Moderna

Life threatening symptom reports

Male, 16 - 25 years

Age Reported Symptoms Notes
16 2021-04-29 grand mal seizure Absence Seizure Tonic Clonic Seizure
17 2021-04-09 anaphylactic reaction The individual starts to show signs of anaphylaxis reaction some minutes after vaccination by the nu... Read more
The individual starts to show signs of anaphylaxis reaction some minutes after vaccination by the nurse. Said"I am not feeling good." Upon assessment, the individual is leaning his head backwards, unable to read how many fingers I held up; complained "can't see"; slow in responding. The individuals appears to be losing consciousness; eyes closed. Color of face pale. HR: 47; Pusle Ox 95%. RR:16. BP 112/64. Epipen 1 dose administered L leg IM. 911 was called. Continue to monitor and check vital signs. BP 143/75, HR: 54 and pulse ox: 94%. At 0850:EMS arrived. VS remain stable. HR: 62; Pulse Ox 94%. The individual starts to open up his eyes and responding. Parents at his side. He is taken to the ER. Followed up with the patient's parent, mom and is stable and doing better.
18 2021-03-05 death Developed fatigue, body aches, headache 1 day after vaccination on 3/3. The morning of 3/5 complaine... Read more
Developed fatigue, body aches, headache 1 day after vaccination on 3/3. The morning of 3/5 complained of chest pain. Took Tylenol at 8:30 am. At 10:30 am his family found him unresponsive. EMS was called and he was pronounced dead in the home.
18 2021-03-15 death Resident did not express having any symptoms, the only thing that the POC observed abscesses in the ... Read more
Resident did not express having any symptoms, the only thing that the POC observed abscesses in the arm, groin, thigh and knees after the first vaccination. After the second dose, he was hypoactive. On 2/27 at about 3:30 am he asked him to turn on his side, between 4 am and 5 am POC went to the room I notice it strange, because his head was wrapped in the sheet. When the POC removed the sheet, she observed that her mouth and nose were full of secretions. So he turned it and he himself did not react. He called the emergency who certifies that he had no vital signs. (emergency arrives within 5:45 am to 6:00 am)
18 2021-04-16 fluid around the heart Patient developed mild chest pain roughly 24 hrs after receiving 2nd Moderna Vaccine injection. He i... Read more
Patient developed mild chest pain roughly 24 hrs after receiving 2nd Moderna Vaccine injection. He initially managed this with ibuprofen, but pain intensified and he presented to the ED approximately 1.5 days after 2nd injection with severe chest pain, diffuse ST elevations on EKG and elevated Troponin I measurement of 6 ng/ml. Patient transferred to hospital for further management and remains under inpatient care at time of report. Testing initially suggested pericarditis but cardiac MRI consistent with myocarditis. Troponin I peaked @ 75 ng/ml on 4/16/21.
18 2021-04-29 fluid around the heart The patient presented with chest pain and dyspnea on exertion which started the day after receiving... Read more
The patient presented with chest pain and dyspnea on exertion which started the day after receiving the second dose of the Moderna Covid vaccine. Pt was found to have myocarditis. He was admitted to the hospital and treated with NSAIDS and Steroids. He improved and was discharged after 2 days.
18 2021-05-17 ventricular tachycardia Myocarditis in the setting of recent second Moderna vaccine. Troponin peaked at 9.67 and trended dow... Read more
Myocarditis in the setting of recent second Moderna vaccine. Troponin peaked at 9.67 and trended downward. He was taken for cardiac catheterization on 5/17/2021 and was found to have normal coronaries. He had a cardiac MRI on 5/17/2021 which was found to be positive for myocarditis. Echo completed displaying preserved EF without wall motion abnormality or Due to the episode of NSVT will start low dose metoprolol tartrate until follow up with cardiology in the outpatient setting then hopefully able to discontinue. Post procedure restrictions discussed, patient verbalized understanding. No cardiac rehab indicated.
18 2021-05-19 grand mal seizure not going to receive 2nd dose; tonic-clonic seizure/intense seizure; This spontaneous case was repor... Read more
not going to receive 2nd dose; tonic-clonic seizure/intense seizure; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Seizure (1st time he had seizure when he took Benadryl 10 month ago when he was 17 year old).). Concurrent medical conditions included Autism. Concomitant products included LORATADINE (CLARITINE) for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure/intense seizure) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (not going to receive 2nd dose) had resolved. No treatment details provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication information was provided. The patient was on testing at the time of report. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Causal relationship cannot be excluded for the event of Generalised tonic-clonic seizure. Company causality for Incomplete course of vaccination was assessed as not applicable.
18 2021-05-20 blood clot in the brain Patient received dose 1 of Moderna vaccine on 5/8/2021 and had witnessed seizure 5/12/2021- (first t... Read more
Patient received dose 1 of Moderna vaccine on 5/8/2021 and had witnessed seizure 5/12/2021- (first time ever). He was admitted to ICU on 5/12/2021 and discharged 5/15/2021. He states he had one seizure while in the ICU and another seizure 5/16/2021- at home after discharge. He has since been placed on anti-seizure medications and is scheduled for follow up with neurology on 6/2/2021. Patient's mother states ICU doctors told her they found a blood clot in the brain picked up by MRI.
18 2021-05-27 anaphylactic reaction Took a generic version of Miralax and had anaphylactic reaction and ended up in ER; This spontaneous... Read more
Took a generic version of Miralax and had anaphylactic reaction and ended up in ER; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: Based on the reporter's description of the event after taking Miralax and the temporal relationship occurring closer to Miralax dosing, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the reporter's description of the event after taking Miralax and the temporal relationship occurring closer to Miralax dosing, the event is assessed as unlikely related to mRNA-1273.
18 2021-06-25 severe muscle breakdown Patient is an 18 year old male with history of albinism and bilateral horizontal nystagmus. No othe... Read more
Patient is an 18 year old male with history of albinism and bilateral horizontal nystagmus. No other medical problems. He received the second dose of the Moderna vaccine on 6/15/2021. On 6/21/2021, he developed bilateral thigh/hamstring pain and bilateral pectoral pain that progressively worsened. On 6/24/2021 he noticed red-tinged urine. Patient does not take any medication or OTC supplements. He denies any recent major physical activity or time spent outside.
18 2021-07-19 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed ... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient was administered vaccine in left deltoid. Patient was seated in chair when vaccinated. Patient walked about 5 or 6 steps to waiting room chair to sit down and wait post vaccination. About 90 seconds to 3 minutes post vaccination the patient was seated in chair and fainted forward. Was holding conversation with father in the next chair to him and fainted from chair to the floor. Patient was aware after about 5 to 7 seconds post fainting, arms and hands were rigid.
19 2021-03-05 heart attack Originally seen for chest pain later learned it was a Heart attack and myopericarditis
19 2021-04-15 anaphylactic reaction 4 seizures; anaphylaxis; This spontaneous case was reported by a physician (subsequently medically c... Read more
4 seizures; anaphylaxis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The patient's past medical history included Seizures. Concomitant products included ACETAMINOPHEN, ATOMOXETINE HYDROCHLORIDE (STRATTERA), CLONIDINE, DIAZEPAM (VALIUM), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVETIRACETAM (KEPPRA), ONDANSETRON (ZOFRAN [ONDANSETRON]), OXYCODONE and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 09-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 09-Apr-2021, the patient experienced SEIZURE (4 seizures) (seriousness criteria hospitalization and life threatening) and ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criteria hospitalization and life threatening). On 09-Apr-2021, SEIZURE (4 seizures) had resolved and ANAPHYLACTIC REACTION (anaphylaxis) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) to be related. Hospitalization unknown meds. This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected Reporter did not allow further contact; Sender's Comments: This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected
19 2021-05-20 grand mal seizure ADVERSE OUTCOME: patient experienced tonic clonic seizure not sustained minute after injection He to... Read more
ADVERSE OUTCOME: patient experienced tonic clonic seizure not sustained minute after injection He told our staff this happens every time he has blood drawn or an injection? Dr. in office aware at time of vaccination and present and documented below. Came in for COVID-19 vaccine. 10 minutes after shot (L) deltoid. He was sitting and said to me he was feeling dizzy and immediately he had convulsion and became pale. We called 911. It lasted 1-2 minutes. Dr. came to see him, he had irregular heartbeat, feeling very tired and weak BP (L) arm 100/60 at 4:15pm. 2nd reading after 10 minutes (L) arm 112/78 p-64. He mentioned he has same reaction after injections, or blood draw. He did not want to be taken to hospital. Pt left at 5:00 with his aunt. He is visiting. When I entered the the patient was having convulsion, clonic phase, stiffening arms and legs. The consciousness came back in 1-2 minutus; he could communicate with me. He said he could breath fine. His heart rhythm was still irregular. Blood pressure was checked. He could not walk because he was too tired. 911 called. 911 cleared patient, BP and heart rate regular and stable per staff. Discharged with family member ambulating on his own, alert and oriented. Plan: must see PCP neurologist. NOT to receive second vaccine unless has complete diagnostic work up and clearance. Should have second injection vaccine in a monitored hospital setting with paramedics.
19 2021-05-24 death Found deceased in bed, no known symptoms, undetermined cause and manner of death
19 2021-07-07 heart attack Started feeling sick (light headed, anxious, felt like he was coming down with illness and chest pre... Read more
Started feeling sick (light headed, anxious, felt like he was coming down with illness and chest pressure) on 518, by 6am on 6/19 he woke up crying with massive chest pressure, we took him to urgent care at 12:30p, immediately sent to ER due to abnormal EKG, admitted in ER with more tests & blood work taken(troponin was 1300) so he then was send via ambulance transport to cardiac unit at Hospital where he spent the night and on 5/20 they did a battery of tests to figure out what his diagnosis was. Confirmed a minor heart attack caused by a cardiac embolism. Echocardiogram showed minor heart damage. He was prescribed a ZIO patch to wear for 2 weeks resulting in no issues. Dr confirmed this event was Covid vaccine related.
20 2021-01-20 anaphylactic shock, anaphylactic reaction Anaphylactic shock, my throat started to close and couldn?t breathe
20 2021-02-27 pneumonia Possible adverse effect Pneumonia.
20 2021-04-19 low platelet count, pulmonary embolism Admission HPI: Right-sided chest pain began 2 days prior to admission (3/19) after getting out of ca... Read more
Admission HPI: Right-sided chest pain began 2 days prior to admission (3/19) after getting out of car, without identifiable trigger. Pain was sharp, pleuritic, and worst with movement; didn't feel it when still. Pain not responsive to ibuprofen or heating packs. Reported 30-60 seconds of self-resolving heart racing during ocular migraine which has been his baseline for years. Not associated with SOB (at rest or with exercise), palpitations, presyncope, or syncope. No viral URI symptoms, N/V, or rash. He did receive his 2nd Moderna COVID vaccine about 1 week PTA, followed by 36hrs of fevers, chills, and body aches. Given persistence of pain, Patient asked his parents to present to urgent care. In UC, he was noted to tachycardic with CXR with bibasilar atelectasis and b/l effusions, per report. Given continued tachycardia, decision was made to transfer to ED to r/o PE. In ED, tachycardic to 104-116 and tachypneic 22-26. Had one episode of tachycardia to 182 iso ocular migraine. Endorsed chest pain but points to R middle abdomen when asked where worst. Exam was unremarkable. He received 1 dose of morphine which reduced pain from 10/10 to 0/10. Labs notable for leukocytosis (14.61), thrombocytopenia (422), elevated d-dimer (1.56), and elevated CRP (5.6). Otherwise normal chem and coags. COVID/RVP negative. CXR unremarkable. CTPA showed scattered PEs in b/l lower lobes with small pulmonary infarct in RML. No evidence of right heart strain. Heme was consulted who recommended starting him on lovenox and sending lupus anti-coagulant. Cardiology was consulted who recommended EKG, BNP, and troponin, all of which were normal and reassuring against right heart strain. ECHO was therefore deferred to the AM. The decision was made to admit. Upon arrival to the floor, Patient was tachycardic 114 and tachypneic to 22, otherwise stable vitals. He denied any pain since morphine. Denied any unexpected weight loss; reports that car ride was short. Mom reports that Patient has been less active d/t cold weather and baseball being on hold. Denies family or personal history of clots. Last seizure ~13 years ago. Hospital Course: (3/21 - 3/22) Patient was admitted to the hematology service. He was therapeutically anticoagulated with LMWH injections and his anti-Xa level prior to discharge was 0.92. (goal 0.5-1.0) Lower extremity ultrasound with Doppler showed patent veins and no evidence of DVT and upper extremity ultrasound showed no evidence of DVT, though there was potential evidence of collateralization seen in mid and distal third of right subclavian vein and left internal jugular vein. Since this was an unprovoked PE, a full thrombophilia workup was sent and will be followed up by the outpatient hematology clinic. Cardiology consulted regarding possibility of right heart strain and the tachycardia during migraine episodes. Echocardiogram performed on 3/22 was technically limited but showed no gross abnormalities. The cardiology team requested a repeat echo scheduled outpatient for 1-2 months after discharge.
20 2021-05-02 atrial fibrillation Came into the ER with complaints of sudden-onset palpitations and tachycardia. Received COVID vaccin... Read more
Came into the ER with complaints of sudden-onset palpitations and tachycardia. Received COVID vaccine 3 days ago (2nd Moderna Covid vaccination). Was found to be in AFib with RVR. Was given adenosine 6 mg x 1, then 12 mg x 1 en rote via EmS with no change to heart rate. When in the ER, his heart rate was 189. He was initially started on Cardizem drip. Admitted to CVU. Cardiology was consulted. An echocardiogram was ordered which did not show any significant abnormalities. No further workup recommended at this time. Hemodynamically stable for discharge. Recommend following up with primary care 2-4 weeks post discharge.
20 2021-05-06 anaphylactic reaction 12 minutes after injection - local itching/redness. 30 min. after vaccination anaphylaxis with mult... Read more
12 minutes after injection - local itching/redness. 30 min. after vaccination anaphylaxis with multiple organ involvement - skin injection site and uvula swelling and eyes itchy. Patient had angioedema of throat with swallowing difficulty. Had mild asthma/wheeze. Also had tachycardia and light headed when trying to sit up. Patient given Epi 0.3 ml IM, Benadryl 50 mg IM, and Pepcid 20 mg PO. Transported to hospital by EMS for 4-6 hour observation. Patient responded well to epi.
20 2021-05-11 heart attack Five days after receiving dose 1 of the Moderna COVID vaccine, this 20 year old man developed a spon... Read more
Five days after receiving dose 1 of the Moderna COVID vaccine, this 20 year old man developed a spontaneous coronary artery dissection affecting his LAD and left circumflex arteries. This caused a ST elevation myocardial infarction. Pt received prompt stenting. His troponin peaked at 16,083 ng/L (high sensitivity test). He recovered well.
20 2021-05-22 heart failure, pneumonia Shortness of breath, elevated heart rate, pneumonia, fever, diagnosis of heart failure, hospitaliza... Read more
Shortness of breath, elevated heart rate, pneumonia, fever, diagnosis of heart failure, hospitalization and prescription of drugs to address
20 2021-06-16 ischaemic stroke Acute ischemic stroke. Confirmed on CT angiogram as a left SCA stroke .
20 2021-06-27 systemic inflammatory response syndrome presumptive MIS post vaccine; 2 weeks of headaches, rash, fever to 103, sore throat on 6/26 in ED at... Read more
presumptive MIS post vaccine; 2 weeks of headaches, rash, fever to 103, sore throat on 6/26 in ED at hospital platelets 69K; atypical lymphocytoes 0.71; covid PCR neg; ESR 15; CRP 8.6
20 2021-07-22 blood clot, cardiac failure congestive 7/19 patient presented to ER and was admitted for generalized edema, elevated BNP, tachycardia, DM, ... Read more
7/19 patient presented to ER and was admitted for generalized edema, elevated BNP, tachycardia, DM, and anxiety. Acute CHF, cardiomyopathy, and apical mural thrombus. Patient was diuresed, placed on heparin drip and anticoagulants, insulin adjusted. Echo performed. Labs.
21 2020-12-31 excessive bleeding Itchy eyes. Resolved with 25 mg benadryl. Sore arm for three days. Chilly off and on for three days... Read more
Itchy eyes. Resolved with 25 mg benadryl. Sore arm for three days. Chilly off and on for three days. Still some tired on third day. Does not know if this is related, but an old boil site started bleeding off and on and has not stopped.
21 2021-02-01 heart attack Elevate blood pressure and pulse Abnormal EKG Mild heart attack
21 2021-04-13 respiratory arrest Client passed out while seated in observation falling to the right side of the chair and onto the gr... Read more
Client passed out while seated in observation falling to the right side of the chair and onto the ground Client landed face down on the floor and was turned over onto his side first before being flipped onto his back Client?s head did hit the ground Client reportedly appeared to be having a seizure when he was turned over Multiple people were present to assist client including nurse and EMT At12:09, LVN called 911 and relayed information to the dispatch While on the phone, nurse went to get an Ambu-bag because staff present reported that the Client stopped breathing but had a pulse Upon bringing the Ambu-bag, the Client had already regained normal breathing pattern and no longer needed assistance breathing . Ambu-bag was present but was not used Client was assisted into a wheelchair and taken to the private recovery area. Physician, nurse, and EMT were present Client was alert enough to answer questions Client began to vomit / dry-heave for a short moment Client asked EMT about transport billing and was informed that he might possibly get a bill but that he had the option to choose not to pay it At 12:20, Vitals taken BP 155/112, Pulse 64 Client informed of the need to be further evaluated at the hospital Client verbalized multiple times that he did not want to be transported even after speaking with the physician Physician suspected that the client had some underlining reason that he did not want to disclose regarding his refusal to be transported At 12:25, Vitals taken BP 135/83, Pulse 58, O Sat 97% Blood sugar reading 104 Client reports no pain in the head, no nausea Client reports that he did not eat anything prior to coming At 12:31, Ambulance arrives EMT briefs paramedic regarding the incident and the client?s history Paramedics questioned client Client signed form and verbalized that he did not want to be transported and felt well enough to leave Client called his brother to drive him home At 12:41 Client was wheeled in the wheelchair to the car Client informed of selfcare and instructed to go to the hospital / ER if symptoms worsen or headaches develop Client informed to let further vaccine administrators know that he passed out in the past and needs to have the injection lying down Client verbalized understanding Client?s brother drove him home
21 2021-04-17 heart attack Patient presented to ED with chest pain 10/10 at about 16:48 . Aspirin 324 mg chewed at 17:51. Stat ... Read more
Patient presented to ED with chest pain 10/10 at about 16:48 . Aspirin 324 mg chewed at 17:51. Stat EKG done, STEMI discovered, patient went to cath lab for intervention at 17:20. No recreational drug usage noted. Patient admitted to ICU following procedure for continuing care.
21 2021-04-21 death Per the father, the deceased received his first shot of Moderna vaccine on Saturday, 4/10/2021 at a ... Read more
Per the father, the deceased received his first shot of Moderna vaccine on Saturday, 4/10/2021 at a local church. He did not work on 4/11/2021. Worked on 4/12/2021. The deceased was found dead at 6:43 p.m. at his home.
21 2021-04-23 fluid around the heart Patient presents to ER with chest pain, worse with deep inspiration, lying flat or leaning forward.... Read more
Patient presents to ER with chest pain, worse with deep inspiration, lying flat or leaning forward. Pain is better when sitting up straight. Vomiting x 1 episode. First Moderna shot on 4/9/21. Chest pain started on 4/11/21. On 4/14/21, pain was worse, so came to ER. Patient admitted to hospital, cardiology consult, pulmonology consult. Patient is treated with colchicine 0.6mg twice daily, NSAID and metoprolol 25mg twice daily. Follow up with cards in 2 weeks. Much improved on day 2.
21 2021-05-04 grand mal seizure Grand mal seizure; "extreme sluggishness; "swollen eyes, they were basically swollen shut; dark and ... Read more
Grand mal seizure; "extreme sluggishness; "swollen eyes, they were basically swollen shut; dark and red coloration around his eyes/his eyes were red; difficulty breathing; sore arm; fatigue; he had a high fever just by touching him, he was extremely warm to the touch.; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included ADD. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.). On 28-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) (seriousness criteria hospitalization, medically significant and intervention required). The patient was hospitalized from 28-Apr-2021 to 28-Apr-2021 due to GENERALISED TONIC-CLONIC SEIZURE. On 28-Apr-2021, GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) had resolved. At the time of the report, SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) No results were provided. On an unknown date, Chest X-ray: (Inconclusive) No results were provided. On an unknown date, Computerised tomogram: (Inconclusive) No results were provided. On an unknown date, Urine analysis normal: (Inconclusive) No results were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Treatment included Advil for fever, Maxipime, Keppra for seizure prevention and normal saline. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-098517, MODERNATX, INC.-MOD-2021-097451 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-098517:Case for dose 1 MODERNATX, INC.-MOD-2021-097451:Cross linked case
21 2021-05-12 grand mal seizure Patient received his Moderna vaccine and immediately (10-15 seconds) appeared to be seizing. His mu... Read more
Patient received his Moderna vaccine and immediately (10-15 seconds) appeared to be seizing. His muscles were tensed, tonic clonic, he was pale, hot to the touch, and excessively sweating. However, the fire department reported it as a syncopal episode. The fire department paramedics came and monitored him until his family came to pick him up. His pulse was 57, blood pressure was 102/54, respirations 20, glucose 116, pulse of 96. Patient denied treatment to the hospital and requested to go with his parents. His dad is a physician.
21 2021-06-10 heart attack Patients mother called. Her some began having symptoms (I believe she said) the day after the vaccin... Read more
Patients mother called. Her some began having symptoms (I believe she said) the day after the vaccine. Fever, feeling under the weather. Began having chest pains and shortness of breath. He was admitted to the hospital 2 days after vaccine. An EKG was performed showing the patient was experiencing mini heart attacks.
21 2021-07-17 heart attack Patient received 2nd Moderna vaccine 06/04/2021 through his college. Around 06/30/2021, patient star... Read more
Patient received 2nd Moderna vaccine 06/04/2021 through his college. Around 06/30/2021, patient started having upper respiratory symptoms and sought care on 07/10/2021. At this time he had EKG changes and was scheduled for an ECHO on 07/13/2021. Patient received ECHO on 07/13/2021 and STEMI alerted from ED. Taken to cath lab after ECHO showed acute systolic HF. LHC to work up anterior STEMI, acute systolic heart failure and cardiogenic shock. RRA access. Acute thrombotic occlusion of the distal LAD and the D2. Temporary mechanical circulatory support was placed using an Impella. Patient was transferred to another Medical Center, cannulated and is now status post LVAD and temporary RVAD. Hypercoagulable work up is in process.
22 2021-01-01 grand mal seizure Pt had grand mal seizure approximately 10 minutes post vaccination. Seizure lasted about 3 minutes, ... Read more
Pt had grand mal seizure approximately 10 minutes post vaccination. Seizure lasted about 3 minutes, then another seizure resulted approximately 2 minutes later lasting about 3 minutes, then ambulance arrived. Pts blood sugar was checked and was slightly low as well according to EMS. Pt seemed to stabilize. as being brought away, but in post-ictal phase.
22 2021-03-11 excessive bleeding On Thursday, March 11th, 2021 approximately 3:10 pm, Patient received his first dose of Moderna Vacc... Read more
On Thursday, March 11th, 2021 approximately 3:10 pm, Patient received his first dose of Moderna Vaccine (Lot number: 003A21A) in his left deltoid Patient received the Moderna Vaccine. After which he sat in the designated medical observation area for 15 minutes. Approximately five minutes later around 3:15 pm, Patient experienced syncope, fell out of his chair, hit the left side of his forehead on the ground. Due to the fall, he experienced a mild abrasion on the left side of his forehead, which led to bleeding. The Physician?s Assistant rushed to aid Patient who was lying on the ground in a supine position. Emergency Medical Services (EMS) - Fire Department and ambulance were called immediately and approximately five minutes later EMS arrived. During the time frame prior to EMS arrival, the Physician?s Assistant asked numerous questions to Patient to assess his condition. She asked Patient if he could breathe and he responded ?yes?. She asked Patient if he was short of breath and he responded ?no?. She asked Patient if he felt like his throat was closing and he responded ?no?. At this point, an Epinephrine pen was not used. Patient was alert and the Orient x 4 questions were asked [(1) Who are you? (2) Where are you? (3) What is the date and time? (4) What just happened to you?]. Patient also denied head pain, neck pain, nausea or chest pain. Staff performed a limited neuro-exam and was deemed within normal limits. Patients Glasgow Coma Scale score was 15 Patient mentioned that he has a phobia of needles and something like this has happened before when he was ?young?. Patient initially did not want an ambulance to be called. It was explained to him that it might be in his best interest to call EMS due to syncope and abrasion on his forehead due to the fall. Patient also mentioned that he only consumed two cookies and coffee for that day. When the EMS arrived (about 5 firefighters), they interviewed him and performed a blood pressure test. His sitting blood pressure was 130/82. One of the firefighters assessed his spine and Patient denied cervical, thoracic, and lumbar tenderness or pain. The firefighter assessed Patient's glucose level, which was a bit difficult to obtain in the first initial efforts, with the glucometer reading ?error?. The firefighters eventually were able to obtain a reading on Patient's glucose and it read 86. Patient was able to stand on his own, and a second blood pressure test was performed; his standing blood pressure reading was 145/89. EMS gave Patient gauze to address his head wound Patient initially refused to go to the hospital, but per EMS protocol, fluids needed to be administered. Patient entered the ambulance and was taken to the hospital by EMS.
22 2021-04-14 sepsis pt developed peri rectal abscess 4/1 requiring inpatient management due to sepsis and I&D also noted... Read more
pt developed peri rectal abscess 4/1 requiring inpatient management due to sepsis and I&D also noted to have incidental finding of pseudocyst pt has no h/o etoh use or any abd pain or diarrhea has had abd cramps on and off in the past will be getting referred to GI for IBD work up
22 2021-04-27 sepsis, pneumonia 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 include: severe sepsis, pneumonia, toxic shock, and myocarditis.
22 2021-05-03 low platelet count Pt with history evan's syndrome and chilblain's lupus with stable platelet count x 5 years. 48 hours... Read more
Pt with history evan's syndrome and chilblain's lupus with stable platelet count x 5 years. 48 hours post vaccination first dose pt had routine platelet count found to be 15k. Since that time he has had three hospitlizations for refractory thrombocytopenia. He has received extended high dose prednisone, rituximab x 4, cellcept, IVIG x 2 and NPlate. Currently still refractory. No other cause identified. Planning for Eltrombopag admin
22 2021-06-10 heart attack Severe chest pain started Thursday evening, May 27th. Chest pain lasted throughout the night but wen... Read more
Severe chest pain started Thursday evening, May 27th. Chest pain lasted throughout the night but went away. Friday, May 28th chest pain came back at 10:00am and progressively got worse. Chest pain was localized in the mid- sternum region.
22 2021-06-23 ventricular tachycardia myocarditis; NSVT episodes; chest pain; This literature-non-study case was reported in a literature ... Read more
myocarditis; NSVT episodes; chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), VENTRICULAR TACHYCARDIA (NSVT episodes) (seriousness criteria hospitalization prolonged and medically significant) and CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, MYOCARDITIS and VENTRICULAR TACHYCARDIA. At the time of the report, MYOCARDITIS (myocarditis) and VENTRICULAR TACHYCARDIA (NSVT episodes) was resolving and CHEST PAIN (chest pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: high (High) 4 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).. In 2021, Ejection fraction: abnormal (abnormal) 53%, inferolateral hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Inferior, anterolateral STelevation. In 2021, imaging: abnormal (abnormal) Edema, delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: high (High) baseline-1327 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and high (High) Peak-1433 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) to be possibly related. Discharged in stable condition. Treatment information not provided. Company Comment : Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.
22 2021-07-01 grand mal seizure Witnessed Tonic Clonic seizure lasting 30 seconds
22 2021-07-15 pulmonary embolism 7/6/2021: Hemoptysis, ringing in ears, felt like fainting, shortness of breath -- Right Lower Chest ... Read more
7/6/2021: Hemoptysis, ringing in ears, felt like fainting, shortness of breath -- Right Lower Chest Pain -- EMS called 7/7/2021: ER evaluation showed Acute Pulmonary Embolism --- > Admitted to hospital--- > IV Heparin --- > Xarelto. Also IV Rocephin + Azithromycin. Blood Cultures Negative x 2. EKG Sinus tach 103. Light Hemoptysis continued x 3 days. Venous Duplex Bilateral Lower Extremities Negative for DVT. 7/10/2021: Bilateral Upper Extremity Venous Duplex Negative. 7/12/2021: Discharged Home
22 2021-07-15 blood clot in lung 1st Shot(5/3/21): Soreness in arm, Fatique 2nd shot(5/31/21): Soreness in arm, Fatique, headaches, ... Read more
1st Shot(5/3/21): Soreness in arm, Fatique 2nd shot(5/31/21): Soreness in arm, Fatique, headaches, developed a cough a week later which lasted about a week. Adverse event (7/6/21): Started coughing and spitting blood around 5:00pm. Coughing persisted throughout the evening. At 6:00am I told my mom I was having a problem. around 6:30am my body went numb, loud ringing in my ears, and broke out into a cold sweat, so we called 911. The paramedics arrived and checked me out, and they believed I was okay. When they left we decided to go to the ER. Admitted on 7/7/21-7/12/21
23 2021-03-08 grand mal seizure First vaccine on 1/26/21 began taking three naps a day and arm pain. Given Ibuprofen. Seemed to reso... Read more
First vaccine on 1/26/21 began taking three naps a day and arm pain. Given Ibuprofen. Seemed to resolve after 5 days, but continued to nap three times a day sometimes. No fever, but hot flashes at times. Booster given 2/23/21. Began to nap again three times a day or want to stay in his dark room. Began to have a lot of sinus drainage. Gagging at times. Pain over right eye area. Pain in right flank and stomach area. Severe headaches and possible body aches. No fever, but increased and more severe hot flashes that would wake him. 2/28 had a tonic clonic seizure after presenting with a distressed look throughout the day. Slept and upon waking began vomiting until 3am. Was at the ER and given many tests, pain meds and nausea meds. Ruled out kidney stones with CT scan and urinalysis. No fever, but hot flashing continued. ER visit lasted from 2/28/21 through 3/1/21 ER Physician suspects possible reaction to vaccine. Followed up with Neurologist and General Practitioner and both suspect reaction to vaccine.
23 2021-03-15 death 1/19 began vomiting and was hospitalized. On 1/30 he was discharged and later received the vaccine. ... Read more
1/19 began vomiting and was hospitalized. On 1/30 he was discharged and later received the vaccine. It begins with weakness and a lack of appetite. He started coughing up foul-smelling secretions. He makes the arrangements to take him to the emergency room again, he called 911 to be transported, when they are taking the information from the POC, he is under oxygenation to 44. They take him in the ambulance, he receives CPR, they transport him to the facility where he arrives lifeless.
23 2021-04-20 grand mal seizure The patient developed fatigue, malaise, skin allodynia, fever (103.5F) and took acetaminophen and ib... Read more
The patient developed fatigue, malaise, skin allodynia, fever (103.5F) and took acetaminophen and ibuprofen. The fever resolved but he was diaphoretic. He also had a headache, vomiting, then lost consciousness overnight and had a tonic-clonic seizure lasting 10 minutes. He was brought to the emergency department and had 2 more seizures there which was controlled with lorazepam. He was admitted to the hospital and started on broad spectrum antibiotics (acyclovir, ceftriaxone, and vancomycin). On 4/11/21, the patient was extubated and improved symptomatically, and antibiotics were narrowed to doxycycline. He was then discharged on doxycycline and levetiracetam.
23 2021-04-21 heart attack NSTEMI likely caused by Myocarditis starting with intermittent chest pain on 3/6/21 that was treated... Read more
NSTEMI likely caused by Myocarditis starting with intermittent chest pain on 3/6/21 that was treated with aspirin and carvedilol QD.
23 2021-04-28 grand mal seizure Extreme fatigue, pain in the arm, then swelling in the area around eyes, red-eye, and swollen red ey... Read more
Extreme fatigue, pain in the arm, then swelling in the area around eyes, red-eye, and swollen red eyelids, then the onset of rapid heart rate, difficulty breathing, extreme exhaustion, and low energy first onset of massive grand mal seizure occurred approximately 24 hours after injection.
23 2021-05-12 heart attack Acute NSTEMI versus myopericarditis versus COVID-19 side effect. Patient requires telemetry monitori... Read more
Acute NSTEMI versus myopericarditis versus COVID-19 side effect. Patient requires telemetry monitoring due to high risk for electrolyte imbalance, sudden death from myocardial injury Follow-up cardiology recommendations for discharge planning, recommends to monitor for 24 hours while troponins are trending down. Follow-up respiratory panel possible viral infection as a source of NSTEMI. Replace magnesium.
23 2021-05-23 pulmonary embolism Patient presented with chest pain and found to have bilateral pulmonary emboli. He was 2 weeks post ... Read more
Patient presented with chest pain and found to have bilateral pulmonary emboli. He was 2 weeks post 2nd dose of Moderna vaccine. He has personal history of cerebral venous sinus thrombosis and also has positive family history of DVT's (mom had 2 DVT's during pregnancies)
23 2021-05-24 cerebral haemorrhage Intraparenchymal Hemorrhage causing left sided weakness and left facial droop
23 2021-06-03 blood clot The vaccine is affecting young people; My son felt like he had an aneurysm in his neck/He had pain i... Read more
The vaccine is affecting young people; My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something; The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes; On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes; shoulder pain; On Saturday night he was feeling tired and cold; feeling cold; On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins; On Saturday his legs were very heavy and had pain; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins) and ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included BUPROPION HYDROCHLORIDE (ZYBAN) for an unknown indication. On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins) (seriousness criterion medically significant), PAIN IN EXTREMITY (On Saturday his legs were very heavy and had pain), FEELING COLD (feeling cold) and FATIGUE (On Saturday night he was feeling tired and cold). On 25-May-2021, the patient experienced ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something) (seriousness criterion medically significant), NECK PAIN (The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), SWELLING (On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes) and ARTHRALGIA (shoulder pain). On an unknown date, the patient experienced VACCINATION COMPLICATION (The vaccine is affecting young people). At the time of the report, THROMBOSIS (On Saturday his legs were very heavy and had pain, like he had blood clots or thrombosis in his veins), ANEURYSM (My son felt like he had an aneurysm in his neck/He had pain in the large artery on the right side of his neck like a myocardial inflammation or something), VACCINATION COMPLICATION (The vaccine is affecting young people), PAIN IN EXTREMITY (On Saturday his legs were very heavy and had pain), NECK PAIN (The right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), SWELLING (On Tuesday, on the right side of his neck, between the shoulder and neck, on the inside, he felt swelling, pressure pain, dull pain that comes and goes), FEELING COLD (feeling cold), ARTHRALGIA (shoulder pain) and FATIGUE (On Saturday night he was feeling tired and cold) outcome was unknown. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-182543 (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.
23 2021-06-06 ventricular tachycardia Patient started having generalized weakness, fatigue, fever and headache after the second dose of hi... Read more
Patient started having generalized weakness, fatigue, fever and headache after the second dose of his Moderna Covid-19 vaccine. These symptoms persisted throughout the next day. However, two days after the second Covid-19 shot patient developed severe chest pain that resulted in presentation in the ED. There was associated shortness of breath and diaphoresis. He was treated with Colchicine and Ibuprofen. He was also started on metoprolol because he had an 11-beat run of non-sustained ventricular tachycardia. He was discharged home on the fourth day to follow up with cardiology as outpatient.
23 2021-06-20 heart attack Heart attack
23 2021-06-24 blood clot Patient presented with chest pain, elevated troponin, peaked at 57.12. Echocardiogram showed normal ... Read more
Patient presented with chest pain, elevated troponin, peaked at 57.12. Echocardiogram showed normal but with definite lateral wall and apex mildly hypokinetic. LHC revealed normal coronaries. Assume thrombus, myocarditis.
24 2021-01-20 anaphylactic shock Sharp pain in chest Difficulty breathing DIfficulty Swallowing
24 2021-03-09 anaphylactic reaction Patient was given dose one of Moderna vaccine this morning. Patient returned to our site around 1230... Read more
Patient was given dose one of Moderna vaccine this morning. Patient returned to our site around 1230 pm with ?facial swelling.? He also reported throat itching and tightness.
24 2021-04-01 respiratory failure 3/11/21: patient presented and was admitted through ED for Shortness of Breath and choking on food. ... Read more
3/11/21: patient presented and was admitted through ED for Shortness of Breath and choking on food. His saturation was as low as 70s and placed on nonrebreather. Patient was brought to ED and eventually required to be intubated because of hypoxic respiratory failure. During hospitalization patient has one episode of seizure. Patient had similar presentation in May 2019 and he had to be intubated for choking fluid. per the EUA, hospitalizations to be reported irrespective of attribution of vaccine.
24 2021-05-01 excessive bleeding Systemic: syncope-Mild, Additional Details: pt was okay after shot. he blacked out and fell face dow... Read more
Systemic: syncope-Mild, Additional Details: pt was okay after shot. he blacked out and fell face down as he was lowering himself to sit in chair for observation. his face hurt and was bleeding from hitting and rubbing the carpet, and his glasses broke. he stayed on the ground for about 15 minutes, then called girlfriend to come be with him. then he called some other friends to come help drive his car back.
24 2021-06-08 deep vein blood clot Deep venous thrombosis, pt was treated with blood thinners at Hospital emergency room and is being f... Read more
Deep venous thrombosis, pt was treated with blood thinners at Hospital emergency room and is being followed up by pt's primary care provider.
24 2021-06-12 heart attack acute chest pain starting 6/13/21
24 2021-06-25 severe muscle breakdown I felt really weak after my second dose. I was very sore and tender to even move. I was also state... Read more
I felt really weak after my second dose. I was very sore and tender to even move. I was also stated to look puffy in my neck and chest area. I was diagnosed with Myositis and Rhabdomyolysis. I was hospitalized overnight to keep fluids flushing through me due to the muscle count found in my blood.
24 2021-06-27 brain sinus blood clot Patient is a 24 y.o. male with no significant past medical history who presented on 6/25/21 with int... Read more
Patient is a 24 y.o. male with no significant past medical history who presented on 6/25/21 with intermittent headaches. Patient states he was in his normal state of health but after receiving the COVID-19 vaccination on May 1, he developed a headache shortly after and since then has been having worsening headaches with associated sinus congestion. CT head was done at that time which showed some sinusitis. His headache worsened since then prompting evaluation at an outlying facility. Further evaluation at that facility revealed venous sinus thrombosis on CT head and patient was subsequently started on full dose Lovenox and transferred to ED. MRI brain here also revealed thrombosis of dural venous sinuses. Patient was admitted to the ICU for close neurologic monitoring. He was evaluated by neurology. In the ICU patient remained medically stable. He was deemed stable for non-ICU level of care and transferred to the hospitalist to continue care. Heme-onc was consulted. Patient was evaluated by heme-onc and recommended transitioning to Eliquis and discontinue Lovenox to avoid the possibility of having a HIT type of reaction. Hypercoagulable work-up was initiated hematology recommended Eliquis for 3 months and to follow-up with a local hematologist for discharge follow-up. Patient was cleared for discharge from neurology and hematology standpoint. Patient symptom was controlled on tramadol and Zofran. It was felt patient received maximum benefit of hospitalization and deemed medically stable for discharge. Patient was seen contact his primary care physician who states he will enter the referral to hematologist. Return precautions was discussed with patient and his wife.
24 2021-07-11 sepsis Patient presented to the ED and was subsequently hospitalized for severe sepsis within 6 weeks of re... Read more
Patient presented to the ED and was subsequently hospitalized for severe sepsis within 6 weeks of receiving COVID vaccination.
24 2021-07-20 fluid around the heart, cardio-respiratory arrest Patient was a CODE BLUE on 7/19 - poorly responsive, marginal respiratory efforts, trivial pericardi... Read more
Patient was a CODE BLUE on 7/19 - poorly responsive, marginal respiratory efforts, trivial pericardial effusion, RV had some fair contractility. Per doctors note on 7/19 at 1933 "Doctor called. HEENT discovered that the patient had the moderna Covid vaccine on 6/22/2021. This was the patient's first dose. He raises the possibility of myocarditis related to the vaccine. This is a rare but potentially serious complication that has been reported. Treatments that have been tried include nonsteroidal anti-inflammatory drugs, IVIG and steroids. Some of the mild cases have resolved within a few days to a week.Given the clear lack of an explanation for his myocardial dysfunction, the severity of his illness and the proximity to receiving the moderna vaccine, we will institute all 3 of these interventions tonight."
25 2021-01-11 death Patient received the vaccine on 12/22/20 without complication. It was reported today that the patien... Read more
Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21.
25 2021-02-18 grand mal seizure Grand mal seizure. Lasting 4 minutes , unconscious for 10/12 minutes. Transported to hospital via a... Read more
Grand mal seizure. Lasting 4 minutes , unconscious for 10/12 minutes. Transported to hospital via ambulance. Vomiting and loss of bladder.
25 2021-03-17 anaphylactic reaction Patient developed throat swelling, chest tightness, dizziness, and headache ~30 min after vaccine ad... Read more
Patient developed throat swelling, chest tightness, dizziness, and headache ~30 min after vaccine administration. Benadryl 50mg was given (11:00am) , throat swelling continued and Epi pen was administered 35 min afterwards (11:35am). Advil given at 11:50am. Vitals remained stable
25 2021-04-22 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadn... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: immediately after first dose pt head started to lower, eyes closed, slid down in chair. respiratory rate decreased for several seconds then panic breathing occured thereafter. pt was sweating profusely and skin was cold and clammy. could not verbally respond for 30-45 seconds. after a minute pt could talk and answer question. blood pressure was taken 3 different times 5 minutes apart 75/43, 87/46, 93/52. Pt was feeling fine a half hour later and was called 4 hours later to follow up.
25 2021-04-23 grand mal seizure Seizures gran mal, 3, between 11pm on april 15 to 3 am April 16 Trouble breathing 7am to 3pm april ... Read more
Seizures gran mal, 3, between 11pm on april 15 to 3 am April 16 Trouble breathing 7am to 3pm april 16 Seizure gran mal, april 21
25 2021-04-26 anaphylactic shock Anaphylaxis / anaphylactic shock, hot feeling in throat (a few minutes after receiving second dose),... Read more
Anaphylaxis / anaphylactic shock, hot feeling in throat (a few minutes after receiving second dose), tightness in throat, difficulty breathing, hyperventilation, shallow breathing, wheezing
25 2021-04-28 pulmonary embolism Patient vaccinated with Moderna COVID vaccine 3/25/21 and 4/22/21. Patient presented to Hospital 4/... Read more
Patient vaccinated with Moderna COVID vaccine 3/25/21 and 4/22/21. Patient presented to Hospital 4/29 with SOB. The patient actually stated the SOB started 4/21 and he received his second Moderna vaccination 4/22. SOB progressively worsened from 4/21 until ED visit. Patient thought it was asthma flare. 4/29 04:00 CTA chest showing extensive bilateral pulmonary emboli, left greater than right. Started on heparin protocol for PE in the ER. 4/29 afternoon, patient is currently an inpatient at GSH on a heparin drip for anticoagulation.
25 2021-05-03 low blood platelet count Patient is a 25-year-old male with past medical history of depression with anxiety, esophagitis and ... Read more
Patient is a 25-year-old male with past medical history of depression with anxiety, esophagitis and hemorrhoids. Patient presented with petechial rashes all throughout his body started on Friday 4/9 after getting a tattoo the day prior and his first moderna covid vaccine 3/28. On admission patient was found to have a platelet count of 1. Heme/ onc was consulted and thrombocytopenia was deemed secondary to ITP. Hepatitis B panel, showed previous hepatitis B infection, although results may be inaccurate due to patient receiving IVIG prior to hepatitis panel being done. Patient also had an equivocal syphilis result, which also could be a false positive due to immune response. Patient received 2 IVIG, 4 days of Decadron, and 1 dose of Nplate. Patient did not receive rituximab, due to stable increasing platelet count. Patient received hepatitis-B prophylaxis for 2 days in case he were to receive rituximab. Platelet count now stable at 25, to follow-up with hematology in 1 week outpatient for repeat CBC. Patient also to follow-up with his Primary Care Physician in 1 week.
25 2021-05-23 transient ischaemic attack 5/22/2021 - evening time, right side of body went numb, knee locked up, collapsed on floor, chest pa... Read more
5/22/2021 - evening time, right side of body went numb, knee locked up, collapsed on floor, chest pain, could not move whole body for 30 seconds then couldnt move right side for another 10 minutes, last 10 minutes called 911, dizziness conscious whole time 5/23/2021 - Hospital said had TIA mini stroke, prescribed blood thinner, have to follow up with Dr
25 2021-05-25 heart attack Student started having chest pain the next day on 5/19/2021. Seen at student health on 5/21/21 for a... Read more
Student started having chest pain the next day on 5/19/2021. Seen at student health on 5/21/21 for atypical chest pain. Had normal EKG. Labs drawn for D-Dimer and troponin. Sent to ED next day when troponin came back at critical level - 7.42. He was admitted from ED to hospital 5/22/21 with myocarditis - discharged on 5/52/21 with final Dx of Non-ST elevation myocardial infarction, Of note he has a twin who was diagnosed with myocarditis last year.
25 2021-05-31 low platelet count, low blood platelet count thrombocytopenia; ITP; Petechia rash; Tiredness; This spontaneous case was reported by a consumer (s... Read more
thrombocytopenia; ITP; Petechia rash; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia) and IMMUNE THROMBOCYTOPENIA (ITP) in a 25-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 Anxiety and Stomachache. Concomitant products included LAMOTRIGINE (LAMICTAL) for Anxiety, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (Petechia rash) and FATIGUE (Tiredness). On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia) (seriousness criteria hospitalization and medically significant) and IMMUNE THROMBOCYTOPENIA (ITP) (seriousness criteria hospitalization and medically significant). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, THROMBOCYTOPENIA (thrombocytopenia), IMMUNE THROMBOCYTOPENIA (ITP), RASH (Petechia rash) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No laboratory details was given. Reportedly, the patient had to go to the hospital for a week and was still being monitored. Treatment information was given as steroids Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information received on 20 May 2021 contain significant information includes updation of 2 more medically significant events and patient was hospitalized for the events too.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
25 2021-06-07 ventricular tachycardia Vaccinated 5/20/21. Onset of chest pain 5/26/21. Admitted to hospital 5/28/21. Dx of myopericardi... Read more
Vaccinated 5/20/21. Onset of chest pain 5/26/21. Admitted to hospital 5/28/21. Dx of myopericarditis. Treated with bedrest, analgesia, and telemetry monitoring to r/o ventricular arrhythmias. Patient was recovered 5/30/21 and discharged.
25 2021-06-08 excessive bleeding Patient was walking in waiting room, passed out, fell backwards and hit his head on a chair. When I... Read more
Patient was walking in waiting room, passed out, fell backwards and hit his head on a chair. When I came to the waiting room patient was actively seizing and bleeding from a laceration on the posterior part of his scalp. Patient moved from under chair and placed in recovery position. Active seizure time from my arrival was 30 seconds. Patient was minimally responsive and postictal for approximately 5 minutes and diaphoretic. Vital signs taken and oxygen placed on patient. Color returned to normal, and VSS. BS was 108 on glucometer. EMS called and patient transported out of facility. Patient is a 35 yo M with no sig pmhx presenting after syncopal event after receiving his COVID vaccine. Fell from standing, denies dizziness, SOB, CP, or other symptoms prior to the event. He hit the back of his head when he fell. He presented to the ED, at which time he felt very nauseous and per notes he was confused and perseverating. Admitted to the SICU for R frontal IPH and R frontal SDH.
25 2021-06-09 death The day after the vaccine, reported typical reactions including aches and pains, which improved the ... Read more
The day after the vaccine, reported typical reactions including aches and pains, which improved the following day. The Monday after noted snoring, which was atypical but consistent with the ear infection and seasonal allergies. Sometime on midday Monday 5/24 Pt died. Was found in his bed at approximately 6pm with rigor already set.
25 2021-06-14 atrial fibrillation Patient received second dose of Moderna COVID 19 vaccine on 6/4/21. During this same time, patient a... Read more
Patient received second dose of Moderna COVID 19 vaccine on 6/4/21. During this same time, patient also had URI diagnosed as bronchitis at an urgent care and provided albuterol inhaler. Cough and URI symptoms subsided on approximately 6/12/21 but developed SOB, lightheadedness, and palpitations thereafter prompting presentation to ED on 6/15/21. Patient was started on digoxin, heparin, and furosemide by cardiology team. Work up in progress.
25 2021-06-30 heart attack Had a cough, fever and chills first night after vaccine. Continued to have flu like symptoms for 2 ... Read more
Had a cough, fever and chills first night after vaccine. Continued to have flu like symptoms for 2 days. On the 3rd day after vaccine, woke up to chest tightness and pressure, shortness of breathe. "It Felt like an elephant sitting on my chest." Went to urgent care, abnormal ekg, went by ambulance to emergency dept. Troponins were elevated. Went to cath lab. Diagnosed with heart attack caused by vasospasm. Now on heart meds (plavix, metroprolol for 1 year) and low dose aspirin ongoing.