Moderna

soreness at site 24 hours after injection with associated redness. redness expanded at day 7 and became itchy. 2 days after vaccine, had vaginal spotting. 6 days after vaccine painful swollen node under left arm. dysuria started 6 days after vaccine

Patient received Moderna Covid vaccine on Friday evening 1/8/21. She awoke Saturday am around 2AM with a severe headache. She also developed a fever during the day. She did not seek treatment until Sunday and went to Hospital ED. She was treated and released same day. She went back to hospital on Monday as she felt worse and she was admitted at that time and treated for a bloodstream infection and meningitis. We are not sure it was caused by the vaccine. She consulted her PCP and her PCP feels it may be more coincidental given her medical HX.

Delayed anaphylaxis after receiving the vaccine. Symptoms including hives, shortness of breath, and felt like her throat was closing. Her initial symptoms included hives which began 6 hours after receiving the vaccine. This eventually progressed to anaphylaxis and she went to the ED 2 days later.

On January 4 at 2:00 pm I suddenly started to bleed from the nose from the left nostril and then from both. The event lasted more than 35 minutes so I had to go to the ER. The diagnosis was Epistaxis. I was discharged because at the time of the medical evaluation I removed a large clot from my mouth and the bleeding stopped. Appointment with primary physician for diagnosis and appointment with ENT was ordered. On January 5 at 4:15 am I had another episode of nasal bleeding lasting 25 min. After removing a clot through the mouth, the bleeding stopped. At 4:00 pm I presented Epistaxis again so I had to return to the Emergency Room. I was reevaluated and the instruction was to visit the ENT and Afrin prescription for three days and Claritin D q 12 hrs PRN. From January 6 to 9, I began to eliminate a serous-bloody vaginal discharge. That began with the elimination of a clot and progressively diminished day by day. January 11, 2021, the ENT evaluated me and indicated that it did not observe polyps or anatomical problems. I had not previously prolonged nosebleeds. Previously two minor episodes happened to me, a year ago that resolved in less than 7 minutes. I didn't have a cold or any other symptoms. I want to raise the flag because it was a strange event that occurred after the vaccination and that I had not experienced before in that way.My next dose is January 29, 2021. I am awaiting clot test results

anaphylaxis throat closing ,hives, feeling faint Benadryl 50mg I.M. no effect then epi 1mg I.M. little effect Emergency services called patient was sent to E.R. via ambulance

Sudden onset dizziness, near syncope, tachycardia, shortness of breath, facial numbness, shaking/rigors

I started my menstrual cycle about one week early, experienced dark, brown tinged spotting for 2 days followed by heavy flow with more clotting than I have ever experienced before. Cycle lasted about 8 days, versus my normal 4 days. These symptoms concern me due to several reports of miscarriages while receiving vaccine.

Immediately after getting the 1st vaccine I had a very sore arm that lasted about 3 days. 2 days it was so sore that I took 800mg ibuprofen every 6 hours and put heat and ice on site for 20 min on 20 min off and alternating for 2 days while awake. No other symptoms. For 2nd vaccine, the vaccine itself was extremely painful (burned and pain at site and tingled down to fingertips for a few hours. Applied pressure as I bled for 10 min after administration. Followed by ice off and on for 20 min for first 2 hours. At 22 hours, I started to feel nauseated and lightheaded and had mental fogginess. The following morning, I awoke around 3am and was very ill with flu like symptoms. mild temperature of 99.8, chills, body aches, fatigue, rapid pulse, headache, sore throat, and mental fogginess. This lasted for approx. 36 hours. The worse symptoms were the headache, fatigue, and severe body aches that lasted for 72 hours after vaccine.

Within 1 1/2 to 2 mins after receiving vaccine pt states starting having an anaphylaxis reaction. Immediately transported to the emergency department. Pt had audible wheezes and stridor noted. Patient was given EPI pen her rt outer thigh. IV started. Pt started having relief within 30 seconds. Wheezing and stridor was decreasing. Pt was also started on a racemic epi neb. Pt placed on monitor and oxygen monitor. One hour later the symptoms of feeling "throat was swelling off" returned and EPI 3 mg given and another racemic treatment given. Treated with solumederol, Benadryl and Pepcid. Patient was admitted to the hospital where she remained overnight with no additional symptoms.She was released next day.

Severe headache, from back of head to front forehead. Lasting two weeks exactly. Two grand-mal seizures on day 13. Unknown if seizures were related.

My stomach was hurting while urinating and there was blood in my urine. At another instance, there was a small blood clot.

Lips swelled and throat swelled. Unable to swallow, tongue swollen. Benadryl and epipen administered. Oxygen administered. Declined going to ER. Kept taking Benadryl every 6 hours. Felt heavy chest, nausea and fatigue for 2 days, now all symptoms have resolved by day 3.

patient received the vaccine on March 20th, instantly felt sick, developed a fever. Never fully felt " Well". On March 27th her boyfriend discovered her unresponsive from Cardiac arrest, she has been on life support since. They are pulling the plug today.

Moderna COVID-19 vaccine EVA extremes migraines, Right side occipital cortex infraction, vision loss

On 4/1 at 12pm began have lightheadedness and very shaky. By 4/2 at 6am developed SOB, cough, and heart racing.

On 4/1/21 at 1200 became shaky and light headed. THen on 4/2 deveoped Shortness of breath, cough, and heart racing. See in clinic on 4/5.

Exactly 1 week from vaccination, menstruation began approximately 2 weeks before schedule and roughly 10-12 days after date of start of previous cycle. Heavy with many clots, extreme fatigue, headache, and heavier than usual cramping. Completely unexpected and NOT accompanying any usual, predictable signs of PMS or anticipated cycle. Women need to know this is happening.

The patient received my second Moderna vaccine on Jan 23. On Feb 12 after they got home from work the patient noticed their Left bicep was swollen and hand was discolored. the patient elevated and iced throughout the weekend. When it did not get better by that Monday, they went to the ED. The patient was diagnosised with a Left upper arm DVT and bilat PE's. they were admitted overnight to the hospital, put on Apixaban, and have follow-up appointments.

Pt calls clinic on 4/16/21 about 8:30am to report adverse reaction to vaccine she received the previous day. Pt reports that while driving home after vaccination she suddenly felt difficulty breathing, dizzy, "like she was going to die". She drove herself to closest ED, and was treated for allergic reaction with epinephrine, pepcid and oral benedryl. She was released from ED later that same day. She reports having a "rough night", difficulty sleeping, felt like symptoms of lips tingling, throat tightening return when benedryl was wearing off. She has an epipen and her husband is home with her. She called her local PCP and has follow up appointment on 4/20/21. Pt calls in afternoon, around 3:00pm and reports no improvement and is taking benedryl more frequently, about every 2-3 hours. She is advised to return to local ED.

Migraine High blood pressure Bruises Blood clot Dizziness Nauseous Fatigue Itching Chills Muscle aches

Feeling dizzy and bad; Thought her blood sugar was dropping; Lips started tingling; Started sweating; Felt weak; Felt pressure on chest; Muscles started twitching/legs started twitching; Had difficulty breathing; Anaphylaxis Shock; When the Benadryl wears off I start shaking; When the Benadryl wears off I have shallow breathing; When the Benadryl wears off throat starts tightening; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), PARAESTHESIA ORAL (Lips started tingling), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), MUSCLE TWITCHING (Muscles started twitching/legs started twitching), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) in a 40-year-old female patient who received mRNA-1273 (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy and bad) (seriousness criteria hospitalization and life threatening), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping) (seriousness criteria hospitalization and life threatening), PARAESTHESIA ORAL (Lips started tingling) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Started sweating) (seriousness criteria hospitalization and life threatening), ASTHENIA (Felt weak) (seriousness criteria hospitalization and life threatening), CHEST DISCOMFORT (Felt pressure on chest) (seriousness criteria hospitalization and life threatening), MUSCLE TWITCHING (Muscles started twitching/legs started twitching) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Had difficulty breathing) (seriousness criteria hospitalization and life threatening), ANAPHYLACTIC SHOCK (Anaphylaxis Shock) (seriousness criteria hospitalization, medically significant and life threatening), TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening). The patient was hospitalized from 15-Apr-2021 to 15-Apr-2021 due to ANAPHYLACTIC SHOCK, ASTHENIA, BLOOD GLUCOSE DECREASED, CHEST DISCOMFORT, DIZZINESS, DYSPNOEA, HYPERHIDROSIS, MUSCLE TWITCHING and PARAESTHESIA ORAL. On 15-Apr-2021, DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) had resolved, MUSCLE TWITCHING (Muscles started twitching/legs started twitching) had not resolved. At the time of the report, PARAESTHESIA ORAL (Lips started tingling) had not resolved and TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening) outcome was unknown. Not Provided The action taken with mRNA-1273 (Intramuscular) was unknown. The patient was treated at the closest hospital with epinephrine (epi pen), IV diphenhydramine, and IV Famotidine. The patient was having anaphylaxis shock (confirmed by Emergency Department). She stated epinephrine made her heart beat so fast that it was going to collapse. She was discharged 3 hours later from the hospital with epi pen (emergency use), diphenhydramine(as needed), Famotidine (as needed). Consumer stated that when the Benadryl weaned off she felt tingling of lips, starts shaking, muscles start twitching, throat tightening, and has shallow breathing. 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, excluding other etiologies causal relationship cannot be excluded. Anaphylaxis 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. Anaphylaxis is consistent with the product known safety profile.

Blood clots; Kind of bleeding; arm began being extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and HAEMORRHAGE (Kind of bleeding) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (arm began being extremely itchy). On 05-Apr-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and HAEMORRHAGE (Kind of bleeding) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) and HAEMORRHAGE (Kind of bleeding) outcome was unknown and PRURITUS (arm began being extremely itchy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Pregnancy test: Negative. 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. 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; 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

severe allergic reaction to the vaccine; became incoherent, could not function; I couldn't comprehend or process what my children were saying to me, I could see their lips; Vision blurry; dizziness increased; heart was racing; 154 heart rate; woke up with a "fever"; started throwing up; face started tingling; injection site swollen; injection site with burning sensation; Covid arm; injection site hot; injection site itchy; brain fog; became dizzy, the more I moved around, the worse it would get; It like an out of body experience; I was confused; woke up with severe neck pain; neck to collarbones were swollen; low grade fever, 101.9 degrees.; ymph node in both armpits and both breast were swollen and hurt to touch; chills; extreme fatigue, had no energy at all; headache; injection site was sore to the touch, it hurt bad, but looked fine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), VISION BLURRED (Vision blurry) and DIZZINESS (dizziness increased) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided.). On 01-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 NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), PYREXIA (low grade fever, 101.9 degrees.), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache) and VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine). On 05-Apr-2021, the patient experienced DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused) and FEELING ABNORMAL (brain fog). On 06-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine) (seriousness criterion hospitalization), INCOHERENT (became incoherent, could not function) (seriousness criterion hospitalization), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips) (seriousness criteria hospitalization and disability), VISION BLURRED (Vision blurry) (seriousness criteria hospitalization and disability), DIZZINESS (dizziness increased) (seriousness criterion hospitalization), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE PAIN (injection site with burning sensation) and VACCINATION SITE SWELLING (injection site swollen). On 11-Apr-2021, the patient experienced PARAESTHESIA (face started tingling). On 11-Apr-2021 at 1:15 AM, the patient experienced TACHYCARDIA (heart was racing; 154 heart rate), PYREXIA (woke up with a "fever") and VOMITING (started throwing up). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to ANAPHYLACTIC REACTION, APHASIA, DIZZINESS, INCOHERENT and VISION BLURRED. At the time of the report, ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), DIZZINESS (dizziness increased), NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused), TACHYCARDIA (heart was racing; 154 heart rate), FEELING ABNORMAL (brain fog), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache), VACCINATION SITE PAIN (injection site with burning sensation), VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine), VACCINATION SITE SWELLING (injection site swollen), PYREXIA (woke up with a "fever") and VOMITING (started throwing up) outcome was unknown, VISION BLURRED (Vision blurry) and PYREXIA (low grade fever, 101.9 degrees.) had resolved and PARAESTHESIA (face started tingling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.9 (High) 101.9 degrees. On 11-Apr-2021, Heart rate: 154 (High) 154. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient was taken to the emergency room on 06-Apr-2021 and was then hospitalized. Treatment details included hydroxyzine and IV (intravenous) steroids, and dexamethasone as well as IV fluids. The patient was advised by her HCP (health care provider) to not take the second dose of the vaccine due to having an allergic reaction. On 10-Apr-2021, the patient was released from the hospital but her injection site was sore, swollen and getting bigger. The patient reported additional side effects on 11-Apr-2021 that are ongoing. Based on the current 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.

Suffered blood clotting leading to three strokes. Started with numbness in limbs and face on 3/5 at 8:30AM and led to Ischemic stroke in three parts of the brain.

- Itchy hands and feet (but no visible rash) for about an hour beginning about 9 hours post-injection. - Jumbling up words when speaking for about 30 minutes (about 9 hours post-injection). - Injection site redness and extreme itching which increased over 48 hours then faded over the next 72 hours. The redness and itchiness returned on day 7 post-injection and remained visible for four weeks before it faded away leaving an indentation that lasted about two more weeks. - Diarrhea, bouts of dizziness, nausea, and vaginal blood spotting on post-injection days 1-3. - Difficulty thinking clearly and concentrating on tasks on post-injection days 1-3. - Hives on neck on post-injection day 7. The hives lasted about an hour. Also minor hives and itchiness on right side of forehead accompanying the more prominent neck hives. - Sharp burning sensation on bicep skin on injection arm on post-injection day 7. The sensation lasted less than a minute. - Bouts of dizziness returned on post-injection day 7. - Metallic taste in mouth began around 11 pm on post-injection day 9 and lasted for about four weeks. COVID-19 test was negative. - Abnormal vaginal bleeding for five days beginning on post-injection day 13. - Swollen lymph node in neck on side of injection beginning on post-injection day 15 and lasting a few days. - Sudden ringing in left ear (tinnitus) that lasted about a minute (did not record the date but it was within two weeks of injection). - Sensation of throat numbness (similar to dental numbing) that lasted about an hour (did not record the date but it was either evening of vaccination or next day). - Fatigue- minor fatigue lasted for about a week post-injection. - Minor hives on stomach appeared the night of post-injection day 16 and were gone by the next morning. - Trouble sleeping for two weeks beginning on day 14 post-injection. - Frequent urination for one week beginning on day 14 post-injection. - Loss of appetite for two weeks beginning on day 14 post-injection. - Feeling jittery/shaky, even upon waking, for two weeks beginning on day 14 post-injection. - Anxiety for about three to four weeks beginning on about post-injection day 21. Also some symptoms of depression (crying and feelings of hopelessness) during this time.

Pt was at work on 4/23/21 when coworkers noted pt had slurred speech and L side weakness at 1045 am. EMS arrived, transported pt to ED. CTA of head/neck w/ & w/o contrast w/ right M1 MCA intravascular thrombus/occlusion. Pt treated w/ alteplase 90 mg total dose and had a thrombectomy and was transferred to the ICU. Brain MRI on 4/25 consistent w/ CT Head showing right M1 occlusion w/ minor petechial hemorrhagic transformation in the R temporal lobe and R basal gangliaAs of 4/25/2018 at time of this reporting, pt responsive to verbal stimuli w/ 5/5 grip strength on right side, 0/5 grip strength left side, able to wiggle toes in RLE, absent in LLE, (+) left facial weakness, left hemiparesis.

Right after vaccine, I experienced with Virginal blood spots NEXT DAY, which is NOT period, weird blood spot, and since that, until NOW, no period. If that is not the period, I haven't had a period for 2 months, losing 2 cycles. I AM NOT PREGNANT, I AM VERY HEALTHY.

First ever anaphylaxis experience started in the middle of a run. Ended up taking ambulance to hospital where I got an epi shot.

Pt was seen in Family Medicine on 4/23/2021. Was given her first Moderna vaccine that day. On-call doctor received phone call on 4/24/2021 that pt had expired. Death certificate states cause of death: seizure due to possible complication of COVID 19 vaccine. Conditions if any, leading to immediate cause: cerebellopontine angle tumor of brain

Vaginal spotting was seen the day after the vaccine was administered and has not stopped yet. This spotting is otherwise unexplainable as it is not within my cycle time, nor am I premenopausal as per bloodwork done in the beginning of the year for my wellness checkup. There has also been no sexual activity to explain the vaginal spotting seen after the vaccine was given.

About 2 weeks after the shot I noticed a veiny like bruise on my left arm. Unbeknownst to me, my arm was also swelling. On February 1st my arm was very swollen and I needed to go to the ER. I had a DVT in my subclavian and axillary vein. It has also come to my attention that I have thoracic outlet syndrome which can cause clots in that area but many doctors find it very coincidental that it happened right after my first dose. I have never had any blood clots before this.

The day after I received the first dose I had vaginal bleeding ahead of my expected period which was not due until 2 weeks. The bleeding lasted 2 weeks. After the second dose I again have vaginal bleeding. It still has not gone away.

Following the 2nd shot I had rapid heart beats and high fever. Within 48 hours the heartbeats and chest pain continued to intensify. In 2.26.2021 I went to the ER and my heartrate was in the 150s/160s and my heart presented to be in failure. I was admitted to the hospital for 2 days because my troponin level was high and indicated heart issues. I had mulitple EKGs and other tests as well as a heart catheterization. The catheterization showed no blockages. My heart continued to have an arithmyia and PVCs as well as chest pain. I was diagnosed with myocarditis or periocarditis due to the effects of the vaccine and referred to a cardiologists. I have been seeing the cardiologist for 6 weeks. I had to wear a heart monitor, have an echo cardio gram and many EKGs. I have never had any heart issues prior to this vaccine. I am still under the care of the cardiologist and on heart anti-inflammatory medications due to the myocarditis. I have rapid, irregulary heart beats and am unable to do any physical activity.

Went back to sleep and never woke up; Arm soreness; Feeling bad; very flushed/looked red; very tired/fatigue/nappy women taking a lot of naps; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Went back to sleep and never woke up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neurofibromatosis, type 2 (acoustic neurofibromatosis) (Diagnosed at age 11, had tumor on nerves and all over body.), Blindness (All blind in left eye), Allergy NOS (unspecified allergy), Walker user and Feeding tube user. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DEATH (Went back to sleep and never woke up) (seriousness criterion death), PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps). The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (Arm soreness), VACCINATION COMPLICATION (Feeling bad), FLUSHING (very flushed/looked red) and FATIGUE (very tired/fatigue/nappy women taking a lot of naps) outcome was unknown. The patient was on a feeding tube, lived independently but had a caretaker who came in every day. The patient had long list of medications for her conditions but concomitant medications were not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, 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. However, regarding the event of Death,Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Regarding the events of Pain in extremity, Fatigue, Flushing, Vaccination related malaise, 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. However, regarding the event of Death,Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Blood clot in my eye causing a hemmorage and now I can't see out of lower part of my eye. Vision is expected to come back in 2-4 weeks. My lymph nodes in my armpits are swollen and I have exhaustion. I was sick and my body ached the day after but that was it.

Sudden vaginal bleeding in March, passing a large clot., only lasted a matter of 5-6 hours. Haven?t had a heavy period in years due to birth control. In May, have had a heavy period for 13 straight days. Again, haven?t had a heavy period in 20 years due to continuous birth control and never one that lasted more than 4-5 days. I?m on say 13 now, with no end in sight.

Pt received vaccination at 0955. At approximately 10;15 another patient came over to the admin desk and notified us that pt wasn't doing well. I went over to evaluate and pt told me she felt fine and she would take a Benadryl when she got to the car. I assisted her to the back where we further evaluate her. She had clear signs of anaphylaxis (blood shot eyes, hives, swollen tongue, rapid heart beat) but did not want EPI. I advised her that EPI is NEEDED quickly and that Benadryl was not enough. She then agreed to let me EPI her. Epi was administer in the left thigh at 10;18. A set of vitals were then taken and patient was places on o2. The emergency department was called at 10;20 and arrived at 10;25. During this time another set of vitals were taken. Patient expressed feeling better but jittery. Hives and tongue swelling had significant improvement but patient still had some symptoms so we advised the follow up team of our recommendation for second dose epi. Emergency team took control of patient.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Tachycardia-Severe, Additional Details: Pt presented to the ER complaining of racing heart, chest tightness, and uneasiness. Pt was sent home without dx. Pt returned to ER and insisted to be seen and that something was wrong. MD diagnosed pt with 2 blood clots in lungs, Causality was not confirmed, but relation to vaccine was not ruled out. Pt has been on blood thinner and did not receive 2nd dose.

Anaphylactic shock . Epi Pen, called ambulance and was transported to ER. Oxygen, ER gave IV steroids and IV Benadryl

started with c/o "feels weird in my chest like a pulled muscle", few days later slight short of breath with fatigue, May 2 11:45 cardiac arrest when paramedics placed O2, rounds of CPR and med's, pronounced dead at hospital after attempts of CPR. Out come on death certificate Bilateral Pulmonary Thromboemboli. Coroner stated there were multiple PE's in bilateral lungs. Positive for Covid 19 (Had in Feb, vaccine in April 20)

Blood Clots (2 PE in right lung) Chills Memory Loss Numbness in limbs Tingling in limbs Muscle weakness Rapid Heart Beat

On May 15, I experienced severe pain in my right thigh. By May 17, I was experiencing extreme shortness of breath and pain in my chest and ribs. I ended up in the emergency room on May 20th and was diagnosed with a pulmonary embolism with infarction.

High fever of 104.3 Heart Palpitations with chest pain, shaking/chills throughout body and splitting headache (not migraine). Heavy mentrual bleeding with clots for long periods of time

She got her vaccine, within 10 minutes her heart felt like it was racing. She noticed over the next 2 days that she was unable to move with nausea and body aches from head to toe and had to lie in bed those days. She had been exercising regularly and now she had fatigue and had to stop exercising as her heart was acting strange and not able to do so. On 5/21/21 her heart was beating so fast and went to UC and they tested her blood work. She said that she had left chest pain, pain down her beds, and pain down her arms. They did blood work stated that she had very high troponin levels, and her BP was dropping to low levels and they called 9-1-1 and she was taken to another hospital and they did the same tests and found that her troponin levels were even higher, and that her heart was experiencing some kind of arrest. Her BP was dropping and she was admitted to the ICU where she was there 4 days. While she was there they did angiograms, echocardiograms, and every one came back stating that her heart was good. They told her that she may have had a mild heart attack and they did not know why and she said that she felt it was due to thev accine. on 5/24/21 she was discharged and on 5/25/21 she called 9-1-1 again and her BP was high and her heart rate was high, and she was taken to the ER again. She was tested again and they did not see anything, and they felt that she had myocarditis or pericarditis and that she needed an MRI of the heart and to contact her cardiologist and her PCP. She came home that night and went to the ER again the next day and felt that she was heaving a heart attack, arm pain, heart racing, and did the same things again and told them what tests she was supposed to have, and they have not done an MRI of her heart yet. She is waiting to get a referral from her PCP for the cardiac MRI and she is experiencing the same reactions that she has been having. They have put her on a baby aspirin to take daily, Lopressor 25 mg twice a day, Lipitor 40 mg to take once a day, She continues to have the bouts of the chest pain, erratic heart beat, weakness and not able to take a shower due to the weakness and the heart racing and the shortness of breath. They were telling her during this time that parts of her heart were dying, and all kinds of other things, and that's when they put her in the ICU. She went to UC, and was transferred to ER and admitted to the ICU and stayed 4 days. She was discharged from there on 5/24/21. Then back to the ER on 5/25/21, and discharged from the ER. Then she went back again last night 5/27/21 to ER and they treated her partially, they did an EKG and tried to explain her situation and they told her that she was fine, and she told them that her troponin levels were high and he more or less dismissed her and said that his troponin levels would be high if he exercises excessively. She left the ER as they were not going to do anything for her. She has a phone appointment scheduled for Tuesday as they have nothing until later in June.

March 31, 2021 they give me the vaccine on my left arm, and I get an allergic reaction a few minutes later left side of my throat felt like it was swelling in my throat ganglion and my tongue became numb from the middle back and I felt obstruction in my throat, also my breath as if I was short of air. Walking home I felt my nose dry and inflamed. I took a BENADRYL and the symptom went away but it also gave me a pain in the belly for a few minutes this was 2:30 pm On the 21st and 22nd. I had another allergic reaction itchiness on my body took BENADRYL the two days had never happened to me. On April 27, 2021 I decide to apply the second dose of MODERNA and it gave me a reaction again, I applied it to my right arm and the reaction began on the right side this time my throat, my tongue and my cheek went numb in addition to what I felt like an obstruction in the throat, a few more minutes passed and the rest of my face and throat went numb and my head from the right side from back to front. I stayed there 50 minutes later I vomited liquid and accompanied by foam. On May 8 he gave me another Allergic reaction, the same inflammation in the throat and I felt obstruction, I took a BENADRYL. On May 18, I got an allergic reaction and I had to go to the emergency room. On May 19, the allergic reaction returned accompanied by soreness in my arms, while there my body began to shake, they put me in a CT scan and they told me that I had a transient ischemic attack.

Patient presented to our facility complaining of shortness of breath. A CTA of the chest revealed bilateral pulmonary emboli.

Heart rate irregular; vision was blurry; pale; face was itchy/itching all over body sporadic and not localized; Redness in face/blotchy red hot; metallic taste afte the vaccine was administered; anaphylatic reaction; warmness up the arm and into the neck after getting the vaccine; facial swelling; Hives; Irritable; didn't feel good/truck ran over her; Vaccination site warmth; itchiness at injection site; Fatigue; Headache; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylatic reaction) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy (developed hives and stomach upset when young adult) and Drug allergy (Erythromycin -developed hives when young adult). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 11-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylatic reaction) (seriousness criterion medically significant), FEELING HOT (warmness up the arm and into the neck after getting the vaccine), SWELLING FACE (facial swelling), URTICARIA (Hives), IRRITABILITY (Irritable), VACCINATION COMPLICATION (didn't feel good/truck ran over her), PALLOR (pale), PRURITUS (face was itchy/itching all over body sporadic and not localized), ERYTHEMA (Redness in face/blotchy red hot), DYSGEUSIA (metallic taste afte the vaccine was administered), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (itchiness at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Jan-2021, the patient experienced VISION BLURRED (vision was blurry). On an unknown date, the patient experienced HEART RATE IRREGULAR (Heart rate irregular). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) on 11-Jan-2021 for Nausea, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-Jan-2021 for Nausea, at an unspecified dose and frequency; EPINEPHRINE on 11-Jan-2021 at an unspecified dose and frequency and PREDNISONE on 11-Jan-2021 at an unspecified dose and frequency. On 19-Jan-2021, ANAPHYLACTIC REACTION (anaphylatic reaction) had resolved. At the time of the report, FEELING HOT (warmness up the arm and into the neck after getting the vaccine), SWELLING FACE (facial swelling), URTICARIA (Hives), IRRITABILITY (Irritable), VACCINATION COMPLICATION (didn't feel good/truck ran over her), PALLOR (pale), PRURITUS (face was itchy/itching all over body sporadic and not localized), ERYTHEMA (Redness in face/blotchy red hot), VACCINATION SITE PRURITUS (itchiness at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had resolved, VISION BLURRED (vision was blurry) had not resolved and DYSGEUSIA (metallic taste afte the vaccine was administered), HEART RATE IRREGULAR (Heart rate irregular) and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Blood pressure measurement (120-80 mmHg): 104/60 mmHg (Inconclusive) at 10:16 am and 164/90 mmHg (Inconclusive) at 10:25 am. On 11-Jan-2021, Heart rate: 129 (Inconclusive) at 10:16 am, 79 (Inconclusive) at 10:20 am and 125 (Inconclusive) at 10:25 am. On 11-Jan-2021, Oxygen saturation: 84 (Inconclusive) 84 and 97 (Inconclusive) 97. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous), the reporter did not provide any causality assessments. The patient received the vaccine at 9:50 am on 11-Jan-2021 and returned to the room at 10:10 am with the symptoms. EMS was notified and Epi Pen administered at 10:16 am. The patient's oxygen saturation was initially 80% and the hands were very cold. The patient was transported to ER and was dismissed later on in the day. The signs and symptoms of anaphylactic reaction were reported as itching/pruritis, hives/uriticria, irregular heart rate/palpitations, nausea, difficulty breathing, swelling of upper airway, sensation of throat closing, angioedema, prickling/tingling sensation, feeling hot and flushing. Based on the current 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-Jan-2021: Additional event was updated. On 14-Apr-2021: The diagnosis, symptoms, patient information and vaccination site details were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Unknown lot, site ED visit, Non-prescription medication, Prescription medication Anaphylaxis PMH significant for 40-year-old female presenting to the ER after second Covid vaccine. Concerns for allergic reaction. States that after her vaccine she felt like her throat was closing. Called 911. EMS gave her a dose of epinephrine in the field. On arrival symptoms have completely resolved. No lip or tongue swelling. No stridor. Handling secretions. Denies chest pain or shortness of breath. Denies lightheaded or dizzy. Denies any hives. Denies any abdominal pain nausea or vomiting. Patient presents to the ER for allergic reaction after COVID-19 vaccine. Given a dose of epinephrine in the field. On arrival no signs of anaphylaxis. Normal physical exam. No stridor, no lip or tongue swelling, clear breath sounds, no abdominal tenderness and no skin rash. Patient be given a dose of Benadryl and steroids (Prednisone) in the ER. Will observe for period of hours due to epinephrine administration to watch for rebound anaphylaxis. 1912: Patient asymptomatic. No feeling much better. Observe for period of time without any rebound symptoms. Heart rate is resolved 94 on monitor. No signs of anaphylaxis. Will discharge with instructions to follow-up with primary care doctor in 1 to 2 days.

eclampsia; Deep vein thrombosis on her right leg/ blood clot; scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ECLAMPSIA (eclampsia) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was provided. Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]) and LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) for an unknown indication. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 20-May-2021. On 12-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 09-Jun-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy). On an unknown date, the patient experienced ECLAMPSIA (eclampsia) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 12-May-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 09-Jun-2021, INTENTIONAL PRODUCT USE ISSUE (scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy) had resolved. At the time of the report, ECLAMPSIA (eclampsia) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. The reporter stated that while screening for 2nd dose that was scheduled for 09-Jun-2021, patient checked yes for blood thinner and blood clot. Company Comment This is a case of product exposure during pregnancy and intentional product use issue with associated AEs of eclampsia and deep vein thrombosis reported for this 40-year-old female. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of product exposure during pregnancy and intentional product use issue with associated AEs of eclampsia and deep vein thrombosis reported for this 40-year-old female. Very limited information regarding these events has been provided at this time. Further information has been requested.

2nd COVID shot o 1/27 (Wednesday). Started having right sided lower back pain on Friday that continued to become worse each day. By Tuesday 2/2/21 the pain was significant. I went to ER. During the time at the ER - lab work was completed and a abdominal CT. Then a chest CT and was diagnosed with a Pulmonary Embolism. I was then started on Eliquis 10 mg BID (eventually moved down to 5 mg BID). I then followed up with my PCP. I was then referred to a Hematologist. I was on Eliquis for 3 months starting February 2, 2021 and was on light duty with both my work and with my teaching of karate.

Was diagnosed on 6/19/2021 with pneumonia of left lung after fever and other symptoms reported through VSAFE started on 6/15/2021. At the time of doing the daily VSAFE check in, had not yet been diagnosed but decided honesty about health was important. Treatment was a five day course of z-pack and ten day course of Ceftin. Followup with primary was 6/23/2021, chest x-ray has been ordered for July at one month mark. At present, symptoms gone but I am still taking Ceftin as prescribed.

On March 27, 2021 I got a 102 that night and the fever lasted for 48 hours and there was body pain and after the fever broke I got the covid arm. I didn't call the doctor until three months later and that is when I got the blood clot, on Monday June 13, 2021. I also went to the urgent care: immediate care at the Hospital, the same day, June 13, 2021 because their was a pain in my right hand underneath the thumb and I couldn't move it at all. In the urgent they said it could be that my joints were swollen and they gave medication/shot in my buttocks: Toradol. After that, that night a hemorrhage appeared. I called my Dr. and she gave me an appointment on Friday, June 18, 2021. She said that it could have been a clot and wanted further imaging and my appointment is this Friday, July 2, 2021.

G3P2002, due date 9/23/21, pregnancy complicated by hyperemesis gravidium, received first dose vaccine Moderna march 19th. Starting 2-3 weeks later, she has progressive rash that initially improves with steroids but after rapid taper of steroids in early June progresses to include fevers, body aches, fatigue, joint pain, headache. She is admitted to the hospital, found to have bilateral infiltrates on imaging, oxygen requirement, thrombocytopenia, mild transaminitis. Extensive infectious and rheum eval neg. Skin biopsy positive for eosinophila. Represents to hospital beginning of July with nearly identical symptoms, which never fully improved from first hospitalization. ICU stay, multiple consultants involved. Diagnosed with DRESS (drug reaction with eosinophilic systemic symptoms). Based on medication list and timing, this is vaccine induced.

Adverse: (Common adverse effects-Fever, chills, body aches, joint pain) Vaginal bleeding the same night of vaccination 5/3/2021, last menstrual period 4/19/2021, no abdominal pain or cramps, light to moderate vaginal bleeding with clots Treatment: Medroxyprogesterone 10mg 2 tabs PO BID started on 6/24/2021, Biopsy and PAP smear performed on 7/9/2021, Hysrteroscopy, D & C and possible polypectomy scheduled on 7/26/2021, 2 weeks post-op check up on 8/10/2021, Decidua cast passed on 7/19/2021.

Anaphylaxis- throat tightness , nausea , rash , pruritis , chest tightness, wheezing . 9-11 called epinephrine x 2 , decade on , IV Benadryl , duo-nebs, famotidine, admission to icu high dose prednisone , nebulizers , zofran , duo-neb nebulizers

Pt. Was seen for covid-19 vaccination on 1/13/21. She presented to observation at 12:29pm for her 15 minute observation. Between 12:34-12:38pm pt. Endorsed sudden onset of dizziness and chills. I called for RN assistance who obtained VS and I began clinical assessment. Pt. Denied CP, SOB, DOE, difficulty swallowing was reported. She was able to speak in full sentences, no audible wheezing, facial swelling, one sided weakness or difficulty with speech production. On exam: breath sounds clear, pt. diaphoretic, cool to touch, visible pallor. She denies prior allergic rxn to vaccinations, denies daily medication. Reports medical hx including Sjögren's syndrome and psoriasis. She reports eating breakfast (meal&juice) prior to vaccine administration. Denies allergies to food or medications. 12:40pm: BP 60/49, pulse 81, 02 sat 100%, RR 16. Repeat BP 60/33, rapid response (code blue) was called. Pt assisted transferred to clinical reclining chair, placed in supine reclining position, fluids started (500 bolus NS),FS glucose 93, and EMS called. Patient remained a&o x3, no syncope. 12:46-12:50pm: reported onset of stiffening of hands and l/e. below the knee. AROM remained intact in extremities. Approximately 12:56pm EMS arrived, EKG WNL (per EMS), patient able to ambulate with assistance from reclining chair to EMS transport chair. Approximately 12:58pm BP 93/47. Pt. was stabilized in DTMO following 500 mL NS, BP 92/54 prior to departure to ED at 1:05pm. RN contacted pt. Emergency contact (as documented in RN note) with EMS arrival and prior to ED departure. Pt. Belongings were collected, including cellular phone, and placed in patient belonging bag and given to patient prior to her departure. RN will follow up with patient tomorrow and schedule in office follow up. PCP notified per rapid response report.

On 1/30/2021, I developed a mild headache followed by an acute change in my vision. I went to the emergency room 24 hours later after the symptoms had not resolved and was found to have a left superior quadrantanopia and a 2.3cm x 1.9cm hemorrhage in my right occipital lobe. I was admitted to hopsital and discharged today 2/3/2021. My headache has resolved but I continue to have a visual field deficit. I had been scheduled to receive the second dose of Moderna on 2/1/2021 but was unable to receive it due to my hospitalization.

Thrombocytopenia. Platelets went from 175K day of vaccine to 56K four days later. Petechiae on feet and legs morning after vaccine. Additionally, cold sweats overnight. Woke up with headache, body aches and extreme fatigue, as well as injection site soreness.

ON FEBRUARY 19,2021, PATIENT HAD A GRAND MAL SEIZURE IN THE EVENING. SHE REPORTED TO THE EMERGENCY DEPARTMENT AND THE CASE WAS DISMISSED AND SHE WAS SENT HOME. ON FEBRUARY 21, 2021, PATIENT HAD ANOTHER GRAND MAL SEIZURE AND WAS HOSPITALIZED. SHE WAS DISCHARGED ON KEPPRA 1000 MG TWICE DAILY. SHE REPORTS SHE HAS SWELLING ON THE LEFT SIDE OF HER BRAIN AND CONTINUES TO HAVE SMALLER SEIZURES WHERE SHE IS AWAKE BUT NOT RESPONSIVE.

With the second dose I had bad headaches, fever (99.9F), injection site got swollen after a couple of days, painful, had to use ice pack and it still hurts (not swollen anymore) ? symptoms were milder than 1st dose, heavy bleeding for an extended amount of time even with meds to try to stop it and the coloring was darker, brown, not really bright red as usual. I still have a little bit of headache not as bad as in the beginning and body aches and pains.

Had COVID shot March 2, got headache right away, lasted 4 days, resolved. Then on March 8 she had a stroke affecting R side of the body. It was not severe, and it is already partially recovering.

Got the shot Friday March 5th. Sore arm and muscle aches like the first dose on 2/5. Woke up March 7th with swollen lips/throat/tongue. went to urgent care and received an EpiPen and steroid. Monitored for a couple of hrs and went home for a nap. (refused the ER at this time as I felt better). Woke up around 2:30 and my symptoms worsened . We to ER and received another Epipen for anaphylactic shock. Remained at the hospital for 5 days. Had 5 episodes while there. Also, had tightening in chest and what felt like a heart attack. Been resting, still very tired and swollen nodes in my neck and sore throat as well as aches. Also, might be developing thrush. Didn't run a fever and Ive never had an allergic reaction before this.

Anaphylaxis. Initially, pt experienced palpitations and tightness in throat after vaccination and wasn't sure if she was experiencing swelling in her arms. BP was 130/79 and HR 93 initially. Pt started to feel better without intervention but given diphenhydramine as a precaution while we continued to monitor her. 10 mins later she started to have tingling in lips and tongue and visible lip swelling in addition to palpitations. Immediately administered Epipen (0.3mg) x 1. EMS was called. No worsening but not improvement after 5 mins so a second dose of Epipen (0.3mg) was administered. By the time EMS arrived (9 mins after first epipen dose) pt was feeling better, swelling had resolved, no throat tightness. Pt was transported to local hospital by EMS for monitoring.

Pt had anaphylactic reaction including throat, mouth swelling and SOB, administered Epinephrine 0.3mg, sent patient to ER via ambulance.

Approximately 30 minutes after administration of Covid vaccine in left upper arm patient complained of a tingling sensation down the entire arm and into the palm. She then began noticing a sensation that she needed to clear her throat and cough. Reports it started to feel tight. No facial edema no oropharyngeal edema visible. Lungs clear to auscultation. Blood pressure and pulse remained normal throughout the visit. anaphylactoid reaction 1. 9:28 am given Epinephrine 0.5mg/0.5ml given IM, in the left thigh; administered by: healthcare professional: ( lot #344615; exp. 01/2022; Par Pharmaceutical ) 2. 09:31 am given Diphenhydramine 50mg/1ml given IM, in the right upper arm; administered by: healthcare professional; ( lot #070101; exp. 07/2022; west-ward ) Epinephrine was administered followed by Benadryl. Patient was observed for another 30 minutes and noted the throat symptom disappeared and was feeling back to her normal self. 9:45am felt better, 10:00am discharged Discussed with patient anaphylactoid reaction. She is well versed in anaphylactic reactions having had them in the past. Has an in date epinephrine pen on her at all times. Is being driven home by friends and has family members at home to help observe her. Discussed rare cases of delayed second reactions up to 12 hours later. She will observe for this.

Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock 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 tumeric, multivitamin, vitamin d, lexapro and adderall. On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection. On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock. Treatment for the event included was given steroids, benadryl, and prescription antihistamine. Action taken with mrna-1273 in response to the events was not provided. The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.

@11:35 pt complain of palpations and throat closing. pt was in distressed. epi pen given @ 11:37. @ 11:44 pt symptoms improving and transported to the hospital by ambulance @ 11: 50.

Cold sweats, headache, fatigue and body aches started about 12 hours after vaccine and lasted to about 36 hours post vaccine. Petechiae and bruising started about 36-72 hours after vaccine. Platelet count on day of vaccine was 175K, and was 56K four days later. I have immune thrombocytopenia that was stable with counts around 175K regularly prior to COVID-19 vaccination. My counts have been unstable and trending lower since vaccination.

I developed a sudden, sharp stabbing pain in the left side of my head while at work. I had not fallen nor had any injuries/illness. I went to ER; CT scan was concerning for clot in sinus so I was sent via ambulance to inpatient neurology where further MRI/MRV scans determined it was not in fact a clot, but a small bleed of unknown origin. Again, I had no injuries. I was hospitalized while multiple scans were completed along with lab work. Home now following up with neurology, still have head pain, unable to fully work, etc. Hematoma is still there but not growing.

3 weeks and 3 days after the vaccine, I experienced 2 days of intense menstrual cramping and moderate bleeding. Since I am on my 2nd Mirena IUD, I have had a Mirena for over 9 years, and this is the first time I have had any menstrual bleeding during that time.

Day 9 after injection noticed small suspicious bruises. Day 10 slight vaginal bleeding assumed was UTI called for prescription was given Bactrim. Day 12 large contusion on back, right breast, left hand and left foot. Went to emergency per doctors request. Diagnosed with ITP and confirmed UTIPlatelet level was severely low (18,000) . Changed antibiotic from Bactrim to Kefflex and was given 60mg of Prednisone. Increased platelets to 68000. Reduced Steroid to 20mg. due to progress. Continued to increase platelets. Stopped steroid and continued to see increase in platelet production. Today levels are 148,000. Did not take second scheduled vaccine.

Within 15 to 20 minutes of receiving vaccine got severe headache. Within 2 hours felt tired and sleepy. Within one day had sweats alternating with cold chills and fever of 99.5 degrees F. Within 3 days my INR level increased from normal range of 2.0 to 3.0. INR became 4.7 and began easily bleeding. Went to ER on Sunday April 18, 2021 due to severe headache and numbness & tingling in right arm and leg.

I was about 6.5 weeks pregnant and experienced medium to heavy bleeding. I went to the emergency room, and they indicated that the fetus was fine. The next day I would bleed if I was moving around so I stayed in bed for two days. I have had three miscarriages prior to this pregnancy, but i did not have this bleeding in any of them? they seem to have been due to a septum which has now been removed.

I had a couple of blood clots earlier in the week which I found weird. On Saturday morning I went to the bathroom and wiped and there was very bright red blood. I called and was told as long as I did not bleed through a tampon or pad not to worry and if I was still having issues to contact my primary on Monday. I went through 2 super tampons on Saturday. The color was very dark, almost black in color and sticky to the touch. I did not need another tampon that night and it was gone the next day. I am and always have been VERY regular. My period is not due to start until the 15th of this month.

Menstrual cycle abnormalities - no stop bleeding since first shot, became significantly worse with second shot. 2 months have passed and I still have excessive menstrual bleeding and very large menstrual blood clots.

Started with headache and dizziness. Was seen in ER and discharged home. Headache, dizziness and now Nausea and vomiting. Eyes tracking to one side continued. Returned and head CT was read as negative. Transferred to Hospital MRI showed two cerebral infarcts. She remains in ICU. Her speech and one side of her body was affected. She is scheduled to be moved to rehab this week.

Patient suffered a ischemic stroke to the thalmus part of the brain and lost motor functions on the left side of her body. Patient was rushed to hospital and given numerous tests to dicipher a cause for the event. All tests came back negative as to what could have caused the event. Patient is young and healthy otherwise. Patient was given blood thinners and monitored for 3 days and her symptoms improved rapidly. She was released after 3 days.

Patient is a 41 y.o. female, reported history of asthma, obesity, polysubstance use, is transferred to the hospital via EMS in cardiac arrest. Per EMS report, the patient was found in an apartment complex by a neighbor unconscious. The initial report was that she was breathing however EMS was called back and then told that she was not breathing and not responsive. Estimated downtime was between 5 and 8 minutes before paramedics arrived and initiated CPR. Due to the patient's body habitus, it did take approximately 15 minutes to get the patient transported to the hospital. 3 rounds of epinephrine were given in the field. Her rhythm has been asystole prior to getting to the emergency department. Intraosseous access is obtained. There is an OPA in place.

Fatigued the night of 4/30/21. Woke up at 2:00am and had trouble breathing. Checked oxygen and it was 90. Had a fever of 102 and full body aches. 5/1/21-Chills and fever of 99 continue the following day. Oxygen went down to 87. elevated to 90-93. Heart rate was up and blood pressure was low. Light headed, nauseous. Pale and weak. This lasted about 4 days. 5/3/21- Sweating started and felt like knives poking through skin. 5/4/21- Rash developed under entire left arm. 5/6/21- Oxygen finally reach 97 and increased to normal. Nausea finally subsided. Doctor said I likely had anaphylaxis and a immunologic driven reaction.

Passing bright red blood mixed with clear mucus-like discharge from my uterus/vagina even though my period is due 2 weeks away. Spotting for the past few days -- and still spotting. Some lower abdomen cramping.

On about 12 May, I began experiencing pain in my left calf, as if I had a pulled muscle. Since I saw no redness, swelling, nor noticed any warmth to the area, I thought I had just pulled the muscle. After 3-4 days, the pain began dissipating, but then I started having shortness of breath. On 19 May, the shortness of breath became extreme and I went to the ER where I was diagnosed with numerous pulmonary embolisms in all lobes of both lungs and also DVTs in my left calf, as well as slight enlargment of the right ventricle of my heart. I was hospitalized until 24 May. During my hospitalization, I was on a heparin IV, as well as had a catheter in my neck to administer TPA to my lungs for 24 hours. I also had a filter placed in my inferior vena cava. I was discharged on 24 May with a prescription for Xarelto and follow-ups scheduled with my family doctor and cardiologist.

On 4/16-4/18 minor soreness and fatigue that temporarily disappeared. Then on 4/21, I experienced High Fever (103.8), Body aches, headache, extreme fatigue that lasted through Monday 4/26. Through that time I went and got a Covid test on Friday 4/23 and it came back negative. On Thursday 4/29, I started having pain on the right upper side of my abdomen. Friday evening, the pain grew even more intense which I could not lay down to sleep and no pain meds were taking it away. Saturday, 4/30 at 6 am ended up in ER at Facility. They were testing me for blood clots due to the chest pain and sever right side pain and the results showed no blood clots and my heart was fine. CT scan showed pneumonia, scarring in my lungs and a nodule growth on my lung. The doctor asked me if I was in the dessert recently if I had ever had valley fever. Valley Fever came back negative, another Covid 19 test came back negative. I completed taking 2 antibiotics and now on 5/25 (day 40) I am still feeling bouts of fatigue, wheezing in my lung and pain in my lung. I was healthy prior to getting the 2nd dose of Moderna and can't help but feel the vaccine triggered something in my system. Reporting this just in case it is an adverse effect from the vaccine.

Anaphylactic reaction; tingling in the roof of mouth; arm soreness; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (tingling in the roof of mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder (mast cell disease, its autoimmune.), Nausea, Vomiting, Numbness and Nerve pain. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and CIMETIDINE (H2 BLOCKER [CIMETIDINE]) for an unknown indication. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling in the roof of mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at a dose of 400 mg; EPINEPHRINE (EPIPEN) for Swelling, at a dose of UNK dosage form; ALBUTEROL [SALBUTAMOL] at a dose of UNK dosage form; IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) at a dose of UNK dosage form; BUDESONIDE (PULMICORT) at a dose of UNK dosage form and ARFORMOTEROL TARTRATE (BROVANA) at a dose of UNK dosage form. At the time of the report, PARAESTHESIA ORAL (tingling in the roof of mouth) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment Benadryl 300 mg and EpiPen. Then Albuterol, Duoneb, Pulmicort, Brovana, Epinephrin and 900 Benadryl. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25 May 2021 includes 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. The patient's medical history of mast cell disease autoimmune remains a risk factor.

A 41-year-old female patient with a past medical history significant for ADHD, GERD, and past pulmonary embolism who reports to the hospital with shortness of breath. This started about 3 to 4 days ago and has become progressively worse to the point where she has having difficulty performing her ADLs without having to sit down and rest. She also endorses pain in her left calf has been present for about 1 week. She did develop chest pain which she describes as a sharp sensation on her right chest wall that is exacerbated with deep breaths. The patient was treated with tPA for acute PE and right heart strain. She had an IVC filter placed prior to discharge.

anaphylactic reaction .. she received the 2nd dose of the vaccine today around 10 AM at clinic and started feeling throat swelling, generalized itching, and trouble breathing. Patient reports having a mild allergic reaction after the first dose but was discharged from the ED.

ITCHING WHILE IN 30 MINUTE WAIT PERIOD AFTER INJECTION. WITHIN 1 HOUR HAD BODY WIDE HIVES THAT LASTED 3 HOURS, TOOK BENADRYL. LATER THAT DAY HAD HEADACHE ,MYALGIA,NAUSEA, DIARRHEA, CHILLSX 2DAYS. 2ND DAY AXILLARY LYMPH NODE SWELLING RIGHT ARM. 1 WEEK AFTER INJECTION DEVELPED DVT LEFT LEG. WAS ON BCP/SMOKER. STOPPED BCP AND ON ELOQUIS. SOME COSMETICS, LOTIONS AND ICE CREAM CAUSE THIS PATIENT HIVES AS WELL.

Started feeling toes on right foot numb days passed felt pain on knee swollen leg went to hospital have a DVT in leg, started blood thinner .Then I received second dose 5/8/2021 at 12:00 pm same day around 7:00pm I started feeling pain on left leg went to the hospital on 5/10/2021 have another clot on left leg

Acute pulmonary embolism 6/3/2021 at 9:24am prescribed eliquis 10mg, potassium 60 meq, magnesium 2g, morphine 4mg

Re-infected with Covid 6/8/2021 Admitted to ICU 6/12/21 for shortness of breath and hypoxia, gastroenteritis Treating with Remdesivir and solumedrol

Doctors think that this caused blood clots in my left leg from my groin down to my toes. Had 5 surgeries in order to try to clear them, but had to have a 6th surgery to amputate below the knee.

4/25/2021-woke up sweating, could not stand up right felt as if I was in labor. This lasted for several hours then I started my menstrual cycle. Since I never experienced this pain outside of actual labor went to urgent care. Thought could have kidney stones so walked next door to ER. Luckily it was not stones and I was fine. Went to ob and everything checked out fine. I experienced this pain for roughly 6 hours prior to my menstrual cycle. Once I would start the pain was better but I was bleeding clots (semi deflated grapes look). This was 5/20/2021 and 6/14/2021. When I started on 7/11/2021 the pain was gone. So three periods after first dose extreme pain. Unable to move or do anything.

This patient has MS and is on ocrevus. Had COVID-19 vaccination with second shot about 5 weeks before most recent ocrevus infusion. It is well reported in the literature, now that is, that these sub section of patients (MS on CD20 monoclonal antibodies) may not produce an antibody titer to vaccination. However, she had a breakthrough COVID-19 infection that started on 7/11/2021. Admitted to the hospital on 7/21/2021, discharged 7/26/2021. Severe COVID-19 that required BiPaP therapy. Treated for secondary pneumonia as well. Treated with ivermectin, remdesivir, dexamethasone.

Grandma seizure last 30 seconds then she came too and started throwing up. Little blood in stool. Now 7 hrs. later she has a headache and is nauseous with occasional stomach cramps and diarrhea. Kept at home didn't seem to need hospital.

Extremely fatigued; Tightness in sternum; Bilateral leg weakness; Difficulty in walking; Atelectasis; Anaphylactic shock; A spontaneous report was received from a consumer who was a 42-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking. The patient's medical history included allergy to shellfish, bee sting, and mushrooms. No concomitant medications were reported. On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020, five minutes after receiving the vaccine, the patient experienced anaphylactic shock. Some of the symptoms experienced included chest tightness, difficulty breathing, throat swelling, and weakness. The patient was transported to the hospital by the emergency medical services (EMS). Treatment for the event included epinephrine several times. On 01 Jan 2021, the patient experienced extreme fatigue, tightness in sternum, and weakness at home. She returned to the hospital where she was admitted. It was noted that a computed tomography (CT) scan revealed atelectasis. The patient also experienced extreme bilateral leg weakness and difficulty walking. The patient was advised to be placed in a nursing home/rehabilitation center. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking, was unknown.; Reporter's Comments: This case concerns a 42- year old, female patient with medical history of allergy to shellfish, bee sting and mushrooms, who experienced a serious, unexpected event of anaphylactic shock, chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis. The event of anaphylactic shock occurred 5 minutes after first dose of the mRNA-1273. The event of chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis occurred 2 days after first dose of the mRNA-1273. The treatment included epinephrine. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded..

Developed cough and throat tightness, difficulty breathing, inability to talk. Seen at local emergency department and treated for anaphylaxis

42yo G2P0010 at 3+6 weeks GA by LMP 1/1/2021 with EDD 10/8/2021 on day of Vaccine Dose #2 (1/28/2021), positive urine pregnancy test on 1/30/21. Bleeding began on 2/4/2021, and complete miscarriage occurred on 2/5-2/6.

ANAPHYLASXIS/DIFFICULTY BREATHING - ER EVALUATION AND 23 HR OBSERVATION; MED ADMINISTRATION OF EPI X3; BENADRYL; FAMOTIDINE; STEROIDS.

Adverse event: I had anaphylaxis on 2/12/21 that required transport via ambulance to the nearest emergency room for life saving treatment. Background information. I took a 7 day course of celebrex (200mg orally once daily) on 1/25/21, prescribed by my primary physician for a flare up of low back pain. A 14 day course was prescribed; I stopped taking it after 7 days because my stomach was getting upset and I didn't want to take it close to my 2nd covid moderna booster. I got my 2nd moderna covid vaccine booster on 2/8/21. For 1-2 days, my left arm (injection site) was sore and I was mildly fatigued. I took over the counter advil (200mg twice daily) and tylenol (500mg twice daily); the day I took advil, I was sneezing and developed signs of allergic rhinitis (congestion/runny eyes and nose). I did not have any other immediate adverse reaction and by Thursday, 2/11, the arm soreness and fatigue resolved. My low back pain began to bother me again, so I took a 200mg oral dose of celebrex at 7:30a on 2/12/21. I went to work (I am a veterinary neurologist. While at work, at 9:30a on 2/12/21, I had a severe anaphylactic reaction and had to be taken via ambulance to Medical Center. I developed hives/welts/burning/itching all over my body, within 5 minutes my throat closed up, I couldn't breathe, I became hypotensive/collapsed; in the ambulance, I was given IM epinephrine; then at the ER, I was given IV steroids (solumedrol), benedryl, famotidine, zofran (due to abdominal pain/nausea) and IV fluids. This stabilized my signs within 1 hour and I improved and was going to be discharged at 2pm. However, the hives returned at that time, so I was given additional IV benedryl, famotidine, fluids and oral prednisone and kept in the hospital overnight for monitoring; I was discharged to go home on 2/13/21 on a 4 day course of oral famotidine, benedryl and prednisone; I remained itchy and continued sneezing at home on 2/13/21. Today, 2/14/21, all signs of this reaction have resolved. The ER doctors and myself believe the 2nd moderna covid booster on 2/8/21 stimulated my innate immune system, leading to this anaphylactic reaction to celebrex (a medication I had taken 2 weeks prior with no problem). The doctors feel the celebrex is what set off the anaphylactic shock, but that my immune system was primed to do so after the vaccine. In hindsight, I realized that I was having allergic rhinitis symptoms after taking oral advil on 2/9 the day after my booster (which has never happened to me before either). I am a person with no pre-existing allergies of any kind. There was nothing different at all in my routine including food or potential environmental exposures) on 2/12, the day of my anaphylactic reaction, other than my taking a 200mg dose of oral celebrex. I am not allowed to take NSAIDs until I see an allergist for testing now. I am reporting this adverse event as I believe the moderna booster caused an anaphylaxis to the celebrex medication.

The staff member was given a Covid-19 vaccination as part of the LTCF Covid-19 clinic scheduled on 2/25/2021. During the 20 minute observation period the patient lost consciousness and begin to have seizure-like shaking. An 0.3mg epi-pen was administered in the lateral thigh. The patient then experienced cardiac arrest at which point nurses from the LTCF began and completed 2 cycles of CPR before the staff member was resuscitated. EMS arrived and assessed the patient. Patient was taken to the hospital for further evaluation.

The evening of my vaccination, I began to feel feverish, weak and achy. During the night I woke with heavy bleeding and found out the following morning I had miscarried my otherwise healthy pregnancy.

Sudden vaginal bleeding. I had a very strong reaction to the second dose - 103F fever, chills, sweating, aches. My period ended several days before vaccination, so this bleeding is sudden and worrisome.

anaphylaxis - throat tightness, hoarseness, coughing, trouble swallowing, nausea, dizziness, pallor, watery eyes, urinary incontinence, sense of impending doom

Expanding red raised rash at injection site that grew until I had an anaphylactic event. It is unknown if it is due to the vaccine due to it taking 3 days to happen but I strongly suspect it. Taken by ambulance to hospital and epinephrine.

DVT blood clot and surface blood clot in lower left leg diagnosed at the ER on 2/12/21. Levonox injections and warfarin have been started. Twice weekly INR checks. No longer need the injections; warfarin is continued. Next INR check is scheduled for Thursday March 11, 2021. Warfarin may need to continue life-long.

EDC: 25 APR 2021 AE1: Superficial Venous Thrombosis: On 10 Feb 2021, patient presents with RLL pain and swelling. Dopplers with non-occlusive Superficial Venous Thrombosis. Started on 40 Lovenox qd. On 23 Feb, had worsening pain and repeat doppler showed occlusive SVT. Her Lovenox was increased to 40 mg BID and referred to Hematology. Her hematologist increased her lovenox to 80 mg bid. SAE: Pulmonary Embolism: On 3/9 patient developed Shortness of breath and chest pain and went to ED where she was diagnosed with Bilateral pulmonary emboli. She was admitted to the hospital and started on an heparin drip. AE2: SVT: Patient developed a second SVT after discharge from hospital on 17 Mar 2021 that is located away from original SVT site.

Weird headache at top of head which would come on quickly for a minute or two then vanish and repeat every 10-15 minutes or so. Very tired. Had started menstrual cycle on March 17, but post vaccine it was lighter than normal and then on the 22nd it became very heavy and there were lots of large blood clots. This has lasted an additional three days. My cycle usually lasts 5-7 days but day 2/3 are the heaviest and it?s usually very light by day 6/7. I have not had blood clots in several years. These are very large.

Tingling sensation and swelling in neck and rash at her chest. Treated as anaphylactic reaction. Epi 0.3 x 2IM with Benadryl 25 mg IM and albuterol inhaler. Rash/symptoms improved after.

The week after receiving the 2nd dose, I had multiple grand mal seizures and loss of consciousness. Debilitating pain, weakness, & numbness in left side of body especially the leg. I went to the ER 2/21 & 2/2/26 because I was worried I was having strokes. BP 177/90, d-dimer 662 ng/ml, oxygen saturation ven - resp 56.2%, Ct scans done on upper thorax multiple nodules Brain scans small region of encephalomacia in right post. Perirolandic frontal lobe remote lacuna infarction left inf basal ganglia

Brother called pharmacy on 04.13.2021 at approximately 10am and informed pharmacist that his sister had passed away due to a pulmonary embolism about 2 weeks after receiving her first dose of the Moderna COVID vaccination at our pharmacy. He mentioned that healthcare provider was looking at possible gene mutation in family that may have contributed.

global headache which began around 7 pm on injection day, still present fever, chills, fatigue on injection day around 7pm which resolved after a day new onset left leg numbness and pallor on 4/12-4/13. Not actively pulseless here in ED but patient reported diminished pulse

Moderate Anaphylaxis. Treated with Epinephrine, Diphenhydramine and Solumedrol. Symptoms mostly resolved within 30 minutes and stable for 4 hours.

I woke up in the middle of night with chest pain and trouble breathing. I had a pulmonary embolism. The pain and difficulty breathing lasted several days. Since then, I have experience a flare of the antiphospholipid syndrome - low platelets (blood work), splinter hemorrhages, clots, and the like. Whether from the embolism or other, the pulmonary hypertension has gotten drastically worse - with increased shortness of breath, irregular heart beats, dropping pulse ox.

Shortly after the vaccine I returned home to work. I started having stomach cramps like my cycle was starting. The cramps became worse and I started spotting. I took two ibuprofen but they provided no relief. I became nauseas and had a headache as well. I felt better the next day except my arm aches and mild stomach cramps. The cramps have continued still.

OS 42 Y.o. Female AAox4, anaphylactic reaction. translator was used. Pt complained of extreme difficulty breathing, swollen tongue, difficulty swallowing. Pt was out side of vehicle pacing back and forth in distress. Prior to epi admin pt. Was having near syncope also. Pt. Appeared pale in color and distressed, pacing back and forth with anxious look on her face. Pt pulse rate also was approx 110 prior to administration, and strong. RR was approximately 20. Bp 186/92 post administration. Tx. Pt was examined and verbal interview conducted through interpreter. EMS summonsed. Pt advised tongue was starting to swell significantly, and increase in SOB, nausea and. Near syncope. Pt administered 0.3 mg epinephrine through autoinjector to r thigh @ 1128. Pt advised after approx 6 min post injection that tongue swelling was decreasing and she was able to breath again and was not having near syncopal episodes. Pt care transfers to hospital with a non-emergent transfer to hospital.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CONTRACEPTIVE HD) for Birth control. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (headache) (seriousness criterion hospitalization prolonged). On 02-Apr-2021, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to CEREBRAL VENOUS SINUS THROMBOSIS and HEADACHE. At the time of the report, CEREBRAL VENOUS SINUS THROMBOSIS (Cerebral Venous Sinus Thrombosis) had not resolved, and HEADACHE (headache) outcome was unknown. Not Provided, DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Computerized tomogram: abnormal (abnormal) Cerebral Venus Thrombosis in the brain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of the events included Pradaxa. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's recent history of starting back on oral contraceptives may remain a risk factor for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's recent history of starting back on oral contraceptives may remain a risk factor for this event.

two grand mal seizures; migraine; under skull feels like it itches; persistent cough; body aches; chills; pain at vaccination site; extreme n/v; extreme n/v; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) in a 42-year-old female 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. The patient's past medical history included Seizures. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), CARBAMAZEPINE (TEGRETOL), TRAZODONE and POTASSIUM GLUCONATE 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 20-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) (seriousness criterion medically significant), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain at vaccination site), NAUSEA (extreme n/v) and VOMITING (extreme n/v). On 20-Apr-2021, VACCINATION SITE PAIN (pain at vaccination site) had resolved. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), NAUSEA (extreme n/v) and VOMITING (extreme n/v) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication: Norco 10mg, Zofran 8mg, Tylenol, Motrin. 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .; 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .

1 day after shot I had flu symptoms and was basically out of the whole day. 2 days after my fever cleared and I noticed a pain in my left leg calf. I thought it was because of my shot but that it was just body aches. The pain increased and eventually spread to my inside thigh. I went to the urgent care on 5/17/21 and an ultrasound discovered blood clots (Deep Vein Thrombosis) Please note that I also had traveled 5 hours on a flight on 5/6/21 but I was stretching on the flight and have never had a DVT before.

Starting the following it started with a really big hive that looked like a welt on my right arm, it was about half the size of my arm, Day 8 I left work early because I didnt feel right, My throat was closing up. Was treated at the ER for anaphylaxis. It persisted for a few days, was sent home with a epi-pens, I had to take meds for about a week,

Two hours after the patient took the shot, she experienced mouth swelling and took allergy meds. She had persistant redness and swelling that resolved with allergy meds. On 1/17/2021, the patient developed a fever of 101.2. She developed cough, headache, and body aches. On 1/18/2021, the patient was diagnosed with SARS CoV-2. On 04/28/2021, the patient went to the doctor with stroke like symptoms, facial droop, and hypertension. She had apparently experienced two strokes in the prior weeks, according to her chart. On 04/28/2021, the patient stated she had been on her period for 5 days, the heaviest period she's experienced. She was taken off her birth control meds due to TIA's she experienced a few weeks earlier, according to the patient encounter.

According to patient: Approximately 24 hours after receiving the first dose of the Moderna COVID vaccine this patient reported difficulty breathing, swelling of the wrists, ankles and tongue. She was treated at the ED for anaphylactic adverse reaction with good effect.

Blood clots, one on the lung; Gonna pass out; Extremely dizzy; Lightheaded; Little bit of soreness after injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood clots, one on the lung) and LOSS OF CONSCIOUSNESS (Gonna pass out) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD and Diabetes. Concomitant products included INSULIN and OMEPRAZOLE for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Little bit of soreness after injection). On 04-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Gonna pass out) (seriousness criterion medically significant), DIZZINESS (Extremely dizzy) and DIZZINESS (Lightheaded). On 06-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood clots, one on the lung) (seriousness criteria hospitalization and medically significant). On 03-Apr-2021, VACCINATION SITE PAIN (Little bit of soreness after injection) had resolved. On 04-Apr-2021, LOSS OF CONSCIOUSNESS (Gonna pass out) and DIZZINESS (Extremely dizzy) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood clots, one on the lung) outcome was unknown and DIZZINESS (Lightheaded) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included medications for (diabetic) nerve pain and inhalers used for chronic obstructive pulmonary disease. Treatment for the event included blood thinners. Based on the current available information and temporal association between the use of the product and the start date of the event vaccination site pain, a causal relationship cannot be excluded. Very limited information regarding the events loss of consciousness, dizziness, and pulmonary embolism has been provided at this time. However, the patient's underlying medical conditions remains as confounders. Further information is not expected.; 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 vaccination site pain, a causal relationship cannot be excluded. Very limited information regarding the events loss of consciousness, dizziness, and pulmonary embolism has been provided at this time. However, the patient's underlying medical conditions remains as confounders. Further information is not expected.

Felt fine first few hours 9pm Fri felt headache went to bed early Felt fine 12:10 midnight Monday sharp pains in chest took over counter advil and then took sleep aide- still had sharp pains 4:00am really hard to breathe- started to drive self to ER- could not make it - half way called for ambulance Oxygen level 61 when EMS arrived In ER Chest xrays and mouth xrays show double clot in lungs In hospital with IV and breathing treatments til Wed.

PT RECEIVED VACCINE 6/8 AND EXPERIENCED STANDARD INJECTION SITE SORENESS FOR 2 DAYS. SHE REPORTS BEING FINE UNTIL ONE WEEK LATER, ON 6/15, LATE IN THE DAY SHE DEVELOPED A SMALL BUMP AT THE INJECTION SITE. ON 6/16 (WED) HER ENTIRE ARM WAS SWOLLEN/INFLAMMED AND WARM TO THE TOUCH. SHE WENT TO ER AND WAS ADMITTED TO HOSPITAL AND TREATED FOR MULTIPLE BLOOD CLOTS. PATIENT REPORTED REACTION TO PHARMACY ON 6/17 AND WAS STILL IN HOSPITAL ON IV ANTICOAGULANTS. SHE IS POTENTIALLY GOING TO BE DISCHARGED ON 6/18 PER PATIENT.

Developed severe headache day after vaccine received. 2 days later developed left leg weakness, numbness and tingling. Went to ER and was admitted to hospital, diagnosed with right parietal parasagittal IPH.

Developed severe headache 1-2 days after vaccination. Then on day 3 developed left leg weakness, numbness, tingling. Patient admitted to hospital and diagnosed with Right parietal parasagittal IPH.

May 14th I found a blood clot on my thumb near the metacarpal joint. It was red, swollen and painful to bend. 3 days later on May 17th I developed a new blood clot on my index finger PIP joint. I went to urgent care who sent me to the ER to make sure I did not have a DVT in my arm. Prior to this I have NEVER had any issues with blood clots. I did not injure my hand in anyway either. They did an xray and ultrasound which did not show any injury or DVT so they sent me home and told me to follow up with primary care.

DVT and pulmonary Embolus. Other risk factors exist (recent surgery, OCP, immobilization (driving and work). Second Vaccine in series given on 05/18/2021

2nd dose COVID Moderna vaccine given 5/4/21 (1st dose on 4/6/21), admitted on 6/28/21 w/ DKA and E.coli bacteremia, found to also be COVID+ via PCR. CXR showed infiltrates, but patient only with minimal respiratory impairment (up to 2L NC for a couple of days). Patient was admitted to ICU, but due to other illnesses (not respiratory infection).

hives breaking all over her body; rash; About one and half hour later she started to have symptoms of anaphylactic reactions; some trouble breathing; complained of dry throat; This spontaneous case was reported by a pharmacist and describes the occurrence of ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Latex allergy, Penicillin allergy, Drug hypersensitivity (Morphine), Drug hypersensitivity (Vicodin), Drug hypersensitivity (Oxycodone), Drug hypersensitivity (Azithromycin) and Drug hypersensitivity (Anaphylactic reaction to IV Benadryl). On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions) (seriousness criterion medically significant), DYSPNOEA (some trouble breathing) and DRY THROAT (complained of dry throat). On an unknown date, the patient experienced URTICARIA (hives breaking all over her body) and RASH (rash). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) (oral) on 21-May-2021 for Anaphylactic reaction, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (About one and half hour later she started to have symptoms of anaphylactic reactions), DYSPNOEA (some trouble breathing), DRY THROAT (complained of dry throat) and URTICARIA (hives breaking all over her body) outcome was unknown and RASH (rash) had 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. Concomitant products were not provided/unknown. Patient was issued a box of Epipen used as needed. Rash on her body took three weeks to clear. Company Comment : This case concerns a 42-year-old female with a serious unexpected event of anaphylactic reaction, and nonserious dyspnea, dry throat, urticaria, and rash. Event latency 1.5 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 42-year-old female with a serious unexpected event of anaphylactic reaction, and nonserious dyspnea, dry throat, urticaria, and rash. Event latency 1.5 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Very heavy vaginal bleeding, it was a whole lot of blood; Very Tired; weak; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Very heavy vaginal bleeding, it was a whole lot of blood) in a 42-year-old female 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. The patient's past medical history included Anaemia. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced ASTHENIA (weak). On 17-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Very heavy vaginal bleeding, it was a whole lot of blood) (seriousness criteria hospitalization and medically significant) and FATIGUE (Very Tired). The patient was hospitalized from 24-Jun-2021 to 26-Jun-2021 due to VAGINAL HAEMORRHAGE. The patient was treated with TRANEXAMIC ACID on 23-Jun-2021 for Vaginal bleeding, at a dose of 1 dosage form and Surgery (hysterectomy) for Vaginal haemorrhage. At the time of the report, VAGINAL HAEMORRHAGE (Very heavy vaginal bleeding, it was a whole lot of blood), ASTHENIA (weak) and FATIGUE (Very Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's concomitant medications were not reported. On 02-Jun-2021, the patient had her normal period and was not pregnant at the time of the report. On 17-Jun-2021, the patient called her gynecologist and made an appointment for 06-Jul-2021 to do an ultrasound. On 23-Jun-2021, Wednesday, the patient stated that she could not wait to see the doctor and went to the emergency room at night. It was reported that the patient was discharged at 2 am, as the bleeding stopped for a little bit. On 24-Jun-2021, Thursday morning, the patient woke up with whole lot of blood and went to her obstetrician/ gynecologist (OBGYN). The patient's OBGYN could not believe the amount of blood patient had lost and stated that if the patient had lost any more blood, she could possibly have died as the patient's blood was so low. The patient was hospitalized, and an emergency hysterectomy was performed. On 26-Jun-2021, the patent was discharged from the hospital. It was reported that the patient's second shot was due on 30-Jun-2021. Company comment: This case concerns a 42-year-old female hospitalized with a serious unexpected event of vaginal hemorrhage, and nonserious asthenia and fatigue. Event latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-jun-2021 contains significant information regarding seriousness and surgery, medical history and event details.; Sender's Comments: This case concerns a 42-year-old female hospitalized with a serious unexpected event of vaginal haemorrhage, and nonserious asthenia and fatigue. Event latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Feeling flu like ill/body aches/fatigue? 7 days Fever of 101f - 24 hours Headache - 4 days Stroke - 3/8/2021

Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine. Clinically suspicious for ITP.

Several minutes after receiving Moderna COVID-19 vaccine, patient's face started to become flushed, swollen, and she had trouble breathing. This anaphylaxis reaction started at 3:40 PM . First dose of epi was given at 3:43 PM. After first dose of epi was given, patient's breathing normalized and swelling was reduced. EMS was called during this time period. At 3:49 PM, patients lips and mouth started to swell and patient couldn't breathe. At 3:50 PM, a second epi pen was given and patient could breathe easier. EMS arrived shortly after and was taken to emergency room.

Had analphylaxis reaction 5 minutes after recieving COVID vaccine at 0916. She was having wheezing, tightness of throat, and difficulty breathing, nausea. She was treated with Albuterol inhaler followed by self injecting epipen at 0925 with improvement subsequent respiratory distress She was given supplememental oxygen and code team was called and arrived within 3 minutes. IVs started and given IV benadryl 50 mg and IV solumedrol 125mg @0941. She continue to be in respiratory distress and 2nd dose of epipen at 0946 was administered. She continue to revert back to anaphylaxsis, She was adminstered 3rd epi injection at 0958 am administered by the paramedics and transported to Hospital.

Anaphylaxis. 2 minutes after injection I developed tingling of lips and tongue. 5 minutes after I couldn't speak well and developed a cough. 10 minutes after ER doc gave me pepcid 20mg and zyrtec 10mg. Cough and shortness of breath started and tongue swelling. I was then taken back to an area with team including ER doc and 2 nurses. Given benadryl liquid and ultimately epi injection. Called Ambulance and taken to Hospital where I was given more benadryl IVP, ativan, and monitoried for 8 hours. Pruritic, congestion, and difficulty talking since day of shot. this is day 2 after injection

Took vaccine on 1/21/21. Symptoms on 1/23/21 included widespread rash, lips swelling, hives, dizziness, trouble breathing. Received epinephrine, steroids, benadryl. Diagnosed with acute anaphylaxis due to possible allergy to Polyethylene Glycol

During the 15 minute observation following the 1st Moderna vaccine dose, the patient reported her tongue 'felt thick,' flushed skin, redness on face, neck, hands, BP=98/60, HR=100. Patient felt 'jittery' and 'heart racing.' Was transferred to ED for evaluation given that patient reported her tongue 'getting tighter.' In the ED, the patient was treated with diphenhydramine 25mg x 2 doses, methylprednisolone 125mg x 1 dose, famotidine 20mg x 1 dose, and NS IV fluids. Hypoglycemia was ruled out with CBG=87. The physician avoided treatment with epinephrine due to it being listed on her allergy list with a reaction of 'shortness of breath.' Symptoms resolved over the next 3 hours. The patient was discharged home with a new prescription of oral prednisone taper. Subsequent follow-up with her primary care provider, in consultation with an ID provider, recommended that this patient NOT get a 2nd dose. Covid-19 vaccine was added to her allergy list with a reaction of 'anaphylaxis.'

developed fever and chills within 24 hours of vaccine and at 4 weeks out had unprovoked acute DVT in the axillary and subclavian vein on the side of the vaccine.

30 min post-injection the following anaphylactic reactions occurred; swelling of tongue, difficulty swallowing, swelling in face focused under my eyes. No medication was taken for these symptoms. Around 3 hours post-injection the reactions began to dissipate with full resolution by 4 hours post-injection.

I got a little dizzy while walking to my seat. I got a rush of adrenaline and my heart rate shot up. I went and sat with the paramedics and they took my BP, but it wasn't considered abnormal. They walked me outside and I felt better. I had some splotches under my throat, but that happens sometimes when I get upset. There was no swelling or anything and it resolved within 25 minutes. That night, I had a 101 temp, was really cold and just generally felt crummy. The following Thursday, I was using ammonia and couldn't smell it. My son complained of being cold that night, which isn't normal for him. We got tested the next day and we both were positive for COVID. I had an exposure on Jan 12, but didn't find out until I called my boss and she told my coworker had it. I was sick for another 10 days, but was never hospitalized. I had a Chest x-ray done on 1/31 and I had developed pneumonia. I got my 2nd dose on Feb 19th. I experienced basic symptoms along with residual tightening in the chest and fogginess, but I think that was because I had just had COVID. About 36 hours later, I was back to normal.

Sore arm at injection site, extreme fatigue, sudden onset uncontrolable menstrual bleeding & blood clots, felt faint & had some blurred vision. Heavy bleeding & heavy clotting continued until next morning (I have not had any issues with my cycle since my surgery last year so this was not normal). Woke up with fever of 100.7 Saturday morning at 4:57am; fever did not go away until Saturday 8:45pm. Had flu-like symptoms, fatigue, fever, chills, intense all over muscle soreness. Felt better & symptoms were gone by Tuesday 03/02/2021. Menstrual cycles went back to normal following month after 2nd vaccine.

sunday I had my face start drying up and all my joints hurt. today the dermatologist said its part of my original anaphalactic reaction

Complained of throat discomfort and swelling. Speech became slurred and slow responsiveness to questions. Anaphylactic reaction: throat swelling. Benadryl 50 mg given IM. Epipen given. Symptoms improved with Benadryl and Epinephrine. Patient became more responsive and alert. She was transported to ER via ambulance for further evaluation and monitoring.

Fever, malaise , body aches, headache, foggy memory, fast heart rate lasting more then a week and progress worse each day diagnosis with sepsis in the hospital

New onset DVT/PE blood clots. Diagnosed after patient had new onset right calf pain and cramping about 9 days after receiving second Moderna COVID vaccine, came to hospital had an ultrasound which showed clot, then had CTA chest which confirmed pulmonary embolism (both done on 4/7/2021). She has no other known risk factors for thromboembolism, however a hypercoagulability work-up is also underway and will not be completed for several months.

Have had tiredness since 2nd vaccine in February and noticed shortness of breath when walking or going up stairs in mid March. Around 4/1, I started having left rib pain preventing me from sleeping on my left side and then could not breath during a massage on 4/8. On April 9th, I was diagnosed with multiple pulmonary embolisms (clots) in both lungs, reducing my lung capacity to only 30% of normal. This could be due to Loestrin birth control but I have taken hormones in the past for IVF and when younger for birth control. The reaction may be due to a combination of vaccine, Loestrin and iron but triggered by vaccine. I am currently on Eliquis to treat pulmonary embolisms.

Pt's symptoms started 01/01/2021. Started with LUQ pain. Her symptoms progressed 01/04/2021. Developed SOB,. fatigue, aches. She went to the LMH ER that day. Imaging showed pneumonia and PE. Started on Elliquis, referred to Hematology.

oropharyngeal pain; chest soreness; coughing; gagging; Gastrointestinal upset; oedema; shortness of breath; fatigue; joints hurt; nausea; headaches; pneumonia; Occasional shortness of breath at rest; Occasional palpitations; Weight increased, weight was up approximately 10 pounds; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) and DYSPNOEA AT REST (Occasional shortness of breath at rest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products TREPROSTINIL DIOLAMIN for Secondary pulmonary arterial hypertension, TREPROSTINIL DIOLAMIN (ORENITRAM) for Secondary pulmonary arterial hypertension and RIOCIGUAT (ADEMPAS) for an unknown indication. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included APIXABAN (ELIQUIS). On 21-May-2020, the patient started TREPROSTINIL DIOLAMIN (Oral) 4 mg every eight hours. On 21-May-2020, TREPROSTINIL DIOLAMIN (Oral) dosage was changed to 1 mg. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) at an unspecified dose On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to at an unspecified dose. and RIOCIGUAT (ADEMPAS) (unknown route) 1.5 mg. On 08-Feb-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). In February 2021, the patient experienced DYSPNOEA AT REST (Occasional shortness of breath at rest) (seriousness criterion medically significant), WEIGHT INCREASED (Weight increased, weight was up approximately 10 pounds), DIZZINESS (Dizziness) and PALPITATIONS (Occasional palpitations). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (oropharyngeal pain), CHEST PAIN (chest soreness), COUGH (coughing), RETCHING (gagging), ABDOMINAL DISCOMFORT (Gastrointestinal upset ), OEDEMA (oedema), DYSPNOEA (shortness of breath), FATIGUE (fatigue), ARTHRALGIA (joints hurt), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA AT REST (Occasional shortness of breath at rest), WEIGHT INCREASED (Weight increased, weight was up approximately 10 pounds), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Gastrointestinal upset ), DYSPNOEA (shortness of breath) and HEADACHE (headaches) was resolving, OROPHARYNGEAL PAIN (oropharyngeal pain), CHEST PAIN (chest soreness), RETCHING (gagging), PALPITATIONS (Occasional palpitations), FATIGUE (fatigue), ARTHRALGIA (joints hurt) and NAUSEA (nausea) outcome was unknown and COUGH (coughing) and OEDEMA (oedema) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: 170 lb (High) Weight gain of 7 pounds. In March 2021, Weight: 164 lb High. In 2021, Weight: up approximately 10 lbs High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Prescribed levofloxacin antibiotic for 7 days for pneumonia. The patient did not need to use oxygen as often. Reporter did not allow further contact; Sender's Comments: This case concerns a 44-year-old female with serious unexpected events of pneumonia and dyspnea at rest, and nonserious unexpected dyspnea, chest pain, cough, oropharyngeal pain, retching, abdominal discomfort, palpitations, dizziness, edema, weight increased and expected fatigue, headache, nausea, arthralgia. 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.

3/2 - Received the first round of Moderna vaccination. No immediate side-effects noted. I talked with my physician prior to getting the vaccine due to medical conditions and medications that I am taking. I was taking Xarelto due to chronic DVT/Blood clots in my left leg. After 2.5 weeks I noted my left leg was swelling and I started to have discomfort in my leg. No noticeable changes to my leg at this time that made me concerned about getting the second vaccine. 3/30 - I received my second vaccination in the morning. I ended up going into the hospital at 4 pm due to numbness and pain in my left leg. I ended up being admitted to the hospital due to a DVT behind my L knee and in my femoral/iliac veins. I was also diagnosed with May-Thurbers syndrome. All the physicians, hematologists, and surgeons were surprised that I ended up with a severe blood clot as I was on Xarelto for over two years without an incident or problem. I did not have a fall or any change in my life that would have caused this issue to happen and they were all stumped. I was switched to a heparin drip while Xarelto was clearing out of my system and in two days I had two stints put in my femoral/iliac vein on my left leg. I was changed over to Lovenox and Coumadin 5-7.5 mg before leaving the hospital. There were no concerns and I was in the hospital from 3/30 to 4/3/21. After I was discharged from the hospital I went to my primary care follow up on Tuesday 4/6/21. I was having increased pain behind my knee and overall not feeling well. I ended up having more labs completed and another ultrasound to indicate I had a small DVT behind my knee from my procedure. On Friday 4/9/21 I went in for my INR and found my coumadin was within therapeutic range. When I got home I changed into comfy clothing and noted that I had a red/purplish rash looking dots/bumps from my toes to my knees on both LE, my Left was more significant than my right. I went back into the doctor and I was prescribed a topical steroid to help decrease the edema, pain and redness. Saturday 4/10/21 - my legs became painful to the touch, they felt like they were going to burst due to pressure, and the rash/reddness was looking worse and spreading. I was sent back to the ER and was admitted back to the hospital. They diagnosed me with heparin-induced thrombocytopenia, removed me off of coumadin, and started me on Arixtra. The hematologist, physicians and staff did not know what to do and I was now deemed medically complex and had to be monitored for a few days and gave me prednisone. Once removed from coumadin the rash/pain/swelling subsided and started to diminish. I was discharged from the hospital. I returned to work on Tuesday 4/13 and after returning home I had increased pain, pressure and rash that now was visible from my knees to my hips and this was not present in the hospital. My physician is asking for a biopsy and increased my prednisone to stay at 20 mg a day. At night I have to elevate my legs or they become swollen and will become painful. 4/16/21 I wore compression tights per physician guidelines and when I came home from work I had new spots and rashes on my feet, they were swollen and had increased pain. My left ankle had a rash on it as well. After elevation and a nights rest the rash started to diminish and the rest of my legs have started to diminish or disappear.

Probably unrelated but I am on day 3 of my normal menstrual cycle (typically 5-7 days). Approximately 2 hours after receiving the vaccination I began passing large clots and my flow went from regular to heavy. I do have heavy cycles from time to time but found the abrupt change in cycle interesting. Other than being sore in the arm and tired I feel fine.

Hospitalized with cerebral venous sinus thrombosis from 1/26/2021-1/29/2021. Presented with severe headache. Treatment included anticoagulation initially with heparin infusion, followed by oral anticoagulation with Eliquis. She required prescription medications for management of headache. Discharged home with ongoing headache.

Sore arm from shoulder to bicep same day. Soreness still present 4 weeks later? still present. Cold symptoms next day lasting about 3-4 days. Extreme fatigue starting that evening and still present. Leg pain about 12 days following vaccine? still present. Massive DVT groin to ankle diagnosed in hospital 18 days after vaccine? still present.

43-year-old female with past medical history of breast cancer (on chemo), hypertension, GERD, and obesity, fully vaccinated for covid 19 as of 3/23/2021 who presented on 4/20/2021 with fever, chills, cough for 3 days and covid 19 pcr positive with CT chest with b/l pneumonia. Was diagnosed with breast cancer in January and was on week 3 of a 3-month cycle of chemotherapy with taxol. She required oxygen during her hospital course for hypoxia of 79% and was discharged home on it. she received remdesivir and decadron. she was not a candidate for regeneron or toci. Her hospital course was protracted due to pneumonia, refractory diarrhea, nausea, vomiting , fatigue, poor po and anemia. she needed 2 units of blood. She was discharged home 4/26 on oxygen. Further chemo on hold till she fully recovers.

On April 16th I was weight training when my R arm became suddenly painful and heavy feeling. A few hours later I noticed my arm had gotten very swollen and blue. I went to urgent care and was sent for an US. It showed a large clot in my internal jugular vein as well as clots in my R subclavian, axillary, brachial, proximal cephalic, and proximal basilic veins. They sent me to ER and did a CT and also found a small PE in my L lower lobe pulmonary artery. Currently I am on enoxaparin and very limited in use of my R arm. The cause of my clots remains unknown. I am waiting on blood tests to see if I have any genetic factors. It seems unlikely that this is tied to the vaccination but I wanted to report in case there end up being similar cases.

4/7/21 around 630pm began to feel ill and had sore arm. By about 1030pm, had significant body aches, headache, clammy skin, vomiting, diarrhea, near passing out, fast heart beat, with fever. These symptoms lasted about 48 hours. The next 48 hours just had ill feeling with extreme fatigue. Come 4/12/21, I had nausea, headache, fever of about 100.4 and body aches. By 4/14/21, I ended up going to the ER for shortness of breath, chest tightness, extreme fatigue and voice hoarseness. Those doctors performed several labs to include Chest CT which showed elevated D-Dimer levels. An EKG was performed which was baseline. Ultrasound of my veins was performed. They also did a COVID test which was negative. They sent me home and told me to rest and drink lots of fluid. On 4/16/21, I had a video call with my doctor who didn't like the sound of my voice and straining to catch my breath and I was sent to urgent care/ER. They admitted me as an ER visit due to my continued shortness of breath, cough, sore throat, night sweats, dizziness, chest tightness along with my voice being hoarse. Another COVID test was performed and was negative. During their exam, my oxygen levels were dropping into the low 80s and my heart rate was in the 120s and 130s. Their CT scan was down so they sent me to another ER where another CT scan was performed. Another COVID test was performed and was negative. My D-Dimer was elevated, liver enzymes was slightly elevated and again my oxygen levels were lower than would like to see and elevated heart rate. I ended up being admitted into the hospital for an overnight stay to monitor my symptoms. They treated me for suspected blood clot, shortness of breath, chest tightness. I was given 2 shots of heparin in the stomach, IV fluids, multiple vitamins in attempt to boost my immune system, along with ADVAIR and Albuteral. My discharge diagnose from the hosptial was Acute Bronchitis, Anxiety disorder, Recent Moderna 2nd dose COVID vaccine with significant side effects in the form of fever, generalized weakness and dizziness.

This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID-19 pcr positive), PNEUMONIA (B/l pneumonia), HYPOXIA (Hypoxia), DIARRHOEA (Refractory diarrhea), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), HYPOPHAGIA (Poor po) and ANAEMIA (Anemia) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. patient is on chemotherapy (taxol for chemo)for breast cancer once a week. Concurrent medical conditions included Breast cancer (on week 3 of a 3-month cycle of chemotherapy with taxol), Hypertension, Depression, GERD, Drug allergy (allergic to clindamycin) and Obesity. Concomitant products included TAXOL for Chemotherapy, BUPROPION and TRAZODONE for Depression, OMEPRAZOLE for GERD, AMLODIPINE BESILATE (NORVASC) and LISINOPRIL for Hypertension, SENNOSIDE A+B (SENNA [SENNOSIDE A+B]) for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced COVID-19 (COVID-19 pcr positive) (seriousness criterion hospitalization), PNEUMONIA (B/l pneumonia) (seriousness criterion hospitalization prolonged), HYPOXIA (Hypoxia) (seriousness criterion hospitalization), DIARRHOEA (Refractory diarrhea) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization prolonged), VOMITING (Vomiting) (seriousness criterion hospitalization prolonged), HYPOPHAGIA (Poor po) (seriousness criterion hospitalization prolonged) and ANAEMIA (Anemia) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion hospitalization prolonged). The patient was hospitalized until 26-Apr-2021 due to COVID-19 and PNEUMONIA. At the time of the report, COVID-19 (COVID-19 pcr positive), PNEUMONIA (B/l pneumonia), HYPOXIA (Hypoxia), DIARRHOEA (Refractory diarrhea), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), HYPOPHAGIA (Poor po) and ANAEMIA (Anemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood culture: negative (Negative) Negative. In April 2021, Computerised tomogram thorax: b/l pneumonia (abnormal) b/l pneumonia and negative for pe (Negative) Negative for PE. In April 2021, Influenza virus test: negative (Negative) Negative. In April 2021, Legionella test: negative (Negative) Negative. In April 2021, Oxygen saturation: 79 % (Low) low requiring oxygen. In April 2021, SARS-CoV-2 test: positive (Positive) Positive. 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 required oxygen during hospital course for hypoxia and was discharged home on it. Patient also needed two units of blood for anemia. Patient was not a candidate for regeneron or toci. Company comment :This case concerns a 43-year-old female hospitalized with serious unexpected events of COVID-19, pneumonia, hypoxia, diarrhea, nausea, vomiting, hypophagia, anemia and fatigue. Event latency 29 days from first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 43-year-old female hospitalized with serious unexpected events of COVID-19, pneumonia, hypoxia, diarrhea, nausea, vomiting, hypophagia, anemia and fatigue. Event latency 29 days from first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Pulmonary Embolism. I saw her in clinic 6 days after her second dose. She had started feeling increasingly short of breath starting day 1 post 2nd dose. Vitals were stable, CXR and labs done. D-dimer 2020, sent to ER, CTA done and dx made. Started on outpatient Eliquis and was DC'd from ER hemodynamically stable.

Severe rash covering scalp, face, neck, chest all the way down the body that got worse every day, despite being on Zyrtec daily, and then taking benedryl every 4-6 hours. Rash continues to spread over even more of the body. Is red, slightly raised. My entire body burned and itched, even on benedryl, creams to stop itching. Body temp of 99.6. Started getting blood clots when blowing nose starting Thursday morning. Rash was even inside my ears. Was worst 72 hours after 2nd dose, and has gotten a little bit better each day. Still have mild rash and itching even 1 week after shot.

Day 15 post-vaccination, woke up with a vaginal bleeding similar to menstruation. It was very heavy, lasted 6 days, and I was passing clots. No medical help was needed or sought, but it was uncomfortable. I am in premature menopause and do not menstruate. I take HRT. Following my first Moderna shot, I had a very similar bleeding as well, starting the morning after. I have not had any vaginal bleeding following these two (after the first and second Moderna shot). Besides these effects, within hours of this second dose, I was feeling tired. I woke up the next morning with body aches similar to that of influenza, a temperature of 99.5, which is quite elevated for me, and overall tiredness. These symptoms resolved by next morning, when I woke up with a throbbing headache. It resolve following one dose of 200mg generic ibuprofen.

Mild pain in the injection site. Ovarian cramps and discomfort starting at 11 pm (vaccine administered around 3 pm the same day). Woke up the next morning with a vaginal bleeding resembling a period. I am in premature menopause and do not menstruate. I also take HRT for my menopausal symptoms. The bleeding lasted 6 days, just like my period would have.

Patient received her 2nd COVID vaccine on 4/22/21; patient was seen at Hospital on 5/3/21 for leg swelling and pain; patient seen at Hospital by NP on 5/6/21 for hospital follow up appointment with continued leg swelling and calf pain; patient was confirmed to have an acute DVT in her lower left leg (patient does have a history of a prior unprovoked DVT more than 10 years ago)

PATIENT CAME TO THE PHARMACY WITH SWOLLEN LIPS AND END UP HAVING ANAPHYLATIC REACTION AND BLOOD CLOT

Patient presented with 3-4 days of increasing shortness of breath/chest pain. Was found to have a pulmonary embolism. started on Heparin drip, transitioned to apixaban after 24 hrs and DCed home

Bad case of Pneumonia; Acute bronchitis; lost her voice from coughing so much; Voice is very hoarse; Diarrhea because of the antibiotics; lost her voice; Sometimes coughs so hard she vomits; experienced fatigue (immediately after vaccine); This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Bad case of Pneumonia) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ex-smoker (It was reported that the patient quit smoking and had a patch.). Concurrent medical conditions included COPD and Hypertension. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Bad case of Pneumonia) (seriousness criterion medically significant), BRONCHITIS (Acute bronchitis), COUGH (lost her voice from coughing so much), DYSPHONIA (Voice is very hoarse), DIARRHOEA (Diarrhea because of the antibiotics), APHONIA (lost her voice), POST-TUSSIVE VOMITING (Sometimes coughs so hard she vomits) and FATIGUE (experienced fatigue (immediately after vaccine)). At the time of the report, PNEUMONIA (Bad case of Pneumonia), BRONCHITIS (Acute bronchitis), COUGH (lost her voice from coughing so much), DYSPHONIA (Voice is very hoarse), DIARRHOEA (Diarrhea because of the antibiotics), APHONIA (lost her voice), POST-TUSSIVE VOMITING (Sometimes coughs so hard she vomits) and FATIGUE (experienced fatigue (immediately after vaccine)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Chest X-ray: Results unknown. In May 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PNEUMONIA (Bad case of Pneumonia), BRONCHITIS (Acute bronchitis), COUGH (lost her voice from coughing so much), DYSPHONIA (Voice is very hoarse), DIARRHOEA (Diarrhea because of the antibiotics), APHONIA (lost her voice), POST-TUSSIVE VOMITING (Sometimes coughs so hard she vomits) and FATIGUE (experienced fatigue (immediately after vaccine)) to be possibly related. Concomitant medications included several unspecified cardiac meds. On an unspecified date, two to three days after the vaccine shot, it was reported that the patient went to the urgent care and was diagnosed with acute bronchitis. Treatment medications provided included Solumedrol (methylprednisolone). 4-5 days later, the patient went to the emergency room and had a chest x-ray- no results provided. The patient was diagnosed with pneumonia. Treatment medications provided included two types of intravenous antibiotics and a prescription for two oral antibiotics and an albuterol inhaler. This report was received from the patient's niece. 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 MOD21-088666 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded MOD21-088666:Invalid Case

I started feeling nausea, extreme flushing of skin, heat radiating throughout body, vomiting, and swelling in throat within 3 minutes of injection. I started to actively throw up and shortness of breath I could feel my throat closing off and was struggling to breath. Within the first 10-15 minutes, I could not breath, swallow, and my body started to contract. I was given epinephrine, steroids, and other medications and emergency services dispatched. I was in Anaphylaxis

Severe anaphylaxis with SOB, angioedema requiring 3 doses of Epipen, 1 dose of Benadryl 25 mg, Solumedrol. Transported to ER and was on Epinephrine drip for 10 hours.

Anaphylactic reaction; Dysphagia; Orbital swelling; Swelling face; Swollen tongue; 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 ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient stated that no treatment medication was taken.; 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.

Disrupted menstrual cycle: Expected June 4th, started spotted on June 1st (possibly a side effect of first dose received May 4). June 1st and morning of 2nd: spotting. - June 2nd - bleeding stopped altogether immediately after 2nd dose received. - June 6th - bleeding started back up 4 days later. - June 7-8 -- extremely heavy bleeding (unusual). - June 9 -- light - June 10 -- nothing (also unusual as my periods usually taper off and last at least 7-8 days) - June 11 -- back up again with a light day (strange). - June 12 -- official end but post-period I did not have the usual ovulation discharge . This was a highly unusual and erratic cycle, that was inconsistent with my typically predictable periods.

I woke up on the morning of 2/25, I was having almost double vision in my eyes and I had a really bad headache. I kept asking my husband and son if I looked okay because I just felt really bad. I thought it was maybe a really bad migraine but I had never had a migraine that bad before. I tried to go about my day and drive my son to school By the time I got him to school I was a lot worse. On the way home I got lost coming home because I could not see anything in my left peripheral vision field. Since I got lost, I approached my house from the left. Coming into my driveway from the left meant I could not see so I hit my husbands truck. I had very choppy movements with my legs. I told my husband something was seriously wrong and when he looked at me my entire left side of my face was drooping At that point we went to the hospital. At the hospital I was brought in as a potential stroke I was given a CAT scan and tons of blood works. I was admitted for observation to monitor my heart because my symptoms were so similar to a stroke. An MRI showed that I did in fact have a stroke. I was given atorvastatin 40mg and 80mg aspirin I was in the hospital about a day. At that time a lot of mobility on my left side came back. My peripheral vision came back extremely slow. When I came home I took the week off from work. I followed up with my PCP and neurologist. The neurologist put me on 243mg aspirin and atorvastatin. Since the stroke I've had a really bad headache. I also followed up with a cardiologist who put a heart monito on me for a month. They could not find anything, so I am to follow up with them in 6 months. At this time I am being treated for chronic headaches/migraine. I have noticed that I have weird carpal tunnel symptoms in both hands. I followed up with a hand specialist who informed me that a lot of patients she's seen have had the same issue. I have never had carpal tunnel before so it is strange for me seeing that I have been out of work since February. It is still unknown as to what caused the stroke. I do not have high blood pressure, I did a normal MRI and then an MRV with contrast to make sure that blood flow to my brain was correct. Everything came back normal. The only thing that was different within that month of February was the vaccine. I also am experiencing short term memory loss but I believe it is more of a stroke symptom rather than it being due to the vaccine. I was taken off of my birth control pills while at the hospital and I am still off indefinitely.

"Moderna COVID-19 Vaccine EUA" Initial mild pain in lower left calf lasting 3 days. Described as "pulled muscle feeling." Dissipated after 3 days. Then, mild, left sided middle back pain that progressively worsened over 3-4 days. Pain eventually felt across entire front and back of chest. Shortness of breath worsened. Difficulty pulling air into lungs and pushing it out. After a total of 5 days from onset of back pain, emergency room visit required.

The patient is a very pleasant 43-year-old female with morbid obesity (167 kilos at 5 foot 6 inches height) and asthma. She is without a prior cardiac history. She has been under significant emotional stress after the unexpected death of her husband approximately 2 weeks ago. She remained medically well, however, until approximately midnight this morning, 06/13/21, when she developed acute onset of chest discomfort at rest. These symptoms were sufficiently severe such that the paramedics were summoned. Her EKG en route was suggestive of anterior ST-segment elevation. However, upon her arrival, her presenting EKG was without significant ST segment changes. Despite the latter and despite aggressive medical therapy, including high-dose heparin, aspirin and Brilinta, at 0215 hours, she developed recurrent severe chest discomfort, as well as new anterior ST-segment elevation on her EKG. In summary, the patient presented with an evolving anterior ST-segment elevation myocardial infarction diagnosed by qualifying EKG at 0215 hours. For this, she underwent successful thrombectomy, angioplasty, and drug-eluting stenting with excellent result both by angiography and by optical imaging.

04/20/2021 developed rash on body. Symptoms off and on. 05/31/2021 patient developed worsening rash 06/02/2021 patient evaluated. Admitted to hospital for ITP. 06/14/2021 patient re-admitted for ITP

On March 8th I was diagnosed with a superficial blood clot. A second clot was identified on April 22nd

Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable. As per the report patient had heart attack after the second dose of the COVID-19 Vaccine however the reporter did not know the manufacturer. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Seizure - Grand Mal; upon my MRI - found I had a stroke - cerebral stroke. I take seizure medications and aspirin for life. I had never had a seizure before. Doctor visit follow up and I have seen two different neurologists.

Patient reported that she received her 1st motor in a vaccination on June 2nd, and then the 2nd vaccination on July 2nd. Patient states that she started having symptoms of significant weakness and lethargy 3 days after her 2nd vaccination. Patient came to the hospital with acute encephalopathy. Symptoms associated with generalized weakness, especially profound weakness in the bilateral lower extremity. Patient reported difficulty with ambulation. Patient also noted to have initial findings of pneumonia-which is treated with IV antibiotics. Multiple specialties evaluate the patient. Workup included lumbar punctures. Abnormal values noted-including elevation in Neuron specific Enolase (NSESF) initially elevated at 53 and then repeat value was elevated at 58. Other organic medical cause was ruled out, and elevation in abnormal levels resulting in acute encephalopathy is thought to be secondary to murder in a vaccination. Per the medical service and including specialists: Interpretation of abnormal CSF fluids from 07/20 and 7/22 of NSESF (with an otherwise negative Neuro Work up) - suggests that this could be secondary to the 2nd Moderna vaccination received on July 2, 2021.

Woke up on 1/6/2021 with hot flashes, palpitations, dizziness and heart racing. Went to urgent care and they did an EKG which showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021. No cause was found and no history of A-Fib or family history.

Anaphylactic reaction, initially unresponsive to IM epinepherine, IV famotidine, IV steroids. Symptoms worsened, requiring intubation, mechanical ventilation, ICU admission

Anaphylaxis, angioedema. Unresponsive to epinepherine, steroids. Patient required intubation, mechanical ventilation, and ICU admission. Patient started on high dose steroids, BID IV famotidine, nebulizer therapy, with improvement in symptoms. Pt still in ICU at time of this submission.

At 6:45AM on 1/19/21 patient developed numbness and tingling on right side of body which progressed to right hemiparesis and right-sided facial droop. Brought to ED by EMS and worked up for stroke. Found to have acute infarct on MRI and treated with dual antiplatelet therapy.

Per summary of primary hospitalist. Pt admitted for acute hypoxic respiratory failure requiring mechanical ventilation secondary to angioedema from Moderna COVID-19 vaccination. Pt presented with a chief complaint of tongue and facial swelling approximately 10 minutes after receiving first dose of the vaccination. She did not respond to Benadryl or IM epinephrine. She was admitted to ICU and intubated. She was started on IVsteroids, famotidine and diphenhydramine. Swelling gradually improved and she was successfully extubated. Her hospital course was complicated by steroid-induced hyperglycemia requiring insulin.

Anaphylaxis: hives all over her body, lightheadedness, throat closing. Hypotension about 2 hours after the moderna was administered.. She received 2 doses of epipen before paramedics took her to the ER.

Anaphylaxis reaction; Angioedema; Shortness of breath; Wheezing; Fast heart rate; A spontaneous report was received from a physician concerning a 44-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylaxis reaction, angioedema, shortness of breath, wheezing, and increased heart rate. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021 at 18:00, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, approximately 10 minutes after receiving her injection, the patient began to have tongue swelling. She was given diphenhydramine and epinephrine by epi pen. She went to the emergency room where she displayed symptoms including a fast heart rate, wheezing, and shortness of breath with an angioedema or anaphylaxis like appearance. She was given more epinephrine, famotidine, scheduled diphenhydramine at 50 QAs intravenously (IV), IV steroids, was intubated and placed on a ventilator. She was on the ventilator for approximately 18-20 hours following admission. She eventually responded to a high dose of dexamethasone. She was also given duonebs for her shortness of breath, regular sedation for the ventilator, and a dose of ketorolac. Consent was given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown at the time of this report.; Reporter's Comments: This case concerns a 44 year old female patient who experienced a serious unexpected event of Anaphylactic reaction. The event occurred approximately 10 minutes after first dose of the study medication administration. She was treated with epinephrine, famotidine, diphenhydramine, IV steroids, intubated and placed on a ventilator. 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.

First I got a headache, then I felt extra mucus in my throat. Then I started feeling compression, pressure, and pain in my diaphragm; and then the middle of my chest. Finally, I started coughing, and I wasn't able to breathe. I had told all of the nursing staff that I had anaphylaxis to the first shot, but they acted like they didn't believe me. Also, there was no EMS staff on hand this time, unlike the first time, where they were on site. I think that made the difference in my medical care, because my husband heard the nurses at the facility say they were treating me for anxiety, not anaphylaxis, despite the fact that I was getting worse. The nurses on staff didn't seem to understand or believe that a person could have anaphylaxis from the Covid injection, even though it's on record at the hospital that that's what happened the first time. It wasn't the same staff as last time, which also contributed to the problem. Once the ambulance staff got there, he took me seriously, and finally administered an EpiPen, and also put me on oxygen, which helped a little bit. that was the most comprehensive care I got that day, from someone who was actually listening to me he also took an EKG, which which was normal. When I got to Facility, the treatment wasn't as good as last time, either. Apparently they've been really busy the day before, and all of the staff seemed fatigued because of it. Nobody really checked on me, offered me even ice chips to moisten my mouth, and didn't offer me any assistance in getting to the bathroom, either. a respiratory therapist came in to give me a couple puffs on an albuterol inhaler, and I got a Benadryl shot, but nothing else. I think if I had not taken my coterie of prescriptions to stave off anaphylaxis, it would have been worse. 20 minutes before the shot I took: two aspirin, a CBD capsule, and one each of the following pills -cetirizine, benadryl, famotidine, 20 mg of prednisone, hydroxyzine. I think that's what enabled me to recover with only one EpiPen, instead of two, like last time. if there's a third Moderna shot for the varients, or a booster, I'll try to take all those pills an hour beforehand, and see if having them in my system for a longer period of time we'll make the difference. It will be nice to have *no* anaphylaxis, and skip the hospital trip . Since then, it's taken me about a week to recover fully, the same as after the first shot. I've had problems breathing, fatigue, muscle aches and pains, flushing, fever/chills, and in general just felt like I had the flu.

Middle of the first night following the administration of the vaccine, I woke up with notable lower back and hip pain that became increasingly severe over the next 7 days. On Days 5-Day 7 I also developed a rash on my torso and chest. Did not itch or cause discomfort and resolved within days of onset. By the end of the week, I was literally forced to lay flat on the floor all day. I was completely floor-ridden Day 7-Day 10 . Pain was predominantly on the lower right side, hip, glute, thigh...had some tingling on top of right foot. This pain most definitely interfered with my daily routine. Could not get comfortable, could not exercise, could not sleep well. I eventually took my meals on the floor....only up to use restroom and shower. From Day 10- Day 12 things very slowly started to improve with complete resolution by the 2 week mark. It was as if the shot caused my muscles to spasm so badly that my back was thrown completely out? Or I had some kind of systemic inflammatory process that triggered my low back pain? I NEVER suffer from this kind of debilitating back pain . Typically hike 3- 5 miles per day. Was extremely bizarre timing and perhaps it was a coincidence? However the sudden onset of this issue in conjunction with the timing of the shot seemed important. I was able to treat pain with Tylenol, muscle relaxers, and lots of rest.

Began having noticeable muscle pain in my chest in the first part of 2/2021. I continued to think it was just muscle pain. Symptoms worsened with severe sharp/stabbing pain with movement and breathing that radiated to my back. Went to the emergency room 3/7/2021. Dx of multiple small pulmonary artery webs that may represent sequela of pulmonary thromboembolism. There is also a 2 mm nodule in lower R lobe of lung. Eliquis dose increased to 10 mg BID x 7 days then decrease to 5 mg BID.

Anaphylactic Reaction. Tightening of throat, coughing, difficulty breathing, confusion. Given epinephrine hci, diphenhydramine, famotidine, solumedrol, ipratropium-albuterol

The patient had an anaphylactic reaction. The patient experienced angioedema and could not speak. The patient presented with difficulty swallowing, shortness of breath, wheezing, and was unable to talk. As a result to the reaction the patient had to be intubated. However, the patient has a history of excessive anaphylaxis with multiple intubations.

Lost control and feeling of my right leg and right arm for approximately three minutes. Started with tingling and then no feeling or control of them. I had blurry vision and was disoriented.

Pt presented on 3/27 with 1-2 days of rash, increased bleeding at site of scabs, and bruising with hematoma, and petechial rash. Platelets <1, and concern for ITP. Undergoing workup inpatient.

patient received 2nd dose of Moderna on 3/13/2021; reported by Police Department as having passed away on 3/14/2021. No other details available.

patient received dose #2, then had a total of 5 ED visits for dyspnea and other symptoms including overnight admission. patient with bilateral, sub segmental pulmonary emboli. no prior history of PE, is a long distance runner. received at outreach clinic due to being a teacher

anaphylactic reaction - angioedema of tongue and pruritis of face. treated with epi, Benadryl, pepcid, steroids.

Fevers, unable to move arm, chills, nausea, fatigue, migraine. I had my menstrual cycle over 1 1/2 week ago. This week no menstrual cycle. Started bleeding vaginal today in the midst of the adverse symptoms. I got scared. Called my dr no literature about bleeding . Just one study of women reported menstrual bleeding after shot. Is this a side affect and will this affects me long term

Significant swelling at base of skull with severe headache starting 11 hrs after vaccination. Superficial swelling of vein on left forearm started 46 hrs after vaccination in left upper arm. This vein had a clot that proceeded to swell and burst causing significance pooling of blood with tracking on inside of L forearm. Left arm remains warm and throbbing.

Severe inflammatory response in arm that has lead to Frozen Shoulder diagnosis. Limited Range of Motion. Now attending physical therapy to regain strength in arm & range of motion

When given the second dose of the moderna vaccine the nurse slipped and jabbed my arm very hard. My arm started bleeding a lot. She commented, " You are really a bleeder". I'm not actually. My arm was instantly sore. I bruise developed within a day and lasted about 3 weeks. I have had constant arm pain since. Unable to have full range of motion, sleep on the left side, and OTC medication does not stop the constant pain.

Note that this patient is an employee of the facility where the vaccine was administered. Five minutes after injection on 3/31/2021, c/o chest tightness followed by nausea and heaving. Treated for anaphylaxis, transferred by ambulance to Medical Center; and discharged to home later that afternoon. The employee worked her regular schedule 4/2/21 and 4/5/21 with no stated complaints. On 4/6/21, received notification from the Employee that she was to be off work through 4/12/21 as her physician feels that the vaccine has damaged her heart. She states she has a heart rate down to 38 BPM, experiences black outs, has left sided head pain and weakness. Her personal physician is scheduling her for Holter Monitor and Echocardiogram. Her physician has now stated she cannot work through 4/16/21. I have no supporting written documentation from the physician for these medical concerns.

About 10 minutes after vaccination- developed numbness on left side of face. Resolved within 15 minutes. Intermittent over next 2 months. On Jan 12- noted new lymphadenopathy left supraclavicular region into left axillary. On Jan 16- left hand became dusky/ blue- seen in ED. Abnormal Allen?s test, CTA left arm no occlusion. New diagnosis HTN and EKG with intermittent a fib/ a flutter. Subsequently seen by PCP (new HTN), Vascular (tests normal), Neuro (left arm EMG) and cards EP (28 day monitor pending). Symptoms of left face numbness and arm numbness persisted through January. Resolved by mid Feb. in addition, was started on HCTZ for HTN with new SBP max 160s and DBP 100s. By March, SBP down to 100s and HCTZ stopped. BP since normal. No recurrence of face or arm numbness. Persistent left supraclavicular LAD , although decreased since January.

Profound weakness, shortness of breath, saddle pulmonary embolism diagnosed by CT angiogram at healthcare facility on 4/.5/2021.

Several hours after receiving the second vaccine, I started having a dull ache in my chest. By morning, it went away. 7 days later it came back and was consistent. I went to the ER after 5 days of consistently having a dull ache in my chest. On March 12th, I had a CT scan of my chest and the result was as follows: Pulmonary Embolism: a filling defect along a branch point of a right lower lobe segmental pulmonary artery with decreased opacification of the distal subsegmental pulmonary arteries at this location.

The day after her first Moderna COVID-19 shot (3/14/2021) she developed groin pain that lasted for about 2 days before going away, but then on 3/16/2021 she developed Chest Pain in her mid-chest and associated shortness of breath which did not go away, so she went to the emergency room on 3/17/2021 and was diagnosed with a Pulmonary Embolism. (I assume the groin pain was cause by a blood clot in her upper leg that moved up into her lungs.)

Small amount of blood clots; Potassium levels dropped; Increased hypertension; dizziness; Arm pain from her elbow to shoulder; Shortness of breath; Blood pressure increased; fatigue; chills; Hear arm was hot to touch; Itchiness; Red circle near injection site the size of a quarter; not to take the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Small amount of blood clots) and HYPOKALAEMIA (Potassium levels dropped) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction. On 15-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 VACCINATION SITE ERYTHEMA (Red circle near injection site the size of a quarter). On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hear arm was hot to touch) and VACCINATION SITE PRURITUS (Itchiness). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain from her elbow to shoulder), DYSPNOEA (Shortness of breath), BLOOD PRESSURE INCREASED (Blood pressure increased), DIZZINESS (dizziness), FATIGUE (fatigue) and CHILLS (chills). On 01-Apr-2021, the patient experienced THROMBOSIS (Small amount of blood clots) (seriousness criterion medically significant), HYPOKALAEMIA (Potassium levels dropped) (seriousness criterion medically significant) and HYPERTENSION (Increased hypertension). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not to take the second dose). At the time of the report, THROMBOSIS (Small amount of blood clots), HYPOKALAEMIA (Potassium levels dropped), PAIN IN EXTREMITY (Arm pain from her elbow to shoulder), DYSPNOEA (Shortness of breath), BLOOD PRESSURE INCREASED (Blood pressure increased), HYPERTENSION (Increased hypertension), VACCINATION SITE WARMTH (Hear arm was hot to touch), DIZZINESS (dizziness), VACCINATION SITE PRURITUS (Itchiness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red circle near injection site the size of a quarter) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not to take the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 01-Apr-2021 patient went to the ER for 2 hours. The HCP at the ER stated she had increased hypertension, potassium levels dropped and there was a small amount of blood clots. Her primary care physician said not to take the second dose. Patient inquired about what she can do to manage her symptoms. Concomitant drugs were not reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information is 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 event, a causal relationship cannot be excluded. However, Further information is requested.

Moderate anaphylactic response - throat closing, tightness in chest. No history of anaphylactic response to vaccines BUT I do have a history with bee stings, sulfa drugs, and the the initial allergy shot from a new, stronger vial. Symptoms remained moderate - I didn?t treat with my epi pen, and eventually took Benadryl and was ok.

Three weeks after my first Covid Vaccine, I began having irregular vaginal bleeding even though I am on Birth control pill. I have been having spotting/bleeding daily since 2/2/21. Second vaccine was on 3/10/21. No history of abnormal bleeding in the past.

Pneumonia that put her in the Hospital. Followed by brain,lung,kidney. & Death after over a month in the Hospital.

patient reports feeling subjective fevers, sore throat, headaches, decreased appetite, and fatigue for at least 2-3 weeks after her first dose; this recurred with the second dose. A blood draw taken less than two weeks after her second dose was significant for leukopenia (WBC down to 3.0) and thrombocytopenia (Platelets to 154) whereas her CBC just 3 months prior had normal indices. Both her WBC and platelets are recovering however she continues to complain of fatigue and decreased appetite since her second dose on 4/23.

Daily bleeding not heavy but enough to have to wear a pad. Have had three half dollar size clots there has been no let up on the bleeding .

with this 1st of 2 shots I began getting a headache that began within 1 hour after the shot. The headache immediately became intense and stayed. Advil did not do anything for it. That same evening I began having intense abdominal pain on my right side, it became so bad I was scared my appendix was going to burst. I had my son on standby to take me to the hospital. It was so severe I could not stand. The only way that I can describe the pain would be: after natural birth and you begin nursing, the insanely intense contractions of the uterus to shed the afterbirth is how intense the pain was. I then started my menstrual cycle but was not supposed to for another week and 1/2. The pain stayed, but did dull some, it wasn't as sharp but still intense. My flow was extraordinarily heavy and I lost count of how many huge blood clots I passed. Some clots were the size of my palm. This cycle lasted a full 7 days. My normal cycle starts with a little spotting, then 1 or 2 days of medium flow, then a couple days of spotting. I also do not have my cycle every 30 days, more like 38-40. I figure its pre-menopause.

Patient presented to the hospital on 5/25/21 with left dysarthria, left arm and leg weakness that presented acutely. Patient has a pre-existing left facial weakness from previous Bell's palsy. Patient did not have any falls.

Patient asked how to report a missed abortion (miscarriage) after the second dose of the Moderna vaccine since she was told by doctors to report it. Patient had a positive pregnancy test on 3/14/21 after receiving the second dose of Moderna on 3/11/21 but did not know prior to receiving the second dose. Patient stated that it was determined she was 6 weeks pregnant 6 days after the second shot. On 4/1/2021 patient had abdominal pain and bleeding so went to the emergency room and an ultrasound was performed. It was determined that the missed abortion occurred when the baby was at 6 weeks. After several doctor visits, the patient was advised to report this and that is why this was brought to our attention. She simply asked how to report this and then I asked her some questions and gathered information. She was okay and sounded fine.

Patient received Moderna COVID vaccine at nursing home on 5/4/2021. Patient developed facial swelling, mouth pain, dysphagia and was admitted to Hospital Center on 5/8/2021 with bleeding from mouth. Patient denied any new medications, sick contacts or travel. Lab results revealed pancytopenia, high AST/ALT, Bilirubin, Hepatitis B antigen +, Hepatitis B PCR 1601 IU/ml. Patient had multiple bleeding events. Bone marrow testing was consistent with aplastic anemia. Patient was treated for re-activation of hepatitis B and aplastic anemia. Hematology consult think that COVID 19 vaccination induced aplastic anemia or COVID 19 vaccination caused re-activation of hepatitis B that induced aplastic anemia. Patient is still hospitalized at date of this reporting 6/3/2021

Anaphylactic reaction, sent to ED. Received Epi pen, dexamethasone, benadryl, pepcid, methylprednisolne. Sx resolve after observation and pt sent home

Acute Non-STEMI (myocardial infarction). She presented by ambulance to the emergency department with atypical chest pain in a very low risk group for coronary artery disease and ended up having elevated cardiac troponins levels leading to emergency heart catheterization for myocardial infarction.

Anaphylactic reaction; sensitive to touch / thighs were sensitive to touch; sore joints; drowsiness; knot on forhead over my eye; hives; Swallowing difficult; sore arm/ bilateral aching of hands; swollen lips; Angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylaxis. Concomitant products included MINOCYCLINE from 21-May-2010 to 20-May-2021 and CLINDAMYCIN PHOSPHATE from 11-Mar-2021 to an unknown date for Acne, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) from 22-Feb-2008 to an unknown date for Allergy, AMLODIPINE from 20-May-2010 to an unknown date and HCTZ from 21-May-2010 to an unknown date for Hypertension. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 9:00 AM, 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 ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), LIP SWELLING (swollen lips), ARTHRALGIA (sore joints), SOMNOLENCE (drowsiness), SWELLING FACE (knot on forhead over my eye), URTICARIA (hives), DYSPHAGIA (Swallowing difficult) and MYALGIA (sore arm/ bilateral aching of hands). On 30-Mar-2021, the patient experienced SENSITIVE SKIN (sensitive to touch / thighs were sensitive to touch). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE (intramuscular) on 20-Apr-2021 for Adverse event, at a dose of .3 mg as required; METHYLPREDNISOLONE (oral) from 29-Mar-2021 to 03-Apr-2021 for Adverse event, at a dose of 04 mg METHYLPREDNISONE; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) (oral) ongoing from 22-Feb-2008 at a dose of 10 mg twice a day and FAMOTIDINE for Adverse event, at a dose of 20 mg four times per day. On 30-Mar-2021, ANGIOEDEMA (Angioedema), LIP SWELLING (swollen lips), SENSITIVE SKIN (sensitive to touch / thighs were sensitive to touch), ARTHRALGIA (sore joints), SOMNOLENCE (drowsiness), SWELLING FACE (knot on forhead over my eye), URTICARIA (hives), DYSPHAGIA (Swallowing difficult) and MYALGIA (sore arm/ bilateral aching of hands) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Blood pressure measurement: 108/72 mmHg (Inconclusive) 108/72. On 29-May-2021, Body temperature: 99.1 (Inconclusive) 99.1 Fahrenheit. On 29-May-2021, Heart rate: 103 (Inconclusive) 103 beat per min. On 29-May-2021, Respiratory rate: 20 (Inconclusive) 20 breaths per minute. Patient reported that she experienced hypersensitivity in the skin of the thigh after shower and knot on forehead. Patient was diagnosed with anaphylactic reaction which was recovered on 30-Mar-2021. Based on the current 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 16-Jun-2021: Patient received the second dose,, vitals reported, Urticaria ,swelling of the upper airway, difficulty swallowing, angioedema adverse events were reported. Treatment medications were reported. Outcome of the events were recovered/resolved .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

SOB and chest pain after reporting to work, sent to ED. Reported that she had blood clots in her lungs

Stroke; the nuisance on the eye; lost the sight; a sensation that something burst in the corner of the right eye; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS (lost the sight) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (The patient said that had COVID-19 back in April. It started in April 5th with symptoms and on April 7th got the results back. Since April 7th was isolated on the household. It was negative to the rapid check and positive to the PCR. Just had fever, chills, and lots of head ache on the first day. 14 days of quarantine. Started having lots of cough and the doctors said that had nodules on the lungs due to COVID.) on 05-Apr-2021 and Lung nodule (the doctors said that had nodules on the lungs due to COVID. In 6 months needs to check it's lungs again.). Concurrent medical conditions included Migraine (The patient said that usually has migraine). Concomitant products included METFORMIN for an unknown indication. On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced BLINDNESS (lost the sight) (seriousness criterion medically significant) and ABNORMAL SENSATION IN EYE (a sensation that something burst in the corner of the right eye). On 17-Jun-2021, the patient experienced VITREOUS FLOATERS (the nuisance on the eye). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 23-Jun-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), BLINDNESS (lost the sight), ABNORMAL SENSATION IN EYE (a sensation that something burst in the corner of the right eye) and VITREOUS FLOATERS (the nuisance on the eye) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: fine from the heart (normal) fine from the heart. On an unknown date, SARS-CoV-2 test: positive (Positive) positive to the PCR and negative (Negative) It was negative to the rapid check. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CEREBROVASCULAR ACCIDENT (Stroke) to be related. No further causality assessments were provided for BLINDNESS (lost the sight), ABNORMAL SENSATION IN EYE (a sensation that something burst in the corner of the right eye) and VITREOUS FLOATERS (the nuisance on the eye). No treatment information was provided. The patient said that usually had migraine and thought that was a migraine. The patient had a scan of the head, an MRI, and Blood test - No results were provided. The patient also received oxygen due to the eye problem while being on ER. The patient said on Friday was transferred to a hospital room where it stayed until June 23rd at 12:00 due to a Stroke which the doctors said could have been related to the vaccine. 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.

PAIN SORENESS AT INJECTION SITE WEEK LATER LEG PAIN LEFT CALF 03/26/2021 RAPID HEART RATE 03/27/2021 RAPID HEART RATE CHEST PAINS IN MIDDLE 03/28/2021 RAPID HEART RATE CHEST PAINS IN MIDDLE SHORTNESS OF BREATH 03/29/2021 RAPID HEART RATE CHEST PAINS IN MIDDLE SHORTNESS OF BREATH VIRTUAL DOCTORS VISIT HAD CT SCAN, DEVELOPED PE ADMITTED INTO ER. HAD A IR ANGIOGRAHM PULMANARY SELECTIVE BILATERAL PROCEDURE BLOOD THINNERS

Anaphylactic reaction. Fever. full body hives - Went to urgent care and Emergency room for treatment. Had low oxygen lvels and hives. Eyes swollen and lips swollen.

Saddle Pulmonary Embolism and a Pulmonary Embolism (2 clots total in my lung); Shortness of breath; chest heaviness; Inpatient from 6/16/2021-6/20/2021 for treatment; still undergoing outpatient treatment with a hematologist

24 minutes post shot developed itchy scratchy throat, clearing throat, dry cough, sweating, sense of impending anaphylaxis ( same feeling I get with shellfish reaction) Bp stable, o2 says dropped 88%RA, tachycardia. Epi x 1 given 50 mg IM Benadryl and O2 placed seats normalized. Symptoms did not resolve, 6 minutes later second Epi shot given. Within 3 minutes symptoms starting to resolve. 125 Iv solumedrol, and given oral pred 40 mg daily x 3 days Felt fine next day(1/3) then 1/4/2020 recurrence of symptoms ( 2nd dose pred a little late 30 hours after last dose) Gave Epi shot, Benadryl 50 mg po ( pred on board) Symptoms did not resolve but no desaturation , bp stable, tachy, persistent throat clearing and dry cough 2nd Epi shot given Iv famotidine Iv solumedrol 125 mg, symptoms resolved, albuterol helpful lungs clear Pred 40 mg daily x 3 days add famotidine bid, add cetirizine bid 1/5/2021 felt fine in am, sensation of throat swelling itching and dry cough recurred , albuterol used helped temporarily ( had already taken morning cetirizine, famotidine and pred 40 mg) Saw allergist. Says fine, breathing fine slightly tachy, lungs clear, O2 says wnl, sweaty Albuterol given, helped Laryngoscopes with ENT negative for swelling, just mild vocal cord swelling from cough Started on pred taper 40 mg daily x 3, 20 mg qd x3, 10 mg dailyx3 Add Benadryl prn Add advair bid Continue cetirizine and famotidine

possibly got it at clinic, possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole day but that in the middle of the night the pt passed away.

Abdominal pain followed by vomiting hives difficulty breathing and itching with mental fog. Had to be given epinephrine - anaphylactic reaction

I received the first dose of the Moderna vaccine on 1/1/21. Initially, I had a sore arm for 24 hours but otherwise no problems. Then, on day 8, my left deltoid area started itching and there was a red, slightly raised area just larger than a golf ball. I called the hotline at that time and took a Benadryl. Then, 24 hrs later, the area had expanded to over 3 times the size and felt warm. I actually went and saw a friend who lived in my neighborhood who is a general surgeon and he thought I should get it checked out to make sure it wasn't an NSTI. Being Saturday at 9pm, I went to the ER where they started me on Keflex/Bactrim for a presumed cellulitis. By the next morning, the redness and itching were gone and my arm felt totally back to normal the next day after that. Unfortunately, on day 3 of the antibiotics (Tuesday the 12th), I had symptoms of anaphylaxis (chest tightness, wheezing, throat clearing, lip swelling, hoarse voice, impending doom sensation). I took Benadryl 50mg and got my epi pen ready but did not use it. (I have a tree nut allergy). The symptoms resolved completely about 1 hour later.

Nurse did hit a capillary and I bled immediately after injection- enough where it ran down my arm and went onto floor. I felt pretty okay except for the feeling of my arm hot and fuzzy and fuzzy fingers on my left hand until my "leave time' of 10:03 am. I stayed a little longer, and was home by 10:30 when I became extremely nauseous, dry heaving, left side of face numb. Headache started at 10:40. Tried calling medical facility but was on hold for soo long- no one answered so since I don't have insurance I decided to just rest and drink fluids. By 11:40 my face was back to normal, no longer nauseous but extremely lethargic and was the rest of the day. The following day I felt ok -slight swelling on my arm at injection site and a bruise that I still have.

Severe fever, chills, head ache, body aches, and cough lasing about 36 hours. Low grade fever and cough still persisting as of today, 9 February. Saw the NP on 5 February for both symptoms. Breathing treatments and Azithromycin prescribed by NP. Chest x-ray taken on 8 February showing pneumonia is clearing up.

Developed fever, chills, loss of taste and smell, severe headaches, and body aches beginning 31 December. Went to urgent care on 3 January and tested positive for COVID-19. Cough developed and worsened. Scheduled an appointment with primary care on 6 January, pneumonia developed and course of treatment was given (Ivermectin, Doxycycline, Hydroxycholoroquine, and prednisone was prescribed). Low grade fever still present even after treatment was completed.

10 days after second dose awoke at 11:30 at night with nausea then after a few minutes began to itch and break out into hives then proceeded to get chest pressure and unable to breath until I passed out. Husband able to revive me 3 times until 911 came then went to urgent care Nausea with vomiting and chest pain, back pain, heart burn, and urinal incontinence. Sent to MC for NSTEMI work up of echo and cardiac stress test. Cardiologist said NSTEMI from low oxygen and hypotension.

History of anaphylaxis to IV Taxol in her past. She did well after her first dose of the Covid vaccine, Within 10 minutes of receiving her second dose of Covid vaccine she c/o throat tightness, lightheadedness, flushed/warm sensation in her chest, C/O of SOB. She was injected with Epi, given Benadryl 25mg po, Zyrtec 10mg po. A CODE Blue was called and she was transported to the ED where she received a second Epi injection. She was monitored in the ED overnight, was given Benadryl every 6 hours, treated with prednisone and pepcid and Tylenol for headache. Was discharged from the ED the next morning and given Rx for prednisone, benadryl, pepcid for 5 days and and Epi pen.

TIAStroke headache with partial visual loss and expressive aphasia dx stroke 2/11/21 by MRI Narrative: no residual from stroke, also found to have small patent foramen ovale

Died at home; Gasping for air/difficulty breathing; Soreness; A spontaneous report was received from a physician concerning a 45 years-old, female patient who experienced soreness/MedDRA PT: pain, gasping for air/difficulty breathing/MedDRA PT: dyspnoea and subsequently died/MedDRA PT: death. The patient's medical history included blood pressure (disorder not specified), thyroid disorder, depression and anxiety. Concomitant product use included blood pressure medication, thyroid medication and possibly depression and anxiety medication. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection. On 28 Jan 2021, following the vaccination, the patient was fine but had experienced some soreness. Per patient's coworker, the patient did not take any medication as it made the patient sick. The physician was not aware of any complaints from the vaccine. On 13 Feb 2021 at 3:31am, the patient called 911. Per the 911 call, the patient was gasping for air on the call and having difficulty breathing. The patient subsequently died on 13 Feb 2021 at home. The physician inquired whether Moderna gets involved with the autopsy and logistics of the death of patients and wanted to know the time frame for reporting a death of a patient who received the vaccine. The physician did not know who administered the patient's vaccine. Action taken with mRNA-1273 in response to the events was not applicable as the patient deceased. The event died was fatal. The outcome for the events soreness and gasping for air/difficulty breathing was unknown. The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of dyspnea and death has been provided at this time. Further information has been requested. Patient's medical history of blood pressure is considered a risk factor. Based on the current available information and temporal association between the use of the product and the onset of the pain, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died at home

Received a phone call stating that the patient complained of not feeling well on 3/11/21 while at work and that the patient died that night while at home.

Developed R calf pain on 1/16/21, progressively worsening over 3-4 weeks. Diagnosed with R posterior tibial DVT on 2/6/21 and started on apixaban.

Took shot and have flu like symptoms for 19 days so far have run up to 102 fever for19 days have taken ibuprofen to help keep fever down but when it wears off fever comes back and now she has developed pneumonia in one lung. She is very fatigued this has gone on for 19 days I fear we may lose her if something is not done.

L JUGULAR AND UE DVT LEFT UPPER EXTREMITY SWELLING ACUTE THROMBOSIS OF LEFT BRACHIAL VEIN ACUTE THROMBOSISOF LEFT BASILIC VEIN ACUTE THROMBOSIS OF LEFT INTERNAL JUGULAR VEIN

anaphylactic reaction; A spontaneous report was received from a health care professional concerning a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction. The patient's medical history was not provided. Concomitant medications reported included levothyroxine sodium for unknown indication. On 14 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) in the right arm for prophylaxis of COVID-19 infection. On 14 Jan 2021, prior to receiving mRNA-1273, the patient felt anaphylactic reaction and was medically significant. Patient received treatment in Hospital ER and got discharged after 10 hours of observation. Treatment for the events included intravenous steroid, Pepcid ,Oxygen and Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event anaphylactic reaction was unknown. ; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

pt presented in ER 3/17/21 with SOB and back pain; felt bad since vaccine given; UTI diagnosis-given keflex 500 tid and rocephin shot pt presented to clinic 3/19/21 with continuing back pain dx low back pain and candidia given methocarbamol, diflucan, and ibuprofen pt presented to clinic 3/26/21 with continuing back pain, difficulty urination. given ceftin and rocephin shot pt presented to ER 3/27/21 renal failure and expired within 10 min of arrival no fever documented at any visit

The evening (3/20/21)I received the vaccine I noticed fatigue, headache and chills. The next morning I developed shortness of breath. The day after that my left left began swelling for no reason, was slightly discolored and warm to the touch. As the week went on my shortness of breath became greater and my leg more swollen. On (3/26/21) I sent to the ER by my doctor. Had a ultra sound and discovered an extensive DVT in my left groin down to behind left knee. Had a CT and discovered blood clots in my lungs. I had never had any underlying health conditions or been on medications, don't smoke, no complaints prior. Was transported to hospital spent 2.5 days in ICU before being moved to a regular bed for a total of (4) days hospitalized. The doctor installed two sheaths on each side of groin, injected my lungs with medication to blast/dissolve the clots and installed a filter in the main artery to catch any clots that may break away from leg. I was also put on a Heparin drip while in ICU. The next day the doctor went and the procedure was a success dissolving the clots. He removed the sheaths. I went back to ICU. The next day (3/28/21) a second utlra sound was done to left leg and DVT is still in left leg. Have been described Eliquis blood thinner.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Abdominal Pain-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Pt fainted 1 to 2 minutes after getting vaccinated and regained consciousness immediately. Her BP was normal - 108/80 and HR was 86. Pt's breathing was normal. She felt mild stomach pain and headache after gaining consciousness.

My last period prior to my first vaccine shot had been in June 2020. All signs, including blood work, pointed to me having entered menopause. My mom also went through menopause at age 45 when her periods suddenly stopped, so I figured I was following in her footsteps. On Saturday, February 13, 2021, I received my first dose of the Moderna vaccine, and by Thursday morning, I was spotting. This was very surprising since I had not had a period in several months. Over the course of a couple of days, it turned into a full-blown period with the most severe cramping I've ever had in my life. By Saturday, they felt like labor contractions, and I was releasing sizable blood clots. I made an appointment at our health clinic, and all bloodwork again pointed to menopause. After my 2nd Moderna vaccine, I again experienced just a tiny bit of brown spotting a few days after the vaccine. However, it did not progress into a full-blown period that time.

Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion death). The patient died on 05-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. Concomitant medications were not reported. The patient was not hospitalized prior to or during the stroke. The reporter mentioned that the organs were donated as the patient was on a ventilator.; Reported Cause(s) of Death: Stroke

Started with increased heart rate, fatigue and shortness of breath. Didn?t go to Dr until April 23, 2021 & April 26, 2021, syncope, multiple large bilateral pulmonary Emboli & DVT & right heart strain

Small Pulmonary Embolism; blood clots in upper arm, arm pit, neck, across right side of chest; Opposite arm blew up like a baloon; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Small Pulmonary Embolism) and THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PULMONARY EMBOLISM (Small Pulmonary Embolism) (seriousness criteria medically significant and life threatening), THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) (seriousness criteria medically significant and life threatening) and PERIPHERAL SWELLING (Opposite arm blew up like a baloon). At the time of the report, PULMONARY EMBOLISM (Small Pulmonary Embolism), THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) and PERIPHERAL SWELLING (Opposite arm blew up like a baloon) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided by the reporter. Treatment medications for the events included Xarelto (rivaroxaban). Reporter states patient went to Urgent Care on 22-Apr-2021 due to the events and was then told to go to the Emergency Room. Based on the current 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.

I started to feel very tired and shortness of breath at the end of the week after the vaccine on 02/01/2021. I seen my provider on 02/22/2021. I was told at that visit I either had and enlarged heart or fluid around my heart. I was referred to heart doctor. I had a echocardiogram done on 02/26/2021 and was told that I had an EF of 10%. I was sent to a heart specialist and was admitted for 6 days.

Ischemic stroke on 5/27, with acute onset right sided weakness in upper and lower extremities, right sided facial droop, aphasia. Received TPA and thrombectomy with interventional neuroradiology. Deficits persisted. No significant other comorbidities.

After my terrible chills and fever were gone I got my period 2 weeks early. It was a normal period however only 5 days later I got ANOTHER period. This was was much heavier than normal with done quarter sized blood clots. It lasted 7 days.

The 1st dose was on May 2, 2021, bleeding started on day 3, I thought it was my period, but it was different, scarce, and so I spent almost 3 weeks spotting, and on May 24, I started a "normal" bleeding. Which on June 30 (the day I had the 2nd Moderna vaccination) is supposed to stop the bleeding and it seemed that way. But on June 1 when I got up, the bleeding returned more profuse, until today June 2 continues and does not seem to stop. And everything happened to me after the vaccines. I don't know if it has anything to do with it. And I have not been able to see any gynecologist because everything is by appointment and the closest appointments are for November or December. And they don't see it as something of an emergency or priority. And I worry about my hemoglobin. Although for the rest I feel normal.

Sharp, Stabbing Chest Pain, Breast Pain, Back Pain, Fatigue, Loss of Appetite Treatment: ER visit 5/12/21 resulting in discovery and diagnosis of Pericarditis and Pericardial Effusion

its ischemic stroke; I was at store and passed out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (its ischemic stroke) and LOSS OF CONSCIOUSNESS (I was at store and passed out) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 020B21A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR), ROPINIROLE, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), FUROSEMIDE (LASIX [FUROSEMIDE]), QUETIAPINE FUMARATE (SEROQUEL), BUSPIRONE HYDROCHLORIDE (BUSPAR), ESTRADIOL and TRAZODONE for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced ISCHAEMIC STROKE (its ischemic stroke) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (I was at store and passed out) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 27-May-2021 due to ISCHAEMIC STROKE. The patient was treated with ALTEPLASE ongoing since an unknown date at a dose of Activase Alteplase. At the time of the report, ISCHAEMIC STROKE (its ischemic stroke) and LOSS OF CONSCIOUSNESS (I was at store and passed out) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Computerised tomogram: abnormal (abnormal) ischemic stroke.. On 27-May-2021, Magnetic resonance imaging: abnormal (abnormal) ischemic stroke.. Patient was in Emergency room for 3 days and 2 days in ICU. patient was shifted to room and 1 day in regular room. In emergency room patient was prescribed with Activase Alteplase for treatment along with her daily medication. Company comment: Very limited information regarding this events has been provided at this time. Further information can't be requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information can't be requested.

After I got home the injection site began to get numb. Within that hour my entire left arm down to the fingers my shoulders, chest, upper back, face, lips tongue, throat went numb. I called the pharmacy they told me to take Benadryl and call back in 30 min. I took two Benadryl's, it did not help. I called back and they said to call my primary care doctor . My Primary care doctor said I was having a stroke, go to the ER. The numbness was not getting better nor worse. They decided to admit me to do further tests. This was around 9pm. I saw a neurologist. He had them do an MRI of my head. I also saw an ENT to make sure there was no blockage with swallowing. By the second day the numbness in my face mouth tongue and throat were getting better but my arm chest and shoulder was not. They discharged me and said follow up w primary care. I met with her on the following Monday 4/12. At that point everything was still numb. She sent in a referral for a neurologist to do more tests. She also ordered a carotid ultrasound. I met with the neurologist on 4/29. I had XRAY and ULTEASOUND 5/10. Neurologist wanted MRI but insurance denied it. I am still numb in my arm, About 3 weeks after injection I started getting lump on my arm about 3 inches from injection. Lump is still there. Pain at the injection site has gotten worse despite them saying it would resolve. If I put pressure on the arm it will wake me up at night. If a blood pressure cuff was put on the arm the numbness worsens. The injection site is still red as well. I have another follow up appt on 6/15 with my primary care. I won't see the neurologist until after the MRI which depends on the insurance.

Very heavy period with large clots of blood and cycle began 2 weeks earlier than expected. Became extremely fatigued bleeding so heavily 5 days in a row.

suffered life threatening bilateral pulmonary emboli; acute cor pulmonale; accompanying gastrointestinal; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli) and COR PULMONALE ACUTE (acute cor pulmonale) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli) (seriousness criterion medically significant), COR PULMONALE ACUTE (acute cor pulmonale) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (accompanying gastrointestinal). At the time of the report, PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli), COR PULMONALE ACUTE (acute cor pulmonale) and GASTROINTESTINAL DISORDER (accompanying gastrointestinal) outcome was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Chest pain and left arm pain 8 days after shot. Pain turned to tingling then numbness then pain again creeping up arm into neck and side of left face. Injection area became itchy, sore and swollen. Light headed, nausea, hot & cold sweats began. Rapid heart rate through the night went to ER the next day. ER Dr. confirmed I suffered mild heart attach after 2nd series of blood work & tests came back at which point I was admitted and transferred to hospital to be monitored overnight & have tests ran the next morning, as the ER I was at was not equipped to handle cardiac patients.

Spotting, cramping, menstruation at least 6 weeks, and still continuing. No menstruation for 20 years due to suppressive hormonal treatment.

The main reaction I am experiencing is vaginal bleeding started May 20th 2021 and has not stopped it is now July 7th 20th 21 there have been days where it was spotty others were just normal type. Days. In the beginning I was 10 days early for my typical menstrual cycle and the blood seemed to be old. It was dark in color and not like a fresh shedding of the uterine wall. And then we're my normal period cycle came up it turned to what appeared to be my typical bleeding I continued to spot. And today on July 7th I started having clots large blood clots fresh in color but a lot of bleeding I have had two periods since it's began and July 7th would be a week after what would have been my typical cycle. Another side effect of experiencing is painful cramping of my hands and feet and occasionally my calves. It's to the point where pressing on the gas pedal can make my toes cramp when driving holding grocery bags with my hand cramp. Any kind of body stretch will make any of my muscles cramp I never know which one. I've had multiple side effects starting with a raised bumpy rash on both sides of my face. They were not pimples they never came to a head a few of the bumps ended with small scab on them I'm not sure if that's from me scratching at times it was itchy they started May 20th and I have just a scattering of the bumps at this point July 7th 2021.

As reported by patient's home health nurse patient started with confusion and hallucinations that were found to be seizures on 6/17/2021. The ER also stated she had a stroke, but then a secondary Hospital stated she did not upon further evaluation per the patient's family. So far, no health care providers can come to decision on the cause of the seizures based on all the tests they have done so far. Patient has seizure every time she stands and has developed limited function of left leg.

Received vaccination in my L shoulder. One week later at injection sight a medium sized knot formed. It was warm to touch, hard and painful to touch. Called doctor to get in to see her and three days later after the knot formed it traveled to my forearm. Received an ultrasound of forearm and confirmed it was a superficial bloodclot

Within 5 minutes had pulse 160 and bp 180/100; five minutes after receiving the Moderna vaccine. The reaction lasted about 15 minutes and resolve without any medication or intervention. Reports she ?felt like garbage ?the rest of the day. Local medics are saying that this was an anaphylactic reaction and are refusing to offer the second vaccine dose . Patient states she felt more like an ?adrenaline dump? or maybe an ?infusion reaction?

Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest

Patient had positive COVID test 12/18/2020 and had the COVID vaccine 1/5/21. THis may have been too soon, as she presented to ER on 1/10/21 with N/V and new dx of left leg DVT. Could or could not have been related to vaccine vs recent COVID infection, not sure. Other Relevant Hx: Phlebitis & Nausea Vomitin

02/04/21-groin pain/burning, buttocks and thighs muscle tightness, unable to sit for extended period of time due to groin discomfort 02/05/21-continued groin pain, new bilateral arm/bicept muscle pain with right side worse than left 02/06/21- headache, loss of appetite, chills, shoulder/neck/jaw/hips joint pain 02/07/21-back and ribs pain with sitting or lying- unable to sleep due to extreme pain, unable to transition from lying to sitting to standing due to pain, fever 101.8, worsening of all symptoms. Employee Health contacted, instructed to obtain Covid test, results negative. 02/08/21-First day missed work. Continued worsening of pain, groin and hip pain radiating down the back of both legs to back of both knees 02/09/21- Excruciating pain, difficulty with ambulating. Seen at Emergency Department, labs and imaging obtained, informed of bilateral Pulmonary Embolisms, admitted for treatment.

L arm pain, HA, body aches/chills starting 12/29/2020. Chest pain, SOB, cough, fevers starting 1/3/2021. Hemoptysis 1/7/2021 with worsening SOB and positional cough. Multiple PEs found on chest CT 1/10/2021 and hospitalized on heparin drip for >24hrs. DVT found on lower leg US 1/10/2021. Remain on DOAC for anticoagulation.

I got the vaccine on the 8th and then about at 8 at night on the tenth, and my throat started to close, and I couldn't breathe. I was sent to the hospital where I was intubated. I went into anaphylactic shock and cardiac arrest and then respitory failure.

Pneumonia; Loss of taste; Loss of smell; stared into space for hours; Covid Positive Test; Felt Spacy; Cough; A spontaneous report was received from a consumer concerning a 46 year-old female patient who experienced Covid-19 positive test [COVID-19], felt spacy [dizziness], stared into space for hours [staring], and pneumonia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021, approximately five days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient started experiencing symptoms of coughing. On 17 Jan 2021, the patient tested positive for Covid-19. The patient reported she felt spacy and stared into space for hours. On 19 Jan 2021, the patient experienced symptoms of loss of taste and smell. On 24 Jan 2021, the patient's oxygen levels were going down. Treatment for the event of Covid-19 included azithromycin, prednisone, albuterol, and cough medicine. On 28 Jan 2021, the patient tested positive for pneumonia. Treatment for the event of pneumonia included levofloxacin. Action taken with mRNA-1273 in response to the events was unknown. The event of pneumonia was considered resolved on an unknown date. The outcome of the event of Covid-19 was unknown. The events, felt spacy and stared into space for hours, were considered resolved on an unknown date.; Reporter's Comments: Based on the concurrent Covid-19 infection, the events are assessed as unlikely related to mRNA-1273.

About 16 hours later I had a heart attack, 20% plaque and the rest was a blood clot that acute my artery. I was in the Hospital for two days. I ended up having angioplasty and a stent. When I went home I had post heart attack issues and a sore arm for about 3 weeks.

Went to bed around 10pm on 2/10, experienced right arm stiffness and hemiparesis. Lived by herself, unable to reach her until 1/11. Admitted with Left MCA infarct, several foci on left occipital lobe points to cardioembolic etiology. No motor deficits, mixed aphasia. Central embolic etiology. No fam hx of coagulopathy.

Asphyxiation; like had a heart attack; Blood pressure was 150/90; sever allergic reaction; lethargic; Arrhythmia; Fast heartbeat; A spontaneous report was received from a 46 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced asphyxiation, fast heartbeat, lethargy, blood pressure 150/90, arrhythmia and a heart attack like episode. The consumer received the first of the two planned doses of mRNA-1273 on 05-FEB-2021 (Batch #: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 06-FEB-2021, Patient experienced fast heartbeat. On 07-FEB-2021, she became lethargic. On 08-FEB-2021, she called the EMT due to complaints of rapid heartbeat as if she was experiencing arrhythmia. The patient stated that her blood pressure was 150/90, as well as, she had asphyxiation and felt like she had a heart attack. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The patient's medical history was not provided. No relevant concomitant medications were reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unusual pain in her legs, hips, lower back, pain in both arms, neck jaw and ribs, decrease in appetite, fever, and pulmonary embolism. The patient's medical history was not provided. Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban. On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches. On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on 07-Feb-2021, she had a temperature of 101.8. She reported feeling like she had the flu. Patient reported having a COVID-19 test that came back negative. The pain continued to increase between Sunday night and Tuesday morning. Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021. She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable. The outcomes of the events, pain in her legs, hips, lower back, neck, jaw bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; 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.

Within 10 minutes of receiving injection in right arm I felt a BOOM flush all over my body like I just had an IV Contrast. Then I became dizzy, my heart started racing, I started cold sweats and felt tightness in my mid upper chest to the base of my throat. The ED RN on site took my BP and HR and had me lie down because I felt that I couldn't breath. She called paramedics who took my BP and HR, then did a 12 lead EKG. They transported me to the ED. I was worked up for cardiac, lung, chemistry. My troponin-HS was slightly elevated and a cardiologist was called. He did an echo on my heart, liver and right kidney -- normal. Chest X-ray was normal. A second 12 lead EKG was done, normal sinus. Hematology, Chemistry was normal. Was in the ED from 11:30 to 4:00 p.m. Advised by ED Doctor, and Cardiologist, that it seems the stress of the anaphylaxis reaction stressed the heart which caused the spill of troponin. Advised to see my cardiologist and get a stress test. I have already informed my Primary Care Doctor and he has prescribed me an EPI-PEN to carry. I have no history of allergic reactions/anaphylaxis reactions to vaccines. I am up to date with all other vaccines and just had my yearly flu shot in November 2020. This was my first allergic reaction/anaphylaxis reaction to a vaccine.

Patient's received 2nd dose of Moderna vaccine Friday 3/12. Her husband reported she had not unexpected fatigue, malaise, and fever for 1 day but better after that. On Monday she began complaining of shortness of breath. This progressively worsened and she started having presyncopal episodes. On Saturday she was unable to come down the stairs in the house so husband planned to take her to the hospital but she stood up and passed out and woke up quickly. He decided to call EMS. By the time she presented to our hospital she was cyanotic and agonal breathing. On moving her from EMS stretcher to ED bed she had PEA cardiac arrest. She underwent mechanical device CPR with only brief (<1 min) ROSC x1. She at some point did have a shockable rhythm. Cath lab was notified and she was taken emergently to the cath lab with ongoing mechanical device CPR. Peripheral VA ECMO was placed after about 1.5 hours. Pulmonary angiogram was done which showed massive saddle PE with near complete obliteration of the right pulmonary tree and some filling defects in the left tree as well. At that time she had severe mixed respiratory and metabolic acidosis with a lactate of 24. She also had no gag or corneal reflex, minimally responsive pupils, and no response to noxious stimuli. Mechanical thrombectomy was attempted with some result. She was transferred to the SICU with increasing pressor requirement, and DIC. Ultimately, the venous catheter of the ECMO circuit malfunctioned thought to be secondary propagating IVC thrombosis. Family decided to withdraw care and she passed away.

Volunteered on March 1st to help with vaccines- I filled syringes with the Moderna vaccine. On 3/6/2021 at 11:24 AM I presented with dizziness, slurred speech, a feeling of my lip dropping to the right, and weakness in left upper extremity. Called my daughter whom arrived within 10 minutes. After asking me some questions and exercises she said my strength in the left upper extremity was weak compared to the right. My daughter took me to ER, at check in I said I think I had a stroke. I was admitted, and neurology was consulted. In the ER they called it a TIA, and after imaging a diagnosis of stroke was made. Acute frontoparietal infarct, ASA/plavix, lipitor, PT/OT, Neurologist follow up. After discharge I have been meeting with PT/OT following exercises. Met with my PCP and continued medications Aspirin 81 mg, atorvastatin 80 mg, clopidogrel 75 mg. Still have muscle aches, and pain in the left upper extremity- especially 3rd and 5th digits.

5-6 mins after injection c/o thick tongue, dizziness, hot feeling, nausea, numbness of chest that spontaneously resolved but recurred 10 mins later; no SOB, rash, itch. IMP: Impending anaphylactic/severe allergic reaction; pt given Benadryl 50mg/ml 1ml IM, Solumedrol 125 mg IM but no EPI since no SOB.

Had 2nd vaccine shot on 3/11, body aches and fever on 3/12, woke on 3/13 with excessive uterine bleeding, bleeding slowed in the afternoon, returned during the night into morning of 3/14, went to er. Received labwork and vaginal ultrasound, discharged and told to follow up with gynecologist. Contacted gynecologist on the evening of 3/15-Dr called in prescription for progesterin Took progesterin and bleeding continued. Saw Dr in office on 3/16-had 6+ hours of uncontrolled bleeding (using 5 super plus tampons and pads per hour. Dr prescribed Tranxemic acid-took until the afternoon of 3/18 when I contacted his office asking if the bleeding should have stopped. I was told to go the ER. I continued to bleed uncontrollably. I was admitted to Hospital - received 2 blood transfusions, heart monitoring- on 3/19/21 I had emergency surgery for a cervical polyp. D&C /Polypectomy due to uncontrolled bleeding. Both surgeons state there is no explanation and I could have died. I still have low hemoglobin and am going to receive iron infusions. I am happy to supply lab work & results . This was an occurrence w/ no real explanation. It was very scary.

TIA; Right side of her face was drooping; Left arm was paralyzed; Slurred speech; Dizzy; Confused; A spontaneous report was received from a consumer concerning a 46-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced TIA (transient ischaemic attack), dizzy (dizziness), her left arm was paralyzed (paralysis), right side of her face was drooping (facial paralysis), slurred speech (dysarthria), and she was confused (confusional state). The patient denied having any allergies, past medical history or concomitant medications. Therefore, no medical history or concomitant medications were reported. On 14-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot #: 251L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10-Feb-2021, approximately twenty-four days prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot #: 16M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06-Mar-2021 the patient had a "TIA" (transient ischemic attack). She was sitting down and when she got up, she got dizzy and her left arm was paralyzed. The right side of her face was drooping, she had slurred speech and she was confused. The patient went to the hospital where she was hospitalized for 2 days. The MD (medical doctor) said she had a "7 mm focal diffusion." Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcomes of the events, TIA, dizzy, her left arm was paralyzed, right side of her face was drooping, slurred speech, and she was confused, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

during routine lab work, low platelets were observed (101) upon recheck they were 74. Patient/employee routinely has these labs performed and has not shown thrombocytopenia previously even while on the escitalopram which has been a medication used many times over the years for episodic depression.

Patient a 46 yo female with a history of Bechet's presenting to the ED yesterday due to a history of progressive bruising with later appearance of petechiae and gum bleeding. CBC yesterday revealed an isolated thrombocytopenia with platelets of 19k (>340k all previous checks), suspected ITP. She was given 1 unit of platelets, solumedrol x 1 and IVIG. Platelets this morning have responded but more likely related to the platelet transfusion. Today I discussed continuation of IVIG and transitioning over to pulse dexamethasone 40 mg x 4 days q 14 days for 4 cycles in order to put the ITP in remission. Considerations for precipitating event leading to the ITP include autoimmune condition recently undergoing dose adjustment, history of recent infection (viral gastroenteritis), and post Covid 19 vaccination induced ITP-currently described incidence between 1 in 100,000 to 1 in 1,000,000 and seen between 1-3 wks after vaccination. This is unlikely to be related to vaccine induced thrombotic thrombocytopenia (VITT) as there is no sign of clotting. In addition she received an mRNA vaccine (Moderna) which has not been reported to cause VITT. A HIT antibody was sent.

I had a bruise on my arm for almost two weeks at the site of the shot. I started to feel cramping as if I was getting ready to start my cycle on Sunday. They lasted almost two weeks every day and some days I needed to take Ibprofen because they were strong. I also had very sore and tender breasts and became bloated like I was going to start my cycle. I finished my cycle two days prior to getting the shot, so these symptoms are not normal at this time. I still have some cramping and off and on bloating. My breasts hurt off and on. I have started slightly spotting. I should not have my cycle until the end of the month. I told my doctor about these symptoms and she said they sound related and to report this.

Vaginal Bleeding began 2 days after vaccine. I had a uterine ablation in 2018 and have not had a period at all until 2 days after receiving 2nd dose of Moderna. It was not a regular period. I bled heavily for a couple of weeks, then lightly for a week or so, and then started bleeding heavily again following. Currently I am still experiencing vaginal bleeding like a period but more frequent (every 2 weeks as opposed to once a month). It has now been 2 months since the last dose of the vaccine and I continue to have this pattern of bleeding. My MD is aware and when I questioned the vaccine, I was told it probably was not related, but offers no other explanation.

Only slight swelling at injection site occurred following the administration of the second dose. Swelling only lasted approximately 2 days. 11 days later on 02/17/2021, my mother was found (at approx 11- 11:30am) to be having a stroke unbeknownst to us. Barely responsive when paramedics came, and going in and out of consciousness. There were NO typical stroke symptoms not exhibited leading up to the time of stroke on 02/17/21 as she just received a clean bill of health the December prior.

Normal menstrual cycle (i.e. week 4/inactive pills) on birth control pill ran April 4-10, but menstruation continued for 1 further week while taking the first week of active BC pills, April 11-17, 2021. Everything seemed normal for the second week, but menstruation began again during the third week of active BC pills, April 25-today. Menstrual flow has been heavier than normal, and I've noticed many blood clots.

Shortness of breath started later in day on day of second vaccine (4/20/21) . Presented to hospital 4/25/2021 with chest pain and shortness of breath. Found to have large pulmonary embolism and elevated troponin. Patient was discharged on 4/28/2021 on apixaban. Patient did already have lower extremity vein disease and previous ablation to right great saphenous vein in 2019. Has family history of pulmonary embolism in her sister. Patient was also on depot medroxyprogesterone acetate injections.

This 46 year old female received the Moderna Covid shot on 3/12 /21 and went to the ED on 3/23/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

After both shots of the vaccine my menstrual period was extremely heaving with golf ball size blood clots, extreme cramping and extremely heavy flows. The first period after my first shot lasted eight days compared to my usual five days.

Patient developed Immune Thrombocytopenic Purpura- bleeding gums, bleeding lip, petechia all over body and bruising, fatigue, abdominal pain...2 weeks after 2nd COVID Moderna vaccine.

On 5/4/2021, I was admitted to the Hospital for shortness of breath. I was diagnosed with a double pulmonary embolism. I had an emobolectomy and was released from the hospital on 5/7/2021.

Heart failure; was scheduled for her second dose, but was unable to get it because she was hospitalized; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart failure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disorder (heart condition) and Blood pressure high. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criteria hospitalization and medically significant). On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was scheduled for her second dose, but was unable to get it because she was hospitalized). The patient was hospitalized from 09-May-2021 to 13-May-2021 due to CARDIAC FAILURE. On 11-May-2021, PRODUCT DOSE OMISSION ISSUE (was scheduled for her second dose, but was unable to get it because she was hospitalized) had resolved. On 13-May-2021, CARDIAC FAILURE (Heart failure) outcome was unknown. The patient's concomitant medications included unspecified high blood pressure pills and heart pills. Treatment information was not provided. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

On March 24th, I awoke from sleeping to a thunderclap headache, 6/10 pain. I tried to treat the pain with Tylenol and benadryl, but it wouldn't go away. I also developed visual aura of zig zag lines on my peripheral vision. I presented to the ER on March 26th, and they did an MRI. MRI showed multiple bilateral strokes. My hospitalist stated I should report it to VAERS.

Covid arm (rash and itching) for 1 week. Resolved on its own. Leg swelling and pain as well as shortness of breath. Had Doppler scan on leg and CTs on chest. Diagnosed?DVT left leg and PE in lungs. On blood thinner and TED hose x 6 months. On treatment now.

24 hours after receiving vaccine reported vaginal bleeding like she was getting a period. patient on Nexplanon and usually does not get a period. Received first vaccine on 4/26/21 and second one on 5/24/21

haven't had a menstrual cycle in over 2 years...in menopause, however after send dose of covid vaccine, passed blood clot and experiencing mild to moderate menstruation. received 2nd dose on Jun 1, started bleeding on June 3 and as of today, still bleeding

body is inflammed; body is completely red; Inflammation in ears and tongue; red line in her front; Chest pain; body is all disfigured; Headache; Hands were swollen; back of my was inflammed; balls at back of my head, red and hot areas; red and hot areas that itched; Inflammation of eyes; Chest pain; a little feverish; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (red line in her front) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Sulfa allergy). Concomitant products included SERTRALINE, BUPROPION, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ZOLPIDEM for an unknown indication. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-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 PYREXIA (a little feverish). On 26-May-2021, the patient experienced the first episode of CHEST PAIN (Chest pain), INFLAMMATION (Inflammation of eyes) and ITCHING SCAR (red and hot areas that itched). On 28-May-2021, the patient experienced SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed) and INFECTION (balls at back of my head, red and hot areas). On 30-May-2021, the patient experienced SEPSIS (red line in her front) (seriousness criterion medically significant), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), the second episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache). On 20-Apr-2021, PYREXIA (a little feverish) outcome was unknown. At the time of the report, SEPSIS (red line in her front), INFECTION (body is inflammed), INFECTION (body is completely red), INFLAMMATION (Inflammation in ears and tongue), INFLAMMATION (Inflammation of eyes), SWOLLEN JOINT COUNT (Hands were swollen), INFLAMMATION (back of my was inflammed), INFECTION (balls at back of my head, red and hot areas), ITCHING SCAR (red and hot areas that itched), the last episode of CHEST PAIN (Chest pain), WOUND (body is all disfigured) and HEADACHE (Headache) outcome was unknown. Treatment medications included Injectable steroids, epinephrine, Benadryl and prednisone 20 mg. Based on the current 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 01-Jun-2021: Updated medication list and allergies.; 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.

Anaphylactic shock; full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face/ hives progressing and getting worse; Itchy hives; red marks; Flu like symptoms; aches; Fever/ low grade fever; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis. Concurrent medical conditions included Eczema. Concomitant products included FLUTICASONE FUROATE (ARNUITY ELLIPTA), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) and MONTELUKAST for an unknown indication. In 2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg once a day. In September 2019, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 mg. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aches), PYREXIA (Fever/ low grade fever), FATIGUE (Fatigue) and NAUSEA (Nausea). On 19-Mar-2021, the patient experienced PRURITUS (Itchy hives) and ERYTHEMA (red marks). On 19-Mar-2021 at 9:00 PM, the patient experienced URTICARIA (full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face/ hives progressing and getting worse). On 21-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Mar-2021 for Urticaria, at a dose of 1 dosage form; PREDNISONE on 21-Mar-2021 for Urticaria, at a dose of 50 mg and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Fever, Fatigue, Nausea, Flu like symptoms and Ache, at an unspecified dose and frequency. On 15-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aches), PYREXIA (Fever/ low grade fever), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), PRURITUS (Itchy hives) and URTICARIA (full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face/ hives progressing and getting worse) outcome was unknown and ERYTHEMA (red marks) had resolved. Patient experienced anaphylactic shock, got itchy hives described noticing red marks, hives progressing and getting worse, full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face, flu like symptoms, fatigue, low grade fever and aches and pains, while she was treated with dupilumab [Dupixent] delivered via dupilumab prefilled syringe. Action taken with mRNA-1273 in response to the event was not applicable . Company Comment: Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Anaphylaxis, fever, fatigue and nausea are consistent with the product known safety profile. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added new historical condition, treatment and events. Added new serious event anaphylactic shock.; Sender's Comments: Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Anaphylaxis, fever, fatigue and nausea are consistent with the product known safety profile.

Almost right after receiving the vaccine, I started to feel sore under my neck and my shoulder. The gave me an ice pack. I took 800mg of Motrin. The same night I started to feel like I had the flu. There was muscle and joint pain throughout my body. I had a headache and my stomach was hurting me. I developed a fever and it went as high as 105 degrees. I called the on-call doctor the next day and she said that I would probably be fine by Sunday. I did not feel better and my symptoms continued. My blood pressure became very high too, and I was advised to see my doctor, but it got better. My knees felt like they were on fire. My appetite went away come completely. On Sunday, I called the doctor again and told her how I was feeling. My doctor told me to go to the hospital to get an IV because I wasn't drinking fluids. I couldn't even get out of my bed and I had urinated on myself. I did experience a couple of UTI's after the vaccine. I told the doctor that I would drink broth and my son made me some. Sunday my fever went up and down and at one point. On Monday I started having a headache again and I was very nauseous. I went back to work on Wednesday with a headache. I took homemade soup and I ate there. I still had a headache throughout the day. On Thursday, I felt a lot better. A few days later, I experienced some dark vaginal bleeding, not related to my period. I had a vaginal ultrasound. I had a biopsy and everything was fine. The heavy bleeding continued and I ended up having to get an IUD to control the bleeding. I had some blood work done and my live enzymes were elevated. I had an ultrasound to check everything. I had a fibroid scan as well. I had an endoscopy. The doctor thinks I might have liver sclerosis. I told him that I do not drink. I'm meeting with my liver doctor tomorrow. There are now complications with my thyroid. I saw an endocrinologist and he said that I may need calcium in my body.

on March 20 I initially woke up with vertigo which I later found out was an adverse reaction to the first shot of the vaccine. Approximately three weeks after the second shot of the vaccine I endured a chest pain and had to call 911, where I later woke up after having open heart surgery, Due to the fact that I had an aortic tear I needed Emergency open heart surgery. In the midst of that I had a mild stroke, two seizures and blockage in my carotid artery, Which I will need additional surgery to fix and put a stent in my neck.

After having the vaccine I have had nose bleeds and severe headaches. I have never had a nose bleed in my life. I have had 12-13 in about a 3 week period. I have only had one in the last week. I can stand on the toilet and it will just pour out of my nose. The first time that it happened there was a big clot but after that I have not seen another clot. I work for a doctor and I asked him about it after I have had about 6 nose bleeds. He kind of checked me out a little bit and told me to keep a watch on it and see what happens. He did not see anything when he checked me. I continued to have them and he suggested that I go with an EMG.

10 minutes after receiving her 2nd Covid vaccine, patient went into a tonic-clonic seizure. 5 minutes after the onset of seizure, Epi-pen 0.3 mg was administered per physician order. Paramedics arrived shortly after, transported the patient to the emergency room.

Pneumonia; Meningitis; Sepsis; Probable lupus; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), MENINGITIS (Meningitis) (seriousness criteria hospitalization prolonged and medically significant), SEPSIS (Sepsis) (seriousness criteria hospitalization prolonged and medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized on 24-May-2021 due to MENINGITIS, PNEUMONIA, SEPSIS and SYSTEMIC LUPUS ERYTHEMATOSUS. At the time of the report, PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) had not resolved. Concomitant medication were not reported. No known allergies for the patient. No treatment information was provided. The reporter stated that the patient is currently admitted in a hospital on a critical condition. The patient was first hospitalized last month on 14 May 2021, and was discharged on 18 May 2021. The patient was re-admitted on 24 May 2021 under critical condition. The patient doesn't have the vaccination card and was unable to provide some important details. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

arm pain, knot on left arm for 3 days, fever lasted 2-3 days, headache, fatigue, blood clot in lower left leg. Was prescribed a blood thinner, swollen arm, inflammation in previous energy places.

Severe, severe menstrual cramping and bleeding. Blood clots that range in size from small dime size to large clots the size of marbles. Filling an ultra tampon in 5 minutes. Going through tampon, pad, underclothes, outer clothes, and through a sweater onto car seat in less than 15 minutes. This bleeding has been going on now for 5 days. This is my first cycle since having the 2nd vaccine and I've NEVER experienced bleeding like this, especially with an IUD. It's debilitating. I literally ran out of my office and into my car after being stranded in the work bathroom for 10 minutes hoping the bleeding would slow enough to get to my car. Changing tampon and pad every 15 minutes. I can't leave the house. I am afraid to go out in public for fear of bleed through accidents. I'm traveling with extra clothes, sanitary supplies and layer up.

Lung Infection; Difficulty Breathing; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung Infection) and DYSPNOEA (Difficulty Breathing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 10-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Difficulty Breathing) (seriousness criterion hospitalization prolonged). On 12-Apr-2021, the patient experienced PNEUMONIA (Lung Infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 12-Apr-2021 due to DYSPNOEA and PNEUMONIA. On 14-Apr-2021, PNEUMONIA (Lung Infection) had resolved. At the time of the report, DYSPNOEA (Difficulty Breathing) outcome was unknown. Reporter states patient got released from hospital after 1.5days , Patient never had lung infection in the past and all of a sudden she had one right about 2 hours after vaccination No concomitant medications reported by Reporter No treatment medications provided by the reporter Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

The next day I developed what I thought was a cold but it transitioned into pneumonia and wasn't resolved until April. Mid June, I had an acute hypertensive crisis, I lost my ability to speak and was incoherent, my BP was 214/108, and I had high heart rate went to to meet with doctor. She sent me for CAT Scan at Providence Milwaukie Hospital and they admitted me for a day to hospital due to my high blood pressure. My eyes have gotten terrible and show blood clots and I see an ophthalmologist regularly, I have lost my ability to focus. Northwest eyecare professionals. 503-657-0321

Patient stated that about 5 days after receiving 2nd dose she had a mild stroke, she was having seizures, she was a ventilator at the hospital when she was taken, 2 blood transfusion, large intestine enlarged, heart is enlarged , liver is enlarged,. Patient stated that she is still having seizures

Low blood pressure; Sweating; Concussion; Diarrhea; Irregular menstrual cycle; Lightheadedness; Dehydrated; Heart pounding; Fever; Covid arm of left arm which was hard in between elbow and shoulder; like hives and was pink; like hives and was pink; Weakness; Eye discomfort; Fainted; Woke up covered in blood gashed forehead open above right eye; Stomach pain; Nausea; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) and HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Chronic myeloid leukemia. Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) for Chemotherapy, VITAMIN C [ASCORBIC ACID] for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (Nausea). On 09-Jun-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Heart pounding), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), DIARRHOEA (Diarrhea), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainted), HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye), PALPITATIONS (Heart pounding), ABDOMINAL PAIN UPPER (Stomach pain), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 67/30 (Low) 67/30. On an unknown date, Heart rate: low (Low) Low. 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-2021-253122 (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.

pt says received vaccine on 5/1 and had a stroke ion 5/7 Dr said could have come from vaccine but unsure Told pt to receive second dose and had no issues Notified rph today and says she is ok

deep vein thrombosis; Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination; Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination; Hypotensive shock; This literature-non-study case was reported in a literature article and describes the occurrence of CAPILLARY LEAK SYNDROME (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination), CONDITION AGGRAVATED (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination), SHOCK (Hypotensive shock) and DEEP VEIN THROMBOSIS (deep vein thrombosis) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Vaginal delivery (normal) in 2002, Amniotic fluid embolism (hypotension and edema) in 2002, Hypotension (systolic blood pressure was approximately 50mmHg) in 2018, Anasarca (after several days of upper respiratory symptoms) in 2018, Sepsis in 2018 and Capillary leak syndrome. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CAPILLARY LEAK SYNDROME (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination) (seriousness criteria hospitalization, medically significant and life threatening) and CONDITION AGGRAVATED (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination) (seriousness criteria hospitalization and life threatening). February 2021, the patient experienced SHOCK (Hypotensive shock) (seriousness criteria hospitalization, medically significant and life threatening) and DEEP VEIN THROMBOSIS (deep vein thrombosis) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized from sometime in February 2021 to sometime in February 2021 due to CAPILLARY LEAK SYNDROME, CONDITION AGGRAVATED and SHOCK, and then from sometime in February 2021 to sometime in February 2021 due to DEEP VEIN THROMBOSIS. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) for Adverse event, at an unspecified dose and frequency; ANTIBIOTICS for Adverse event, at an unspecified dose and frequency and CORTICOSTEROIDS for Adverse event, at an unspecified dose and frequency. In February 2021, CAPILLARY LEAK SYNDROME (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination), CONDITION AGGRAVATED (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination), SHOCK (Hypotensive shock) and DEEP VEIN THROMBOSIS (deep vein thrombosis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Adenovirus test: negative (Negative) Negative. In February 2021, Aspartate aminotransferase (5 u/l-34 u/l): 47 u/l (High) 47 U/L. In February 2021, Blood albumin (35 g/l-52 g/l): 20 g/l (Low) 20 g/L. In February 2021, Blood creatine phosphokinase (0.48 µkat/l-2.8 µkat/l): 23.19 µkat/l (High) 23.19 µkat/L. In February 2021, Blood creatinine (0.55 mg/dl-1.2 mg/dl): 1.5 mg/dl (High) 1.5 mg/dl and 132.63 µmol/l (High) 132.63 µmol/L. In February 2021, Blood immunoglobulin G (7.00 g/l-16.00 g/l): <2.70 (Low) <2.70 g/L. In February 2021, Blood lactic acid (0.5 mmol/l-2.2 mmol/l): 7.7 mmol/l (High) 7.7 mmol/L. In February 2021, Blood pressure systolic: 60 mm hg (Low) 60 mm Hg. In February 2021, Bordetella test: negative (Negative) Negative. In February 2021, Chlamydia test: negative (Negative) Negative. In February 2021, Haematocrit (0.341-0.449): 0.686 (High) 0.686. In February 2021, Haemoglobin (112 g/l-157 g/l): 233 g/l (High) 233 g/L. In February 2021, Heart rate: 120 beats/min. (High) 120 beats/min.. In February 2021, Human metapneumovirus test: negative (Negative) Negative. In February 2021, Human rhinovirus test: negative (Negative) Negative. In February 2021, Influenza A virus test: negative (Negative) Negative. In February 2021, Influenza B virus test: negative (Negative) Negative. In February 2021, Influenza virus test: negative (Negative) Negative. In February 2021, Mycoplasma test: negative (Negative) Negative. In February 2021, Platelet count (150.00 10^9/l-440.00 10^9/l): 213.00 10^9/l (normal) 2113.00 10^9/L. In February 2021, Red blood cell sedimentation rate (0 mm/hr-25 mm/hr): 1 mm/hr (normal) 1 mm/hr. In February 2021, Respiratory syncytial virus test: negative (Negative) Negative. In February 2021, SARS-CoV-2 test: negative (Negative) Negative for 229E, HKU1, NL63, and OC43 coronaviruses. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CAPILLARY LEAK SYNDROME (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination), CONDITION AGGRAVATED (Severe exacerbations of systemic capillary leak syndrome after covid-19 vaccination), SHOCK (Hypotensive shock) and DEEP VEIN THROMBOSIS (deep vein thrombosis) to be possibly related. On an unspecified date in Feb-2021, patient presented to hospital with influenza-like syndrome, hypotension and tachycardia. During the hospitalization, the patient experienced anasarca, bilateral lower-extremity pain and a pericardial effusion. The patient gained 18 kgs of weight. Patient's additional treatment included vasopressors and Intravenous fluids. On an unspecified date, patient was discharged on day 7 of hospitalization. Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Full text article received : clinical course of events, laboratory investigations, treatment details and medical history were added.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected.

7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation

Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found to have a right lower lobe pulmonary embolism. Treated with Xarelto and sent home with outpatient follow up.

My colitis acted up - I had increasingly severe abdominal pain, diarrhea and bleeding. The severity subsided after 3 days, now after 2 weeks I have minimal pain and bloody stools.

Anaphylactic Reaction within 1 minute of receiving vaccine. Received Epipen injection & taken to ER by ambulance. Given IV steroids, anti-inflammatory. Prescribed Prednisone 20mg for 4 days. T Instant weird feeling, dizzy, throat closing, trouble breathing & swallowing, fast heart rate, tongue & lips tingling and numbness

Anaphylactic reaction: 911 dispatched: IV diphenhydramine administered by EMS; patient stable/coherent and transported to local hospital.

New sensitives to face cleansers; Anaphylactic shock; A spontaneous report was received from a consumer, concerning herself, a 47-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic shock and "newsensitives to face cleansers". The patient's medical history was not provided. Concomitant product use included face cleansers. On 08-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08-Jan-2021, approximately five minutes after receiving the vaccine, the patient experienced anaphylactic shock as evidenced by throat warm and tingling, arms was bright red and warm to touch, trouble breathing, felt like choking, and nausea. Hence, she was treated with "epinephrine quite a few times along with steroids and ranitidine". On 09-Jan-2021, the patient went to the hospital two more times for "breathing issues", however she was not admitted. On 10-Jan-2021, in the morning, the patient had "passed out" and was given another epinephrine injection as she went into anaphylaxis shock again. On-29 Jan-2021, the patient also reported her arm, legs and chest are "bright red" and "burns". The patient also experienced new sensitivities to the face cleansers she has used for over 12 years. Action taken with mRNA-1273 in response to the events were unknown. The events, anaphylactic shock, was considered newsensitives to face cleanser" were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient, who experienced serious event of anaphylactic shock and non-serious event of sensitive skin. The event of anaphylactic shock occurred on the same day and re-occurred again approximately 2 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Received vaccine at 825 am, low grade temp, chills, body aches, temp never over 100.4, at approximately 1:00am woke up to use restroom, felt lightheaded, nauseated. Passed out, hit head and had tonic-clonic seizure. No history of syncope or seizures. Transported to ER by EMS. given fluids, completed labwork and CT head, given concussion protocol. Discharged and arrived home by 5:00am.

Three days after initial Moderna Vaccine, I developed signs and symptoms consistent with DVT. I presented to my PCP's office for evaluation on Thursday; February 4 and was sent for an ultrasound at Imaging. Ultrasound of right leg showed 2 DVT's. I was started on Pradaxa but experienced an adverse reaction (excessive bleeding with menstruation) which resulted in an emergency room visit on 2/8/2021 and 2 additional days of prescribed bed rest.

reported bad headaches on the day following the vaccine--did not see the doctor--later died. the coroner reported that the preliminary autopsy showed an enlarged heart and liver

Patient said she came down with pneumonia 1 week after this dose and has been in the hospital since then.

Abnormal menses. Huge clots. Velocity and volume of blood extreme. (Different from previous experiences of menorrhagia). The only other time I experienced this type of dramatic and concerning bleeding was after I took the Hepatitis vaccine (first shot) about 2 years ago. I think that's the only other vaccine I've had as an adult. There is mention of heavy bleeding as a rare side effect for Hepatitis vaccine, and I surely hope you will study this effect from Covid vaccine as it took nearly a year to regulate my cycle after the Hepatitis vaccine reaction. I've seen some reports suggesting that the excessive bleeding that women are experiencing after the Covid vaccine is due to stress and that is just plain insulting. Stress does affect the menstrual cycle; that is well-known, but this is something entirely different. I have also had small clots in the nose during the past several days, which again, is highly abnormal for me. Thank you for looking into the bleeding side effects that hundreds (if not more) women are struggling with at this time.

Left lower leg pain started on 3/9/2021. Doctor appointment on 3/12/2021 for worsening leg pain. Ultrasound - diagnosed with DVT. 3/12/2021 started on Eliquis.

I had a blood clot in my right leg . It started to bother me on 3/19/21. I called my doctor on 3/22/21 and she advised that I be seen in the ER. The ER doctor confirmed that I had a blood clot in my leg and I was treated with Lovenex. In addition to the clot in my leg, I have multiple bruises on my arms and legs where blood vessels broke in the couple days before and after the ER visit. I also felt very out of shape, with trouble getting enough breath. Within 2 days of getting the Lovenex, I felt like I could breath normally and my symptoms improved. Not sure if it is connected to the vaccine but thought it was important to report. I am an active, otherwise healthy person who walk at least 5 miles daily. The blood clot was very unexpected.

Pulmonary embolism diagnosed following CT scan on 4/9/2021. Noticed pain in right lung a few days previous (4/7/2021). Prescribed Xarelto.

Roughly 7 to 10 days after injection I presented with raised, red and itchy injection site. Roughly 13 days after the injection I presented with a tight right calf muscle that felt similar to a constant "charlie horse". It continued to worsen over the next 5 days until my right foot went numb and cold on Sunday April 4. I called my doctor the next day (Mon April 5) and they got me in that day and I went to the hospital the same day for an ultrasound. The hospital confirmed I had a blood clot in my lower leg.

Patient vaccinated around 9:57 AM. In observation and felt it was "hard to swallow". RN walked patient to the bed and took vital signs. DOC of the day called to assess the patient. Patient reporting difficulty swallowing. Speaking in full sentences. Denies itchiness, vomiting, or hives. Patient given water which visibly looked difficult to swallow. 50 mg IM Benadryl given to patient. Will continue to monitor. After giving Benadryl, patient reported improvement in symptoms. About 10 minutes later, patient stated symptoms were coming back and were worse with posterior tongue swelling and throat constriction. 0.3 mg EPI pen administered to patient. EMS transport recommended to patient when EPI was given. Patient denied transport at that time. Patient instructed and educated on the risks of denying EMS transport. After ten minutes post EPI pen, patient and provider both agreed it necessary to call 911 because patient reported no significant improvement after EPI pen. 911 called at 1041 and arrived on scene at 1055. Patient taken to hospital. Patient awake and alert speaking in full sentences at the time of transport.

Like the reaction to the first dose, pain and swelling at injection site, swollen lymph node under armpit, fever of 101 F, headache , severe joint pain, fatigue and unusual and heavy menstrual bleeding starting two days after the injection. Bleeding so heavily medical care was sought after first injection. Thought it might be my IUD, which was removed after the first episode. Full gynecological exam indicated everything was normal. Menstrual bleeding happened again 2 days after second vaccine, characterized by early arrival, heavy flow and clotting.

Entered ER for wholebody rash 12 days post 2nd vaccine with throbbing headaches, chronic lumbar pain and acute, left and right shoulder aches and elevated resting heartrate >100bpm. Admitted into hospital for further observation for bacterial infection, pneumonia based upon labwork and chest xray. Further tests pending results from CT scanfor the headaches and lumbar puncture to rule out meningitis. Tests ordered for labwork for liver enzymes and ultrasound. Root causes for all symptoms are still in investigation.

very mild heart attack; chest started burning; couldn't breath; incomplete course of vaccination; very sick; arm got little sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (very mild heart attack) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product SIMVASTATIN for an unknown indication. The patient's past medical history included Allergic reaction (MMR vaccine allergic reaction as an infant) in 1973. Concomitant products included PANTOPRAZOLE, SERTRALINE and VARENICLINE TARTRATE (CHANTIX) for an unknown indication, ACETYLSALICYLATE LYSINE (ASPARIN). On 24-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SIMVASTATIN (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm got little sore). On 25-Mar-2021, the patient experienced ILLNESS (very sick), DYSPNOEA (couldn't breath) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On 25-Mar-2021 at 8:00 AM, the patient experienced MYOCARDIAL INFARCTION (very mild heart attack) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (chest started burning). The patient was hospitalized on 25-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (very mild heart attack), ILLNESS (very sick), CHEST PAIN (chest started burning), DYSPNOEA (couldn't breath), INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) and VACCINATION SITE PAIN (arm got little sore) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Angiogram: normal (normal) no signs of plaque buildup. On 25-Mar-2021, Blood creatinine: abnormal (abnormal) levels determined patient was having a mild heart attack. On 25-Mar-2021, Electrocardiogram: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was very panicky about getting the second dose for fear that she would have another heart attack. She went to the cardiologist for a follow up and the doctor could not determine why she had a heart attack. The patient reported that it was not a normal heart attack in that her blood pressure and pulse were not raised, but instead, were low. The patient agreed to follow up with her HCP (health care provider). Treatment for the heart attack included SIMVASTATIN and BABY ASPIRIN to prevent blood clots. Based on the current 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.

DIARRHEA, SWOLLEN TONGUE, TONGUE SORES, FEVER, CHILLS, ACHES, HEADACHE, TONGUE SWELLED MORE THE NEXT DAY AND SORES WERE BECOMING INTOLLERABLE. MAJOR FATIGUE. HEART PALPITATIONS, WEAK LEGS. EVERYTHING SEEMED FOGGY.

Urinary Track Infection and bleeding like menstrual bleeding for 3 weeks straight starting 2 weeks after 1st vaccine.

5/17/2021 pt. c/o "bad" period & increased heaviness with clots @ 5/18/2021. c/o feeling tired, cramps, slight nausea

Heart Rate and blood pressure increased after 2nd dose within 12 hours. HR did not return to normal since 2nd vaccine. 3 months after 2nd dose, visits to doctor and emergency room for chest pain, increase heart rate and short of breath showed 2 blood clots, one in each lung (bilateral pulmonary embolism)

Severe headache, chills, fever SEVERE SPASMS IN URETHRA AND VAGINA. Spotting next day. (Menopausal, no period in 3 years before this)

ER visit on 05/09/2021 due to left lower leg pain and swelling. Diagnosis was Superficial thrombophlebitis. Follow-up with primary care on 05/12/2021, then endovascular doctor on 05/19/2021 confirmed diagnosis, no deeper clots found at that time via ultrasound. Received prescription for blood thinner (Xarelto). ER visit on 05/22/2021 due to leg pain higher up the leg. Doctor had recommended ER if pain seemed to move up the leg. Diagnosis via ultrasound of a popliteal vein thrombosis behind the left knee. Follow-up with endovascular doctor, received prescription for blood thinner (Eliquis) instead of Xarelto due to nausea.

Standard reactions except I have been spotting vaginally and cramping since the day after getting the shot. I have the Mirena birth control implant and do not have a monthly period and have not had one for many years nor do I get the cramps and other symptoms of having a period. For the past 9 days since getting the vaccine, I have had spotting and cramping off and on daily. This is NOT normal for me!

Vaccine was given on second day of menstruation cycle on 4th day of mensuration when normally my cycle is finished or tapering off. I had an increase amount of bleeding with large blood clots. At the same time my birth control brand was switched to another brand so didn't know if the change in bleeding/clots was related to change in birth control or moderna vaccine. I reached out to my gyne and made her aware she stated that it was not related to the birth control as it was the same med/dosage. That more than likely was related to moderna vaccine and if the bleeding didn't stop or if it increased to seek medical attention. My cycle lasted for a total of 9 days vs 4-5 days. Clots were from day 4-9.

Approx. 9:00 pm on 6/15/2021 I was relaxing and sitting on my couch for about 2 hours. I was scrolling through my phone reading when I had a gradual onset of confusion to the written word. I recognized that I was struggling to comprehend, so I tried to verbalize the words. I was unable to formulate words and my speech was slurred and garbled. I summoned help and my son drove over to my home. He proceeded to take my blood pressure and heart rate and asses the situation. The symptoms subsided after approximately 5 minutes. I regained my ability to speak and communicate. I went to the hospital the following morning and was admitted for testing. All subsequent scans and blood work all came back normal with no indication of neuro-vascular irregularities. I was diagnosed with a Transient Eschemic Attack or a mini stroke with no known cause. Continuing care will include a baby aspirin and a statin drug to prevent any further strokes.

I have been spotting ever since my covid shot and 3 days prior the skin peeled off of both my feet with layers of skin peeling off. I had to soak my feet to soften and lather lotion for weeks. I had such sever itching in different areas and had to apply hydrocortisone and numbing cream to alleviate the itching. I thought this has all been normal ?things? in my life?!?!? The spotting still has not stopped and my Pap smear was normal.

Patient admitted for Headache and fever, found to be COVID-19 Positive upon admission, post vaccination. Pt received both COVID vaccines-Moderna- last dose was 04/22- developed COVID. Allergies (drug/food and reaction):__Niacin Date of Vaccination 1 :__3/25/2021- Moderna-Lot 018B21A Date of Vaccination 2 :__4/22/2021- Moderna ?lot 046b2A Clinic Administering Vaccine: County Health department Injection site: Unknown (Arm) Hospital Admission 6/3/2021 for headache and low grade fevers Positive covid test 6/3/2021 Discharged 6/5/2021

12/24/2020 PT is a 47 y.o. female who arrived by Car presented to the emergency department for Stroke symptoms. Patient awoke at 6:15 this morning, some difficulty seeing out of the right eye and also was stumbling towards the left and to table. Concerned about things not being right so brought to the emergency department. Patient feels her speaking and swallowing are okay. She did drink a bit of coffee earlier. She denies headache or significant vision problems presently. Continues to not feel normal on her left side. No history of stroke and parents or siblings. She does give personal history of an occipital migraine many years ago at which time she did not have a headache but had some vision troubles. Patient's speech seems a bit slurred to me. Absence of ocular movements towards left noted as well as upward movements. Tongue is midline. Patient is unable to shrug the left shoulder or lift the left arm off the bed. Grip strength is 4 out of 5 on the left. Left leg strength is 3 out of 5. Extremity strength on right arm and leg is 5 out of 5. Pt transferred to another facility. PT is a 47 y.o. female with benign past medical history apart from tobacco use presents as a transfer to our facility from ER for further evaluation and treatment sudden onset bilateral blurred vision, difficulty with visual tracking as well as slurred speech, perioral paresthesias, with left hemiparesis. Patient was last known well last evening. She awoke today at approximately 6:15 AM with above described focal neurologic deficits. She does have a history of migraines (specifically citing an ocular migraine roughly 12 years ago which resulted in similar strokelike symptoms) but denied aura, headaches in the last 24 hours. No other physical complaints noted including chest pain, shortness of breath, GI upset, irritative urinary symptoms; no fevers, body aches or chills; no recent illnesses. She does work in the lab at Hospital and admits to possible Covid encounters but denies Covid symptoms. She was in fact vaccinated yesterday 12/23/2020. Pt has had extensive rehab and therapies. PT is a 47-year-old female with a history of PFO, CVA and tobacco abuse. On 12/24/2020 she awoke with vision changes and some issues with walking and depth perception. She was diagnosed with acute ischemic stroke. MRI showed a basal ganglia stroke, CT of the head and neck arteries were without significant carotid disease. She had an extended Holter monitor that did not suggest significant arrhythmias. Her hypercoagulable work-up was positive for MTHFR mutation. She is on single antiplatelet therapy with aspirin and high intensity statin. She presented to Hospital on 4/15/2021 with planned PFO closure procedure. 6/29/21 HPI patient is seen today to discuss going back to work. She feels like she is ready to go back to work and did have a work well functional capacity evaluation on 6/15/21. This did demonstrate that she is able to work at medium physical demand level VIII hours a day for 5 days a week. She continues to follow with neuro-ophthalmology for her left eye. She is currently wearing a frosted lens on the left and states that she was told that her eye is a 20% chance of improving on its own or 80% chance of having to proceed with surgery. She feels like her gait and balance are much improved. She has been doing household chores, shopping, gardening, even mowing the yard and has tolerated this well. Sometimes she gets more tired but does feel like her excessive fatigue is not quite as bad since she has been more active. She continues to sleep well at night. She does occasionally have to take a nap in the afternoon. She does have chronic neck and back pain which she uses tramadol occasionally for. She has been having more achiness in her hips, legs as well as arms but is wondering if this is due to lack of activity and she also blames weight gain since her stroke. She has not had any swelling in her lower extremities. She does have some varicose veins of lower extremities and has support hose but has not been wearing them. Plan: She will continue with her current medications. She states that her neurologist to decrease her Lipitor to 40 milligrams daily. She does not feel like this has necessarily caused increased myalgias or arthralgias. She does have varicosities of the lower extremities and encouraged her to use her support hose especially when she returns to work. She does feel like she is ready and capable to return to work and will gradually ease back into this. I think it is best to start with 4 hours a day 3 times a week the first week then increase to 4 times a week (or 16 hours a week) for 1?2 weeks and if tolerated increase this to 32 hours a week. Once she is able to tolerate 32 hours a week for 4 weeks then would try to resume her normal 40 hours a week. She is going to give us a phone report in 2 weeks however she is to call or return sooner if she cannot tolerate this.

A few days after 2nd vaccine, she experienced on and off neck pain which was treated with massage, exercise and pain medication. On Feb. 28, still woke up with pain and personally massaged neck and head. Immediately experienced diziness - room spinning, a minute later had nausea and vomiting. Relieved for a few minutes and restarted. Called 911 due to severe weakness. At ER in the evening, she experienced right side weakness. CT head was done with negative result. She was transferred to core hospital due to intractable hypertension. Neuro saw her at another hospital and MD declared she had a stroke. It was verified via head MRI: cerebellar and medullary. Stayed in neuro ICU for 6 days in which PT (next page)

She had enlarged heart; She had enlarged liver; She is very angry that this happened to her.; She felt as if she was dying.; Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021; Within 7 days after receiving 2nd dose, she had a stroke.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.), FEELING ABNORMAL (She felt as if she was dying.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021). At the time of the report, CEREBROVASCULAR ACCIDENT (Within 7 days after receiving 2nd dose, she had a stroke.), CARDIOMEGALY (She had enlarged heart), HEPATOMEGALY (She had enlarged liver), ANGER (She is very angry that this happened to her.) and FEELING ABNORMAL (She felt as if she was dying.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her 1st dose on 06Apr2021 and 2nd dose on 18May2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication were not provided Treatment medication were not reported Patient went to ER within those 7 days. Patient mentioned that her husband was also sick after receiving vaccine. Action taken with mRNA-1273 in response to the events was not applicable. As an intervention patient had 3 blood transfusions and was on ventilator Based on the current available information and temporal association between the use of the product and the start date (within 7 days) 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 (within 7 days) of the events, a causal relationship cannot be excluded.

A few days after the shot I felt bad. About a month afterwards, I got pneumonia and went to the ER. During a chest x-ray, they found that my heart was enlarged. They sent me home and two weeks later I went to work. I started having chest pains, but I thought that I pulled a muscle at work. I went to the ER and was told about the inflammation of my heart and they thought I was having a heart attack. I also tested positive COVID and was rushed to another hospital that was better staffed to treat people like myself. I was diagnosed with a leaky valve, arrhythmia, and myocarditis.

I had Covid-19 in January of 2021. I had mild symptoms. One week after the second dose of the vaccine I passed out. I was hospitalized for five days. My heartbeat was very low I had a heart attack. I was also treated by a Pulmonologist. I now have a C-Pap machine and I have a pacemaker. I have not returned to work and it has been 10 weeks.

For three days after vaccine had head and body ache, chill, fever. Felt better after this for a few days. On April 26 went for a walk with neighbor, heart shaking and pounding very tired. Over next few weeks at different times felt very tired heart pounding near faint low and high pulse at times. May 24 almost pass out dizzy heart pounding. Tried to see Dr. no appoints available. On June 11 went to urgent care and referred to hospital emergency room, did many test, told had Premature Ventricular Contractions. June 18 saw cardiologist. Did EKG Holter monitor. July 19 cardiologist said had "Right Ventricular Outflow Tract Tachycardia. Will see heart specialist at the hospital on August 3, 2021. Patient currently can not do any physical activity. Many times she feels she is having a heart attack. Her life has changed dramatically. We will see what the Special Cardiologist recommends for treatment on August 3rd. Patient was in excellent health before this. Never has smoke or drank alcohol. Would drink one cup of coffee in morning and drink water the rest of the day. Eats healthy lean meat and vegetables etc. Exercises regularly. No one in her family (parents siblings) has had any heart problems. For three days after vaccine had severe flu like symptoms. Felt better for a few days and then went on a 2 mile walk with a 73 year old neighbor. A walk that she has done many times before this with no problems Had reaction during walk as state above. We feel the vaccine caused something to happen with her heart. She had never had any issue before the vaccine and was in excellent health.

9 days after second shot body covered with pimple bumps, skin rash reaction, appeared again after 6 weeks of 1st skin reaction. Same thing red pimple bumps all over body looked like chicken pox. Emailed doctor who cofirmed a reaction from Covid shot. 7 weeks after Covid shot got a bad UTI. Called doctor got meds. Did not go away after taking meds. Went in on May 25, 2021 to take a urine test at doctor. Confirmed UTI still. Given different meds. Did go away after 7 days of new meds. Did not have a menstrual cycle for 2 months after the 2nd Covid shot. Menstrual cycle resumed after 2 months. Extreme pain, huge blood clots, super heavy, lasted 10 days. It has been a month and a half and I am still not having a menstrual cycle. Menstrual cycle not the same since taking the Covid shot. Ongoing issues.

Vaginal bleeding and genital herpes outbreak within 24hrs of receiving first dose of vaccine. Bleeding for 6 days straight even though previous menses ended two days before receiving the shot. It was a normal period prior to that.

Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf, warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in the hospital now.

The patient was seen in my office on 1/19/21 with complaint of heavy vaginal bleeding. A CBC was obtained which revealed an H/H of 12.2/36.1 and a platelet count of 1 (not 1K, but 1 platelet!) and this was confirmed on smear review. She was immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and she has received platelet transfusions but her platelet count is still critically low. She is also receiving steroids and immunoglobulin and is under the care of MD (Heme/Onc)

Had a headache within 10 mins. After 30 mins of shot -had bottom lip numbness and loss of taste then swelling of throat and left side of face. Anaphylactic symptom and all other symptom were worsening until decreased when Benadryl and Pepcid AC which was taken an hour later due driving en route to destination. Within 2 hrs all symptoms were gone except for throat tenderness. Continued Benadryl and Pepcid AC for 2 days now.

patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.

Anaphylactic reaction; Scratchy throat; Pain-near injection site; A spontaneous report was received from a consumer concerning a 48-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, scratchy throat and pain near the injection site. The patient's medical history included COVID-19. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) on 06 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 06 Jan 2021, almost immediately after receiving the vaccine the patient reported having a scratchy throat and pain near the injection site. She stated she spoke with her health care provider who advised her she was having an anaphylactic reaction. Treatment for the event included Benadryl. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events anaphylactic reaction, scratchy throat and pain near the injection site were unknown.; Reporter's Comments: This case concerns a 48-year-old female patient. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant, and an unexpected non-serious event of Scratchy throat along with an expected non-serious event of pain near the injection site. The events occurred almost immediately after receiving first dose of first of two planned doses of mRNA-1273 (Lot number 039K20-2A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. Treatment included Benadryl. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.

Pt was treated with bactrim days before COVID vaccination. Then days after COVID vaccination, had Bactrim again. Anaphylactic rxn occurred 1-2 days later. Reaction was likely related to Bactrim, but did receive COVID vaccination in same time period.

01/25/21 developed "Covid Arm" rash, heat, itch continued for ~3 days - treated with antihistamine. 02/15/21 experienced a TIA - no know risk factors prior to this event.

Red blister rash all over body and head, bleeding on scalp and gums, and extremely easy bruising. Period longer and heavier bleeding. When symptoms had not resolved one week after appearing, went in-person to GP. Blood test revealed extremely low platelet count. Hematologist consulted diagnosed Immune Thrombocytopenia (Immunte Thrombocytopenic Purpura) or ITP.

I experienced a runny nose with mucus, blood running from nose with blood clots four to five times a day from March 8th 2021 up to March 10th 2021. It is unknown rather I have blood clots within my body.

Patient was received her covid vaccine and sat for her observation period. When driving home she noticed her throat was itching and feeling tight. She returned to the clinic. At 3:50 pm patient's symptoms progressed (throat itching, uvula swelling, and pt developed a migraine) and Dr. administered Epi .03 ml IM in right anteriolateral thigh. Patient diagnosed with anaphylaxis/angioedema, hyperventilation, and right side migraine. Paramedics dispatched. Patient transported to Hospital. Dr called report to ER.

Patient experienced anaphylactic reaction which includes fainting, sudden increase in secretions from eyes and nose, weakness, numbness in upper extremity (fingertips) agitation, flushing dizziness, feeling something wrong, and extreme headache. The patient was treated with epipen and pharmacist called 911 and advised patient to go to the hospital. Patient recovered in approximately 30 minutes but refused to go to the hospital and called in a ride by the husband.

Patient presented to a local ED on 3/25/2021 & was diagnosed with a deep vein thrombosis in the right lower extremity. She is convinced it is related to the vaccine she received on 3/9/21 and cancelled her appt for her second vaccine.

3 hrs. after my injection I suffered a grand mal seizure. I have a history of seizures but have not had one in 3 years. I was not breathing for 1 minute, hands and face were blue. Unconscious for over 20 minutes. Rushed to ER was given an IV of anti seizure medication.

7 AM 3/25/2021 - Patient called out to husband from the bathroom where she experienced a syncopal event, then passed out. An ambulance was called and she was revived for a short period of time. She was taken to Hospital where she coded 3 times. She was then life-flighted to second Hospital. According to the hospital records, tests conducted over the course of several days determined that she had no neurological activity. Initial reports in the records indicate pulmonary embolism, cardiac and respiratory arrest. She was on life support for the remainder of her time. Organ donation is being pursued at present and results of this are pending at time of this report submission. Date of death is unknown until organ retrieval is accomplished. Family will be contacted in the next few days to ask further questions about any other kinds of vaccine-related reactions that may have happened more immediately to days after the vaccination on 3/17/2021. A co-worker thought that she had shortness of breath for 3-4 days before this critical event occurred on 3/25/2021.

PT STARTED HAVING A FEELING OF HEAVINESS, MALAISE, FATIGUE, HEADACHES ABOUT AN HOUR OR TWO AFTER THE SHOT WAS ADMINISTERED. THE SIDE EFFECTS CONTINUED THRU THE WEEKEND AND SHE TOOK TYLENOL TO HELP WITH SYMPTOMS. ON MONDAY, 3/15/21 AROUND 720PM SHE COLLAPSED AT HOME AND WAS RUSHED TO THE HOPSITAL E.R. CT SCAN WAS ORDERED BECAUSE DR WANTED TO RULE OUT STROKE DUE TO WEAKNESS ON RIGHT SIDE,SPEECH IMPAIRMENT,HEADACHE,WEAKNESS, AND SHE HAD BITTEN HER TONGUE. SHE WAS ADMITTED INTO THE HOSPITAL. TUESDAY 3/16/21 - DR ORDERED CT SCAN AND MRI TO RULE OUT STROKE...PT WAS CONFIRMED TO HAVE HAD STROKE WEDNESDAY 3/17/21- EEG ORDERED AND PT POSITIVE FOR SEIZURES PT DISCHARGED FROM HOSPITAL 3/17/21 AND PRESCRIBED CLOPIDIGREL AND ATORVASTATIN AS TAKE HOME MEDS.

Pt developed MIS-A with a significant hospitalization (6 days) from 2/8-14, 2021. However, this was felt much more likely to be due to her antecedent SARS-2 infection, which preceded her vaccination. She was dx'd w/COVID w/onset of URI/sinus sx onset 12/31/20, dx'd w/pos PCR on 1/2/21. Experienced fairly modest sxs and did well w/conservative tx (cough suppressants, rest, no steroids), returned to work subsequently. Then took 1st COVID vaccine )Moderna, 1/22/21) uneventfully. Developed MIS-A in early Feb, within 6 wks of her SARS-2 infection--GI sxs, rash, conjunctival injxn, encephalopathy, elevated BNP though LVEF intact, tx'd w/IVIG x 1, steroids, aspirin, w/extensive inpt ID, Rheum eval and good response. Received 2nd mRNA vax completely uneventfully on 2/19/21. Largely recovered from her MIS-A currently. MIS-A form completed and submitted.

It started at about 07:00 pm and I do have chronic hives but it exacerbated those symptoms extensively - the symptoms almost with going up my neck, and face and up towards my mouth - Anaphylactic reaction kind of. This was much worse than I had after having chronic hives for last seven years. I contacted Hospital. I wasn't short of breath. They said to go to ER but I was not feeling that I needed to do that. I went to a clinic on the 23rd - and when I was there the doctor could see more hives appear as I was sitting there. The doctor gave me a prescription for steroids in case I needed it. I doubled up on the Benadryl and the antihistamines - the hydroxyzine that I normally take for the hives. The doctor said the vaccine may not work if I took the Steroids. The medicine just made me sleepy so that I didn't care if it hurt or not. It was really really uncomfortable. It was really bad for a day and a half and within three days it was gone. With my chronic hives - I can have them come and go in a day but they don't usually linger at day or more at a time.

48 yo female who presented today for her first dose of the Moderna vaccine. Vaccine was administered at 1400 in the left deltoid. Patient was directed to go to the observation area for a 15 minute observation period after administration of her Moderna vaccine. While walking, patient was assisted to the floor by two volunteers, amid a suspected seizure. Arriving on scene, patient was unconscious and having a tonic-clonic seizure that lasted 20 seconds. EMT's were on scene placing an 18g PIV in the right forearm, collecting a BG, and had placing the patient on the monitor. Patient was placed on a NRB mask at 15 L of O2. Patient again fell unconscious and had a second tonic-clonic seizure that lasted 20 seconds. Patient regained consciousness and requested that provider unlock cell phone to collect patient medication list and husband's information. Husband was contacted and requested to enter to be by her side. Husband reported a history of seizures (tonic clonic) and current treatment/management. He requested that patient not to be taken to the ER. Provider advised husband and patient that the paramedics would determine the necessity of her transfer to the ER. Ambulance was notified and Fire reported to the patient's side by 1435. Upon arrival, husband and patient requested not to be transferred to the ER. While answering questions, patient again was assisted to the floor and sustained a third tonic-clonic seizure lasting approximately 20 seconds. Provider aided paramedics in transferring patient to the gurney. Patient was transferred to hospital with husband and all personal belongings.

Woke up on 4/4 with a golf ball sized, raised welt at the injection site. It was hot and very red. The next day, it was even larger, by 4/7, it had completely gone away. Everyone thinks I should also mention that I was admitted to the hospital with chest pain, high BP/Pulse on 3/31, they did a D-Dimer on me and it was elevated, suggesting a clot has formed and is in the process of breaking down. I had a CT of my chest and no PE was found, but I had thickening of my left lobar pulmonary artery wall, further supporting the suggestion of a possible blood clot. After an echo stress test, I was discharged the next day on HTN meds. I was experiencing chest discomfort prior to my vaccine, but again, EVERYONE is telling me I need to report this, so I am. :)

Anaphylactic episode- 911 called, transported to the hospital. Administration of PO Benadryl 50mg, IV Push Benadryl 50mg, epinephrine injection, IV Solu-Medrol, IV hydration. Symptoms: difficulty breathing, swelling of throat and tongue, dizziness, nausea, rash/hives over entire upper body, rapid pulse, metallic taste in mouth.

Grand mal seizure and upper body rash Emergency room treatment (4/12/2021 @ 9:30Pm) including IV saline and magnesium CT scan results were normal Magnesium level normal Follow-up with GP within 48 hours

Pt reported to PCP office on 04/15/21 with itchy and painful red lesions to L elbow, L hand, L neck, and face x1 week - 10 days. Onset around 04/05/21. She reported a sudden onset of sharp pain to face lesions the day before while at work. She has been using creams for that she had at home including Triamcinelone and Desonide cream to no relief. Pt reports some swelling to L elbow and blood when she scratched. PCP diagnosed her with Herpes Zoster and prescribed valACYclovir 1 GM Tab Take 1 Tab 3 times Daily for 7 days on 04/15/21.

I suffered a severe hypoglycemic seizure which nearly took my life and I believe that it was caused by my recent covid vaccine (moderna). I?m not a diabetic nor have I ever been. I received my second covid vaccine on February 26 and on March 14th at around 6:45 PM and while at work, I suffered a grand mal seizure while working at the Hospital (I?m a respiratory therapist). I was alerted overhead and a team of clinicians rushed to my aid. My glucose was measured and it had decreased to the low 40?s. They had a difficult time getting it to normalize and I ended up being admitted into the ICU. I had a severe tongue laceration and headaches afterwards. Strangely, less than an hour before the seizure, I had eaten a piece of cheesecake so my glucose had no reason to all of a sudden bottom out as it did. There were no other circumstances that could or would have led to a hypoglycemic seizure.

On April 6, I donated blood, which is something I do routinely at my local blood bank. I was lightheaded for a prolonged period of time after the donation; by the time I got home around 11am, my blood pressure was very low and I could not stand up or I would get dizzy and off balance. I was unable to work. My blood pressure resumed to normal the next morning after a full night's sleep. On April 7, I had an appointment to receive trigger point injections and the nurse practitioner who administered them said I was bleeding at every injection site, which was highly unusual for me.

Patient states that on Friday 4/2/2021 she received her first dose of a moderna Covid vaccine at around 1 PM. She was started having a hard time swallowing her dinner around 5 pm. She administered her epi-pen and went to the ER. This patient is not 100% sure if it was due to covid vaccine because 4 days later 4/6 she had another anaphylactic reaction similar to the one on 4/2 but states throat felt tight and itchy along with itchiness on her body.

I began to have worsening fatigue and then started walking slower than normal and then started noticing cramps in legs and then calf pain and finally shortness of breath. The onset and progression was subtle and so I can not say over how.many weeks it occurred. My symptoms continued to worsen and I eventually saw a dr and was worked up and confirmed to have a dvt. 2 days after diagnosis, I progressed to having a bilateral PE.

On 20 Jan 2021, 8 days after immunization developed bullseye rash on L upper arm at site of injection and nodular/papular dermatitits on anterior thiges bilaterally. Was seen by urgent care on 20 Jan 2021 and prescribed prednisone 20mg daily x 5 days. L upper arm lesion resolved after 3 days but anterior thigh lesions remained. She was seen by dermatology on 3 Feb 2021 and biopsy performed. Lesions described at that time as indurated erythematous to violaceous subcutaneous nodules. Seen in follow up at dermatology 9 Feb 2021 and had intralesional steroid injections. Seen by dermatology 16 Feb 2021 as treated lesions persisted, now lesions appeared on anterior thighs and patient c/o increased pruritus. She was treated with 1st and 2nd generation H1 blockers and a 2 week prednisone taper. Biopsy consistent with granulomatous dermatitis/panniculitis. Starting early Feb 2021, noted gradually worening symptoms of dyspnea on exertion. Seen by pulmonologist who ordered a chest CT and subsequently diagnosed with pulmonary embolus. She was started on abixiban daily. She was further evaluated by cardiology, hematology and rheumatology in March and April 2021. She had been on OCP at the time of diagnosis of the PE and this was changed to Nexaplan implant by Gyn. Workup with all specialists ongoing. Pulmonology recently added Fluticasone/Salmeterol inhaler which she finds has not improved her dyspnea.

Went hiking and got a blood clot; beyond 36 days since first dose without receiving second dose; Interfered with work; Glands got super swollen; Trunk Rash; Excruciating headaches for three days; Extremely fatigued; High temperature; Nauseous; Ringing in ears; Taste buds changed; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went hiking and got a blood clot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Grover's disease. Concurrent medical conditions included Allergy NOS (allergies for which she has an epi pen) and Premenopausal symptoms (Rashes with premenopausal condition). 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 TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous). On 30-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose). On 01-May-2021, the patient experienced THROMBOSIS (Went hiking and got a blood clot) (seriousness criterion medically significant). On 30-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose) had resolved. At the time of the report, THROMBOSIS (Went hiking and got a blood clot), TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. Treatment information was not provided. Company Comment Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of rash, fatigue, pyrexia, lymphadenopathy and headache.

Per her father on 5/2/21 she had kidney and liver failure and was admitted to the hospital. Was notified on 5/15/21 by her mother that she passed away. They are performing an autopsy to determine the cause.

I had a heart attack on the evening of May 5. I have no pre-existing conditions (no high blood pressure, cholesterol, diabetes, etc.). I was hospitalized until 5/7.

Anaphylaxis, skin redness within 5 min of taking vaccine. Took one dose epinephrine pen and symptoms started resolving within 2-3 min. 911 called and patient was taken to emergency dept

On 5-4-21 experienced SOB and left sided chest pain. Went to ER and diagnosed with massive bilateral pulmonary embolism. Emergency Thombectomy immediately.

Patient woke up on 5/26/2021 at 8:00AM feeling extremely tired and fatigued. She was not able to get out of bed for three days. She still felt bad on 5/29, but was able to get out of bed. On 5/30/2021 she felt a lot better and was able to do her normal daily activities. On 6/2/2021 she woke up and had slurred speech and was really tired and fatigued again. She went to bed hours earlier than normal. Her husband four her unresponsive by her bed later that night. The patient could not move her lower extremities and could not open up her hands or even talk. She had to be helped back onto her bed. They called 911 and when the ambulance arrived the patient's husband said the patient had a blood pressure of 70/??. They brought her to the hospital where he said they diagnosed her with pneumonia and myocarditis. She was in the hospital from 6/3/2021 at 2:00 am until 6/13/2021 12:00PM. She still has a lot of weakness and cannot walk far without being out of breath and exhausted.

Blood Clots; Altered Speech; Body Is Stiff; Word Finding Difficulties; Left Eye Muscle Feels Gummy; Forgets What They Are Talking About; Nausea; periodic Stumbling/Left Leg Is Dragging; Unable To Draw A Clock For A Cognitive Exam; Afraid Of Being Alone; Lack Of Appetite; Depth Perception Issues; Headaches Everyday; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clots) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included WARFARIN for Clot blood, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), SUMATRIPTAN, CELECOXIB (CELEXA [CELECOXIB]), ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) and BACLOFEN for an unknown indication. On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (Headaches Everyday). On 23-Apr-2021, the patient experienced ILLUSION (Depth Perception Issues), FEAR (Afraid Of Being Alone) and DECREASED APPETITE (Lack Of Appetite). On 30-Apr-2021, the patient experienced THROMBOSIS (Blood Clots) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (periodic Stumbling/Left Leg Is Dragging) and COGNITIVE DISORDER (Unable To Draw A Clock For A Cognitive Exam). On an unknown date, the patient experienced DYSARTHRIA (Altered Speech), MUSCULOSKELETAL STIFFNESS (Body Is Stiff), APHASIA (Word Finding Difficulties), ABNORMAL SENSATION IN EYE (Left Eye Muscle Feels Gummy), MEMORY IMPAIRMENT (Forgets What They Are Talking About) and NAUSEA (Nausea). The patient was hospitalized on 30-Apr-2021 due to THROMBOSIS. The patient was treated with ONDANSETRON ongoing since an unknown date for Nausea, at a dose of 1 UNK and HEPARIN for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood Clots), DYSARTHRIA (Altered Speech), MUSCULOSKELETAL STIFFNESS (Body Is Stiff), ILLUSION (Depth Perception Issues), GAIT DISTURBANCE (periodic Stumbling/Left Leg Is Dragging), APHASIA (Word Finding Difficulties), ABNORMAL SENSATION IN EYE (Left Eye Muscle Feels Gummy), FEAR (Afraid Of Being Alone), DECREASED APPETITE (Lack Of Appetite), MEMORY IMPAIRMENT (Forgets What They Are Talking About), COGNITIVE DISORDER (Unable To Draw A Clock For A Cognitive Exam), HEADACHE (Headaches Everyday) and NAUSEA (Nausea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient reports going to the emergency room on 25Apr2021 and was discharged with medication for the treatment of headaches. During the hospital stay, a MRV (Magnetic Resonance Venography) was conducted, however the results were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-211608 (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.

Covid Arm, Swollen Lymph nodes in neck, under arms and behind knees. After first vaccine, I went to emergency room to have lump behind knee checked - it was lymphacitis. I then went to an endocrinologist and had adrenals checked and. he said to wait a bit before getting next vaccine. After 2nd dose, I was sick for over 4 days with 104 fever. Very sick and adrenals swelled up bigger than last time. I went to emergency room after 6 weeks of lump behind knee and they found a blood clot behind knee. I am getting an ultrasound from vascular surgeon on June 30.

First dose within the first 6 hours hours i had muscle aches,migraine,chills and 102.0 fever. The second dose was the same symptoms which subsided after 12 hours. May 19th i went to the emergency room with a localized migraine and numbness in my head along with numbness in my left arm.I was diagnosed as having a mini stroke.

I got sick the 26th-28th of May. I couldn't get out of bed. On June 6th, I went to the doctor and they sent me home. They couldn't find anything. That night, I fell. My husband couldn't understand what I was saying, I was just mumbling like I had a stroke. I had high blood pressure. The ER said my heart was swollen and the next day I got pneumonias. They gave me antibiotics, an inhaler, and Mucinex. The cardiologist said my heart is swollen and it will take weeks for it to go down

I was a 48 year old woman(at the time of my vaccine) who had not had a mensural cycle in 12 months, rendering me menopausal. Nine days after my first injection, I experienced break through bleeding for roughly 24 hours, requiring a tampon to manage the bleeding. By Monday, April 5 the bleeding had stopped. I have not had any bleeding since that day.

I got light headed and felt like passing out about 3 to 5 minutes after the shot. Felt that way for about an hour after shot. Got Covid arm at injection site and sick with vertigo for two weeks after. After receiving the second shot on April 2, I didn?t react to the second dose like the first. Mild symptoms after second shot. Three weeks after second shot I suffered a Stroke, with extremely painful headache and with left side numbness in head, neck and painful left arm and numbness in left arm and leg

her blood count showed zero platelets; heavy vaginal bleeding; red spots under ankle and wrists; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (her blood count showed zero platelets) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (her blood count showed zero platelets) (seriousness criteria hospitalization and medically significant), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and PURPURA (red spots under ankle and wrists). At the time of the report, THROMBOCYTOPENIA (her blood count showed zero platelets), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and PURPURA (red spots under ankle and wrists) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) blood count showed zero platelets and normal (normal) completely normal blood-test results less than a week before being vaccinated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had a checkup with completely normal blood-test results less than a week before being vaccinated. Patient had spent four days in the hospital, receiving platelet transfusions, immune globulins and steroids to restore her platelet count. Concomitant medication were not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested 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. Further information has been requested

From the very beginning, 4-6 hours after the vaccine I was running a fever of 100.3-100.4 for 30 hours, feeling nauseated, and sweat. About 5 weeks ago, I started developing a bad cough and drainage in my sinus. Not a whole lot of fever but a lot of breathing problems such as shortness of breath. I got spray and shots of steroids (First and last week of June). I got hyper something in my lung where I got issues with breathing and pneumonia. I have an albuterol inhaler and I also got a mammograms along with ultrasounds. Nothing was found but I thought I would report that as well.

I was not coherent, losing consciousness. I would act like I was high, my speech was slurred. I had swelling in my hands, legs, and feet, I went to the ER on June 2nd. I had a blood clot that disappeared. I had pain throughout my body. I now have high blood pressure and have been put on a medication

Myopericarditis on April 10, 2021, followed by 40 strokes on 4/25 caused by myopericarditis, then 2 more strokes on May 30

Patient is hospital employee who completed screening form for COVID-19 vaccine by answering "no" to all contraindication questions. Approx 10 minutes after receiving COVID-19 vaccine dose # 1, patient was still in vaccine clinic area and complained of dizziness, palpitations and flushing. I observed patient fanning herself with papers. She was escorted out of the immediate clinic room, and assessed by paramedics present as having an anaphylactic reaction. Epinephrine 0.3 mg IM and diphenhydramine 50 mg IV given in clinic, Rapid Response was called overhead and patient immediately transported down the hall to the Emergency Dept. In ED, pt was noted as having swollen tongue, large areas of erythema on face, arms and chest, shortness of breath, nausea, dizziness (per ED physician notes). Pt reported being hospitalized in ICU with COVID disease more than 3 months ago, including intubation (not treated at this hospital), and has been back at work since August 2020. ED physical exam noted bilateral wheezing and patient in acute distress. In ED, pt administered racemic epinephrine 2.25% 0.5 mL via neb, epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, Solu-Medrol 125 mg IV, famotidine 20 mg IV and epinephrine 5 mg/250 mL IV drip (started at 0.118 mcg/kg/min). Acute symptoms reported to resolve in ED. COVID test was negative. ED physician discovered that pt had history of multiple medications, including previous anaphylactic reaction to radiocontrast dye requiring intubation (which was not disclosed on the vaccine screening form). Pt admitted to Telemetry floor for observation. Overnight course was unremarkable, and patient was discharged the following day with prescription for Prednisone taper and prescription for Epi-pen. Advised not to return for second dose of COVID vaccine. EMR updated to reflect possible anaphylactic reaction to Moderna COVID-19 vaccine.

Dr. called this morning and reported that an employee that works in billing had her vaccine on Wednesday and developed and anaphylactic reaction to Moderna. This was 24 hours later with rash, SVT heart rate above 140, low grade fever, redness at site. Admitted and treated with steroids and Benadryl.

TIAStroke numbness of R face and RUE Narrative: I recommended transfer via 911 from clinic to nearest ER; she refused and signed out against medical advice. She plans to go to ER by private vehicle driven by a friend.

Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband, patient did not complain of any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of uncertain etiology

Vaccinated 1/6/2021. No issues reported per client until day 5, 1/11/2021. Reports lymphadenopathy, axillary area, left side, left breast area and chest. Reports some swelling noted lymph nodes right axillary and sore to touch. Report fever onset 1/11, 1/12, 1/13. Then Thursday 1/14/2021 contacted PCP and was told on 1/15/2021 to see medical evaluation. Reports on 1/15/2021 went to ER and was evaluated. Reports lymphadenopathy and "small P.E." found. Unsure if incidental as history of P.E. 4 years ago. Also reports over 25 years ago had lymphadenopathy from Flu Vaccine and has not had any vaccines prior to this COVID-19 vaccine. Reports discharged same day to home with Topical Benadryl Cream for redness and itching at site of injection which per client also did not start until day #5 after vaccination. Reports no issues prior to day #5 post vaccination. Home and doing better but with continued lymphadenopathy left side axillary, breast and chest area. Denies any follow-up appointments other than a request to talk w/LHD Doctor to see if she should get vaccine #2. This RN will relay to MD for advisement/consult.

Presented to ED @ 0815 (approx 45 mins after 2nd Moderna vaccine) c.o. dizziness, N/V, chest pain. Patient reports throat swelling although no obvious facial/throat swelling on exam, no wheezing. Treated as anaphylaxis. Temp 36.2, BP 186/103, HR 70, RR 24, O2 sat 99. Benadryl 50mg IV, Epinephrine 0.5mg IM, Pepcid 20mg IV, Zofran 4mg IV, Solu-Medrol 125mg IV, Tylenol 1000mg po, 1L NS IV bolus. H/o covid infection ~ 3 months ago, now recovered from COVID PNA as well.

Patient experienced anaphylaxis to first dose of Covid 19 vaccine. Throat tightness and swelling. She received IM diphenhydramine at 4:28pm, followed by dose of epinephrine IM at 4:30pm and second dose of epinephrine IM at 4:37pm. Patient was transferred via ambulance to hospital.

Patient post vaccine administration approx 20 minutes. Reported feelinging tightness in chest, spreading to throat. Patient was taken to observation portion of clinic. Patient was hypoxic in 70's. Supplemental oxygen applied. Oxygen saturation increased to 88. Epipen administered and albuterol nebulizer treatment started while waiting for ED/Rapid response team to arrive. Patient transferred to ED for further observation. From the physician that treated the patient: "It was a bit of a bizarre presentation. She reported throat tightness after the vaccine. She had a completely normal exam and no other complaints. no signs of airway/oral/pharyngeal abnormality. no respiratory abnormality. Unfortunately she was significantly hypoxic when I took her vitals. as low as 76%. Good waveform. I even checked the pulse ox on myself because I didn't believe it. In addition, with supplemental oxygen, her sats went up. I had to pull the trigger and treat her even though she looked well and I had no objective exam findings to explain her profound hypoxia. She received IM Epinepherine and Albuterol neb. By the time she was in ED she was satting 100% and her throat tightness resolved. So, not sure how to answer your question. Clinically I pulled the trigger and treated her for anaphylaxis following a vaccine administration. I wish it was a problem with my sat monitor but I don't believe it was. I was using a life-pack with wave form and verified with two other people that the O2 saturation function was working properly. Intuitively, it doesn't make sense but I think we should probably consider it a reaction to the vaccine. "

1 week after the first dose patient started to have her period. The period consisted of heavy clots and would go through 6-8 pads /day. Period lasted 3 weeks and went to see GYN and they prescribed Provera, which helped stop the bleeding.

Left side stroke-like symptoms. I was walking and 20 minutes in I started having left leg weakness. This then turned into full left side numb/foggy feeling. I was with my son (and I'm a nurse) so I asked him to test for signs of a stroke. I could smile evenly but it didn't feel like it. I had strength in both hands and could lift my arms. I was able to communicate what to look for to my son without slurred speech. But I was not stable on my left foot and felt as if I was listing to the left side. My left side was foggy. I moved my arm but flet it in slow motion. When I got home, I sat down and stretched. The symptoms went away and I was able to continue the day without episode. The episode lasted 20-30 minutes as I was walking home still. In hind sight, I did have a similar eposide after the first dose (Moderna lot 037K20A on 1/29/20) while exercising at home but sat down and thought it was due to a hard workout. That time it was just a weak left leg that was giving out on me and lasted 5 minutes because I stopped the workout.

After about 2 minutes of receiving the vaccine, patient started to feel itchy, developed hives, and had an "itchy throat"... about a minute later she went into anaphylaxis

After Receiving the second dose on February 9, 2021 I was very ill. Chills, fever, tired, achy. The next day I was great. Then, 9 days later my left side went numb. My arm, leg and face went numb. 20 minutes later all feeling did come back. I went to the Emergency Room and was diagnosed with a TIA. I had many tests completed. (MRI, EKG, CT SCAN, Echocardiogram) The only thing that was found was that I have a PFO in the heart. I am healthy, I eat great, exercise daily at the gym. AFter an overnight hospital stay and being put on PLAVAX and aspirin my life has changed forever. I had a doctor's appointment to discuss the PFO, a meeting with a neurologist and they are not sure why. The paperwork shares that I had a TIA or a migraine which is not possible because I do know what migraines are like as I had these as a young child. I am now looking into closing the PFO. I am going to get a second opinion on this based on what happened.

Within 6 hours I had overwhelming headache with injection site pain that radiated up to my ear and down to my elbow. I had lymph node pain and swelling. The next 36 hours I felt general malaise with a bad headache which continued to linger throughout the week. A few days later on Feb 4 at 3am I woke up with extreme chest pain and trouble breathing. I was rushed to the hospital where I had an NSTEMI event resulting in a cardiac cath/thrombectomy removing a rope-like blood clot in an otherwise healthy heart.

Rash started small area on my right arm (opposite arm of injection) - like eczema red; raised; itchy spot. As a couple of days went I got more and more spots. Sent pictures to my Dr - Pityriasis Roseola - Went to see dermatologist - he diagnosed me with the same thing (January 19th). He gave me cream for it - it was all over my entire body by the time I saw him. It was like a red petechiae rash over my whole body. I usd the cream as instructed per doctor. The following week on that Monday, I was short of breath and not feeling right and I worked. But next day I only worked a couple of hours and went home. I started having vomiting and diarrhea - I went to the ER twice - 1st time they diagnosed - Viral infection - and they discharged me and didn't give me anything but told me to rest and they pushed fluids. The second time I went - they gave me medication and they said it might help with the pain in my abdomen. They didn't do much. I had gone to ER - was there for four and half hours waiting to be seen but didn't get seen. Two days after second ER visit - I went back to the hospital on January 26 and was admitted for heart failure and that is when cardiac symptoms occurred.

Unknown adverse event from vaccination. 3/14/21 Informed by caregiver that client was sent by ambulance to ER and diagnosed with bilat pneumonia. She developed difficulty breathing on 3/13/21. She was seen at Walk In on 3/12/21 for toenail eviscerated and INR, and had been giving tylenol for pain control for toe. 3/15/21 Informed by caregiver client was in ICU, septic, bilat pneumonia, and low oxygen levels. 3/16/21 Informed by caregiver client not doing well authorized indwelling cath due to low blood pressure and ventilator. Client transfered by med flight to ICU. 3/17/21 Informed by caregiver client death last night.

Community partner reported that they found her unresponsive on the 17th (so she may have died on the 16th) from what they believe was a heart attack. The family has requested an autopsy.

hx OF ANAPHYLAXIS TO MMR; PATIENT EXPERIENCING TONGUETHICKNESS AND ITCHING5-7 MIN POST INJECTION. VITAL SIGN 130/78-78-100%.NO TONGUE SWELLING VISIBLEPATIENT TALKININ FULL SENTENCES. USED INHALER. PLACED ON STRETCHER 0915 EPIPEN ADMIN TO LEFT QUAD.; MD IN TO EVALPATIENT TRANSFERRED TO ER FOR EVAL AT 0935.

I was very tired the night of the shot with chills started at 8:00pm on 4/1/21. On 4/2/21 around 7:00am I started vaginal bleeding. (I got my period. I was not due to get this at this time. This also happened after my 1st vaccine on 3/31. Prior to this I have not had my period since November 2020. The following day 4/2 at 1:00pm I had a fever of 100.7 for the afternoon. On 4/3 at 12:00pm I felt better, my fever and chills were gone. I then had a headache until 4/5, which finally subsided around 9:00pm.

Onset of anaphylaxis (tightening of the chest). Mild symptoms. Self-treatment with Epipen, followed by liquid Benadryl.

Asthma flares. Was very bad . Followed by by COVID swabbing by primary office. Then treated for asthmatic bronchitis- nebulaizing treatments and solutions merril dose pack. Felt a bit better. Once steroid stopped 2 days later much worse. Low grade temperatures and coughing. Diagnosed now with pneumonia. On Zpack antibiotics. Tapered prednisone dosing and long acting albuterol inhailers.

Abnormal uterine bleeding. Started morning after an evening 2nd dose. Normally 28 day cycle very routine. Started a week early and has not stopped since, 8 and a half weeks so far. Large clots at times. Is a change from baseline, not blamed on stress please. As still ongoing and labs pending, uncertain outcome at this time.

presents with progressively worsening dyspnea on exertion for the last few weeks, much worse over the last one day. Patient reports feeling fatigued, having cough, and feeling more short of breath for the last day, and has developed central chest pain which is pleuritic in the emergency department. She reports that the chest pain is 4/10 in severity and does not radiate. Her caregiver at bedside reports that the patient has had worsening dyspnea on exertion for the last 3 or so weeks. Of note, she becomes dyspneic with limited exertion, such as going up a flight of stairs, at baseline. She had a fever of 101.4 °F at home earlier today, but denies chills or diaphoresis. He had 1 episode of nonbloody vomiting earlier today. Denies nausea at this time. She received her second dose of the Moderna COVID vaccine yesterday, 4 weeks after the first. They note that approximately 5 years ago, she had a prolonged admission for which she was transferred to OHSU and was on ECMO for a time before making a nearly full recovery. She has had the baseline dyspnea on exertion since that time. Review of Systems Constitutional: Positive for fever and malaise/fatigue. Negative for chills. HENT: Negative for sore throat. Eyes: Negative for blurred vision. Respiratory: Positive for cough and shortness of breath. Negative for hemoptysis, sputum production and wheezing. Cardiovascular: Positive for chest pain. Gastrointestinal: Negative for abdominal pain, diarrhea and vomiting. Genitourinary: Negative for dysuria and frequency. Musculoskeletal: Negative for back pain. Skin: Negative for rash. Neurological: Positive for weakness. Negative for tingling, sensory change and focal weakness. Endo/Heme/Allergies: Does not bruise/bleed easily. Psychiatric/Behavioral: The patient is nervous/anxious. Past Medical History: Past Medical History: Diagnosis Date ? Developmental delay, moderate since birth Functional equivalent to 10-12 year old, no formal testing done otherwise. ? DVT (deep venous thrombosis) (HCC) 1/2016 while on ECMO ? Personal history of ECMO 1/2016 - ARDS after unknown viral illness Past Surgical History: Procedure Laterality Date ? LUNG BIOPSY Left 1995 Mass noted following an MVA, was benign ? MASS EXCISION Right 2006 Growth removed from right knee ? PROCEDURE N/A 1/20/2021 Procedure: LAPAROSCOPIC CHOLECYSTECTOMY; CHOLANGIOGRAMS; Service: Procedures; Laterality: N/A; POSSIBLE COMMON BILE DUCT ? PROCEDURE N/A 1/20/2021 Procedure: RIGID ESOPHAGOGASTRODUODENOSCOPY; Service: Procedures; Laterality: N/A; Medications administered in the ED: Medications doxycycline (VIBRAMYCIN) 100 mg in sodium chloride 0.9 % (NS) 100 mL IVPB (100 mg Intravenous New Bag 4/9/21 2235) ceftriaxone (ROCEPHIN) 1 g in 50 mL SNAP IVPB (0 g Intravenous Stopped 4/9/21 2234) Physical Examination: GEN: Very pleasant female sitting up in bed in NAD. Slightly anxious appearing. HENT: Moist mucous membranes. No posterior oropharyngeal erythema or exudates. NECK: Supple. No cervical or supraclavicular lymphadenopathy. CARDIOVASCULAR: Tachycardic rate and regular rhythm. No murmurs, rubs, or gallops. No pain with palpation of chest wall. PULM: Normal effort. No use of accessory muscles. Clear to auscultation bilaterally. No wheezes or crackles. ABD: Soft. Non tender. Non distended. EXT: No lower extremity edema. SKIN: No suspicious lesions noted on the exposed skin. EKG: 04/09/21 Rhythm: Sinus tachycardia Rate: 111 Axis: normal Intervals: normal Concern for possible inferior infarct noted, but felt less consistent with true ST depression Recent Imaging: Chest x-ray, 04/09/21: FINDINGS: LUNGS: Slightly low lung volumes. There is hazy reticulonodular interstitial opacity seen within the left mid and both lower lung zones suspicious for interstitial pulmonary edema. CARDIAC: Slightly worsened mild cardiomegaly. MEDIASTINUM: Normal. PLEURA: No pleural effusion or pneumothorax. LINES/TUBES: None. BONES: There is mild rightward convexity curvature of the thoracic spine along with minimal multilevel degenerative change. OTHER: Surgical clips overlie the left lung apex medially and the right upper abdominal quadrant. IMPRESSION: 1. See above. CT angiogram pulmonary: FINDINGS: Motion degrades image quality slightly. No pulmonary arterial filling defects are identified. Mild lower lobe predominant atelectasis and/or scarring. A single small bulla is present in the left lower lobe of the lung. Lungs are otherwise clear. Large airways are patent. Small bilateral dependent pleural effusions which are new relative to the comparison examination. No pneumothorax. Heart is normal in size. Relatively low attenuation pericardial effusion is present which is new relative to the comparison examination. Pericardial fluid measures up to 1.7 cm in thickness. No thoracic aortic aneurysm or dissection. No mediastinal mass or lymphadenopathy. Two small enhancing foci are present in the liver, larger 1.8 in length which are similar to the comparison examination. Interval cholecystectomy. Visualized upper abdominal contents are otherwise without significant abnormality. There has been partial resection of the left 5th rib. Osseous structures are otherwise intact. IMPRESSION: 1. No evidence of pulmonary embolism. 2. Pericardial effusion and small bilateral pleural effusions which are new relative to comparison examination. 3. Two small enhancing liver lesions which are not further characterized by this examination but are similar to comparison examination. These could potentially represent hemangiomas. Assessment / Plan a 49 y.o. female with history of hypertension, developmental delay, DVT x1 not currently on anticoagulation, GERD, and anxiety who is being admitted for acute hypoxic respiratory failure, felt likely secondary to fluid overload from cardiomyopathy from pericarditis with associated pericardial effusion. #Acute hypoxic respiratory failure #Elevated Pro BNP #Cardiomegaly #Dyspnea on exertion #Pleuritic chest pain #Elevated D-Dimer Acute. Hemodynamically stable. On room air at home, and requiring 3 L via NC here. Considerations include new onset CHF, PE, PNA, PTX, pericarditis, pericardial effusion. Presentation most concerning for new onset CHF/cardiomyopathy from pericarditis with associated pericardial effusion, as demonstrated on CT angiogram. She has significantly elevated CRP which further supports pericarditis, and onset of symptoms approximately 7 to 10 days after receiving her first COVID-19 vaccine dose 4 weeks ago, which may be associated. Also possible viral or idiopathic. Mildly elevated BNP and pleural effusions suggesting cardiomyopathy. Patient had a fever to 101.4 °F earlier today, per caregiver at bedside, and has had shortness of breath and cough, and thus pulmonary infectious process strongly considered, though clinically I feel infection less likely. She has a chronic leukocytosis and WBC is 21 today. She received ceftriaxone and doxycycline for pneumonia today in the ED, and may consider continuing these tomorrow. No evidence to suggest tamponade on bedside POCUS. - Admit to PCU with tele - Echo in AM - Ibuprofen 800 mg 3 times daily and colchicine 0.6 mg daily for treatment of pericarditis - Diuresis: 40 mg IV Lasix given at 0037 - Respiratory support as needed, wean as tolerated - RTDP - Incentive spirometry - Consider continuing antibiotics pending clinical status in AM #Leukocytosis Acute. WBC 21.5 on admit, increased from 15.1 two and a half months ago, but that was at end of admission for cholecystitis. Potentially due to inflammation, possibly infectious process. See discussion above. - Trend with CBC #Hypertension Chronic, presumed well controlled. - Continue home hydrochlorothiazide and losartan #Thrombocytosis Acute. Suspect reactive thrombocytosis due to inflammation from pericarditis. -Daily CBC while inpatient #Elevated AST and ALT Acute, mild. Most likely secondary to congestive hepatopathy. Will trend. - AM CMP #Hypoosmolar hyponatremia Acute, mild. Considerations include beer potomania, hypothyroidism, SIADH, low solute diet ("tea and toast"), increased free water intake, medication induced (SSRIs, thiazides). Suspect low solute diet. SIADH from pulmonary pathology is also possible. - Repeat BMP #Anxiety Chronic, presumed stable. - Continue home sertraline Ppx: Lovenox Central Lines/IVs/Tubes/Drains: PIV CODE: Full Dispo: PCU with tele Active Hospital Problems Diagnosis SNOMED CT(R) Date Noted ? Elevated brain natriuretic peptide (BNP) level HORMONE LEVEL - FINDING 04/09/2021 ? Cardiomegaly CARDIOMEGALY 04/09/2021 ? Leukocytosis LEUKOCYTOSIS 04/09/2021 ? Acute respiratory failure with hypoxia (HCC) ACUTE RESPIRATORY FAILURE 04/09/2021 ? Dyspnea on exertion DYSPNEA ON EXERTION 12/21/2015

I had my second shot and the same night developed a clot in my arm. I had blood coagulation labs drawn and my C protein and cardiolipin have altered and show I may get clots now. I had labs previous to this because of my gallbladder surgery and all my blood was normal.

stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history provided). On 26-Feb-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) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 12-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. Not Provided No medical history and concomitant medications were provided. No treatment information provided. 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; 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

Patient had pulmonary embolism right around the time of her second vaccine patient also had a rash on her left arm after her second vaccine.

I received the shot at 11:00 am May 6th, by 1:35 pm I was in full respiratory arrest. Spent two days in ICU where a blood clot was found in my lung. Followed up with PCP and suggested I NOT take second dose.

This nurse was at an offsite for employee COVID vaccines. Patient came in for her 2nd Moderna shot. Denies any reaction from first dose. Denies feeling sick at time of injection. Vaccine administered to left Deltoid. Patient waited 15 minutes and then returned to work. At 10:00 am, the Bowater nurse received a call that the patient has been vomiting since she received the injection. Patient was brought to the nurse clinic at Bowater. BP 111/76, HR 106, respirations 18, BP 111/76. Patient states she feels nauseated and very week. Patient stated she feels like it is hard to breath. Bowater had a Nurse Practitioner on staff. NP examined patient and stated her Uvula was swollen. NP stated lung were clear. NP immediately applied O2 @ 2 liters, administered Benadryl 50 mg IM to right deltoid, started IV and hang NS gravity, and administered Dexamethasone. Patient remained alert the entire time. No shortness of breath noted. Bowater has their own EMT's on staff and they were ordered to take her to Hospital ER. Husband was called for patient. Husband reported after patient received all this treatment that she had vomited 3 days prior and that she had not eaten in 3 days prior to her vaccine and has not felt good. Since NP diagnosed this episode as Anaphylactic, this nurse felt it should be reported.

6 weeks out woke up with nose bleed x3 days. Went to ER ran test platlet count was at 2,000.sent to be admitted at hospital started steroids, fusion treatments. Was in hospital 16 days platlet count would not stay steady and was very low had bone marrow Which came back fine. Had spleen removed that was eating up all platelets. Had to have blood and was diagnosed with ITP which I never had before. Was perfectly healthy up to this time

Multiple small blood clots in lungs. Put on blood thinners and is now home. Symptoms began as pain and trouble taking deep breaths on left side of upper side/back.

Symptom onset 4/22/21 (loss of taste/smell, cough, wheezing, congestions, weakness, feverish). 5/3/21 SOB with no relief from rescue inhaler. SPO@ 85% on RA. PCR positive for COVID 4/25/21.

Patient developed fever and 3 episodes of syncope on the day following the vaccine. The third episode of syncope occurred while being driven to the hospital. She arrived at the hospital in cardiac arrest with asystole. She was resuscitated and is currently in the ICU intubated.

1ST VACCINE 03/15. 2ND VACCINE 04/9 04/12 - EXTREMELY HEAVY BLEEDING WITH CLOTS WITH MENSTRUAL CYCLE FOR 2 WEEKS 05/9 - HEAVY BLEEDING WITH CLOTS WITH MESTRUAL CYCLE UP TO CURRENT DATE.

Dizziness (After 2nd Vaccine); Labored Breathing (After 2nd Vaccine); Low Blood Pressure (After 2nd Vaccine); Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine); Spider Veins going from Arm to Chest (After 2nd Vaccine); Hot to the touch left Arm (After 2nd Vaccine); Protruding Red Veins on Left Arm (After 2nd Vaccine); Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine); Red band (3 inches wide and 4-5" long) Below the Injection Site (After 2nd Vaccine); Swollen 1/2 inch below the Injection Site; Fever (After 2nd Vaccine); Chills (After 2nd Vaccine); Left Arm Hurt (After 2nd Vaccine); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine)), PERIPHERAL SWELLING (Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine)), SPIDER VEIN (Spider Veins going from Arm to Chest (After 2nd Vaccine)), DIZZINESS (Dizziness (After 2nd Vaccine)), DYSPNOEA (Labored Breathing (After 2nd Vaccine)), HYPOTENSION (Low Blood Pressure (After 2nd Vaccine)), SKIN WARM (Hot to the touch left Arm (After 2nd Vaccine)), PAIN IN EXTREMITY (Left Arm Hurt (After 2nd Vaccine)), SUPERFICIAL VEIN PROMINENCE (Protruding Red Veins on Left Arm (After 2nd Vaccine)), VACCINATION SITE ERYTHEMA (Red band (3 inches wide and 4-5" long) Below the Injection Site (After 2nd Vaccine)), VACCINATION SITE SWELLING (Swollen 1/2 inch below the Injection Site), PYREXIA (Fever (After 2nd Vaccine)) and CHILLS (Chills (After 2nd Vaccine)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Ulcerative colitis. Concomitant products included MESALAZINE (LIALDA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MULTIVITAMIN [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left Arm Hurt (After 2nd Vaccine), PYREXIA (Fever (After 2nd Vaccine)), and CHILLS (Chills (After 2nd Vaccine)) . On 26-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red band (3 inches wide and 4-5" long) Below the Injection Site (After 2nd Vaccine), and VACCINATION SITE SWELLING (Swollen 1/2 inch below the Injection Site) .On 27-Apr-2021, the patient experienced PERIPHERAL SWELLING (Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine)). On 28-Apr-2021, the patient experienced SPIDER VEIN (Spider Veins going from Arm to Chest (After 2nd Vaccine)), SKIN WARM (Hot to the touch left Arm (After 2nd Vaccine)) and SUPERFICIAL VEIN PROMINENCE (Protruding Red Veins on Left Arm (After 2nd Vaccine)). On 02-May-2021, the patient experienced THROMBOSIS (Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine)) (seriousness criteria medically significant), DIZZINESS (Dizziness (After 2nd Vaccine)) DYSPNOEA (Labored Breathing (After 2nd Vaccine)) and HYPOTENSION (Low Blood Pressure (After 2nd Vaccine)). On 02-May-2021, DIZZINESS (Dizziness (After 2nd Vaccine)) and HYPOTENSION (Low Blood Pressure (After 2nd Vaccine)) outcome was unknown, DYSPNOEA (Labored Breathing (After 2nd Vaccine)) had resolved. On 14-May-2021, PYREXIA (Fever (After 2nd Vaccine)) and CHILLS (Chills (After 2nd Vaccine)) had resolved. At the time of the report, THROMBOSIS (Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine)), PERIPHERAL SWELLING (Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine)), SPIDER VEIN (Spider Veins going from Arm to Chest (After 2nd Vaccine)), SKIN WARM (Hot to the touch left Arm (After 2nd Vaccine)), PAIN IN EXTREMITY (Left Arm Hurt (After 2nd Vaccine)), SUPERFICIAL VEIN PROMINENCE (Protruding Red Veins on Left Arm (After 2nd Vaccine)), VACCINATION SITE ERYTHEMA (Red band (3 inches wide and 4-5" long) Below the Injection Site (After 2nd Vaccine)) and VACCINATION SITE SWELLING (Swollen 1/2 inch below the Injection Site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Blood pressure measurement: low (Low) low. On 10-May-2021, Full blood count: wbc very high (High) WBC very high. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Ultrasound scan: multiple blood clots in the red area (abnormal) Multiple Blood Clots in the Red area under the injection site. The patient did not have a medical history of blood clots. On 25APR2021 the patient experienced fever, chills, and her arm hurt. On 26APR2021 her left arm hurt really bad and was swollen 1/2 inch below the injection site (3 inches wide and 4-5" long) and also had a red band wrapped around the left arm below the injection site. On 27Apr2021 the patient's entire arm from under the Injection site to her fingers became swollen and purple. The patient visited the emergency room (ER) and was told to elevate it and place ice on the area and was prescribed Advil. On 28APR2021 the patients veins were protruding, were red and hot to the touch and she experienced spider veins started going to her chest. On 30Apr2021, she went back to the ER . The doctor gave her a steroid and suggested an ultrasound. 02MAY2021 she started experiencing labored breathing, dizziness, and low blood pressure. She visited the ER again. The doctor performed an ultrasound, an EKG, a chest x-ray, and a hot scan of the heart. The ultrasound of the left arm showed multiple blood clots in the red area under the injection site. The doctor started her on Eliquis. On 10May2021 the symptoms were returning. A complete blood count (CBC) showed white blood cells (WBC) were very high but a second blood level showed, on an unknown date showed normal WBC. On 14May2021, the swelling on the arm had come down and her arm was still purple but a lighter color purple with dark protruding veins and spider veins still visible. The patient continued taking Eliquis. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Significant F/U Case & Email ID Add. Conmeds., medical history, Lab data, Product dsetails, iNarrative updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Initial symptoms consisted of a wave of nausea & lightheadedness, heart rate increased to 88-96 bpm & bp was elevated. Within 15 minutes of injection tongue began to tingle & had another wave of nausea & lightheadedness. The tingling became more intense & spread over tongue into the back of my throat. It became more of a "prickly" feeling. I developed a tightness in my chest. Given dose of epinephrine & benadryl. Taken to hospital by ambulance where I was diagnosed as having an anaphylactic reaction. Released from ER after 4 hours of observation.

81 days of severe vaginal bleeding resulting in D and C and ablation procedure, resulting in sterilization.

heavy bleeding, large blood clots, spotting and two periods in the month following first moderna vaccine ear hissing - tinnitus

I developed mild chest pain on 5/27/21. I saw a doctor on 5/28 who found that my troponin level was elevated. I was sent to the ER and then hospitalized. My troponin remained elevated throughout my 2-day hospital stay. On an echocardiogram, the cardiologist found borderline pericardial effusion and borderline abnormality in wall motion. My troponin level has now normalized but my chest pain continues. I continue to follow up with my cardiologist and primary care doctor.

Patient is a 49 y/o female with ESRD on dialysis T/Th/Sat who presents to the ED with shortness of breath, generalized weakness, left upper back pain and itching x 1 week since having an infusion of immunosuppressant drug for RA. Patient reports new onset chest discomfort today. 5/17 -- admitted to the medical ICU 5/18 -- remdesivir 200mg IV x1 given then discontinued because she is a dialysis patient. dexamethasone 10mg IV daily x 7 doses While in the ICU she was hypotensive and required pressors Maximum oxygen requirement -- 15L High flow, never required mechanical ventilation 5/19 moved to COVID floor (nonICU) 5/24/21 - discharged to home

patient states diagnosed with pneumonia on 5/23, COVID test negative on that day and given antibiotics on 5/28 patient presents to Emergency department for cough, shortness of breath She denies travel and sick contacts. She was fully vaccinated but takes an immunosuppressant drug for multiple sclerosis (Ocrevus) Bamlanivimab 700mg/etesevimab 1400mg IV and dexamethasone 6mg IV administered in the ED The patient went home after 10 hours in the ED.

9 blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (9 blood clots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced THROMBOSIS (9 blood clots) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (9 blood clots) was resolving. No concomitant medications were provided. The patient was in the ICU (intensive care unit) for 3 days. No additional treatment information was provided. The reporter stated that the patient thought that her Moderna COVID-19 vaccinations caused the blood clots.; 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. No further information is expected at this time.

I had fever and chills approximately and hour after receiving the vaccine. That evening my hands went numb and tingling and lower back pain. My lower lip swelled up and went numb the next evening and within the week my legs become stiff and painful. The numbness and tingling in hands, lower back pain and stiffness and pain in legs is still ongoing. I also have been experiencing significant memory loss and extreme fatigue. I have informed the cdc app consistently of my adverse affects. I have an auto immune disease called APLS and thrombocytopenia. Ever since receiving the vaccine I have experienced adverse side effects which have now put me under close drs care. My blood work since the vaccine has now come back very concerning to my doctors and I have now been put on warfarin for life; which has included injections of lovenox twice daily. This has been life changing for me and I am quite traumatised over what I am now experiencing. I now have to travel an hour and 45 minutes to an anticoagulation clinic two to three times a week to be closely monitored. This was not my life before receiving the vaccine.

PATIENT EXPERIENCED A MUSCLE TWITCH AT TIME OF IM INJECTION OF VACCINE. THE DAY AFTER IMMUNIZATION PATIENT HAD RED BAND ON LEFT ARM UNDER INJECTION SITE WHICH WAS HOT TO THE TOUCH AND ARM WAS SWOLLEN, ARM TURNED PURPLE. A WEEK LATER PATIENT HAD ULTRASOUND, RESULTS SHOWED MULTIPLE BLOOD CLOTS IN ARM UNDER THE INJECTION SITE RESTRICTING BLOOD FLOW. PATIENT WAS PLACED ON BLOODTHINNERS. PATIENT STATED SHE HAD WORKED OUT AT GYM THE MORNING OF THE IMMUNIZATION. HER HEMATOLOGIST STATES POSSIBLE INJECTION TRAUMA CAUSED MUSCLE SPASM AND MAY HAVE CAUSED MULTIPLE BLOOD CLOTS IN ARM.

ONSET OF S/S: Approximately a week or two later I noted that when I would walk into work from our employee parking lot/garage that I would have onset of chest pressure, shortness of breath and pain radiating down both arms and occasionally my neck when it was at it's worse. Initially, while I didn't feel like I was feeling stressed, I was concerned that I might be experiencing panic attacks. Dismissing it as that I shared with my Husband my concerns in late February. At that point in time, we were seeing a decrease in cases and so I was hopeful that maybe my mental state and anxieties might resolve. So I continued to dismiss the problem. Disease Progression: Unfortunately, the symptoms continued to progress. It progressed to happening when I was leaving work or when it was required that I go anywhere in an real rush (a frequent occurrence). By early April, we went for a family vacation. Almost every day as we walked into, around and out of the parks I would have to slow down and res to catch my breath and slow my heartrate which would spike up into the 140-160s. By the end of the week it was happening multiple times each day. It was always initiated by an increase in activity or exertion. We decided that it was not anxiety related and that she needed to see a doctor to pursue a diagnosis. 4/12/21: Due to already having an appointment set up with my OB/GYN prior to our vacation - that was the first appointment that I kept because I was hopeful or suspicious that my symptoms may really be menopausal in source. The hormone work-up did not reveal any abnormalities. However, at that time they did send in a referral to Dr., Cardiologist. 5/17/21: I met with Dr. at which an Echo and NM Stress test were ordered. 5/28/21: Echo & routine stress test were completed. Insurance would not cover an actual NM Stress test so the order was changed to routine. I failed the treadmill stress test within 4.42 minutes with the same symptoms I had been experiencing. Test was terminated due to worsening symptoms. , took approximately 10 minutes to recover. HR reached goal HR @ 157. At that time Dr. recommended starting a daily Aspirin tx and suggested that a possible heart cath may be needed. Dr. followed up these tests with a referral for a left heart cath, daily 81mg Aspirin and 12.5mg Metoprolol XR daily. During this almost 3 week time period my symptoms were getting increasingly worse and requiring less and less activity to instigate my symptoms. 6/15/21: Left heart catheterization procedure to evaluate the blood flow to the heart. Impression and plan per Dr. Impression: Severe ostial RCA and left main disease with preserved LV systolic function. Crescendo angina Plan: Findings were reviewed the patient and her family. Ostial coronary disease raise the concern whether she had some type of aortitis but clinically there is no history for this and no prior chest irradiation. Surgical intervention appears indicated as soon as possible and I have consulted Dr. In the interim, continue aspirin, metoprolol. Initiate statin therapy. (The remainder of the following record as documented by my husband and myself) They completed the procedure and it indicated two of the main blood vessels in her heart were constricted. The vessel on the right side was 95% restricted and the vessel on the left was 65-70% restricted. The doctors reported afterward that they had difficulty inserting the catheter. They also indicated that they found no build-up of plaque in other vessels or other reasons for the vessels to be restricted. They expressed surprise and confusion as to the cause of the damage to the vessels. They walked through the risk factors and indicated that she had none of the traditional risk factors. She never smoked. She is not diabetic. She is young and otherwise healthy. They told us that they see this type of damage to the heart from people who had radiation therapy from treatment of Hodgkin?s Lymphoma when they were young. They also indicated that this is something that can happen to Type 1 diabetics. They expressed that this was very unusual and they did not know why she had this condition. They felt there was a high risk of a heart attack due to the blockage and recommended that she be admitted to the hospital. The proposed a course of treatment was traditional bypass surgery. They felt due to the location and type of blockage that other procedures like a stent would not be feasible. It was at this point in the consult room when the doctor shared the information above that I express my first question about whether this could be related either to a Covid infection (she was never diagnosed or had any symptoms) or due to the vaccine. I asked this because the symptoms began after her second shot. Because of her job we followed the news on the virus and vaccines closely. Many reports indicated that the virus causes severe heart and lung damage. Recently there were reports of inflammation of the heart associated with people who had recently been vaccinated. When I proposed this connection, Dr said that the Myocarditis and Pericarditis reported to be associated with the vaccine did not present in this way. He expressed that he did not think it was related. Patient came out of the procedure and was admitted. Later that evening Dr. came in to discuss the upcoming heart procedure. He described the blockage and why it was critical that it be addressed. He also expressed surprise that she was having this issue and did not have any of the normal symptoms of heart disease. He described the surgery as a triple bypass to restore blood flow to the two sides of the heart affected by the blockage. He indicated he would take a vein from her arm and a vein from her leg and bypass the affected areas of the restricted vessels. It was not clear to me (we did not have any pictures or models to visualize the process) exactly how it would proceed but he said it is a very common procedure and of the bypass surgeries it is the easiest due to the location. He did not expect any issues and indicated it was a 99% success rate. In the conversation, he expressed multiple times that this was very unusual. I asked if it was possible it could be Covid or vaccine related. He did not believe it was related. 6/16/21 Wednesday patient spent the day being prepped for surgery. Vein mapping, ABG, CXR completed. 6/17/21 Thursday morning, she went into surgery. We received the updates with no indication of any issues. After surgery Dr. came in for the post op consult. He said that things did not go as planned. They harvested the veins in preparation. When they went in the ascending aorta was severely inflamed. He said that normal thickness is a millimeter and that it is flexible. Patient had a 6mm wall thickness and was very difficult to work with. This caused them to only bypass 2 vessels. He indicated he was concerned about attaching to the inflamed aorta and that it was very difficult to ensure the stitches went all the way through. He was worried about the efficacy of the connection. He also stated that the inflammation was unusual and that it was possible that if they had earlier diagnosed the inflammation as the cause of the restriction it might have been possible to avoid surgery and treating the inflammation would have cleared the restrictions on the vessels. I asked again if this might be related either to Covid or to the vaccine. This time he said that he did not know and that he would consult with others. He also reported that he took a small part of the aorta out and had sent it to the lab for testing. He did not indicate which tests they would do or what they were looking for specifically. Operative Findings - per Dr. notes in MyChart: 1. The entire ascending aorta was noted to be significantly inflamed and thickened. The thickness of the aorta was noted to be approximately 5 to 6 mm in thickness. Because of the thickened aortic leaflets very hard to place an aortic cannula, antegrade catheter and placement of the proximal graft. Initially the plan was to do 2 bypasses to the left system 1 to the left anterior descending artery using the internal mammary artery and vein to the first obtuse marginal branch using a saphenous vein. Because of the inflammatory condition of the aorta it was decided to place only 1 bypass using the left internal mammary artery to the left system. This was done to avoid any unnecessary manipulation of the ascending aorta. The above-mentioned findings are consistent with aortitis. 2. The left anterior descending artery was noted with approximately 2 mm in diameter. 3. The distal right coronary artery was noted to be approximately 2.5 mm in diameter but slightly inflamed. Patient made it to her ICU room (436) and late Thursday evening was extubated and went for a CT to see if they could see the inflammation. That night she had to go on Bipap to help her oxygenation. Per lab work - became very acidotic requiring Bipap post extubation that evening. 6/18/21: Friday, she continued Bipap to maintain oxygenation. She had a heart rate issue late in the morning and had to have a pace maker attached. Dr came back on Friday and said that he had talked to other doctors and they were going to refer patient to a Rheumatologist at OSU to evaluate if she has an autoimmune disease. 2 U RBCs for low Hgb. No s/s of active bleeding 6/19/21: Saturday went smoothly. She came off Bipap. She was able to get up and walk out to the hall. Chest Tubes, Cordis and foley removed. TR to SE6 stepdown unit. Restarted on beta blocker 6/20/21: Sunday She went to the bathroom and got cleaned up. The nurse changed the dressings on her incisions. 6/22/21: Echo completed. Ambulated in the hall. Discharged home.

headache; nausea; chills; Hemorrhage brain; stroke; subarachnoid hemorrhage; was asleep and not aware of anything for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Hemorrhage brain), CEREBROVASCULAR ACCIDENT (stroke), SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage), HEADACHE (headache), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days), NAUSEA (nausea) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced CEREBRAL HAEMORRHAGE (Hemorrhage brain) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization, medically significant, life threatening and intervention required) and SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage) (seriousness criteria hospitalization, medically significant, life threatening and intervention required). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criteria hospitalization, life threatening and intervention required), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), NAUSEA (nausea) (seriousness criteria hospitalization and life threatening) and CHILLS (chills) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 02-Jun-2021 due to CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT, HEADACHE and SUBARACHNOID HAEMORRHAGE. The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, CEREBRAL HAEMORRHAGE (Hemorrhage brain), CEREBROVASCULAR ACCIDENT (stroke), SUBARACHNOID HAEMORRHAGE (subarachnoid hemorrhage), HEADACHE (headache), LOSS OF CONSCIOUSNESS (was asleep and not aware of anything for 3 days), NAUSEA (nausea) and CHILLS (chills) 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. The patient had brain hemorrhage and stroke. The patient was airlifted to nearby hospital from local hospital spent 8 days in the ICU. It was called subarachnoid hemorrhage. They took patient in ambulance and then they found blood in her brain so they flew her to nearby hospital for neurological ICU did EKG, MRIs and ultrasounds of brain (results were not provided). The patient had no underlying health conditions. After getting the vaccine, patient had the worse headache was screaming. The headaches very soon after the vaccine and it kept on getting worse and worse. The patient was taking Tylenol but it was not taking the pain away. The patient was asleep and not aware of anything for 3 days and then patient called an ambulance. The patient had nausea and chills was scared to get the second shot. No concomitant medication were provided. Company Comment: This case concerns a 49-year-old female hospitalized with serious unexpected events of cerebral haemorrhage, cerebrovascular accident, subarachnoid haemorrhage, loss of consciousness, headache, nausea, and chills. Event onset 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 49-year-old female hospitalized with serious unexpected events of cerebral haemorrhage, cerebrovascular accident, subarachnoid haemorrhage, loss of consciousness, headache, nausea, and chills. Event onset 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient received COVID vaccine on 6/30/21. She had been experiencing chronic dyspnea, lower extremity edema. On 7/7 had some nausea, vomiting at home. Found unconscious by her spouse a few hours later and subsequently died.

About 20 minutes after receiving the vaccine my heartbeat started beating fast, I was feeling short of breath as well as dizzy & nauseous. I've never had a problem with vaccines before so I thought the feeling might pass but my symptoms were getting worse so I went to urgent care next to the vaccine clinic to get evaluated. The Dr. felt that I was having an allergic reaction to the vaccine. He ran bloodwork and monitored me for the day. I went home and continued to feel terrible with my symptoms persisting, especially the rapid heartbeat and shortness of breath. A few weeks later I was diagnosed with pneumonia which exacerbated my asthma. It was difficult to breathe and I started developing issues with throat tightness and swallowing as well. I was prescribed prednisone, antibiotics and additional inhalers to help relieve the symptoms. I had a throat and swallow test done and was diagnosed with vocal chord dysphonia. I am currently doing voice therapy to help with that. I don't know if the pneumonia and other problems are a direct result of the vaccine but I do know that I didn't have these issues prior to getting the vaccine so I felt it was important to report it. Please feel free to contact me if you have any questions.

Anaphylactic Reaction; Rapid Heart rate; Narrowing of throat; swelling of tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction), HEART RATE INCREASED (Rapid Heart rate), THROAT TIGHTNESS (Narrowing of throat) and SWOLLEN TONGUE (swelling of tongue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE for an unknown indication. On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction) (seriousness criteria medically significant and life threatening). 06-Jul-2021, the patient experienced HEART RATE INCREASED (Rapid Heart rate) (seriousness criterion medically significant), THROAT TIGHTNESS (Narrowing of throat) (seriousness criterion medically significant) and SWOLLEN TONGUE (swelling of tongue) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of 50 mg; EPINEPHRINE for Adverse event, at a dose of 0.3 mg; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at a dose of 125 mg; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 08-Jul-2021, ANAPHYLACTIC REACTION (Anaphylactic Reaction), HEART RATE INCREASED (Rapid Heart rate), THROAT TIGHTNESS (Narrowing of throat) and SWOLLEN TONGUE (swelling of tongue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant medication included "MP thyroid." Within 12 minutes of receiving the vaccine, the patient developed an anaphylactic reaction, with swelling of tongue, narrowing of the throat and a rapid heart rate. Oral diphenhydramine 50 mg and epinephrine injection 0.3mg was given to the patient by emergency medical technicians. The patient was taken in an ambulance where she received methylprednisolone sodium succinate 125 mg. She was taken to a local emergency room for treatment. In the emergency room, she was given famotidine and then discharged after observation. Approximately 12 hours later, the patient began to experience the same anaphylactic reaction again and was taken to another emergency room. The patient was treated with intravenous diphenhydramine and an epinephrine injection. She was observed in the emergency room then discharged with prescription medicine. Based on the current 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.

Anaphylaxis. Throat closed and I could not breath or swallow. Pharmacist contacted clinic that was on-site. The nurse and dr/PA (not sure) ran over. I am not sure of everything they did, as this triggered a seizure. After several minutes, I was able to whisper and then talk. 911 was called and an ambulance was dispatched. I heard, at that time when they were relaying vital signs, etc. that an epi pen was used on me. The EMTs then checked me over (quick physical for any injuries, rashes), took vitals and advised me to go to the ER because I was still having some issue with swallowing and because I had had the seizure. They wanted to make I was okay because I was still having some symptoms.

She presents to the emergency department after receiving a COVID-19 vaccination today and having signs and symptoms of anaphylaxis. She described having sensation of swelling in her throat as well as cutaneous rash. On presentation she is also coughing very frequently. She is treated with IM epi, IV Benadryl and IV Solu-Medrol. This rapidly improved her overall symptoms. Reported per: Moderna COVID - 19 Vaccine EUA requirements

TIAStoke Employee complained of numbness at injection and stated she would like to wait about 5 minutes to see if it got better. Employee then stated it started to travel down right arm. Employee was offered treatment and was taken to be evaluated. Employee complained of numbness at injection and stated she would like to wait about 5 minutes to see if it got better. Employee then stated it started to travel down right arm. Employee was offered treatment and was taken to be evaluated.

I was short of breath and went to emergency room on 1/5/2021. I was diagnosed with bilateral pulmonary embolisms. I was Covid negative and had no other symptoms.

On January 14, 2021, I noticed generalized petechiae all over my body. I went to seek medical care and was found to have platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the hospital getting treatment today.

Felt slightly dizzy and woozy following the injection. Then had a mild anaphylactic reaction that started about an hour and 45 minutes following the injection. Throat swelled, and had difficulty breathing. I took two courses of Benadryl, and the throat swelling went down, and breathing got better. Lasted about seven hours or so.

Anaphylactic response; A spontaneous report was received from a consumer who was a 50-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic response. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Jan 2021, a few minutes after receiving the vaccine, the patient experienced an anaphylactic response. Her extremities went cold, her mouth was dry, and she couldn't swallow due to her throat being swollen. She was given intravenous fluids and oxygen due to her oxygen saturation being 82 percent. She was also given an epinephrine injection and was taken to the emergency room to be observed for a few hours. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, anaphylactic response, was unknown.; Reporter's Comments: This case concerns a 50-year-old female patient, who experienced a serious unexpected event of Anaphylactic reaction. The event occurred soon after first dose of the study medication administration. The patient was treated with an Epi-pen, Benadryl iv, and oxygen. 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

Anaphylactic Reaction: itching, redness of skin, wheezing, esophageal spasms and constriction requiring 911, ER and anaphylactic protocols

Anaphylactic reaction 15 minutes after receiving injection. Throat and tongue swelling, light-headeness, diaphoresis, hypotension. Treated with Epi-Pen and Benadryl injection, followed by observation in Emergency Dept.

2 days after 2nd vaccination, onset of arm, hand numbness and painful rash, bumps in all extremities and under breasts. Also headache and nose bleeding. Then about 1 week out with some improvement of above, onset of photophobia and bilateral eye pain. 2/20/21 ER evaluation also with ophthalmologist found anterior bilateral uveitis Suspect SIRS/hypersensitivity like reaction from vaccine leading to above and placed in observation overnight at hospital. Improved with pred forte1% q 1hr and cyclogyl 1% BID. Testing for other systemic disease sent. Headache and swelling responded to toradol X1. She is recovered and will be followed by EYE clinic as outpt

10 days post 2nd Covid-19 Vaccine administration I had an anaphylactic response of unknown origin. Extremely itchy eyes, palms of hands, soles of feet, progressed to shortness of breath, Bradycardic, oxygen saturation in 80s even after administration of IM epinephrin, hypotensive, swollen face, neck and tongue, severe vomiting. EMS transported me to hospital mentioned above. IV started in ambulance where IV epinephrin, IV fluids, IV Benadryl, IV solumedrol were all given prior to arrival at the ER. ER then administered more steroids and anti nausea meds and sent me home after observation and stabilization with prescription for epi pen and prednisone.

anaphylactic reaction; A report was received from a healthcare facility staff member concerning a 50 year old, female patient (a nurse) who was participating in the mRNA-1273 Emergency Use Program and experienced an anaphylactic reaction. No relevant concomitant medications and medical history were reported. The patient received their first of two planned doses of mRNA-1273 on 19-DEC-2020. On 26-JAN-2021, the patient received their second of two planned doses of mRNA-1273 (Batch 030L20A) in her Left deltoid arm (IM injection) and on the same day, experienced the serious adverse event of anaphylactic reaction. She was transported by ambulance to the ER. She stayed there for one day and now is fine. Treatment included Benadryl, epinephrine, steroid, advance, peptide, Motrin. Laboratory details was not provided. The event, anaphylactic reaction, was considered recovered on 26-JAN-2021. Action taken with mRNA-1273 in response to the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

I developed Bell's palsy on 2/21/2021, I do have a previous hx of this . It's a very mild case . On 3/01/2021 I suffered a TIA. Waiting on getting MRI to see if there's any blockage. All my vital signs were within normal limits. Not for sure there's a correlation .

UNCONTROLABLE SHAKING , FEVER OF 103, SEVERE ABDOMINAL PAIN, WHICH LED TO MUTLIPLE ORGAN ISSUES WITH LIVER, KIDNEYS AND GALL BLADDER- DIAGNOSIS "SIRS"

Chose not to get second shot; Deep Vein Thrombosis; A spontaneous report was received from a consumer, concerning a 50 year-old, female who received Moderna (mRNA-1273) and developed deep vein thrombosis, and chose not to get second shot. The patient's medical history was not provided. Concomitant product was not provided. On 07Jan2021 (previously reported as 16Jan2021), approximately one week prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. A week post vaccination, she had a thick painful cord down injection arm and was misdiagnosed with tendonitis. After a second opinion, she was diagnosed with deep vein thrombosis. On 01FEB2021, an ultrasound confirmed a blood clot and subsequently, she went to the ER. A computerized tomography (CT) of the lungs ruled out pulmonary embolism. Based on these events, the patient chose not to get the second shot. Treatment included rivaroxaban and follow-up with hematologist. The second dose of mRNA-1273 was discontinued in response to the event. The outcome of the events deep vein thrombosis and chose not to get second shot were unknown. Follow-up information received 08Feb2021 included additional event, date of first dose was updated from 16Jan2021 to 07Jan2021, diagnostic test and treatment.; Reporter's Comments: This case concerns a 50 year-old, female who experienced deep vein thrombosis. Treatment included rivaroxaban and follow-up with hematologist.Very limited information regarding this event has been provided at this time. Further information has been requested. The causality for the event of intentional dose omission is assessed to be not applicable.

in the early am she had bad diarrhea , she went to work and then started having really bad stomach pains and before noon she had to go home because she started puking. She laid down to take a nap around 3:30pm and never woke up.

Began having SOB 3 days post immunization. worsened over then next 2 days when she was seen in clinic and sent for CT angio where submassive PE was discovered and she was experiencing significant right heart strain which led to hospitalization. while hospitalized additional DVT was discovered. received catheter directed TPA. now on likely lifelong xarelto

Blood clots in the left leg, same side as the vaccine was given. Woke up approximately two days afterward (2/11/21) with muscle pain in the left thigh. The pain did not lessen over the week, assumed it was just muscle. The pain migrated down to my calf and then was too painful to stand on or walk on 2/18/21.

DVT right femoral vein . Pain in leg began 3/5 . Diagnosed via ultrasound. Pt has hx of prior dvt and Factor V Leiden

Patient started to have symptoms of progressive shortness of breath two weeks after the 1st vaccine shot and she presents to the hospital on 3/18 and was found to have submissive PE

From the second day I have had persistent and continuous vaginal bleeding lasting three weeks. Upon receiving the second from that moment I continue with persistent and continuous vaginal bleeding. Appearance of multiple bruises (hematomas) in different parts of the body, even with just scratching my skin, blood stains come out.

Stroke; Anaphylactic shock; High blood pressure; A spontaneous report was received from a pharmacist concerning a 50-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, stroke/cerebrovascular accident and high blood pressure/hypertension. The patient's medical history was not reported. The relevant concomitant medications were not reported. On 18 Mar 2021, approximately five minutes prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 032M20A) via unknown route for prophylaxis of COVID-19 infection. On 18 Mar 2021,five minutes after vaccination the patient experienced anaphylactic shock, stroke and was subsequently hospitalised. The patient also had high blood pressure. The events anaphylactic shock and stroke was life threatening. Treatment for the events included steroids, diphenhydramine and epinephrine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events anaphylactic shock, stroke and high blood pressure was not reported.; Reporter's Comments: This is a case of Anaphylaxis and Stroke in a 50-years-old female patient with no medical hx provided who was hospitalized immediately after receiving first dose of vaccine. Very limited information has been provided at this time. Further information is expected

PT STATED THAT SHE INITIALLY HAD A SMALL REACTION AT INJECTION SITE BUT THAT IT WENT AWAY UNTIL A WEEK LATER AND THEN IT LOOKED LIKE A WELP ON HER UPPER ARM. IT WAS TENDER, HOT AND A LITTLE ITCHY. PT ALSO SAID THAT SHE BLEED FOR 2 DAYS AFTERWARDS.. BLED ENOUGH TO HAVE TO CHANGE BANDAIDS MULTIPLE TIMES AND THEN IT STOPPED. PT TREATED THE RASH WITH HYDROCORTISONE CREAM AND IT WENT AWAY.

Menstrual period began two days after 1st Moderna vaccine with spotting on 3/27/21. One week after vaccine, heavy period began with several fist-size clots the evening of 4/1/21. Today is 4/12/21 and I am still having my period. It has lightened up but not stopped after more than two weeks. My age is 50 and I am in peri-menopause.

i suffered two DVT's in my left leg... These occurred 2.5 weeks after second Moderna vaccine. I have a history of DVT and PE 20 years ago....I am on Coumadin... Coumadin was considered a fail and now I am on Xarelto.

First Vaccine: Symptoms of only left arm local errhythemia and itchy, flu like symptoms x 48 hours. Second Vaccine: Delayed anaphylaxis beginning slowly 20 min after injection with SOB/Wheezing without relief using rescue inhaler 4x in 2 hours. Progressed to full waist, chest, arm, face rash/hives with significant SOB, Progressed to full A-fib. Symptoms self treated at home with Benadryl and Prednisone. No epi-pen used. Continued self treatment on 4/11, 4/12 and had follow up with Asthma/Allergy specialist due to not resolving. Added steroids and anti-histamine for rest of this week.

I received vaccine doses on 2/16/21 and second on 3/16/21. Trying to complete good deeds for Lent, I donated Plasma for the first and only time on 3/7/21. On 3/8/21 my right calf starting seizing up and I was experiencing calf pain. I was advised to do stretches and use a heating pad. It persisted for over a week and I went for a Doppler ultrasound scan on 3/17/21. Blood clots were found. The Plasma donation center screening led me to believe that they were concerned with other vaccines but not the Covid19 vaccine. Writing report because I think there is a possible connection to the blood clots, vaccine and plasma donation. I had to "do nothing" for three weeks and have been placed on Eliquis, a blood thinner for four months. Follow-up with Dr. for blood work and Doppler in July.

About a week and a half after 1st vaccine pt had a pain in her knee that eventually spread up and down to ankle and thigh area. On 3/21 she went to urgent care and was referred to the emergency room because she was also having a pain in her chest. She had a stress test, EKG, chest xray, and Doppler and was diagnosed with a large DVT in the thigh and a small clot near the ankle. She was given Lovenox injections inpatient for 3 days and sent home on Xarelto 15/20mg starter pack and Aspirin 81mg. She was also started on metoprolol tartrate 25mg and atorvastatin 40mg. She saw her PCP 4/6 and sees a cardiologist and hematologist within the next couple of weeks for follow-up.

We administered the second dose of the Moderna COVID-19 vaccine on Friday, April 16th. We were contacted by the patients family to report that the patient began a fever and chills the night of 4/16, she subsequently began having nausea, vomitting, and sweating followed by a seizure, and was taken to the emergency department where she died the following day. She was encouraged to receive the vaccine at the encouragement of her oncologist.

Achy left ear, paralyzed left side of face, left side of mouth paralyzed, left eye would not close or blink. This started the day after the vaccine injection. The facial paralysis lasted 5 weeks. The leg pain started 3 weeks after injection.

Bright red vaginal bleeding after no cycle for approximately 8-10 yrs. diagnosed post menopausal approximately 6 yrs ago. Bleeding was too heavy for pantyliner. Lasted 2 days. Mild uterine cramping.

Per patient contacting pharmacy, she indicated approximately 24 hours after her first COVID-19 vaccine (Moderna), patient experienced a grand mal seizure that caused unconciousness for approximately 2 minutes. While unconcious, she bit her tongue and her time to get full functionality was 30-60 minutes after. Patient indicated she contacted her primary neurologist via email and left messages at the office, however still has not heard from her doctor. She did not seek out other medical treatment. Patient has a history of grand mal seizures, but has not experience an event since starting medication.

Blood clots; Gangrene; Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine; patient was sent to rehabilitation center; surgery (a leg was amputated); two clots were removed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots), THROMBECTOMY (two clots were removed), GANGRENE (Gangrene) and LEG AMPUTATION (surgery (a leg was amputated)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Clot blood (blood clots in heart and lungs for last 15 years) and Thrombectomy (40 clots removed from heart and lungs from past 15 years). Concurrent medical conditions included Systemic lupus erythematosus (bad lupus). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant). On 01-Mar-2021, the patient experienced THROMBECTOMY (two clots were removed) (seriousness criterion hospitalization prolonged) and LEG AMPUTATION (surgery (a leg was amputated)) (seriousness criterion hospitalization prolonged). On 12-Mar-2021, the patient experienced REHABILITATION THERAPY (patient was sent to rehabilitation center). On an unknown date, the patient experienced GANGRENE (Gangrene) (seriousness criterion hospitalization prolonged) and PRODUCT ADMINISTRATION INTERRUPTED (Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine). The patient was hospitalized on 10-Feb-2021 due to THROMBOSIS, then on 27-Feb-2021 due to LEG AMPUTATION and THROMBECTOMY. The patient was treated with Surgery for Gangrene. On 01-Mar-2021, THROMBECTOMY (two clots were removed) and LEG AMPUTATION (surgery (a leg was amputated)) had resolved. At the time of the report, THROMBOSIS (Blood clots), PRODUCT ADMINISTRATION INTERRUPTED (Missed her second dose as the hospital where the patient was admitted did not have Moderna vaccine) and REHABILITATION THERAPY (patient was sent to rehabilitation center) outcome was unknown and GANGRENE (Gangrene) 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. As per the patient's doctor, it was too late and dangerous to remove clots from the patient's leg and eventually, the doctor had to amputate the patient's leg because of gangrene. No concomitant medications were reported. Company comment: Based on current available information and the temporal association between product use and het start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and het start date of the events a causal relationship cannot be excluded.

Patient came to pharmacy for 1st Moderna Covid-19 vaccination on 4/21/21. Spouse reported she died on 4/25/21. Our pharmacy does not have information about her medications or health conditions as she wasn't a regular customer of ours.

Delay 2nd dose 2 weeks, after the 42 days post 1st shot; Had an episode of Afib; Elevated Heart rate 4 hours after first dose; Chest pain; Chest pressure; Palpitation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Had an episode of Afib) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation and Costochondritis on 09-Mar-2021. Concomitant products included METOPROLOL, LOSARTAN, SOTALOL, LEVOTHYROXINE, LIOTHYRONINE and METFORMIN for an unknown indication, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and EMPAGLIFLOZIN (JARDIANCE). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (Elevated Heart rate 4 hours after first dose), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest pressure) and PALPITATIONS (Palpitation). On 07-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Had an episode of Afib) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Delay 2nd dose 2 weeks, after the 42 days post 1st shot). At the time of the report, ATRIAL FIBRILLATION (Had an episode of Afib), HEART RATE INCREASED (Elevated Heart rate 4 hours after first dose), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest pressure) and PALPITATIONS (Palpitation) outcome was unknown and PRODUCT DOSE OMISSION IN ERROR (Delay 2nd dose 2 weeks, after the 42 days post 1st shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Chest X-ray: normal (normal) normal. On 09-Mar-2021, Electrocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Her cardiologist changed her medications from: metoprolol Tartrate 50mg BID, Levothyroxine 200MCG QD, Liothyronine 25mcg 1/2 T Bid, Losartan 100mg QD, Metformin 1000mg BID To: DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Chest X-ray: normal normal. On 09-Mar-2021, Electrocardiogram: normal normal. Losartan 25mg QD, Jardiance 25mg 1/2 T QD, Metoprolol t 50 mg TID, Pradaxa 150mg BID Today(26-Apr-2021) evening she is supposed to stop her Metoprolol Tartrate 50mg TID and start Sotalol 80mg 1/2T BID. Company comment:This case concerns a 50-year-old female with a serious unexpected event of atrial fibrillation, and non-serious unexpected heart rate increased, chest pain, chest discomfort, palpitations, and product dose omission in error. Event onset 19 days after 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.; Sender's Comments: This case concerns a 50-year-old female with a serious unexpected event of atrial fibrillation, and nonserious unexpected heart rate increased, chest pain, chest discomfort, palpitations, and product dose omission in error. Event onset 19 days after 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.

Within 3 minutes my ear began to itch and swell. The swelling went down my neck into my throat. Anaphylactic results.

Back pain have been severely bad after she took both doses; Arthritis have been severely bad after she took both doses; Drug Rash; Diagnosed with DVT; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Diagnosed with DVT) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11020A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis, Migraine and Back pain. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced DEEP VEIN THROMBOSIS (Diagnosed with DVT) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (Back pain have been severely bad after she took both doses), ARTHRITIS (Arthritis have been severely bad after she took both doses) and DRUG ERUPTION (Drug Rash). At the time of the report, DEEP VEIN THROMBOSIS (Diagnosed with DVT), BACK PAIN (Back pain have been severely bad after she took both doses), ARTHRITIS (Arthritis have been severely bad after she took both doses) and DRUG ERUPTION (Drug Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. After getting the first shot on 16 Jan2021, she was diagnosed with DVT on 18 Jan 2021 and has been on blood thinner ever since then. She also takes Emgality, a migraine injection every month. She states that ever since she received the vaccine and has been put on blood thinner, she gets rash every month when she take Emgality injection. She also reported that her underlying conditions like back pain and arthritis have been severely bad after she took both doses of the vaccine. Patient is going to speak with her doctor first thing in the morning tomorrow. 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.

Approximately 15 minutes after the shot, I got lightheaded. A couple of hours later, my arm was sore and I started feeling tired. The next morning when I woke up, I felt like I had run a marathon and got hit by a semi-truck at the same time. My legs started having shooting pains. I could not walk normally. I ran marathons before and I had the marathon walk. I could not walk for more than a couple of steps without having severe pain. It felt like all the nerves in my legs were on fire. It took approximately 4 or 5 days for the pain to stop and I could walk normally. I was in bed for 4 days. It took about 2 weeks to feel back normal. Then I started having spotting. I have not had a period or any break through bleeding in over 6 years. That lasted about 3 days. As of today, I am in a small flare. It is not a full flare but am having symptoms. If the symptoms do not improve in the next 2 weeks, I will be going to my GI doctor.

After leaving pharmacy, patient experienced a seizure while riding as a passenger in a vehicle. Patient was hospitalized and diagnosed with a "Brain Bleed" according to mother.

Dose 1 mild possible anaphylaxis lasting only minutes - 6 days severe normal side effects Dose 2 - Pretreated per Allergist recommedations - Extreme fatigue, cognitive impairment, lymphedema, peripheral edema, fluid retention, weight gain, loss of hearing in left ear

4/22/21- Fever, Chills, night sweats, body aches 4/23/21- Fever, Chills, Body aches 4/24/21- Body aches, numbness and weakness on right side of body 4/29/21- Went to healthcare facility complaining of numbness and weakness on the right side of the body. Was seen by a doctor and did a neuro assessment. She then decided that she was having a ?stroke? or a ?brain bleed?. While at ER the PA did another neuro assessment and said could be having a stroke and was admitted into the hospital on 4/29/21

Patient presented in the ED on 5/14/20 at Hospital with a left sided stroke. Was treated with alteplase. Pt was then transferred to another Hospital

On April 3rd 4PM I had shortness of breath and dizziness. I called the online DR telehealth. I then went to an immediate care where I was sent to the hospital. At the ER I was diagnosed with pulmonary emboli across both lungs. I was then admitted to the hospital. In the hospital, they did an echo which was normal and a stress test. I was put on Eliquis. I was discharged on Monday April 5th A few days later, I went back to the ER because I had fallen after feeling very dizzy. That was on Tuesday April 6th. They did a scan of my head which was fine so I was sent home. They asked me to follow up with my pulmonologist and my PCP.

Clots in left arm after taking 2 shots; Swollen arm after 2 vaccine shots; pain in left arm; 50 days gap between 2 vaccine doses; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Clots in left arm after taking 2 shots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Idiopathic thrombocytopenic purpura, Spina bifida and Psoriasis. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clots in left arm after taking 2 shots) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots), VACCINATION SITE PAIN (pain in left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses). The patient was treated with APIXABAN (ELIQUIS) at a dose of 25 mg twice a day and APIXABAN (ELIQUIS) at a dose of 5 mg twice a day. At the time of the report, THROMBOSIS (Clots in left arm after taking 2 shots), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots) and VACCINATION SITE PAIN (pain in left arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) clot in the left arm. Patient went to emergency after 3 weeks of taking Moderna COVID-19 second Vaccine. No relevant concomitant medications were reported Reportedly, the treatment with Apixaban (Eliquis) needed to continue for 6 months. 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.

Patient admitted 4/19/21 with acute hypoxia, bilateral pneumonia found to be Covid-19 positive. Treated with 6 days of dexamethasone, 5 days of remdesivir, and received convalescent plasma. She was discharged on 4/25/21 without an oxygen requirement. Received Moderna vaccine 3/18 and 4/15

This is a 50 year old female, who was identified by me due to anaphylaxis following her 2nd dose Moderna on 5/25/21. Upon further review of her chart, additional administration errors were identified. On 4/9/21, the patient received a J&J vaccine dose (lot#1805018, IM, left arm). A few weeks later, the patients contacted her primary care physician with a concern that she took an ibuprofen prior to the J&J vaccine dose and was concerned about that ibuprofen dose impacted her immune response. She had spoken to a retail pharmacist who recommended an antibody test to check for immunity. Her primary care provider agreed that the antibody test 'would be reasonable to do.' The patient took a SARS -COV2 Antibody IGG test on 4/27/21. The result was negative, and the covering provider communicated to the patient 'covid testing is negative.' No additional chart documentation regarding any communication/interpretation of this lab result as it pertains to her post-vaccination immune status. The patient reported to the vaccine clinic on 4/30/21 and received her 1st dose of Moderna (lot# 021C21A, IM, left arm). She reported this was 'OK with her PCP,' however no chart documentation to confirm that. No adverse events reported following either the J&J dose on 4/9, or the Moderna dose on 4/30. She returned to our vaccine clinic on 5/25/21 and received the 2nd dose of Moderna. Immediately following that dose, she developed swollen eyelids, itching in her throat, and nausea. The onsite provider administered diphenhydramine 50mg IM with some improvement. The symptoms returned within 10 minutes, and the patient was treated with famotidine 10mg orally. EMS was called and evaluated patient. The patient refused EMS/transport to an emergency room. The patient then drove herself to a nearby emergency room where she was observed further. The following day, the primary care clinic contacted patient and she reported resolution of her symptoms. Overall, likely anaphylaxis following her 2nd dose Moderna vaccine AND duplicate therapy (received both J&J and Moderna vaccines).

Experienced more bleeding than usual.; 2nd dose of vaccine was administered 21 days after first dose; Excessive sweat; Sneezing; Runny nose; Back pain around the kidney area; Joint pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Experienced more bleeding than usual.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003RB1A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hemorrhage. Concurrent medical conditions included Anemia. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced HAEMORRHAGE (Experienced more bleeding than usual.) (seriousness criterion medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was administered 21 days after first dose), HYPERHIDROSIS (Excessive sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), BACK PAIN (Back pain around the kidney area), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). The patient was treated with NORETHINDRONE ACETATE for Hemorrhage, at an unspecified dose and frequency; CARVEDILOL at an unspecified dose and frequency; SPIRONOLACTONE at an unspecified dose and frequency and ERGOCALCIFEROL at an unspecified dose and frequency. On 05-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was administered 21 days after first dose) had resolved. At the time of the report, HAEMORRHAGE (Experienced more bleeding than usual.), HYPERHIDROSIS (Excessive sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), BACK PAIN (Back pain around the kidney area), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) outcome was unknown. There was no concomitant medication reported. Patient was treated with zitrone C for unknown indication. Very limited information regarding this event (hemorrhage) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the all other events, a causal relationship cannot be excluded. This report also refers to a case of (Inappropriate schedule of product administration) for mRNA-1273, lot # 003RB1A with no associated AEs. Details regarding the type of hemorrhage is required for further assessment.; Sender's Comments: Very limited information regarding this event (hemorrhage) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the all other events, a causal relationship cannot be excluded. This report also refers to a case of (Inappropriate schedule of product administration) for mRNA-1273, lot # 003RB1A with no associated AEs. Details regarding the type of hemorrhage is required for further assessment.

Pneumonia; cough; headache; chills; fever; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypoglycemia and Fibromyalgia. Concomitant products included DULOXETINE, METHOCARBAMOL, AMITRIPTYLINE and GABAPENTIN for Fibromyalgia, VERAPAMIL and GLUCAGON for Hypoglycemia. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On 21-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Pneumonia, at a dose of 1 dosage form. On 19-Apr-2021, COUGH (cough), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) had resolved. On 30-Apr-2021, PNEUMONIA (Pneumonia) 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. The other concomitant medication provided by the reporter was Rescue inhaler, Epi pen and Air duo Inhaler. It was reported that the consumer took allergy shot about 1.5 weeks after receiving the first dose. Treatment medication provided was antibiotics. 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-2021-200079 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Non-significant Follow up appended for AE Doc Attachment.; 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.

Patient ate her cereal late the next morning. She has been eating the same cereal for years. She said she had an anaphylactic reaction, which was resolved by taking Benadryl 50MG. Her children are all allergic to tree nuts. She ate the same cereal on Monday and said she had another anaphylactic reaction. She now believes she is allergic to tree nuts.

Systemic: vaginal bleeding-Mild, Additional Details: patient called pharmacy 6/17 to ask if a side effect of the moderna shot was vaginal bleeding. she was upset as she had a hysterectomy many years ago (leaving one ovary and her cervix intact) and had began spotting bright red blood on 6/17, attributing it to the immunization. informed her of s/s of an emergent situation if it progresses, and the need to mention it to her pcp/obgyn

I developed chronic pericarditis over the past few weeks leading to incidental Dxof pericardial effusion and cardiac tamponade on 6/16 after presentation of acute gallbladder- my gallbladder was removed, then pericardiocentisis was performed. I am still experiencing inflammation and thick pericardium.

Started having TIA?s not sure if related but seems suspect when I have never had anything like that before the vaccine

On April 2, 2021, person went to the ED at 10:15 AM, where she complained of shortness of breath, fatigue, mild headache and nausea. Patient symptoms were going on for about 3 days. She also reported feeling a bit achy and decreased appetite. She was treated and discharged home the same day. It was later reported by a family member that this person was found unconscious on floor of her bedroom by family members and taken to hospital where she passed away. It was reported hat Doctors were thinking that this was caused by a rare blood disorder (Thrombotic thrombocytopenic purpura, a disease which causes small blood clots and interrupts the blood's ability to deliver oxygen properly).

Headache, fever, nausea, vomiting, diarrhea, pleuritic chest pain starting 6 hours after the second dose of vaccine. Patient reported to the hospital 6 days later(6/25/2021), found to be febrile, tachycardic, hypotensive, concerning for septic shock, also had thrombocytopenia, transaminitis, and Acute Kidney injury. Patient resuscitated with IVF, pressors with improvement in blood pressure and renal function. Patient entire workup as of 6/30/2021 has been negative. Patient continues to spike high fevers to 103, and the etiology of this is unclear at this time.

On 6/15 I began heavy menstrual bleeding with large clotting. I am on oral contraceptives and this bleeding occurred 4 days earlier than it should have. The oral contraceptive keeps me regular and my bleeding is of a medium flow lasting no more than 4 days. I had extremely heavy bleeding for 8 days with continued spotting. I'm also experiencing large bruising from the slightest injury. I even bled and later bruised at the injection site on 6/26 when receiving my second Moderna dose. This was in addition to fatigue, muscle cramping and headaches. But I expected that. The bleeding is extremely unusual.

50 years old female with past medical history of hypertension. Patient presented with chief complaint of chest pain associated with nausea and vomiting. She was found to have a inferior ST elevation. Code heart was called. Patient was taken to Cath Lab. Mid RCA was occluded and one drug-eluting stent was placed. Patient tolerated procedure well. She was transferred to the ICU for the further management.

Started having shortness of breath/coughing around 5/2, had a video visit with dr on 5/6- prescribed Albuterol and allergy pill thinking it was related to allergies. 5/8 went to ER as continuing to have shortness of breath and coughing- in some cases was gasping for air. Admitted to hospital, while they tried to figure out what was wrong- did several tests including COVID, raspatory panel and several others all came back negative. Xrays, looked like "COVID lungs" per the dr but COVID tests were negative. Had chest Xrays twice while in hospital as well as CT scan. No identified cause but was diagnosed with community based pneumonia, one dr said "COVID era". After 6 days in hospital released with o2 and dexamethasone regimen. Seemed to get better, but then digressed approx. 5/25- Dr prescribed 2nd round of steroids' and asked for another chest Xray. Xray showed some things they wanted to look at closer, had second CT on 5/28. Based on that- diagnosed with Pulmonary Fibrosis-- still under treatment, Lung biopsy scheduled for 8/19/21

After about a month after her COVID vaccinations ending April 5, 2021, Moderna, she developed increased excessive abdominal pain and she started passing bloody clots through her rectum. Within a few days of this, she became unresponsive at home and was taken by EMS to the hospital. She was found to be in a severe shock and was treated with Levophed. She was hospitalized for 4 to 5 days and diagnosed with "sepsis" and severe diverticulitis with bloody stools. She was treated with IV antibiotics and discharged on Cipro and Flagyl. . Post this event, she is having overwhelming fatigue and generalized neuropathic pain, muscle pain, and bone pain. She is also having chronic gut dysbiosis

7/4/2021: Patient transferred from Hosptial after presenting with generalized weakness, cough, shortness of breath and blood in the urine. Patient tested positive for COVID on 7/3/2021. Diagnosed with acute bilateral pneumonia secondary to COVID-19, acute hypoxic resp failure, severe ARDS, acute metabolic encephalopathy, AKI. intubated in the ICU. Note: patient fully vaccinated with Moderna COVID-19 vaccine. 7.25.21: patient died.

Was treated for blood clots in my right lung. There was a cluster of blood clots in my lower right lung. I am on blood thinners now. Eloquis is the blood thinner I am on now.

Had a very bad reaction, so bad that was having heart attack; Chest cold; Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.; Tendons are sensitive. I am very sensitive; Flashes of sharp pain/painful/horribly painful like somebody stabbed her/Body aches felt it was terrifying; Muscle spasm from arm to chest; Severe reaction/shot made her feel worse; Knee hurt; Periodic neurologic pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Had a very bad reaction, so bad that was having heart attack), LOWER RESPIRATORY TRACT INFECTION (Chest cold) and ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 038C21A) 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. Family history included Guillain-Barre syndrome. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Had a very bad reaction, so bad that was having heart attack) (seriousness criterion medically significant), LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.) (seriousness criterion medically significant), TENDON DISCOMFORT (Tendons are sensitive. I am very sensitive), PAIN (Flashes of sharp pain/painful/horribly painful like somebody stabbed her/Body aches felt it was terrifying), MUSCLE SPASMS (Muscle spasm from arm to chest), VACCINATION COMPLICATION (Severe reaction/shot made her feel worse), ARTHRALGIA (Knee hurt) and NEURALGIA (Periodic neurologic pain). At the time of the report, MYOCARDIAL INFARCTION (Had a very bad reaction, so bad that was having heart attack), LOWER RESPIRATORY TRACT INFECTION (Chest cold), ANGINA PECTORIS (Thinks she needs to go get her heart checked. She is experiencing enough pain to give someone a Heart Attack.), TENDON DISCOMFORT (Tendons are sensitive. I am very sensitive), PAIN (Flashes of sharp pain/painful/horribly painful like somebody stabbed her/Body aches felt it was terrifying), MUSCLE SPASMS (Muscle spasm from arm to chest), VACCINATION COMPLICATION (Severe reaction/shot made her feel worse), ARTHRALGIA (Knee hurt) and NEURALGIA (Periodic neurologic pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Patient was diagnosed with COVID back in Jan 2021. The concomitant medication included was non specified blood pressure medication. No treatment information was provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-267583 (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.

I had covid nov 23 2020. On jan 25 I had a stroke Couldn't talk. Couldn't move my left arm or leg. I received TPA.

Sepsis, Acute Pancreatitis, Respiratory Failure on Mechanical Ventilation, Disseminated Intravascular Coagulation, Pneumonia, Acute Kidney Injury. Refractory Hypoglycemia

vaginal bleeding. I believe that it is a regular period. The reason this is concerning is because I have been in full menopause for almost 3 full years. I contacted gynecologist already.

After the vaccine dose 1 asked about allergies. I informed by the head of pharmacist and 7 different physicians based on my medical history was told to get Moderna vaccine. Also to bring my Epipen in case I needed to use it.I waited after 15 minutes started to ex cough I was placed on Oxygen and given a shot of Epipen .At the point I wasn't getting enough Oxygen to the brain called code blue until I was stabilized having a anaphylactic.I was discharged not to work 3 days and return to hospital for Prednisone injection. In late Jan I went to my Allergist got tested right and left arm skin test(muscular) it was PEG,Polysorbate 80 I was allergic.Im recommended to not get 2nd dose until Covid test that does contain PEG/Polycarbonate 80.

Initial injection site pain for two days. Around day five, both armpits were discolored significantly. On day nine I was in the ER with left side abdominal cramps that was diagnosed after a CT Scan as a splenic infarction caused by a blot clot. I have not had a blot clot previously and have always been healthy with no surgeries or prescription medications except propranolol for anxiety (since the pandemic started).

Patient presented on 2/24/21 with B pulmonary emboli, with symptoms of dyspnea started around 2/22/2021, she was have headache, dizziness and abdominal bloating on presentation.

Pt presented to the ED in acute anaphylaxis 20 minutes after receiving vaccine dose, in respiratory distress with stridor, wheezing, and difficulty breathing, as well as hives across her chest and arms. Pt had Epipen with her and ED staff assisted her in administering it. Pt received solu-medrol, pepcid, benadryl, and albuterol in the ED. Pt significantly improved within 1 hour and was admitted to the hospital to be monitored overnight.

IMZ GIVEN APPROX 1" FROM BURSA. PATIENT HAD A GOOD AMOUNT OF BLEEDING AFTER IMZ. NOW, SEVERAL HOURS LATER, HAVING A HARD TIME MOVING ARM AND VERY DECREASED RANGE OF MOTION. MAY HAVE HIT BURSA AND CAUSED BURSITIS. TOLD PATIENT TO TAKE TYLENOL, IBUPROFEN, AND USE A COLD PACK FOR 15 MINUTES TO HELP WITH PAIN AND INFLAMMATION. INSTRUCTED PATIENT TO F/U WITH PCP IN AM

EPI ADMINISTERED 0.5 ML IM & BENADRYL 50MG IM; TRANSPORTED TO LOCAL HOSPITAL ANAPHYAXIC RASH PRESENTED BY RASH AND GI DISTURBANCE

Diagnosed with COVID (confirmed with a positive COVID test) the say after her vaccine. Eventually died from complications of COVID. Because vaccine was administered prior to her illness, I am putting this in the VAERS system. Symptoms included SOB, coughing, muscle aches. headache, fever.

waited the required 15 minutes at the vaccination site. As I was driving home, my throat swelled up, breathing was labored, and I became dizzy. I quickly pulled over to a gas station and called 911. EMT's arrived and transported me via ambulance to the hospital. En route, I was administered 50 mg of Benadryl. Diagnosis was anaphylactic reaction to vaccine.

Severe allergic reaction including throat swelling, hives, burning /itching skin (head to toe), swelling of hands and feet. Over a thirty minute span, the reactions started to the time I made it to the ER. They got progressively worse during that 30 minute span. Required a shot of epinephrine due to anaphylaxis.

Patient had grand mal seizure following vaccination X 2. Event occurred approximately 10 minutes following vaccination. Patient does report history of "vasovagal episodes". Pulse maintained throughout episode, no medications given. Patient spontaneously returned to orientation. BP 70/50 and HR 59 upon initial assessment. Patient sent to urgent care clinic for further evaluation by provider.

After administration of COVID-19 vaccine patient complained of chest tightness 2/10 radiating to left arm. Complaining of tongue swelling, nothing observed and airway visibly clear at this time, no rash/urticaria. SBP has increased to >140s, note that she held her beta blocker and has recently diagnosed hypertension. Lungs CTA b/l. We discussed that without decreased blood pressure and wheezing at this time and given her chest pressure we will hold off on epinephrine for now as this is not consistent with suspected anaphylactic reaction but given her hypertension history and chest tightness patient been sent to urgent care at this time. We are giving cetirizine 10 mg and discussed that if objective signs of anaphylaxis clearly epinephrine will be given but with current signs/symptoms further observation where EKG may be done is warranted .Pt in NAD. Appears well, Nontoxic. No respiratory distress at rest, with conversation, or on ambulation. Alert and Oriented times three. Mental Status clear and coherent. Normal conversation. Mucous Membranes moist THROAT: No perioral or oral edema noted. Tolerating all secretions. Voice clear NECK: supple, no lymphadenopathy LUNGS: CTA. Good air movement COR: RRR without murmur No axillary adenopathy No chest wall tenderness to palpation. Procedures/ EKG EKG: NSR . No ischemic changes. NSTWAs Compared with EKG 12/7/20: No significant change. Slight difference in T wave morphology isolated to V1 (nonspecific)

Inability to walk, effectively communicate, raise my arms, suffered sustained premature ventricular tachycardia for a number of hours, life saving procedures enacted, no blood flow to extremities, severe pain, vomiting's, periods of unconsciousness

Slurred speech at 3am on 20Jan2021. Emergency room doctor diagnosed TIA at 7am. Discharged but symptoms returned at 10am. HCP transferred me to hospital for possible Stroke. I was admitted to the hospital on 1/20/2021 at 2pm. MRI indicated that I had a stroke.

On Saturday, April 3rd, patient told her son she was tired and was going to take a nap. Her son tried to wake her the next morning since she had not come out of her room from the day before. He was unable to wake her.

51-year-old female presents to ED with left lower extremity edema. Patient reports left lower extremity swelling, particularly in the calf and ankle couple weeks ago. She denies any specific traumas or injuries, states she initially thought maybe she had sprained her ankle but is noted that the swelling had not improved. Says theres some slight pain but moreso the swelling that was concerning to her. Has not noticed any erythema or ecchymosis. No numbness, tingling, paresthesias. No fevers or chills. No chest pain or shortness of breath. She is currently on estrogen oral contraceptive, no recent travel, immobilization, medical procedure, surgery, or trauma, hemoptysis, malignancy, coagulation disorders, history of DVT or PE. States initially followed up outpatient and had an ultrasound that was done and she was instructed to come to ED for positive result. No further symptoms or complaints at this time. The patient's symptoms, exam, workup, and disposition were discussed with ED attending Doctor, proceeded with management accordingly. Physical exam as above. Patient afebrile, hemodynamically stable, well-appearing. Chart review from earlier today shows ultrasound positive study for subacute nonocclusive proximal DVT in the left popliteal vein, and subacute superficial thrombophlebitis in the left lesser saphenous vein. No evidence of cellulitis or infection at this time there's no warmth or erythema or streaking. No bilateral edema, JVD, or evidence of fluid overload. Suspect patient's symptoms of left lower extremity swelling and pain likely secondary to the DVT and thrombophlebitis. No bony TTP or injuries no indication for bony imaging. No cp, sob, tachycardia, hypoxia. Do not suspect PE. She does have a leukocytosis no urinary or respiratory symptoms lower suspicion UTI or pneumonia. No neck stiffness or pain to suggest meningitis. Area doesn't appear cellulitic at this time but could possibly be due to early cellulitis and the superficial thrombophlebitis. She's afebrile non septic appearing and will be started on abx nonetheless and she is given strict return precautions regarding this. She has no contraindications to anticoagulation including no thrombocytopenia, active hemorrhage, history intracerebral hemorrhage, chronic anticoagulation. No findings suggestive of phlegmasia cerulea dolens. Labs including kidney function, liver enzymes discussed with ED pharmacist matt nagar. Patient has no significant commodities and is an appropriate candidate for outpatient DVT treatment with eliquis. She is educated regarding eliquis by ED pharmacist. Discussed with patient the need to contact her doctor tomorrow regarding the oral contraceptives that she is currently taking, as there may likely need to be a change and/or discontinuation of this secondary to patient's DVT and starting on Eliquis. She is instructed not to make any changes to medication regimen until she contacted her PCP, and again reiterated that she needs to speak with them first thing tomorrow morning regarding her birth control. Patient expresses understanding. Given overall presentation and ED workup, believe patient is stable for discharge home at this time. Discussed at length strict written and verbal ED return precautions with patient. Patient will follow up with PCP, will start on eliquis and clinda. Patient expressed understanding and agreeable to this plan for discharge and follow up.

Convulsions; In and out of consciousness; extreme pain throughout the body; Vomiting; Inability to speak; Couldn't walk; Couldn't raise limbs; Sustained premature ventricular tachycardia; Heart collapsed to 20 BPM; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No historical condition reported). On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia) (seriousness criteria hospitalization, medically significant and life threatening), BRADYCARDIA (Heart collapsed to 20 BPM) (seriousness criteria hospitalization, medically significant and life threatening), SEIZURE (Convulsions) (seriousness criteria hospitalization prolonged and medically significant), SEIZURE (In and out of consciousness) (seriousness criterion hospitalization prolonged), PAIN (extreme pain throughout the body) (seriousness criterion hospitalization prolonged) and VOMITING (Vomiting) (seriousness criterion hospitalization prolonged). 23-Mar-2021, the patient experienced GAIT INABILITY (Couldn't walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs) (seriousness criterion hospitalization) and APHASIA (Inability to speak) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA, BRADYCARDIA, GAIT INABILITY, MUSCULOSKELETAL STIFFNESS and VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: 20 (Low) 20 BPM. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) to be related.

ABOUT hour after injection started with itchy throat, progressed within 5 to 10 minutes to dry cough, the persistent dry cough, about 20 minutes after symptoms started 1 puff from inhaler, coughing increased to non stop unable to breath, co worker (LVN) called a code, code team arrived within 2 minutes continued trouble breathing, coughing, given 2nd puff from inhaler, put on oxygen transported to emergency room treatment started with breathing treatment, steroids, started experiencing chest pressure, right arm tingling and numbness, face numb and mouth monitored for couple hours, EKG, labs, blood work, x ray's done, then IV's started notified transferring to an adult hospital due to cardiac concerns. Transferred by Ambulance Hospital, triaged labs, EKG, X-Rays, seen by Cardiac Doctor on call advised being admitted for Anaphylaxis to Moderna injection. Monitored and treatment then released on 04/01/2021. Discharge medications prescribed and advised to follow up with medical doctor.

Presented to UCC on 3/7/2021 with complaints of left leg pain/swelling, had cervical block 03/02. when she got home she noted some groin pain,. and this morning left leg was so swollen. she is also complaining of mild shortness of breath. denies chest pains, was tachy at triage. She was then transferred to Emergency Department. Per their report: The patient presents with a swollen discolored left lower leg. She does have discoloration and I am concerned for massive DVT and cerulea dolens. She does have really minimal pain to the leg except to the groin, she has intact pulses, I have low suspicion for acute ischemia/arterial clot. She does complain of some mild dyspnea with exertion above baseline so I do have concerns for possible PE. She is hemodynamically stable, appears in no distress. She is on oral contraceptives, mild obesity, no other significant VTE risk factors. I am going to empirically start her on heparin, I have also ordered a CT PE and a CT abdomen pelvis to check for proximal propagation of the DVT along with a left lower extremity duplex Doppler ultrasound. Duplex ultrasound also showed extensive left lower extremity DVT up to the common femoral, she does have bilateral PEs without evidence of significant clot burden or heart strain, she is hemodynamically stable with normal pulse oximetry. The patient also has clots proximal up to her IVC. I discussed this with Dr. of vascular surgery for possible thrombolysis therapy of the left lower extremity. She was discussed with SOUND for admission.

Patient had an anaphylactic shock after the vaccine, had 2 epi pens administered by Dr. ,IM of Benadryl and N/S IV. Paramedics were called and took patient to hospital

She was a healthcare worker. It was reported to me by her immediate supervisor that she tested positive for COVID-19 the day after her first vaccination. She became symptomatic around January 21, 2021. She was scheduled to return to work on January 29, 2021 but did not come in. She died on February 2, 2021.

Headache, labored breathing with cough and congestion. I ended up in the hospital for 5 days with pneumonia. All came on slow but, increased intensity by April 1st.

Non-ST elevation myocardial infarction felt to be due to spontaneous coronary artery dissection in the setting of previously undiagnosed fibromuscular dysplasia.

Body aches, fever, nose blister, headaches swollen and arm diarrhea. 0n 3/2021 I statdetedbtonget pain on my left foot and calf. I went to the hospital and on 3/22/2021 I had a ultrasound and the results showed that I have a blood clot.

Started as severe head & neck pain. Diagnosed as subarachnoid hemorrhage. Onset of pain was instant. Spent 7 days in ICU

Tried Multiple times to report this. since 1 day after vaccine i started feeling short of breath and for several weeks suffered multiple asthm attacks and at one point i was hospitalized for a week my lungs have been partially collapsed and have had pneumoni in both lungs later this month i will start seeing pulmonolgist. I cannot walk long distances without becoming short of breath now. I have a detailed timeline of the events that have happened since the vaccine. I have tried multiple times to report this online and kept getting errored out and have left a few messages with the VAERS phone number no call back. I pray this goes through nd that someone ccontacts me

Received Moderna COVID 19 vaccine second dose on April 16th 2021 and days later began having chest pressure and shortness of breath. Was seen in doctor office and sent to ER. Was diagnosed with several blood clots in the lungs

Flu-like symptoms, then unrelenting hives with mild anaphylaxis over the next week. Consulted emergency doctor, then general practitioner. Then had referral to allergist where full-panel allergy test was conducted. Hives treated with antihistamines. GP prescribed EpiPen to have on-hand for 2nd dose. Wasn't needed, but same hives/mild anaphylaxis after 2nd shot, a day later.

Bleeding from arm in spots of bug bites, BRBPR, and unprovoked nose ~1 week after shot, plt count 6k in ER

I felt sluggish after my second Moderna shot on April 15th. On the evening of April 27th, I really started to feel horrible and was scared as it was hard to breathe and my chest pains were just horrible. I head to ER and am told I have blood clots in both lungs and 2 blood clots in lower leg. Taken by ambulance to the hospital.

Leg started swelling the day of the vaccine. Became painful and eventually became unable to move, according to patient. She was given a prescription for Xarelto,

Patient did not show for 2nd dose appointment scheduled for 5/15/21. Clinic staff contacted caregiver who notified that patient had expired 10 days after her first dose of Moderna.

Horrible hemorrhaging menstrual cycle going on 5+ days which shouldn't be possible because of Natazia. Dr. prescribed 1 week of Medroxyprogesterone 10 mg in place of Natazia to control hemorrhaging.

blood clots in both lungs; blood clots in left leg; shortness of breath; after the administration her arm hurt really bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (blood clots in both lungs) and THROMBOSIS (blood clots in left leg) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (after the administration her arm hurt really bad). On 15-Apr-2021, the patient experienced PULMONARY THROMBOSIS (blood clots in both lungs) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots in left leg) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (shortness of breath). The patient was hospitalized from 15-Apr-2021 to 18-Apr-2021 due to PULMONARY THROMBOSIS and THROMBOSIS. On 01-Apr-2021, VACCINATION SITE PAIN (after the administration her arm hurt really bad) had resolved. At the time of the report, PULMONARY THROMBOSIS (blood clots in both lungs), THROMBOSIS (blood clots in left leg) and DYSPNOEA (shortness of breath) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient received Apixaban as a treatment medication for blood clots. 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. .

Day after second vaccine blood clots in legs and lungs, mesh inserted, started bleeding vaginally and now in intensive care almost on life support.

Blood clots in lungs, legs and brain; She cant speak or stand on her own/in diaper; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots in lungs, legs and brain) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced THROMBOSIS (Blood clots in lungs, legs and brain) (seriousness criteria hospitalization prolonged and medically significant) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) (seriousness criterion hospitalization prolonged). The patient was treated with HEPARIN (intravenous) at a dose of UNK dosage form. At the time of the report, THROMBOSIS (Blood clots in lungs, legs and brain) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) outcome was unknown. Concomitant medications were not provided. Reporter stated that hospital is trying to send the patient to a nursing home. No further 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.

I had a stroke and its hard to talk and my left side is real weak. Getting physical therapy, occupational therapy and speech therapy now.

Multiple blood clots in lungs, and kidney fuction has declined . Was in hospital for 3 days for treatment. I am currently taking xerelto for clots.

Inflammed left armpit lymph node after shot, persisted 5 months. Vaginal bleeding episode in which lymph node shrunk. Then on month 5 post vaccine, developed significant severe joint pain, fatigue. Being referred to autoimmune clinic as inflammatory markers were abnormal. Upcoming appt 7/6/21

Stroke, in and out patient therapy after a Thrombectomy (3/6/2021). Whole left side was unable to use.

02/25/2021: Patient received 1st dose of Moderna 03/17 ? 3/19: 20 days after 1st dose, c/o progressively worsening bilateral lower extremity weakness of several weeks? duration. Patient had also suffered from recurrent falls over the preceding several days prior to admission. subsequent CT scan of the abdomen and pelvis revealed severe hepatic steatosis and a CT angiogram of the chest revealed bilateral pulmonary emboli. She subsequently had a duplex ultrasound of the lower extremities that revealed a right lower extremity DVT. MRI of the lumbar spine was performed for further evaluation of her bilateral lower extremity weakness that revealed some moderate bilateral neuroforaminal narrowing with mild spinal stenosis at L3-L4 and moderate spinal stenosis at L4-L5 with some degenerative endplate changes at similar levels. Dx: Pulmonary embolism - discharged home on Xarelto for complete treatment of her DVT/PE. 3/25: 2nd dose of Moderna given at Primary care - referred to ER for complaints. 3/25: ER encounter - She has been experiencing heavy vaginal bleeding, passing large clots at times, for the past six days. She reports that she usually has regular menstrual cycles, regulated on oral contraceptive pills. Dx: Menorrhagia with regular cycle, Anticoagulated ? treated and discharged on TXA 3/28 ? 4/4: 3 days after 2nd dose. presents with ongoing vaginal bleeding complicated by lightheadedness with standing, generalized weakness and fatigue, and dyspnea on exertion. Patient states she has been bleeding for almost 2 weeks vaginally. Dx: severe symptomatic anemia due to dysfunctional uterine bleeding / Menorrhagia and need for anticoagulation, Folate deficiency anemia, Venous stasis. Rx: Transfused 3 units, Provera, Due to recent VTE in stable hemoglobin cautiously started heparin, Oral contraceptives stopped, resumed Xarelto, folic acid supplement.

Sudden Brain Aneurysm on May 11, 2021, Revived and kept alive on machines until taken off life support and subsequently died on May 21, 2021

Nausea, fever, headache, body aches, chills, shortness of breath, chest tightness, vomiting, and diarrhea for 2 days after injection. Redness, heat, and lump at injection site for approximately 2 weeks after injection. Onset of Atrial Fibrillation with Rapid Ventricle Response, chest tightness, shortness of breath, headache, vomiting, diarrhea 7 days after injection required 3 day hospital stay and medication to treat. Cardiac treatment is ongoing. Shortness of breath, chest tightness and soreness is continuous and is being treated with medications and has required doctor visits and urgent care visit since being discharged from hospital.

patient completed Moderna vaccination series on 3/23/2021 and 04/20/2021. Patient presented to Hospital on 6/27/2021 with 3 weeks of increasing SOB, chest pain and confusion. Upon admission, the patient was found to be tachycardic, hypotensive. CT chest angiogram revealed bilateral pulm embolism and ventricular thrombi. MRI brain revealed multiple areas and foci of acute nonhemorrhagic infarction throughout bilateral cerebral hemispheres, suggestive of embolic infarction; largest area of infarction involves right frontal lobe and superior aspect of right insular cortex. Embolic event work up included an ECHO severe decrease in LV function and size ,mildhypertrophy; estimated LVEF is 15%. Cardiologist reviewed the cardiac MRI and patient met criteria for myocarditis. Cardio highly suspects that this myocarditis is due to COVID19 vaccination. Patient is currently receiving IVIG infusion therapy. Patient also on heparin gtt.

I have been menopausal (no periods) since September 2020. I bled bright red blood (not old blood) starting on or before June 13th 2021. I wasn't paying attention at the beginning because I thought it was nothing, so the start could have been slightly earlier. Once it went on for days and got a little heavier, I started counting and worrying a bit, as I haven't bled for several months. The bright red bleeding (enough to require a pad) stopped after 15 days. It was never unusually heavy. But it was constant, bright red blood. I had read reports about this possibly being linked to the NA vaccine, so I felt I needed to report this. I don't know if it's related. Thanks.

NOTE: no prior TIA or stroke #1 Suspected TIA (chest pain, dizziness, confusion, thick tongue, search for words, weakness left arm and leg, high blood pressure) - transported by ambulance to hospital, hospitalized for 24 hours - put in low dose aspirin regimen and tests ongoing #2 suspected TIA 3 weeks later - same symptoms except no chest pain - exchanged Plavix for aspirin - tests ongoing

swelling has finally eased but my leg and ankle are still so tinder; The ultra sound found 3 blood clots behind my left knee; My left foot was red; My left foot was tender to the touch; I had lost 25%of my strength; I had broken out hives; They itch; They hurt; I still have a few and some scars; I haven't been able to where my shoes over 3 month I've been out of work for 3 months; Catch in my left/continued to hurt and throb / pain got so severe; I was a bit tired; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (The ultra sound found 3 blood clots behind my left knee) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE (I was a bit tired). On 01-Apr-2021, the patient experienced ARTHRALGIA (Catch in my left/continued to hurt and throb / pain got so severe). On an unknown date, the patient experienced THROMBOSIS (The ultra sound found 3 blood clots behind my left knee) (seriousness criterion medically significant), ERYTHEMA (My left foot was red), TENDERNESS (My left foot was tender to the touch), ASTHENIA (I had lost 25%of my strength), URTICARIA (I had broken out hives), PRURITUS (They itch), PAIN (They hurt), SCAR (I still have a few and some scars), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I haven't been able to where my shoes over 3 month I've been out of work for 3 months) and PERIPHERAL SWELLING (swelling has finally eased but my leg and ankle are still so tinder). At the time of the report, THROMBOSIS (The ultra sound found 3 blood clots behind my left knee), ERYTHEMA (My left foot was red), TENDERNESS (My left foot was tender to the touch), ASTHENIA (I had lost 25%of my strength), URTICARIA (I had broken out hives), PRURITUS (They itch), PAIN (They hurt), SCAR (I still have a few and some scars), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I haven't been able to where my shoes over 3 month I've been out of work for 3 months), PERIPHERAL SWELLING (swelling has finally eased but my leg and ankle are still so tinder), FATIGUE (I was a bit tired) and ARTHRALGIA (Catch in my left/continued to hurt and throb / pain got so severe) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Chest X-ray: clear (normal) Normal. In 2021, Ultrasound scan: 3 blood clots behind left knee (abnormal) abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. Reportedly, around the end of Mar-2021 to 01-Apr-2021, the patient noticed a catch in her left knee. The patient then visited the emergency room and had Chest-x Ray and ultra sound and she was told by the doctor that she had 3 blood clots behind her left knee. The patient was prescribed medicines (names not specified). The patient had hives around day 50 (after vaccine). At around day 118 (since the patient received the vaccine), she was still in need of help for wearing her socks. The patient could walk for almost 20 minutes with the walker. No other treatment information was provided. Company Comment: Very limited information regarding this events has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received contained narrative information describing current health status.; Sender's Comments: Very limited information regarding this events has been provided at this time.

The first shot, I did not have any reactions. It was like it didn't happen. However, when I got the 2nd dose, the injection site was swollen and red for 2 days. At the week and a half mark, I felt like I had covid. My chest was tight, I couldn't smell, I couldn't taste, and I was fatigued. I felt every symptom. I was told I had to take 14 days off of work and was not pleased about that. I was having body aches. Everything hurt. When I tried to change the channel on the remote, and it hurt. I was coughing and everything felt like a chore. It was so hard to do anything. I was coughing up foam. Towards the end, I started getting a more solid cough. It was pea-sized yellow chunks. There was no blood. It was never green or clear. Everything was either white or off white. It felt a lot like pneumonia. My oxygen was slightly down. I was not okay. I was doing really great and then all of a sudden I couldn't hardly get from the bathroom to the bed. It was a drastic and sudden change in my abilities. I have never had hip problems before and I appeared to have an infection. I was having to go to the chiropractor and get regular adjustments. They put me on an antibiotic and that caused the inflammation to go down. I get winded pretty easily. I am not back to work. I am still not well. I get tired really easily. I am going to physical therapy. I didn't have an injury. The only thing in my life that changed was that I got the vaccine. I know that I did not contract covid because my test was negative. I started into menopause and my periods were coming every 27 days exactly. After the vaccine, my periods were a whole lot worse. I was bleeding so much that I was going through a pad an hour. It was unmanageable. It hasn't really tapered off at all. I am passing huge clots. The OBGYN can not find anything wrong that could be causing it. All of my labs came back totally normal. I never went to the ER. I was told not to go anywhere or do anything. I was told to stay home.

Heart attack symptoms - chest pain, shortness of breath, pounding heart approx. 1 week after 1st shot. Hospitalized with small heart attack. After 2nd shot, emergency room visit for stroke-related symptoms - numbness in left side of face and left arm. Test results did not reveal cause. 2 months later still experiencing chest pain in and around heart. No prior health issues or heart related issues other than high blood pressure and cholesterol.

Patient received COVID vaccination around 12:15pm. Patient was monitored for the appropriate amount of time by nursing staff. Patient passed away at 2:15pm.

15 minutes after administration patient described her lips as feeling "sunburned" and that the tip of her tongue felt "tingly". She denied any rash, feeling of swelling in her throat or tongue and had no trouble breathing. Patient declined to have EMTs called because she did not feel it was anaphylaxis. A dose of 50mg of Benadryl was via orally and she was closely monitored. Her blood preassure was 128/84 and heart rate was 80. She had offers to drive her to either the ER or urgent care but declined saying it was isolated to her lips and the tip of her tongue. Patient is a nurse and was aware of what to watch for. Pharmacy staff continued to observe her for an additional 45 minutes. At that time she said the issues were resolving and she would like to go home. She was counseled on what to look for with worsening reaction but said she felt more frustrated that anything. Pharmacist encouraged her to reach out to her PCP and also explained we would be unable to give her the next shot at a clinic. She was advised to speak more with her doctor regarding if she should get a second dose. Patient was followed up with 2 hours after vaccination by phone and reported symptoms resolved and she was just tired from the Benadryl. Patient was also called the day after and said she had a bad headache but otherwise no other signs of adverse reaction.

patient presented to ED post covid vaccination with anaphylactic symptoms. Elevated BP, upper lip swelling, mild edema of all four extremities, tachycardia. Patient received epi, Benadryl, famotidine, dexamethasone. Patient was admitted for four days due to edema in all four limbs and difficulty ambulating. Patient has been out of work and subsequently readmitted for cardiac, BP and Edema issues

Anaphylaxis. 2 EpiPens, 50 mg Benadryl PO. Was with patient for 2 hours before ambulance arrived. Tingling and numbness to lips, tongue and mouth. Swelling of lips. Pruritis of throat. Dry unproductive cough. "Feel like I'm being strangled". Grogginess (may have been due to Benadryl). Disorientation. Increase in blood pressure. Increased respiratory rate and labored breathing. Left chest discomfort (non-radiating). Hoarseness. Appeared syncopal and weak.

I had covid 19 last year and was hospitalized from 06/21/20 through 09/23/2020 at the Hospital. Some hours after receiving the vaccine I started feeling chills, headache, started vomiting and my blood pressure started bottoming up that is when I was rushed to the ER. I was admitted and stayed 2 days. They said it was not related to the vaccine. First they told me it was sepsis. Then they told me it was pneumonia, not sepsis. Then said it was a bacterial infection. I sincerely do not know what I had. I am doing better now. My PCP did not recommend me to receive the second dose.

Anaphylaxis, Angioedema & CoughWheeze Narrative: WENT TO ER ON 3/5/2021, MEDICATIONS GIVEN IN ER, DO NOT HAVE AT THIS TIME

pt with history of "anaphylactic" type reax to allergy shots in past and aspaaragas 3 years ago for which she was given epi. today after vax she reports "peppery" feeling in the back of her throat and R side of tongue. Dr administered 25 mg of benadryl po and 45 min later a second dose of 25 mg po. Oral cavity examination was repeatedly negative. Lungs were clear to auscultation. She was monitored closely on site for over an hour before stating she felt well and wanted to go home.

Anaphylactic shock; severe allergic reaction/felt tonge swell; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016A21A and 029A21A) for COVID-19 vaccination. Concurrent medical conditions included Sleep disorder, High cholesterol, MS, Shellfish allergy (anaphylactic shock), Iodine allergy (anaphylactic shock) and Allergy NOS (allergy to "many things"). Concomitant products included ATORVASTATIN for High cholesterol, GLATIRAMER ACETATE (GLATOPA) for Multiple sclerosis, VANEX for Sleep disorder, DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (BABY ASPIRIN), BACLOFEN, VITAMIN D3 and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021 at 2:05 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) (seriousness criteria hospitalization and life threatening). On 01-Apr-2021 at 4:05 PM, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 01-Apr-2021 to 02-Apr-2021 due to ANAPHYLACTIC SHOCK and HYPERSENSITIVITY. On 01-Apr-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock) and HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) had resolved. Symptoms of anaphylactic shock included couldn't breath, throat closed, and face was all red and puffy. Treatment for the events included epinephrine, intravenous steroids and diphenhydramine hydrochloride, and "other stuff" at hospital. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of anaphylactic shock, a causal relationship cannot be excluded. Patient's underlying multiple allergies may have been contributory. This case was linked to MOD-2021-066604 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of anaphylactic shock, a causal relationship cannot be excluded. Patient's underlying multiple allergies may have been contributory.

Patient developed swelling of the right lower extremity 2 days after receiving her second dose of Covid-19 vaccination (Moderna per patient report). Evaluated for this issue 4 days after onset of symptoms, ultrasound showed DVT of RLE.

on 03/16 pt got vaccine, on 03/23 noticed slurred speech and an increase in blood pressure. Went to the ER on 03/25- diagnosed with TIA

Symptomatic Thrombocytopenia c/w ITP with platelet count <5k occurring 7 days after vaccine. Treated with Dexamethasone 40mg PO daily x 4 days with improvement and normalization of platelet count a week later

Chest discomfort and SOB since 3/5/21 Non occlusive thrombus to the RUL anterior segment of the pulmonary artery

Approx. 30 minutes after receiving second dose of Moderna vaccine pt. reported feeling pre-ictal. Reports hx of seizure disorder with recent increase in frequency. Last seizure one week ago. Patient was asked to sit down as she was trying to leave the vaccine clinic. Once seated, she began to have a grand mal seizure and was assisted to floor by two medical staff. HR 107 O2 sat. 93% BP 150/100. Within three minutes O2 sat. increased to 100% HR 120. VS monitored and supported by medical team as she started to become alert and could state where she was. At 2:20pm had a second grand mal seizure. EMS arrived to transport pt. and appeared to have a third seizure just prior to be moved to the cot for transport. HR 110 O

had a mini stroke; was stuttering; wasn't feeling good; blood pressure was high; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had a mini stroke) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 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 reported). On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had a mini stroke) (seriousness criterion medically significant), DYSPHEMIA (was stuttering), FEELING ABNORMAL (wasn't feeling good) and HYPERTENSION (blood pressure was high). On 23-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (had a mini stroke), DYSPHEMIA (was stuttering), FEELING ABNORMAL (wasn't feeling good) and HYPERTENSION (blood pressure was high) had resolved. The Patient has not provided with any Treatment medications. There are no concomitant medications provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031B21a) for COVID-19 vaccination. No Medical History information was reported. 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 an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. No treatment information was provided. No concomitant medication was reported. 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. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

I started bleeding vaginally and am still bleeding 20 hours later. I have been in full menopause since 2013 after having both of my ovaries removed. And, was diagnosed with breast cancer in October of 2019, surgery in February 2020, followed by 5 weeks of radiation therapy. The type of breast cancer I had was due to hormones, so any hormones in my body could potentially cause a recurrence of the cancer.

Pt developed LV thrombus, NSTEMI with LAD lesion, acute R cerebellum stroke shortly after her vaccine, now admitted to HCF for ongoing treatment

This is a 52 Y female with past medical history of GERD, seasonal allergy and maybe early onset of pre-diabetic (A1c of 5.7) who was transferred from the hospital for continuation of care. Patient was initially presented to hospital on 4/25 for chest pain, shortness of breath and TIA symptoms and patient was transferred to after patient was found to have NSTEMI, LV thrombus and sub-acute stroke and r/o pneumonia. Patient was in her usual state of health (was able to do elliptical machine with low resident for 14 mins without feeling any chest pain or shortness of breath) till 4/18 where patient received her 2nd Moderna shot. 1 day after the vaccine, patient developed N/V and then intermittent slurred speech, trouble spelling in her texts, L arm weakness was noted 4/23. + chest pain and shortness of breath. While in hospital, MRI of the brain confirmed sub-acute stroke at R cerebrum, patient was noted to have trop of 20, echo showed EF of 25%, hypokinesis of mid-apical myocardium, large 3.8cm x 2.3cm mural apical thrombus. Patient underwent cardiac cath on 4/26, s/p PCI with DES on proximal LAD, post-cath small hematoma noted on R groin site.

Suspected heart attack; Severe Chest and arm pain; Severe Chest and Arm pain; The injection site became hot to the touch; Itching injection site; Painful Injection Site; Hard to the touch; Raised red spot on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Suspected heart attack), CHEST PAIN (Severe Chest and arm pain) and PAIN IN EXTREMITY (Severe Chest and Arm pain) in a 52-year-old female 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. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Raised red spot on the injection site). On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (The injection site became hot to the touch), VACCINATION SITE PRURITUS (Itching injection site) and VACCINATION SITE PAIN (Painful Injection Site). On 21-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Suspected heart attack) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Severe Chest and arm pain) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (Severe Chest and Arm pain) (seriousness criterion hospitalization). The patient was hospitalized from 21-Apr-2021 to 22-Apr-2021 due to PAIN IN EXTREMITY, and then on 21-Apr-2021 due to MYOCARDIAL INFARCTION. On 27-Apr-2021, VACCINATION SITE WARMTH (The injection site became hot to the touch), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Raised red spot on the injection site) and VACCINATION SITE PAIN (Painful Injection Site) had resolved. On 29-Apr-2021, MYOCARDIAL INFARCTION (Suspected heart attack), CHEST PAIN (Severe Chest and arm pain) and PAIN IN EXTREMITY (Severe Chest and Arm pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Echocardiogram: normal (normal) normal. On 21-Jan-2021, Electrocardiogram: normal (normal) results. On 21-Jan-2021, Myocardial necrosis marker: raised Raised. On 21-Jan-2021, Oxygen saturation: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 21-Apr-2021, the patient had severe chest and arm pain. She went to the emergency room. The ER doctor suspected a heart attack. She was hospitalized overnight under observation and was released the next day. No relevant concomitant medications were provided. No treatment information was provided. Company Comment: Very limited information regarding the events (Myocardial infarction) 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 event (chest pain, pain in extremity and others), a causal relationship cannot be excluded. Additional information regarding medical history, concomitant medications, levels of troponin (I or G) are required for further evaluation.; Sender's Comments: Very limited information regarding the events (Myocardial infarction) 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 event (chest pain, pain in extremity and others), a causal relationship cannot be excluded. Additional information regarding medical history, concomitant medications, levels of troponin (I or G) are required for further evaluation.

I am in menopause and had a cycle, lots of clotting and cramping like when I was a young woman. I have not had a cycle in 3 yeas.

Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull; Vomiting; Coughing; Anaphylactic Reaction; Blood pressure was very high; started rubbing chest, did not feel the same way as when they first arrived at the facility; Dizzy; Vertigo; Feeling unwell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction) in a 52-year-old female 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 Anaphylaxis, Hypersensitivity reaction, Asthma, Hives (Hives/urticaria), Drug allergy (Codeine-Severe Vomiting. Morphine-Fell asleep within minutes of receiving Medication.), Hives (Severe Hives (High Tryptase Level). Under Care of Allergist, taking Bee Sting Shots and Xolair Shots. No hives since November of 2020,) since 01-Aug-2019 and Hydrocephalus on 01-Aug-2004. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 01-May-2020 to an unknown date and FAMOTIDINE from 01-May-2020 to an unknown date for Hives. On 01-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VERTIGO (Vertigo), MALAISE (Feeling unwell) and DIZZINESS (Dizzy). On 01-Apr-2021 at 1:15 PM, the patient experienced CHEST DISCOMFORT (started rubbing chest, did not feel the same way as when they first arrived at the facility). On 01-Apr-2021 at 1:20 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure was very high). On 01-Apr-2021 at 1:30 PM, the patient experienced COUGH (Coughing). On 01-Apr-2021 at 1:35 PM, the patient experienced VOMITING (Vomiting). On 01-Apr-2021 at 5:30 PM, the patient experienced HEADACHE (Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull). On 02-Apr-2021 at 1:00 PM, ANAPHYLACTIC REACTION (Anaphylactic Reaction) had resolved. At the time of the report, VERTIGO (Vertigo), COUGH (Coughing), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHEST DISCOMFORT (started rubbing chest, did not feel the same way as when they first arrived at the facility), VOMITING (Vomiting) and HEADACHE (Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull) had resolved and BLOOD PRESSURE INCREASED (Blood pressure was very high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood chloride (96-106): 109 mmol/l High. On 01-Apr-2021, Blood pressure measurement (unk-unk mmHg): 224/107 mmHg (High) The nurse called the EMT who took her blood pressure about 20 minutes after receiving the injection. Her blood pressure was very high. She didn't remember exact numbers, but stated it was something like 224/107. The EMT asked her if she had taken her blood pressure medications that morning and she told him she does not take blood pressure medications., 194/107 mmHg (High) @15:15 and 194/110 mmHg (High) @16:30. On 01-Apr-2021, Carbon dioxide (24-32): 22 mmol/l Low. On 01-Apr-2021, Chest X-ray: normal (normal) Clear lungs. Thoracic portion of a ventriculoperitoneal shunt catheter was seen to the right of midline and appeared intact. On 01-Apr-2021, Electrocardiogram: normal (normal) EMT did an EKG and stated it was normal. On 01-Apr-2021, Full blood count: normal (normal) normal. On 01-Apr-2021, Metabolic function test: normal (normal) normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient was given two baby aspirin by mouth on 01 Apr 2021 and was then sent to the emergency room (ER) due to her blood pressure. Patient was not given anything for vomiting, but had continued to fill multiple emesis bags. Additional tests included cardiac monitor and continuous pulse oximetry. On 01 Apr 2021 at 19:30, the nurse started an IV and administered Zofran plus another medication the patient could not recall. The patient began to feel better, finished the IV and was able to stand without dizziness. The patient saw another ER physician at 23:30 who did not think the event were related to the vaccine. This physician sent the patient home (discharged at approximately 1:00 on 02 Apr 2021). On 08 Apr 2021, the patient saw her allergist who confirmed it was an anaphylactic reaction to the vaccine. Patient indicated that nausea/vomiting, difficulty breathing, chest tightness, and cough were signs and symptoms experienced. The patient's allergist informed the patient they were not to get the second Moderna shot. Based on the current 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 06-May-2021: No New Information (NNI). On 19-May-2021: ADR response received which provided additional event details, outcomes, treatments, ER lab/diagnostic results.

Two weeks after I received the second dose I began coughing and congestion, after 10 days I went home from work early. I went in the next morning to be seen by my pcp. She said I had pneumonia. I was out from work for 7 days. I never fully stopped coughing. then it got worse and worse. I was sent for a stat referral to a pulmonologist. I mentioned to my pcp and the pulmonologist I had been like this since 2 weeks after receiving the 2nd dose. Both did not believe that was the case. I now have asthma and I am on inhalers. I have to go in June for a pulmonary function test. The visit to the pulmonologist was 7 weeks after the first symptoms had appeared.

As reported by NP that called with event: Pt has had 3 hospital stays after receiving vaccine. Pt initially went in on 3/31/2021. Stays include: 3/31/21-4/5/21 4/12/21-4/16/21 4/29/21-5/5/21 Symptoms/diagnoses include: IJ thrombosis, PE, esophageal strictures d/t nausea/vomiting

About 5 minutes after vaccine administration patient had grand mal seizure lasting about 2-5 minutes.

I had a 101.4 fever the day after the shot. I also experienced respiratory distress that accommodated a pneumonia. It required treatment. On that following Sunday, I went to the ER and I was kept in observation overnight. They let me go the next day. When Friday came along, I knew I had really bad pneumonia. I went to the clinic and they gave me a prescription for antibiotics. I had a fever for 9 days straight.

Blood clot in left leg; Not feeling like herself since second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot in left leg) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FEXOFENADINE, LOSARTAN and SERTRALINE 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 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling like herself since second dose). On 16-May-2021, the patient experienced THROMBOSIS (Blood clot in left leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot in left leg) outcome was unknown and FEELING ABNORMAL (Not feeling like herself since second dose) had not resolved. It was reported that the patient was not feeling like herself since the second dose but was unsure if it was a result of the vaccination. Company Comment : Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Patient presented to the ED and was subsequently hospitalized for acute CVA within 6 weeks of receiving COVID vaccination. Patient received second dose on 5/26/2021

2 weeks after 2nd injection 6/2/2021 I presented in the ED with a red rash on my legs and blood lesions in my mouth with nose bleed. I was admitted to hospital with ITP blood platelet count 4000. After 3 infusions of platelets with no improvement they did a steroid and IVIG. My platelets went up to 51000. After 5 days in hospital they sent me home. Two days later on 6/8/2021 I started having the mouth blood blisters lesions again went back to ED where I was admitted again. They gave iv steroids in ED. On 6/9/2021 gave 65mgs of oral steroids and did a IVIG treatment platelets went up to 26000. On 6/10/2021 continued 65mgs of oral steroids another treatment of IVIG and platelets are at 36000. Not what I or the doctors were expecting we were expecting a higher number. So now 6/11/2021 still in hospital with no answers.

Five blood clots in my lungs. Symptons are shortness of breath. Treatment is blood thinners for 6 months.

Patient received first dose of Moderna on May 18, 2021. Spouse came to the pharmacy and informed us that the patient passed away in the hospital on June 15, 2021. She was diagnosed with COVID-19 during her stay at the hospital.

First, severe body aches, even skin and gums. Then, body aches every other day, feeling of moisture in lungs, asthma, and then diagnosis of lung infection with negative COVID test.

Patient states she was diagnosed with a pulmonary embolism on 4-23-21. She states 2 weeks after her vaccination (4-7-21) she noticed shortness of breath, fatigue, brain fog, and "burning lungs" . She says she has a stressful job and her lungs would feel like they are on fire. She was seen by Dr in urgent care on 4-23-21. She says she was seen by Dr (in the absence of her regular provider) on 5-21-21. She was started on Eliquis 5mg BID on 5-21-21. She also was seen by Dr of Hematology Oncology to evaluate her after the vaccination also. Referred to Pulmonary Dr. seeing on 7-8-21

I have asthma and I have not needed my rescue inhaler for two years so progressively in Mid April my asthma started getting worse. I set up my annual physical for 05/18/2021 because I felt like something was wrong because it felt like an elephant was on my chest. I also thought I had an upper respiratory infection but I did not. I went back to the Doctor on 05/25/2021 to talk about my asthma and my doctor switched my asthma medications which didn't help, she switched me to Breo, a different inhaler and it didn't help. She also put me on prednisone for 10 days and the days after I finished that I got flu-like symptoms and went and got a covid test. On 06/05/2021 I felt so bad with flu symptoms that I messaged my Doctor and told her the prednisone wasn't helping and I was having trouble breathing and ended up getting sharp pains under left armpit--debilitating pains. I went to ER 06/05/2021 and they ran test that determined I had pneumonia. They put me on Augmentin antibiotics for 10 days and now I feel better and haven't needed my rescue inhaler since day two. Two years ago in Feb 2019 I did have chest pains on my R side and went to ER and had a collapsed lung (pneumothorax middle right lobe) and there was infection, so I am susceptible to things in my lungs.

ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000; hearing white noise in her head; she would sleep 10 to 12 hours a day; extreme tiredness; red spots on her lower legs; blood blisters in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced RASH MACULAR (red spots on her lower legs) and ORAL BLOOD BLISTER (blood blisters in her mouth). On 02-Jun-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced TINNITUS (hearing white noise in her head), SOMNOLENCE (she would sleep 10 to 12 hours a day) and FATIGUE (extreme tiredness). The patient was treated with RITUXIMAB at a dose of 1 dosage form; IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) at a dose of 1 dosage form and PLATELETS at a dose of 1 dosage form. At the time of the report, IMMUNE THROMBOCYTOPENIA (ITP , had a blood platelet count of 4000 ,hospitalized again with her platelet count back down to 4000,her platelets down to 5000) and TINNITUS (hearing white noise in her head) had not resolved and SOMNOLENCE (she would sleep 10 to 12 hours a day), RASH MACULAR (red spots on her lower legs), ORAL BLOOD BLISTER (blood blisters in her mouth) and FATIGUE (extreme tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Platelet count: 4000 (Inconclusive) 4000. On 06-Jun-2021, Platelet count: 50000 (Inconclusive) 50000. On 08-Jun-2021, Platelet count: 4000 (Inconclusive) 4000. On 25-Jun-2021, Platelet count: 5000 (Inconclusive) 5000. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. concomitant medication included steroids. Patient called to report what she experienced after her 2nd Moderna Covid-19 Vaccine on 19May2021 (lot number 013M20A). She received both injections in her left arm. She began having extreme tiredness a week after the 2nd dose & she would sleep 10 to 12 hours a day. On 1Jun2021 she had red spots on her lower legs and blood blisters in her mouth. On 2Jun2021 she was admitted to the hospital and diagnosed with ITP, which she did not know what that stands for, and had a blood platelet count of 4000. She was given 3 bags of platelets, steroids, and IVIG as treatment. On 6Jun2021 she was released from the hospital with blood count of 50000. On 8Jun2021 she was hospitalized again with her platelet count back down to 4000 and was hospitalized for 6 more days on very high doses of steroids. During this 2nd hospitalization, she started hearing white noise in her head & it is ongoing. She was released from the hospital on 14Jun2021. On 25Jun2021 she was again admitted to the hospital with her platelets down to 5000. She was released from the hospital again on 27Jun2021. She is still on daily steroids & weekly treatments of Rituximab. She states that she has has no cancers no autoimmune disorders. Based on the current 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.

I had Covid-19 in November of 2020. Some of my symptoms lingered. I still felt low on energy and had some coughing. I had a lingering cough. After the second vaccine I had flu-like symptoms My coughing got much worse about one week after the shot and I felt like I had pressure in my chest. I went to Urgent Care and they did a chest X-Ray. The coughing and pressure got worse over the next few days. I returned to the Urgent Care the following week. They performed a CT Scan. IT was discovered that I had a Pulmonary Embolism in my right upper lung. I was hospitalized on 04/19/2021 for three days. I am now taking Eliquis and I have a scheduled Cardiology consultation.

Admitted 7/9 with left temporal ICH with vasogenic edema and mass effect. Found to have hemorrhagic conversion of a venous infarct due to thormbosis of the left transverse sinus sigmoid sinus, left IJ vein and several left temporal draining cortical veins.

She has trouble with right side and Can't use her right arm; Left injection arm is still very sore; Had a stroke that affected her right side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side) and LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 109B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side) (seriousness criteria disability, medically significant and life threatening). On an unknown date, the patient experienced LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) (seriousness criterion disability) and VACCINATION SITE PAIN (Left injection arm is still very sore). At the time of the report, CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side), LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) and VACCINATION SITE PAIN (Left injection arm is still very sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was not given. No laboratory was not given. No treatment information was not given. Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

possible 2nd stroke with weakness on left side; MRI showed that she had stroke; heart was racing; wasn't feeling well at times/something wasn't right; I wasn't myself. It wasn't me. I was not the same person/I still don't feel myself; has to walk with cane,; can't drive; can't do a lot of things yet; tired/still little tired; sluggish; could not move anything on right side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI showed that she had stroke) and HEMIPARESIS (possible 2nd stroke with weakness on left side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 003A21A) 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 DULOXETINE HYDROCHLORIDE (CYMBALTA), OMEPRAZOLE and AMITRIPTYLINE for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (MRI showed that she had stroke) (seriousness criteria hospitalization, medically significant and life threatening), SLUGGISHNESS (sluggish), MOBILITY DECREASED (could not move anything on right side) and FATIGUE (tired/still little tired). On 13-Jul-2021, the patient experienced HEMIPARESIS (possible 2nd stroke with weakness on left side) (seriousness criteria hospitalization and medically significant) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't drive; can't do a lot of things yet). On an unknown date, the patient experienced PALPITATIONS (heart was racing), MALAISE (wasn't feeling well at times/something wasn't right), FEELING ABNORMAL (I wasn't myself. It wasn't me. I was not the same person/I still don't feel myself) and WALKING AID USER (has to walk with cane,). At the time of the report, CEREBROVASCULAR ACCIDENT (MRI showed that she had stroke), HEMIPARESIS (possible 2nd stroke with weakness on left side), SLUGGISHNESS (sluggish), MOBILITY DECREASED (could not move anything on right side), PALPITATIONS (heart was racing), MALAISE (wasn't feeling well at times/something wasn't right), FEELING ABNORMAL (I wasn't myself. It wasn't me. I was not the same person/I still don't feel myself), WALKING AID USER (has to walk with cane,) and FATIGUE (tired/still little tired) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't drive; can't do a lot of things yet) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Magnetic resonance imaging: abnormal (abnormal) Confirmed stroke. On 13-Jul-2021, Magnetic resonance imaging: negative (Negative) negative for stroke. Based on the current available information; although the use of the product and the start date of the events were more than 3 months apart, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were more than 3 months apart, a causal relationship cannot be excluded. Further information has been requested.

Pt admitted to ED for SOB, choking sensation hours post Moderna COVID-19 vaccine, dose #2. Concerned for possible anaphylaxis/allergic reaction. Pt was diagnosis of acute on chronic hypoxemic respiratory failure. Questionable vaccine related reaction.

Pulmonary Embolism; Clot in her left artery and lung; Didn't receive second dose; Wasn't feeling well; Shortness of breath; Chest pain; having a panic attack; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY EMBOLISM (Pulmonary Embolism) and PULMONARY THROMBOSIS (Clot in her left artery and lung) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure high. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (Wasn't feeling well). In April 2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and PANIC ATTACK (having a panic attack). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary Embolism) (seriousness criteria hospitalization and medically significant) and PULMONARY THROMBOSIS (Clot in her left artery and lung) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Didn't receive second dose). The patient was hospitalized from 24-Apr-2021 to 08-May-2021 due to PULMONARY EMBOLISM and PULMONARY THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO) for Pulmonary embolism, at an unspecified dose and frequency and OXYGEN for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Pulmonary Embolism), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), PANIC ATTACK (having a panic attack) and MALAISE (Wasn't feeling well) outcome was unknown, PULMONARY THROMBOSIS (Clot in her left artery and lung) had not resolved and INTENTIONAL DOSE OMISSION (Didn't receive second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Oxygen saturation: low (Low) went down to 70% in Apr-2021.. 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. This is a case of Intentional dose omission for this 52-year-old female. Regarding events Pulmonary embolism, Pulmonary thrombosis, Dyspnoea, Chest pain, Panic attack, and Malaise, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.; Sender's Comments: This is a case of Intentional dose omission for this 52-year-old female. Regarding events Pulmonary embolism, Pulmonary thrombosis, Dyspnoea, Chest pain, Panic attack, and Malaise, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.

Anaphylaxis, Tachypnea, Rash, Palpitations, facial flushing, facial warmth, throat closing Narrative: employee was treated with Epipen on-site, was transported to ER Via ambulance. She received solumedrol and pepcid in the ER. She received unknown medications while in the ambulance

"Moderna COVID-19 Vaccine EUA" It has been reported to me that pt. had gone into hospital for a heart catheterization on 1/12/2021. It was found during this procedure that pt. had suffered a MI. She was release to home the following day and passed away at her residence on 1/15/2021.

a couple hours after the vaccine, I experienced a bit of rapid heart rate, which resolved after a few minutes. The following day around 3 pm I began to have chills and felt like I had the raid heart rate again. By 5 pm I was beginning to feel really bad, I was freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove me to the emergency department. I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday afternoon. The diagnosis was pneumonia, I don't really believe this, as I felt fine and had no symptoms prior to the onset of the fever.

exaggerated inflammatory response to moderna vaccine - muscle & body aches; tactile static allodynia; chills; headache with sinus pain and photosensitivity; extreme fatigue and malaise with sob and activity intolerance; progressed to bilateral pneumonia requiring IV antibiotics, oral antibiotics; prednisone, nebuilzed steroids and other meds for supportive care.....loss of work 1-15-21 through current date. Still working through dx of moderate persistent asthma, unexplained prolonged sinus congestion and fatigue with activity intolerance.

While at counseling appointment on February 17 patient had witnessed sudden cardiac arrest and was not able to be resuscitated. She was pronounced dead at 12:09. At the time of death her glucose was about 500.

Within 12 hours of receiving my second vaccine, My left leg felt like it internally rotated and started to hurt and feel like lead. On January 28, 2021, I went to the ER and an extensive blood clot (DVT) was found.

Systemic: Allergic: Anaphylaxis-Severe. Systemic: Allergic: Difficulty Breathing-Severe. Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe. Systemic: Allergic: Itch Generalized-Severe. Systemic: Chest Tightness/Heaviness/Pain-Severe. Additional Details: Patient experienced tightness in the throat, followed by coughing, complained of itchy back, was given 2 Benadryl, 2 EpiPens; then transported by ambulance to the ER.

At the end of the 15 minute observation time, the patient stated she felt like her throat was closing and that she was having a difficult time swallowing. Her O2 sat was 98%, HR 61, lungs CTA, right side of neck and jawline had mild swelling. She was given 50 mg of liquid Benadryl and 911 called. She continued to complain of back of tongue tingling. O2 sats remained at 98%. She started to say she was feeling better just before EMS arrived and departed with the patient. Patient spoke Spanish and was interpreted by her car passenger, a medical interpreter was not used as this was an emergency. ED note indicates she had an anaphylactic reaction after 2nd Moderna vaccine. Epinephrine had been given approximately an hour after first complaining of symptoms. ED note says she initially had rash and throat swelling but now is feeling well and tolerating PO. She was counseled on Epi Pen and discharged same day.

Anaphylaxis. Onset 10 minutes. Initially responsive to epinephrine, subsequently not. Ultimately requiring endotracheal intubation

20 min after dose of moderna vaccine she felt her face get hot and swollen and she felt tingling - 10 more minutes and she felt throat was swelling. Waited another 20 min. Went to ER. Got full body shakes and a full body rash. Given pred, benadryl, treated for anaphylaxis. Symptoms began to recur next day and came to PCP office

aside from chills, fever, aches I also had an anaphylactic reaction to the shot. In the evening I was exhausted and could barely move, around 10pm, I think, I started to labor with my breathing. It felt like I would stop breathing and then take 4 gasps for air, and this repeated all night and into the morning. Eventually it stopped the following day, every now and then on the following day I would repeat it but not as often.

Approx. 3 minutes after receiving the 1st dose of the Moderna vaccine, the client c/o "chest tightness," "feeling of blacking out," and "throat closing up." Code Blue was activated and ambulance was notified. An Epi-pen was administered to the left thigh at approx. 12:32pm. Patient was escorted to the Hospital for evaluation.

Patient stated a rash developed away from the site of injection and patient called back today and stated that patient had a stroke on sunday and I'm not sure if it is related to vaccination.

On day after vaccine (2/4/2021) pt reports chills and subjective fever and increased heart rate. Reports hospitalization from 2/16- 2/22 for increased HR., chest pain but no shortness of breath. Discharged on 2/23 on beta blockers. Reports echo showed fluid around heart during 3/6-3/8 hospitalization. Reports no pneumonia.

Anaphylaxis, RespDepression, UrticariaPruritus, tongue swelling, throat closing, itching all over Narrative: states shortly after receiving her injection she begin itching and her throat begin closing as her tongue swelled; states she was given dose of epi and Benadryl and instantly begin to recover;

Patient was seen in ED on 03/12/2021. Symptoms included fatigue and weakness, she was flown out to hospital. She passed away on 03/14/2021 in hospital.

Patient diagnosed with a left arm deep vein thrombosis that extends from the forearm to the lateral part of the subclavian vein- nonocclusive in some areas.

Patient found in pulseless arrest on stairwell of her apartment building on the night of 4/2/21. Patient transported via ambulance to hospital where she passed away.

anaphylactic reaction; anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of ANAPHYLACTIC REACTION (anaphylactic reaction) and the second episode of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, ALBUTEROL SULFATE for Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced the second episode of ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 11-Apr-2021, last episode of ANAPHYLACTIC REACTION (anaphylactic reaction) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient experienced an anaphylactic reaction of constricted throat, face and neck turning red, tingling and numbness in her face and throat, red bumps on her face and throat, and her face felt like it was burning. She used her EpiPen and it wasn't enough (didn't improve the reaction), so she went to the emergency room. They gave 2 prednisone tabs and prescribed prednisone and gave her IV saline and antihistamine. They released her 2 hours later. Her doctor advised her against getting the second dose. After the patient recovered from initial anaphylactic reaction on 12Mar2021, she had 2 episodes of anaphylactic reaction on 09APR2021, requiring the use of two EpiPens, Benadryl, Prednisone, and albuterol. On 10APR2021 at 0100 another anaphylactic reaction requiring EpiPen, Benadryl, Prednisone, and Albuterol. And at 4pm another anaphylactic reaction requiring Benadryl, EpiPen, and albuterol. Currently she has recovered. 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, patient's medical history of asthma and allergy may have been contributory.; 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, patient's medical history of asthma and allergy may have been contributory.

On 02/03/2021 @ 1 am (approx. 1 wk. after 1st vaccine shot), started having pains under ribcage. Pains off and on until on 02/09/2021 about 3 am when the pain got so bad I went to the emergency room. Diagnosed with pulmonary embolism. Never had a blood clot or DVT before. Blood test found I had Factor V. Had pain again under ribcage one week after second vaccine, but blood thinners appears to have dissolved if it was a clot. My father then tested and found positive for Factor V after my diagnosis. He then had a blood clot in leg approx 3 weeks after his second Pfizer vaccine, and had never had a blood clot like that before. Appears to be a connection between Factor V and blood clots after Covid vaccines.

The patient came in for her second dose of Moderna and had concerns because she stated that she developed a nose bleed the day after she received her first dose. She stated that she also passed clots and her nose bled for more than 1 day. She stated that she went to the ER but was only given a nasal spray to use. She denied a history of nosebleeds and does not take blood thinners.

Blood clot behind left knee found on 3/11/21 and traveled to lungs. Admitted to hospital for Heart Failure from Chemo, PE and pneumonia.

At 11:40am on 5-2-21, patient went into anaphylaxis approximately 10 minutes after receiving vaccine. Patient's breathing was labored and patient indicated that her throat was constricted. 0.3mg of epinephrine was administered IM via EpiPen into left thigh at 11:45am. Patient breathing improved, began coughing and deep breathing noted. HR stable at 55 BPM: BP machine was registering BP at >200/100 but machine constricted her arm so numbers were unclear. Patient remained conscious and responded to verbal commands until EMS arrived and took over care at approximately at 11:50am. EMS ordered another dose of epinephrine at approximately 12:05pm. Albuterol administered at 11:50am. Pt transported to Clinic in Hospital via EMS

DVT and PE Right lower leg pain starting 3 days after vaccine, progressively worsening until time of diagnosis 8 days after dose. Hospitalized and undergoing IV anti coagulation

Patient claimed anaphylaxis. Stated that it didn't occur until 1 1/2-2 hours after vaccination but she went to the hospital and was treated accordingly.

5/7/21: Woke up with Extreme Exhaustion, Fever and Nausea - stayed home, took tylenol for fever, did minor activities and slept as necessary 5/8/21: Fever gone. Exhaustion and nausea still present but less severe 5/10/21: Exhaustion still present but less severe 5/15/21 @~8:30 am EST: Notice 5 red areas on inner upper right arm area. No pain or swelling Went to Hospital ER for evaluation. 5/15/21 @~10:30 am EST: ER diagnosed blood clot in upper right arm. Was put on blood thinners (Eliquis) that day and was told to continue for about one month and follow up with primary care physician. 5/19/21: Saw primary care physician to review Hospital data (History: Patient had a provoked blood clot (i.e. due to "bad" blood draw for donation) in Summer 2019 in the upper left arm. Was on blood thinners for 3 months - clot gone after that. Didn't continue taking blood thinners due to good medical health history and no personal history of blood clots or family blood clot issues). As of this report submittal, still on blood thinners.

left side numbness,unable to walk. Went to ER immediately and code stroke was called. Received TPA and went to ICU

My wife presented with severe stomach pain, which was believed to be a sign of pancreatitis (a known adverse effect due to her ALK+ lung cancer tyrosine kinase inhibitor treatment) so we went to the ER on Apr 23. Following a CT scan, she was diagnosed with acute appendicitis. She had elevated IGA and IGG. Additionally, she was discovered to have a pulmonary embolism. Through the ER treatment, her blood pressure dropped below 60/40 - which was later discovered to be an unknown allergy to beta lactam antibiotics (piperacillin). This required her to be admitted to the ICU. Surgery was scheduled to remove her appendix Apr 24. Post surgical complications ensued resulting in an additional 9 day hospital stay to correct a herniated surgical site and eventually remove a hematoma. The NSCLC treatment had started 3 days prior to the vaccine , and was dose escalated on Apr 19th. The tyrosine kinase inhibitor (TKI) is particularly susceptible to CYP3A4 inhibitors and inducers, which she was also taking (e.g. Dexamethasone, omeprazole, and THC). Her blood pressure was well above baseline at the ER on Apr 23 before the blood pressure crash following administration of piperacillin, which was mostly reversed through administration of norepinephrine. Whether the appendicitis was triggered by an unsafe pooling of her TKI due to the concomitant use of other CYP3A4 inducers and inhibitors, or whether the vaccine played a role is unknown. At the time, we were unaware of the need to avoid CYP3A4 inhibitors. However the higher IGA levels has been previously shown to tie more to a vaccine response which led us to believe the appendix played a role in IGA levels rather than adverse effects from the TKI and concomitant use of CYP3A4 inhibitors. For this reason, it was suggested that we fill out a VEARS report.

Had a stroke; Minor heart attack the same day as the stroke; Did not feel right; Could not lift her arm, it felt like a thousand pounds; Could not get up, her right leg gave out; Kidney disease; Felt tired; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a stroke) and MYOCARDIAL INFARCTION (Minor heart attack the same day as the stroke) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke) (seriousness criteria hospitalization and medically significant), FEELING ABNORMAL (Did not feel right), LIMB DISCOMFORT (Could not lift her arm, it felt like a thousand pounds), MUSCULAR WEAKNESS (Could not get up, her right leg gave out) and FATIGUE (Felt tired). an unknown date, the patient experienced MYOCARDIAL INFARCTION (Minor heart attack the same day as the stroke) (seriousness criterion medically significant) and RENAL DISORDER (Kidney disease). The patient was hospitalized from sometime in May 2021 to 28-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Had a stroke), MYOCARDIAL INFARCTION (Minor heart attack the same day as the stroke), FEELING ABNORMAL (Did not feel right), LIMB DISCOMFORT (Could not lift her arm, it felt like a thousand pounds), MUSCULAR WEAKNESS (Could not get up, her right leg gave out), RENAL DISORDER (Kidney disease) and FATIGUE (Felt tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Around 8:30-9:00pm, the patient did not feel right, could not lift her right arm, could not get up and her right leg gave out. She was taken to the hospital where "they said she had a stroke." She was hospitalized then and was released 28-May-2021. The patient would require rehab for next 6-12 months. Additionally, it was also reported that the patient suffered a minor heart attack the same day as the stroke. It was reported that the patient suffered two strokes, however, there was no further information about the second stroke. At the hospital, in regards to patient's medical history, the doctors mentioned "kidney disease" and that the patient had "blood pressure" before. Concomitant medication use included "blood pressure pills." Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Systemic: Allergic: Anaphylaxis-Severe, Additional Details: patient called 6/14 after being notified that she was due for second dose to report she had anaphylactic reaction after first dose and would not be getting second dose. Patient did not experience anaphylactic reaction during observation period after the vaccine so unsure of timing of the reaction

Headache, nausea, and emesis 3 days after the vaccine with sudden worsening the day prior to hospitalization. Subarachnoid hemorrhage and multifocal white matter changes.

I was diagnosed with Accute IPT - platelet count dropped to 10,000 and was hospitalized for 2 days. Also, noted petechial rash in bilateral lower extremities. I received Platelet infusions. I quite smoking in 2003 - over 18 years ago.

I had been having shortness of breath since being sick in February, 2020. However, after receiving the Moderna vaccine, my shortness of breath became much worse. I visited my primary care physician who sent me to the hospital for testing. A Chest CT showed heart failure, an enlarged heart and a lot of fluid around my heart.

I developed a cough about two weeks after the last vaccine and had difficulty breathing. I couldn't take a deep breath. I went in and I had bilateral pneumonia. Then I was given albuterol sulfate and I still need it from time to time and I've never had any type of asthma issues before. She sent me to get pulmonary function testing which came back okay but with moderate need for the inhaler. I also had some heart palpations and went to have EKG after I finished the antibiotics that I was prescribed. After that I had another CAT scan done of my chest and the pneumonia was clear. I still have a wheeze and it gets sometimes rather than all the times and I do have the inhaler on me. I don't breathe like I did before and feel like there is still something wrong so I'm going back to see her on the 14th.

Chest pain, pulmonary embolism diagnosed June 25, 2021 at Hospital treated with Eliquis and discharged from ER. Still undergoing treatment and symptoms still persisting as of today.

heart attacks; blood clots from vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attacks) and THROMBOSIS (blood clots from vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attacks) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots from vaccine) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attacks) and THROMBOSIS (blood clots from vaccine) outcome was unknown. No concomitant medication information was mentioned. No treatment medication information was mentioned Additional information was mentioned patient had a vitals and internal bleeding Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Thrombosis is an adverse event of special interest. Further information is expected.; 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. Thrombosis is an adverse event of special interest. Further information is expected.

Started having indigestion/acid reflux. Was vomiting on occasion. Started to investigate if I had a gall bladder issue but before that could be done I had a heart attack. No blockages or blood clots. Have not gotten an explanation yet but I was in great health before a shoulder surgery in December. EKG done before surgery was good. I had some viral sinus issue that Dr gave me Prednisone for just before the heart attack so any heart inflammation would have been masked by medication.

Dizziness, Headache, Bleeding, Myalgia, "lethargic"; "flush in face"; "difficulty sleepy"; "bloody nose"

Received 1st Moderna vaccine on 1/12, woke up feeling sluggish, headache, low back pain, slight nausea. Went to work, had to go home. She is a diabetic, and was also hospitalized in march she was dx with Covid and bilat pneumonia.

hypoxia to 30%, only improved to 82% on Nonrebreather at 100%, intubated for hypoxic respiratory failure

Patient vaccinated on 1/22. The next morning (1/23), patient experienced diminished sensory and motor function in left arm and leg, as well as facial numbness. Presented to the hospital on 1/24, and was found to have a small stroke in pontine medullary junction. Discharged on 1/25. There is some suspicion that her COVID infection in December may have precipitated this, and patient is currently being evaluated for coagulation disorders, primarily antiphospholipid antibody testing. It is unlikely that the vaccine contributed to this, but given close timeline between the two, filing this report.

vaginal bleeding. I have not had a period in over a year and 2 days after the shot I started bleeding. After talking to others that have had the vaccine, several have had breakthrough bleeding a couple days after the vaccine and thought nothing of it, but people aren't reporting because they think its just them. I think it should be reported, and maybe some investigation follow up as to why this may have occurred.

New onset atrial fibrillation; Shortness of breath; Very tired; Her arm was sore; Headaches; A spontaneous report was received from a nurse concerning a 54-year-old, White, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headaches, atrial fibrillation, very tired, and shortness of breath. The patient's medical history was not provided. Concomitant product use was not provided. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021 the patient experienced headaches after vaccination. On 05 Jan 2021 the patient's arm was sore. On 14 Jan 2021 at 6:00 am the patient's heart rate started at 136 and went as high as 180. She reported having heart palpitations, shortness of breath, and headaches. The patient went to the emergency room and was hospitalized for 14 hours. She was diagnosed with new onset of atrial fibrillation. While in the hospital she was started on a Diltiazem and Heparin. On 17 Jan 2021, the patient reported she was now in sinus rhythm but was very tired. Her cardiologist prescribed Rivaroxaban and Metoprolol. Action taken with mRNA-1273 in response to the events was not provided. The events, sore arm, headaches, atrial fibrillation, and shortness of breath, were unknown. The event, very tired, was considered not resolved.; Reporter's Comments: This case concerns a 54 years old female patient, who experienced a serious unexpected event of atrial fibrillation and non-serious unexpected event of dyspnea, and non- serious expected event of injection site pain, fatigue and headache. The event of headache occurred 1 days after first dose of mRNA-1273, lot # 039K20A. The event of injection site pain occurred 2 days after first dose of mRNA-1273, lot # 039K20A. The event of atrial fibrillation, dyspnoea, and fatigue occurred 11 days after the first dose of mRNA-1273, lot # 039K20A. Treatment included Cardizem drip, heparin, Xarelto and Lopressor. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Developed headache, fever and cough on 1/25 unable to come to work 1/26 and 1/17. Saw provider 1/28 was admitted to hospital with fever, pneumonia, dehydration, elevated d-dimer, headache and cough. Given IV fluids, antibiotics, steroids and nebulizers. Discharged home 1/30/2021.

Resident developed low grade fever next day and it continued through Monday morning with some mottling starting to appear on resident's skin. Sent to ER on Monday. Resident sent to higher level of care and diagnosed with pneumonia and bilateral pulmonary embolism

Death. EMS called to residence 9 hours later for cardiac arrest. Pt pronounced at Emergency Room. Pt sent to ME office for autopsy.

Patient presented to medical center emergency room on 02/21/2020 at 19:00, patient complained of shortness of breath and feeling fullness of her throat. Patient stated that she had Motrin 800 mg TID and Flexeril PRN due to her back pain. Patient also stated that she ate a banana after she took her medications. Her systolic blood pressure was 50, and her HR was 109, patient also stated that she had her 2 shots of Moderna Vaccine, her first shot was on 01/06 and her second shot was on 02/02. Patient was treated with: 1 Duoneb, 0.3 ML IM of epinephrine, Solumedrol 125 mg, Benadryl IV 50 mg, Normal Saline infusion IV 1000 ml/hr, and Pepcid IV 20 mg. Patient lactic acid was 10.6, WBC 24.2 and Temp 97 F, patient was diagnosed as sepsis shock and patient received: Piperacillin-tazobactam 3.375 g in D5W 50 ml IVPB (3.375 g once) Vancomycin 1 g in D5W 200 ml IVPB (1 g once). Patient pH was < 6.780 and PCO2 was 55 and bicarbonate level was 5.0, patient received Sodium bicarbonate IV 50 mEq once. Patient was not stable as her BP and HR were fluctuating patient received DilTlazem IV 2.5 mg for 2 doses. Patient received Levophed 16 mg /NS 250 ml IV. At 23:13 patient was intubated, patient received a local anesthesia through a central line of lidocaine 2% without epinephrine, and patient was transferred to the ICU to be monitored. At 00:33 CODE BLUE was called and patient became unresponsive and lost pulse while patient was brought to ICU. Patient was coded twice before ROSC, during intubation patient patient noted to have coffee-ground drainage.

Developed numerous blood clots in left saphenous vein and likely pulomary embolism (did not do test for embolism b/c I am allergic to the contrast but I was very short of breath for several weeks). Not sure if this is related to the vaccine since I was post bone surgery and also on estrogen therapy (ovaries removed 5 years ago) but I have not ever developed a problem before after surgery and while on estrogen.

After 1st dose on 2/9/21 My breasts were extremely sore, like I was going to get my period. (Which I have not had in 4 years) I am in menopause. 5 days after 2nd covid shot again breasts were tender & I had vaginal bleeding & cramping. Ultrasound showed inflammation of my uterus.

Blue/black blood clot on middle finger right hand; Burning in middle finger on right hand; Itchiness on middle finger on right hand; Pain in middle finger on right hand; A spontaneous report was received from a Consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning in middle finger on right hand/burning sensation, itchiness on middle finger on right hand/pruritus, pain in middle finger on right hand/pain in extremity, blue black blood clot on middle finger right hand/thrombosis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 2 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 JAN 2021 1.00 pm, after taking mRNA-1273, the patient felt weird sensation in right hand middle finger. She felt burning, itchiness, pain and had a dark blue/black blood clot on inside of finger. 2 hours later it started to fade down (purple in color). In the evening it was considerably lighter. On 21 Jan 2021 there was a light imprint of the blood clot. Blood clot went away later that day. Patient did not received treatment. Action taken with mRNA-1273 in response to the events was not reported. On 20 Jan 2021 the outcome of events burning in middle finger, itchiness on middle finger on right hand, pain in middle finger on right hand was resolving. On 21 Jan 2021 the outcome of event blue black blood clot on middle finger right hand was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Reaction: Anaphylaxis Severity: High ED Note: 54-year-old female presents throat swelling, cough after receiving a vaccine. On exam patient appears distressed with persistent dry cough. Patient's posterior oropharynx is mildly erythematous. No wheezing or stridor. Given patient's persistent coughing and subjective throat swelling will treat with IM epinephrine, Benadryl, Pepcid, prednisone. Will observe in the emergency department. On reevaluation symptoms improved patient still complaining of throat tightness. Will treat with albuterol nebs. Reassess. Symptoms resolved on reevaluation. Patient observed for 2 hours emergency department with no rebound of symptoms. Patient stable for discharge. Will write for EpiPen. Return precautions discussed.

Reaction started ~25mins after shot with itchy and swelling eyes. Progressed to anaphylactic reaction requiring Ambulance to ER, admission, four day stay.

Stroke, Alteplase, double vision on left eye, ear pain and ringing, left arm mobility compromised, left leg mobility compromised. In at jospital via ER, then ICU, discharged 4/9/2021, occupational and physical therapy. Being performed .

MASSIVE STROKE AT AGE 54 - 3/26 received vaccine began feeling weak and light headed. Saturday - 3/27 Was still feeling light headed fell down a few times - Sunday 3/28 - Woke up immediately had massive vertigo within minutes could not breathe or swallow was taken by ambulance to medical center - Diagnosed with Massive stroke in a VERY RARE PART OF THE BRAIN - Modulla controls balance- SO MUCH MORE.....My sister is lucky to be alive.

Massive stroke; After second vaccination, immediately felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided.). Concomitant products included DIAZEPAM (VALIUM), ONDANSETRON (ZOFRAN [ONDANSETRON]), ATORVASTATIN CALCIUM (LIPITOR) and LISINOPRIL for an unknown indication. On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION COMPLICATION (After second vaccination, immediately felt terrible). On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criteria hospitalization and disability). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) and VACCINATION COMPLICATION (After second vaccination, immediately felt terrible) outcome was unknown. Treatment included t pack clot bursting stroke medication. Stroke has affected the patient's vestibular system and balance and has caused vertigo, she is now crippled. These symptoms are ongoing and similar to what the reporter experienced Based on the current 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.

The pt missed her scheduled appointment for COVID vaccine #2, so I called her to reschedule. Today I reached her mother, who informed me that pt passed away last Tuesday. I did not ask for any details of her death at this time.

This patient was at work two days after her vaccine and went to the bathroom. When she did not come back to work after around 20 minutes, she was found unresponsive and an ambulance was called. The patient was declared deceased at the ER with the cause of death initially as cardiac arrest however a full autopsy was performed and Coroner's office is awaiting that report at this time. We did not know of the death until we went back this week to complete the second round of vaccinations. Since the death happened in such close proximity to the vaccination date we felt it prudent to report.

Time Course/Signs/Symptoms: 8-10minutes after vaccine -> bilateral arm "paralysis", Then, syncope. Was laid down. Awake and spoke her name. Then, Hyperventilation x 3-5 minutes @ about 100 rpm. Lost consciousness. O2 applied. BP=135/90; HR = 90/min. No wheezing, good B breath sounds. Ambulance arrived @ about 11:40am. Reportedly prolonged seizures and severe hypertension. Helicopter ambulance met road ambulance in route. Personnel immediately intubated the patient. Reportedly, this led to "a fountain of blood".

One day following vaccination, patient became presyncopal and tachycardic. She presented to local ER, where she was found to have multiple pulmonary emboli. She is being treated with heparin. We are seeking to obtain medical records now.

very tired and sleep 18 hours; passed away; severe flu-like symptoms; chest pain; Soreness at injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (passed away) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dermatomyositis, Polymyositis, Osteoarthritis, Degenerative bone disease, Osteoporosis, Muscular dystrophy, Rheumatoid arthritis, Immune disorder (NOS) and Raynaud's phenomenon. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma, PILOCARPINE for Dry mouth, IRBESARTAN for Hypertension, DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for Hypertension and Chest pain, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, TIZANIDINE for Muscle spasms, PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]) and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, GABAPENTIN (NEURONTIN) for Nerve pain, OXYCODONE for Pain, LEFLUNOMIDE and UPADACITINIB (RINVOQ) for Rheumatoid arthritis, ZOLPIDEM TARTRATE (AMBIEN CR), ACETYLSALICYLIC ACID (BAYER ASPIRIN), LANSOPRAZOLE (PREVACID), DIAZEPAM (VALIUM), CANNABIDIOL (CBD OIL) and IRON (IRON COMPLEX [IRON]) 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 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu-like symptoms) and CHEST PAIN (chest pain). On an unknown date, the patient experienced FATIGUE (very tired and sleep 18 hours). On 02-Apr-2021, INFLUENZA LIKE ILLNESS (severe flu-like symptoms), CHEST PAIN (chest pain), FATIGUE (very tired and sleep 18 hours) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. The patient died on 02-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. On 02-APR-2021 at 1: 30 AM mother found her daughter lying on the floor unresponsive. Paramedics and police came to the house. Paramedics tried to revive her and she was pronounced dead at the scene. This is a 54 year-old, female patient who received mRNA-1273 Vaccine) (batch no. 020B21A) and died 3 days after receiving first dose of vaccine and experiencing Influenza like symptoms. Medical hx of several auto immune disorders were provided. Conmeds include Hypertensive and Chest pain meds. The fatal outcome may be related to the patient's pre-existing comorbidities Very limited information has been reported at this time. No further information is expected.; Sender's Comments: This is a 54 year-old, female patient who received mRNA-1273 Vaccine) (batch no. 020B21A) and died 3 days after receiving first dose of vaccine and experiencing Influenza like symptoms. Medical hx of several auto immune disorders were provided. Conmeds include Hypertensive and Chest pain meds. The fatal outcome may be related to the patient's pre-existing comorbidities Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death

On Friday 4/9 I experienced chills, fever and body aches. I called the on call doctor and he informed me my symptoms would be better in 24 hours and to call back if my symptoms worsened. On Saturday 4/10 I started having problems breathing and pain in my chest which lasted all day. Sunday 4/11 I went to the emergency room of which I was admitted and was told I had Pulmonary Embolism. I am currently being treated with Eliquis.

On 2/28/21, had first COVID Shot. On 3/16/21 had Hysterectomy. On 3/30/21 had second COVID shot. On 4/19/21, was diagnosed with blood clot. The doctor reported that it was not the norm for someone my age and with my good health to get a blood clot after a hysterectomy.

Pt. passed away 2 days after vaccination. At time of vaccination pt. already in moribund state related to long term diabetes mellitus1 with ESRD, chronic foot wound since 2017, severe osteoarthritis. In March 2021 pt. hospitalized d/t severe pain. Findings were acute encephalopathy likely multifactoral, abnormal EEG and NSTEMI. Pt. refused further diagnostic in the hospital and resumed home hemodiaysis with help of her spouse. Hospice care was considered by the couple shortly before the time of vaccination.

Profuse menstrual bleeding- large clots for 2 days. Pain behind eyes morning after injection. Painful lymph nodes on underarms.

Patient received her COVID 19 moderna vaccine 2 weeks ago. I week ago she developed shortness of breath and chest tightness, She was diagnosed with extensive bilateral pulmonary emoboli with a left popliteal DVT.

Who: See above What: EMS called and patient transported to ED Where: vaccine site When: See above: Why: Anaphylaxis to first dose of Moderna. After vaccination pt presented with coughing, redness of the face and arms, and stated that it felt like her neck was swelling. She explained it as "it feels like someone has their hand on my neck and choking me." Pt has hx of anaphylaxis and has an Epi pen. HR was 120, RR 30, BP 170/90. Pts condition was getting worse so she was administered an adult epi pen. HR increased but after 5 min pt was coughing less and face became less red. She also said she felt better. Vitals were reassessed and pt handoff was given to

pneumonia; blood coming like yellow; extremely sick; Covid-19; High Fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included SPIRONOLACTONE and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ILLNESS (sick at home). On 16-Jan-2021, the patient experienced PYREXIA (High Fever). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), HAEMOPTYSIS (blood coming like yellow) (seriousness criterion hospitalization), ILLNESS (extremely sick) (seriousness criterion hospitalization) and COVID-19 (Covid-19). The patient was hospitalized from 25-Jan-2021 to 01-Feb-2021 due to HAEMOPTYSIS, ILLNESS and PNEUMONIA. At the time of the report, PNEUMONIA (pneumonia), HAEMOPTYSIS (blood coming like yellow), ILLNESS (extremely sick), ILLNESS (sick at home), PYREXIA (High Fever) and COVID-19 (Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive positive (Positive) 21Jan2021 she received positive covid- 19 result. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 17-Jan-2021 Patient was prescribed steroid, Z-pack, and zinc for Treatment of the events and steroids and antibiotics for Covid-19 This case was linked to US-MODERNATX, INC.-MOD-2021-118681 (E2B Linked Report).; Sender's Comments: The vaccine does not cause or result in full blown COVID 19, thus the event is assessed as unlikely related to mRNA-1273. In addition, based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-118681:Cross linked to Dose 2

I got a red rash that goes all the way down my right arm right after on the next day, and it latest a week to clear up. A month after the 2 does, I had a lot of vaginal bleeding lasting a week before I saw the dr. I ended up passing out due to the blood loss. The dr did an ultrasound and found a fibroid tumor, and they did a dnc,

Neck tightening (immediate but was most likely the lymph nodes reacting and not allergy), 35 minutes after receiving the vaccine, tingling tongue and lips, tongue swelling with difficulty speaking. These went away as soon as I got close to the hospital so I did not seek medical treatment. 45 minutes after receiving vaccine, headache and lymph node swelling. 30 hours after receiving the vaccine rashon arm that started out as small hives and then grew to a rash 4 inches side and 2 inches tall and this lasted for 5 days. The rash was so inflamed that an ice pack could not cool the skin. Dizziness for 2 days. Hives on left foot the 3rd day that went away quickly and hives on right food on the 4th day after receiving the vaccine that went away quickly. Excessive thirst the first 2 days and dry mouth. Bleeding/spotting for 5 days even though my period had ended 2 days prior to receiving the vaccine.

Patient described an increase of vaginal bleeding similar to menstruation she had not had for 2 years, although patient had vaginal spotting prior to May and June Moderna vaccines leading to pelvic ultrasound and endometrial biopsy by her gyn in Feb 2021 (benign path). However, endometrial stripe was 6mm and she had a fibroid, it is therefore possible the increase in bleeding after the vaccines was coincidental and I referred her back to gyn for re-evaluation as she remains at increased risk for endometrial cancer

They say that I suffered a CVA on 05/27/2021 around 8AM that morning. I had nausea, vomiting, my vision was distorted, and my heart rate was increased. I couldn't walk. I was taken to the ER and they did a CT of my head. They also did an MRI. That's when they told me that I had a stroke. They prescribed medications. I was in the hospital for 05/30/2021. On 05/31/2021, I had the same thing happen. I went to the ER and they said I had a TIA. They did a CT and MRI. I was released from the hospital on June 2nd. I have been doing home physical therapy and speech therapy. I have also been doing occupational therapy. I will be starting outpatient in July.

From the time of vaccine until first onset of symptoms was approx five hours. Fever of 104, chills that felt like a seizure, headache that was blinding - worst I've ever had, and I have a history of migraines. Was not a migraine, was worse. Body aches. Over the next three days, I got worse. Went to the ER, sent home, went back two days later and was admitted for four days. Same symptoms, with the addition of pneumonia and sepsis.

Day after the vaccine she had a seizure or mini stroke that lasted between 35 minutes and 1 hour. She is currently being tested. This was her second seizure if it was a seizure. The other one occurred almost a month previously. She saw a Dr. who said it could possibly be a side effect of the vaccine.

Suffered a heart attack on 3/13/2021. Took medication. On 3/31/ 2021, had three separate heart attacks. Daughter took you to the hospital. Given Nitros and aspirin. Given stint. Got very angry and agumentative. Cannot remember ever getting that way. Getting swollen legs and feet from sitting just a couple of hours. Previously, no swelling. Given clean bill of health just months ago prior to knee surgery. Currently on various medications (up to 13 pills and shots). Not on those medication previous. On B12. Experiencing extreme fatigue. Vague memory, but could have had several trips. Cardiologist has advised against getting second dose. Half of heart damanged (right side) 99-100% blocked.

Vaginal bleeding and cramping began nine days after the second dose. Lasted three days the first time. Second round of bleeding for three days approximately one month later. Third round of bleeding lasting six days started July 19 until July 24, which was heavier and longer than previous two cycles. Went to primary physician approximately one week after initial bleeding.

I have longstanding epilepsy but have not had a grand mal seizure in many years until the night I received my second Covid vaccination.

Developed immediate fever & cills within 2 hours. By next morning had pain & difficulty producing urine. Saw primary care doctor and urgent care center, infection not treated w/PO Macrobid after 2 days. Admitted to Hospital w/sepsis, kidney infection and acute renal injury?creatinine 4.25 (baseline=1.5)

10 minutes after vaccine--throat became tight, some scattered itching, O2 sat to 93%, lungs mild-moderate decreased air movement. Took Proair inhaler, 10 mg Prednisone, 25 mg Benadryl. 1 hour after injection symptoms resolved and sat up to 98+% and lung clear moving better air per the RN monitoring for reactions. 1 day post injection-- exhausted, spordaic and severe muscle cramps, chills 2 day post injection, chills better, muscle cramps stronger, abdominal muscles and intestines cramping

Moderna COVID-19 Vaccine EUA Patient received the Moderna Covid vaccine and 5 minutes after this began to have the sensation of tongue swelling and nausea. She was given epinephrine and Benadryl IM prior to arrival at the emergency department. Upon arrival at ED, she states that she feels a little odd, but is otherwise back to baseline. Denies any difficulty breathing, lightheadedness, abdominal pain, nausea, or diarrhea. States this feels similar to her prior reactions to shellfish. In the emergency department patient given dexamethasone given concern for anaphylactic reaction. Patient was observed for several hours with no worsening of symptoms. She was discharged home in stable condition.

Anaphylactic reaction; rash 3.5 x 5 inches below the injection site; A spontaneous report was received from a consumer concerning a 65-year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction and a vaccination site rash. The patient's medical history included diabetes since an unknown date. Relevant concomitant medications included an unspecified diabetes medication. On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 18-Jan-2021, the patient experienced the event anaphylactic reaction and a vaccination site rash 3.5 x 5 inches. Laboratory details were not provided. Treatment information included fexofenadine and diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. On 23-Jan-2021, the outcome of the events, anaphylactic reaction and vaccination site rash, was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I was swimming in a lake when suddenly I couldn't breath and my heart started pounding. I was gasping for air. My pulse went from a normal working out pulse to above 145 bps. It did not come down when floating on my back or resting when I eventually got back into shore. Then when I got home I had to climb stairs and I lost my breath again.

full anaphylaxis including tongue and throat swelling, elevated heart rate, elevated blood pressure, delirium, face slightly swollen, shortness of breath, dizziness

Patient reports feeling unwell, collapsed on floor, skin tone became grey, 911 called, epinephrine 0.3 mg IM autoinjector administered, patient put in recovery position, BP monitored, vomitted X 3 or 4, EMT's arrived and transported patient to Hospital. Call from MD at hospital confirming anaphylaxis and patient recovery. Spoke with patient at 15:50 and confirmed recovery.

Pt seen at ED for anaphylaxis after Moderna Vaccine pt received 1st Moderna COVID19 vaccine at pharmacy today, within 2 mins felt throat closing, itching, SOB. had slight hives on abdomen. received epi-pen and po benadryl at pharmacy. was given additional epi-pen , iv solumedrol, iv benadryl in ED. discharged after improvement and 6 hr observation

Patient developed nausea, headache, vomiting, and lower extremity numbness within 10-15 minutes after vaccine administration. Initial BP was 190 systolic. Patient was given Aspirin and Oxygen . She was transferred to the emergency department for management of acute stroke. TPA was administered and she is in ICU.

Heartbeat thing; High BP; ministroke; transient global amnesia; sore arm; A Spontaneous report was sent by Consumer concerning a 55 year female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke, transient global amnesia, heart rate increased and blood pressure is high. No medical history was reported. Concomitant medications was not reported. 22 Jan 2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection and experienced sore arm in the evening. She took Tylenol and Motrin. On 02 Mar 2021 the patient received the second dose of vaccine and experienced sore arm before she received the shot. On 21 Mar 2021 she had mild stroke, and she was diagnosed with Transient global amnesia. Which they said is precursor to stroke. On 22 Mar 2021, patient experienced heartbeat thing; blood pressure recorded high.The patient has undergone MRI, CAT scan, EKG, Chest x-ray done and blood drawn in ER. Laboratory details are not provided. Action taken with mRNA-1273 in response to the events was not applicable. At the time of this report, the outcome of the events, mild stroke, transient global amnesia, heart rate increased and blood pressure is high was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Woke up at 1 AM sweaty and heard pounding. Got up and checked heart rate and it was varying 130-180 bpm. Had my husband take me to ER. They determined that I was in afib. They gave me some meds and my heart went back into rhythm after an hour or so. I had fever and headache for 3 days and then cleared up. I have had the afib episodes 2 more times since then. I had never had heart issues before getting the vaccine.

CVA while at work. Brought in by ambulance, tpA administered with reduction of NIH score from 25 to zero within 6 hours of onset.

Patient had her 2nd dose of Moderna COVID vaccine on 3/29. Starting 4/8, she was having shortness of breath on exertion with a mild cough. On 4/11, her husband states that he saw her sitting down watching TV, then he heard a thud in the next room and went in to see her on the floor and she started crying for help which led to him calling the paramedics. The paramedics noticed the patient was in PEA and resuscitated her and brought her to the ER. The patient appeared to have an NSTEMI and she was diagnosed with a pulmonary embolism that led to the cardiac arrest event. Patient was taking to cath lab and was found to have normal coronary arteries with no evidence of coronary artery disease. Patient was also in sepsis and had an extensive bilateral pneumonia. Patient is currently inpatient and intubated.

moderate pain in arm; moderate headache then sudden bloody nose 2 days later from right nostril with two large blood clots. Headache remains.

possible stroke; small clot that went through and resolved on its own; Loss use of left leg/couldn't use her leg; tingling in left arm; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The patient's past medical history included Familial hypercholesterolemia, Peripheral arterial disease and Stent placement (has stents in her iliac ery). Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and SERTRALINE for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (possible stroke) (seriousness criterion hospitalization), THROMBOSIS (small clot that went through and resolved on its own) (seriousness criterion hospitalization), MONOPLEGIA (Loss use of left leg/couldn't use her leg) (seriousness criterion hospitalization) and PARAESTHESIA (tingling in left arm) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 28-Mar-2021 due to CEREBROVASCULAR ACCIDENT, MONOPLEGIA, PARAESTHESIA and THROMBOSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: Inconclusive. In March 2021, Magnetic resonance imaging: Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Patient reports an MRI and CT scan was done, and she was informed that they suspected she had a small cot that went through and resolved on its own. Company Comment: Based on the temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However patient's hx of familial hypercholesterolemia, peripheral arterial disease and stent placement are confounding factors that may play a possible contributory role.

Doctor felt it was an anaphylaxis reaction; Cough; Left arm is still so sore she can not lift it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) in a 55-year-old female 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 reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COUGH (Cough) and VACCINATION SITE PAIN (Left arm is still so sore she can not lift it). On 17-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Doctor felt it was an anaphylaxis reaction) outcome was unknown and COUGH (Cough) and VACCINATION SITE PAIN (Left arm is still so sore she can not lift it) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was treated with antihistamine for tingling in her lips and whole face became swollen and her lips were huge and it started to go away. On 18-APR-2021, it started again so patient had seen her physician on 19-APR-2021 who referred her to a specialist. The patient was tested for an allergy to the vaccine. The doctor felt it was an anaphylaxis reaction. The reporter did not provide an assessment for the events. 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.

Patient was given the 2nd dose of Moderna vaccine on 28th day after her 1st was given. She tolerated the 2nd vaccine well and waited her 15 min here in the office. Vaccine given at 2:39pm and at 4pm she called our office and stated she was having problems with her left side of her body and could not go down her stairs in her house. The whole left side of her body she had no feeling in. We advised her to go to ER. She went immediately to the emergency room and they transported her to another Hospital. After arriving at the hospital they diagnosed her as having a CVA of her right thalmus. She came in to the office today for hosp f/u and she is still having numbness, tingling and weakness on her left side.

About 1 week after receiving 2nd dose of a moderna vaccination, patient states she experienced gradual onset of shortness of breath. Patient presents to PCP at week 3 post vaccination due to increased shortness of breath. PCP send patient for CT of chest and discovered bilateral PEs. Patient was sent to emergency room, was treated with anticoagulants and sent home on anticoagulant therapy of Eliquis.

ON 3/28/2021 AT APPROXIMATELY 11:00 A.M. PT WAS ON HER STATIONARY BIKE EXERCISING WHEN SHE HAD A SUDDEN ONSET HEADACHE WITH SHARP PAINS THAT WENT DOWN HER NECK. SHE BECAME LIGHTHEADED AND NAUSEATED. SHE CALLED EMS AND WAS TAKEN TO LOCAL HOSPITAL WHERE IT WAS FOUND BY CAT SCAN THAT SHE HAD AN ACUTE SUBARACHNOID HEMORRHAGE IN THE BASILAR CISTERNS. SHE WAS AIRLIFTED TO ANOTHER HOSPITAL WHERE SHE SPENT 8 DAYS BEFORE DISCHARGE HOME. SHE CONTINUES TO HAVE SOME NECK PAIN AND HEADACHES AS WELL AS DEPRESSION.

The next day after receiving the second vaccination the patient described light vaginal bleeding, dark in color. Bleeding has been light and continuous for the past 5 days. Patient has been post menopausal for several years and has been on hormone replacement for this condition. Patient also described having pains and aches and fever the evening after receiving the shot, which have resolved.

Slurring her speech; "I could not open my eyes and look at a screen"; Periorbital edema; Could not think clearly; Thought she was having a stroke; Could not focus on a computer screen, tv, phone, or read; Headache/Whole entire head hurt; Vomiting; Diarrhea; Miserable; Eyes were swollen all around her eyes; Migraine/ chain of migraines/ migraine pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Could not think clearly) and CEREBROVASCULAR ACCIDENT (Thought she was having a stroke) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine (History of migraines). Concomitant products included ELETRIPTAN HYDROBROMIDE (RELPAX) and NAPROXEN SODIUM (ALEVE) for Migraine. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced MIGRAINE (Migraine/ chain of migraines/ migraine pain). On 07-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), FEELING ABNORMAL (Miserable) and VOMITING (Vomiting). In January 2021, the patient experienced EYE SWELLING (Eyes were swollen all around her eyes). On an unknown date, the patient experienced MENTAL IMPAIRMENT (Could not think clearly) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought she was having a stroke) (seriousness criterion intervention required), DYSARTHRIA (Slurring her speech), PHOTOPHOBIA ("I could not open my eyes and look at a screen"), PERIORBITAL OEDEMA (Periorbital edema), DISTURBANCE IN ATTENTION (Could not focus on a computer screen, tv, phone, or read) and HEADACHE (Headache/Whole entire head hurt). At the time of the report, MENTAL IMPAIRMENT (Could not think clearly), CEREBROVASCULAR ACCIDENT (Thought she was having a stroke), MIGRAINE (Migraine/ chain of migraines/ migraine pain), DYSARTHRIA (Slurring her speech), PHOTOPHOBIA ("I could not open my eyes and look at a screen"), PERIORBITAL OEDEMA (Periorbital edema), DIARRHOEA (Diarrhea), FEELING ABNORMAL (Miserable), EYE SWELLING (Eyes were swollen all around her eyes), DISTURBANCE IN ATTENTION (Could not focus on a computer screen, tv, phone, or read), VOMITING (Vomiting) and HEADACHE (Headache/Whole entire head hurt) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Magnetic resonance imaging: indicates bright spot which could be migraine (abnormal) Bright spot which could be migraine. In January 2021, SARS-CoV-2 test: Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information mentioned while in ER had infusions of pain medications and ketorolac, steroids, and antihistamines. Would also ice head for pain relief. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional events, Medical history, event outcome and action taken updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, noting the medical history of migraines in the patient as a confounder.

Moderna vaccine #2 given 3/5/2021. Within 24 hours severe fatigue, myalgia, abnormal taste in mouth, dizziness. For weeks similar severe fatigue (not able drive, walking 100 feet only with shortness of breath). Ongoing lightheadedness both seated and standing and worse with going up 1 flight stairs. Holter identified nonsustained ventricular tachycardia and eventually with episodes of sustained ventricular tachycardia x 5 and ongoing nonsustained ventricular tachycardia patient was admitted to hospital for third time and underwent cardiac radioablation 4/26/21.

For over the past week, I have had hives everyday, and anaphylaxis episodes after most meals. I?ve been to the ER and am scheduled for allergy testing. I believe my Modena vaccines kicked my Hashimoto disease into over drive.