Moderna COVID-19 Vaccine EUA" Hypersensitivity & fleeting / flowing pains spread throughout left... Read more
"Moderna COVID-19 Vaccine EUA" Hypersensitivity & fleeting / flowing pains spread throughout left side of body from tip of nose across face, up and down neck and left side of head out through fingers of left hand, down left side of back, down left thigh / leg and out through toes of left foot. It was as if the left side of my body was in a different time zone than the right side. I called the nurse line; they suggested a visit to the ER. My BP was way up, and I panicked just a little; but, tried to use my mindfulness practice to observe the unfolding events, rather than being consumed by them. There was a CT of my skull wherein they found indications of "an old" stroke; so, they decided that it was possible I had a stroke. I was transferred from the Medical Center to the Stroke Center at the Medical Center under the care of Dr. Another CT with contrast and a MRI confirmed "OLD" stroke, but nothing new. I was assured the vaccine had nothing to do do with my symptoms, and that I most likely experienced a Trans Ischemic Attack (TIA), and that the situation was merely a coincidence as they believe the vaccine had nothing to do with the TIA. However, based on my personal experience of the events as they unfolded, it is my sincere belief that the vaccine was incidental to the effects as I experienced them. I was kept overnight for further observation, released the next day, and had a follow-up with my primary care physician at the Med Center. I am now taking an 81 mg aspirin, Plavix, and 80 MG Clopidogrel as a precaution, and my symptoms have been gradually fading away.
56 2021-02-22 heart attack Found lying face down without respiration or pulse, believed to be within 5 minutes of event. ACLS ... Read more
Found lying face down without respiration or pulse, believed to be within 5 minutes of event. ACLS procedures unsuccessful. Unable to get autopsy. Believed to be heart attack secondary to COVID infection, but unconfirmed. Relative contribution of recent vaccination unknown.
56 2021-02-25 palpitations, blood pressure increased 15 minutes after vaccine administration, patient reported feeling "his heart pounding" but denied al... Read more
15 minutes after vaccine administration, patient reported feeling "his heart pounding" but denied all other symptoms. Vitals were obtained (HR 72, o2 Sat was 96%, BP 176/102). Pt reported he takes lisinopril daily and normal runs in 120s/80s. Pt remained with nursing staff for additional 15 minutes and vitals rechecked which remained the same. Pt educated on being evaluated at hospital and pt denied. Pt encouraged to call primary care provider. Pt reported to staff he was going to take additional BP med when home.
56 2021-02-25 fainting Episode of syncope approximately 14 hours after receiving the vaccination. Recovered within several ... Read more
Episode of syncope approximately 14 hours after receiving the vaccination. Recovered within several minutes without adverse consequences.
56 2021-03-02 blood pressure increased Pt stated when he left after his 15 minute observation he felt like he had a tickle in his throat. ... Read more
Pt stated when he left after his 15 minute observation he felt like he had a tickle in his throat. He got back to work within a few minutes and his eyes were bloodshot and watery. He began to feel hot and like he had to cough. Fire department was called and arrived within a few minutes and checked pt's B/P and did an EKG that was normal. Pt's B/P was more elevated that normal, "160 systolic over 100 something." Pt stated he took 2 extra amlodipine and worked the remained of the day. That night he began to feel hot, muscle aches, no appetite, and no energy. The next day felt the same symptoms and stayed in his chair all day. On 3/3/2021 he was able to go to work but still had no energy.
56 2021-03-03 loss of consciousness, cardiac arrest According to NJIIS registry, patient received Moderna dose 1 at "Rite Aid 00994" on 3/3/2021. Patie... Read more
According to NJIIS registry, patient received Moderna dose 1 at "Rite Aid 00994" on 3/3/2021. Patient arrived in ED on 3/4/21 at approx 9AM via ambulance. ED physician note: "56-year-old male brought in by EMS intubated with CPR in progress. It was reported that he arrived to work and then passed out. CPR was initiated almost immediately. BLS determined that he was pulseless and AED was applied. He was defibrillated twice. He was then intubated by ALS and administered epinephrine twice with return of spontaneous circulation. He maintained a pulse for approximately 20 minutes when he again developed cardiac arrest. ACLS guidelines were again initiated and there was no return of pulse for approximately 20-25 minutes until he arrived in the emergency department. Emergency department CPR was continued and he was administered an additional epinephrine with return of a pulse. Is reported that he had no complaints prior to the event." Patient was intubated and ventilated, started on norepinephrine drip in ED. Twelve-lead EKG demonstrated right bundle branch block with left posterior fascicular block and diffuse QRS widening and diffuse repolarization abnormalities. Family consented to Cath Lab. Per Interventional Cardiologist note: "1. Angiography demonstrated proximal to mid LAD hazy 90-95% lesion likely culprit for cardiac arrest. 1 stent placed. 2. Diffuse distal right coronary disease that is likely nonculprit for cardiac arrest. 3. Left ventriculography demonstrated severe anterior wall hypokinesis with overall left ventricular ejection fraction of 40%. 4. Patient electrically and hemodynamically stable. Levophed has been stopped. Amiodarone bolus given in the Cath Lab for frequent ventricular ectopy. No drip was continued due to resolution of ectopy. 5. Dyslipidemia he will be on high-dose statin therapy. 6. Diabetic management as per primary team. 7. Quad-Lumen placed by me. Hypothermia protocol to be initiated in the ICU given GCS score less than 8 with no purposeful movements. Head CT scan completed before cardiac catheterization that demonstrated diffuse cerebral edema. 8. Prognosis guarded and likely poor. The next 24 to 40 hours will be critical. Family was updated in detail." Patient transferred to ICU post Cath Lab. Remains intubated, ventilated in ICU.
56 2021-03-07 blood pressure decreased, chest pain, heart rate irregular, oxygen saturation decreased My arm was sore. Then I had fatigue and then at about 14 hours after the injection, I started having... Read more
My arm was sore. Then I had fatigue and then at about 14 hours after the injection, I started having chills - like I had temperature with hot and cold chills. I got very cold; my blood pressure dropped - I happened to have a doctor appt the day following the vaccine - the bottom level was very low of my blood pressure - it was 45. I couldn't warm up - my extremities were very cold. I had chest pain and it felt like my heart rate was going in an out of atrial fibulation. I had shortness of breath. I measured my blood oxygen concentration and had dropped down to 90%. I didn't sleep well because I was so chilled and not feeling well. I felt like I had a bad flu. I rested the next day (10th) the symptoms slowly went away between 10 am and 1:00. At 3:00 pm, I saw my pain doctor and I told him about it but I was feeling much better although blood pressure was low. Fatigue lasted for 3-5 days afterwards but it wasn't anything last the first 24 hours. I didn't go to ER because it seemed to resolve itself in the day.
56 2021-03-08 chest discomfort His arm was swollen and sore, felt like fever in it, coughing until he would strangle. He also had ... Read more
His arm was swollen and sore, felt like fever in it, coughing until he would strangle. He also had really bad headaches, extreme tiredness and not feeling well. Last night he was given Tylenol, which helped him.
56 2021-03-12 blood pressure increased, heart rate increased Three days after the vaccination I started having severe nightmares and vivid violent dreams that pr... Read more
Three days after the vaccination I started having severe nightmares and vivid violent dreams that prevent me from sleeping. They happen 5-6 times a night and each time my body experiences an Adrenaline rush. I jump from my sleep with high pulse and elevated blood pressure. It subsides quickly after I am awake. But then after I fall back to sleep and within one hour, the event repeats. I wake up again and again. The sleep has become very light and filled with violent dreams that I can remember vividly.
56 2021-03-12 body temperature decreased Chills, body aches,flushed face, low temp
56 2021-03-14 heart rate decreased, loss of consciousness, hypotension Client received Moderna vaccine and walked to the monitoring area. A few minutes into his 15 minutes... Read more
Client received Moderna vaccine and walked to the monitoring area. A few minutes into his 15 minutes of monitoring he passed out fell and his head on the floor. Blood pressure 79/40 Pulse 39. He awakened and was able to sit up with help take a few drinks of soda. States he had not ate breakfast. He then stated he started to feel dizziness and wanted to lay back flat on the floor. Blood pressure rechecked and increased to 110/70 with a heart rate on 69. EMSA called and transported him to Medical Center. Followed up with client today and he states they evaluated him in the ER, gave him something to eat and sent him home. States only symptom he has currently is arm soreness.
56 2021-03-15 hypotension, pallor, loss of consciousness Patient became pale, diaphoretic and loss of consciousness. Patient was coming in and out of conscio... Read more
Patient became pale, diaphoretic and loss of consciousness. Patient was coming in and out of consciousness. Patient's wife stated that "he gets this way when he gives blood." Patient's B/P was 90/60, Pulse 160, 02 @ 67% and increase to 81% on nasal cannula @ 12:33. Patient was given 0.3mg Epinephrine auto-injector IM to the right thigh. EMS arrived @ 12:33. Patient was transported to near hospital for evaluation. Today I talked with Patient's wife and she sates , He was released from the hospital yesterday with no complications and he is at home and doing fine with no complications.
56 2021-03-17 blood glucose increased Received vaccine at 1103, 1110 noted decreased responsiveness, color became blue. Lowered to floor c... Read more
Received vaccine at 1103, 1110 noted decreased responsiveness, color became blue. Lowered to floor chest compression given and airway opened. Began to respond, did vomit, was diaphoretic. Was taken to ER, responsive at that time states last he remembers was feeling lightheaded and dizzy like he was going to pass out. Upon arrival to the ER he was diaphoretic, gray in color. C/O L) arm pain where received shot, felt like Charlie horse pain. Cardiologist consulted and ordered patient to be transferred to higher level of care. Was transferred via ambulance on 3/17/21
56 2021-03-20 chest discomfort, heart rate increased 1:00 A.M. early morning on the day after getting the shot I woke up from sleeping. I had fever, chi... Read more
1:00 A.M. early morning on the day after getting the shot I woke up from sleeping. I had fever, chills, rapid pulse (108 bpm normally runs 70), & chest tightness. Almost called ambulance because of the pulse and chest tightness. Within a couple hours of waking up I also began to have muscle cramps in my feet, toes, and thighs. Worse than I have ever experienced and I have been diagnosed with PAD for over 10 years. I tried to get some sleep. I couldn't. My PCP also did not like the way my lungs sounded that morning at the Clinic. I was told after a xray that my lungs were ok. My injection site has been sore until today. It is better. I did have Covid in October 2020.
56 2021-03-21 fast heart rate Tachycardia
56 2021-03-23 loss of consciousness The patient walked back in to the provider area and fell in the hallway. The patient was breathing ... Read more
The patient walked back in to the provider area and fell in the hallway. The patient was breathing with a pulse but was unresponsive for about 10 seconds. The patient then began to wake up and respond to questions. EMS was called initially when the patient was noted to be unconcious. The patient began answereing question and explaining tha the felt light headed and was sweating and wanted to come back in the hallway because he "didn't want to cause a scene in the lobby." The patient was noted to have mild sanguinous drainage on the right forehead around his temple. EMS arrived and assessed the patient and took vita signs. The local EMS took the patient to local emergency department to be evaluated. The patient left in stable condition.
56 2021-03-24 chest discomfort Moderna COVID - 19 Vaccine EUA three days after injection site pain had gone away I started have sin... Read more
Moderna COVID - 19 Vaccine EUA three days after injection site pain had gone away I started have sinus discomfort and joint pain, next day was fatigue not severe/ and continued joint pain. Upper respiratory discomfort and minor cough . Today had trouble sleeping minor headache slight cough Hips and legs pain, Appetite is good I am drinking plenty of fluids. I am taking acetaminophen and ibuprofen for pain as needed.
56 2021-03-25 loss of consciousness, pallor Patient recieved his vaccine at vaccine clinic. During his 15 min post vaccine wait, he lost conciou... Read more
Patient recieved his vaccine at vaccine clinic. During his 15 min post vaccine wait, he lost conciousness and rolled off of the chair onto the floor. Pt was unconcious for approx 5-10 seconds. He woke up and was able to stand and walk with assistance to the treatment area. He was markedly diaphoretic and grey in color. He was oriented to name and location at this time. Reports he did not eat today and drank a beer this morning only. He worked all day, then came for his vaccine. Initial vials as follows: 95/44, Pulse 75, Pulse ox 95% on RA. Dexi 104. temp 97.7 oral. Pt is not a diabetic and denies any heart disease or other medical conditions. He does not have a primary care provider and has not had any check up in years. Given a protein bar, a juice and a bottle of water. Also 1 glucose tablet. He reports he is feeling better. Second set of vitals as follows: 97/59, pulse 80, Pulse 97% on RA. LCTA bil, RRR with no murmurs. Palpated skull, spine and pt denied any pain. No chest pain, difficulty breathing, dizziness or confusion. Second water given. Vitals as follows: 100/60, Pulse 85, Pulse ox 96% on RA. Pt is refusing ambulance. Risks and benefits of EMS evaluation and transport to ER given and pt still refusing x 2. Spoke to supervising nurse who contacted Dr. Dr states pt ok to be monitored if he is refusing the ambulance. Pt will be discharged home under the care of his wife and his daughter. Daughter will drive him home. Dexi repeated: 125. Repeat vitals: 109/67, pulse 77, Pulse ox is 95% on RA. Discussed with patient need to eat a high protein meal, drink plenty of water and get rest. No work tomorrow and no alcohol. Pt has appt with PCP tomorrow at 11 am for an evaluation. Pt taken outside with RN in wheelchair with a 3rd water. Wife at his side. APN
56 2021-03-25 fainting Syncope lasting 2 minutes
56 2021-03-27 heart rate increased Within 30-60 minutes after vaccination he experienced numbness of his lips and face following by rap... Read more
Within 30-60 minutes after vaccination he experienced numbness of his lips and face following by rapid onset of swelling of the lips and face. He then developed a rapid heart beat with shortness of breath. He then developed a lump in his throat with a throat closing sensation with worsening of shortness of breath. He elected to stay home without seeking medical attention. The shortness of breath attenuated over the next few hours but rapid heart rate continued for two more days
56 2021-03-29 palpitations At approximately 11:45 p.m. I began to experience shortness of breath difficulty breathing - my thro... Read more
At approximately 11:45 p.m. I began to experience shortness of breath difficulty breathing - my throat began to swell up - and my heart was racing. Symptoms subsided after 90 minutes-2 hours
56 2021-03-30 cerebrovascular accident stroke
56 2021-04-04 fainting Pt received covid 19 vaccine. Few minutes later, pt was feeling dizzy and syncope. EMS responded to ... Read more
Pt received covid 19 vaccine. Few minutes later, pt was feeling dizzy and syncope. EMS responded to evaluate, however PT's condition was unchanged. Fire/Rescue was called in to assist. Fire/Rescue evaluated PT on scene at 17:25 hours. Pt declined transport.
56 2021-04-05 heart rate increased, pulmonary embolism Leg pain Shortness of breath , rapid heart rate , Dizziness , Nights sweat Symptoms started March 2... Read more
Leg pain Shortness of breath , rapid heart rate , Dizziness , Nights sweat Symptoms started March 24 .Went to Urgent care April 2, they referred me to the ER . I went to the Hospital ER April 6 , They admitted me at noon after finding Blood Clot down my right Leg and Chest . 2 shots of Lovinox for 3 to for days
56 2021-04-05 blood clot, cerebrovascular accident Patient states that he woke up the next day extremely fatigued. About 3pm, he could not move his arm... Read more
Patient states that he woke up the next day extremely fatigued. About 3pm, he could not move his arm/right hand and had trouble walking. He called his doctor's office who told him to call 911. At the hospital, he was given emergency medication for a blood clot. He states the ER told him his stoke was from the covid vaccine.
56 2021-04-10 palpitations Extreme sensitivity to caffeine, body rashes and severe itchiness. Palpitations and skin crawling
56 2021-04-11 cerebrovascular accident Sent patient to the hospital for further evaluation. 911 called. Noted to be sent out for right-side... Read more
Sent patient to the hospital for further evaluation. 911 called. Noted to be sent out for right-sided weakness and re-admitted with a noted diagnosis of stroke.. noted history of HTN
56 2021-04-12 blood pressure decreased Nausea and decreased blood pressure per EMS. Transported to local ER via ambulance. Patient transpor... Read more
Nausea and decreased blood pressure per EMS. Transported to local ER via ambulance. Patient transported to ER via ambulance for evaluation before staff could asses the patient. Evaluation done by MD. (Name) noted 4/13/202 @ 2:45 PM: No telephone number to contact patient for f/u. Sent email requesting a call back.
56 2021-04-12 fainting Patient was given IM dose of Moderna COVID-19 vaccine. Within 2-3 minutes the patient collapsed in h... Read more
Patient was given IM dose of Moderna COVID-19 vaccine. Within 2-3 minutes the patient collapsed in his seat and fainted. Patient was non-responsive for 1-2 minutes then became responsive before intervention was given. 9-1-1- was called and EMS took patient to hospital.
56 2021-04-13 heart failure, oxygen saturation decreased, cardiac arrest Presented to the ER on 3/19 at 23:57 with 2 days of worsening shortness of breath. HR 60, Pulse Ox: ... Read more
Presented to the ER on 3/19 at 23:57 with 2 days of worsening shortness of breath. HR 60, Pulse Ox: 85% on Room air. Placed on BiPAP. could not maintain oxygen, intubated. The patient rapidly decompensated and went into cardiac arrest with PEA. ACLS performed for 35 minutes without the ability to reverse. Patient expired at 0222 on 3/20/21.
56 2021-04-14 cerebrovascular accident 56 year old gentleman with only medical history being COVID-19 infection in October. Admitted on 4/1... Read more
56 year old gentleman with only medical history being COVID-19 infection in October. Admitted on 4/13/2021 for a cerebral vascular accident due to thrombosis of right posterior cerebral artery hemorrhagic conversion (I63.331). Has left-sided weakness. Patient also tested positive by PCR (Panther Aptima) on 4/14/2021.
56 2021-04-14 palpitations, blood pressure increased Approximately 15 minutes after vaccination patient experienced metallic taste in mouth, felt flushed... Read more
Approximately 15 minutes after vaccination patient experienced metallic taste in mouth, felt flushed, heart was racing, sweating, and felt clammy. He was taken to a room to lie down and he reports blood pressure was elevated at 152/110. He was given Benadryl and after approximately 45 minutes his blood pressure went back to normal and patient was feeling well enough to go home. Over the course of 24 hours after the vaccine he felt very achey and at one point had a fever of 103 degrees Fahrenheit, which lasted about 4-6 hours. Patient said he took Tylenol to help with these adverse effects but it did not help very much. Around the injection site he had a bump the size of a ping pong ball and it was red and warm, but the bump completely went away by the fourth day after receiving the vaccine.
56 2021-04-14 palpitations, blood pressure increased Approximately 15 minutes after receiving vaccine patient experienced metallic taste in mouth, felt f... Read more
Approximately 15 minutes after receiving vaccine patient experienced metallic taste in mouth, felt flushed, heart racing, sweating, and felt clammy. Blood pressure was elevated at 142/102. Patient states he drank a lot of water and after approximately an hour and a half of being at the clinic he felt well enough to go home. In the 24 hours after receiving the vaccine, he felt very achy, specifically in the bottoms of his feet. He felt so achy that he could barely walk. He also experienced a fever and did not take anything to help with these side effects because he reports Tylenol does not work for him very well. All adverse effects were gone by 2-3am on 3/14/2021.
56 2021-04-14 blood clot 2nd dose Moderna administered on Feb 3rd, fatigue/ shortness of breath week of Feb 23rd, admitted to... Read more
2nd dose Moderna administered on Feb 3rd, fatigue/ shortness of breath week of Feb 23rd, admitted to Hospital on March 1st, spent 18 days in ICU, developed Blood CLOTS which one attached to lung, blood clots In left leg as well, no family history of blood clots and no injuries to cause blood clots.
56 2021-04-15 blood pressure decreased, loss of consciousness dizziness within 5 minutes, pt moved to chair with arms against wall for support. blood pressure con... Read more
dizziness within 5 minutes, pt moved to chair with arms against wall for support. blood pressure continued to drop and and dizziness increased until pt lost consciousness. Epinephrine administered which resulted in pt becoming alert, once alert pt was given 15ml of hydroxyzine 10mg/5ml and pt then stabilized. pt left with paramedics about 15 minutes later
56 2021-04-15 cardiac failure congestive, low blood oxigenation Previously diagnosed with Covid PNA in 11/2020 that was treated with course of Remdesivir and steroi... Read more
Previously diagnosed with Covid PNA in 11/2020 that was treated with course of Remdesivir and steroids, has 2 negative covid tests in the interim. He received his first Moderna COVID vaccine on 1/4/2021, but did not get the second dose. He had recently been hospitalized at a healthcare provider for COPD/CHF exacerbation was discharged 4/13/2021, returned this morning with URI symptoms, found to by hypoxic with O2 sats in the 80s, encephalopathic, and Covid test was subsequently positive (4/15/2021). Pt transferred that evening to our hospital for ICU level care.
56 2021-04-15 pallor Administered the Moderna COVID-19 vaccine today by IM injection to Left delt. Pt became diaphoretic,... Read more
Administered the Moderna COVID-19 vaccine today by IM injection to Left delt. Pt became diaphoretic, pale, dilated pupils, nauseated, feeling 'unable to focus' at 10 minutes with VS: BP 90/59, HR 40 bpm, resp 22, SpO2 95%. Cool cloth applied. Pt remained in chair with eyes closed until nausea passed within 2 min. Diaphoresis, palor, pupil dilation passed by 30 min but pt cont to feel 'shakey' so staff member was called to evaluate pt. Pt was advised not to have a second Moderna vaccine and was allowed to leave ambulatory at 35 min with BP of 159/96, HR 59. Pt was asked to call office this afternoon with update.
56 2021-04-15 blood clot pain, swelling, tightness and increased temperature in lower right leg
56 2021-04-17 chest pain chest pain Nausea
56 2021-04-18 fainting Patient was administered vaccine approximately around 2:40pm. Patient was sitting down in observatio... Read more
Patient was administered vaccine approximately around 2:40pm. Patient was sitting down in observation area when he fainted and fell out of his chair approximately around 2:50pm. Both pharmacists on duty went to assist patient and technician was instructed to call 911. Pharmacist started one round of compressions. Patient regained consciousness approximately one minute after passing out. It appeared pt hit head during fall. Patient was sweating. EMT arrived shortly after and treated patient. Patient was released by EMT to go home on his own.
56 2021-04-19 blood pressure decreased Sudden loss of blood pressure 6 hours after injection. Dropped me like a stone into the street.
56 2021-04-19 blood clot Blood clot in lower leg. After ultrasound, Doctor gave treatment protocol. Still undergoing treatm... Read more
Blood clot in lower leg. After ultrasound, Doctor gave treatment protocol. Still undergoing treatment course.
56 2021-04-20 heart rate increased Increased heart rate of 150 beats per minute started at 8:30 pm the night of vaccine dose 1.
56 2021-04-20 heart attack heartache, 99% blockage
56 2021-04-21 blood pressure decreased, blood glucose increased patient felt unsteady/ faint Blood Pressure 82/50 Pulse 60/ mon No resp symptoms no rash Patient pl... Read more
patient felt unsteady/ faint Blood Pressure 82/50 Pulse 60/ mon No resp symptoms no rash Patient placed supine for 10 -15 min. Improved and BP 114/80 No postural changes
56 2021-04-21 chest pain Patient care coordinator on PCP team learned of patient death, as documented: TC to pt family for a... Read more
Patient care coordinator on PCP team learned of patient death, as documented: TC to pt family for a welfare ck d/t co-worker mentioned saw in social media pt had passed? PCC-spoke with pt daughter states father passed on 4/18/2021 in the PM unknown exact time of death at home. PCC gave family condolences for their loss. Patient reports father got covid-19 vaccine on 4/13/2021 and he started having severe HA's on this day. Sx increased for the next few days, he had dry cough,sore throat,chest pain,SOB. States father declined for family to called an ambulance while sx were increasing. States ambulance was called on Sunday 4/18/2021 to take body to the morgue. States they are awaiting for autopsy results,and death certificate. States father's body will be taken to his family. On what date did they pass away? 418/2021 unknown time, at home Do you know what the cause was? Family is not sure of cause of death
56 2021-04-22 fainting Patient received first dose of Moderna COVID-19 vaccine. Vaccine given 1511. Patient complained of S... Read more
Patient received first dose of Moderna COVID-19 vaccine. Vaccine given 1511. Patient complained of SOB and sweating. Patient had syncope, urinary incontinence, and nonbloody vomiting. Patient was seen by Dr. and EMS. Patient refused to be transported to ED. Patient's wife drove their car but within 20 yards, car stopped and patient vomited again. Patient re-encouraged to go to ED and got into EMS vehicle but then demanded to be let out and go home. Patient's wife then drove patient home.
56 2021-04-25 chest pain Chest pain in less than 10 hours of shot administered
56 2021-04-26 hypertension I was feeling fine/normal prior to vaccine injection on 4/26/21. In the middle of the night on 4/27... Read more
I was feeling fine/normal prior to vaccine injection on 4/26/21. In the middle of the night on 4/27 I woke up due to severe pain in my right ankle, right knee and right hip. It was a full blown Rheumatoid Arthritis flair up. I couldn't walk, required crutches to move from room to room. Right knee was swollen. Right foot became numb which has not happened to me with previous flair ups. Blood pressure was taken and running high. Called on line doctor and she recommended going to ER. I sent my Rheumotolgist doctor an email. I have yet to hear back. Symptoms began subsiding around 3pm on 4/27. I am able to walk now without crutches. Swelling has subsided in right knee. Right foot is still
56 2021-04-26 fast heart rate pt on 4/26/2021 had episode of svt, resolved with adenosine at outside er. recurrent episode today
56 2021-04-27 chest pain, loss of consciousness 2 minutes after vaccine patient loss consciousness and passed out. Very dizzy with headache, nausea ... Read more
2 minutes after vaccine patient loss consciousness and passed out. Very dizzy with headache, nausea and some chest pain.
56 2021-04-29 loss of consciousness 4/30/21- Pt is a 56yo White male who presented to the Clinic for 1st Moderna vaccine via MyTurn regi... Read more
4/30/21- Pt is a 56yo White male who presented to the Clinic for 1st Moderna vaccine via MyTurn registration. Patient answered No to all of the vaccination screening questions on MyTurn. At 1000, patient was checked in by staff. Immunization was administered approximately at 1002. Around 1007, the clinic providers were called for emergency response by CORE team member who was stationed at the observation area because this patient lost consciousness, fell down, and hit his head. NP arrived to the scene with Emergency Epinephrine pen and benadryl tablets. RN was already at scene and assessed for patient's consciousness. EMS was called by Google volunteer. Patient was seated in the chair, being monitored by the clinic and CORE team member. Pt was unresponsive and actively undergoing tonic seizure-like activity with sustained posturing of bilateral hands in decorticate "cup" position. Patient's eyes were open during entire seizure-like activity, but unresponsive to stimuli. Inflamed abrasions were noted on patient's right temporal lobe, right cheek, and bilateral lower extremities near the knees. No active bleeding was seen. At 1008, Pt regained consciousness after 10 seconds of seizure activity and began to answer RN's questions. Patient stated that he was "fine" and answered that he knew his current location "at the vaccination site." Pt was unaware that he lost consciousness, fell to the ground, and hit his head. Pt denied any active medical illnesses, hx of seizures, or reactions to prior vaccinations. Pt stated that he drove here to the appointment. Patient was given bottle of water, which he started drinking. NP measured pt with pulse oximeter, reading 98% O2 Saturation and 61bpm for heart rate. NP arrived to the scene. The medical staff RN, NP, and NP advised for patient to stay and wait for EMS out of concern for his own safety and the safety of others because he will be driving home. We informed pt that EMS has already been called and for him to stay hydrated while waiting. Pt stated "I do not want to go to the hospital" and refused EMS evaluation. I informed pt that due to sustained head injury, LOC, and seizure activity, we highly advise for patient to seek further medical evaluation. Pt refused and walked away from the observation area to his car. Adverse Reaction was reported to VAERS and CMO of the clinic.
56 2021-04-29 platelet count decreased, nosebleed Patient reported he developed blood blisters on his 3rd and 4th fingers, and thumb on tuesday on 4/1... Read more
Patient reported he developed blood blisters on his 3rd and 4th fingers, and thumb on tuesday on 4/13, and nose bleed, which resolved on its own.
56 2021-05-02 fainting, pallor, loss of consciousness Prolonged syncopal event - loss of consciousness for unknown period of time (not witnessed, but prob... Read more
Prolonged syncopal event - loss of consciousness for unknown period of time (not witnessed, but probably less than 30-60 minutes), followed by severe weakness, unable to stand, pallor, clammy/sweaty, nausea and vomiting, and lightheadedness for approximately 2 hours. Pulse was stable in the 80's-90's, O2 saturation was 96% by finger pulse ox, no focal limb weakness or facial droop. No pain. No shortness of breath. Symptoms mostly resolved and only fatigue remained for the rest of the day, but normal activities could be resumed.
56 2021-05-03 chest pain, hypotension EMS evaluated patient after he reported dizziness, chest pains, sweating, and chills. His blood pres... Read more
EMS evaluated patient after he reported dizziness, chest pains, sweating, and chills. His blood pressure was taken and recorded as 66/39, then 85/55, then 127/55.
56 2021-05-03 loss of consciousness, blood pressure decreased passing out; blood pressure of 70/40; Feeling hot; Sweaty; Dizziness; Lethargy; Sore arm; Achy all o... Read more
passing out; blood pressure of 70/40; Feeling hot; Sweaty; Dizziness; Lethargy; Sore arm; Achy all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passing out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passing out) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over). On 21-Apr-2021, LOSS OF CONSCIOUSNESS (passing out) had resolved. At the time of the report, BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Patient reports that paramedics had to come after he passed out. Treatment of the events included acetaminophen. Company comment: This case concerns a 56-year-old male with a serious unexpected event of loss of consciousness, and nonserious unexpected blood pressure decreased, feeling hot, hyperhidrosis, dizziness, lethargy and expected pain in extremity. Event onset the same day 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.
56 2021-05-04 skin turning blue, blood pressure decreased Patient was given the Moderna covid 19 vaccine on the morning of Saturday May 1. His wife came in to... Read more
Patient was given the Moderna covid 19 vaccine on the morning of Saturday May 1. His wife came in to the pharmacy today (5/5/21) and explained his adverse reaction which started Sunday evening. His symptoms included high temp (102.8), confusion, blue lips, bad headache, decrease in blood pressure He was taken by his wife to local hospital then transferred to another facility. His wife said he had sepsis. He was treated and released from hospital. She said he still had a headache.
56 2021-05-04 hypertension 10:35 WAS SWEATING SITTING IN CHAIR IN POST VACCINE AREA. C/O DIZZINESS, NAUSEA. NO HIVES, NO SWEL... Read more
10:35 WAS SWEATING SITTING IN CHAIR IN POST VACCINE AREA. C/O DIZZINESS, NAUSEA. NO HIVES, NO SWELLING OF FACE, NO SOB. 10:40 BP 168/90 P 80 R 18 CHEST CLEAR GOOD AERATION GAVE WATER ,POWERADE, STAYED RESTING IN CHAIR OFFERED COT, DID NOT WANT TO LAY DOWN 10:47 BP 138/90 80 R 18 HAS HYPERTENSION DID TAKES MEDICATION AT NIGHT ATE CEREAL FOR BREAKFAST 10:47 FELT BETTER, NO LONGER NAUSEATED NOR DIZZY 11:00 AM AMBULATED WITH STEADY GAIT ACCOMPANIED BY LINE FLOW TO HIS SISTERS CAR WHO DROVE HIM TO THE VACCINE SITE.
56 2021-05-05 deep vein blood clot, chest pain, pulmonary embolism Pt was walking up a gentle hill, felt chest pain radiating to both shoulders, pt was driven to ER an... Read more
Pt was walking up a gentle hill, felt chest pain radiating to both shoulders, pt was driven to ER and diagnosed with a massive bilateral saddle pulmonary emboli with right heart strain. No prior history of lower extremity DVT. Inpatient admission. Pt was discharged on 3/22/21 and follow up with PCP and ONC for blood thinner medications.
56 2021-05-06 blood pressure increased My blood pressure was elevated after the first dose of Moderna for about 9 days, going from 150/100 ... Read more
My blood pressure was elevated after the first dose of Moderna for about 9 days, going from 150/100 to 175/115 first thing in the morning, with a pulse of 65 (my BMI is normal, 165 lbs. and 5'11"). I also experienced a slightly uncomfortable pressure , like a small pulled muscle, in my left armpit, that went away about the same time the BP dropped back down to my typical readings.
56 2021-05-06 deep vein blood clot Pt developed R calf and knee pain about 24 hours after his first dose of the Moderna Covid vaccine. ... Read more
Pt developed R calf and knee pain about 24 hours after his first dose of the Moderna Covid vaccine. We saw him first on 5/4/21 and he had a R LE doppler which showed a deep vein thrombosis in his Right posterior tibial vein.
56 2021-05-08 heart rate increased Racing heartbeat (143-157 bpm) waking from sleep.which lasted approximately 30 min. Consulted primar... Read more
Racing heartbeat (143-157 bpm) waking from sleep.which lasted approximately 30 min. Consulted primary Dr office. They did EKG and sent me to hospital emergency room. I was admitted for overnight stay. Ultrasound and catheterization procedure was done. No blockages or issues found. No previous issues know. Last nuclear stress test was done in 2017 with no issues found. Currently on 24 hr heart monitoring.
56 2021-05-10 heart attack, nosebleed, loss of consciousness sometime between 4:30 and 5:00 PM (1-1.5 hours after the vaccination) Patient felt bad and went to t... Read more
sometime between 4:30 and 5:00 PM (1-1.5 hours after the vaccination) Patient felt bad and went to take his BP with a monitor. He passed out before he took it and woke up face down in carpet with a bloody nose and had urinated on himself. He called his daughter for help. Upon her arrival, he passed out several times, complained of severe headaches, had severe vomiting, has trouble breathing, pain shot up up his neck and face, his BP reading was around 83/60 with a heart beat of 45. The Ambulance service arrived an confirmed he was having an active stemi heart attack. He was taken to hospital where the heart attack was confirmed again and he was taken immediately to the Cath Lab to have a stent placed. He was placed in ICU
56 2021-05-11 cerebrovascular accident Patient came to vaccine site on 4/23/21 to get second COVID Moderna vaccine. He reported a stroke a... Read more
Patient came to vaccine site on 4/23/21 to get second COVID Moderna vaccine. He reported a stroke a day after his previous 1st dose Moderna on 3/24/21. He was hospitalized with stroke and seizures. He has a history of uncontrolled diabetes, high cholesterol, and triglycerides. He smokes and has a history of cirrhosis. Dr. spoke with the pt and approved the second dose administration. No reactions documented following the vaccine.
56 2021-05-11 pulmonary embolism diagnosed with bilateral Pulmonary Emboli on 5/11 (8 days later). Patient had immediate fatigue, mya... Read more
diagnosed with bilateral Pulmonary Emboli on 5/11 (8 days later). Patient had immediate fatigue, myalgias and shortness of breath on exertion the day following his vaccination until the diagnosis of PE.
56 2021-05-11 fainting Patient had second Moderna covid vaccine on 5/10/2021 at 10:30 am, the following day he was fatigued... Read more
Patient had second Moderna covid vaccine on 5/10/2021 at 10:30 am, the following day he was fatigued with chills when he then became dizzy and had a syncopal episode 5/11/2021 at 8:30 am.
56 2021-05-13 chest discomfort, inflammation of the pericardium, chest pain Minor chest pain start 22:30. At 13:00 on 05/09, pain quickly Increased to Severe Chest pressure wi... Read more
Minor chest pain start 22:30. At 13:00 on 05/09, pain quickly Increased to Severe Chest pressure within 15 min . EMS dispatched. Initially treated as possible heart attack with aspirin and nitro with no results. Pain stable and controlled in approx. 4 hrs with Morphine. Acute Pericarditis diagnosed. Released 05/11 approx . 19:00 hr. Follow up treatment with Ibuprofen and Mitigare.
56 2021-05-17 blood pressure increased, hypertension My blood pressure has increased significantly since my second vaccine shot.
56 2021-05-23 blood glucose increased patient had moderna covid vaccine on 4-26-21, administered in his left arm. He states that within a... Read more
patient had moderna covid vaccine on 4-26-21, administered in his left arm. He states that within a week he started having pain in his left foot that eventually moved up to just below his knee. This included swelling. He saw his physician, who began treating him for gout. His also said that he felt off and insisted that his doctor checks his blood sugar, although he had no previous issues with his blood sugars. He came back at a 241. He is now taking allopurinol and metformin. The pain and swelling in his left leg is subsiding now. He did go thru one period of 4 days where he said he could not stand on his left leg. He was due for his second shot today, 5/24/21, but chose not to out of caution, until his doctor figures out what is going on. Also, his dietician recommended he not get the vaccine at this time
56 2021-05-24 chest pain A friend texted me today at 1231 on 1-11-21 asking me how I was doing following the COVID vaccinatio... Read more
A friend texted me today at 1231 on 1-11-21 asking me how I was doing following the COVID vaccination given 10 Jan 21 which we both received. In subsequent texts he disclosed that he was had difficulty sleeping last night due to fever and 7/10 chest pain. He took motrin 800mg and ½ of a Percocet, but did not relieve chest pain. He denied any SOB and he described his pulse as wnl. He also noted dizziness, sweating and left arm pain. He denied hx of HTN, but did relate a history of dyslipidemia which he felt was controlled. I then contacted him by phone and he verified his text messages. As he is over 50 yo and has symptoms suggestive of an Acute Coronary Syndrome he was advised to take aspirin and call 911...He was seen at Hospital, ER on 1-11-21. A mediastinal mass was noted on imaging. This mass was initially thought to be the cause of his chest pain and not related to his Covid vaccination. He was later seen by a thoracic surgeon with follow-up imaging showing significant decrease in the size of the mass raising the possibility in may be inflammatory or infectious in nature. He continues to be followed and has not had any surgeries for this condition. His thoracic surgeon is: MD thoracic surgery Specialized cancer program Hospital Name of a cancer institute Listed Address Listed phone number and fax number
56 2021-05-25 blood clot Patient received first dose Moderna vaccine on 3/31/2021. Approximately two weeks after receiving t... Read more
Patient received first dose Moderna vaccine on 3/31/2021. Approximately two weeks after receiving the first Moderna vaccine patient states he started to have pain in the lower leg which was not normal. Pain increased to a point that patient seeked care and was evaluated for a blood clot which he was told was "negative" as no clot was initially found. On 4/28/2021 Patient presented to pharmacy to receive second dose. Pharmacist asked how patient tolerated first dose to which he replied he had no issues, so the second dose was administered. AFTER the second dose, patient did state he was seen by a CNP for leg pain but a clot was ruled out. Approximately 3 weeks after the second dose of Moderna vaccine the patients leg pain increased to a point that he presented to the local ER and it was determined at that visit that he did indeed have a large blood clot in the leg and a second smaller clot in the upper thigh. He was sent home on Eliquis. He subsequently presented to another ER approximately one week later for uncontrolled leg pain due to massive size of blood clot in leg. At this point, patient is at home recovering.
56 2021-05-27 blood glucose increased Patient tolerated well at the time of documentation. Patient will wait for 30 minutes due to history... Read more
Patient tolerated well at the time of documentation. Patient will wait for 30 minutes due to history of severe reaction to PCN during childhood. Patient scheduled for second dose on June 25, 2021 At 11:47 (12 minutes post injection) patient started experiencing dizziness. Patient stated he's diabetic and did not take his medication morning or eat this morning. Blood sugar checked - 200. another HCP came to evaluate patient. Pt declined snack and declined to lie down. Patient given 25mg Benadryl at 12:00pm At 12:05pm Patient stated dizziness very slightly improved. Patient offered and accepted snack. Will continue to monitor. 12:10pm B/P 157/82, HR 64, SPO2 97% on RA, RR 16 12:20pm Patient stated he's feeling much better have eating snack and drinking water. Patient stated "it's there a tiny bit". 12:35pm Patient ambulated to restroom, unassisted, steady gate. Patient stated he's now "feeling great!" 12:45pm Updated the doctor that patient states he feels great. No dizziness, ambulated to restroom with steady gate. Doctor stated patient could leave since symptoms have resolved and wanted patient reminded to have his labs done. Patient stated since he's currently unemployed, his funds are restricted, but will get them done as soon as he can. 12:50pm Patient ambulated to exit with steady gate
56 2021-05-27 cerebrovascular accident patient had 2nd dose moderna vaccine and 2 days later developed dizziness followed by numbness left ... Read more
patient had 2nd dose moderna vaccine and 2 days later developed dizziness followed by numbness left upper extremity and then fine motor difficulty left hand.
56 2021-05-28 loss of consciousness passed out, faint; Bad dry cough; fell and his head hit the concrete; This spontaneous case was repo... Read more
passed out, faint; Bad dry cough; fell and his head hit the concrete; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out, faint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G26-B21A and G17-C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Past medical history included, smoking for 30+ years and vaping for past two years. The patient's past medical history included Ex-smoker. Concurrent medical conditions included Vapor cigarette smoker. Concomitant products included BENZTROPINE [BENZATROPINE], FLUOXETINE, TAMSULOSIN, CLONAZEPAM, AMLODIPINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication. On 05-Apr-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 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out, faint) (seriousness criterion medically significant), COUGH (Bad dry cough) and FALL (fell and his head hit the concrete). On 12-May-2021, LOSS OF CONSCIOUSNESS (passed out, faint), COUGH (Bad dry cough) and FALL (fell and his head hit the concrete) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Negative. Treatment information included, an inhaler to help with the "lungs and stuff", cough syrup for a night was provided. Very limited information regarding these events has been provided at this time. No follow up is possible. This case was linked to MOD-2021-139015 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
56 2021-05-31 chest pain Short term (6-10 hours) low grade fever after first dose. Vomiting, fever (100-102.5) for 2-3 days a... Read more
Short term (6-10 hours) low grade fever after first dose. Vomiting, fever (100-102.5) for 2-3 days after second dose; difficulty breathing. Four weeks after second dose, chest pain, low-grade fever, and difficulty breating.
56 2021-05-31 loss of consciousness Passing out, dry cough so bad that he would faint; Stood up to cough, passed out, and fell and his h... Read more
Passing out, dry cough so bad that he would faint; Stood up to cough, passed out, and fell and his head hit the concrete; Head hit the concrete floor, hitting head on floor; Bad, dry cough; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G17-C21A and G26-B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker (30+ years of smoking.) and Vapor cigarette smoker (vaping the past two years.). Concomitant products included BENZTROPINE [BENZATROPINE], FLUOXETINE, TAMSULOSIN, CLONAZEPAM, AMLODIPINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication. On 05-Apr-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 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) (seriousness criterion medically significant), FALL (Stood up to cough, passed out, and fell and his head hit the concrete), HEAD INJURY (Head hit the concrete floor, hitting head on floor) and COUGH (Bad, dry cough). On 12-May-2021, LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) and COUGH (Bad, dry cough) had resolved. At the time of the report, FALL (Stood up to cough, passed out, and fell and his head hit the concrete) and HEAD INJURY (Head hit the concrete floor, hitting head on floor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Went to get tested for COVID-19 due to dry, bad cough and came back negative. The patient stated that approximately one week after the first dose, he was having a bad dry cough. The dry cough was so bad that when he was sitting on recliner he would cough so bad, he would faint and pass out. One time the patient stood up to cough, passed out, and fell and his head hit the concrete floor. He went to emergency department three times because of this cough. On 12 MAY 2021, the patient stopped experiencing coughing and passing out. The patient also stated that he has no other side effects and that his healthcare provider thinks this experience was attributed to the first vaccine. Patient was prescribed an "inhaler" from his healthcare provider to help with "lungs and stuff." The patient also has an appointment with a pulmonologist in June. Action taken with mRNA-1273 in response to the events was not applicable. Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use. The other events are temporarily associated with the product use and a causal relationship cannot be excluded This case was linked to MOD-2021-138832 (Patient Link).; Sender's Comments: Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use. The other events are temporarily associated with the product use and a causal relationship cannot be excluded
56 2021-06-02 pallor Rash that was red, flat, blanching, itchy, covered about half my body. I took Zyrtec and the intens... Read more
Rash that was red, flat, blanching, itchy, covered about half my body. I took Zyrtec and the intensity of rash/itchiness seemed to decrease. The rash/itchiness migrated over several days, some days on legs, some days on trunk, less on arms. It resolved after 3-4 days.
56 2021-06-03 blood pressure increased After receiving his vaccine at 1020, patient c/o dizziness and lightheadedness at 1037, reporting he... Read more
After receiving his vaccine at 1020, patient c/o dizziness and lightheadedness at 1037, reporting he had similar mild side effects with the first dose. VS monitored, initially exhibiting elevated BPs. The following VS were obtained throughout monitoring: 1037 BP149/85, HR 69, O2 Sats 100% 1040 BP 133/67, HR 70, O2 sats 100% 1043 BP135/67, HR 75, O2 sats 100% 1048 BP 133/72, HR 73, O2 sats 99% 1055 BP 131/72, HR 69, O2 sats 97% 1105 BP 122/77, HR 67, O2 sats 97% Patient was given a bottled water. No meds given. Patient just monitored for extra minutes with final VS as follows: BP 122/77, HR 67, O2 sat 97%. Pt discharged in stable condition accompanied by spouse.
56 2021-06-09 palpitations I had heart palpitations, mostly at night but occasionally during the day, for approx. 3 weeks. The... Read more
I had heart palpitations, mostly at night but occasionally during the day, for approx. 3 weeks. The palpitations have gone away and have not reoccurred.
56 2021-06-13 troponin increased, heart flutter, atrial fibrillation, chest discomfort, palpitations Dizziness, "flutters" (heart palpitations), chest heaviness, short of breath.
56 2021-06-15 pulmonary embolism, chest pain Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA for shortness of breath and chest pain, on... Read more
Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA for shortness of breath and chest pain, on June 1st. Diagonosed with Pulmonary Embolism in Right Lung. Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA on June 14th for shortness of breath and chest pain, later diagnosed with a Heart Block
56 2021-06-16 blood glucose increased Patient is a 56 year old male who has completed a 15 minute observation period with the following si... Read more
Patient is a 56 year old male who has completed a 15 minute observation period with the following signs and symptoms of an adverse reaction: dizzyness . #1 in series administered. Vitals: 06/17/21 1714 06/17/21 1725 06/17/21 1745 06/17/21 1809 BP: 115/77 117/78 128/78 111/75 Pulse: 79 88 90 75 Resp: 15 18 15 18 SpO2: 96% 96% 96% 97% Action(s) taken: monitored for 45min. No improvement. refused to go to ED or urgent care. Still feels dizzy, advised to go to ED. Patient agreed.Called paramedics. Blood sugar checked,445. Sent to ED Patient advised to discuss second dose considerations with a clinician and have a driver for 2nd dose appt
56 2021-06-17 chest pain, oxygen saturation decreased Can't even walk; Couldn't catch his breath; fatigue; Acute hypoxy respiratory failure; Pleuritic che... Read more
Can't even walk; Couldn't catch his breath; fatigue; Acute hypoxy respiratory failure; Pleuritic chest pain; Red ithcy eyes; HS pneumonitis; Decreased level of conciousness; ILD; non necrotizing granuloma; Flushing; Pulse ox reading in the 70's; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No adverse event reported. The patient's past medical history included Type 2 diabetes mellitus. Previously administered products included for an unreported indication: Accupril in 1996 and Accupril. Past adverse reactions to the above products included Ankle swelling with Accupril; and Knee swelling with Accupril. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Blood pressure, METFORMIN, SERTRALINE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), IBUPROFEN, TADALAFIL (CIALIS), INSULIN LISPRO, CALCIUM, COLECALCIFEROL (CALCIUM VITAMIN D) and INSULIN GLARGINE (BASAGLAR KWIKPEN) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's) (seriousness criterion medically significant), GAIT INABILITY (Can't even walk) (seriousness criterion hospitalization), DYSPNOEA (Couldn't catch his breath) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Acute hypoxy respiratory failure) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Pleuritic chest pain) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red ithcy eyes) (seriousness criterion hospitalization), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis) (seriousness criteria hospitalization and medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness) (seriousness criteria hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (ILD) (seriousness criteria hospitalization and medically significant), PULMONARY GRANULOMA (non necrotizing granuloma) (seriousness criterion hospitalization) and FLUSHING (Flushing) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 02-Apr-2021 due to CHEST PAIN, DEPRESSED LEVEL OF CONSCIOUSNESS, FLUSHING, HYPERSENSITIVITY PNEUMONITIS, INTERSTITIAL LUNG DISEASE, OCULAR HYPERAEMIA, PULMONARY GRANULOMA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: 7.6. 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 While hospitalized, the consumer was started on 100mg Prednisone, now at 60mg of Prednisone, calcium, vitamin D, insulin lispro, protonix, bactrim, and is currently on oxygen. Concomitant medications Glucometer, Insullin pen and Lansets. Company Comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09/6/21: New event added: Acute hypoxy respiratory failure, Pleuritic chest pain, Red ithcy eyes, HS pneumonitis, Decreased level of consciousness, ILD, non necrotizing granuloma and Flushing.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.
56 2021-06-17 heart rate irregular Arthritis type pain in all joints that has persisted since the day of the vaccine. Ibuprofen does no... Read more
Arthritis type pain in all joints that has persisted since the day of the vaccine. Ibuprofen does not help. Sporadic periods of rapid and irregular heartbeat since vaccine Swelling in lower legs since vaccine
56 2021-06-19 inflammation of the pericardium, chest pain Pericarditis with chest pain, fever. Treated with colchicine and improved after 2 days
56 2021-06-20 chest discomfort Felt weak, shortness of breathe, heaviness in chest
56 2021-06-21 heart rate increased Blurred vision head ache fast heart beat
56 2021-06-21 heart rate irregular, chest discomfort, heart rate increased, fast heart rate RAPID / ERRATIC HEARTBEAT, LIGHT HEADED, CHEST DISCOMFORT LASTING ABOUT 4 HOURS 3/23 PRIMARY CARE P... Read more
RAPID / ERRATIC HEARTBEAT, LIGHT HEADED, CHEST DISCOMFORT LASTING ABOUT 4 HOURS 3/23 PRIMARY CARE PROVIDER APPT 4/8 RAPID / ERRATIC HEARTBEAT, LIGHT HEADED, CHEST DISCOMFORT LASTING ABOUT 1 HOUR 4/22 CARDIOLOGIST APPT 4/23
56 2021-06-22 chest pain, heart rate increased, fainting, inflammation of the heart muscle, atrial fibrillation, inflammation of the pericardium Chest Pain - Heart Attack like, Dizziness, Nausea, Fainting, and eventually AFIB. First emergency ... Read more
Chest Pain - Heart Attack like, Dizziness, Nausea, Fainting, and eventually AFIB. First emergency room visit was via ambulance on May 3, 2021 approximately 3 weeks after firs vaccination. 1st vaccination date was May 14 at 9:30AM. Was transported by ambulance as heart attach symptoms were severe. Monitored by EKG and in emergency room cardiac unit for the day. Ran two blood tests and troponin levels were acceptable so released at approximately 6:00 PM. Second event was two days after receiving second vaccination. Vaccination occurred on May 19 at 9:00 AM and was again transported to the hospital with Heart attack symptoms at 10:00 AM on Friday May 21. Monitored by EKG and in emergency room cardiac unit for the day. Ran two blood tests and troponin levels were acceptable. Prescribed a Heart Monitor for 14 days and released at approximately 5:00 PM. Third occurrence was Monday May 31. Heart attack symptoms chest pain, accelerated heart rate. Went into AFIB. Transported to Hospital. (Morton Plant). Verified AFIB reading by heart monitor. Admitted to the hospital for two days. EKG monitors, Blood tests. Released Tuesday at 4:00 PM. Prescribed Multaq by on call Cardiologist to prevent AFIB. Met with Cardiologist Monday June 7th. Diagnosed as Pericarditis or myocarditis. Prescribed Mutlaq for the AFIB, Indomethacin for anti inflammatory and Low dose aspirin for stroke and blood thinner. Recover expected to be Long.
56 2021-06-22 inflammation of the pericardium Pericarditis and ended up in the Hospital twice. Once to the emergency room on March 8th, 2021 and a... Read more
Pericarditis and ended up in the Hospital twice. Once to the emergency room on March 8th, 2021 and again onMarch 17th-19th with a diagnosis of Pericarditis. First hospital stay was at hospital and then at Hospital on 3/17.
56 2021-06-29 cerebrovascular accident lost short term memory temporally; sight was affected; Mild stroke/that affected the area of the bra... Read more
lost short term memory temporally; sight was affected; Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory; teeth were chattering/chills; fever; headache; a numbness in the jaw and his hand; lips tingling; left arm was weak; arm were tingling and left arm was tingling; face was red; felt like crap; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History details provided. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (a numbness in the jaw and his hand), PARAESTHESIA ORAL (lips tingling), MUSCULAR WEAKNESS (left arm was weak), PARAESTHESIA (arm were tingling and left arm was tingling), ERYTHEMA (face was red), FEELING ABNORMAL (felt like crap), PYREXIA (fever) and HEADACHE (headache). On 18-Apr-2021, the patient experienced CHILLS (teeth were chattering/chills). On 08-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced AMNESIA (lost short term memory temporally) and VISUAL IMPAIRMENT (sight was affected). The patient was treated with ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency and CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency. On 17-Apr-2021, HYPOAESTHESIA (a numbness in the jaw and his hand), PARAESTHESIA ORAL (lips tingling), MUSCULAR WEAKNESS (left arm was weak) and PARAESTHESIA (arm were tingling and left arm was tingling) had resolved. On 18-Apr-2021, ERYTHEMA (face was red), FEELING ABNORMAL (felt like crap), PYREXIA (fever) and HEADACHE (headache) had resolved. On 20-Apr-2021, CHILLS (teeth were chattering/chills) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: stroke (abnormal) stroke. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. Patient taking unknown medications for anxiety. Patient was admitted to a clinic one afternoon on an unknown date ,had a cat scan and was overnight in observation. The next day he was discharged. Following week he had MRI, Battery of tests to his heart: to his carotid arteries are being done,"bubble test", he is wearing a 30-day monitor; they will also be performing a sleep apnea test. Based on the current 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.
56 2021-07-07 heart rate increased Heart rate elevated to 188 hours after receiving the vaccine. Normally ranges around 55-60.
56 2021-07-10 pulmonary embolism, palpitations 5/15/21 - 2nd Moderna shot given to me. No reaction 1st 15 minutes. 5/15/21 - small fever in t... Read more
5/15/21 - 2nd Moderna shot given to me. No reaction 1st 15 minutes. 5/15/21 - small fever in the evening 5/16/21 In bed all day with Fever and Fatigue. 5/20/21 Becoming short of breathe going upstairs in my residence. Complained to my wife after a couple of days saying I was getting winded just climbing the stairs. I thought maybe it was common chest cold. 5/29/21 1:00 am - woke up to 102 degree fever. Fever went down to 99 and up to 100.8 over the next 4 days cycling throughout the day and night. Shortness of breath was getting a little worse and it would take 10 seconds to recover going up the stairs in my home, after several deep breathes. June 1st, I went to CVC pharmacy to take a COVID19 test. The scheduled me for the next morning, June 2, 2021 at 10:00 am. I completed that test and returned home. At about 2:00 - 2:30 pm, I stood up from the couch and walked out to my front porch. I bent over to pick up some light items from the porch so the gardener could trim the bushes near the porch. As I walked to the garage (main front 2 car entrance), I suddenly became very short of breathe, my heart began racing, and I could not get a full breathe. I walked slowly inside my house and used my blood pressure cuff and oximeter. Blood pressure was at 170/121 heart rate 112, and the oximeter showed oxygen level 75 %SPo2 with heart rate 110. I was taken directly to the Emergency Room where X-ray and CT scans showed I had numerous blood clots throughout my lung arteries. I am on oxygen and blood thinners for an indefinite amount of time.
56 2021-07-12 palpitations, atrial fibrillation I had a Lifeline screening ( they did an EKG and a Carotid and Blood tests on me) after the vaccin... Read more
I had a Lifeline screening ( they did an EKG and a Carotid and Blood tests on me) after the vaccine- I got a odd reading on a c-reactive protein - inflammation and infection in the body - Can get those records from them. Started taking my blood pressure and I noticed thing weren't right with my heart. I went to my doctor his office clinic they are moving their office, though next month) with a federally funded program for the testosterone replacement therapy- he had give me testosterone replacement therapy which I have since stopped with recommendation by the cardiologist - it makes my blood very thick ) and he told me I had A-Fib - gave me samples of Xarelto and he said to come back on Monday and confirmed the A-Fib. doctor cardiologist and he confirmed A-Fib and recommended a procedure - to reset the heart with the paddles - I haven't done that yet. Since then, I have had chronic fatigue, heart palpitations, difficulty breathing; I think it's related to my heart. I am taking naps every day. I wake up and I'm just wasted. I go run errands and then I'm exhausted. Chronic fatigue. I will be seeing my brand new primary care doctor on Thursday and I want to talk to Doctor provided me with a whole bunch of diagnoses for all of it. They are saying on the diagnoses paperwork that I could have "blood cancer." But it could come from TRT treatment. Dental at first and then went to Affordable Dental - Periodontal work done - there was an infection there and they gave me antibiotic mouthwash. I will be going back in three months. I have not recovered from A-Fib - have to get Cardio Version test and I have chronic fatigue - it comes and goes. The blood cancer - I haven't had a chance to talk to anyone about it yet and no one has been in touch with me about it. I went to Hospital ER the other day - mostly to get a more accurate diagnosis - I do have chemical disorder history in past. I had mental confusion - it was chemical - it was just like what I had in 2000. But hospital misdiagnosed it.
56 2021-07-12 pulmonary embolism, fibrin d dimer increased, chest pain He presented to the emergency room at Hospital 4/16/21 with chest pain and shortness of breath. D-di... Read more
He presented to the emergency room at Hospital 4/16/21 with chest pain and shortness of breath. D-dimer was elevated. Bilateral pulmonary embolism diagnosed by CT 4/16/21
56 2021-07-12 blood clot I received dose 1 on 3/19/21 at 10:30 AM. I went on with my day and evening and noted no issues. The... Read more
I received dose 1 on 3/19/21 at 10:30 AM. I went on with my day and evening and noted no issues. The next morning I woke with lower leg pain in my R leg. I thought it may be a pulled muscle as I work out at a gym 5 days a week. The pain persisted as did some swelling in my lower leg so I sought out a medical opinion thinking it may be a torn muscle. I was finally able to get in to see a DR. on 4/1/2021 at which time an ultrasound was ordered which showed multiple blood clots in my R leg (Ankle, Calf and behind the knee). I was immediately placed on XARELTO. I have never had any issues before with clotting. Dr. referred me to Oncologist. Dr. examined me and the ultrasound test results and agreed with the assessment. I have follow a up scheduled with both doctor's. I have been on XARELTO since. I did get the second COVID shot because both doctor's could not agree as to if I should or should not get it.
56 2021-07-14 blood glucose increased, chest pain, troponin increased, fainting, loss of consciousness, hypotension, chest discomfort 7/5/21 ER HPI: 56 y.o. male who presents with complaint of syncopal episode about 1.5 hr ago that ha... Read more
7/5/21 ER HPI: 56 y.o. male who presents with complaint of syncopal episode about 1.5 hr ago that happened at home. Patient said he woke up to fix sandwich and felt like his blood sugar was low, sat down to check his blood sugar and passed out for unknown length of time. Patient complained of some chest pressure left lower anterior chest without radiation. No cough or shortness of breath, no nausea or vomiting, no headache or dizziness, no abdominal pain. Patient blood pressure was low 88/64. Discharged home 7/13/21 ER to inpt admission: 56 y.o. male with a past medical history of ischemic cardiomyopathy status post biventricular ICD, CAD with last stent placed 11/2020, atrial fibrillation on Xarelto, insulin-dependent diabetic who presents to the ED with chest pain. Patient states that he has had some episodes of low blood pressure in the past. Last week he had an episode of low blood pressure and a syncopal event. He states that he was seen on July 5th in Hospital ED where he was hypotensive. He states that since this event he has been quite felt right. He states that this evening he was watching TV and started feeling bad. He took his blood pressure and it was 146/113 on his home monitor. He states that he was sweating, having chest discomfort and epigastric pain. He states that his chest pain was a 4 to 5/10 when it occurred. He was having a little bit of nausea but no vomiting. He states that he kept on feeling well therefore he took 4 baby aspirin and nitro. He states that the nitro seemed to improve his chest pain. He states that now his pain is just a mild discomfort. He states that this is not similar to any of his previous chest pain. He denies any abdominal pain, shortness of breath, swelling. He states that he follows with the Dr. at the hospital. In the ED, vital signs showed a blood pressure 115/76 temperature 97.8, pulse 84, respiratory rate 18, SpO2 94%. CBC is unremarkable. CMP shows a glucose of 178, creatinine 0.7, sodium 137, potassium 4.0 (hemolyzed). Troponin is 11. EKG shows normal sinus rhythm at 81 beats per minute, QTC 420. Patient was given nitroglycerin patch in the ED. Patient was admitted for further evaluation and management of his chest pain.
56 2021-07-19 heart attack Death. Body was found and pronounced dead on 6/14/2021. It is assumed he died on 6/4/2021 as body wa... Read more
Death. Body was found and pronounced dead on 6/14/2021. It is assumed he died on 6/4/2021 as body was badly decomposed at time he was pronounced dead.
57 2021-01-03 blood pressure increased Recipient described feeling dizzy with blurry vision. Vitals taken. All WNL, except blood pressure... Read more
Recipient described feeling dizzy with blurry vision. Vitals taken. All WNL, except blood pressure elevated to 142/90. He was escorted to wheel chair and remained with us for 15 minutes. He was still reporting blurry vision and some dizziness. Vital signs remained stable with approximately same elevated BP. He was taken to Emergency Department for observation.
57 2021-01-04 lightheadedness, heart rate decreased $ hours following the vaccination, I felt very faint and dizzy and nearly passed out. I checked my b... Read more
$ hours following the vaccination, I felt very faint and dizzy and nearly passed out. I checked my blood pressure, which was normal. My pulse rate was low (58). I remained dizzy and weak for the rest of the day, with some nausea, but no vomitting. My dizzyness and weakness gradually dissipated over the next 3 days.
57 2021-01-06 deep vein blood clot Developed left lower leg discomfort on day 5 post-vaccination with dose 1 of Moderna COVID-19 vaccin... Read more
Developed left lower leg discomfort on day 5 post-vaccination with dose 1 of Moderna COVID-19 vaccine. Developed worsening pain, swelling and mild erythema of the left lower leg distal to the knee over the next 48 hours. Seen on 1/05/2021, and STAT venous duplex ultrasound ordered, which revealed a prominent deep vein thrombosis partially occlusive, partially nonocclusive extending from the left femoral vein distally. Started on anticoagulation with apixiban. No signs/symptoms of pulmonary embolus. No precipitating event that would raise risk of acute DVT (He does not have any open areas of his skin concerning for infection in the leg. No recent injury to the leg. No recent surgeries or period of immobility. No prior personal history of DVT, provoked or unprovoked. He does not smoke. He does drink alcohol in small amounts, to moderate amounts on occasion. No history of alcohol misuse or abuse.). He has chronic HIV infection, well controlled. He does have a family history of DVT (his mother had 1 provoked and 1 non-provoked DVT).
57 2021-01-07 chest discomfort Chest tightness and chest warmth
57 2021-01-08 pallor, hypertension 55 y/o male with hx of anaphylaxis due to peanut allergy. Guardian pharmacist noted the change in f... Read more
55 y/o male with hx of anaphylaxis due to peanut allergy. Guardian pharmacist noted the change in facial color and alerted RN who was monitoring s/p vaccination of her observations. He was red with facial edema upon my arrival. Benadryl 25mg PO while he was still able to swallow by RN. EMS called while he took the Benadryl. After Benadryl, checked vitals ? VERY hypertensive and increasing diaphoresis; Started to wax and wane with consciousness. Administered epi pen by RN in attendance once change in level of consciousness was noted. After epi, became pale, increasing diaphoresis with change in level of consciousness. BP was lower, still hypertensive. Placed on floor by staff. While on the floor, consciousness improved. EMS arrived and assumed care.
57 2021-01-12 chest discomfort 0937 - states left wrist feels "clogged", can feel the blood flowing through, denies headache, itc... Read more
0937 - states left wrist feels "clogged", can feel the blood flowing through, denies headache, itching or nausea 0940 - given Benadryl 25 mg po 0950 - states left chest feels heavy, feels dizzy, left arm tingling - escorted to EMS tent 0954 - HR 73, BP 133/93, pulse ox 97%, 12 lead ekg initiated 0957 - called individual @ patient's request - advised that patient will be late returning to work 0959 - HR 76, BP 133/93, pulse ox 93% 1005 - states chest heaviness, left arm tingling resolving, no longer dizzy 1007 - declined transport to hospital, will go home - wife is at home, feels fine to drive, not dizzy. call to individual advising that patient is going home for the day 1015 - left clinic to go home, feeling better
57 2021-01-14 palpitations, heart rate decreased I became dizzy and heart racing after 2 minutes of receiving this vaccine. I had a pulse oximetry... Read more
I became dizzy and heart racing after 2 minutes of receiving this vaccine. I had a pulse oximetry. My heart rate was 132 (my normal is around 60). I told the RN was having a reaction. I had brought my liquid benadryl in case I might have a reaction due to my severe food allergies. I immediately drank 50 mg of benadryl. In 2 to 3 minutes my heart rate came down and I felt better. I was able to leave and drive home. I am an RN myself so I knew how to manage this situation.
57 2021-01-15 blood pressure fluctuation, chest pain On 12/26/20 I had chase pain I felt like I was going to have a gerd attack, my blood pressure was al... Read more
On 12/26/20 I had chase pain I felt like I was going to have a gerd attack, my blood pressure was all over the place sometimes it will be high other times it would be low, I felt like I was going to break a sweat but never got a fever, under my chin & under my armpit I had swollen it was tender to the touch. On 12/30/2020 I seen my doctor and I was also feeling better.
57 2021-01-18 palpitations After pt's 15 min of monitoring was over and he was backing up in his vehicle, he became dizzy and p... Read more
After pt's 15 min of monitoring was over and he was backing up in his vehicle, he became dizzy and pulled back in to see the nurse. States he didn't tell anyone, but immediately after receiving the shot, pt had dull headache, facial tingling and some dizziness. Upon notifying the nurse, he stated he felt like his heart was beating out of his chest, but pulse only 56 and regular (normal rate for him). BP was 180/90 O2 at 96%. (normal BP for pt was 130's/80's). Pt very chatty and nervous, which he said was not normal for him. Stated he felt almost intoxicated or drugged "out of body". Continued to monitor pt and BP trended down (last was 150/82 P56 R16 O2 sat 95-96%). Pt's facial tingling, dizziness resolved, headache improved. Pt stated he almost felt like it was a migraine coming on immediately after getting the shot. Pt refused transport or further evaluation. Pt phoned on 1/14 and he stated his s/s had completely resolved and no further complications.
57 2021-01-18 fast heart rate Pt brought to the ER with SVT. He was given 2 doses of adenosine by EMT's. Pt was found to have hy... Read more
Pt brought to the ER with SVT. He was given 2 doses of adenosine by EMT's. Pt was found to have hypomagnesemia and hypophosphatemia in the ER. He was admitted for observation and evaluated by Cardiology. He remained stable with NSR during admission. Pt has a follow up appt with Cardiology EP clinic on 2/18/21.
57 2021-01-20 blood pressure increased The patient received the second dose of the Moderna vaccine at the Health Department. The patient ex... Read more
The patient received the second dose of the Moderna vaccine at the Health Department. The patient experienced a rapid onset of a dry mouth and throat, followed by a restricted airway and elevated blood pressure. The patient was given 2 x 25 mg pf Benadryl, however, due to rapid restriction of the airway .05 of epinephrine was administered by injection. The symptoms subsided slightly. A second injection of .05 mg was administered. The patient was observed and released with instructions to contact his primary care physician.
57 2021-01-24 chest pain presents with sudden onset of subjective fever, chills, headache, n/d/ since yesterday. received a C... Read more
presents with sudden onset of subjective fever, chills, headache, n/d/ since yesterday. received a COVID vaccine at the end of Dec 2020. denies chest pain, sob, abd pain. supposes to have 2nd vaccine on 28 Jan 2021.
57 2021-01-25 deep vein blood clot Left calf pain and swelling, +DVT
57 2021-01-26 blood pressure increased had to administer epi-epen after patient reported difficulty breathing and elevated blood pressure
57 2021-01-28 chest discomfort, chest pain vaccination given at 0756am symptom onset 0759 episodic chest pain, light headedness, nausea, flushi... Read more
vaccination given at 0756am symptom onset 0759 episodic chest pain, light headedness, nausea, flushing, inclusive of chest pressure rated at 2/10 lasting minutes in duration- intermittent, intermittent light headedness 0812 136/69 hr 61 o2 sat 98 on room air. 0820 rapid response called 0822 132/79 hr 54 o2sat 98 on room air. 0827 127/76 hr 54 o2sat 98 on room air. 0832 pt wheeled to ED with RRT.
57 2021-02-01 hypertension 1) very sore arm 2) slight flu like symptoms for the first 3-4 days: tired, foggy, slight headache 3... Read more
1) very sore arm 2) slight flu like symptoms for the first 3-4 days: tired, foggy, slight headache 3) starting on day 4/5, got really sick: intense headache that wouldn?t go away, intense exhaustion, dizziness, nausea, high blood pressure. This lasted for 6 days.
57 2021-02-02 blood pressure increased Patient came to the emergency department on 02/02/2020 at 2:30 pm to be evaluated for possible strok... Read more
Patient came to the emergency department on 02/02/2020 at 2:30 pm to be evaluated for possible stroke due to sudden acute numbness, weakness in right wrist and arm, but no pain. Patient has no prior history of sudden acute numbness in arm and did not report any recent injury to his arm. Neurologist evaluated patient for possible stroke and patient was unable to lift right wrist and hand. Patient was able to lift both arms overhead, lift both legs, smile normal, open and close mouth and move tongue. Both CT Scan and MRI were normal. Neurologist and emergency medical specialist determined that patient did not have a stroke and diagnosed acute brachial plexus palsy possibly due to patient sleeping in an awkward position. Emergency specialist said it was unlikely but could not rule out the possibility of an adverse reaction to the Moderna vaccine, which patient had received 10 days earlier (second dose, see details above.)
57 2021-02-03 pallor (first 24 hours) extreme fatigue, severe headache, photosensitivity, nausea and loss of appetite, mu... Read more
(first 24 hours) extreme fatigue, severe headache, photosensitivity, nausea and loss of appetite, muscle aches, joint pain, neck and back aches, swollen/puffy eyes, loss of color, sudden and extreme feelings of being cold and unable to warm self, extreme shacking /muscle spasms, shooting pain like lightning in feet when moved, labored breathing, 102 temperature, (next 24) severe headache, major fatigue, loss of appetite, body, muscle aches, Joint pain. loss of color (next 12) feeling hot and sweating, headache, inability to be comfortable to sleep, color loss
57 2021-02-04 chest discomfort Subjective 57 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVI... Read more
Subjective 57 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He was given the Moderna vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience Right sided chest discomfort, mild shortness of breath and intermittent dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. patient denies any previous cardiac history but does have Asthma. Chest discomfort did not worsen with activity and actually improved some per his report. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness (Right side, no radiation) and dizziness (Intermittent) Previous Reactions: None Objective Vitals Vitals: 02/05/21 1009 02/05/21 1019 BP: 136/83 130/83 Pulse: 70 62 Resp: 14 SpO2: 98% 98% Physical Exam Vitals signs reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not diaphoretic. Cardiovascular: Rate and Rhythm: Normal rate. Heart sounds: Normal heart sounds. No murmur. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Neurological: Mental Status: He is alert. Assessment/Plan Treatment included: albuterol, water and Acetaminophen Follow up response to treatment: Excellent Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Symptoms developed just prior to patient leaving, started visit at 10:05 am, self administered albuterol at 10:10am. Self administered Acetaminophen 1,000 mg at 10:24 AM, Symptoms resolved and patient discharged around 10:30 AM. History of anxiety. Showed great relief of symptoms with use of his personal Albuterol inhaler and 1,000 mg of Acetaminophen (also his own). Symptoms completely subsided prior to discharge.
57 2021-02-06 loss of consciousness Fainted twice. During the second faint had a mild shaking (seizure) he was out for about about 10 se... Read more
Fainted twice. During the second faint had a mild shaking (seizure) he was out for about about 10 seconds then came awake. Sweating and hot. He slept for an hour, then was able to stand, and take the stairs up to bed. I'm calling his doctor tomorrow (Monday).
57 2021-02-10 blood glucose increased, blood pressure increased I had my first shot on January 13th, my blood sugar levels stayed above 200 for almost two weeks. Ye... Read more
I had my first shot on January 13th, my blood sugar levels stayed above 200 for almost two weeks. Yesterday I had my second dose and my blood sugar level jumped to over 500 at 11PM last night and until just a few hours ago has dropped down to 134, I feel light headed and my blood pressure is elevated.
57 2021-02-12 cerebrovascular accident Narrative: Patient evaluated for stroke. No bleeding. Maybe ischemia - Further testing results stil... Read more
Narrative: Patient evaluated for stroke. No bleeding. Maybe ischemia - Further testing results still pending at the time of this initial report
57 2021-02-12 cerebrovascular accident R thalamic stroke 2 days after 2nd dose of Moderna vaccine with L sided numbness acute in onset
57 2021-02-12 loss of consciousness Patient had not been feeling well yesterday after 2nd dose of Moderna (vaccination time unknown) and... Read more
Patient had not been feeling well yesterday after 2nd dose of Moderna (vaccination time unknown) and had told coworkers he was feeling tired today. When walking from car at work (at vaccine site) security observed him fall in parking lot. Hit head, +loss of consciousness. Laceration noted. RNs, MD, Pod Director and Fire rescue were all on site and responded immediately. Denied headache or blurry vision. BP 172/92. Sp02 91% on RA. AA&0x2. Oxygen applied. Repeat vitals 162/88, HR 103, O2 96%. Blood sugar 167. Ambulance called. Transported to ER.
57 2021-02-14 heart rate increased Had injection late Friday afternoon (2/12/21). After going to bed that night, started feeling extrem... Read more
Had injection late Friday afternoon (2/12/21). After going to bed that night, started feeling extreme body aches, chills, nausea, dizziness, with fever (101 temperature). According, my heart rate went up dramatically overnight and was elevated all day on Saturday (showing 3 hours 16 minutes in exercise zone doing 19 minutes cardio and 2 hours 57 minutes fat burn although I was in bed all day). It is important to note that on December 26th I tested Positive for Covid. I work for Health Care Agency and have been working at with option for Vaccine.
57 2021-02-15 chest discomfort sore throat, congestion, fever. 01/02/2021: COVID positive. Given Balmlinivimab and Decadron. Admitt... Read more
sore throat, congestion, fever. 01/02/2021: COVID positive. Given Balmlinivimab and Decadron. Admitted to hospital through ER on !/5/2021 with chest tightness and shortness of breath. Throughout stay given Cardizem, Amiodarone without conversion. 1/5/2021 1800 transported by ambulance to medical center. Cardioverted at medical center.
57 2021-02-16 pulmonary embolism, chest pain Patient developed chest pain and was admitted to ED with pulmonary embolism.
57 2021-02-20 chest pain 02/10/21 received the shot in right arm - pain at site of injection, developed headache; 02/11/21 wo... Read more
02/10/21 received the shot in right arm - pain at site of injection, developed headache; 02/11/21 woke up with nausea, tiredness, headache, pain in arm - symptoms continued 4 days; 02/14/21 developed itching all over body- itching lasted one day, severe joint pain in right shoulder continued 4 days; 02/18/21 mild joint pain in right shoulder, mild pain started again in right shoulder, itching and rash developed at injection site; 02/19/21 woke up in night due to pain in chest and back when breathing in, this continued through the day so contacted doctor's office was was told to go to ER to get checked, went to ER 3:30 pm - Diagnosis chest pain, unspecified, pleurisy; 02/21/21 pain in chest with breathes continues
57 2021-02-21 arrhythmia, heart flutter unusual heart Rhythm. captured on my loop recorder. early heartbeat. symptoms-, "fluttering" sens... Read more
unusual heart Rhythm. captured on my loop recorder. early heartbeat. symptoms-, "fluttering" sensation in chest. tiredness
57 2021-02-21 fibrin d dimer increased, chest pain I had right sided chest pain that was non radiating. It was localized pain between the sternum and t... Read more
I had right sided chest pain that was non radiating. It was localized pain between the sternum and the right breast that would last for 5-10 seconds. It was irregular as far as when the pain would return.
57 2021-02-21 fluid around the heart Developed Shortness of Breath about four days after being vaccinated. Went to the ER 2/21. Had blood... Read more
Developed Shortness of Breath about four days after being vaccinated. Went to the ER 2/21. Had bloody fluid removed from around his heart or lung 2/22//2021.
57 2021-02-25 palpitations, heart rate increased Within 7-10 minutes after receiving his second dose of COVID-19, patient started complaining of rapi... Read more
Within 7-10 minutes after receiving his second dose of COVID-19, patient started complaining of rapid heart rate and palpitations which then progressed into dizziness and lightheadedness during his observation period. Patient was subsequently moved to a room and further evaluated including vital signs and 12 lead EKG. It was determined that patient is currently undergoing workup for possible cardiac issue, was recently started on Nitroglycerin yesterday and has a tentative angiogram scheduled Monday 3/1/21. After lying down during the evaluation patient's dizziness began to worsen. Talked with patient and spouse and recommended transport to the hospital for further evaluation.
57 2021-03-01 increased heart rate Patient got vaccine on 2/3/21. Developed fever of 102 F and malaise on 2/4/21. Reported "low grade ... Read more
Patient got vaccine on 2/3/21. Developed fever of 102 F and malaise on 2/4/21. Reported "low grade fever" on 2/5/21. Had witnessed convulsive seizure on 2/7/21 and went to the ED for evaluation.
57 2021-03-03 pallor At approximately 16:36 pt was noted writhing on the floor in the post-vaccine waiting area. Upon rap... Read more
At approximately 16:36 pt was noted writhing on the floor in the post-vaccine waiting area. Upon rapid assessment of pt, others advised to call 911. 911 was called. Pt appeared to be in pain and tense, eyes were tightly shut but pt was breathing and moving throughout the entire time, after about 10 seconds was able to speak and stated that he felt sudden onset of dizziness and fell onto the ground. Pt denied head injury or pain from fall, no signs of trauma noted to face, dentition, or head. He stated that he was able to hear the voices of people talking to him the entire time he was on the floor. Pt denied any LOC, recalled all events leading up to falling. Pt reports hx of syncope after an injection once before, years ago. Pt denied any past medical history. Pt denies taking any medications, and denies any allergies. Pt states he only take medication when he has headaches. Assessment: Pt appeared in mild acute distress. Pt moaning and grimacing initially, once verbal, speech was clear and he was able to speak in complete sentences. Pt face was symmetrical and had purposeful movement of all extremities. Moderate diaphoresis and facial pallor noted. VS @16:38 BP 162/100 HR 113 RR 24 O2 98% @1642 BP162/99 HR 94 RR 20 O2 97%. EMS arrival @1647 and pt was refusing to be transported to the hospital. Pt and pt's mother were advised of the importance of further evaluation in the ED despite pt insisting he felt better. Spoke with pt mother and family while pt was speaking with EMS and urged them to take pt to the hospital via private vehicle even if pt were to refuse ambulance transport. Understanding was verbalized.
57 2021-03-07 pallor, lightheadedness Patient received his first Moderna covid vaccine shot at about 4:00pm on 3/7/2021 and procedd to the... Read more
Patient received his first Moderna covid vaccine shot at about 4:00pm on 3/7/2021 and procedd to the post-vaccination observation area for his 15 minute observation period. About 10 minutes after his shot, patient alerted the an observation staff member that he was starting to feel hot. Staff member alert the pharmacist who had given him his shot and the pharmacist came over. Patient told the pharmacist he feels like he is burning up. Pharmacist took hi temperature an it in the 98 rang (can't remember the exact temp but was 98. something) Patient then then told the pharmacist that he feels like he is getting an aura of a coming seizure. The pharmacist applied an intant ice pack to the back of the patient neck and provided a bottle of cold water. Pharmacist stayed next to him talking to him and asking how he was doing and kept a hand on him in case he had a full blown seizure. Patient was awake but looked pale and seemed like he was going to fainted. Stayed like that for about 10 minutes. after about 10 minutes patient "came back". He looked back to normal and felt fine. During the process he called his wife to come get him and he was fine when she aroungs a few minutes later. Patient, wife, and pharmacist chatted for about 15 minutes before wife took him home. Patient said based on his history that it was a petit mal seizure.
57 2021-03-09 blood pressure decreased, loss of consciousness Around 5 pm patient got his first dose of the Moderna Covid-19 vaccine, and after 5 mins,he passed ... Read more
Around 5 pm patient got his first dose of the Moderna Covid-19 vaccine, and after 5 mins,he passed out while he was sitting in the observation area,his wife was with him, once that incident had been noticed, I ran quickly to him but when I reached him he started to wake up again, I brought the emergency kit , a bottle of water, also I asked pharmacy tech to call store manager to come over. I asked patient what happened and he stated that suddenly he felt dizzy and that he was anxious about the vaccine from the beginning and excited to get it at the same time, then I measured the blood pressure it was 125/61 with pulse of 45/min.I offered him and his wife to call 911 but they declined it. I asked him to go back to my consultation area so he could lie down on the floor and raise his legs up so we can bring back the blood pressure up, he did that, and he went with me over there and laid down on the floor and we raised his legs up,later I measured his blood pressure again, and it was 113/71 with pulse 51/minute, I offered again to call 911 but he refused and he said that he was feeling better. I left him about 10 more minutes,then he started to get up and sit by the chair and I re-measured the blood pressure and it was 121/76 with pulse of 54/minute, he started to drink water. He stated he felt better than he was about 20 minutes ago, then they left once their driver came to pick them up.
57 2021-03-10 coughing up blood Moderna Covid-19 Vaccine EUA - 3/6/2021 Went to hospital at 4pm because I was coughing up blood and ... Read more
Moderna Covid-19 Vaccine EUA - 3/6/2021 Went to hospital at 4pm because I was coughing up blood and having a hard time breathing. Air lifted to another Hospital. admitted 19:00 hrs. Chest X-rays 2 sets, CT Scan, Ultrasound, Bloodwork and 2 Covid-19 test. I was told i had pnuemonia followin first chest x-ray on 03/06/2021. on 03/07/2021 after CT Scan and 2nd chest x-ray I was told I did not have pnuemonia or Bronchitus. I was dischrged on 03/08/2021. I have shortness of breath with little to no energy. I am not retired. I own a business and have not been sick until 03/06/2021
57 2021-03-10 hypotension PT DISCOVERED WITH HEAD DOWN. PT C/O OF DIZZINESS, SWEATING, AND FEELING SLUGISH. PT DENIES ANY PRE... Read more
PT DISCOVERED WITH HEAD DOWN. PT C/O OF DIZZINESS, SWEATING, AND FEELING SLUGISH. PT DENIES ANY PREVIOUS ADVERSE REACTIONS TO VACCINES. DENIED CHEST PAIN OR PRESSURE. PT WAS DISCOVERED TO BE HYPOTENSIVE. VS @ 15:24 PM BP 65/40 HR 68 SpO2 91% PT DID NOT APPEAR IN ACCUTE DISTRESS AFTER ONSET OF INITIAL SYMPTOMS. HE WAS INSTRUCTED TO BRING HIS KNEES UP TOWARDS HIS CHEST AND GIVEN GATORADE TO INCREASE HIS BP. AFTER 15-18 MIN PT SYMPTOMS RECOVERED AND BP RETURNED TO NORMAL. PT WAS STABLE TO LEAVE THE OBSERVATION SITE WITH WIFE. PT INFORMED TO F/U WITH PCP. BP 124/80 HR 88 SpO2 96%
57 2021-03-11 pallor, palpitations, heart rate decreased Pt was hot and clammy. Became very pale and had low pulse. He stated his heart was racing and he cou... Read more
Pt was hot and clammy. Became very pale and had low pulse. He stated his heart was racing and he couldn't swallow. He stated he felt this way every time he gives blood minus the difficulty swallowing. We took off his jacket and sweater and opened doors to cool him. We called 911, Gave him water and a granola bar. He stated he was feeling better. 911 responded.
57 2021-03-12 hypertension HIGH FEVER, CHILLS, BODY ACHES, FATIGUE, DIARRHEA, VOMITTING, HIGH BLOOD PRESSURE, DEHYDRATION, MINO... Read more
HIGH FEVER, CHILLS, BODY ACHES, FATIGUE, DIARRHEA, VOMITTING, HIGH BLOOD PRESSURE, DEHYDRATION, MINOR COUGH AFTER OTHER SYMPTOMS HAD CLEARED.
57 2021-03-12 low blood platelet count Immune thrombocytopenia requiring hospitalization and platelet transfusion
57 2021-03-14 chest pain I have had numerous side effects from the vaccine. The chills, flu like symptoms, cough and chest c... Read more
I have had numerous side effects from the vaccine. The chills, flu like symptoms, cough and chest congestion continue to linger on a week after the vaccine was received. I am not running a fever however I do feel feverish. I still feel tired and have no energy. I contacted my primary health on Friday 3/12 concerning the pain in my chest cavity from extreme coughing attacks. I was instructed to take some Tylenol and Mucinex.
57 2021-03-15 loss of consciousness Got an increasing headache - annoying fuzzy and headache by 11pm and went to sleep. Had plenty of w... Read more
Got an increasing headache - annoying fuzzy and headache by 11pm and went to sleep. Had plenty of water/fluids throughout the night. urinated often about ever 1 3/4 hrs-I cath and good at it (big prostate) and use a bucket. Had a nasty headache by 3am and while cathing I stayed low because I felt real sick sweaty nauseous and went blind passed out, covered with half quart of urine, woke up on the floor with face against the wall-didn't know anything for a few seconds. Went back to bed-headache lasted for about four days.
57 2021-03-16 cardiac arrhythmia, heart rate increased, heart rate irregular, increased heart rate About 12 hours after getting the second Moderna dose, while trying to sleep, my heart rate was 100-1... Read more
About 12 hours after getting the second Moderna dose, while trying to sleep, my heart rate was 100-110, with the feeling of repeated PVCs in my heart. I knew this feeling because I had dealt with episodes of repeated PVCs (and later PACs) from about 2016 to February 2020. After being in the hospital in February 2020 for life-threatening sepsis, pneumonia, and strep, the arrhythmias stopped completely. I had been trying to control the episodes by taking atenolol 25mg/d; upon realizing that the PVC episodes had stopped, I terminated the medication. So at about 1AM on 3/7/2021 or so, I noticed the PVCs and the rapid heart rate and could not sleep. Fever went up to 102.4, thirsty and possibly dehydrated. Went to ER at 7am. Tests showed repeated PVCs. Kidney function was slightly abnormal. Started taking atenolol through Tuesday, 3/9. Heart monitor halter showed PVCs continued through Tuesday. By Thursday, 3/11, it was apparent that the PVCs had stopped and heart rate was normal. I stopped the atenolol and the irregular heartbeat has not returned.
57 2021-03-18 cerebral haemorrhage Patient found covered in vomit and know is in a coma with a brain bleed
57 2021-03-18 pallor I received my first shot (COVID) 9 Mar 2021. One week later I started developing lighter patches of... Read more
I received my first shot (COVID) 9 Mar 2021. One week later I started developing lighter patches of skin on my forehead and around the outer edges of both eyes. I have been diagnose with very mild case of vitiligo (1%) on my face about 4-5 years ago but it went into remission. Now it has seem to resurface after my first shot but only around the areas as I described which I have never had these areas effected by vitiligo. My question should I get the second and final round of the vaccine?
57 2021-03-19 loss of consciousness Patient received vaccine, was waiting his 15 minutes, got up and got pharmacy staff attention saying... Read more
Patient received vaccine, was waiting his 15 minutes, got up and got pharmacy staff attention saying he was not feeling well. Pharmacist went our to waiting area, and patient lost consciousness momentarily. Patient was able to regain a seat in a chair, but then blanked out and was not responsive to his name. He was breathing and had a pulse, but eyes were open in a blank stare and he did not respond to verbal or to gentle shaking. After a few minutes he came out of it and said he was feeling better. A few minutes later, the episode happened again. Emergency responders was called and the pharmacist continued to monitor him until paramedics arrived. The episode happened again while paramedics were attending to him and he was taken to the hospital. Patient did return about 6 hours later looking much better and thanked the staff who helped him.
57 2021-03-19 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seiz... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Systemic: Vomiting-Severe, Additional Details: After couple minutes receiving second dose of covid vaccine, patient passed out and lost consicousness for less than a minute. Patient woke up with brief seizure(jerky movement) and vomited couple times. Patient complained about dizzness. Patient was taken to the emergency room.
57 2021-03-21 atrial fibrillation atrial Fibrillation with rapid ventricular response Narrative: Patient presented in Atrial fibrillat... Read more
atrial Fibrillation with rapid ventricular response Narrative: Patient presented in Atrial fibrillation with rapid ventricular response within 24 hours of receiving second dose of MODERNA COVID-19 vaccine. Required inpatient hospitalization and IV anti-arrhythmic medications.
57 2021-03-21 chest pain Report chest pain that pain on day 1 post vaccination and progressively got worst. Treatment: Seen i... Read more
Report chest pain that pain on day 1 post vaccination and progressively got worst. Treatment: Seen in the emergency room. Outcome: Need to follow-up with primary care doctor and off 3 days of work before returning.
57 2021-03-21 palpitations Beginning Saturday morning, patient reports headache, unable to sleep, ringing in ears, not feeling ... Read more
Beginning Saturday morning, patient reports headache, unable to sleep, ringing in ears, not feeling hunger, strong feeling of his heartbeat, night sweats and an ache in his bones.
57 2021-03-22 cardiac failure congestive, blood clot, cerebrovascular accident, atrial fibrillation A stroke occurred approximately 3 hrs after receiving vaccine. He was flown by helicopter to Medica... Read more
A stroke occurred approximately 3 hrs after receiving vaccine. He was flown by helicopter to Medical Center. He had dysphasia which did resolve by the time he was admitted into the ER. He has since had CHF and Afib and is now on anticoagulation and diuretics. He continues to have problems with CHF, SOB, weakness and is undergoing treatment as outpatient. He is now followed by Cardiology, Neurology.
57 2021-03-22 palpitations Hard shaking chills enough that he almost fell while walking to the bathroom. These shaking chills l... Read more
Hard shaking chills enough that he almost fell while walking to the bathroom. These shaking chills lasted about an hour and he could feel his heart racing and a feeling that he was going to die. Every injury he has had since childhood hurt. He stayed in bed and in pain for eight hours. The next 48 hours were less eventful and he stayed in bed but mostly for fatigue. Patient did have COVID in December 2020.
57 2021-03-24 deep vein blood clot Diagnosed with DVT; Leg got really swollen/swelling of the lower calf area; Sore arm; Sore arm; Pull... Read more
Diagnosed with DVT; Leg got really swollen/swelling of the lower calf area; Sore arm; Sore arm; Pulled a muscle; A spontaneous report was received from a consumer concerning a 57-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, DVT/ deep vein thrombosis, pulled a muscle/myalgia, swelling of the lower calf area(leg got really swollen)/peripheral swelling and calf pain(sore arm)/pain in extremity. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, 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 09 FEB 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 right arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, after receiving the vaccine the patient had sore arm. On an unspecified date in Jan 2021, the patient had experienced a pull in his muscle in his calf and lower calf area got swollen. On 09 Feb 2021, after receiving the second dose of vaccine he had experienced a sore arm. On 11 Mar 2021, his leg got really swollen and on 12 Mar 2021, he visited hospital where it got diagnosed as DVT in his right lower calf. Treatment for the events included blood thinner Apixaban. Patient is concerned about possibility of indirect relation of events to the vaccine. 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 event DVT, leg got really swollen, swelling of the lower calf area and calf pain were unknown at the time of this report. The event pulled a muscle is not resolved. The event sore arm which the patient experienced for both the doses got resolved on 13 Jan and 14 Jan 2021, respectively.; Reporter's Comments: Based on the information provided which includes a strong temporal association a causal association between the event of sore arm and the administration of mRNA-1273 cannot be excluded. The evens of DVT , pulled muscle and swelling of lower calf is assessed as unlikely related to mRNA-1273. Events were all attributed to muscle strain.
57 2021-03-25 cerebrovascular accident Had a stroke; A spontaneous report was received from a healthcare professional concerning a 57-years... Read more
Had a stroke; A spontaneous report was received from a healthcare professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a stroke. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10-Mar-2021, at 13:30, the patient received first of two planned doses of mRNA-1273 (batch: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 10-Mar-2021, at 15:30, the patient had a stroke and was admitted. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event had a stroke was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
57 2021-03-27 heart rate increased Elevated heart rate of 145. Elevated respiration. Severe joint pain. Body ached. Fatigue. All sym... Read more
Elevated heart rate of 145. Elevated respiration. Severe joint pain. Body ached. Fatigue. All symptoms continued for st least 24 hours. Taking Tylenol and plenty of water.
57 2021-03-28 chest pain A previous event was submitted 03/22/21 VAERS. Employee was seen in the ER initially for chest pain... Read more
A previous event was submitted 03/22/21 VAERS. Employee was seen in the ER initially for chest pain and under the care of a doctor. He his not working at this time. He reports additional symptoms of bilateral ankle swelling, Shortness of breath and easily fatigue, which he states he did not have before the vaccine. Employee reports his doctor believe it is a negative reaction to the Covid-19 Moderna Vaccine.
57 2021-03-28 loss of consciousness Patient had Moderna Vaccine Dose #1. He started to feel light headed. He fell from chair to floor. H... Read more
Patient had Moderna Vaccine Dose #1. He started to feel light headed. He fell from chair to floor. He was unconscious when first found approx 950 am. Nurse administered Chest compressions. Patient regained consciousness. EMS was called 9:52 am by clinical staff. At same time vitals were stable 129/62, oxygen sat at 95%, pulse 77. No supplemental oxygen or medications were administered. Vitals at 10:02am 130/74 pulse 78 oxygen sat 95%. Vitals at 10:07 were 113/76 oxygen sat 98% pulse 79. EMS was on scene at 10:08am. Patient stated he has a history of vasovagal syncope. He denies any current medications, medical history, or allergies. He refused EMS services to be transported to hospital stating he was "fine" and he "usually has these reactions". He denied any diffculty breathing, shortness or breath, chest pain, palpitations, or any symptoms pertaining to an anaphylaxis reaction.
57 2021-03-30 blood clot blood clot in lower leg; achy; Pain in the back of leg that would not go away; body ache/ache; heada... Read more
blood clot in lower leg; achy; Pain in the back of leg that would not go away; body ache/ache; headache; A spontaneous report was received from a consumer concerning a patient age ,57 years old male patient who developed Blood clot in lower leg/Thrombosis, Body ache/Myalgia, Headache/Headache and pain in the back of the leg that would not go away/pain in extremity. The patient's medical history included Central Retinal vein occlusion (CRVO). Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date. The patient received their second of two planned doses of mRNA-1273 (Batch number not provided) on 03 Feb 2021, intramuscularly in the (unknown injection site) for prophylaxis of COVID-19 infection. On the same day as receiving the vaccine 03 Feb 2021 patient reported as having pain in back of the leg that would not go away. Patient also had body aches, felt achy and had headache. Patient went to Emergency room on 03 Feb 2021 and was diagnosed a blood clot in lower leg. The event blood clot in lower leg was assessed as medically significant based on IME list. Treatment information was not provided/unknown. Patient is following up with a hematologist. 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 event(s), Blood clot in lower leg/Thrombosis, Body ache/Myalgia, Headache/Headache and pain the 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 (pain, myalgia, and headache) a causal relationship cannot be excluded. A very limited information regarding these event (Thrombosis) has been provided at this time. Noting the history of central retinal vein occlusion may remain as a risk factor for thrombosis. Further information has been requested.
57 2021-03-31 anaemia, low platelet count, platelet count decreased, chest pain Chest pain onset day of vaccine, tested positive COVID-19 3/29/2021- 2 days after vaccine. Left hear... Read more
Chest pain onset day of vaccine, tested positive COVID-19 3/29/2021- 2 days after vaccine. Left heart cath placed 3/29/2021
57 2021-03-31 fainting syncope 2 hours after his vaccination. he felt nauseous and fainted. LOC lasted 30 seconds. no palpi... Read more
syncope 2 hours after his vaccination. he felt nauseous and fainted. LOC lasted 30 seconds. no palpitations, dizziness, diaphoresis, chest pain. no seizure activity noted, but states he had urinary and fecal incontinence.
57 2021-04-01 blood pressure increased Chills, fever of 102, body aches and pains, nauseousness, dizziness, loss of appetite, night sweats,... Read more
Chills, fever of 102, body aches and pains, nauseousness, dizziness, loss of appetite, night sweats, increase in blood pressure.
57 2021-04-05 blood pressure increased Extreme spike in BP, dizziness/lightheaded, dehydration - all within about 10 minutes. Spike in adre... Read more
Extreme spike in BP, dizziness/lightheaded, dehydration - all within about 10 minutes. Spike in adrenaline (pr/ EMT). Had to call ambulance. I was instructed to leave the facility after less than 10 minutes waiting. Veins seemed to collapse (dehydration) - I was very well hydrated prior to vaccine
57 2021-04-05 very slow heart rate, hypotension, pallor feeling faint, diaphorertic, clammy, pale, hypotensive, bradycardic, ten min after receiving first ... Read more
feeling faint, diaphorertic, clammy, pale, hypotensive, bradycardic, ten min after receiving first dose moderna
57 2021-04-06 deep vein blood clot Right lower extremity deep venous thrombosis in popliteal and femoral veins, swollen discolored leg
57 2021-04-06 heart rate increased, atrial fibrillation, arrhythmia procedure in which his heart was cut from top to bottom/pacemaker dependent; fast heart rate; afib; ... Read more
procedure in which his heart was cut from top to bottom/pacemaker dependent; fast heart rate; afib; red dots on both of his arms; rash on both arms; dizzy; sick; very weak/no energy; hard time walking; cannot do the simplest of tasks; flutter; A spontaneous report was received from a Consumer concerning herself, a 57-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, Atrial flutter, very weak and no energy, hard time walking, and cannot do the simplest of tasks. The patient's medical history included atrial fibrillation and had a pacemaker placed about 8-9 months ago. Products known to have been used by the patient, within two weeks prior to the event were blood pressure medication, antiarrhythmics. On 01 Mar 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 030m20a) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, after vaccination, the patient developed red dots on both of his arms. For next two days, the patient had rash on both arms, was dizzy, felt sick, developed fast heart rate; went to hospital twice for heart rate either 07 Mar 2021 or 13 Mar 2021.During first visit to hospital, fast rate was brought under control, while in the second visit, the patient had a procedure in which his heart was cut from top to bottom and was made pacemaker dependent. The atrial fibrillation could not be controlled for 26 hours and had a flutter which was not identified and could not be controlled. Flutter returned after stopping amlodipine and hence patient was restarted on amlodipine. The patient now feels very weak, has a hard time walking, has no energy, cannot do the simplest of tasks, still experiences fast heart rate and flutter every now and then. No Laboratory investigations were provided. The Treatment information included pacemaker, amlodipine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, atrial flutter, very weak and no energy, hard time walking, cannot do the simplest of tasks were unknown.
57 2021-04-06 hypotension While under Observation after receiving the vaccine he felt lightheaded and throat tightness. He was... Read more
While under Observation after receiving the vaccine he felt lightheaded and throat tightness. He was found to be diaphoretic and hypotensive by the vaccination staff. He denies similar symptoms with previous injections or vaccinations. Symptoms resolved after a 500 mL fluid bolus given by EMS. Patient felt he was in his normal state of health upon ED arrival
57 2021-04-08 chest pain 6 days after receiving the shot I had significant pain in my left side around around mid-rib and at ... Read more
6 days after receiving the shot I had significant pain in my left side around around mid-rib and at the top of my left shoulder. the significant pain last for at least 72 hours. I took Tylenol, which helped, but never completely relieved the pain. The pain moved at times to other areas, including my neck and back and right side of my chest. I also had shortness of breath, which continues to this day. 9 days after the shot I noticed redness at the site of the shot.
57 2021-04-08 heart rate irregular, blood pressure increased, blood pressure fluctuation, heart rate increased, pallor 04/08/2021 at 1440 immediately after injection patient experienced dizziness, was clammy to touch, p... Read more
04/08/2021 at 1440 immediately after injection patient experienced dizziness, was clammy to touch, pale in color. Patient verbalized not feeling well. Blood pressure 160/82, pulse 70 bpm. Pt became sweaty and laid down, continued with "wave of dizziness," so decided to alternate between standing and sitting. At 1500, symptoms continued. blood pressure 180/100 pulse 70 bpm, drinking water c/o some shakiness. 1510 blood pressure 164/84 still c/o waves of dizziness, clammy. No respiratory distress. 1520 blood pressure 180/100 pulse 85 bpm 97% O2. No longer feels clammy, states that he "feels normal other than lightheaded and dizzy. Seems to subside then comes back again." Examined skin: pt had slight erythema on upper chest, blanches when pressed. No itching sensation. 1530 blood pressure 182/102, pulse 85 bpm, 97% O2. "I feel dizzy when you take my blood pressure." When asked about his breathing pt states "breathing feels fine." 1540 no itching. Erythema appears more red and more spread out on chest. "just don't feel right" Still c/o waves of dizziness and states he feels like felt when he took bactrim approximately 12 years ago- slow onset- pt experienced rash and just overall "not feeling right." 1545 blood pressure 172/102 pulse 92 bpm 97% O2. Erythema appears better, not as spread out across chest, more condensed. "Dizziness still comes in waves." 1607 blood pressure 204/102, pulse 90bpm, 97% O2- clammy to touch. After discussing with patient and patients spouse, agree that patient needs to be seen by either PCP, Dr. or go to ER. At the time pt did not wish to go to ER. Wife proceeded to call Dr.'s office to see about getting him in. Pt then started to feel worse and like he needed to go to ER. offered to call for an ambulance, pt refused as his wife could take him and would probably be quicker. staff offered diphenhydramine and pt declined, stating he would wait until he got to ER for treatment. Pt appeared very anxious and nervous. transported him via wheelchair to his vehicle at 1620, his wife then drove him to ER. 04/09/2021 at 0828 I left a voicemail with pt for follow up. 0830 I called to get follow up on pt. I spoke with the nurse that treated the patient. Pt did indeed come to ER and was treated for a reaction. He was given a dose of benadryl and solumedrol. Pt verbalized feeling like he was having a severe anxiety attack and that his adrenaline was really high. Nurse stated that she agreed with him. Pt was later discharged that evening. No epinephrine use reported.
57 2021-04-10 fainting Pt has 8x4cm bruising with faint redness and warmth to left upper arm vaccine injection site. He fi... Read more
Pt has 8x4cm bruising with faint redness and warmth to left upper arm vaccine injection site. He first noticed it afternoon of 4/11; had vaccine on 4/8. MD diagnosed pt with cellulitis left upper arm and ordered Amoxicillin 875mg po BID for 14 doses
57 2021-04-13 deep vein blood clot, pulmonary embolism DVT in right leg with multiple PE?s bilaterally. Treatment: oral Xarelto
57 2021-04-13 heart rate increased Severe headache, body ache , extreme fatigue, rapid heart rate 112 fever chills
57 2021-04-13 fainting 2 syncopal events occurred over the course of the same evening, sought care at Hospital Emergency Ro... Read more
2 syncopal events occurred over the course of the same evening, sought care at Hospital Emergency Room. In first episode, sustained left flank and head trauma.
57 2021-04-17 cerebrovascular accident Patient developed acute mental status change, gait instability, confusion, and seizure like activity... Read more
Patient developed acute mental status change, gait instability, confusion, and seizure like activity several hours after vaccine administration. Presented to the ER the following day for evaluation and was found to have acute CVA with embolic phenomenon confirmed on MRI, radiologist felt possible demyelination
57 2021-04-18 blood glucose increased, hypertension, heart rate increased Painful itchy rash, in area of inoculation and upper arm and shoulder. Treated with Benadryl. Rash a... Read more
Painful itchy rash, in area of inoculation and upper arm and shoulder. Treated with Benadryl. Rash as lasts 6 days. High blood pressure, elevated heart rate and elevated blood glucose for 24 hours. Treated with extra strength Tylenol.
57 2021-04-18 nosebleed nose bleed, never before had one in lifetime, difficulty breathing even with oxygen tank carried in ... Read more
nose bleed, never before had one in lifetime, difficulty breathing even with oxygen tank carried in car, almost got in car accident, extreme stress - drove to emergency room at hospital, they did nothing. Security kicked me out before I was seen by physician.
57 2021-04-19 deep vein blood clot Developed fever and chills that evening through next day. April 16, 2021, I began having pain in my... Read more
Developed fever and chills that evening through next day. April 16, 2021, I began having pain in my left leg with tightening and deep pain inside. Right leg experienced pain when touched. After first Moderna vaccine I experienced arm pain, fever and chills the evening of the vaccine March 16m 2021 and the next day. The third day was tired. The swelling of legs came a few days after it on about March 18, 2021.
57 2021-04-19 fainting chills, fever, nausea, light headed and fainting
57 2021-04-20 chest pain, pulmonary embolism Acute pulmonary embolism/two blood clots in lung; Chest pain; Pain over left arm; pain all over join... Read more
Acute pulmonary embolism/two blood clots in lung; Chest pain; Pain over left arm; pain all over joints; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 provided). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced CHEST PAIN (Chest pain). On 13-Apr-2021, the patient experienced PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Computerised tomogram: abnormal (abnormal) diagnosed acute pulmonary embolism.. Two blood clots in lung. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Description: The patient experienced pain over left arm, pain all over joints, nausea after vaccine administration. On 12 Apr2 021, the patient experienced chest pain and went to Emergency. Room where blood test and D-dimer was done. The treatment information included apixaban. Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
57 2021-04-20 pallor Day following shot it felt flu like, days following shortness of breath, stopped to rest and catch b... Read more
Day following shot it felt flu like, days following shortness of breath, stopped to rest and catch breath. 04/04/21 after getting coffee in hotel I could not regain my breath, became pale, sweaty and chilled. Was taken to emergency room, given oxygen and CT was taken of lungs, CT showed numerous blood clots throughout lungs with two larger at the bridge between, one on either side. Was give oxygen to help breathing, given Heparin to stop clot growth and T__ (something) to dissolve clots. Morning 04/05 was taken off oxygen and that evening clot medication was removed. Discharged morning 04/06 and put on Eliquis and to be reevaluated in three months by PCP. Sometime in the spring of 2020 I was asymptomatic for COVID, it was not until June last year until I knew after donating blood and it was test for COVID antibodies and I was positive.
57 2021-04-21 blood pressure fluctuation 7 days in , Heavy migraine , chills , body aches, nausea, Pain 2 night in a row on both legs around... Read more
7 days in , Heavy migraine , chills , body aches, nausea, Pain 2 night in a row on both legs around knee area , blood pressure at 160/95 today , the high was 180/110 my daily normal BP is 130/71
57 2021-04-21 ischaemic stroke 12:30PM - dizziness in cheeks 1:30PM - dizziness moves to top of his head 5PM - dizziness changes to... Read more
12:30PM - dizziness in cheeks 1:30PM - dizziness moves to top of his head 5PM - dizziness changes to pain, took 2 Tylenol 8PM - started to throw up, lost balance due to numbness on left side of his body - tried to sleep it off as he thought he was just exhausted and a side effect of the shot NEXT DAY 7AM - called ambulance had a "Stroke Ischemic"
57 2021-04-21 transient ischaemic attack On 2/23/2021 patient had to have carotid endarterectomy to remove a clot from his aortic arch to his... Read more
On 2/23/2021 patient had to have carotid endarterectomy to remove a clot from his aortic arch to his carotid siphon. Patient also had several mini strokes per wife and now has neurological deficits. He received his second Moderna vaccine on 3/8/2021 at another pharmacy and 5 days after he had another series of mini strokes.
57 2021-04-23 blood pressure decreased, pallor, heart rate decreased Pt was sitting in vehicle during observation period post vaccine. Complained of lightheadedness. Was... Read more
Pt was sitting in vehicle during observation period post vaccine. Complained of lightheadedness. Was laid back in seat. HR 40's. BP 40's. Pale appearing and diaphoretic. Alert and oriented. Complained of feeling weak. HR remained low. Bp remained low. EMS called. 20 ga L AC PIV started 0.0% NaCl IVF 200ml administered and patient was sent to emergency department per EMS for evaluation.
57 2021-04-23 chest discomfort tight in chest and throat. feeling pressure in chest and throat. Pt came into pharmacy on 04-24-2... Read more
tight in chest and throat. feeling pressure in chest and throat. Pt came into pharmacy on 04-24-2021 at about noon time complaining of these symptoms.
57 2021-04-24 ischemic chest pain Had sharp pains in my heart that would last five to six seconds. This occurred a couple dozen times ... Read more
Had sharp pains in my heart that would last five to six seconds. This occurred a couple dozen times between 18:00 Thursday night and midnight Friday. It has occurred three times since then.
57 2021-04-24 nosebleed NOse bleed that would not stop, weakness in body, leg pain, feeling of stiffness in back.
57 2021-04-25 fibrin d dimer increased, blood glucose increased Pt. received COVID19 Moderna vaccination (2nd dose) on 4/16/2021. That evening he developed a low gr... Read more
Pt. received COVID19 Moderna vaccination (2nd dose) on 4/16/2021. That evening he developed a low grade fever which he took Tylenol for and it took it away. On Sunday 4/18/2021 in the evening Pt. states his tongue felt sluggish and he wasn't able to pronounce his words like he usually does. By Wednesday 4/21/2021- Pt. felt like mouth had been numbed by the dentist and he was having trouble swallowing. Pt. underwent CT Chest PE protocol as well as CT head to rule out thrombosis/ stroke. Testing was negative at that time. Pt. was changed to Aspirin 325mg and was told to follow up. On 4/26/2021 Pt. returns to clinic with 15 lb weight loss. Continued asphasia and dysphagic sx. An MRI w/w.o contrast of the brain is being ordered.
57 2021-04-27 blood pressure decreased Blood pressure dropped from around 135/80 to 116/66 for several hours Tuesday afternoon. Today it is... Read more
Blood pressure dropped from around 135/80 to 116/66 for several hours Tuesday afternoon. Today it is back to where it has been. Last night I woke at 2am with a 101.8 fever. (I'm normally 107.8) Today soreness at site of injection, Muscle aches, Slight fever, and shortness of breath.
57 2021-04-27 chest pain, dilation of blood vessels Chest Pain Acute onset of Dilation and erythema of Temporal Blood vessels and vessels of the scalp B... Read more
Chest Pain Acute onset of Dilation and erythema of Temporal Blood vessels and vessels of the scalp Bilaterally
57 2021-04-29 blood pressure increased, loss of consciousness 1st shot migraine head ache for week, dizzy ness, fell down steps, hard to breath, pain in chest, ca... Read more
1st shot migraine head ache for week, dizzy ness, fell down steps, hard to breath, pain in chest, call and ask health clinic if should get second shot they said ok to. blood pressure up by 10-15 pts 2nd shot- 3 hours dizzy, head ache, 8 hours later, gaunt start in right foot, hot and freezing every 15 minutes rotation in for day, stabbing stomach pains, 3 black outs for up to 4 hours each, 2 day burning eyes, and gaunt start in other foot left foot, and gaunt move up to ankle on right foot. blood pressure now 20-25 pts higher. notified heath clinic again.
57 2021-04-29 brain sinus blood clot On 3/23/21. Pt admitted w/R sided, pulsatile HA associated w/vomiting. Patient was found to have oc... Read more
On 3/23/21. Pt admitted w/R sided, pulsatile HA associated w/vomiting. Patient was found to have occlusive dural venous sinus thrombosis involving the dominant R transverse and sigmoid sinuses, extending into upper jugular vein. He received his second COVID-19 vaccination 5 days prior to onset of HA. Report this for record keeping.
57 2021-04-30 chest discomfort, arrhythmia multiple heart arrhythmias; increased sense of pressure in his chest; shortness of breath; light hea... Read more
multiple heart arrhythmias; increased sense of pressure in his chest; shortness of breath; light headed feeling; weakness; welt that was red, sore, and very hot; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (multiple heart arrhythmias) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertrophic cardiomyopathy (experiencing flare ups which he says he has had before). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (multiple heart arrhythmias) (seriousness criterion medically significant), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness). At the time of the report, ARRHYTHMIA (multiple heart arrhythmias), CHEST DISCOMFORT (increased sense of pressure in his chest), DYSPNOEA (shortness of breath), DIZZINESS (light headed feeling), ASTHENIA (weakness), URTICARIA (welt that was red, sore, and very hot) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
57 2021-05-02 fast heart rate Tachacardic response. Normal resting heartrate is 53. Resting heartrate jumped to 141. Awoken fro... Read more
Tachacardic response. Normal resting heartrate is 53. Resting heartrate jumped to 141. Awoken from sleep with racing heart rate. Slowly resolved over the next 8-12 hours. Blood pressure at 6am was 82/51 with a RHR of 123. I have since returned to baseline.
57 2021-05-03 fainting, loss of consciousness -loss of consciousness; faint -Minor injury to the elbow.
57 2021-05-07 pallor Pt had MODERNA (COVID19) Vaccine 5/8/21; went over VAR questions, administered vaccine, pt was asked... Read more
Pt had MODERNA (COVID19) Vaccine 5/8/21; went over VAR questions, administered vaccine, pt was asked to wait for 15 minutes for monitoring. Pt reported feeling faint, dizzy, sweating and went pale. Laid him on flat surface. Pt was responsive and breathing. Called 911 immediately
57 2021-05-10 palpitations, heart attack, chest pain Palpitations, sweats, nausea/vomiting, chest pain. Transported by EMS to hospital, found to be havin... Read more
Palpitations, sweats, nausea/vomiting, chest pain. Transported by EMS to hospital, found to be having massive MI requiring emergent open heart surgery.
57 2021-05-12 loss of consciousness Pt came to drive through clinic to receive second COVID19 dose. Interview revealed no adverse reacti... Read more
Pt came to drive through clinic to receive second COVID19 dose. Interview revealed no adverse reaction to first dose on 4-14-21 other than expected sore arm. Pt received 0.5ml dose at approximately 1:15pm while seated in the driver's seat. . Within a 2-3 minute time frame after his vaccine the wife alerted me that her husband was not doing well. She stated his eyes were rolling back in his head and he was having a seizure. 911 was called. She stated that patient was unconscious for 20-30-seconds but that he revived and was able to resume basic communications. Shortly thereafter the patient began vomiting repeatedly. The patient's seat was leaned forward and to the outside of the vehicle to prevent aspiration. EMT teams arrived quickly to take over patient care. patient was transported to emergency department.
57 2021-05-15 palpitations Insomnia and heart palpitations
57 2021-05-16 ischaemic stroke Patient came to hospital 6 days after vaccination on 4/19/2021. He was diagnosed with cryptogenic s... Read more
Patient came to hospital 6 days after vaccination on 4/19/2021. He was diagnosed with cryptogenic stroke. Patient was on anticoagulation at the time of his stroke. Thought that patient was non-compliant with his medications but patient and family insist he took his Xarelto consistently.
57 2021-05-17 blood clot in the brain, cerebrovascular accident Stroke due to blood clot in right side of brain. Severely affected speech, mildly affected left hand... Read more
Stroke due to blood clot in right side of brain. Severely affected speech, mildly affected left hand. Is currently going through speech therapy.
57 2021-05-17 pulmonary embolism First vaccine dose administered on 4/20/21. Patient was admitted on 4/29/21 with shortness of breath... Read more
First vaccine dose administered on 4/20/21. Patient was admitted on 4/29/21 with shortness of breath and pleuritic chest pain. CT scan revealed pulmonary embolism and doppler showed vascular access (Hero graft) thrombosis. Patient was treated with heparin and warfarin, and was discharged on 5/5/2021 after being converted to apixaban. Patient missed scheduled dialysis treatment (no call/no show) on 5/8/21 and 5/11/21. Subsequent welfare check found the patient expired at home.
57 2021-05-18 arrhythmia Awoke early Sunday 16th with Heart arrhythmia - VTach. Necessitated 911 call and hospitalization fo... Read more
Awoke early Sunday 16th with Heart arrhythmia - VTach. Necessitated 911 call and hospitalization for cardioversion.
57 2021-05-18 heart rate increased, arrhythmia PATIENT REPORTS WAKING UP SUNDAY 5:30 AM 5/16/2021 (15H POST VACCINATION) FEELING "HOT, SWEATY, DIZZ... Read more
PATIENT REPORTS WAKING UP SUNDAY 5:30 AM 5/16/2021 (15H POST VACCINATION) FEELING "HOT, SWEATY, DIZZY, SHORT OF BREATH, BODY ACHES, AND A FAST HEARTBEAT". NAUSEA STARTED ABOUT 10:00AM AND CONTINUED ON AND OFF ALL DAY. PATIENT REPORTS HE WAS UNABLE TO EAT OR DRINK MUCH AT ALL. PATIENT STATES THAT HE ASSUMED THIS WAS A NORMAL REACTION TO THE VACCINE. THE EVENT CONTINUED WITHOUT IMPROVEMENT AND PATIENT FELT HE WAS WORSENING AND IT WAS CARDIAC RELATED. HE CALLED FOR 911 ABOUT 1:00AM MONDAY AND WAS TAKEN TO THE ER. ER DISCOVERED THAT HIS VENTRICULAR TACHYCARDIA HAD BEEN TRIGGERED @ 2:30 AM ON SUNDAY. ER CONFIRMED THAT PATIENT SUSTAINED AN ELEVATED VT ARRYTHMIA FOR MANY HOURS.
57 2021-05-18 heart rate increased Sore injection site within 6 hours. Poor sleep and higher than usual heart rate the 1st night. Fatig... Read more
Sore injection site within 6 hours. Poor sleep and higher than usual heart rate the 1st night. Fatigue/bedridden the entire 2nd day. Mild fever (99.4F) at one point the 2nd day. Slept well the 2nd night. Mild fatigue the 3rd day but able to do light work.
57 2021-05-20 haemoglobin decreased Patient admitted to hospital a few weeks after his second Moderna vaccine with an acute febrile illn... Read more
Patient admitted to hospital a few weeks after his second Moderna vaccine with an acute febrile illness of unclear etiology. Patient was felt to be septic due an atypical infection with an elevated procalcitonin level. All tests for infectious etiology were negative. He responded to ceftriaxone and doxycycline and was feeling better at transitional care management follow-up on 5/21/21.
57 2021-05-22 blood pressure fluctuation, blood pressure increased After 1st shot 4/13/2021 exactly two days later I started having sever neck pain at the base of my n... Read more
After 1st shot 4/13/2021 exactly two days later I started having sever neck pain at the base of my neck right side in the trapezius muscle and scapula region. Pain dissipated after 5 days. 1 week later I had a sever prostate infection. - no prior history of prostate issues. Took a 3 week dosage of ciprofloxcin. A few days later on May 2nd my blood pressure started running high and spiked at 199/122. It has not been stable since then. It?s gone from 133/62 - 185/ 84 . 2nd shot 5/11/21 - exactly two days the pain returns but much more severe. It attacks the same spot but this time radiates through my rt shoulder and rt arm. Injection site left arm. Tramadol administered for pain. The pain has caused me to have to sleep sitting up as lying down causes sever nerve pain in spine at the base of the neck, behind the scapula and radiating down my rt arm . 5/15. Pain has been unbearable and my arm lost function today. Paralysis set in. 12:45 pm , couldn?t hold my head up too painful
57 2021-05-22 heart rate increased, heart rate irregular, palpitations Rapid irregular heart beat, heart palpitations, fatigue, light headed, hard pounding heart
57 2021-05-23 blood pressure increased About 2 hours after vaccination, patient reported headache and numbness/pain in right arm. Blood pre... Read more
About 2 hours after vaccination, patient reported headache and numbness/pain in right arm. Blood pressure elevated to 254/110. Patient also described white " floaters" in view and shortness of breath. Patient also had anxiety and tension.
57 2021-05-23 haemoglobin decreased, pulmonary embolism, hypotension Patient presented to the ED after being found down outside. Initially hypotensive, was intubated in ... Read more
Patient presented to the ED after being found down outside. Initially hypotensive, was intubated in ED. Required increasing pressor support. Found to have profound anion gap metabolic acidosis with lactate peaking at >27. Initial workup also significant for WBC 40s, AKI with Cr peak at 2.5. Transaminitis likely 2/2 shock liver. Toxicologic workup was negative for alcohol, Tylenol, salicylates, urine drug screen. Blood cultures grew S. hominis. Other infectious workup including covid, hepatitis, hiv, rocky mountain spotted fever, respiratory panel, GI PCR, all negative. Also found to have a PE which was removed via thrombectomy. Developed DIC requiring multiple transfusions of cryo, FFP, and RBCs. Condition improved slowly with lactate downtrending currently and pressor requirement weaning.
57 2021-05-23 haemoglobin decreased fever 102 starting day after vaccination, and 12 days later diagnosed with Left lower lobe atypical ... Read more
fever 102 starting day after vaccination, and 12 days later diagnosed with Left lower lobe atypical pneumonia. Symptoms SOB, Fever, cough, hospitalized at medical center 5/16/21 to 5/17/21 Initially fever without sob or cough: with normal CXR but elevated ESR, CRP. Was treated with Solumedrol dose pack 2 days before he developed symptoms.
57 2021-05-24 blood pressure increased, heart rate increased, atrial fibrillation Increased heart rate, raised blood pressure, then went into atrial fibrillation
57 2021-05-24 cerebral haemorrhage Patient presented to the ED and was subsequently hospitalized on 5/10/2021. Diagnosis was Intraparen... Read more
Patient presented to the ED and was subsequently hospitalized on 5/10/2021. Diagnosis was Intraparenchymal hemorrhage of right temporal lobe of brain, nontraumatic. He was also admitted on 5/19/21 for angiogram. These visits are within 6 weeks of receiving COVID vaccination.
57 2021-05-24 chest pain Shortness of breath, Fatigue, Slight pain in chest.
57 2021-05-26 chest discomfort, heart attack On 3/27/21 at around 9pm He felt tightness in chest which lead to heart attack and death
57 2021-05-26 blood clot About 3 weeks after receiving the first Moderna shot I developed, what i believed to be a severe cha... Read more
About 3 weeks after receiving the first Moderna shot I developed, what i believed to be a severe charlie horse in my left lower leg that lasted about. week and disopated. A few weeks later May 9,2021; I noticed discomfort and swelling in the same lower left leg and my, medical alert service dog, kept alerting to it. I had a regular appointment with my cardioligist on May 10,2021 and advised of my issue and he ordered an ultrasound. The ultra sound revealed blood clots on my llower left leg. I have never had clotting issues in my life and absolutely believe that this colt was caused by the Moderna vaccine, since i have been on anticoagulants and asprin theray since 2008.
57 2021-05-27 chest pain chest pain starting at 330am along with pain as I breath in. No prior heart problems at all. Made ... Read more
chest pain starting at 330am along with pain as I breath in. No prior heart problems at all. Made an appointment with the cardiology (Jun 14).
57 2021-05-27 deep vein blood clot, fibrin d dimer increased developed dvt/blood clot after first dose. bell's palsy after second dose.
57 2021-05-28 palpitations, chest pain Shortly after being vaccinated felt dizzy and developed a headache. Headache got progressively wors... Read more
Shortly after being vaccinated felt dizzy and developed a headache. Headache got progressively worse throughout the day. By that evening, headache evolved into a migraine and needed bed rest. Also started to develop a fever. About 99.5 deg. Around that time, several hours after vaccination, heart began to race and had mild chest pains. Chest pain subsided a couple of hours later. Headache/ migraine persisted until the next day. The following day, 24 hours after vaccination, headache subsided but I developed fever 101.5 deg. and chills. This lasted about 24 hours. All symptoms subsided after about 48 hours.
57 2021-05-31 stroke possible linked to isquemic stroke. Patient was given TPa. Left MCA acute infart
57 2021-06-01 chest pain throat closed and choked on me; chest pain; trouble breathing and chocked on me/cannot breath; throa... Read more
throat closed and choked on me; chest pain; trouble breathing and chocked on me/cannot breath; throat closed and chocked on me; muscle weakness; getting week for some reason; dizzy; pain shoot up at left side; Feeling strange; headache; started to whack out; lung capacity is down to half; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (throat closed and choked on me) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack in 2007 and Angioplasty in 2007. Concurrent medical conditions included Gastroesophageal reflux disease, Chronic obstructive pulmonary disease and Heart disorder. Concomitant products included METOPROLOL for Blood pressure high, IPRATROPIUM BROMIDE and SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for Chronic obstructive pulmonary disease, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disorder, VILAZODONE HYDROCHLORIDE (VIIBRYD), DESVENLAFAXINE, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT) for Psychosis. On 17-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 14-May-2021, the patient experienced TOTAL LUNG CAPACITY DECREASED (lung capacity is down to half). On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHOKING (throat closed and choked on me) (seriousness criterion medically significant), CHEST PAIN (chest pain), DYSPNOEA (trouble breathing and chocked on me/cannot breath), THROAT TIGHTNESS (throat closed and chocked on me), MUSCULAR WEAKNESS (muscle weakness), ASTHENIA (getting week for some reason), DIZZINESS (dizzy), PAIN (pain shoot up at left side), FEELING ABNORMAL (Feeling strange), HEADACHE (headache) and FATIGUE (started to whack out). At the time of the report, CHOKING (throat closed and choked on me), CHEST PAIN (chest pain), DYSPNOEA (trouble breathing and chocked on me/cannot breath), THROAT TIGHTNESS (throat closed and chocked on me), TOTAL LUNG CAPACITY DECREASED (lung capacity is down to half), MUSCULAR WEAKNESS (muscle weakness), ASTHENIA (getting week for some reason), DIZZINESS (dizzy), PAIN (pain shoot up at left side), FEELING ABNORMAL (Feeling strange), HEADACHE (headache) and FATIGUE (started to whack out) outcome was unknown. The patient presented to the Emergency Room for his symptoms on 22-Apr-2021 and 01-May-2021. Additionally, on 17-May-2021, he went to his doctor who told him his lung capacity was down to half. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events 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 MOD-2021-148103 (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.
57 2021-06-01 loss of consciousness blacked out twice; Sore arm/ sore left arm; This spontaneous case was reported by a consumer and des... Read more
blacked out twice; Sore arm/ sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack in 2007, Angioplasty in 2007 and Stent placement in 2007. Concurrent medical conditions included Chronic obstructive pulmonary disease, Blood pressure abnormal, Gastroesophageal reflux disease and Psychosis. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT) for Chronic obstructive pulmonary disease, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder and Blood pressure abnormal, VILAZODONE HYDROCHLORIDE (VIIBRYD), DESVENLAFAXINE, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), IPRATROPIUM BROMIDE and SALBUTAMOL SULFATE (ALBUTEROL SULFATE) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm/ sore left arm). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out twice) and PAIN IN EXTREMITY (Sore arm/ sore left arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products also included psychosis medication (not specified). The patient had sore arm and was blacked out twice after the vaccine. According to the patient, his sore left arm went away for two days and again came back after a week and then went away. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-148160 (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.
57 2021-06-03 loss of consciousness, fainting Patient admitted with high grade AV block, sinus pause, and recurrent syncope. 57-year-old white mal... Read more
Patient admitted with high grade AV block, sinus pause, and recurrent syncope. 57-year-old white male with PMH only of cigarette use who notes about 2 weeks of generalized malaise, then in the last 24 hours has had 2 syncopal episodes that were accompanied by diaphoresis only without other prodrome. He got his second dose of Moderna COVID-19 vaccine on 5/28/21, then on the following day had been working in the barn without any dyspnea chest pain or shortness of breath but felt generally fatigued so went to take a nap. He got up to check his temperature, then "just hit the floor". Not preceded by blackout of vision, lightheadedness, chest pain, dyspnea palpitations, nausea but was accompanied by sweats. He believes he was out only briefly, and when he awoke was not confused and did not have tongue biting or loss of bladder or bowel continence. He then got up and went about his day normally, then around 2 AM awoke to let the dogs out and had an identical event, but this time hit his chin on a chain saw on the floor and suffered a laceration. He presented to ED for evaluation where his laceration was sutured. He is hemodynamically stable and afebrile. Initial labs and diagnostics are unrevealing and an EKG showed a normal sinus rhythm without acute or chronic ischemic changes. Noncontrast CT of the head and the face showed no evidence of bony damage, no intracranial bleed or large territory infarct. While in the ED, the patient had a brief bradycardic episode accompanied by diaphoresis although a dedicated strip is not available and it is unclear what his rhythm was. He did not syncopize. Hospitalist service was asked to accept for syncope evaluation. When admitting physician saw patient, he reported feeling completely well without any other issues. He does note he had about 2 weeks of malaise before all of this started and a mild decrease in his ability to work intensely, but had attributed this to cigarette smoking. Review of systems was essentially negative. He is a hobby farmer and has had a couple of tick bites this year. While admitting physician was in the room at the end of the visit, the patient had an episode of diaphoresis and went into a high-grade second-degree AV block with disappearance of atrial activity without ventricular escape and lost consciousness for about a second. No jerking or twitching observed. The episode a couple of seconds then self terminated and the patient awoke and completely recovered mentation and was in a sinus rhythm. He was diaphoretic and felt ill afterward this. He had no chest pain or dyspnea. Immediately after the episode with repeat vitals the patient's heart rate was in the 70s and a normal sinus rhythm and blood pressure is 136/80. Oxygen saturations are preserved. Not on any rate limiting agents either here in emergency department or at home. Patient found to have P-P interval prolongation with AV block and subsequent sinus arrest possibly situational in the setting of coming off of a colonoscopy and receiving second Moderna COVID-19 vaccine. A pacemaker was placed 6/1/2021 without complication and the patient was discharged in stable condition on 6/2/2021.
57 2021-06-06 chest pain I woke up on Saturday morning with whole body soreness, but this passed by that afternoon. Saturday... Read more
I woke up on Saturday morning with whole body soreness, but this passed by that afternoon. Saturday night through to Sunday, I had chest pains on my entire left side. This worsened all of Sunday and I developed dyspnea (shortness of breath) if I tried to lay down on my back or side along with the pain. I could not sleep or rest Sunday to Monday night so I had to prop myself forward over a bundle of pillows in order to rest. Monday I still had some pain though less, but the dyspnea was more pronounced with any moderate exertion. I called the medical director where I work to ask for advice. He told me it was ok to take an antihistamine. I had taken nothing from the time I received my second dose Thu until then. I took over the counter Chlorpheniramine (4mg) one time and that seemed to relieve the symptoms. The next day I was 85% better (Tue), but it took exactly 7 days (Thu) before I was back to normal. For the 3 - 5 day period following my second dose, it was a little bit scary struggling to breathe and thinking I was having a heart attack. I almost went to the hospital, but I didn't because I take care of my elderly father and could not leave him by himself. If this had happened to me out of the blue, I would have gone to the emergency, but I had read of people having reactions to the vaccine after the second dose so I was mentally prepared to ride it out. I didn't read about people having my particular side effect, so I thought I was an outlier of sorts. I am filling this out now because there are reports coming out that the Pfizer vaccine may be tied to myocarditis in men, and from the symptoms explained, it seems to line up with what I experienced. Although I had Moderna, not Pfizer, I thought maybe I should report it in case it is a generic "mrna vaccine" issue.
57 2021-06-07 chest pain, chest discomfort Chest pain/tightness Neck pain Headache Shortness of Breath
57 2021-06-07 chest pain Developed chest pain requiring hospitalization.
57 2021-06-08 deep vein blood clot Swelling, pain, warmth, and tightness started in left leg the same night I had the second dose of va... Read more
Swelling, pain, warmth, and tightness started in left leg the same night I had the second dose of vaccine. Approximately 10 hours after second dose
57 2021-06-08 fast heart rate Initially sore arm; severe headache. positive COVID test on 1/21/2021 - doctors assume he was positi... Read more
Initially sore arm; severe headache. positive COVID test on 1/21/2021 - doctors assume he was positive at time of vaccination but we didn't know it yet; severe covid pneumonia; supraventricular tachycardia; diabetes; iron deficiency anemia
57 2021-06-09 blood glucose increased Increased fasting blood sugars and liver function tests
57 2021-06-10 transient ischaemic attack, cerebrovascular accident 48 hours after the shot began experiencing Vertigo and a dryness headache. 8 Days after the shot had... Read more
48 hours after the shot began experiencing Vertigo and a dryness headache. 8 Days after the shot had a TIA and Stroke.
57 2021-06-13 cerebrovascular accident, blood clot in the brain on Sunday 6-13-2021 10:45am Had a stroke and blood cot in head. Was take to emergency and is still c... Read more
on Sunday 6-13-2021 10:45am Had a stroke and blood cot in head. Was take to emergency and is still currently there.
57 2021-06-14 chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemi... Read more
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe
57 2021-06-15 chest discomfort, heart attack Three days after the vaccine I started to have tightness in my chest when exercising. On June 9, I ... Read more
Three days after the vaccine I started to have tightness in my chest when exercising. On June 9, I had a mild heart attack. One June 10th, heart catheterization revealed that I had blockage in two arteries
57 2021-06-18 heart attack Pt suffered a heart attack
57 2021-06-20 troponin increased Acute respiratory failure with fevers, elevated troponin
57 2021-06-22 atrial fibrillation, heart rate irregular About two weeks after vaccination I noticed my heart beat was irregular. The episodes we initially ... Read more
About two weeks after vaccination I noticed my heart beat was irregular. The episodes we initially short, 3-5 minutes. After 4 weeks, the episodes lasted longer, up to 3 to 4 hours. On April 27th, I was taken by ambulance to the Emergency Room as I was in AFIB.
57 2021-06-23 blood glucose increased Patient reported that he went to ER and was told Sugar level was at 500 and had to received Insulin.... Read more
Patient reported that he went to ER and was told Sugar level was at 500 and had to received Insulin... Hasnt been to work in over a month and he is Bloated badly and is taking medication for
57 2021-06-23 chest pain, palpitations flu-like symptoms, palpitations, chest pain dependent on position, mild shortness of breath that res... Read more
flu-like symptoms, palpitations, chest pain dependent on position, mild shortness of breath that resolved after a few days
57 2021-06-23 fast heart rate Symptoms: lasting mild fever (99F), rapid at rest heart beats (85 - 95 bpm), hand tremors Diagnostic... Read more
Symptoms: lasting mild fever (99F), rapid at rest heart beats (85 - 95 bpm), hand tremors Diagnostic: Hyperthyroidism (per lab results) with inflame thyroid (per Ultrasound) Treatment: Referred to Endocrinologist. Prescribed Methimazole 5mg twice daily Outcome (as of 6/24/2021): Condition improved. Will continue Endocrinologist visit to monitor condition
57 2021-06-24 palpitations Heart palpitations. Palpitations were gone around June 17, 2021. It lasted about 7 weeks.
57 2021-06-25 heart rate increased After and elevated heart rate for 15 hours.
57 2021-06-25 fainting, heart rate decreased, hypotension Patient fainted while sitting upright in chair approximately 2-3 minutes after receiving Moderna sho... Read more
Patient fainted while sitting upright in chair approximately 2-3 minutes after receiving Moderna shot. He was unresponsive to touch or sensation for about 3 minutes but did stop breathing/circulation. He had some clamminess and low blood pressure/pulse during the event. However, he did not show symptoms of swelling, itching, or anaphylaxis. We applied a cool towel to his head and neck, and when he became conscious, gave him a bottle of water. Patient waited until EMS arrived where he was found to have had syncope/hypotension. Patient remained in pharmacy area another 15 minutes after being cleared by EMS before leaving. He did not require any further medications or treatment.
57 2021-06-28 chest pain, heart attack, chest discomfort Within 12-14 hours of getting the Maderna shot(1st shot), not only did I have a sore arm, but my sho... Read more
Within 12-14 hours of getting the Maderna shot(1st shot), not only did I have a sore arm, but my shoulder had pain. Each day the pain got a little worse and started stretching to my chest. My chest and heart were uncomfortable. My wife was having the same symptoms so we just tried to manage through the pain. One April 28, the pain was so severe it woke me up in the middle of the night. I took some antacids and that seemed to help. The next 3 days the pain was on and off until May 1 evening, the pain was so severe and I was vomiting that we decided to go to the hospital. It was determined that I had a heart attack.
57 2021-06-28 heart rate increased, loss of consciousness My heart went into v-fib flurry and the AICD I have went off 5 times in 3 days. I had a bio-polar v-... Read more
My heart went into v-fib flurry and the AICD I have went off 5 times in 3 days. I had a bio-polar v-tach ablation in 2018 that was successful and had no V-fib since May 2019. The symptoms cause my heart rate to elevate 300 bpm in a fraction of a second and passed out each time. I was hospitalized and had to have amiodarone added to my system to get it to stop. Since I have had no v-fib and the only change in my life was the vaccine I received just 1 week prior.
57 2021-06-29 blood pressure increased, heart rate increased I have had a overactive thyroid with a thyroid nodule for over 10 years and no issues. After I recei... Read more
I have had a overactive thyroid with a thyroid nodule for over 10 years and no issues. After I received my first Moderna vaccine shot I started to not feel well with TSH numbers going down. After the second Moderna vaccine shot my TSH number went down even more and I went to the Emergency Room multiple times as it seems the vaccine could have accelrated my TSH numbers to go down more they were previously. Due to my thyroid I experienced tremors, rapid heart beat and elevated blood pressure. On June 5,2021 I was put on thyroid medication, Before the vaccine shots I did not experience any of these thyroid issues or symptoms.
57 2021-06-29 cardiac arrest Block; cardiac arrest; This spontaneous case was reported by a nurse and describes the occurrence of... Read more
Block; cardiac arrest; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC ARREST (cardiac arrest) and CAROTID ARTERY OCCLUSION (Block) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A,) for COVID-19 vaccination. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL PHOSPHATE and ROSUVASTATIN CALCIUM for an unknown indication. On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion medically significant). On an unknown date, the patient experienced CAROTID ARTERY OCCLUSION (Block) (seriousness criterion medically significant). At the time of the report, CARDIAC ARREST (cardiac arrest) had resolved and CAROTID ARTERY OCCLUSION (Block) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment 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. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional 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. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional information has been requested.
57 2021-06-30 pulmonary embolism, palpitations Patient is a 57-year-old male currently in rehab facility with past medical history of heroin depend... Read more
Patient is a 57-year-old male currently in rehab facility with past medical history of heroin dependence, mood disorder, nephrolithiasis, history of 20 foot fall 5/21/2021 from fire escape to concrete floor with polytrauma , burst fracture L1 and L2 vertebral bodies, right lateral malleolar fracture, open right calcaneal fracture, sacrococcygeal fracture and left avulsion fracture of tibia, admitted to hospital, patient status post posterior fusion T11-L4, incision and drainage of right calcaneal wound and pinning, I&D left leg abscess, patient has resultant neurogenic bladder and neurogenic bowel post fall and has been self catheterizing, patient was initially discharged to current and rehab on 5/29/2021 and patient was discharged to rehab facility on 6/15/2021, presented to Medical Center emergency room with 3-day history of palpitation and shortness of breath, 2-day history of hematuria,, work-up in the emergency room at Medical Center included CTA of the chest which showed bilateral pulmonary embolism, CT scan of the abdomen pelvis showed multiple bilateral nonobstructive renal stones, bladder stones, fracture of L1-L2 vertebrae with postoperative changes, fracture of coccyx. Patient started on IV heparin, patient received 2 L of IV fluids and patient was also given Rocephin and cefuroxime initially hospital was contacted for transfer apparently they did not have any beds and patient was transferred to Hospital. When seen patient noted to be alert awake oriented x3 patient has a indwelling Foley catheter with gross hematuria, patient is on heparin drip, patient is complaining of pain lower back, numbness left foot.
57 2021-07-08 atrial fibrillation Atrial Fibrillation , Cardioversion
57 2021-07-08 fast heart rate Fever three days Muscle aches three days Tachycardia continues till this date Headache two days
57 2021-07-09 palpitations, inflammation of the heart muscle Day 5 palpitations and shortness of breath, lessened over 3-4 days. Diagnostic testing only. No trea... Read more
Day 5 palpitations and shortness of breath, lessened over 3-4 days. Diagnostic testing only. No treatment.
57 2021-07-10 pulmonary embolism, deep vein blood clot DVT/Pulmonary embolus
57 2021-07-11 blood pressure increased My blood pressure rose to 180/120 and I felt like I had a stroke. The hospital said it was not a str... Read more
My blood pressure rose to 180/120 and I felt like I had a stroke. The hospital said it was not a stroke but may have been a TIA. My blood pressure is still elevated. The hospital raised my blood pressure medication to double the dose I have been taking for over 10 years. I have a follow up with my doctor. But most days I don?t feel well because my feet are very swollen and my head feels like I am going to faint.
57 2021-07-11 cerebrovascular accident Shot 1: Vaccine was given on March 24, 2021 and I woke up at 2:00/am March 25, 2021 with horrible h... Read more
Shot 1: Vaccine was given on March 24, 2021 and I woke up at 2:00/am March 25, 2021 with horrible headache and pain behind right eye. Seen ophthalmologist on April 2, 2021. Pain and headache continued and became worse. Continued regular visits with ophthalmologist. Pain continued behind right eye so I was sent for CT scan of brain, which showed normal at that time. Pain behind right eye continued. I had my second vaccine on April 21, 2021 and April 25, 2021 woke up feeling very strange. Throat was getting numb and left side of body was numb. Layed back down for a few hours and then went to work. By 6:15/pm was not feeling well at all and went home and went to bed. April 26, 2021 8:00/am was headed to Ophthalmologist and started having very blurry vision and numbness again and went straight to ER instead.. Was given MRI and CT scans and diagnosed with a Arterial Stroke of the Occipital lobe. Was admitted to Hospital Pain behind right eye went away after stroke but now have no vision midline to the left out of either eye. Currently being treated by the specialist of for vision issues
57 2021-07-13 chest pain, coughing up blood Blood clots in both their lungs; though they had covid-19; Difficulty breathing; Sharp pain in chest... Read more
Blood clots in both their lungs; though they had covid-19; Difficulty breathing; Sharp pain in chest; Though they have pulled a muscle; Spiting up blood; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clots in both their lungs), DYSPNOEA (Difficulty breathing), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), CHEST PAIN (Sharp pain in chest) (seriousness criterion hospitalization), MUSCLE STRAIN (Though they have pulled a muscle) (seriousness criterion hospitalization) and HAEMOPTYSIS (Spiting up blood) (seriousness criterion hospitalization). On 04-Jul-2021, the patient experienced SUSPECTED COVID-19 (though they had covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clots in both their lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Jul-2021 to 05-Jul-2021 due to CHEST PAIN, DYSPNOEA, HAEMOPTYSIS, MUSCLE STRAIN, PULMONARY THROMBOSIS and SUSPECTED COVID-19. At the time of the report, PULMONARY THROMBOSIS (Blood clots in both their lungs), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, Oxygen saturation: unknown (abnormal) unable to have a good oxygen level. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications included High blood pressure medication and cholesterol medication. Treatment medications included antibiotics and pain medication. Reportedly, the patient was scheduled to get the second dose on 20-Jul-2021. Company Comment: 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.
57 2021-07-13 heart rate increased Pt called hospital reporting after pt got the Moderna vaccine, pt stated the rapid heart beat came b... Read more
Pt called hospital reporting after pt got the Moderna vaccine, pt stated the rapid heart beat came back and becomes almost daily with increased frequency.Pt stated he was previously positive for covid19 in September of 2020 and started experiencing rapid heart beat at times. Advised pt to go to ED immediately to get evaluated.
57 2021-07-13 fast heart rate, blood pressure increased For about six days I was miserable and not feeling very good. Fever, fatigue, headaches and just fe... Read more
For about six days I was miserable and not feeling very good. Fever, fatigue, headaches and just felt like crap. I had a fever of 100.5 (highest) for three or four days. It broke and then it started feeling better on the 6th day. I had very sore shoulder for the first two days. I have regular side affects of medicine that affects me daily. I felt very miserable. (This was worse symptoms than after I got the second vaccine.) I have long term COVID - low oxygen issue - I went to Hospital - 11 liter 02 and 60% pressure. I was still dealing with low 02 during the day; I have insulin issues - still out of whack - doctors are monitoring it. My blood pressure has been up in the 200 range - they got it into the 160's or so but they are increasing the heart meds - they are doubling the heart meds (have some new ones - Metoprolol was ended - and Carvedilol 25 mg take one tab twice a day; Mepacrine ER Osmtic - 30 mg one, twice a day now )- my heart is still unstable - electrical tachycardia is the name for it and that is affecting me. Inflammatory of the voice box caused by what they don't know - it comes and goes (the voice) -I will get it examined it soon - it is also causing Thrush - burning redness of the tongue. Monday the 19th of April - was in ER for 15 hours before they got me upstairs - admitted the 20th. (Have a previous spinal cord injury, hip injury etc. from work related.) Potassium - was taking one a day and I'm taking four a day now - they are not sure why but I need to take that many now. I am also going thru a Respiratory therapist - every couple of weeks I'm going through that to strengthen my lungs.
57 2021-07-13 transient ischaemic attack, chest pain Severe pain in the left side of his chest; Pain in calf; Had to use a cane to walk; Severe pain in t... Read more
Severe pain in the left side of his chest; Pain in calf; Had to use a cane to walk; Severe pain in the left side of hip and knee; First dose drained him; Nerve root disorder; The first dose drained him, and he made his whole right side numb; Severe pain in the left side of his temple; It feels like he had a mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) and NERVE ROOT INJURY (Nerve root disorder) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced HEADACHE (Severe pain in the left side of his temple). On 27-Jun-2021, the patient experienced HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb). On 05-Jul-2021, the patient experienced NERVE ROOT INJURY (Nerve root disorder) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee) and FATIGUE (First dose drained him). The patient was treated with PREDNISONE at a dose of 20 mg. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke), NERVE ROOT INJURY (Nerve root disorder), HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb), CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee), FATIGUE (First dose drained him) and HEADACHE (Severe pain in the left side of his temple) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication was reported. Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
57 2021-07-14 chest pain Some Chest pain in the middle @ 2:30 AM while sleeping . 06/25/2021
57 2021-07-15 deep vein blood clot Patient reported having left arm swelling for about 2 weeks. Both injections were done on his left d... Read more
Patient reported having left arm swelling for about 2 weeks. Both injections were done on his left deltoid. Underwent screening, patient had a positive left upper extremity DVT and was given an apixaban prescription to take 10 mg by mouth twice daily for 7 days followed by 5 mg twice daily. Doctor reached out to the patient after discharge from the emergency department, patient did not pick up the call on 07/12/21 or the second follow up call on 07/13/2021. They are waiting for the patient contact them back regarding his symptoms.
57 2021-07-17 heart rate increased, oxygen saturation decreased, chest discomfort First shot: symptoms appeared within 6 hours, headache, fatigue, fever, muscle aches and shortness o... Read more
First shot: symptoms appeared within 6 hours, headache, fatigue, fever, muscle aches and shortness of breath. stayed about a week (fever and headache_. Then had a bit of itchy outbreaks for about another week Reported all on Second shot: Symptoms appeared within 4 hours. Felt lightheaded just leaving the innoculation center. Within a couple of hours, felt really tired, fell asleep, woke an hour or so later, massive headache, feverish, light sensitive, achey, shortness of breath. Light sensitivity went away after a few days but all other symptoms were much more intense and of longer duration then the first shot reactions. I noted that my health app showed a drop in my O2 levels at night and unexplained increased heart rate episodes (over 160) this went on for weeks. Got more severed itchy episodes several weeks after the second shot and that lasted for acouple of weeks. Noted three of four tiny "blood blisters" that itched on the arm I got the shot on. Got really dizzy at points too. I had chest tightness and breathing difficulties leading to light headiness when wearing covid masks, which did not have previously. SEE CONTINUATION PAGE
57 2021-07-23 chest pain, heart attack, troponin increased Pt. came into ED with chest pain. Labs were done and pt. has an elevated troponin. Was diagnosed wit... Read more
Pt. came into ED with chest pain. Labs were done and pt. has an elevated troponin. Was diagnosed with NSTEMI and transferred to a hospital with a cath lab.
57 2021-07-27 loss of consciousness Patient passed out while waiting until his post injection required 15 minutes. Eyes rolled back and ... Read more
Patient passed out while waiting until his post injection required 15 minutes. Eyes rolled back and he vomiting all over himself. He was sweating perfusely. Called paramedics and they checked his blood pressure, and remained until he was stable. Patient left sometime later after he had rested .
58 2021-01-03 blood pressure increased About 2 minutes after receiving vaccine the individual reported feeling light headed. He also descr... Read more
About 2 minutes after receiving vaccine the individual reported feeling light headed. He also described an uncomfortable tingling sensation in his throat. Blood pressure had been normal prior to vaccination and became elevated. After about 30 minutes of persistent reaction, one dose of epi-pen (generic) was given. About 3 minutes after receiving the epinephrine he felt safe to stand up and more to a more comfortable chair. Lightheadedness, throat sensation, and elevated blood pressure resolved. He stayed another 15 minutes for observation and has no return of symptoms.
58 2021-01-04 blood pressure increased blurred vision, elevated BP Went to PCP. Given BP med and advised not to take second dose of vaccin... Read more
blurred vision, elevated BP Went to PCP. Given BP med and advised not to take second dose of vaccine
58 2021-01-04 hypertension, heart rate increased Patient has a history of heart disease. Post vaccine patient experienced abnormally high blood press... Read more
Patient has a history of heart disease. Post vaccine patient experienced abnormally high blood pressure, even for that of a patient with preexisting disease. Blood pressure was monitored and recorded at least three times a day. Around 48 hours post vaccine, patient experienced sweats and shortness of breath while at work. Heart rate per monitoring device recorded around 145+ even reaching a max heart rate of 160. 72 hours post dose on New Years Eve around 23:00 patient experienced high blood pressure and sinus arrhythmia resulting in admission to the emergency department. Labs and an ECG were ordered.
58 2021-01-07 pallor Dizziness Narrative: became pale. Minimal breakfast.
58 2021-01-09 hypertension, fast heart rate HYPERtension & Tachycardia Narrative: went to the emergency room when he started to feel tachycardi... Read more
HYPERtension & Tachycardia Narrative: went to the emergency room when he started to feel tachycardia and his BP was 160's over 100's. Employee has a history of AAA and was observed, CT scan with contrast and released. no medicine.
58 2021-01-11 heart rate increased Pt complained of difficulty swallowing, lump in throat, and increasing heart rate. VS 98.9 181/100... Read more
Pt complained of difficulty swallowing, lump in throat, and increasing heart rate. VS 98.9 181/100 87 99 RA. Activated Alert, brought to the ED. Epi and benadryl given.
58 2021-01-14 fast heart rate Fever, Chills, Tachycardia, Headache, Dehydration, Muscle aches, Sleeplessness. Onset approximately ... Read more
Fever, Chills, Tachycardia, Headache, Dehydration, Muscle aches, Sleeplessness. Onset approximately 8:00 pm evening of vaccination, 1-14-2021. Fever, tachycardia , dehydration relieved approx 10:00 am following morning, 1-15-2021. Headache and muscle soreness persist.
58 2021-01-18 heart rate increased, blood pressure increased About 10 minutes after receiving the vaccine, patient became dizzy. Symptoms then progressed to inc... Read more
About 10 minutes after receiving the vaccine, patient became dizzy. Symptoms then progressed to increased heart rate (104), increased blood pressure (~180/120), tremors, and blurred vision. Patient stated he was diabetic, glucose was checked (198 - was ~4 hours after eating a bagel - had taken lantus the night before and victoza that morning). Oxygen was good, no trouble breathing. Pupils dilated.
58 2021-01-20 heart rate irregular, palpitations some arm soreness around injection site, chills, then body aches and headache. The worst seemed to ... Read more
some arm soreness around injection site, chills, then body aches and headache. The worst seemed to be heart palpitations. My heart began racing to about one and one half the normal to a rate of 100, at about 30 hours after the injection. It then slowed to 50 bpm for about 15 minutes before racing back to 100 and becoming somewhat irregular, slow pace followed by several quick beats then a beat or two slow again and then several quick beats. This lasted for a few hours and then I fell asleep. When I woke up about 7 hours later, it was back to normal. Some slight body ache and headache.
58 2021-01-21 cardiac arrest Cardiac arrest Narrative:
58 2021-01-22 heart attack, chest pain Chest pain, leading to STEMI
58 2021-01-23 chest pain CHEST PAIN
58 2021-01-24 fast heart rate About an hour after he received his vaccine, he experienced tachycardia, tremors that lasted about a... Read more
About an hour after he received his vaccine, he experienced tachycardia, tremors that lasted about an hour, his hands and face turned red, he experienced mental fogginess, and his vision "went out" for a short time. He ate a little bit of food, took some food, went home and rested and his symptoms calmed down. The next day (Saturday) he just felt fatigued. He did say that he had not ate breakfast before receiving his vaccine. He also spoke with a family member who is a doctor but did not actually go to a doctor's office/clinic.
58 2021-01-27 blood pressure increased, hypertension Myalgia, Fever, HYPERtension, Fatigue, insomnia Narrative: Patient experienced symptoms of body ach... Read more
Myalgia, Fever, HYPERtension, Fatigue, insomnia Narrative: Patient experienced symptoms of body aches, low grade fever, fatigue, elevated BP, and local arm pain starting four hours after vaccination. Patient had insomnia that night. Symptoms lasted approximately 24 hours.
58 2021-02-02 atrial fibrillation Patient is a 58-year-old male with above-mentioned comorbidities presented with feeling hot and fain... Read more
Patient is a 58-year-old male with above-mentioned comorbidities presented with feeling hot and faint. Patient was found to have A. fib with RVR which was new onset received IV Cardizem. Patient was kept on telemetry serial cardiac enzymes were negative for acute coronary syndrome. Echo done showed an ejection fraction of 58%. Cardiology evaluation was done by Dr. Cardiology did not recommend any long-term anticoagulation, recommended outpatient follow-up and possible Holter monitor. Patient reverted to normal sinus rhythm) clinically stable. Patient was cleared for discharge per cardiology.
58 2021-02-02 chest discomfort Moderna COVID-19 Vaccine EUA Patient received first COVID-19 Vaccine (Moderna Lot #011M20A) at 11:17... Read more
Moderna COVID-19 Vaccine EUA Patient received first COVID-19 Vaccine (Moderna Lot #011M20A) at 11:17. He was waiting his half hour post vaccine to go back to cell and then got held in gym for count. Around 11:55 he presented to healthcare staff with c/o diaphoresis, chest "tightness", blurred vision, and "tasting ammonia". Vitals 193/121, HR 73, T 98.3, sPo2 98% RA. Inmate taken to HC via wheelchair accompanied by MP. 12:10 Chest pain "8" BP 196/111, 1 SL NTG given, oxygen via 2L n/c admin, spo2 96% up to 98%, EMS called 12:15 Chest pain "6" BP 182/111, 1 SL NTG given, Blood Sugar 105, EKG hook-up 12:17 EKG, Sinus Rhythm w/ inverted T waves, no acute ST changes 12:20 Chest pain "5" BP 182/105, 1 SL NTG given, inmate chewed 325 mg ASA 12:25 BP 185/111, CP remains "5", IV started with NS gtt 13:08 off-gounds for hospital evaluation
58 2021-02-03 blood glucose increased blood sugar levels began to be about 20% higher than normal within about 24 to 48 hours after the in... Read more
blood sugar levels began to be about 20% higher than normal within about 24 to 48 hours after the injection and have stayed that way for over two weeks. No other symptoms have been experienced aside from soreness at the injection site for less than 8 hours after the shot.
58 2021-02-03 oxygen saturation decreased, hypotension Patient awake at 0300. When going into the room to get him ready for dialysis he was cold to touch, ... Read more
Patient awake at 0300. When going into the room to get him ready for dialysis he was cold to touch, unresponsive other than to sound, and nonverbal. O2 sat was 67 via finger probe. Oxygen immediately initiated and a venturi mask retrieved and initiated. When unable to arouse him via sternal rub this RN called 911. Send to ED. Febrile 39.2 and hypotensive 58/43. Admitted. unknown after that as patient expired in hospital.
58 2021-02-04 hypotension, low blood oxigenation The patient, who was a pharmacist, developed fatigue and shortness of breath hours after receiving ... Read more
The patient, who was a pharmacist, developed fatigue and shortness of breath hours after receiving vaccine. Two days later, on 01/28/2021, the patient went to local urgent care for worsening shortness of breath and was referred to Hospital for worsening dyspnea and hypoxia. The patient was admitted to the hospital We was found to have bilateral pulmonary infiltrates and treated for pneumonia with Rocephin and azithromycin. He was tested for COVID-19 multiple times, but each of the results were negative. Despite the negative results, there was high clinical suspicion for COVID-19 and the patient was started on Remdesivir and Decadron. The patient's oxygen requirements continued to worsen and the patient was transferred to another facility for higher level of care. There his hypoxia worsened and he required mechanical ventilation. Patient then developed hypotension and required vasopressors for blood pressure support. Furthermore, patient developed acute renal failure requiring hemodialysis. Despite mechanical ventilation with FiO2 100%, and for vasopressors, patient clinically deteriorated and family decided to palliatively extubate on 02/05/2021.
58 2021-02-04 heart attack Patient had a heart attack two days after receiving first Covid Vaccine. Doctor reports that artery... Read more
Patient had a heart attack two days after receiving first Covid Vaccine. Doctor reports that artery was 99% blocked.
58 2021-02-07 fast heart rate, atrial fibrillation, heart rate increased started having tachycardia on 2/4/21 while watching TV, HR from 110-150. Went to ER in am on 2/5/21 ... Read more
started having tachycardia on 2/4/21 while watching TV, HR from 110-150. Went to ER in am on 2/5/21 and admitted with A-Fib RVR.
58 2021-02-17 lightheadedness, loss of consciousness vagal response leading to unconsciousness
58 2021-02-18 heart flutter Rush of hot flash through chest and throat. Rested until subsided for at least 10 minutes. At 30_35... Read more
Rush of hot flash through chest and throat. Rested until subsided for at least 10 minutes. At 30_35 minutes had a rapid fluttering in my chest. Once home 45 minutes after shot my wife who is a medical aide checked pulse at 130bpm. 4 hours after shot down to 104bpm
58 2021-02-23 platelet count decreased, fluid around the heart Abdominal pain, nausea and vomiting, shortness of breath, acidosis, hypoglycemia, death. Onset of a... Read more
Abdominal pain, nausea and vomiting, shortness of breath, acidosis, hypoglycemia, death. Onset of abdominal pain was 30 minutes after administration of the vaccine followed by 20+ episodes of vomiting and dry heaving.
58 2021-02-24 chest pain After second Moderns COVID -19 vaccine, along with fever and body aches, individual also experience... Read more
After second Moderns COVID -19 vaccine, along with fever and body aches, individual also experienced chest pain, which he called 911 for. He was kept in hospital for observation x 24 hours, and released with dx of chest pains r/t body aches from vaccine. He states no long-term concerns.
58 2021-02-26 heart rate increased fever, body aches, chills, rapid heart beat, headache,
58 2021-03-01 heart rate increased Fast Heartbeat ( 110per minute)
58 2021-03-02 oxygen saturation decreased 2/11/21 wife and I both took 1st Vaccine Shot 2/23/21 Wife and I Both Tested Positive for Covid. Oxv... Read more
2/11/21 wife and I both took 1st Vaccine Shot 2/23/21 Wife and I Both Tested Positive for Covid. Oxvgen level for patient 93. X-RAY SHOW COVID SPREAD 2/24/21 Admitted to (hospital). Low Oxygen/elevated heart enzymes 2/25/21 Released with Oxygen
58 2021-03-03 fainting After developing soreness at the injection site about 6-8 hours post injection, I developed chills a... Read more
After developing soreness at the injection site about 6-8 hours post injection, I developed chills and thirst, at 4:30am I got up to go to urinate and afterward I was feeling light headed. I sat on the edge of the tub. After a couple of minutes I went to get up and fainted on the floor. My BP was 89/49 with a pulse of 86bpm. I was helped off the floor and back to bed where I lay with my feet elevated by a couple of pillows. No further issues at this time.
58 2021-03-05 atrial fibrillation, heart flutter, cardiac arrhythmia Moderna COVID-19 Vaccine EUA 1h15min after injection - inital symptom of sweating without chills or ... Read more
Moderna COVID-19 Vaccine EUA 1h15min after injection - inital symptom of sweating without chills or fever, 2hr after injection - significant episode of atrial fibrillation, flutter, and PVCs for approx 90 minutes. I have a history of a-fib which was successfully treated in 2008 with a PVI, this is only the second episode since that treatment
58 2021-03-05 oxygen saturation decreased Constant fatigue, low oxygen saturation percentages
58 2021-03-07 platelet count decreased, low platelet count Severe thrombocytopenia approx. 10 days after vaccine administration.
58 2021-03-09 heart rate increased Intense swelling of left arm, headaches, dizziness, elevated heart rate, possible neurological sympt... Read more
Intense swelling of left arm, headaches, dizziness, elevated heart rate, possible neurological symptoms as well. Headaches and dizziness continuing 6 days after vaccination.
58 2021-03-11 blood clot Thrombosis of the vein branch of the left eye.
58 2021-03-12 palpitations Sustained heart palpitations, nausea, diarrhea
58 2021-03-14 cardiac failure congestive, anaemia, fainting, hypotension Per MD Clinical Note 3/14/21, "Further discussion with his daughter today-patient has not been able ... Read more
Per MD Clinical Note 3/14/21, "Further discussion with his daughter today-patient has not been able to walk and has had unclear mentation for approximately 8 years after an alcohol related decline. Was in a nursing home until he moved into his parent's house. His mother actually passed away and December and his stepfather has been trying to take care of him since. Patient may periodically stand but is a house where he is pretty much confined to his bedroom and bathroom. Patient received his COVID-19 vaccine at the prescription shop 03/04/2021 and since then he has had a steady decline starting with aches and pains to increased weakness and confusion and then collapse which brought him to the emergency room. Assessment and plan Syncope with altered mental status/toxic metabolic encephalopathy Acute on chronic respiratory failure with hypercapnia Sepsis Supratherapeutic Coumadin level INR greater than 9 Anemia Small hemoperitoneum Hypotension Chronic pain syndrome COPD UTI Enteritis Subsegmental atelectatic changes with nodule left lower lobe the-recheck 3 months Cirrhosis Nicotine dependence CHF-chronic diastolic Functional quadriplegia One week post COVID-19 vaccination Agitation Other: GI bleed, PAD, hypothyroidism, history of DVT left leg, neuropathy, depression, BPH, CAD, subdural hematoma, acquired thyroid disease, GERD, Wernicke -continue to trend the LFTs downward. Is on Precedex currently to allow him to further recover. He was using accessory muscles and poor inspiratory effort today but maintaining his oxygenation. BiPAP was reinstituted to avoid CO2 retention. One possibility is that the patient consumed a significant amount of Tylenol due to the discomfort exacerbated with the cirrhosis. LFTs are trending upward still. -hypercapnia patient consume both the benzodiazepine and morphine supported initially for the 1st 36 hours with BiPAP. Has had periods where he is off and answers appropriately. -consider rescanning in a.m. To further evaluate the hemoperitoneum. Continue broad-spectrum antibiotics and hemoglobins. Patient is NPO until further delineation Patient is a functional quadriplegic year and at home is fairly dependent on his stepfather for a total care family seeking long-term care which may mentally benefit the patient with broadening his activities -blood cultures pending. " Per Clinical note 3/13/21, "Assessment and plan Syncope with altered mental status/toxic metabolic encephalopathy Acute on chronic respiratory failure with hypercapnia Sepsis Supratherapeutic Coumadin level INR greater than 9 Anemia Small hemoperitoneum Hypotension Chronic pain syndrome COPD UTI Enteritis Subsegmental atelectatic changes with nodule left lower lobe the-recheck 3 months Cirrhosis Nicotine dependence CHF-chronic diastolic Functional quadriplegia Other: GI bleed, PAD, hypothyroidism, history of DVT left leg, neuropathy, depression, BPH, CAD, subdural hematoma, acquired thyroid disease, GERD -patient is more awake and wakening a hourly on BiPAP will remove 1 fully alert and functioning will use BiPAP overnight. Nicoderm avoid tobacco. NPO unless ammonia level is elevated. Continue empiric antibiotics. Last evening required to units packed RBC. If hypotensive and or increase in anemia will rescanned. Monitor for DTs and withdraws. Was advised by the nursing staff patient is following orders. Functional quadriplegic rotation every 2 hours had bed at 20-30 degrees to avoid aspiration. Patient and his family confirm DNR status. Long-term placement required as his stepfather is unable to care for him without assistance. Anticipate restarting diet in a.m.. One fully alert will ascertain if this was delivered or accidental. Drug screen was positive for both benzos and morphine. He has been and prescribed the morphine. The dual combination liver failure patient with depression likely ill-advised "
58 2021-03-15 blood pressure increased Elevated Blood Pressure
58 2021-03-15 inflammation of the pericardium, chest pain Ablation procedure for pericarditis occurred on 3/5/21. Received 1st dose of Moderna on 3/10. That n... Read more
Ablation procedure for pericarditis occurred on 3/5/21. Received 1st dose of Moderna on 3/10. That night experienced fevers (101.7F) and fever like symptoms (sweats, chills, body aches). Continued to "not feel well". 3/15/21, presented to ED with chest pains and dx with pericarditis again. Treated with IV Vanco x1 and IV Zosyn x2 until blood work came back and cultures were negative. Due to no infection and negative for an MI, Dr. determined pericarditis was a rxn to the vaccine. Other tests results include: Elevated BNP, BUN, and CRP. CT of chest, abdomen, and pelvis is clear. 5 covid tests since admission, all negative. IgG antibodies for COVID negative. PT currently is stable and bloodwork somewhat improved. On O2, fluids and Morphine for chest pain. An acute Hepatitis panel is currently pending.
58 2021-03-16 blood glucose increased The sore arm and mild fever of 100.6 24 hours after vaccination wasn?t a surprise, but the blood sug... Read more
The sore arm and mild fever of 100.6 24 hours after vaccination wasn?t a surprise, but the blood sugar spike for four days after was. I monitor glucose with a fasting check every morning, and went from a steady average in the low 130s to a peak of 162, with four days running at 150-plus. My levels haven?t been that high since shortly after I was diagnosed, and my diet did not change. Just something I think has likely been under-reported.
58 2021-03-16 loss of consciousness Patient received injection and walked to observation area. Upon sitting down patient complained of d... Read more
Patient received injection and walked to observation area. Upon sitting down patient complained of dizziness and feeling very tired. Patient leaned back in their chair and became unresponsive upon questioning. At this point 911 was called and an ambulance was dispatched. It appeared patient was unconscious for a short period of time (5-10 seconds) and failing to respond to questions. Pt was experiencing mild diaphoresis. Pulse and breathing were being manually monitored. Patient seemed to regain consciousness however was still not answering our questions. Patient was then able to sit up and very slowly (taking many breaks) was able to walk (with assistance) to an observation room closer to the doorway. Paramedics loaded patient onto stretcher and took patient to hospital.
58 2021-03-17 blood glucose increased Patient seated in Observation area. 1740: Suddenly diaphoretic, complains of blurred vision, dizzy... Read more
Patient seated in Observation area. 1740: Suddenly diaphoretic, complains of blurred vision, dizzy and a feeling of cold in his chest. 1740:- patient placed on floor/legs up. EMS in attendance; NP in attendance. BP109/66; HR88; O2 96% on RA/ BS 118. EKG NSR 1741: patient more lucid. Answering questions 1742: patient able to drink water and eat a breakfast bar. 1817: VS 124/82; HR 62; O2 sats on RA 97%/ EKG NSR 1823: Patient discharged from observation with Son to home. Walking on his own. A & Ox3
58 2021-03-17 chest discomfort Episode of right sided chest tightness. Denies SOB and all other associated s/s. Assisted to cot to ... Read more
Episode of right sided chest tightness. Denies SOB and all other associated s/s. Assisted to cot to lay down, pt reported tightness subsided 5 minutes after rest.
58 2021-03-17 palpitations, heart rate increased chills, fever, body aches and then through out the night developed palpitations... heart rate elevat... Read more
chills, fever, body aches and then through out the night developed palpitations... heart rate elevated by > 20 bph at visit
58 2021-03-18 ischaemic stroke, cerebrovascular accident COVID and stroke December 2020. Patient's mother talked to him at 4:30 and he said he was not feeli... Read more
COVID and stroke December 2020. Patient's mother talked to him at 4:30 and he said he was not feeling well. Driving to work when coworkers found pt after he curbed his vehicle with AMS. Right side deficit with aphasia, unknown last normal. Pt had sz upon EMS arrival and 2.5mg versed given. was initially unresponsive while going into the CT suite and apparently had a seizure as soon as he arrived to the ED. but alert by the time he was done with CT head, CTA and CTP. He was followed to the ED assigned room and he was more alert but aphasic and only say 'yep' and did not follow commands. He was able to move his left side initially but not to command. about 2 minutes later he was able to move his right lower extremity to pain followed by right upper extremity. He is febrile with temp >103F. Diagnosed with seizure and Left acute arterial ischemic stroke, MCA.
58 2021-03-21 blood glucose increased I had blood work on the 11th, 5 days after vaccine. I am normally very healthy, vegetarian. My glu... Read more
I had blood work on the 11th, 5 days after vaccine. I am normally very healthy, vegetarian. My glucose levels are at 121 and my Triglyceride level is at 393. Both are considered high according to results. I have also been a little short of breath at times...a sense on indigestion, which I rarely get but seem to have it after every meal. I am not sure if this is related to my shot but I wanted to be aware of any adverse reactions. I didn't see any posted on this site. Why?
58 2021-03-22 fainting Patient started feeling lightheaded and fainted. Patient was responsive within seconds. The ambulan... Read more
Patient started feeling lightheaded and fainted. Patient was responsive within seconds. The ambulance was called and he was taken away responsive.
58 2021-03-25 loss of consciousness believes blacked out for 5 to 8 minutes; left side of face felt weird; blurry vision in both eyes; s... Read more
believes blacked out for 5 to 8 minutes; left side of face felt weird; blurry vision in both eyes; slurred speech; metallic taste in mouth; unable to sit up; arm pain near injection site; A spontaneous report was received from a consumer concerning a 58 years old, male patient who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced a loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 19 Mar 2021, the patient received their 0.5 ml of planned dose of mRNA-1273 (Lot number: 046A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19Mar2021, within 15 minutes of receiving the vaccine, the patient experienced face feeling weird, blurry vision in left eye, blurry vision in right eye, speech slurred, inability to sit up, metallic taste in the mouth, loss of consciousness, and some arm pain near injection site. The patient went to the emergency room (ER) and underwent electrocardiogram (EKG), unspecified blood work, neurological tests, and computerized tomography (CT scan). Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events loss of consciousness and slurred speech was resolved, and the outcome of the other events was not resolved. The reported events are loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain, were considered related to mRNA-1273.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
58 2021-03-28 blood pressure increased Dizziness, Nausea started within 5 minutes of vaccine. Paramedics onsite checked vitals, oxygen lev... Read more
Dizziness, Nausea started within 5 minutes of vaccine. Paramedics onsite checked vitals, oxygen levels good, pulse good, however BP was 200/120. Normal BP for patient is 145/85.
58 2021-03-28 pallor Pt. Became ?Dizzy & clammy?, looking a little pale.
58 2021-03-29 ischaemic stroke, stroke ischemic stroke of the L corona radiata with speech changes
58 2021-03-30 heart rate decreased, pallor Patient was seated and in 15 minute observation period (approx 10 mins in) and when questioned if he... Read more
Patient was seated and in 15 minute observation period (approx 10 mins in) and when questioned if he was ok, replied that he was light headed. His pallor was very pale and he was sweating. When the pharmacist approached him to help, he was slumping over in the chair and in and out of coherence. He answered questions about his breathing and confirmed that he only felt light headed and breathing was not labored. After removing his sweatshirt and mask to cool him off and allow better breathing and giving him some water, his skin color returned to normal and he was again speaking coherently. His pulse and heart rate were a bit slow throughout. Ambulance was called and the patient refused to go to the hospital claiming he felt fine.
58 2021-03-31 pallor STATES DIAPHORETIC, DIZZY, PALE AFTER RECEIVING VACCINE. RECEIVED 1 LITER OF NORMAL SALINE IN ER ON... Read more
STATES DIAPHORETIC, DIZZY, PALE AFTER RECEIVING VACCINE. RECEIVED 1 LITER OF NORMAL SALINE IN ER ON 12/23/20
58 2021-04-01 blood pressure increased Evaluated patient in Covid vaccine clinic after alerted that patient developed severe occipital head... Read more
Evaluated patient in Covid vaccine clinic after alerted that patient developed severe occipital headache about 10 minutes after his 2nd dose of Moderna Covid vaccine. He denies any history of headaches. He denies any other symptoms. No nausea, no vision changes, no numbness or weakness. No swelling, itching, rash, no shortness of breath, dizziness, or abdominal symptoms. He denies side effects from his 1st Covid vaccine. He denies a history of significant health problems and states he takes no medications. Exam revealed a middle aged male sitting comfortably in NAD. Alert and oriented x3 PERRL, no photophobia, EOMI, CNs grossly intact. RRR without murmur. Neuro exam without focal deficits. Normal gait. Patient was monitored for about 20 min at which time he felt he could safely drive himself home - 4 blocks down the road. He was instructed to take some Tylenol when he gets home and rest. Call 911 in the event of numbness, weakness, vision changes, dizziness, slurred speech or other severe symptoms. He is supposed to work and plans to call in sick so he can rest. I did mention his elevated BP which is probably isolated but he should make an appt with his PCP for a recheck of his blood pressure. Vitals BP=157/94; Sitting Temp=97.1 F Oral; Pulse=76; Resp=20; Vitals Comment: SaO2 96% 3/31/2021 2:20 PM by MD
58 2021-04-01 chest pain Extreme chest pain (first 3 hours), arm pain (both arms, 24 hours) nausea (24 hours+), alternating c... Read more
Extreme chest pain (first 3 hours), arm pain (both arms, 24 hours) nausea (24 hours+), alternating chills and sweating, (36 hours, no temperature taken). Extreme lack of energy, sleepyness (36 hours) Everything started about the same time, very suddenly.
58 2021-04-02 cardiac arrest Began with weakness of March 24th and stroke- like symptoms despite a clear CT Scan and EKG. Trouble... Read more
Began with weakness of March 24th and stroke- like symptoms despite a clear CT Scan and EKG. Trouble walking or staying awake. Heart stopped on March 28th. Deceased.
58 2021-04-05 heart rate increased, cardiac arrest, oxygen saturation decreased sore arm, lethargy, chronic fatigue, fever, fluid on lungs, lack of oxygen, death Husband received f... Read more
sore arm, lethargy, chronic fatigue, fever, fluid on lungs, lack of oxygen, death Husband received first dose of MODERNA vaccine on 1/30/21. Mild side effects. Received second dose on 2/24/21. For the first week after the second dose, the side effects seemed normal. By the second week he was gasping for air. Rused to ER via ambulance on 3/9/21. High heart rate, poor oxygen. Received numerous blood transfusions over 3-days (typical treatment for his blood disorder), yet body would not retain the transfused products. Died on 3/12/21 at 4:35 am from cardia arrest caused by respiratory failure.
58 2021-04-12 heart rate decreased Fever 102, Fatigue, Sweats, Diarrhea, low pulse ox Possible groundglass opacity within the bilateral... Read more
Fever 102, Fatigue, Sweats, Diarrhea, low pulse ox Possible groundglass opacity within the bilateral lower lobes which may represent inflammatory/ifectious process. Prescribed azithromycin
58 2021-04-12 pulmonary embolism, deep vein blood clot Swelling of the legs began on the 28th of February, Patient went to ER on March7th and diagnosed wit... Read more
Swelling of the legs began on the 28th of February, Patient went to ER on March7th and diagnosed with DVT. Patient was discharged about 12 hours after arrival and put on rivaroxaban. Patient returned to the ER on March 13th and was diagnosed with bilateral Pulmonary Embolism patient was kept overnight put on heparin drip and then transitioned to rivaroxaban. Patient does not know if the vaccine was the cause as patient has had 2 previous DVT's (no previous PE's). DVT's both occurred after transcontinental flights. This recent DVT and PE occurred with no know reason. Patient is positive for Leiden5
58 2021-04-13 chest discomfort Pressure in chest at 24 hours afterwards lasting 5 minutes, again 10 days later lasting 10 minutes t... Read more
Pressure in chest at 24 hours afterwards lasting 5 minutes, again 10 days later lasting 10 minutes then 11 days after lasting longer and went to the ER. EKG test good, heart enzyme (troponin) tests showed slightly increasing damage over the first 6 hours, then decreasing. chest X-Ray, Lexiscan, heart Cath and stent in the MLAD on 4/3/21.
58 2021-04-13 loss of consciousness, cardiac arrest We both got our shot at the same time on March 17, 2021. Then on March 22, 2021 at 9:20 PM my husban... Read more
We both got our shot at the same time on March 17, 2021. Then on March 22, 2021 at 9:20 PM my husband suffered cardiac arrest and a seizure. His heart was revived however, due to lack of oxygen to his brain he suffered brain damage and never regained consciousness and passed on 4/3/21 with acute respiratory failure.
58 2021-04-14 blood pressure decreased Swelling of the lips and cheek area. Major and rapid drop in blood pressure. Chills and slight fev... Read more
Swelling of the lips and cheek area. Major and rapid drop in blood pressure. Chills and slight fever
58 2021-04-15 cardiac arrest Patient's sister, spoke to Public Health staff to say that he passed away suddenly on 4/3/21 from a ... Read more
Patient's sister, spoke to Public Health staff to say that he passed away suddenly on 4/3/21 from a cardiac arrest, he had no underlying health conditions she states but did take some medications, she believes for blood pressure.
58 2021-04-15 platelet count decreased Patient had routine labs done the morning following his injection and his wbc and platelet count wer... Read more
Patient had routine labs done the morning following his injection and his wbc and platelet count were both low. His wbc count was 2.25 and his platelet count was 32. Patient was asymptomatic. He was a new patient that had not seen a doctor in several years so there was no previous labs to compare. Lab work was ordered as part of a yearly screening.
58 2021-04-16 chest pain chest pain, severe headache , inability to walk 30 feet, fever.
58 2021-04-17 blood clot blood clotting in brain
58 2021-04-18 blood pressure increased Elevated blood pressure ~30-40 higher than normal systolic and ~10-20 higher than normal diastolic f... Read more
Elevated blood pressure ~30-40 higher than normal systolic and ~10-20 higher than normal diastolic for 4 days following vaccination. Values gradually descending towards normal on days 4-6. Max measured resting BP was 161/101. Accompanying headaches, neck, back, and shoulder pains may have been related. Occasional "dizziness" at times assumed to be higher BP occurrences.
58 2021-04-18 fainting, loss of consciousness That evening chills, fever, headache started, little nausea, more frequent urination. Continued int... Read more
That evening chills, fever, headache started, little nausea, more frequent urination. Continued into the next day. Dizziness started 03-20-21. Blacked out if stood up too fast, but didn't hit your head. Severe dizziness, fainting spells continued with fever. At that point went 2 PM.
58 2021-04-18 blood clot, deep vein blood clot He got his vaccine, and on Easter he thought that he had a cramp in his leg, and asked his wife and ... Read more
He got his vaccine, and on Easter he thought that he had a cramp in his leg, and asked his wife and told her that he had this. By that afternoon he still had the cramping feeling, and started drinking water as his wife is a nurse and felt that he may be dehydrated. Throughout the week he had a Charlie Horse pain in his left calf, and felt that it was getting worse and not going away. The whole week he went to work and on the 7th day it started swelling and went to Hospital after he got off of work, and he saw a resident who said that his leg was swollen and told him that she was going to schedule an ultrasound. He had that on Friday on 4/16/21, and was scheduled for 4:00 but due to the pain went to the ER and gave him IV and checked his blood work. The ultrasound showed that he did have a blood clot and prescribed Eliquis and gave him a dose while in the ER. He told him that he would be on 2 a dat for 7 days and then 1 a day, but did not tell him how long. He is supposed to see the resident this afternoon for recheck. He is still having pain and wanting to know where he is going to do from this point. He does work out every day at his home gym and has not smoked, and now wanting to know how this is going to affect his life from this point into the future. He also jumps rope 3 times a day and now not able to do this.
58 2021-04-18 blood clot He got his vaccine, and on Sunday he thought that he had a cramp in his leg, and asked his wife and ... Read more
He got his vaccine, and on Sunday he thought that he had a cramp in his leg, and asked his wife and told her that he had this. By that afternoon he still had the cramping feeling, and started drinking water as his wife is a nurse and felt that he may be dehydrated. Throughout the week he had a Charlie Horse pain in his left calf, and felt that it was getting worse and not going away. The whole week he went to work and on the 7th day it started swelling and went to Hospital after he got off of work, and he saw a resident Dr. who said that his leg was swollen and told him that she was going to schedule an ultrasound. He had that on Friday on 4/16/21, and was scheduled for 4:00 but due to the pain went to the ER and gave him IV and checked his blood work. The ultrasound showed that he did have a blood clot and prescribed Eliquis and gave him a dose while in the ER. He told him that he would be on that for a while. He is supposed to see the resident this afternoon for recheck. He is still having pain and wanting to know where he is going to do from this point. He does work out every day at his home gym and has not smoked, and now wanting to know how this is going to affect his life from this point into the future. He also jumps rope 3 times a day and now not able to do this.
58 2021-04-19 cerebrovascular accident diagnosed of a stroke, tested positive for covid-19
58 2021-04-19 nosebleed Three (so far) episodes of VERY severe nosebleeds lasting up to 30 minutes. Not normal for me.
58 2021-04-19 loss of consciousness, fainting The patient is a 58-year-old male who presents as a transfer from Hospital for evaluation and of rec... Read more
The patient is a 58-year-old male who presents as a transfer from Hospital for evaluation and of recurrent syncope and management of a left-sided mandibular fracture. The patient reports that his symptoms first started after his first dose of the moderna vaccine. He reports that he felt recurrent nausea and diaphoresis however had no syncopal episodes. Following his second dose of vaccine on 4/13 he reports 3 episodes of syncope. He describes the sensation of nausea and diaphoresis followed by loss of consciousness. After the first episode he passed out and he hit him his jaw and has pain in his left jaw since that time. He had 2 further episodes of syncope 2 of which were witnessed. No seizure activity was described by by witnesses and the episode lasted approximately 1-1/2 minutes. He denies any palpitations or chest pain or incontinence or tongue biting. He denies similar symptoms previously.
58 2021-04-19 pulmonary embolism Patient admitted to Hospital on 4/19/21 for bilateral pulmonary embolisms.
58 2021-04-20 heart rate increased, pulmonary embolism, deep vein blood clot Could not walk; Leg was swollen; Nurse told him his leg was hot; blood clot in both his lungs; Blood... Read more
Could not walk; Leg was swollen; Nurse told him his leg was hot; blood clot in both his lungs; Blood clot in both his legs; Fast heartbeat; Soreness in left calf; Ultrasonography NOS abnormal; CT abnormal; Ankle and foot still swollen; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in left calf), GAIT DISTURBANCE (Could not walk), PERIPHERAL SWELLING (Leg was swollen), FEELING HOT (Nurse told him his leg was hot), PULMONARY EMBOLISM (blood clot in both his lungs), DEEP VEIN THROMBOSIS (Blood clot in both his legs), HEART RATE INCREASED (Fast heartbeat) and ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal) in a 58-year-old male 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 No adverse event. Concomitant products included IRBESARTAN and LEVOTHYROXINE for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in left calf) (seriousness criterion hospitalization). On 17-Mar-2021, the patient experienced GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Leg was swollen) (seriousness criterion hospitalization), FEELING HOT (Nurse told him his leg was hot) (seriousness criterion hospitalization), PULMONARY EMBOLISM (blood clot in both his lungs) (seriousness criterion hospitalization), DEEP VEIN THROMBOSIS (Blood clot in both his legs) (seriousness criterion hospitalization) and HEART RATE INCREASED (Fast heartbeat) (seriousness criterion hospitalization). On 14-Apr-2021, the patient experienced JOINT SWELLING (Ankle and foot still swollen). On an unknown date, the patient experienced ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal) (seriousness criterion hospitalization prolonged) and COMPUTERISED TOMOGRAM ABNORMAL (CT abnormal). The patient was hospitalized from 17-Mar-2021 to 20-Mar-2021 due to DEEP VEIN THROMBOSIS, PAIN IN EXTREMITY and PULMONARY EMBOLISM. At the time of the report, PAIN IN EXTREMITY (Soreness in left calf), GAIT DISTURBANCE (Could not walk), PERIPHERAL SWELLING (Leg was swollen), FEELING HOT (Nurse told him his leg was hot), PULMONARY EMBOLISM (blood clot in both his lungs), DEEP VEIN THROMBOSIS (Blood clot in both his legs), HEART RATE INCREASED (Fast heartbeat), ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal), COMPUTERISED TOMOGRAM ABNORMAL (CT abnormal) and JOINT SWELLING (Ankle and foot still swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: abnormal (abnormal) Abnormal. In 2021, Ultrasound scan: abnormal (abnormal) Abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) 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. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
58 2021-04-20 heart rate increased Fever, chills, body aches and pains, vomiting, headaches, rapid heart rate, inability to sleep, naus... Read more
Fever, chills, body aches and pains, vomiting, headaches, rapid heart rate, inability to sleep, nausea 7 days and counting, diarrhea, lack of energy
58 2021-04-20 hypotension Within few days after shot patient had very low energy lasting even to this day 4/21/21. Patient con... Read more
Within few days after shot patient had very low energy lasting even to this day 4/21/21. Patient contacted doctor's office and nurse said he needs to get better before taking the second dose. Some of these side effects he had before his shot because he has COPD already but he describes it as it is much worse now. The doctor's office set up a blood test to further investigate what it is due to. Patient didn't even have energy to move boxes while moving locations. Oxygen usually 96 or 97 now it is 92 or 94. He describes really low energy level, nauseated throughout the day a lot, fatigue, feel sleepy a lot , so out of breath and started hyperventilated but it could be from panic attack he says. He still feels these symptoms to this day. He says it goes away when wife talks and rubs his back and when he lays still. BP is little low diastolic in 60s but normally 70s. yesterday 91/62. He says it could be due to synthroid discontinuation which he stopped taking one year ago but started back the morning of 4/21/21 to see if that is what is the cause. He can not raise left arm above shoulder. Having excruciating, tear jerking pain but got his vaccine in right arm. He describes some pain is in the right shoulder.
58 2021-04-20 loss of consciousness He presented to the ER via ambulance after he had 3 witnessed seizures which included full loss of c... Read more
He presented to the ER via ambulance after he had 3 witnessed seizures which included full loss of consciousness and rhythmic jerking lasting for an unknown duration. En route apparently he was seizing and prehospital personnel gave him 5 mg IM versed as well as 5mg iv versed which did seem to abate the seizure. He was apparently quite combative and has no prior history of seizures. In the ER the patient was apparently having right sided eye deviation and was given 2mg of Ativan. A stat CT of the head did not reveal any acute process. Telemetry neurology was consulted. During his work up the patient was found to have a urine toxicology positive for amphetamines as well as opiates. Telemetry neurology recommended loading the patient with Keppra, initiating regular Keppra doses and indicated they believed the etiology of his seizures was polysubstance abuse.
58 2021-04-21 loss of consciousness Upon getting second vaccine dose, patient immediately lost consciousness and appeared to be having a... Read more
Upon getting second vaccine dose, patient immediately lost consciousness and appeared to be having a seizure and difficulty breathing. Patient became responsive and was talking to EMS upon their arrival. Pt then lost consciousness for second episode and EMS transported to local ER.
58 2021-04-22 chest pain Client came to the vaccine clinic with no complaints according to the vaccine check sheet. After the... Read more
Client came to the vaccine clinic with no complaints according to the vaccine check sheet. After the vaccine was administered he told a worker that he was having chest pain. Upon examination he stated that he was having chest pain before he came to the clinic this morning and that he gets the chest pain on a frequent basis. He had a stress test yesterday that was not reported until after the vaccine was administered.
58 2021-04-22 loss of consciousness Patient came for his second dose of COVID-19 vaccine. Before giving the vaccine, I asked the patient... Read more
Patient came for his second dose of COVID-19 vaccine. Before giving the vaccine, I asked the patient if they had any problems with the first dose and they stated that they did not. After giving the vaccine I went back inside the pharmacy to throw away the supplies and his son-in-law called me over to take a look at the patient. The patient had his eyes closed and head tilted back and started shaking for a couple of seconds. I had my technician call 911 at this moment. The patient has lost consciousness and I took the patients mask off to assess and confirm that he was breathing which he was. Upon regaining consciousness the patient was disoriented and sweating. Unfortunately it was difficult to find out how the patient was feeling due to a language barrier. I monitored the patient until the paramedics arrived which they took out the EKG and injected him with an IV. His BP was 107/62, HR in the 70s, and not sure if I overheard correctly but bloodsugar of 163. The EKG report stated that the patient was having a STEMI but when they printed it out there was no ST elevation. The paramedics took care of the situation and took him in for further evaluation.
58 2021-04-22 palpitations Heart palpatations
58 2021-04-23 nosebleed Nasal bleeding in left nostril that I could not stop. Required ER trip and then hospitalisation. Ble... Read more
Nasal bleeding in left nostril that I could not stop. Required ER trip and then hospitalisation. Bleeding began about 12 hours after injection. I also had severe flu-like symptoms. I don?t know that the vaccine caused the bleeding but I?ve never had bleeding to that extent and I?ve been taking Plavix and aspirin post heart attack since Sep 3, 2020 with nothing like this event 12 hours after second Moderna.
58 2021-04-24 arrhythmia, heart rate increased Got my second does of Moderna vaccines 20 hours after. My heart rate rise to 130bpm and rhythm bec... Read more
Got my second does of Moderna vaccines 20 hours after. My heart rate rise to 130bpm and rhythm become Irregularly. Added Metoprolol from 25 to 50. Hart rate around 100bpm(my usually heart rate is 55 to 60bpm) It already last 48 hours.
58 2021-04-26 low platelet count, troponin increased Patient present with altered mental status and fevers, headache generalized body ache fever chills a... Read more
Patient present with altered mental status and fevers, headache generalized body ache fever chills at the time of admission (4/21) generalized rash mild splenomegaly mild thrombocytopenia and elevated ferritin and CRP. He did not have any evidence of coagulopathy. His lactate and LDH are also within normal limits. Vasculitic workup and infectious disease workup till date have been negative. His CSF protein and glucose were within normal limits. He developed Worsening altered mental status as well as renal failure requiring hemodialysis. treatments for the most part have been supportive including steroids, intubation for altered mental status, antibiotics empirically, hemodialysis for renal failure. To date ( 04/27/2021) there has been no significant improvement in patient's status.
58 2021-04-27 chest discomfort 10 minutes after the injection, my heart rate went up to 90bpm (when checked by nurse), I felt faint... Read more
10 minutes after the injection, my heart rate went up to 90bpm (when checked by nurse), I felt faint, chest was tight, felt throat tight and it was hard to take a deep breath or swallow saliva. This is similar to what I experience with milk or small amounts of cheese. This lasted about 20 minutes and subsided over the next 15 min. Stayed at the facility a total of an hour to be sure.
58 2021-04-27 fibrin d dimer increased, troponin increased, cardiac arrest Death due to cardiac arrest on 4/26/2021
58 2021-04-28 blood glucose increased Upon getting my second shot of Maderna for COVID, my blood sugars, which are under control in normal... Read more
Upon getting my second shot of Maderna for COVID, my blood sugars, which are under control in normal situations for a diabetic (A1C in the low 6s) spiked for 2 weeks. They only just this past Monday returned to normal and I am now in normal ranges. I am not sure this is a symptem or not but it is peculiar because I kept exercising and dieting the same as before the shot.
58 2021-04-28 fainting, loss of consciousness Patient had syncopal episode in observation area about 10-15 minutes after receiving 2nd dose of Mod... Read more
Patient had syncopal episode in observation area about 10-15 minutes after receiving 2nd dose of Moderna vaccine. Episode witnessed by wife who stated he "briefly lost consciousness" but denied any injury as he was already seated when it happened. Patient taken to extended observation, where Dr came down to assess. Patient was alert, awake, oriented, and stated he felt "sweaty". Patient laid flat on exam table with legs elevated. VSS on RA. Patient given orange juice and snack bar as he reported he had not had anything to eat since breakfast around 0900 today. Patient was observed for 90 minutes and reported dizziness when sitting and standing. Patient's vital signs remained stable. Patient was discharged with wife and was advised to go to emergency department per doctor's recommendation. Unknown if patient actually followed up with emergency department.
58 2021-04-29 heart rate increased patient reported sweating, tingling in fingers, rapid heart beat, lightheadedness, nausea. 911 was c... Read more
patient reported sweating, tingling in fingers, rapid heart beat, lightheadedness, nausea. 911 was called patient was taken to the hospital
58 2021-04-30 pulmonary embolism, blood clot Blood clot on 2/9/2021, just thought it was a severe calf cramp and took ibuprofen for several days ... Read more
Blood clot on 2/9/2021, just thought it was a severe calf cramp and took ibuprofen for several days until the calf felt somewhat better. Went to ER on 3/20 for dual pulmonary embolisms.
58 2021-05-02 atrial fibrillation, hypertension Blood pressure have been high,can't walk far ,hard to breed,,light headed,A-fib,and the hospital E.R... Read more
Blood pressure have been high,can't walk far ,hard to breed,,light headed,A-fib,and the hospital E.R. done scans ,Blood tests, and everything came back negative,,,
58 2021-05-02 deep vein blood clot Patient was diagnosed with an extensive DVT of Left-lower leg on 4-27-21. He had second Moderna vac... Read more
Patient was diagnosed with an extensive DVT of Left-lower leg on 4-27-21. He had second Moderna vaccination on 4-8-21 and stated 4 days later he was mowing his yard and afterwards started having leg pain. Over the next two weeks he stated his leg swelled and pain became more intense and he presented to me as an acute visit on 4-27-21. He was sent for a state venous doppler and was diagnosed with above. Patient was started on Eliquis and his leg is improving. Follow up today in office. (5-3-21). Will be sent to Hematologist for further evaluation as he had no prior known risk factors
58 2021-05-03 blood clot Superficial blood clot; This spontaneous case was reported by a consumer (subsequently medically con... Read more
Superficial blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Superficial blood clot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Superficial blood clot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Ultrasound scan: abnormal (abnormal) Ultrasound of left arm was done and determined a blood clot in that arm.. Patient went to the emergency room on 24 Apr 2021, approximately 7 pm. The patient was a healthy individual and used to do bike ride 11 miles per day with average speed 16mph. He did bike ride the evening of his second covid shot. No relevant concomitant medications were reported. Treatment information included anti-inflammatory medicine. Action taken with mRNA-1273 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 events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information was received on 26 Apr 2021. Added lab data and treatment; 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.
58 2021-05-05 loss of consciousness Within five minutes of receiving the vaccination, I felt weak and dizzy, then lost consciousness. I ... Read more
Within five minutes of receiving the vaccination, I felt weak and dizzy, then lost consciousness. I was told I was out a few minutes before the store called the ambulance. I was under observation for a few more minutes and felt dizzy again and started trembling and losing consciousness again. I was taken to the emergency room where I had a reported heart rate of 40bpm and it took several hours before my blood pressure and heart rate normalized again. I was given IV fluids and zofran for the nausea. I maintained flu like symptoms, fatigue, muscle pain, dizziness, memory loss, and disorientation for three days after receiving the vaccination. It took one week to get back to normal health.
58 2021-05-06 deep vein blood clot LEFT LOWER EXTREMITY DEEP VENOUS THROMBOSIS
58 2021-05-09 haemoglobin decreased 4/28 H&P: HPI: Hx obatined form chart review and wife. 58 y/o male patient with history of B-cell ly... Read more
4/28 H&P: HPI: Hx obatined form chart review and wife. 58 y/o male patient with history of B-cell lymphoblastic leukemia who was treated with hyper CVAD then dasatinib s/p allogenic stem cell transplant in 2018 on remission and cGVH 5/19/2020 requiring prednisone 5 mg daily on chronic acyclovir, bactrim and fluconazole who follows up at UM with Dr., also pt with hx of hypothyroidism, hyperlipidemia and hyponatremia presented today complaining of weakness for the last 2 days and headache the day prior to admission. Pt was taking Tylenol for the headache, and per wife he had a temp of 99 F. Denies any GI, urinary or abdominal symptom. Pt was being treated for a toe infection (ingrown toenail) with clindamycin. Pt travel during the weekend for 2 days where he did not have contact with any infected person. Pt is compliant with his medications and follows for his medical care. Today at the ED pt was having headache and during the afternoon started with AMS, became agitated, with upper extremity tremors and nuchal rigidity. Ct head did not showed any acute abnormality. However, pt developed a fever. LP was performed pending results. Started on empiric treatment for meningitis: vancomycin, acyclovir and ceftriaxone. MICU was called to admit patient due to worsening of mental status. PMH: hyperlipidemia, primary hypothyroidism, hx ALL s/p bone marrow transplant and cGVH. Allergies: denies. Medications: Acyclovir 800 mg BID, amlodipine 5 mg daily, fluconazole 200 mg BID, levothyroxine 175 mcg, pantoprazole, prednisone 5 mg daily, bactrim 1 tab 3 times a week, terbinafine cream and triamcinolone. Social: form Miami. No hx of alcohol, smoking. Physical Exam: Nursing note and vitals reviewed. Constitutional: Vital signs are normal. Pt lethargic, disoriented, no following commands w/o respiratory distress. HENT: Head: Normocephalic and atraumatic. Eyes: Conjunctivae and EOM are normal. Neck: No JVD present. Cardiovascular: Regular rhythm, normal heart sounds and intact distal pulses. Exam reveals no friction rub. No murmur heard. Pulmonary/Chest: Effort normal and breath sounds normal. No respiratory distress. He has no wheezes. He has no rales. He exhibits no tenderness. Abdominal: Bowel sounds are normal. There is no abdominal tenderness. There is no rebound and no guarding. Lymphadenopathy: He has no cervical adenopathy. Neurological: Disoriented. Nuchal rigidity. Resting tremors. Hyperreflexia lower extremities. No clonus. Does not follow commands. Moves 4 extremities. Skin: Skin is warm. 4/29 ID note: 58yo M patient who comes with CC of 2 days of weakness and 1 day of headache. Progressive onset and no other associated symptoms, weakness referred as generalized by wife and headache really started on day of admission. He has an important history of B-cell lymphoblastic leukemia diagnosed 03/12/2018 ( +), treated with 2 cycles of hyperCVAD, and desatinib (latter stopped on 02/22/21 due to fluid retention), on remission. s/p allogenic stem cell transplant on 08/21/18 (CMV +/+) from brother (10/10 donor), which engrafted 09/01/2018. And chronic graft vs host disease diagnosed on 05/19/20 due to scleroderma of bl upper extremities, elevated LFTs and swelling of upper and lower extremities with decreased ROM, started on steroid initially 40mg bid and eventually 5mg qd since 03/16/21 He was on prophylaxis with Acyclovir, Bactrim 1 tab 3 times a week, and Fluconazole. In the ED patient found to be initially alert and oriented, but during the day became more agitated, eventually having altered mental status and becoming non verbal. He also presented fever. On evaluation physical exam showed a patient making incoherent sounds, with tremors which stopped, increased muscle tone and some rigidity and increased reflexes, nystagmus, not following command but retracting extremities when touched or moved, with possible kernig and brudzinski signs. Started on Ceftriaxone, Vancomycin and Acyclovir and changed to Cefepime, Vancomycin, Ampicillin and Acyclovir by MICU team. Acyclovir changed to Ganciclovir by ID. CSF without pleocytosis, normal glucose and only mild elevated protein. CT and MRI without acute findings. Assessment: 58yo M patient with history of ALL in 2018 s/p Allo-SCT (CMV+/+) at UM 2018, and complicated by chronic GVHD, currently on prednisone 5mg daily and prophylaxis with Bactrim three times a week, Acyclovir and Fluconazole, who presented with headache, fever and generalized weakness for 2 days. Became encephalopathic and was admitted to MICU. 1. Meningoencephalitis in immunocompromised patient - No changes since yesterday, leukocytosis 15.22 and Tmax 100.2- Negative HIV, RPR, - Culture CSF NGTD, Blood culture negative day 1, respiratory panel negative- Repeat LP- Pending additional studies, 2. Other problems- Hypothyroidism- Hyperlipidemia- Hyponatremia- Toe infection (ingrown nail) - 01/2021- CKD II and congenital solitary kidney -Baseline Cr 1.3 Plan: - Continue Ampicillin, Cefepime, Vancomycin and Ganciclovir- In process CSF HSV 1/2, CMV, culture- Ordered serum VZV,Crypoptococcus, Fungitell, Galactomannan, West Nile IgM, CMV PCR- Ordered Quantiferon-Gold- Needs LP and CSF - Measure opening pressure, Encephalitis panel, cryptococcus, Fungal, AFB, viral culture, HHV6 PCR, EBV DNA PCR, VZV PCR, West Nile virus, Adenovirus, NMDA- Plan for LP today, family agreed. 5/3 ICU update: Patient has been accepted at where he is well known to the heme/onc service. Will transfer today.
58 2021-05-11 deep vein blood clot, pulmonary embolism, chest pain tongue and face swelling occurring on 5/7/21. shortness of breath and chest pain 5/8/21. Confirme... Read more
tongue and face swelling occurring on 5/7/21. shortness of breath and chest pain 5/8/21. Confirmed pulmonary embolus and left lower extremity DVT on 5/11/21-5/12/21
58 2021-05-11 excessive bleeding He started hemorraging and throwing up necrotic Tissue. It started 8 days after the first vaccine. ... Read more
He started hemorraging and throwing up necrotic Tissue. It started 8 days after the first vaccine. It continued happened March 17th, then about two weeks later on March 30, then he had the second vaccine on April 8th and it happened again on April 16th and then the 20th. He was given 5 units of Blood during that time.
58 2021-05-11 blood vessels inflammation Unknown which vaccine was given. Pt reported two weeks after vaccine he developed red dot rash on an... Read more
Unknown which vaccine was given. Pt reported two weeks after vaccine he developed red dot rash on ankles and feet. He went to rheumatologist and diagnosed with a vasculitis. The rash resolved with corticosteroid cream.
58 2021-05-12 coughing up blood, chest discomfort My husband was sleeping the night of getting his 2nd Moderna Vaccination... He, during his sleep, h... Read more
My husband was sleeping the night of getting his 2nd Moderna Vaccination... He, during his sleep, had a SEVERE Grand Mal Seizure with NOTHING leading up to it and NO PREVIOUS HISTORY WHATSOEVER of having ANY Seizures in his lifetime, nor ANY Epilepsy... EVER! It was TERRIFYING, to me - I ran to his bedside (I happened to be in the livingroom watching television) after hearing loud grunts and a crash and came to find him convulsing, severely spewing blood and frothing at the mouth. Grunting, convulsing, and thrashing. Stiffening, arms and hands (both in a fist) tight and stiff in front of his chest, legs straight, rigid as a board and thrashing about spitting blood, eyes rolled back in his head. As things began to becoming a little less severe, while waiting for the Fire Dept & EMTs to arrive I felt his legs which were hit to the touch and his face was drenched in sweat! With NEVER EXPERIENCING Anything like this before, and after 30 years of marriage, I thought my husband was dying ???????? He did NOT go with the EMTs, since once he was awake and somewhat cognitive we realized he was over it for the moment and we're in a wait and see basis. He saw our GP first thing the next morning.
58 2021-05-13 chest discomfort joints aching, fatigue, gurgling in chest area, some phelgm, coughing. psoriasis exploded on hands
58 2021-05-15 loss of consciousness 1. 58 y/o white male c/o dizziness 10 mins after receiving the 2nd dose of the vaccine. He was immed... Read more
1. 58 y/o white male c/o dizziness 10 mins after receiving the 2nd dose of the vaccine. He was immediately assessed by NP. He became diaphoretic and briefly passed out in arms of NP but quickly regained consciousness. He was transported via stretcher to area where he was further assessed and monitored by NP, EMT and paramedic. BP 102/70 HR 54, O2 saturation 95% room air. SB w/o ectopy on monitor. Hx of CAD with CABG X4 vessels, HTN, HLP, and takes Lisinopril, metoprolol, atrovastatin, and reported that he took Advil as prophylaxis prior to receiving the vaccine this morning. He noted he ran 2 miles this morning and ate a banana. He was given water and cool washcloth placed on his forehead. He was kept at site until he reported that he felt better and had no complaints. He was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to go to the ED, follow up with his primary care physician, register with V-safe, he verbalized understanding and willingness to comply. He left site in no acute distress, awake alert oriented to person, place time and situation.
58 2021-05-16 cerebrovascular accident -1 day post Dose #2 of Moderna Covid-19 Vaccine: Patient awoke on Tuesday, May 11 with symptoms of ... Read more
-1 day post Dose #2 of Moderna Covid-19 Vaccine: Patient awoke on Tuesday, May 11 with symptoms of dizziness, off-balance gait where he is leaning on something, stuttering speech, difficulty swallowing resulting in coughing, but trumped that to possible side effects of the vaccine. Patient woke up on Wednesday continuing to have further weakness to the point where he is holding onto rails just to stay upright and walking and he was stumbled down the stairs but catching himself before he impacted the floor. -MRI is positive for acute left stroke.
58 2021-05-16 excessive bleeding PATIENT FELT DIZZY AND FELL AS HE WAS WALKING OUT OF THE IMMUNIZATION ROOM. HE WAS BROUGHT BACK INTO... Read more
PATIENT FELT DIZZY AND FELL AS HE WAS WALKING OUT OF THE IMMUNIZATION ROOM. HE WAS BROUGHT BACK INTO THE IMMUNIZATION ROOM AND BLEEDING WAS STOPPED. HE STATED HE WAS FINE AND DID NOT WANT US TO FILE A CLAIM/REPORT. HE LATER CONTACTED US TO LET US KNOW HIS KNEE WAS SWOLLEN. WE FORWARDED TO OUR CLAIMS DEPARTMENT AND THEY ARE HANDLING IT FROM THERE.
58 2021-05-17 palpitations, chest pain Patient reported having palpitations about 2 hours after receiving the first dose of Moderna. He con... Read more
Patient reported having palpitations about 2 hours after receiving the first dose of Moderna. He continued to have palpitations and chest pain off and on for about 3 weeks. He went to see his doctor and the patient said the doctor said all tests were negative. The patient has not received any treatment for the adverse reaction and we are holding the second dose for now until confirmation from his doctor.
58 2021-05-18 chest discomfort 2nd day mild fever, pain at injection site. 4th day severe tightening of the chest, pain about the n... Read more
2nd day mild fever, pain at injection site. 4th day severe tightening of the chest, pain about the neck shoulders and chest, difficulty breathing with constant pain, difficulty sleeping due to shortness of breath and mild fever. This condition persisted for 5 days lessening in severity until today. Only slight pain when taking a deep breath.
58 2021-05-22 palpitations Red Dots over my body, and groin area in my eyes, infection in my eye lids, palipatation's, vision,... Read more
Red Dots over my body, and groin area in my eyes, infection in my eye lids, palipatation's, vision, more than usual pain in legs, urinating every 2 minutes, eye twitches, dizziness, rashes in groin and under eyes since a couple days after second vaccine still ongoing , Doctor gave me antibiotics thinking a bacteria infection on 05/11/2021 no difference as of yet anxiety bad a sometimes went to urgent care 05/22/2021 because of Eye Doctor said warm compresses and if not better in 48 hrs see an eye doctor so far it's worse. Sweating alot in groin area and rash in and around that area
58 2021-05-24 low platelet count, deep vein blood clot, blood clot THROMBOSIS-THROMBOCYTOEPNIA SYNDROME--- LEFT LEG DVT
58 2021-05-25 chest pain, inflammation of the pericardium, heart rate decreased after receiving the vaccine 4/20 and three weeks later I couldn't breath and called 911 and went to ... Read more
after receiving the vaccine 4/20 and three weeks later I couldn't breath and called 911 and went to hospital and diagnosed with pericarditis. But the day before I felt like I had a fractured rib and it intensified that evening and I took pain medication, then the pain in the left side intensified and I could not breath it felt like a knife piercing and had to breath with very shallow breath into my upper chest and the pain was so intense. I called 911 and they did an EKG, my heart rate went down to 30. One doctor gave me morphine to help me, they did test to check for blood clots and EKG's and blood test. I was also given Oxycodone. Test showed that there was a virus that got into it that caused pericarditis. I'm taking Ibuprofen and anti-inflammatories to help. I'm very active and never had health issues and believe this was a response to the vaccine. First dose was given on 3/23/2021 Lot 047A21A and experienced Molluscum contagion a few days later, and this is a virus. I was prescribe a topical cream, Imiquimod a topical cream to put on it to break down the virus. Triamcinolone Acetonide cream was prescribed later and I'm still taking it now and the site was oozing puss and bleeding.
58 2021-05-27 fainting Hx of COVID in Feb 2021. Hospitalized Days 8-10 (No vent). Day 8 had high fever, dehydration, sync... Read more
Hx of COVID in Feb 2021. Hospitalized Days 8-10 (No vent). Day 8 had high fever, dehydration, syncope and delirium. Vaccinated with dose 1 of Moderna on 5/18/2021. Next day had high fever (102.8), dehydration and altered level of consciousness. Taken to ER. Improved with IV fluid, observed and discharged. Physician does not recommend dose 2.
58 2021-06-02 cerebrovascular accident, chest pain, heart rate increased sustained a stroke; lot of chest pain; experienced difficulty in breathing; heart rate went high up;... Read more
sustained a stroke; lot of chest pain; experienced difficulty in breathing; heart rate went high up; headache; tingling sensation over the face, tingling sensation in the tongue; problem to speak well; " face felt wearied", "squeezing felling of the face"; 'I can't see clearly, can't read clearly, all letters are seen double; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (sustained a stroke), CHEST PAIN (lot of chest pain) and DYSPNOEA (experienced difficulty in breathing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent placement. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRASUGREL for an unknown indication. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PARAESTHESIA (tingling sensation over the face, tingling sensation in the tongue), SPEECH DISORDER (problem to speak well), FEELING ABNORMAL (" face felt wearied", "squeezing felling of the face"), VISUAL IMPAIRMENT ('I can't see clearly, can't read clearly, all letters are seen double) and HEADACHE (headache). On 19-May-2021 at 5:00 AM, the patient experienced CHEST PAIN (lot of chest pain) (seriousness criterion hospitalization), DYSPNOEA (experienced difficulty in breathing) (seriousness criterion hospitalization) and HEART RATE INCREASED (heart rate went high up). On 20-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sustained a stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 20-May-2021 to 23-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (sustained a stroke), CHEST PAIN (lot of chest pain), DYSPNOEA (experienced difficulty in breathing), PARAESTHESIA (tingling sensation over the face, tingling sensation in the tongue), SPEECH DISORDER (problem to speak well), FEELING ABNORMAL (" face felt wearied", "squeezing felling of the face"), VISUAL IMPAIRMENT ('I can't see clearly, can't read clearly, all letters are seen double), HEART RATE INCREASED (heart rate went high up) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included blood thinner medications started while the patient was at the hospital. The patient saw their healthcare provider on 23-May-2021 who advised them to cancel the scheduled second dose of the vaccine until the patients health is stabilized. The stent placement is in the heart. Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested. Subject's history of stent placement in the heart can be a confounding factor.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested. Subject's history of stent placement in the heart can be a confounding factor.
58 2021-06-06 heart attack 2 heart attacks happened 2 days after first dose of vaccine. patient was hospitalized. It could have... Read more
2 heart attacks happened 2 days after first dose of vaccine. patient was hospitalized. It could have been not related to the vaccine.
58 2021-06-09 cerebrovascular accident Mother reporting. He got his vaccine, approximately 3 weeks later he came home from work, was not f... Read more
Mother reporting. He got his vaccine, approximately 3 weeks later he came home from work, was not feeling good, laid down, went to sleep and when he woke up he was not able to walk, paralyzed on left side. He called 9-1-1 and was taken to the ER. In the ER he was diagnosed with a stroke, and is still in the hospital undergo rehab. They are hoping that he is going to make a full recovery. He is still totally paralyzed on his left side. He was initially admitted to the Hospital, and then transferred to rehab unit at Rehabilitation Hospital since 6/5/21.
58 2021-06-09 chest discomfort Pt C/O dizziness after 10 min of receiving vaccine. he also C/O chest pressure. Pt was hydrated (wa... Read more
Pt C/O dizziness after 10 min of receiving vaccine. he also C/O chest pressure. Pt was hydrated (water) advised rest and 12 lead EKG was done
58 2021-06-09 palpitations, palpitations, blood pressure increased, arrhythmia 1st Dose: Mild flu-like reaction within 24 hours, lasting 2 days. 2nd Dose: Moderate flu-like react... Read more
1st Dose: Mild flu-like reaction within 24 hours, lasting 2 days. 2nd Dose: Moderate flu-like reaction to 2nd shot, fatigue, weakness, and body aches, lasting 3 days. On the 4th day, woke up in the middle of the night to elevated blood pressure (160/100) with skipping heart beats. Arrythmia was intermittent but persistant for about 14 days, interspersed with several bouts of elevated blood pressure lasting for about 1 hour. Sensation of pounding heart with skipping, but normal blood pressure, has lessened with time, but is still present. Saw my GP about 10 days after the 2nd dose. Heart rhythm was normal during the visit, so no action was taken.
58 2021-06-10 cerebrovascular accident Patient presented to the ED and was subsequently hospitalized for Cerebrovascular accident (CVA) due... Read more
Patient presented to the ED and was subsequently hospitalized for Cerebrovascular accident (CVA) due to occlusion of left middle cerebral artery within 6 weeks of receiving COVID vaccination.
58 2021-06-10 palpitations, heart rate increased, heart rate irregular, chest discomfort Sporadic heart beat (rapid or skipped beat) and pressure in left chest and side area. Rapid heart r... Read more
Sporadic heart beat (rapid or skipped beat) and pressure in left chest and side area. Rapid heart rate usually upon waking or when tired; skipped beats when physically active. Aggravated dry cough.
58 2021-06-10 heart rate increased, palpitations Heart palpatations, rapid beat,dehadration,
58 2021-06-11 atrial fibrillation, heart rate increased I am submitting this report because I am hoping to help others with the vaccine and to see if the CD... Read more
I am submitting this report because I am hoping to help others with the vaccine and to see if the CDC can assist with any guidance for my treatment with Cardiologist. I am glad to share any of my medical records if it?s helpful I had a heart condition in 2018 that was fully cleared and recovered over 2 years prior to the moderna vaccine. In Dec 2018 I had congestive heart failure (high heart rate, afib, and swelling). The congestive heart failure was resolved within a week with medication only, no stints or surgery. The recovery of my heart to a health condition was confirmed with a heart MRI on Feb 5th 2019. I still had afib that was confirmed cleared on Feb 12th 2020 by an office visit with my cardiologist. He recommended I continue medication and monitoring. I continued in a fully cleared condition with no Afib or any issues for a year and 3 months up to my 2nd moderna shot. I had an annual heart MRI on May 3rd 2021 showing no issues and no afib. I had a visit with my cardiologist who said the test results were great. On May 15th 2021 I had my second moderna shot. My shot was Moderna 025C21A, at Pharmacy. Within 24 hours I was in an afib condition with my heart rate between 90 to 100 bpm resting. I contacted my cardiologist. On 6/11/21 he confirmed the afib condition and the elevated heart rate. He is now guiding me through procedures to clear my afib. I am quite concerned that my health had fully recovered and now have heart issues directly related to the 2nd moderna vaccine. Any assistance you can give me, my cardiologist to help us thru this is appreciated. I hope the information I am sharing can help others with the vaccine.
58 2021-06-13 deep vein blood clot, pulmonary embolism Shortness of breath while exercising on 4/24/21, progressively got worse. Went to ER on 5/5/21 wher... Read more
Shortness of breath while exercising on 4/24/21, progressively got worse. Went to ER on 5/5/21 where they discovered numerous DVTs in right leg and Pulmonary Embolisms in both lobes of lungs. Heparin administered in ER and admitted for two nights to regulate dosage and to have echo cardiogram performed which also showed a thrombus in right atrium of heart. Doctors said no other underlying cause of clotting and attributed it to the vaccine. Now on maintenance course of Xarelto.
58 2021-06-14 nosebleed Nosebleed 1:15 minutes long 06/08/2021 Nosebleed 20 minutes 06/09/2021 Nosebleed 20 minutes on Stop ... Read more
Nosebleed 1:15 minutes long 06/08/2021 Nosebleed 20 minutes 06/09/2021 Nosebleed 20 minutes on Stop 5-7 minutes this pattern for about 3 hours 06/10/2021 Nosebleed 10 minutes 06/11/2021 Noseblee 7 minutes. 06/12/2021 Nosebleed 5 minutes. 06/13/2021
58 2021-06-14 loss of consciousness Was extremely sick after the second shot with flu like symptoms. On the second day, my blood pressu... Read more
Was extremely sick after the second shot with flu like symptoms. On the second day, my blood pressure was 190 over 110 and still sick with flu like symptoms. Got the blood pressure to come down by doubling up on high blood pressure meds. Remained sick for 13 days. During this time, was working full time (Office duties) and off hours working extreme hours to physical exhaustion on family farm. On the 13th day, suffered severe seizures that broke my collarbone and shoulder to the point my shoulder needs to be replaced. The broken bones were not from the fall when I passed out, as my brother caught me and took me to the ground. No medical history of seizures with me or my family. Right before the seizure I could only describe myself as feeling off, like I was in a slight fog and not clear of thought or sight. My brother told me I had about 10 mini seizures while standing and holding on the tailgate of the truck and then one big one that knocked me out for about 15 minutes dislocating and breaking my should and collarbone.
58 2021-06-20 stroke Acute inflammatory demyelinating polyneuropathy that developed ten days following first dose of Mode... Read more
Acute inflammatory demyelinating polyneuropathy that developed ten days following first dose of Moderna vaccination. Patient developed progressive weakness/numbness/tingling and presented to outside hospital 6/10; weakness progressed to near immobility with associated respiratory distress, resulting in intubation 6/19. EMG consistent with AIDP. S/p 5 days of IVIG without improvement; now started on PLEX s/p 2 days. LP with protein, which can also be explained by AIDP. Remains intubated and hospitalized presently.
58 2021-06-20 deep vein blood clot, pulmonary embolism Within a couple of days feet started swelling and breathing became more labored on runs. I was diag... Read more
Within a couple of days feet started swelling and breathing became more labored on runs. I was diagnosed with DVT and PE
58 2021-06-20 fainting Floppy foot (fell down stairs and syncope) and fingers getting number, brain fog (memory loss), apha... Read more
Floppy foot (fell down stairs and syncope) and fingers getting number, brain fog (memory loss), aphasia, slurred speech. Went to ER and was discharged with hydrocortisone cream. No stroke diagnosis.
58 2021-06-21 ischaemic stroke Low grade Fever started overnight. Severe Pain in location of injection. Zero engergy, slept for 2... Read more
Low grade Fever started overnight. Severe Pain in location of injection. Zero engergy, slept for 24 hours. less than 24 hours later: Verigo/dizzy, could not swollow, impated breathing, Arterial Ischemic Stroke, veryebrobasial, brainstem, actute
58 2021-06-22 blood clot in the brain blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minute... Read more
blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset); poor, wavy eyesight; slurred speech; extreme exhaustion within 20-30 minutes of clot onset; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset)), OCULAR DISCOMFORT (poor, wavy eyesight), DYSARTHRIA (slurred speech) and FATIGUE (extreme exhaustion within 20-30 minutes of clot onset) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was reported. The patient's past medical history included Cerebral thrombosis on 09-Apr-2021, Cerebral thrombosis on 26-Apr-2021, Cerebral thrombosis on 13-May-2021, Cerebral thrombosis on 19-May-2021, Cerebral thrombosis on 05-Jun-2021 and Cerebral thrombosis. Concomitant products included OMEPRAZOLE, SIMVASTATIN, LOSARTAN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Mar-2021, the patient experienced CEREBRAL THROMBOSIS (blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset)) (seriousness criteria hospitalization, disability, medically significant and life threatening), OCULAR DISCOMFORT (poor, wavy eyesight) (seriousness criteria hospitalization, disability and life threatening), DYSARTHRIA (slurred speech) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (extreme exhaustion within 20-30 minutes of clot onset) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized from 29-Mar-2021 to 01-Apr-2021 due to CEREBRAL THROMBOSIS, DYSARTHRIA, FATIGUE and OCULAR DISCOMFORT. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Thrombosis, at an unspecified dose and frequency and AMLODIPINE for Thrombosis, at a dose of 5 mg. At the time of the report, CEREBRAL THROMBOSIS (blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset)), OCULAR DISCOMFORT (poor, wavy eyesight), DYSARTHRIA (slurred speech) and FATIGUE (extreme exhaustion within 20-30 minutes of clot onset) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: unknown (Inconclusive) unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. While admitted, the patient had "a bunch of tests done" and was started on clopidogrel and amlodipine. After discharge, the patient had an ultrasound of the arteries in his head and neck, the results of which were not provided. The reporter stated that the patient had five known episodes (and one episode on an unknown date and time) that mimicked the events on 29March2021 except without the eyesight and speech problems. These occurred on 09April 021 around 1730, 26April 2021 around 1300, 13May2021 around 1600, 19May2021 around 0940 and 05June2021 around 0739. 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.
58 2021-06-22 palpitations, atrial fibrillation, chest discomfort Heart Palpitations, Atrial Fibrillation, Chest discomfort, out of breath, weekness, dizziness
58 2021-06-25 fainting Delirium; Syncope; Altered state of consciousness; Dehydration; Pyrexia; This case was received via ... Read more
Delirium; Syncope; Altered state of consciousness; Dehydration; Pyrexia; This case was received via VAERS (Reference number: 1358559) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirium), SYNCOPE (Syncope) and ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Hospitalized for 8-10 (No vent).) in February 2021. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criterion medically significant), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia). At the time of the report, DELIRIUM (Delirium), SYNCOPE (Syncope), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia) 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. Patient was treated with IV fluid and condition improved after that. Physician did not recommend dose 2. Based on the current 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.
58 2021-06-29 ejection fraction decreased Patient developed atrial tachycardia requiring emergency room treatment. He does have a bicuspid aor... Read more
Patient developed atrial tachycardia requiring emergency room treatment. He does have a bicuspid aortic valve but had not previously had cardiac issues. Required adenosine then cardioversion that failed. Now on tikosyn.
58 2021-06-29 palpitations I experienced heart palpitations, dizziness, light-headiness, a bit of nausea and for only two days ... Read more
I experienced heart palpitations, dizziness, light-headiness, a bit of nausea and for only two days I broke out in sweats around the 12th and 13th day after the vaccine. The episodes have lessen as far as the heart palpitations. I spoke with the telephone triage nurse at the hospital and was told to report to the nearest ER and I did. The ER Doctor said that he couldn't rule it in or out that the symptoms were brought on by the vaccine. He consulted the records that were sent from the hospital and some follow up was set up. All medical records were sent back to the hospital to have them follow up on my symptoms.
58 2021-06-30 chest discomfort, loss of consciousness, chest pain I had the chills and shakes the night of the shot. My abdomen started hurting and on June 12 I star... Read more
I had the chills and shakes the night of the shot. My abdomen started hurting and on June 12 I started having diarrhea which lasted for 2 weeks (reminder that I also started Lexapro on June 11 and started Cipro and Flagyl on June 12). I ended up losing 15 lbs due to loss of appetite and the diarrhea. On June 19, I had a vagal episode where I passed out while standing up. Luckily my head landing softly. I had just drank a smoothy and felt a pressure/pain in my chest. After passing out and then coming to, I vomited the smoothy and found some relief.
58 2021-06-30 chest pain, chest discomfort Headache, chest pains, whooshing through chest, feel pressure in chest.
58 2021-06-30 hypertension, fibrin d dimer increased Patient noted fatigue, severe new onset HTN refractory, night sweats, dyspnea on exertion, abdominal... Read more
Patient noted fatigue, severe new onset HTN refractory, night sweats, dyspnea on exertion, abdominal bloating and epigastrict pain/rib cage area, shoulder blade pain starting in first week of April with progressive symptoms Evaluated with labs etc. D dimer ordered and 4 times upper limit of normal. ED end of June CTA showed large portal vein thrombosis, as well as right heart strain on echo- normal EF. HTN resolved off medications once started heparin drip and now on Eliquis.
58 2021-07-06 chest pain Pain inside the lower-left rib cage After injection #2, pain expanded to upper left chest and lower-... Read more
Pain inside the lower-left rib cage After injection #2, pain expanded to upper left chest and lower-right rib area upon exhale. Extremely painful when sneezing Worsens with a cough or breathing deeply. Feeling fatigued and sleepy
58 2021-07-08 chest discomfort, pulmonary embolism, deep vein blood clot Presented on 7/5 2 months of intermittent dyspnea and chest pain. Patient states it all began about... Read more
Presented on 7/5 2 months of intermittent dyspnea and chest pain. Patient states it all began about 2 weeks after his first Moderna covid vaccine at mid/end of April. He developed exertional chest pain that felt like a squeezing. He was recommended a stress test at that time, but didn't have health insurance and wanted to wait until he was covered. He was put on a 5 day course of prednisone, that seemed to improve his symptoms and he felt back to baseline and was able to proceed with the 2nd moderna vaccine in the middle of May. Shortly after that, he developed intermittent dyspnea on exertion and chest tightness. It was difficult to take a deep breath in, felt like something was grabbing him when he tried to take a full deep breath. This has been becoming more constant over the last 2 weeks. Today, he was outside moving a lawnmower when his symptoms significantly worsened. He felt lightheaded. His wife convinced him to go to clinic, where he got a CTA that showed an saddle PE.
58 2021-07-08 deep vein blood clot, haemoglobin decreased, platelet count decreased Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time... Read more
Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg, and ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
58 2021-07-12 heart rate abnormal, arrhythmia, chest discomfort, heart rate increased, palpitations, cardiac arrhythmia Approximately ten hours after the vaccine, I began having what I consider an extreme reaction. Inten... Read more
Approximately ten hours after the vaccine, I began having what I consider an extreme reaction. Intense body aches, chills, headache, fever, sweating, and general feeling of being very unwell. Along with the expected symptoms, I had shaking that was not just from having chills, rapid resting heart rate that was running well above 100. My normal resting heart rate is in the 60s and sometimes even 50s. I also had a feeling of "deep, intense cold." The symptoms gradually eased after the first 24 hours but persisted enough that I was in bed for three days. After the three days, I struggled with extreme fatigue and felt like I was always freezing cold. I was also having strange changes in my heart rate.My heart would race and then slow down again. After about three weeks, I began to have palpitations which continued to get worse over the following months, especially with any exertion. The fatigue and cold feeling lasted for a few months, and my hands were always ice cold. I am still having the palpitations/arrhythmias. Around April, I felt like I was getting out of shape because of the fatigue and inability to do what I normally did. I decided to start increasing my activity, walking exercising, etc. in order to combat the fatigue and "get back in shape." This caused an increase in my palpitations, chest discomfort and shortness of breath which caused me to go home from work a few times and to seek medical attention. I was unable to get right in to see a doctor so I purchases a device for my tablet so that I could try and capture what was occurring and show the doctor. I eventually saw my GP and was referred to a Cardiologist. I was having PVCs. and at this point I had on average eight per minute with episode of many more at times. This has continued and fluctuates in intensity. I think maybe it is slightly improving but sometimes I still have episodes of increased arrhythmias so this is not resolved and is still continuing and limiting my normal activities. The cardiologist ruled out Mi or ischemia as a cause. We believe there is inflammation in the heart muscle. I should note here that prior to this I have never had any problems with my heart. Not even high blood pressure.
58 2021-07-13 blood pressure decreased Vertigo would happen when I moved my head, for example if I lifted my head to look up at a shelf, or... Read more
Vertigo would happen when I moved my head, for example if I lifted my head to look up at a shelf, or if lying down it would happen if I picked up my head off the pillow. Even moving my eyes up to look at someone would cause a feeling of vertigo. But, it did not happen after repeatedly lifting heavy objects (I work as a stock person). And did not occur when standing up, only when I would move my eyes or lifted my head.
58 2021-07-13 blood pressure decreased Experienced variation in BP that BP was ?way down? from normal and losing breath as though he would ... Read more
Experienced variation in BP that BP was ?way down? from normal and losing breath as though he would pass out within one day, did not report to doctor, c/o hungry all of time, stated having attacks of anxiety since injection
58 2021-07-13 blood pressure increased, cerebrovascular accident I experienced weakness on my right side along with numbness/dizziness and a headache and went to see... Read more
I experienced weakness on my right side along with numbness/dizziness and a headache and went to see my doctor who informed me that I was having a stroke while I was at the clinic from work. I was immediately transported to the hospital by the fire department (feeling in my right side started to return while being transported to the hospital). I was admitted to the hospital and a series of tests were administered to find out the cause of my stroke. I was administered medication to reduce my blood pressure and cholesterol along with aspirin 81mg and Atorvastatin during my 3-day stay. I received a prescription for the medication upon being released from the hospital.
58 2021-07-13 deep vein blood clot, chest discomfort, increased heart rate, pulmonary embolism, hypertension, fibrin d dimer increased 58 years old gentleman seen today. He has anticoagulant therapy is a 58-year-old gentleman otherwis... Read more
58 years old gentleman seen today. He has anticoagulant therapy is a 58-year-old gentleman otherwise quite healthy COVID-19 vaccination , received in May 2021. Approximately 6 weeks later He developed acute shortness of breath, tightness in the chest evaluated emergency room(6/16/2021).. 80 NGO was done and he was diagnosed of bilateral pulmonary embolism with subsegmental blood clots in both lungs. Placed on heparin and subsequently switch him to Xarelto charged home seen by cardiology with subsequent referral to us additional evaluation including the duration of anticoagulant therapy.
58 2021-07-13 pulmonary embolism, deep vein blood clot, fainting Patient had 1st dose of Moderna COVID-19 vaccine on 5/10/2021. Several days after he complained of ... Read more
Patient had 1st dose of Moderna COVID-19 vaccine on 5/10/2021. Several days after he complained of "not feeling well" and fatigue, but did not give more specific symptomatology. On 5/17/2021 he had a sudden collapse at home and was transported to local hospital, where he was pronounced dead. Case accepted as medical examiner jurisdiction due to no apparent medical history and sudden death after vaccine administration. Full autopsy completed on 5/19/21 revealed obstructive pulmonary thromboemboli as cause of death, with lower extremity DVT. Both portions of the pulmonary thromboembolus and the DVT show organization, thus raising question of whether this process started before or after the vaccination. No known history of thrombophilic disorder, recent injury, or prolonged stasis/immobility. Not known to be current smoker. See below for additional autopsy information.
58 2021-07-15 pulmonary embolism, heart attack, cardiac arrest no known cardiovascular disease. He has been feeling less well recently . About 1 month ago, he rec... Read more
no known cardiovascular disease. He has been feeling less well recently . About 1 month ago, he received the 2nd dose of the Moderna COVID-19 vaccine, and he developed an erythematous, non-raised rash involving the upper and lower extremities. This has subsided, but still persists on his thighs. He presented to the emergency department on 7/3 with worsening dyspnea. and diagnosed with pulmonary emboli. After a week in the hospital deteriorating with the following the patient expired. Pulmonary embolism Active Problems: Cardiogenic shock NSTEMI (non-ST elevated myocardial infarction) Cardiomyopathy Acute liver failure without hepatic coma Rheumatoid arthritis Renal failure Aortic stenosis Lactic acidosis Cardiac arrest Cerebral anoxia
58 2021-07-16 loss of consciousness Loss of consciousness; Dizziness; Hyperhidrosis; This case was received via FDA VAERS (Reference num... Read more
Loss of consciousness; Dizziness; Hyperhidrosis; This case was received via FDA VAERS (Reference number: 1321990) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery bypass graft (X4 vessels). Concurrent medical conditions included Coronary artery disease, Hypertension and Hyperkeratosis lenticularis perstans. Concomitant products included LISINOPRIL, METOPROLOL, ATORVASTATIN and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 16-May-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 16-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 102/70 (Inconclusive) 102/70. On an unknown date, Heart rate: 54 (Inconclusive) 54. On an unknown date, Oxygen saturation: 95 percent (Inconclusive) 95 percent room air. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported that he left site in no acute distress, awake alert oriented to person, place time and situation. No treatment information was given. 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.
58 2021-07-17 cerebral haemorrhage 1st shot was in the left arm, 2nd shot was is in the right. Experienced overwhelming headache for se... Read more
1st shot was in the left arm, 2nd shot was is in the right. Experienced overwhelming headache for several days from Friday afternoon through Monday Morning. Was given a CT scan and was found to have bleeding on the base of the brain and swelling so heavy, they could not determine where the leak was.
58 2021-07-18 atrial fibrillation I felt very tired, no energy, couldn't really walk, I was out of breath. The day I went to the hospi... Read more
I felt very tired, no energy, couldn't really walk, I was out of breath. The day I went to the hospital they took me in an ambulance. I was admitted for a week and 3 days. They did blood work, x-rays, and stuff like that. They gave me two types of IV, Diltiazem in liquid form and sodium chloride. They diagnosed me with A fib, I was already an A fib patient.
58 2021-07-19 chest discomfort, fast heart rate, chest pain Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium
58 2021-07-19 fast heart rate, chest pain, hypertension, chest discomfort Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium
58 2021-07-20 fainting, cardiac arrest, blood glucose increased Family notes patient started to have issues controlling blood glucose levels, prior to day of event ... Read more
Family notes patient started to have issues controlling blood glucose levels, prior to day of event patient had syncope episodes. 7/21/2021 patient had sudden cardiac arrest.
58 2021-07-22 chest pain, inflammation of the pericardium I awoke on the morning of 02/04/2021 (the day after my 2nd Moderna vaccination) with severe chest pa... Read more
I awoke on the morning of 02/04/2021 (the day after my 2nd Moderna vaccination) with severe chest pain and moderate shortness of breath. I called the nurse in charge of running the vaccination site and was told it was possibly a normal reaction to the vaccine, or maybe some other concurrent illness. So, I waited a couple of days and started feeling a little better. Then I experienced a sudden worsening again, this time with radiation into the middle of my upper back, and went to the ER for Evaluation. In the ER they drew bloodwork including a CBC, chemistry panel and cardiac enzymes (Troponin). All returned relatively normal. An EKG and chest x-ray were performed as well as a CT angiogram of the chest to rule out both a pulmonary embolism and dissecting aortic aneurysm. Eventually, I was discharged and instructed to follow up with Cardiology. This is when I underwent evaluation by MD who diagnosed me with pericarditis. I have been doing much better since.
58 2021-07-24 hypertension Started with symptoms similar to sinus infection. Stuffy nose, headache. Turned in to extreme spas... Read more
Started with symptoms similar to sinus infection. Stuffy nose, headache. Turned in to extreme spasms at base of neck/brain stem on 5/7. Telehealth visit diagnosis was Sinus Infection, given a Z-Pack. 5/8 pain was better throughout the day. Later in the evening pain worsened. 5/9 pain was severe. Continued with Z-pack and Tylenol and Advil. 5/10 pain was a 15 on scale of 1-10. Went to ER, blood pressure was extremely high and a cough had developed. Upon triage patient did not have a fever. After CT was done and was clear fever was checked and it was 102.3. Spinal Tap was performed and chest X-rays and bloodwork. Patient admitted to hospital for four days. Later diagnosed with double pneumonia, sepsis and viral meningitis. The Spinal Tap came back as borderline. Doctors felt the results were skewed due to Z-Pack.
58 2021-07-25 cerebrovascular accident After the second moderna vaccine on May 10th I started having stroke symptoms May the 11th dizziness... Read more
After the second moderna vaccine on May 10th I started having stroke symptoms May the 11th dizziness could not walk straight in the morning of the 12th my speech was slurred and my mouth was crooked and could not swallow my food so my family rushed me to the emergency room at straub hospital where they diagnosed me having two strokes I remained in straub hospital for 5 days after once I was transferred to the rehab hospital for further stroke therapy where I am undergoing speech therapy occupational therapy and physical therapy and I'm walking with a cane because of the weakness in my right side of my body and am currently still an outpatient for further stroke therapy
58 2021-07-26 blood clot Blood clot
58 2021-07-27 pulmonary embolism, deep vein blood clot Large pulmonary embolisms in both lungs resulting from DVT in left leg. About 2-3 weeks after recei... Read more
Large pulmonary embolisms in both lungs resulting from DVT in left leg. About 2-3 weeks after receiving 2nd Covid-19 vaccine shot, I started to have unusual breathing/fatigue symptoms. I did not seek any treatment for these symptoms but now believe that these were due to several small blood clots in my lungs. After another 3 weeks on May 10, 2021, I suffered a pulmonary embolism from a blood clot in my left lung. I still did not seek treatment. Two days later on May 12, I suffered a pulmonary embolism from a blood clot in my right lung. This was sufficiently painful that I went to the Emergency Room on May 13 where an MRI diagnosed blood clots in both left and right lungs. I was hospitalized until May 15 and now am required to take blood thinner Eloquis. In the hospital, a DVT was identified in my left leg as a source for the clots, though I had no reason to develop such a DVT. 10 years prior in 2011, I had a DVT resulting from a long plane flight but no symptoms since.
58 2021-07-28 very slow heart rate, fibrin d dimer increased 3/17/21-patient started to have SOA, fatigue and cough-CT scan done showed infiltrate RUL-TX'd with ... Read more
3/17/21-patient started to have SOA, fatigue and cough-CT scan done showed infiltrate RUL-TX'd with antibiotic with resolution of infiltrate on repeat CT scan of chest 5/2021-patient noted to have bradycardia (asymptomatic) on Fit bit 4/1/21- EKG done showed 2nd degree block mobitz type 1-patient scheduled to have pace maker placed in one week
59 2021-01-01 heart rate increased Patient felt "flush" sensation immediately after vaccination. Flush lasted "30 seconds" and went awa... Read more
Patient felt "flush" sensation immediately after vaccination. Flush lasted "30 seconds" and went away. Five minutes later, patient reported "fast heart rate for 30 seconds" and went away. He stated the fast heart rate was likely from being more aware of his body. He was monitored for 15 minutes and reported feeling well. No other symptoms.
59 2021-01-04 blood pressure increased After three days, couldn't sleep the whole night. The next day, went to work, came home felt jitter... Read more
After three days, couldn't sleep the whole night. The next day, went to work, came home felt jittery. Close to midnight bp 200/90. Took Clonidine 0.1 and went to ER, bp 180/90. waited for almost two hours bp came down to 141/80. Today, bp is back to normal. Took sleeping medication Zzzquil to go to sleep.
59 2021-01-05 blood glucose increased Elevated glucose level
59 2021-01-06 chest pain, heart rate increased PT COMPLAINED OF HEADACHE, SHORTNESS OF BREATH, INCREASED HEART RATE AND CHEST PAIN. PT TOOK IBUPROF... Read more
PT COMPLAINED OF HEADACHE, SHORTNESS OF BREATH, INCREASED HEART RATE AND CHEST PAIN. PT TOOK IBUPROFEN 400MG FOR HEADACHE. RESTED FOR ABOUT 30 MINUTES AND FELT BETTER. HAD A NURSE MONITOR HIM FOR ANOTHER 30 MINUTES.
59 2021-01-08 heart rate increased, palpitations Approximately 3 minutes after the injection I began to experience palpitations and felt flushed. My... Read more
Approximately 3 minutes after the injection I began to experience palpitations and felt flushed. My heart rate increased from about 70 to 110. This lasted for approximately 5 minutes and then recurred about 10 minutes later. After the second event I took Benadryl 50mg po. I experienced palpitations and felt flush a third time about 5 minutes after taking Benadryl lasting about 2 minutes. Approximately 40 minutes after the injection I began to feel cold and clammy, this lasted about 35 minutes. My pulse was about 75 and BP 140/90 during this last event. Approximately 90 minutes after the injection I went home and experienced intermittent chills for a few hours then I was asymptotic.
59 2021-01-13 chest pain, heart rate increased Fatigue, sore arm, headache, chest pain (intense heartbeat), malaise
59 2021-01-13 fast heart rate, hypertension Narrative : Symptoms: HYPERtension, Tachycardia & FLUSHING, SWEATY Treatment:
59 2021-01-14 increased heart rate Fever to 103. Sinus Tachycardia to 124.
59 2021-01-18 blood pressure increased, heart flutter After vaccination, pt stated he felt light-headed and heart/chest was fluttering. BP 152/98 (pt nor... Read more
After vaccination, pt stated he felt light-headed and heart/chest was fluttering. BP 152/98 (pt normally runs 110/60) and pulse 109-112 (pt states is normal for him). O2 sat 95-97% R16. Pt also c/o headache. Pt monitored for 20 minutes and states still some "feeling funny", but no worsening of s/s. Last BP 146/90 P105. Pt refused transport, continued nurse monitoring or EMS evaluation, even with cardiac history. Advised to call EMS if he continued to have any problems. Phoned pt on 1/14 to check status and said he was "extremely sick" with cough, body aches, possible fever. Advised pt to have medical evaluation asap.
59 2021-01-21 blood pressure increased, heart rate increased, chest pain 12/30 almost immediately increase HR to 100, Increase BP 165/95, CP, light headed. Monitored for an ... Read more
12/30 almost immediately increase HR to 100, Increase BP 165/95, CP, light headed. Monitored for an hour. symptoms resolved within 45 minutes.
59 2021-01-30 hypertension, blood pressure increased Severe hypertension- began almost immediately after vaccination snd is continuing to date of report.... Read more
Severe hypertension- began almost immediately after vaccination snd is continuing to date of report. Normal bp range is 220/84. Blood pressure since vaccination has ranged from 162/94 to 194/100.
59 2021-01-31 heart rate increased Dizziness, vertigo - bedrest, continue but diminishing. Facial swelling, rapid heartbeat - diminis... Read more
Dizziness, vertigo - bedrest, continue but diminishing. Facial swelling, rapid heartbeat - diminishing. Headache , nasal congestion. Fatigue.
59 2021-02-01 atrial fibrillation, palpitations presented to ED 3 days post injection with c/o palpatations and some SOB,. Patient was found to be i... Read more
presented to ED 3 days post injection with c/o palpatations and some SOB,. Patient was found to be in AFib with RVR. Labs showed severe hypokalemia. Three doses of potassium chloride were administered with improvement of potassium. Patient underwent a DC cardioversion Patient also reported positive COVID 19 test on 1/15/2021
59 2021-02-04 blood pressure increased Pt felt flush after injection. Started to sweat. Gave a cool drink, checked BP 138/108. Pt calm down... Read more
Pt felt flush after injection. Started to sweat. Gave a cool drink, checked BP 138/108. Pt calm down and was monitored for a 30 minutes and he returned to work.
59 2021-02-04 hypertension presented to healthcare alert with mild confusion and hypotensive. Temp 100.4 IV fluids started an... Read more
presented to healthcare alert with mild confusion and hypotensive. Temp 100.4 IV fluids started and sent to ER for further evaluation.
59 2021-02-07 pallor Patient got dizzy, his skin was pale and clammy. He had itchy throat and cough. These symptoms happe... Read more
Patient got dizzy, his skin was pale and clammy. He had itchy throat and cough. These symptoms happened about one hour after receiving the vaccine.
59 2021-02-11 very slow heart rate Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Can´t c... Read more
Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Can´t close eyes; Right leg is numb; Severe headache; Some eye issues, sees blurry; A spontaneous report was received from a paramedic, who was also a 59-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia. The patient's medical history was not provided. Concomitant product use reported included, insulin, statin, losartan, and metformin. On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Jan 2021, after receiving the vaccine, the patient experienced eye issues and would see blurry and had a severe headache. On 23 Jan 2021, the patient was hospitalized for 36 hours because he thought he was having a stroke. Test results showed the patient did not have a stroke. The patient did, however, experience facial paralysis, couldn't close his eyes, bradycardia, weakness in the right arm and right leg, difficulty talking, and his right leg felt numb. Treatment for the events included prednisone, valaciclovir, and unspecified calming medication while at the hospital. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right am and right leg, right leg is numb, can't close eyes, and bradycardia, was considered not resolved.; Reporter's Comments: This case concerns a 59 year old male was hospitalized with a serious events of some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia after first dose to mRNA-1273 in the left arm. Comcomitant medications include insulin, metformin, atorvastatin, losartan. Hospital work-up showed ne did not have a stroke, and he was treated with prednisone, valaciclovir and a "calming medicine". b) 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. + b) 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.
59 2021-02-14 blood pressure increased Patient states 5 minutes after receiving the vaccine he developed lip numbness, eye swelling and bot... Read more
Patient states 5 minutes after receiving the vaccine he developed lip numbness, eye swelling and both hands were tingling. He then developed tingling in his chest. He was evaluated at the vaccination site by EMS and was administered oxygen and po Benadryl. HIs BP was elevated. His symptoms persisted for about 10 minutes and he was sent to the ER. En route to the ER he received IV steroids and Benadryl. He states his symptoms improved after treatment and by the time he got to the hospital (about 20 minutes) his eyes were normal. In the ER patient received Iv medications but he is unsure of what was given. A few hours after being monitored in the ER he noticed his chest tingling went away. He was discharged from the ER on 5 days of steroids. He states the next day he felt fatigued and on the day after the vaccine his hand tingling resolved. Patient states two days after the vaccine he felt completely back to normal and went to work.
59 2021-02-15 blood pressure increased Facial and Neck Flushing, Shaking Chills, Involuntary Leg Movement, Increasing Blood Pressure toppin... Read more
Facial and Neck Flushing, Shaking Chills, Involuntary Leg Movement, Increasing Blood Pressure topping out at 198/101
59 2021-02-15 chest pain, heart rate increased Nausea, vomiting, increased heart rate (217bpm at time of paramedics arrival), crushing chest pain, ... Read more
Nausea, vomiting, increased heart rate (217bpm at time of paramedics arrival), crushing chest pain, massive headache, and fever. Hospital gave me fluids, took blood test, EKG, and x-rays then sent me home. Increased heart rate lasted approximately one week. Headache lasted two weeks.
59 2021-02-25 heart rate increased, blood pressure increased Elevated BP and Heart Rate for 48 hours. Treatment was rest at home.
59 2021-02-25 loss of consciousness About 8 hours after my second injection I had alot of muscle aches, felt hot with no fever, and was ... Read more
About 8 hours after my second injection I had alot of muscle aches, felt hot with no fever, and was very tired. At about the 13 hour mark I had a seizure, was unconscious and unresponsive. My wife called an ambulance and I was taken to the ER.
59 2021-02-28 hypotension, loss of consciousness, very slow heart rate Patient received covid shot, was sitting in chair after shot, felt sudden urge to have BM, stood up ... Read more
Patient received covid shot, was sitting in chair after shot, felt sudden urge to have BM, stood up and passed out. Bradycardia (Per ems reading of 58 and then 41, current in hospital 62), and Hypotension (Per ems 88/64 and then 68/42) He was required to stay for 15 mins afterward for symptom monitoring. He then proceeded to feel ill after the vaccine, became sweaty, lightheaded, and felt gassy. He then stood up to use the restroom, and stated he felt he was going to pass out and fell to the ground, hitting his head against the ground. He denies any full LOC. Did sustain a laceration to L forehead. He denies any preceding vertigo, chest pain, or DIB.
59 2021-03-01 chest pain, fibrin d dimer increased, blood glucose increased, oxygen saturation decreased 2/22/21 positive for covid and flu b 2/23/21 requested bamlanivimab infusion d/t not eating and wea... Read more
2/22/21 positive for covid and flu b 2/23/21 requested bamlanivimab infusion d/t not eating and weakness 2/24/21 emergency room after infusion: HPI 59 y.o. male who presents with left-sided posterolateral chest pain. Pain has been present 4-5 days time. It is worsened by deep inspiration or coughing. The patient has also had nausea and vomiting. Fever has been as high as 101.6°. He was tested and found to be positive for both influenza and COVID-19. He denies anterior or central chest pain dyspnea or orthopnea palpitations sputum production. 3/1/21 emergency room for worsening condition: 59 y.o. male presented to the emergency room with a several day history of intractable nausea vomiting and severe weakness. The patient does have a known history of recent coronavirus (COVID-19) infection. He was diagnosed on February 22nd and did receive Bamlanivimab. He started feeling a little bit better after this, but a few days ago started having increasing weakness and nausea/vomiting. He called me this morning and stated he had been unable will keep anything down for several days and was extremely weak and I asked that he go to the emergency room. In the emergency room is lactic acid was found to be elevated. His CT scan of his chest with contrast showed severe coronavirus (COVID-19) pneumonia. This was run after he was found to have an elevated D-dimer. He was found to be extremely weak and deconditioned. His oxygen saturations at times or found to be in the low 90s. Because of all of this he will be admitted and treated for sepsis from coronavirus (COVID-19).. 3/2/21 currently remains hospitalized
59 2021-03-01 fast heart rate fatigue, muscle pain, fever, fast heart beats taking pain-killer at 7:00pm and fever is gone at arou... Read more
fatigue, muscle pain, fever, fast heart beats taking pain-killer at 7:00pm and fever is gone at around 10:00pm still fatigue with some level of muscle pain
59 2021-03-10 pulse abnormal Very shortly after receiving initial vaccine dose recipient felt weak and slightly nauseated without... Read more
Very shortly after receiving initial vaccine dose recipient felt weak and slightly nauseated without rash, shortness of breath or sense of tissue swelling or itching. He had no chest pain He endorsed a history of well controlled hypertension and hypercholesterolemia. He had no history of adverse experiences with injections He became sweaty and had a somewhat weak pulse so was moved to the medical area where his initial blood pressure was 88/47 with a pulse of 71. He was encourgaed to lie down and his symptoms improved. He had an intravenous line established and an ambulance arrived promptly to transport him for emergency evaluation.
59 2021-03-11 chest discomfort on day 3 after vaccine patient had heart/chest/breathing hurts and shortness of breath, fever, weak,... Read more
on day 3 after vaccine patient had heart/chest/breathing hurts and shortness of breath, fever, weak, and got worse as day went on and woke up on day 4 soaked in sweat
59 2021-03-14 palpitations On Monday, March 9th, I tested positive for the COVID antibodies and believe it was linked to an ill... Read more
On Monday, March 9th, I tested positive for the COVID antibodies and believe it was linked to an illness that I experienced last fall (COVID test was not administered at that time). Approximately 16 hours after receiving the first injection of COVID-19 MODERNA I began to experience joint pain/stiffness, muscle soreness, headaches, nausea, chills, sweats, malaise, heart racing, numbness to the fingers on my left hand, etc. I became progressively worse until become bed ridden at 5:15 pm on Thursday, March 11th. I remained bed ridden with symptoms becoming progressively worse until Friday evening, March 12th. At that point, my condition began to improve. I began to feel somewhat better by mid-morning on Saturday, March 13th. My condition finally improved to ~90% by Monday, March 15th, with lingering muscle soreness and loss of feeling to the fingers on my left hand remaining.
59 2021-03-14 blood clot Development of blood clots in lower right leg causing swelling and pain. Pt. visited doctor who pres... Read more
Development of blood clots in lower right leg causing swelling and pain. Pt. visited doctor who prescribed an ultrasound which revealed the clots. Doctor has now put pt. on blood thinners indefinitely.
59 2021-03-15 heart rate increased, heart rate irregular, fast heart rate Accelerated heart rate/irregular heart beat. Resting HR is normally 80bpm. At around 1pm RHR went... Read more
Accelerated heart rate/irregular heart beat. Resting HR is normally 80bpm. At around 1pm RHR went up to 110-120 with SVT
59 2021-03-16 heart rate increased Increased Resting heart rate (up from 75 to 95), increased working heart rate (up from 100 to 140). ... Read more
Increased Resting heart rate (up from 75 to 95), increased working heart rate (up from 100 to 140). As per my watch and confirmed by hand.
59 2021-03-16 lightheadedness 15 minutes after pt received his first dose of the Moderna COVID19 vaccine he reported feeling light... Read more
15 minutes after pt received his first dose of the Moderna COVID19 vaccine he reported feeling light headed. Lost color in skin, diaphoretic. Near syncopal episode. Laid pt down. Pt began feeling much better. BP 130/84 HR 59 O2 Sat 98 Repeat BP 150/92 HR 63 O2 Sat 98 % EMS called and evaluated pt. Sitting up BP 154/92. Pt signed refusal for transport to hospital with EMS. Pt was given information for high risk clinic at HHC for 2nd dose.
59 2021-03-16 ventricular tachycardia, cardiac arrest, fainting cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collaps... Read more
cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collapsed. Wife started CPR until medics arrived. Patient arrived at the hospital after 20min of pulseless V tach and 10 min of PEA.
59 2021-03-17 blood glucose increased At approximately 3;15 PM, I was administered the 2nd dose of Moderna Covid-19 Vaccine(EUA. At approx... Read more
At approximately 3;15 PM, I was administered the 2nd dose of Moderna Covid-19 Vaccine(EUA. At approximately 5:30 pm, my blood sugars rose in excess of 400 mg/dl, felt lightheaded followed by quick onset of high pressure and volume diarrhea. I was in my girlfriend's home and was barely able to get to the toilet in time. The diarrhea appeared pea soup green in color and consistency and very smelly. Of interest, my girlfriend who also received the second dose of the Moderna vaccine on the same date, time and location, was awaken at approximately 2:00 AM with the same rapid onset of diarrhea. On the second day following the vaccine, we both had elevated temperatures of 101.5 and 102 lasting approximately 24 hours.
59 2021-03-18 hypotension, fainting Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
59 2021-03-18 pulse abnormal, pallor The patient received his vaccine. Within a minute he started rubbing his neck. I asked him if he ... Read more
The patient received his vaccine. Within a minute he started rubbing his neck. I asked him if he was okay. He stated he was, it was just his neck hurting. He told me it's was going on for a long time and he is supposed to have surgery soon to correct the problem. He began to lean forward. I again asked if he was okay. He said he was but when I asked him to sit up for me, his color was pale. Myself and the patients wife accompanied him to the holding area where the EMT's were on standby. The patient was able to walk. 02 applied at 8l/m per FM rebreather. A+)x2 Temp: 98.6 B/P 0/40 P:69 weak and thready, Skin: pale; coool; clammy. Respirations 20 shallow ; The patient after about a minute or so with the O2 mask asked that the mask be removed. He said he felt better without the 02. Spo2= 97% on RA. The patient was transfered to the stretcher. The EMT's started an IV and placed the patient on a heart monitor. The patient was transfered to the ambulance for transfer. The patient became unresponsive for approximately 90 while en route to the hospital.
59 2021-03-20 cardiac arrhythmia DIZZINESS WITHIN 10 MINUTES OF INJECTION AND PERSISITING FOR UP TO A DAY AFTER. PATIENT REPORTED FEV... Read more
DIZZINESS WITHIN 10 MINUTES OF INJECTION AND PERSISITING FOR UP TO A DAY AFTER. PATIENT REPORTED FEVER AND CHILLS THE DAY AFTER VACCINATION. PATIENT HAS EXPERIENCED REDUCED/POOR SLEEP SINCE DATE OF VACCINATION. PATIENT HAS SEEN RETURN OF PREMATURE VENTRICULAR CONTRACTIONS (PVCs) SINCE VACCINATION AND REPORTS BENIGH BEATS AT 20-22%.
59 2021-03-21 blood glucose increased Friday 3/19/21: Sore shoulder later that evening. Took two Extra Strength Tylenol before bed at 9:00... Read more
Friday 3/19/21: Sore shoulder later that evening. Took two Extra Strength Tylenol before bed at 9:00 pm. Saturday 3/20/21: Woke at 2:00 am having the chills. Saturday 3/20/21: Got up out of bed at 5:30 am with Body Aches, Headache, Extremely Sore Left Shoulder/Injection Site, Elevated Fasting Glucose level of 174 with a temperature of 101.6. Started taking two Extra Strength Tylenol every four hours while continuing to drink lots of water. Went to bed that night at 8:00 pm with all symptoms remaining the same but with an elevated temperature reaching 103. Sunday 3/21/21: Got up out of bed at 5:00 am with Slight Body Aches, a Moderate Headache, Moderately sore Left Shoulder, a Temperature down to 100.2, but now with the addition of Moderately Sore Left Underarm Lymph Nodes. Continued taking Extra Strength Tylenol every four hours while continuing to drink lot of water. Temperature back to normal by 5:00 pm and all additional symptoms now slight. Monday 3/22/21: No Temp and only slight lymph node soreness and Shoulder.
59 2021-03-21 blood glucose increased Patient reported feeling dizzy shortly after receiving his COVID19 vaccination. Denied Chest pain or... Read more
Patient reported feeling dizzy shortly after receiving his COVID19 vaccination. Denied Chest pain or SOB
59 2021-03-21 brain sinus blood clot nonocclusive left sigmoid venous sinus thrombosis without ischemic stroke
59 2021-03-24 stroke Patient did not have any symptoms at the time of covid vaccination or during the observation period.... Read more
Patient did not have any symptoms at the time of covid vaccination or during the observation period. Patient started having left arm and foot numbness the day after moderna covid vaccination. He developed left facial droop 2 days after vaccination and went to local ER on 02/28/2021. CT/MRI revealed acute right occipital and right thalamic infarct and old left occipital infarct. Carotid US showed fully occluded left carotid. Patient smoked for 40 years and quit March 2021 and previously used crack cocaine and quit 1 year ago. He was discharged from hospital on amlodipine, clopidogrel, atorvastatin, and aspirin, which were new medications. Patient has returned to work for over 2 weeks.
59 2021-03-25 platelet count decreased, heart attack, haemoglobin decreased, fast heart rate Brought in from ED, family concerned for altered mental status, hyperthermia, Tmax in 105. The pati... Read more
Brought in from ED, family concerned for altered mental status, hyperthermia, Tmax in 105. The patient stated that after the covid-19 vaccine on Friday, he experienced acute onset of R shoulder pain, constant, associated with decreased ROM. On PM Monday, he noticed first episode of chills, that lasted a few minutes, accompanied with sweating. This episode recurred 4 times over the week, then the family started noticed the patient was unable to answer questions and was somnolent. Blood Cultures in the ED were positive for MRSA 2:2. He was positive for endocarditis (previous dental work). Acute metabolic encephalopathy due to severe sepsis most likely 2/2 MRSA bacteremia complicated by NSTEMI and AKI in setting of newly diagnosed aortic valve endocarditis complicated by septic emboli to the bilateral cerebral hemispheres
59 2021-03-25 fast heart rate PATIENT STATES APPROXIMATELY 10 HOURS AFTER RECEIVING THE VACCINE, HE EXPERIENCED DIZZINESS AND TIRE... Read more
PATIENT STATES APPROXIMATELY 10 HOURS AFTER RECEIVING THE VACCINE, HE EXPERIENCED DIZZINESS AND TIREDNESS, THEN 2 HOURS LATER HE EXPERIENCED TACHYCARDIA - PATIENT STATES HE WAS ADMITTED TO HOSPITAL ICU BASED ON HIS HEART RATE AND WAS DISCHARGED 2 DAYS LATER.
59 2021-03-28 heart rate increased Accelerated heartbeat for about 20 minutes. This symptom had an onset approximately 45 minutes afte... Read more
Accelerated heartbeat for about 20 minutes. This symptom had an onset approximately 45 minutes after receiving the first vaccine injection.
59 2021-03-29 cardiac failure congestive Patient received vaccine at hosptal. Presented to ER on 3/9 due to shortness of breath. Patient re... Read more
Patient received vaccine at hosptal. Presented to ER on 3/9 due to shortness of breath. Patient received vaccine the day prior (3/8). Patient states that shortness of breath started a few hours after COVID vaccine. Dx in ER: Acute on chronic CHF, Dyspnea, elevated BNP level, acute resp failure with hypoxia. H&P states that patient felt fever, chills, N/V, joint pain and shortness of breath. CXR had bilateral opacities/pleural effusion- likely pulmonary edema. Patient is still currently admitted- appears more related to fluid overload/CHF.
59 2021-03-29 heart rate increased My shot was on Saturday 3/26 and I started having a fever (101), body aches, pulse was elevated to a... Read more
My shot was on Saturday 3/26 and I started having a fever (101), body aches, pulse was elevated to around 75 bpm through Monday 3/29 late afternoon. Not sure if this helps but I had contracted COVID-19 in mid-March 2020 and had been giving COVID convalescent plasma for several months up until February of 2021. Maybe my previously generated antibodies amplified my symptoms?
59 2021-03-30 chest discomfort 3/25/2021 THURS 5:30pm Dizzy, achy, tired. runny nose, congestion, cough. restless night hard to sl... Read more
3/25/2021 THURS 5:30pm Dizzy, achy, tired. runny nose, congestion, cough. restless night hard to sleep with coughing hard to breathe 3/26/2021 called off work. could not function. same as above... general malaise . by far worst day! weight on chest just want to sleep 3/27/2021 general malaise eased up. less tired...BUT late in day low grade fever and chills. super tired want to sleep 3/28/2021 general malaise lifts a bit. The fever and chills are gone. still stuffed up coughing/hacking up. productive cough with mucus/sputum . 3/29.2021 MONDAY back to work. still feel "not right" congestin and coughing BUT feel better energy wise.
59 2021-03-31 loss of consciousness Collapsed -- full blackout -- next evening after 2nd vaccination. Recovered next day except for spra... Read more
Collapsed -- full blackout -- next evening after 2nd vaccination. Recovered next day except for sprained foot.
59 2021-03-31 cardiac arrhythmia, heart flutter heart fluttering, a really bad one; premature ventricular contractions; all sweat; dizziness; weakne... Read more
heart fluttering, a really bad one; premature ventricular contractions; all sweat; dizziness; weakness; A spontaneous report, was received from a consumer, concerning himself, a 59 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial flutter and PVCs. The patient's medical history included bladder surgery. concomitant medications was not included by the reporter. On 24 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 24 MAR 2021, 10 hours after first dose, the patient experienced sweats, dizziness, fluttering heart/increased heart rate and was seen at the ER and then transferred to ICU, she was told that she had 360 bpm atrial heart rate and PVCs. The patient stated that two years ago he was under anesthesia for bladder surgery and had something similar where the patient had rapid atrial heart beat which wasn't this long and the doctor stated that it was related to the anesthesia . The action taken with mRNA-1273 was not reported. The outcome of the events was 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. Further information has been requested.
59 2021-04-02 chest discomfort CHEST FELL TIGHT HAD SHORT BREATHS NO TREATMENT LASTED ABOUT LEST THAN 8 MINUTES
59 2021-04-03 blood pressure increased Systemic: increased in blood pressure-Mild, Systemic: Numbness (specify: facial area, extremities)-M... Read more
Systemic: increased in blood pressure-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient developed numbness in left arm, blood pressure mesured and it was elevated. Patient was monitored for 30 minutes and blood pressure decreased. Patient symptoms resolved on their own. Patient did not required medical help at time and left with family members. Patient was counseled to visit primary care or emergency room if symptom returns.
59 2021-04-04 chest discomfort Guest walked up stairs to get to his seat in the post vaccination area. Once he sat down he began to... Read more
Guest walked up stairs to get to his seat in the post vaccination area. Once he sat down he began to report feeling dizzy and a heaviness in his chest. EMS were called to attend to the guest. Vital signs were taken, all within normal limits. Drank some water. Once guest was sitting for a bit, he stated that he felt better. EMS did clear guest to leave on his own once his observation time was up. Guest was going to drive himself home.
59 2021-04-06 blood pressure increased aggravated neuropathy; pain in shoulders, described as going up neck; cannot walk far before getting... Read more
aggravated neuropathy; pain in shoulders, described as going up neck; cannot walk far before getting leg pain and starting to limp; ankles changing color and now turning blue; legs going numb, starting at ankles and now at mid-thighs which are tingling and itching; legs going numb, starting at ankles and now at mid-thighs which are tingling and itching; legs going numb, starting at ankles and now at mid-thighs which are tingling and itching; feeling very bad leg pains in both legs,constant right calf pain,pain in hand,pain in his wrists, elbows, and shoulders, described as going up on his neck,The pains are in his extremities and not his body cavity, feeling pulse while getting pain; pain in wrists, ankles, elbows/pain in shoulders, described as going up neck; pain at the injection site; vein pop out bulging all over legs when standing and walking; sleepless nights with severe pain; vascular symptoms, described as blood pressure spikes in the 150's/110 range; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (aggravated neuropathy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cancer (NOS) and Surgery (Patient had kidney surgery, back surgery, arm surgery, and a missing gall bladder.). Concomitant products included AMLODIPINE, LOSARTAN, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO), GABAPENTIN, MULTIVITAMINS [VITAMINS NOS] and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced VARICOSE VEIN (vein pop out bulging all over legs when standing and walking), INSOMNIA (sleepless nights with severe pain), BLOOD PRESSURE INCREASED (vascular symptoms, described as blood pressure spikes in the 150's/110 range) and VACCINATION SITE PAIN (pain at the injection site). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (aggravated neuropathy) (seriousness criterion medically significant), NECK PAIN (pain in shoulders, described as going up neck), GAIT DISTURBANCE (cannot walk far before getting leg pain and starting to limp), SKIN DISCOLOURATION (ankles changing color and now turning blue), HYPOAESTHESIA (legs going numb, starting at ankles and now at mid-thighs which are tingling and itching), PARAESTHESIA (legs going numb, starting at ankles and now at mid-thighs which are tingling and itching), PRURITUS (legs going numb, starting at ankles and now at mid-thighs which are tingling and itching), PAIN IN EXTREMITY (feeling very bad leg pains in both legs,constant right calf pain,pain in hand,pain in his wrists, elbows, and shoulders, described as going up on his neck,The pains are in his extremities and not his body cavity, feeling pulse while getting pain) and ARTHRALGIA (pain in wrists, ankles, elbows/pain in shoulders, described as going up neck). At the time of the report, NEUROPATHY PERIPHERAL (aggravated neuropathy), NECK PAIN (pain in shoulders, described as going up neck), GAIT DISTURBANCE (cannot walk far before getting leg pain and starting to limp), SKIN DISCOLOURATION (ankles changing color and now turning blue), HYPOAESTHESIA (legs going numb, starting at ankles and now at mid-thighs which are tingling and itching), PARAESTHESIA (legs going numb, starting at ankles and now at mid-thighs which are tingling and itching), PRURITUS (legs going numb, starting at ankles and now at mid-thighs which are tingling and itching), VARICOSE VEIN (vein pop out bulging all over legs when standing and walking), INSOMNIA (sleepless nights with severe pain), BLOOD PRESSURE INCREASED (vascular symptoms, described as blood pressure spikes in the 150's/110 range), PAIN IN EXTREMITY (feeling very bad leg pains in both legs,constant right calf pain,pain in hand,pain in his wrists, elbows, and shoulders, described as going up on his neck,The pains are in his extremities and not his body cavity, feeling pulse while getting pain), ARTHRALGIA (pain in wrists, ankles, elbows/pain in shoulders, described as going up neck) and VACCINATION SITE PAIN (pain at the injection site) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Nerve conduction studies: inconclusive (Inconclusive) Inconclusive. On 14-Feb-2021, Blood pressure measurement: increased having blood pressures in the 150's over 110 range. Treatment of events was done with gabapentin. Concomitant drug includes Super Beets for heart health and blood pressure; 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.
59 2021-04-06 fainting 3 days of intense diarrhea, lost about 10 pounds; Weak, no appetite, lethargic, sleeping a lot; Weak... Read more
3 days of intense diarrhea, lost about 10 pounds; Weak, no appetite, lethargic, sleeping a lot; Weak, no appetite, lethargic, sleeping a lot; Weak, no appetite, lethargic, sleeping a lot; Weak, no appetite, lethargic, sleeping a lot; Still just don't have the energy to this day; Chills all the time, fever of 102 for 5 days - went up every time after eating; Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up; Thursday, started not feeling great; 3 days of intense diarrhea, lost about 10 pounds; Chills all the time, fever of 102 for 5 days - went up every time after eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 023M20A) 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). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LEVOTHYROXINE SODIUM (SYNTHROID) and FINASTERIDE for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Thursday, started not feeling great). On 19-Mar-2021, the patient experienced SYNCOPE (Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (3 days of intense diarrhea, lost about 10 pounds), WEIGHT DECREASED (3 days of intense diarrhea, lost about 10 pounds), ASTHENIA (Weak, no appetite, lethargic, sleeping a lot), DECREASED APPETITE (Weak, no appetite, lethargic, sleeping a lot), LETHARGY (Weak, no appetite, lethargic, sleeping a lot), HYPERSOMNIA (Weak, no appetite, lethargic, sleeping a lot), ASTHENIA (Still just don't have the energy to this day), CHILLS (Chills all the time, fever of 102 for 5 days - went up every time after eating) and PYREXIA (Chills all the time, fever of 102 for 5 days - went up every time after eating). The patient was treated with Bed rest for Feeling abnormal. At the time of the report, SYNCOPE (Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up) and DIARRHOEA (3 days of intense diarrhea, lost about 10 pounds) had resolved and FEELING ABNORMAL (Thursday, started not feeling great), WEIGHT DECREASED (3 days of intense diarrhea, lost about 10 pounds), ASTHENIA (Weak, no appetite, lethargic, sleeping a lot), DECREASED APPETITE (Weak, no appetite, lethargic, sleeping a lot), LETHARGY (Weak, no appetite, lethargic, sleeping a lot), HYPERSOMNIA (Weak, no appetite, lethargic, sleeping a lot), ASTHENIA (Still just don't have the energy to this day), CHILLS (Chills all the time, fever of 102 for 5 days - went up every time after eating) and PYREXIA (Chills all the time, fever of 102 for 5 days - went up every time after eating) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Diagnostic procedure: all normal (normal) All normal. The patient has taken acetaminophen (TYLENOL), loperamide (IMMODIUM), and an unspecified prescription nausea medication to alleviate his discomfort. The patient saw a doctor who ran unspecified tests and they were all normal. This case was linked to MOD21-065196 (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.
59 2021-04-07 pallor, very slow heart rate, lightheadedness Patient experienced a vasovagal response and was presyncopal; felt lightheaded, then developed a bri... Read more
Patient experienced a vasovagal response and was presyncopal; felt lightheaded, then developed a brief headache, stated his vision was "fading." He was pale and diaphoretic. Developed nausea. Found to be bradycardic but otherwise normal vitals (131/73, HR 48, T 97.5, O2 98%; HR later increased to mid 50s). Patient was moved from chair to exam table and laid supine then later elevated his head. Cool cloth was applied. Emesis bag and water were provided. Snack was offered and declined. Patient kept in exam room with spouse and frequent checks by staff for ~30 minutes then moved to the waiting room when symptoms had significantly improved where he waited another 30-40 minutes. His spouse was instructed to drive home and patient was instructed to rest the remainder of the day with ER precautions given. Patient was called at ~7 pm and stated he felt much better with resolution of his symptoms.
59 2021-04-07 fainting Minutes after vaccination, patient complained of nausea. Was on his way to the bathroom, when he col... Read more
Minutes after vaccination, patient complained of nausea. Was on his way to the bathroom, when he collapsed. Patient was cold, clammy and diaphoretic. Weak but responsive. BP 70/40. Continued to complain of nausea but no vomiting. Paramedic onsite. IV fluids initiated and patient was transported to Bridgeport Hospital via ambulance. Stabilized in hospital and discharged that evening.
59 2021-04-08 fainting FULL BODY RASH STARTING 36 HOURS AFTER VACCINATION. ONE EPISODE OF SYNCOPE AT 42 HOURS POST VACCINAT... Read more
FULL BODY RASH STARTING 36 HOURS AFTER VACCINATION. ONE EPISODE OF SYNCOPE AT 42 HOURS POST VACCINATION
59 2021-04-10 atrial fibrillation, heart rate irregular Woke up with A-fib (6:00 am) on 3/29/2021. Had old medication on hand Metoprolol tartrate 50 mg To... Read more
Woke up with A-fib (6:00 am) on 3/29/2021. Had old medication on hand Metoprolol tartrate 50 mg Took 50 mg at 9:00 am and then at 9:00 pm. Took same dose next day (3/302021). Third day dropped dose to 25 mg every 12 hours; continued with that for a total of 3 days. Then dropped to 25 mg per 24 hours for 2 days total. By bed time of same day A-fib started (10:30pm) heart beat was not in A-fib, but erratic - skipped beats, long pauses. Waking up the next day (3/30/2021) rhythm was mostly normal with occasional skips or pause. This has slowly stabilized to normal all the time about a week after A-fib started. Note: I have had 2 pulmonary vein ablations. The last one was about 7 years ago. I have been in normal rhythm ever since except when I contracted the flu in January 2018. I was treated at that time with the Metoprolol and normal rhythm was restored in about a day.
59 2021-04-12 cerebrovascular accident Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and desc... Read more
Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 038AZIA) for COVID-19 immunisation. The patient's past medical history included No adverse event (No medical history reported). On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Mar-2021 to 25-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) was resolving.; 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.
59 2021-04-12 loss of consciousness, hypotension 10 minutes after getting vaccine pt stated he was getting dizzy and felt short of breath. He lost co... Read more
10 minutes after getting vaccine pt stated he was getting dizzy and felt short of breath. He lost consciousness for about 30 seconds, was shaking and gasping for air. We laid him on the ground and did a sternal rub and called 911. Patient was breathing on his own during this time and started to gain consciousness. EMTs then arrived on the scene and placed him on oxygen.
59 2021-04-13 deep vein blood clot admitted to hospital on 3/25/21 for Cholelithiasis and during the workups had an Ultrasound - VL Low... Read more
admitted to hospital on 3/25/21 for Cholelithiasis and during the workups had an Ultrasound - VL Lower Ext Veenous Duplex Bilateral study on 3/26/21.
59 2021-04-13 pallor Weakness. feeling faint. paleness. Pt. vs assessed. Pt. monitored until patient felt better.
59 2021-04-14 hypotension, heart rate increased Approximately 1.5 hours after receiving the vaccine - High heart rate up to 180 bpm. Very low BP. Ch... Read more
Approximately 1.5 hours after receiving the vaccine - High heart rate up to 180 bpm. Very low BP. Chills & sweats.
59 2021-04-16 heart rate decreased, increased heart rate 11:24 Patient stated my heart is going too fast. Immediate assessment by onsite NP and EMS. Placed... Read more
11:24 Patient stated my heart is going too fast. Immediate assessment by onsite NP and EMS. Placed on cardiac monitor which showed sinus tachycardia, rate of 113. SAO2 = 98% on room air. 11:29 Benadryl 25mg po with water. Patient given bottle of water and cereal bar. VS P109; BP 187/139; O2 Sat 97 11:31 HR decreased to 98; 149/97; 97% on RA. 11:40 HR 92; 142/92- SAT 96% on RA. Discharged with wife @ 11:56. Stated he felt much better.
59 2021-04-19 deep vein blood clot DVT
59 2021-04-19 pulmonary embolism Extensive bilateral numerous large central pulmonary emboli including a saddle-type embolism. Right... Read more
Extensive bilateral numerous large central pulmonary emboli including a saddle-type embolism. Right heart strain with the reflux of contrast into the inferior vena cava (per CT angio Chest PE protocol) Started on Eliquis, has follow up ECHO today
59 2021-04-20 atrial fibrillation Atrial fibrillation with RVR
59 2021-04-20 loss of consciousness Patient was vaccinated at 1242 and immediately loss consciousness upon standing. Patient was positi... Read more
Patient was vaccinated at 1242 and immediately loss consciousness upon standing. Patient was positioned supine with legs elevated. Ammonia inhalant placed under nose for patient to breathe. BP, HR, and O2 sat was monitored every 3-5 minutes.
59 2021-04-21 deep vein blood clot DVT BLOOD CLOTD
59 2021-04-22 cerebrovascular accident sent to the emergency room because his doctor thought he was having a stroke.; blood vessels had bur... Read more
sent to the emergency room because his doctor thought he was having a stroke.; blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included DULAGLUTIDE (TRULICITY) for an unknown indication. On 09-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 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) (seriousness criteria hospitalization and medically significant) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to CEREBROVASCULAR ACCIDENT and PURPURA. At the time of the report, CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) outcome was unknown. The lot number of the second vaccine was thought by the patient to be 0L161521A but patient was unsure. The patient was hospitalized for one day due to the events. Magnetic resonance imaging (MRI) and computerized axial tomography (CAT) scan were performed (results not provided). Treatment information was not provided. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-080378, US-MODERNATX, INC.-MOD-2021-080378 (E2B Linked Report). This case was linked to MOD-2021-080340 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. -MODERNATX, INC.-MOD-2021-080378:Physician case -MODERNATX, INC.-MOD-2021-080378:
59 2021-04-22 chest discomfort Severe headache, joint pains, nausea, sweating, fever, shivers, difficulty breathing, chest feels ... Read more
Severe headache, joint pains, nausea, sweating, fever, shivers, difficulty breathing, chest feels compressed, my feet ( in which I have neuropathy ) went numb. Started the evening of the injection, and is now - 3 days later still as intense
59 2021-04-24 deep vein blood clot Pain in calf, ultrasound positive for DVT
59 2021-04-25 chest discomfort Tingling sensation on chin Tongue numbness Burning sensation and tightness on both chest
59 2021-04-25 chest pain After he received his vaccine, he became altered and hallucinating later that night- unsure exact ti... Read more
After he received his vaccine, he became altered and hallucinating later that night- unsure exact time. Family got him to bed that night and woke up the next day still altered. Patient brought to ER ultimately with complaint of aches and pain all over, headache and chest pain. ER physicians primary impression was COVID vaccine reaction and patient was not admitted.
59 2021-04-26 heart attack 5 days after receiving Moderna vaccination suffer acute myocardial infraction. Requiring stent place... Read more
5 days after receiving Moderna vaccination suffer acute myocardial infraction. Requiring stent placement of the right coronary artery. Recovering from MI.
59 2021-04-26 hypertension, atrial fibrillation Pneumonia; Atrial Fibrillation; Heart damage; High Blood Pressure; Chills; Body aches; Fever; Very s... Read more
Pneumonia; Atrial Fibrillation; Heart damage; High Blood Pressure; Chills; Body aches; Fever; Very sick; Breathing difficult; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (Pneumonia), ATRIAL FIBRILLATION (Atrial Fibrillation), HEART INJURY (Heart damage), DYSPNOEA (Breathing difficult), HYPERTENSION (High Blood Pressure), ILLNESS (Very sick), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DYSPNOEA (Breathing difficult) (seriousness criterion hospitalization prolonged) and ILLNESS (Very sick) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization), ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion hospitalization), HEART INJURY (Heart damage) (seriousness criterion hospitalization), HYPERTENSION (High Blood Pressure) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), MYALGIA (Body aches) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). The patient was hospitalized on 09-Apr-2021 due to ATRIAL FIBRILLATION, CHILLS, DYSPNOEA, HEART INJURY, HYPERTENSION, ILLNESS, MYALGIA, PNEUMONIA and PYREXIA. At the time of the report, PNEUMONIA (Pneumonia), ATRIAL FIBRILLATION (Atrial Fibrillation), HEART INJURY (Heart damage), DYSPNOEA (Breathing difficult), HYPERTENSION (High Blood Pressure), ILLNESS (Very sick), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chest X-ray: Inconclusive. In April 2021, Echocardiogram: Inconclusive. In April 2021, Ejection fraction: 35 percent. In April 2021, Electrocardiogram: Inconclusive. In April 2021, Heart rate: (High) increased. In April 2021, Laboratory test: (Negative) tested for viruses, Covid-19 and other Infectious diseases all came back negative. In April 2021, Magnetic resonance imaging: Inconclusive. In April 2021, SARS-CoV-2 test negative: (Negative) Negative. In April 2021, Viral test: (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was fine until 05-Apr-2021 and felt very sick, with trouble breathing, body aches, fever, chills, pneumonia and heart damage. He went into atrial fibrillation, high blood pressure, high heart rate, and an ejection fraction of 35%. He had an EKG, echocardiogram, MRI, and chest x-ray. He was tested for viruses, COVID-19 and other Infectious diseases all came back negative. He went to the emergency room on 09-Apr-2021 and was admitted to the hospital for 6 days. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information has been provided at this time. Further information has been requested. Based on the current 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-2021-081630, US-MODERNATX, INC.-MOD-2021-081642 (Patient Link).; Sender's Comments: Very limited information has been provided at this time. Further information has been requested. Based on the current information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
59 2021-04-27 loss of consciousness A minute or two after patient received vaccine he was on his way to the post vaccination waiting are... Read more
A minute or two after patient received vaccine he was on his way to the post vaccination waiting area he passed out and fell against a display where he slid to the ground. Within a minute of this event and getting to the patient he was already conscious although lethargic and kept closing his eyes. Over the next 5-10 minutes he became much more responsive and eventually stood up and had a seat in a chair. EMS was already called and came to check on him and eventually they let him go and he indicated he was fine and continued to finish his shopping.
59 2021-04-28 anaemia, chest pain In a nutshell, patient was fine, got the first shot of the Moderna Vaccine on 3/24/21, then began to... Read more
In a nutshell, patient was fine, got the first shot of the Moderna Vaccine on 3/24/21, then began to exhibit many covid-like symptoms starting around 4 hours later but 3 times nasal swap tested negative for COVID19 including before and after vaccination. Suffered with various attempts at treatments and tests for approximately a month and then was admitted to the ER at hospital on 4/28/21. Wife (former smoker who lives in same house and has lung problems) who took the vaccine at the same time from the same lot suffered minor arm pain, aches and pains and fatigue but was fine the next day. Patient (59) had normal blood pressure and clear lungs in good health, non-smoker, good weight, exercises regularly and strenuously, good diet, rarely gets ill. He works as a ship?s captain and engineer and has worked in boatyards for years doing physical work. Has tintinnitis and in one eye, glaucoma drops but is on no other prescription medicines. Details: March: had nasal congestion, cough and suspected bronchitis, aches and pains, no fever, PCR tested negative for COVID19, and was treated with antibiotics (azithromycin and then a run of amoxycillin), proair, advair discuss a couple of days, various vitamins/minerals, over the counter cold/flu medicines. Seemed to work with most symptoms going away prior to Marcch 24, 2021. March 24, 2021 morning: Got first shot of the Moderna Vaccine at pharmacy. Lot 045A21A at same time as spouse. That morning had no cough and felt ok. Approximately 4 hours later, patient started to cough, felt congested, felt like flu/pneumonia, trouble breathing, aches and pains especially in joints, extreme fatigue, headache, (but suffered no loss of taste or smell throughout 3/24-present) took Theraflu and went to bed early, slept well. Following days, struggled with intensifying symptoms. Felt like the vaccine gave him covid symptoms without the loss of smell/taste. Spouse experienced minor pain at point of injection, some fatigue, aches and pains which went away by end of next day 3/25/21. Spouse had some lingering cough left over from earlier bronchitis before getting the vaccine which cough/congested breathing continued with no noticeable change. [Spouse was also not adversely impacted by the second shot of Moderna vaccine a month later.) Apr Wk1 & Wk2: Increasing difficulty sleeping due to lung congestion or suddenly waking up wide awake for no reason. At end of Wk2, had some minor tremors in muscles for a couple of days. Suffered from extreme fatigue, congestion, trouble breathing, nightmares, aches and pains. Took azithromycin run then a run of amoxicillin, proair, prednisone, albuterol nebulizer, occasional Theraflu or over-the-counter cold/flu medicines, vitamins/minerals (including heavier doses of Vitamin D, Zinc, C, etc.), probiotic acidophilus, tonic water with quinine or Perrier, melatonin 10mg and magnesium 500mg at night, occasionally a Unisom sleeping pill. Started to lose appetite where rarely hungry. Would force himself to eat anyway, but occasionally vomited it up. Apr Wk3 4/13/21: Patient got another PCR covid test which was negative, chest xray, blood work done at Urgent Care. Showed some elevated liver/kidney enzymes and low red blood cell count/anemia, vague thickening of the plura, swollen lymphnode in the chest xray, no sign of cardiovascular issue. (Some yellow flags but nothing flashing red.) Dr. recommended followup tests and bloodwork and that he get GI/Cardio/pulmonary workups w/specialists. Patient continued to take antibiotics, pregnizone, albuterol nebulizer, vitamins/minerals, and occasional cold/flu/cough medicines, etc. Added SuperB Complex. One day he had hot/cold chills for a few hours. Apr Wk4: While lungs felt clearer, still coughing and now occasionally vomiting productively or dry heaves, insomnia grew into bigger issue with hallucinations not just with nightmares but occasionally during the day where it was difficult to separate reality from dream, trouble remembering, started to feel paranoid/irrational sometimes, trouble sleeping was not due to lung congestion but more due to panic-attack like heavy breathing or sudden central chest/sternum pain (maybe from coughs), aches in joints, but biggest problem was extreme fatigue and tiring when walking up a flight of stairs, etc. Took some Tramadol occasionally for pain relief (but never with aspirin, Tylenol or cold medicine). Could be sitting comfortably watching a mellow tv program but suddenly need to breathe really heavy, hyperventilating and felt need to standup and walk around until it eased. Extreme trouble sleeping. Most comfortable position was kneeling with body bent over a pillow on the bed. [He'd never had panic-attacks/heavy breathing issues before the Moderna shot and doesn't abuse substances.] Wk5: 4/24/21 feet swelled up and turned purple on the soles. Went for a walk around the block and raised feet. No longer on antibiotics or pregnizone, only taking the albuterol nebulizer, vitamins/minerals/probiotics, melatonin and a OTC cough/flu medicine before bed. Knelt for hours while trying to sleep. 4/25/21, feet more swollen with fluid and more discolored. When searched online, they looked like "covid toes". Took no medicines except nebulizer and took only a couple of vitamins/calcium-vitaminD and before bed a beer, melatonin, magnesium & nyquil. 4/26/21, feet less swollen and no longer purple except a small line on the side of one foot. Patient indicated he had not knelt when trying to sleep prone during night. But only got a couple of hours of sleep, nighttime hallucinations and panic-breathing attacks. Daytime inability to focus, extreme fatigue, aches and pains, quick to tire on any exertion, vomiting food or dry heaves 2 or 3 times that day, panic-like-attacks with need to heavy breathe/hyperventilate. Wheezing with occasional rattle at end. Coughs sometimes productive, sometimes not but lungs didn?t feel very congested and oxygenation/blood pressure was good. 4/27/21, went to work in morning and was able to perform but very tired. In early afternoon, came home, ate, took nyquil and nebulizer and tried to sleep. 4/28/21, felt much worse, feet and knees swollen, extreme exhaustion, felt miserable. Went to work anyway. Came home around 2pm, ate. Felt much worse so we went to the ER at Hospital. Spouse provided MMC with his medical conditions, medicines, the info on COVID IGG serology test and informed them of the chest xrays and bloodwork that had been done at the Urgent Care center 2 weeks prior. ER indicated he needed to stay overnight and they performed additional bloodwork, xrays, scans and MRIs. The ER doctor called in specialists in Nephrology and Cardiology to provide consultations.
59 2021-04-29 ejection fraction decreased, heart failure New-onset heart failure from cardiomyopathy, possible myocarditis
59 2021-04-29 loss of consciousness PT WAS SITTING FOR 15 MINUTES AFTER HIS SHOT. AROUND 10 MINUTES AFTER HE DID NOT LOOK RIGHT. I ASKED... Read more
PT WAS SITTING FOR 15 MINUTES AFTER HIS SHOT. AROUND 10 MINUTES AFTER HE DID NOT LOOK RIGHT. I ASKED IS HE WAS OK AND HE SAID NO, HE IS NOT AND THEN PASSED OUT. HE DID HAVE A PULSE. HE WAS OUT OF IT LESS THAN 2 MINUTES. HE DID URINATE HIMSELF. AMBULANCE WAS CALLED AND HE WAS EXAMINED. HIS BP, PULSE, AND O2 RETURNED TO NORMAL. THE PATIENT REFUSED FURTHER MEDICAL EVALUATION AND REFUSED GOING TO EMERGENCY DEPARTMENT.
59 2021-04-30 heart rate abnormal Body Aches from head to toe. Violent nausea and vomiting and diarrhea, severe weakness, rapid heart ... Read more
Body Aches from head to toe. Violent nausea and vomiting and diarrhea, severe weakness, rapid heart rate, chills and low grade fever (99*) which lasted 6 days before eventually going to ER.
59 2021-05-03 platelet count decreased, haemoglobin decreased, heart rate increased, blood glucose increased, blood pressure increased Fever, confusion. He received the vaccine about 10:30 AM. He worked in the yard during the day and ... Read more
Fever, confusion. He received the vaccine about 10:30 AM. He worked in the yard during the day and seemed to be doing fine. After eating dinner, he seemed to be unusually drowsy. Over the course of the evening, the wife realized that he was very confused and was too weak to ambulate. She summoned EMS, and he was taken to ED. Of note, he had an episode of confusion lasting several days in 2/2021. No fever at that time. Evaluated in ED on 2/20/2021. CT Head and labs unrevealing. Released to home. Initial vital signs 4/30/2021 at 00:59: Temperature-100.4°, blood pressure-133/68, pulse-110, respirations-18, room air O2 saturation-97%. He subsequently had a T-max of 102.8°. He received empiric therapy with dexamethasone, vancomycin, ceftriaxone, ampicillin, acyclovir on the evening of 4/30. The morning of 5/1 he was afebrile, alert, oriented x3. Steroids and anti-infective discontinued. He was observed in the hospital for another 24 hours and had no recurrence of fever, confusion.
59 2021-05-03 blood clot The patient developed a blood clot in the left calf 2 weeks after the first dose of Moderna COVID va... Read more
The patient developed a blood clot in the left calf 2 weeks after the first dose of Moderna COVID vaccine, which required treatment with Eliquis 5 mg twice daily. The patient also reported hearing loss that needed treatment with a tapering steroid protocol. The sense of hearing did not recover after the most recent loss event.
59 2021-05-03 transient ischaemic attack TIA Stroke (transient ischemic attack); loss of memory for 15 minues could not spell the word "side"... Read more
TIA Stroke (transient ischemic attack); loss of memory for 15 minues could not spell the word "side" nor "effect"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) (seriousness criterion medically significant) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect"). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect") 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 medication included vitamin-c and fish oil 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.
59 2021-05-03 cardiac arrhythmia New onset frequent pvc?s.
59 2021-05-05 chest discomfort Swelling lips, tongue swelling, asthma started to tighten chest, itchy hands, feet, umber arms, ar... Read more
Swelling lips, tongue swelling, asthma started to tighten chest, itchy hands, feet, umber arms, around the waist, treated with over the counter antihistamines for two weeks. Very sensitive to things I am allergic too. Hope it goes away.
59 2021-05-06 cerebrovascular accident 12h after administration, patient developed dysphagia and dysarthria with RL facial droop. Diagnosed... Read more
12h after administration, patient developed dysphagia and dysarthria with RL facial droop. Diagnosed with acute ischemic CVA of left corona radiata.
59 2021-05-06 chest pain, lightheadedness chest pain, near syncope
59 2021-05-07 loss of consciousness Within 10 seconds patient became diaphoretic, dizzy, I eased him to ground, eyes rolled back, I did... Read more
Within 10 seconds patient became diaphoretic, dizzy, I eased him to ground, eyes rolled back, I did sternal rub, because more awake. Slight loss of conscience. Cold and clammy.
59 2021-05-09 hypertension Hypertension requiring additional mediation to control. Prior to COVID-19 vaccination, patient's blo... Read more
Hypertension requiring additional mediation to control. Prior to COVID-19 vaccination, patient's blood pressure was controlled.
59 2021-05-09 loss of consciousness 5 minutes after the vaccine, while patient was sitting in the waiting area, patient started having a... Read more
5 minutes after the vaccine, while patient was sitting in the waiting area, patient started having a breathing problem and because unconscious. His head was moving forward and backward rapidly, almost like having a seizure reaction. Had a team member call 911 and Immediately injected 0.3mg generic epipen in his left thigh. Patient became conscious in less than a minute after epinephrine shot. Stayed with patient until EMS came. EMS checked his vital and concluded that patient was having a immunization stress response since he did not have any hives or swelling from the first dose. Patient was given an option to follow EMS to the local hospital but he decided to go home with his family.
59 2021-05-09 heart attack Became extremely disoriented about 10 hours after vaccine. Could not "find"words, speaking complete... Read more
Became extremely disoriented about 10 hours after vaccine. Could not "find"words, speaking complete nonsense. Felt very, very out of it and confused. Fell asleep and felt still confused but not as badly and could talk. Arm and mouth felt tingling / numb. Went to work but left as felt similar symptoms to mini-stroke 15 years previous. Went to urgent care and then ER. ER stated EKG was abnormal indicating heart attack at some point.
59 2021-05-09 palpitations Patient describes palpitations 2 weeks after receiving 2nd dose of Moderna vaccine for COVID 19. ECG... Read more
Patient describes palpitations 2 weeks after receiving 2nd dose of Moderna vaccine for COVID 19. ECG in hospital demonstrates multifocal atrial tachycardia.
59 2021-05-10 loss of consciousness He got his vaccine, was in the store at the meat counter and then had a visual effect as people were... Read more
He got his vaccine, was in the store at the meat counter and then had a visual effect as people were looking at him funny, and things went from black/white to black/gray/white and passed out (told he had a seizure and on film at the grocery store), then woke up in the back of the ambulance on the way to the hospital. In the hospital he was given an injection to slow his heart rate down, said that he drank a pot of coffee and then had another 16 oz coffee after that. He was not admitted, treated in the ER, fed him and was discharged home and then walked about 1/2 mile to his truck at the supermarket, and finished his shopping. He has been a little tired since then, has been taking it easy and not pushing himself too hard and not working too many hours.
59 2021-05-10 pulmonary embolism Admitted with moderate pulmonary embolism 9 days after vaccine, not sure it's related. He had a long... Read more
Admitted with moderate pulmonary embolism 9 days after vaccine, not sure it's related. He had a long travel prior as well and could be cause for thromboembolism too.
59 2021-05-12 platelet count decreased, low blood platelet count ITP with wet purpura and platelet count <10. No ICH at the time of admission.
59 2021-05-12 pulmonary embolism, deep vein blood clot right lower extremity DVT and pulmonary embolism
59 2021-05-16 atrial fibrillation Atrial Fibrillation episodes became much more frequent and longer lasting over the course of the nex... Read more
Atrial Fibrillation episodes became much more frequent and longer lasting over the course of the next 24 days.
59 2021-05-17 blood pressure increased Noted severe lower back pain and stiffness starting evening after injection. Prior to that mild feve... Read more
Noted severe lower back pain and stiffness starting evening after injection. Prior to that mild fever (100.5) and chills. Morning of 14th extreme difficulty getting out of bed, upon standing, legs buckled causing contact with the floor. Took over 1 hour to get vertical again. No sleep evening of 14th to morning of 15th. Morning of 15th, pain 8/10, started crying. ER visit. BP elevated. Tylenol, Flexeril, Lidocane and Toradol given for pain management. Discharged on 15th. Morning of 16th, no change, spent day immobile. Morning of 17th, slight decrease, mobility decreased as day progressed. Morning of 18th, attempted to shower, lost balance and fell. Lower back pain 7/10. Started gathering documentation.
59 2021-05-23 arrhythmia shortness of breath, arrhythmia. Referred to Cardiologist. Recommended scope to check the heart fo... Read more
shortness of breath, arrhythmia. Referred to Cardiologist. Recommended scope to check the heart for clots, shocked heart back to normal sinus rhythm.
59 2021-05-23 heart rate increased, chest pain Pain at the left side of the heart coinciding with each heartbeat, then heartbeats accelerated to a ... Read more
Pain at the left side of the heart coinciding with each heartbeat, then heartbeats accelerated to a very rapid beat lasting about 15 seconds the returning back to normal within milliseconds. Never experienced this my entire life, even after running 10 miles, 4 times weekly. Usual minor flu-like symptoms were also felt like dizziness, and then tiredness. Slept a lot on the day my heart rate went up.
59 2021-05-23 hypertension My blood pressure is through the roof, and have had to double my medication. I get very, very winde... Read more
My blood pressure is through the roof, and have had to double my medication. I get very, very winded going up only one flight of stairs, and have to sit and rest for one to two minutes after I go up stairs.
59 2021-05-23 inflammation of the pericardium Patient received first dose of vaccine on 4/18/2021, and second dose on 5/22/2021. Now presents wit... Read more
Patient received first dose of vaccine on 4/18/2021, and second dose on 5/22/2021. Now presents with pericarditis on 5/24/2021. I know there has been some potential association of pericarditis with vaccination
59 2021-05-26 blood glucose increased Patient one week later had aseptic meningitis. LP showed elevated glucose, protein, monocytic lymph... Read more
Patient one week later had aseptic meningitis. LP showed elevated glucose, protein, monocytic lymphocytosis. Recovered after 2-3 days with antivirals and antibiotics
59 2021-05-31 chest pain So on April 19th I got the second Covid vaccine, I went to the urgent care on the following day at a... Read more
So on April 19th I got the second Covid vaccine, I went to the urgent care on the following day at approx. 11:30 AM. They did an EKG they said it looked fine and they sent me on my way regardless of it hurting me real bad (my chest). When I woke up Sunday morning, there was a crushing pain in my chest. On the 25th I woke up, got dressed and went right over to the hospital. I was in so much pain I had to go back to the hospital. I was there from the 25th-29th, they said I needed to have an angiogram with a possible stint in my left artery. On the 28th they put that stint in and I left on the 29th of April in the afternoon at about 4pm. I still am not feeling right, my chest hurts not like it did then, but shortness of breath. I also have to take a blood thinner and a baby aspirin. I have new symptoms in both my arms, from my bicep to my triceps is very achy - it has never done that before. My arms are very stiff. I still have trouble taking deep breathes.
59 2021-06-01 inflammation of the heart muscle, chest pain, troponin increased Patient was diagnosed, admitted to hospital for 7 days and discharged home without O2, he got his 1 ... Read more
Patient was diagnosed, admitted to hospital for 7 days and discharged home without O2, he got his 1 dose of Moderna vaccine after 45 days of COVID19 diagnosis. With in 8 hours patient started developing Shortness of breath, Chest pain and myalgia so admitted to ICU, intubated and found to have Diffuse alveolar hemorrhage and Myocarditis.
59 2021-06-01 platelet count decreased I had the vaccine and the day after I had fever, chills, aches, and on the third day vomiting and a ... Read more
I had the vaccine and the day after I had fever, chills, aches, and on the third day vomiting and a 104 temperature. I decided to go to the hospital. They tested for flu, covid and a full blood work and an MRI. 4 days prior to the vaccine my platelet count was 253000 and three days after the vaccine was 45000 and it continued to drop the next few days. My immune system destroyed my blood platelets. They gave me dexametasone, steroids for 4 days.
59 2021-06-03 blood glucose increased On 10th day after vaccine, he developed Bell's Palsy with onset diabetes.
59 2021-06-03 chest pain, inflammation of the pericardium Pericarditis; Pain in their chest; shallow breathing; Fever; Chills; Inappropriate schedule of vacci... Read more
Pericarditis; Pain in their chest; shallow breathing; Fever; Chills; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Molluscum contagiosum ('triamcinolone acetonide' as treatment) since 02-Apr-2021. Concomitant products included EZETIMIBE, PANTOPRAZOLE, IBUPROFEN and COLCHICINE for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 21-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 11-May-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Pain in their chest). 11-May-2021, the patient experienced HYPOPNOEA (shallow breathing). The patient was hospitalized on 11-May-2021 due to PERICARDITIS. The patient was treated with MORPHINE for Pain prophylaxis, at an unspecified dose and frequency and OXYCODONE for Shallow breathing, at an unspecified dose and frequency. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PERICARDITIS (Pericarditis), CHEST PAIN (Pain in their chest), HYPOPNOEA (shallow breathing), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Treatment medications included morphine and oxycodone. Company comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot # 037b21a) with AEs of Pericarditis, Chest pain, Hypopnoea, Pyrexia and Chills 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. This case was linked to MOD-2021-177226 (Patient Link).; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot # 037b21a) with AEs of Pericarditis, Chest pain, Hypopnoea, Pyrexia and Chills 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.
59 2021-06-03 excessive bleeding First dose was on 01/09/21 no reaction 2nd dose was on 02/06/21 cold and flu symptoms for 1 day. Wi... Read more
First dose was on 01/09/21 no reaction 2nd dose was on 02/06/21 cold and flu symptoms for 1 day. With in 2-3 weeks increase abdominal pain, and discomfort, I thought it was a Crohn?s flair, so I just tried to wait it out. Early April I went to the ED, for eval and treatment , it was discovered via CT of abdomen I developed Portal Vein Thrombosis, admitted for anti coagulation, and further studies like JAK 2. Place on heparin, followed by lovonox SQ injections, and bridged to Pradaxa. Symptoms returned after a couple of weeks, and persisted, ,back tp the hospital new CZt scans, showed increase in Portal vein thrombosis, but now included splenic vein thrombosis, and mesenteric vein thrombosis. Went back on anticoagulation therapy, transferred to hospital for Intervention Radiology procedure to have a portal vein shunt placed in, and thrombectomy of the spleen, and mesenteric veins. Had bleeding issues, returned to OR for a second IR procedure, and finally a 3rd procedure of splenectomy, blood transfusion for hemorrhagic shock. Discharged on warfarin, and lovonox as needed
59 2021-06-07 platelet count decreased After second injection on 6/3/2021, I felt fine. Upon waking on 6/4, I had a fever of 101, severe he... Read more
After second injection on 6/3/2021, I felt fine. Upon waking on 6/4, I had a fever of 101, severe headache and body pain. On 6/5, I developed a 5? x 5? irritated red patch on my injection arm. On 6/6 I awoke to no fever. I then noticed sores in my mouth and busies on my abdomen, left leg and left foot. I went to urgent care. They ran a CBC. My platelet count was down 30% since ,my last test a few months ago. My average was about 180,000 for the last 6 years. My test number was 127,000. I have no history of a low platelet count. This appeared within days of the 2nd vaccination along with the sores and spontaneous bruising. A CAT and v,MRI were performed that same day. Those tests were normal.
59 2021-06-08 fast heart rate, ejection fraction decreased, inflammation of the heart muscle Patient had GI symptoms 4 days after vaccination and then developed dyspnea. By seven days post vacc... Read more
Patient had GI symptoms 4 days after vaccination and then developed dyspnea. By seven days post vaccination, patient had difficulty breathing and then came to the hospital. He was found to be in acute heart failure and multisystem organ failure. Leading diagnosis was post covid vaccination myopericarditis
59 2021-06-10 chest pain J18.9 - Pneumonia FATIGUE FEVER CHEST PAIN COUGH
59 2021-06-10 chest pain BAD CHEST PAIN , UPPER CHEST LEFT SIDE , FEELS LIKE I GOT HIT IN CHEST , LIKE A BIG BRUISE TYPE PAIN... Read more
BAD CHEST PAIN , UPPER CHEST LEFT SIDE , FEELS LIKE I GOT HIT IN CHEST , LIKE A BIG BRUISE TYPE PAIN WHEN I TOUCH IT . TODAY IS JUNE 11 2021 AND STILL HAVE PAIN .
59 2021-06-10 loss of consciousness, atrial fibrillation Atrial fibrillation; Blacked out; This spontaneous case was reported by a consumer (subsequently med... Read more
Atrial fibrillation; Blacked out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included DVT. Concurrent medical conditions included Chronic pain and Spinal stenosis lumbar. 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 05-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant). On 12-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 12-Feb-2021, Chest X-ray: abnormal (abnormal) Abnormal. On 12-Feb-2021, Electrocardiogram: abnormal (abnormal) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication used was not provided. 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 MOD-2021-194935 (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.
59 2021-06-16 palpitations, chest pain starting that evening of the vaccine, pt developed tremors, paresthesias, erectile dysfunction, naus... Read more
starting that evening of the vaccine, pt developed tremors, paresthesias, erectile dysfunction, nausea, vision changes, chest pain, insomnia, and palpitations. The chest pain resolved with tylenol. The other symptoms have not remitted.
59 2021-06-20 chest pain Acute respiratory failure, chest pain coughing
59 2021-06-22 coughing up blood He had the onset of respiratory complaints, hemoptysis. Led to CT Scans, biopsy. It returned no infe... Read more
He had the onset of respiratory complaints, hemoptysis. Led to CT Scans, biopsy. It returned no infection or cancer
59 2021-06-23 deep vein blood clot Patient received 2nd Moderna vaccination on 6/14/2021. Had labs drawn on 6/22 notable for AKI (Cr of... Read more
Patient received 2nd Moderna vaccination on 6/14/2021. Had labs drawn on 6/22 notable for AKI (Cr of 3.55 above baseline 1.6). Also had R calf pain and swelling. Presented to ER and found to have acute DVT of RLE femoral and popliteal veins. Given IVFs and AKI improved, and started on Apixaban for RLE DVT
59 2021-06-23 fainting, palpitations, heart attack suffered a massive heart attack; Feeling of faintness; Palpitations; Shortness of Breath; This spont... Read more
suffered a massive heart attack; Feeling of faintness; Palpitations; Shortness of Breath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (suffered a massive heart attack), SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Feeling of faintness) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant) and DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant). On 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (suffered a massive heart attack) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was suffered a massive heart attack. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) outcome was unknown. No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 was not applicable. A Patient called to report that two weeks after the first dose of the Moderna Covid-19 vaccine on 27-May-2021, his boyfriend began to experience palpitations, shortness of breath and feeling of faintness. The caller stated that her boyfriend did not want to go to the emergency room and only set an appointment with his Health Care Provider, but on the 09-Jun-2021, the day that he was going to the appointment, he suffered a massive heart attack and passed away. This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Sender's Comments: This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Reported Cause(s) of Death: suffered a massive heart attack
59 2021-06-24 chest pain, palpitations heart palpatations , the sweats, ears ringing, chest pain, did not see my dr yet. seems to me like M... Read more
heart palpatations , the sweats, ears ringing, chest pain, did not see my dr yet. seems to me like MYOCARDITIS . symtoms are a match dizzyness.
59 2021-06-26 inflammation of the pericardium, chest pain, inflammation of the heart muscle 4 weeks after second dose of moderna, admitted to the hospital with chest pain, found to have acute ... Read more
4 weeks after second dose of moderna, admitted to the hospital with chest pain, found to have acute peri/myocarditis. Troponin 17. Taken for emergent cath due to concern for ST-elevations, but cath negatative, dx ultimatly with peri-myocarditis.
59 2021-06-28 blood clot Admitted to hospital -- almost lost leg -- almost died -- 16 hours of surgery to clear blood clottin... Read more
Admitted to hospital -- almost lost leg -- almost died -- 16 hours of surgery to clear blood clotting in left leg.
59 2021-06-29 chest pain Chest pain, trouble walking ,trouble Standing,headache ,dizzy,hard to breath
59 2021-06-30 loss of consciousness passed out after dinner BP around 80/40 for an hour
59 2021-06-30 blood clot Blood clotting in left leg that got so serious that I went to the ER and experienced four days of su... Read more
Blood clotting in left leg that got so serious that I went to the ER and experienced four days of surgery.
59 2021-07-01 chest pain, troponin increased Presented to Hospital ED on 6/14/2021 with self reported third episode of chest pain in past month. ... Read more
Presented to Hospital ED on 6/14/2021 with self reported third episode of chest pain in past month. Troponin was elevated and EKG showed ST elevations. Pt was transferred to Hospital in another area.
59 2021-07-02 blood clot Blood clot; feels like his skin is going to rip open; arm was a little sore; Left leg was swollen, T... Read more
Blood clot; feels like his skin is going to rip open; arm was a little sore; Left leg was swollen, Twice the size of his right leg; Really tight; Very uncomfortable; Can't walk dog; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable) and GAIT DISTURBANCE (Can't walk dog). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable), GAIT DISTURBANCE (Can't walk dog), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was not given No concomitant medication 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.; 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.
59 2021-07-03 cerebrovascular accident, fainting, blood clot, heart attack Died of cardiac complications, heart attack, stroke or blood clot were all mentioned. Collapsed at w... Read more
Died of cardiac complications, heart attack, stroke or blood clot were all mentioned. Collapsed at work, grabbing his chest. Was revived 5 times before dying. Doctors mentioned his chest was oddly discolored so they thought blood clot but ekg was abnormal as well so heart attack was also mentioned.
59 2021-07-07 blood pressure increased About 15 minutes after injection, started to feel a headache. BP 179/82, HR 72. On recheck, BP 170/... Read more
About 15 minutes after injection, started to feel a headache. BP 179/82, HR 72. On recheck, BP 170/80. EMS was called to evaluate the patient. BP 196/87 - transferred to ED. Patient was worked up - found to only be vertigo - meclizine given and helped. Ruled out - no s/s of stroke. Discharged from the ED.
59 2021-07-08 heart rate irregular three days before the patent died he started having sloop apnea and for several days before the even... Read more
three days before the patent died he started having sloop apnea and for several days before the event he started having memory problems and the day before the event he started having a issue with his heart where he just said his heart felt irregular.
59 2021-07-12 atrial fibrillation development of A-fib
59 2021-07-12 chest pain Chest pain Bloating in the torso Pain in the torso General discomfort
59 2021-07-12 deep vein blood clot 1st COVID dose was 5/14/21 and 2nd COVID dose was6/29/21 he started w/ right calf pain on or about 6... Read more
1st COVID dose was 5/14/21 and 2nd COVID dose was6/29/21 he started w/ right calf pain on or about 6/21/21. he came to PCP for appointment on 7/12/21 and a sonogram was ordered to r/o DVT. he was unable to get to hospital until 7/13/21 and the songram revealed right DVT from groin to knee
59 2021-07-12 pulmonary embolism Pulmonary Embolism
59 2021-07-13 fainting patient fainted-- gave water and monitored bp--
59 2021-07-17 heart attack Admitted for anterior STEMI requiring PCI to LAD on 5/6
59 2021-07-25 blood pressure increased My BP went up and stayed for a week to 10 days and my doctor increased lisinopril 1.25 milligrams to... Read more
My BP went up and stayed for a week to 10 days and my doctor increased lisinopril 1.25 milligrams to now its increased to 5 milligrams. Felt like had drank a lot of caffeine and I don't drink caffeine, felt hyper. I had my check on 28 Jun 2021 at 9am and eye appt 153 over 90, at home 160 over 90 BP. I called my doctor to increase, that whole week 150 over 90s. After I started taking 2.5 milligram, my Bp 130 over 80s. On Jul the 3rd I took 5 milligrams it leveled off.
59 2021-07-25 chest pain The patient experienced arm and joint pain developing on Thursday July 22nd. Those symptoms went awa... Read more
The patient experienced arm and joint pain developing on Thursday July 22nd. Those symptoms went away by July 23rd. The patient woke up with severe pain in his side on Monday July 26th. He went to the emergency department and was diagnosed with pleurisy.
59 2021-07-26 blood pressure increased, chest pain 02/26/21 - Patient felt slight cramp in chest. Blood pressure reading; 252/110. Patient now on mul... Read more
02/26/21 - Patient felt slight cramp in chest. Blood pressure reading; 252/110. Patient now on multiple hyper tension medication Patient quit FT employment due to continued elevated stress levels (05/27/21)
59 2021-07-26 hypertension vomiting, intense dizziness, ultra high blood pressure.
59 2021-07-28 dilation of blood vessels Several months later, I experienced left arm pain. It felt vascular in nature, then affected the ner... Read more
Several months later, I experienced left arm pain. It felt vascular in nature, then affected the nerves. The pain was severe, awakening during the night. It happened 5 nights in a row. Then several weeks later, it happened again. This time in my right arm. I attributed that to being on Levaquin, for an infection but once again after 4-5 days it disappeared. A few weeks later, I lost vision in my left eye, lasting about 2-3 minutes at time. There were several episodes of this over the course of 5 days. The optometrist took pictures and stated that the blood vessels were irritated and that I could have a stroke in it at any time. Once again, I thought it might be a reaction to Levaquin as I was on it for a procedure. But, the initial left arm pain did not include Levaquin. I am not sure if this is truly a symptom from the shot, but I am afraid to get my second dose.