Moderna

generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine. She was released from the ER on 23 Dec 2020. On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue. The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.

Pt received first dose 1/5/2021. Pt received second dose 02/01/2021. Pt started to have SOB and tachycardia 2/2/20201. She presented to Hospital and was diagnosed and admitted with a pulmonary embolism. She is a paramedic in our EMS system. It is not known to me whether she had other risk factors for a pulmonary embolism.

Very swollen and painful lymph nodes all over entire body (chest, shoulders, arms, stomach, calves) for 1 week. Felt nauseous, dizzy, and exhausted. No appetite. Struggled to read and process things. Could not work. Sharp pains in lymph nodes at various times throughout the day. Chest felt very tight and arm hurt to the point I thought I might be having a heart attack. Had trouble sleeping due to lymph node pain. Ibuprofen did not help. The arm pain at injection site was annoying but I barely noticed it due to my other symptoms.

tingling in her mouth and lips; lump in throat; dizziness; tunnel vision; shaking; headache; anaphylaxis; A spontaneous report was received from a physician concerning a 26-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced Anaphylactic reaction, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness, tunnel vision and shakiness. The patient's medical history included: allergy to azithromycin and penicillin. Concomitant product use was not provided by the reporter. On 19 Feb 2021, approximately four minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 031L20A) for prophylaxis of COVID-19 infection. On 19 Feb 2021 at 14.09, the patient had tingling in their mouth and lips and a lump in their throat. The patient's heart rate noted was 130s. The patient also reported very bad headache dizziness and tunnel vision. The patient developed shakiness which was noted on exam. The reporter reported for an anaphylaxis reaction . The patient's Blood pressure reported was 156/80. At 14.29, the patient's Blood pressure reported was 176/87. Treatment information provided included EpiPen (0.3mg) given Intramuscularly to right thigh at 14.22 and supplemental O2 provided. The reporter stated ambulance was called, husband of the patient was called. Reports were given to ambulance services. The systolic BP upon transport was 168. Action taken with mRNA-1273 in response to the event(s) was Not applicable. On 19 Feb 2021, the outcome of the events, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness and tunnel vision were considered resolved and the outcome of the event, shakiness was considered not resolved. On an unknown date, the outcome of the event, Anaphylactic reaction was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.

The day after I got the vaccine, I felt severe muscle pain in my both legs, and the next day my legs got swollen and have a Hematuria. When I visited the hospital, I was diagnosed with Rhabdomyolysis and it took about three weeks for the symptoms to get better.

Fell out of chair and found lying on left side of body. Positive LOC for 10 seconds. Responded thereafter. Remembers sitting in chair but not falling. Last meal with last night History of fasting for 17 hours at a time. A+Ox3 upon awaking Very small hematoma and contusion to forehead/top of head, minimal bleeding. Hands too cold for obtaining O2 sat BP 90/palp Paramedics obtained BP of 98/71 and pulse of 58 and a blood sugar of 75. After sitting up for about fifteen minutes and drinking water and eating a chocolate chip cookie, patient ambulated to building from outside observation area. Post VS 115/69 66 20 98% O2 sat on RA. Discharged home with mother in law and sister. MAEW, NAD , STEADY GAIT A+OX3

Severe headache, has continued intermittently until present. Strange menstrual flow, was very heavy, with clotting, unusual per patient

Stroke; Complex migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and MIGRAINE (Complex migraine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A.) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and MIGRAINE (Complex migraine) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and MIGRAINE (Complex migraine) outcome was unknown. Company comment:Very limited information regarding these events has been provided at this time. Further information has been requested. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

The Patient has an anaphylactic history to an oral pain medication she didn't know the name of, food allergies, and to the flu vaccine (with eggs). She has gotten the flu shot without eggs and been fine. The administering RN asked the med led to further assess. We discussed that she is at a higher risk for anaphylaxis than most people given her allergy history. She said that she was not Allergic to any component of the covid 19 vaccine when shown the list, and this was double checked. We discussed that if she gets the vaccine and has a reaction, she will need emergency room treatment and that she may want to consider being vaccinated at a hospital where they have more resources. However, given she did have known anaphylaxis to a component of the vaccine we will give it to her if she so chooses. It was explained that if she gets the vaccine, we will monitor her for 45 minutes, and if she has a reaction, she will be treated and sent to the E.R. She verbalized consenting to getting the vaccine after being thoroughly educated. She was vaccinated at 1337 with 0.5 ml of Moderna Vaccine in the left deltoid. I was not present upon the administration. I was informed shortly after administration that she had cold sweaty palms and felt a little lightheaded. She was placed in a wheelchair and taken to a private observation tent to be further assessed. Initially in the tent she was not showing alarming signs of anaphylaxis and appeared stable. She had clear lung sounds and her oxygen level was 99% with no respiratory distress or airway compromise. At 1405 she felt her lips and throat get tingly and slightly bigger, although upon assessment they did not appear swollen. She was fasting and refused to swallow water or Benadryl when offered. She was able to swallow her spit with no issues. We explained to her that we are going to keep monitoring her, but if things change at all we are going to have to call 911 and administer epinephrine. She kept saying she is fine and that she did not want it and that her boyfriend would take her home. Currently her VS were BP 94/70, HR 72, O2 99%, RR 22. She was rubbing her back and her lungs were clear. At 1410 her bp was 90/62, HR 74, o2 98% and RR 24. Again, she was rubbing her back. Her lungs sounded clear. At 1415 her BP was 84/60, HR 80, O2 93%, and RR rate of 30. She had small expiratory wheezes when listening to her breath sounds. She appeared to be in respiratory distress as she was coughing and rubbing her chest. She stated her chest felt back, neck, and chest felt tight. She still stated she was fine, and she did not have insurance. She was informed that this was a life-threatening emergency At this time 911 was called as it was determined she was having an anaphylactic reaction needing epinephrine. Her Emergency contact was notified as he was on the phone with her. At 1417 0.3 mg of epinephrine was administered into the left deltoid, which is where I was informed, she had received the vaccine. At 1420 her VS read 118/74, HR 122, O2 99%. Her respiratory distress appeared to be improving, and her VS improving. She stated she felt better, and she wanted to go home, but per policy she was taken to EMS in a wheelchair. She was handed off to EMS around 225 and verbal report was given. She was transferred to her emergency contact was present for transfer and filled in of the events.

Swelling of lymph nodes ~20mins after, benadryl Anaphylaxis ~20mins after, benadryl Migraines, ~24 hours after Fatigue, ~20 hours after Body aches, ~20 hours after

Miscarriage less than a week after the second vaccine with Moderna. Estimated due date 01/07/2022, started with extreme dizziness and ended with Contraction like cramps and bleeding. History of very healthy full term pregnancies.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: dizziness-Medium, Additional Details: patient was taken to the er after receiving the epipen. She was monitored for a couple of hours and released. I spoke with husband, when they were home, and was informed that she was feeling well.

No blood clot but testing shows signs of blood clot; Unable to eat; Chest pains; Red spots; Muscles feel like needles; She has not taken second dose; Fainted; hand turned red; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (No blood clot but testing shows signs of blood clot) and SYNCOPE (Fainted) in a 26-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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), ERYTHEMA (hand turned red) and PALPITATIONS (Palpitations). On an unknown date, the patient experienced THROMBOSIS (No blood clot but testing shows signs of blood clot) (seriousness criterion medically significant), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose). At the time of the report, THROMBOSIS (No blood clot but testing shows signs of blood clot), SYNCOPE (Fainted), ERYTHEMA (hand turned red), PALPITATIONS (Palpitations), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coagulation test: signs of blood clot (abnormal) signs of blood clot. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that within 3 minutes of receiving dose, patient's hand turned red and she fainted. Patient was brought to the hospital and was released a couple hours later when palpitations stopped. No medication given to treat symptoms. The patient was receiving unspecified acid reflux medication. Company comment Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.

Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: The pt bled after injection and I wiped it with a paper towel and alcohol swab. after the 15min waiting period she had a pea sized hard bump at injection site and pink/red slightly swollen area a little bigger than a quarter around it.

Got the modern a shot in my left arm, with in 10 minutes, I began to feel like I was gonna pass out, I ended up passing out after sitting down for 45 minutes. The pharmacy called 911 ems came and checked out my vitals. They were normal by then. Then when I got home I began to bleed vaginally. I was in the middle of ovulating. ( not normal for me to bleed then) And now I am late for my normal period.

Approx 4AM 6/19/21 is when I noticed I was experiencing vaginal bleeding beyond what I had ever experienced before. I was not due for a menstrual cycle. Between 4AM and 10AM I went through 3 overnight sanitary pads. Over the course of the rest of the day I went through 8 regular pads, soaking them through with blood. I contemplated going to the ER. The blood was excessive and bright red, freely flowing and passing clots larger than a dollar coin. The bleeding finally slowed around 36hr after it began. I used ibuprofen beginning the evening of 6/19/21 to help stop the bleeding. The bleeding finally stopped entirely the evening of 6/21/21. The most unique part is that there was little to no pain, even before I began to take the ibuprofen.

I am at my peak ovulation day today (28), have had a regular period since age 10, with no bleeding during ovulation from any point in time. I woke up at 6:48am with a hardened uterus and went to the bathroom at 7:00am. I saw that I had light bleeding within my underwear, which had just started.

After the 2nd dose vaccine, I had nausea, vomiting and diarrhea. A few days later, I developed a rash on both my arms. The rash looked like little raised bumps and was itchy. I applied some Benadryl cream on it and it hasn't improved. About a week after my vaccination, I had flu like symptoms- shortness of breath, cough, low grade fever, body aches and joint pain. I went to the ER (Hospital) and was given oxygen, breathing treatments and was diagnosed with pneumonia. I was given a prescription of Z-pak azithromycin and discharged to follow up with my PCP.

Patient was diagnosed with Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Patient was diagnosed with Blood clots) in a 26-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 an unknown date, the patient experienced THROMBOSIS (Patient was diagnosed with Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Patient was diagnosed with Blood clots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product information was provided. No treatment information was provided. The reporter called on 19-Jul-2021 to report that his 26-year-old daughter received her first dose of the Moderna COVID-19 vaccine (no date or lot number was provided). The patient was later diagnosed with blood clots. The reporter did not provide any additional information. 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.

Vaccine was administered around 5 PM on 1/14/2021. Chest pain started around 9 PM the same day and continued, also had some shortness of breath. Headed to emergency room around 4 AM on 1/15/2021. Several tests were done, found general systemic inflammation. Chest pain caused by inflammation in lungs and airways. Treated with ibuprofen and chest pain cleared in about 40 minutes. Discharged at 1/15/2021 around 7 AM.

Pulmonary Embolism 27 year old female presented to ED with chest pain and shortness of breath that began within 24 hours of receiving second Covid vaccine injection on 1/29/21. Chest pain subsided with Tylenol and time, but shortness of breath persisted, worsening on 2/8/21 which brought patient to ED. CTA confirmed PE diagnosis and treated with out patient oral therapy - Xarelto.

Patient began feeling nauseous about 30 minutes after vaccine, then dizzy. A few minutes later she appeared to faint and became unresponsive. She did not appear to be breathing and looked cyanotic. Epipen was administered and patient began responding a few moments later. EMS arrived and was taken to the emergency room. Patient reported feeling fine and was back at home around 7 pm.

1/8 vaccination HA went away after a week bleeding in between vaccinations ultra sounds weekly, blood work 1st went to ER, 2nd bleeding episode went to PCM for same day visit 2/2 miscarriage, D&C

I got the Covid vaccine on 2/13/21, I lost a small clot and started to bleed on 2/19/21. I was due around Oct 4th, at the time of the vaccine I was 6 weeks pregnant. I miscarried at home on 2/25/21- I lost a very large clot and was bleeding heavily for a week. Doctor confirmed with HCG test that I miscarried. This was my second pregnancy, I had my first child 1/10/20.

I got a blood clot in my left leg, as well as numerous blood clots in both my lungs. I have never had a blood clot before, and my family does not have a history of them.

mild anaphylactic shock; Tachycardia; deep Flush; Missed dose; A spontaneous report was received from a nurse concerning a female patient of 27 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced tachycardia,deep flush and anaphylactic reaction. The patients medical history was not provided.No relevant Concomitant medications were reported. On 09 jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A ) vaccine for prophylaxis of COVID-19 infection. On an unknown date,patient experienced mild anaphylactic shock to vaccine and developed tachycardia and deep flush. No Treatment information for the event was provided. At the time of the report it as 42 days since the first dose, and patient has not received the second dose. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event tachycardia,deep flush and anaphylactic reaction was not provided.; 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.

Patient appeared warm and RN asked her to consider taking her jacket off. Patient suddenly fell forward and appeared unresponsive; two nurses eased pt down to the floor. Within a few seconds, pt began having tonic clonic seizure and promptly turned onto her right side. EMS, came to pt's side. First seizure lasting 56 seconds; IV access to right AC secured. 2 min postictal/rest followed by 15 second seizure and 5 mg Versed infused to right AC access. Roughly a 60 second postictal/rest followed by 15 second seizure; more paramedics at site at this point. During this time, very little oral secretions, lungs clear, pulse 102; unable to obtain BP. 10 sec seizure began with postictal/rest. Pt remained on right side approx 2 minutes followed by an 8 second seizure. Paramedic directed another 2.5 mg versed. Within approx 60 seconds pt had sixth seizure lasting 31 seconds. Pt placed on stretcher and transferred to care of EMS.

-Hard raised red lump at the injection site that became present a week following injection -Early menstruation cycle: The previous bleeding part of the cycle concluded 03/07/2021. Patient began experiencing PMS symptoms around 03/23/2021, and bleeding began again 03/26/2021. Patient's period is almost always regular. Patient's periods typically last between 2-3 days, but at the time of this report has been going on for 4 days now.

Right lower lobe Pulmonary Embolism diagnosed in the ER after presenting with severe right sided flank pain and shortness of breath,

Anaphylaxis approx. 5 minutes after injection, recieved Epi Pen injection, Benadryl injecton, rescue inhaler used, symptoms resolved after 5-10 minutes

My menstrual cycle came on 5 days early but when it came on I had large blood clots. I?ve never had my cycle come on early. I take birth control tablets the correct way and the Saturday when I started bleed, I had taken my tablet at my regular time that day. I also usually don?t have heavy periods at all so the amount of blood so early was unusual for me.

Anaphylaxis (nausea, dizziness, lost vision, muffled hearing, difficulty breathing, swollen-feeling throat, blue under fingernails). Nausea began < 5 min after vaccine; everything else began within 10 min of vaccination. Was treated with epinephrine, water, and Benadryl. Most symptoms subsided within a minutes. Breathing ease returned to normal within 5-10(?) minutes. Was only monitored for 30 min or so after epinephrine. No EMS called; was not advised to go to hospital.

4.21.2021- I spoke with (patient's husband) related to spouse. Husband stated the patient has a history of 2nd Degree Type 2 heart block, pacemaker placed at the age of 14, and she currently has issues with an eating disorder dx with anorexia. Patient is reported to be approximately 68-70 pounds at the time of vaccination. March 8.2021- Husband states he and his wife came to receive the vaccine around 1630. After, receiving the vaccine the patient stated to her Husband "my arm really hurts." She begin experiencing s/s at approximately 1900 including: fever, chills, runny nose, fatigued and tired - reportedly temperature was 100.0 and the patient began to drink Gatorade and take Tylenol. Monday, 3.15.2021 patient continued to have symptoms therefore, (husband) contacted Moderna Representatives from the safety team, to determine if it would be safe for the patient to get the 2nd vaccine dose - advised everyone that does not have contraindications should be vaccinated-advised to reach out to PCP. Husband stated that the patient did not want to go to her PCP because of her eating disorder. The patient worked from bed during the week per the husband and spent 90-95% of her time in the bed after receiving the vaccine. Husband states on Saturday 3.20.2021 the patients fever had subsided however, she continued to feel poorly and remained bedbound most of the time. Husband is an Pilot 3.23.2021 stated once, he had landed he began trying to contact wife but she was not answering the phone, after several attempts to contact wife - Husband called a neighbor to check on wife. Upon, entering the residence the neighbor found wife lying on the floor unconscious and not breathing. The neighbor notified Husband and called 911. EMS arrived at the scene and pronounced the patient as a DOA. Husband states that the death certification list cardiac arrest, electrolyte imbalance, and heart block, as causes for death. Husband is concerned that the vaccine may have contributed in some way demise of his wife as he stated "she was never the same after the vaccination."

Patient had blood work drawn on 2/18 which came back on 2/19 with thrombocytopenia. The platelet count has continued to drop since that date.

Body aches, fever, high blood sugars, diarrhea & extreme nausea-could not eat or drink for 2 days No clotting during menstrual cycle, EXTREMELY heavy and long flow

About 25 minutes after getting vaccine, patient's upper lip was starting to feel tingly. Pharmacist gave patient diphenhydramine 50mg. Patient stated she had an epipen on her. Patient stated she was ok to drive home with the instructions that if any other allergic reactions came on, to use the epipen and call 911. On the way home, patient started experiencing anaphylaxis. She went to a nearby fire department where they called the EMTs. Patient was doing ok the next day when pharmacist spoke to her, but was aware to use Benadryl/epipen if any other reactions came up.

In February I have been having abnormal vaginal bleeding, it was pretty frequent and it would last as long as three weeks of bleeding. Also during this time I had experienced fever, chills and was very fatigue. I sought care from my ob/gyn and she ordered for me to receive a trans vaginal ultra sound to make sure everything was okay, and the results came back everything was fine I was just experiencing abnormal bleeding.

MODERNA COVID-1- VACCINE June 20, 2021 @ 7:00 PM: Sudden onset chest/neck/jaw pain; profuse sweating; tachycardia; dizziness. At the time, I was on a daily regimen of Eliquis 5 mg BID, Amlodipine, Toprol, Lexapro. Evaluated in the Emergency Department at Hospital EKG #1: Abnormal - unsure of the interpretation. Sent for CTA Chest to R/O Aortic dissection. The study was negative. Labs done revealed significantly elevated Troponin and D-dimer. Other lab results are unknown to me. EKG #2: STEMI/Acute MI. Code heart was called in the ER and transferred to the cardiac cath lab where I was diagnosed with 100% blockage of the LAD. DES placed in the LAD. After cardiac cath, I remained in the ICU for several days and was started on Heparin drip, Brilinta, Aspirin, and others. Hypercoagulable workup (done during previous hospitalization 5/29/2021) was suggestive of Antiphospholipid antibody syndrome. Decision made to start on Coumadin. Remained in the hospital for several days until INR therapeutic. Currently on a daily regimen of Coumadin, Brilinta, Lipitor, Toprol. Following closely with hematology and cardiology. Will need to remain on Coumadin indefinitely.

Anaphylaxis reaction; A spontaneous report was received from a nurse concerning her co-worker, a 28 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced anaphylaxis reaction. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 23 Dec 2020, within five minutes of vaccine administration, the patient experienced anaphylaxis reaction. The patient had symptoms of throat tightness, dizziness, nausea, weakness, and increased heart rate. Treatment for the event included an epinephrine pen On 29 Dec 2020, the nurse reported that the patient was still having some of the symptoms, including dizziness, nausea, and weakness. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis reaction, was considered not resolved. The reporter assessed the event, anaphylaxis reaction, as related to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 28 year old female patient, who experienced a serious unexpected event of anaphylactic reaction. The event occurred apparently 5 min after first dose of mRNA-1273 (Lot# unknown) vaccine administration. She was treated with epinephrine pen. 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; Significant angioedema; Severe allergic reaction; A spontaneous report was received from a nurse, who was also a 28-year old, female patient who received Moderna's COVID-19 vaccine and experienced an anaphylactic reaction, a severe allergic reaction, and significant angioedema. The patient's medical history, as provided by the reporter, included Hashimoto's disease and thyroid disease. No relevant concomitant medications were reported. On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced an anaphylactic reaction, significant angioedema and a severe allergic reaction. Treatment for the events included epinephrine, unspecified antihistamines and unspecified intravenous fluids. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was considered not resolved.; Reporter's Comments: This case concerns a 28 year old, female patient with medical history of autoimmune disorders including Hashimotos disease and thyroid disease, who experienced a serious unexpected event of anaphylactic reaction, angioedema and hypersensitivity reaction. The event occurred on an unspecified date after first dose mRNA-1273 ((Lot# 039K20-2A) administration. The subject's concomitant medication was not provided. The event was treated with epinephrine, iv fluids and anti-histamines. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Anaphylaxis. Epi Pen given and ambulance called. Given anaphylaxis cocktail in ER. 2:30pm: Vaccine administered 3:30pm: Headache & teeth ache which continued 7:00pm asthmatic cough which continued throughout 11:00pm fever and chills 9:00am felt generally very ill--stomach pain (more anaphylactic type pain) 10:00am nausea, severe stomach pain, diarreaha, vomiting, lungs very tight, continued coughing 11:00am excruciating stomach pain (stomach on fire) Throat felt "thick", feeling faint, brain fog, dizzy (These are my typical anaphylactic reactions) Epi pen administered & ambulance called Anaphylaxis symptoms returned in ER. The pain was the worst since my bowel obstructions several years ago.

Anaphylactic reaction; A spontaneous report was received from a consumer concerning a 28 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed anaphylactic reaction. The patient's medical history and concomitant medications were not provided. On an unknown date, approximately three weeks prior to the onset of the event, the patient received her first of two doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient developed an anaphylactic reaction. Treatment information was not provided. The patient wanted to know if the Moderna vaccine contains shellfish and shark ingredients. Action taken with mRNA-1273 in response to the event 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 onset of the event, a causal relationship cannot be excluded.

Stroke (blood clot in vein in left side of brain), occurred Wednesday March 17 at 5:15 pm. Immediately admitted to emergency room/stroke unit and given blood thinner IV and anti-seizure medicine

Died January 21 after she received an mRNA shot; A spontaneous report was received from a consumer via social media concerning a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died two days later (death). The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, per social media post, the patient received one of their two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient was dead on 21 Jan 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was done. The reporter stated that the autopsy showed no other red flags, otherwise, no additional autopsy results were reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

Likely nocturnal seizure. Woke up and noticed a bitten and bleeding lip and bitten tongue and some confusion and brain fog, and sore muscles.

As reported by the patient's mother, the patient received the vaccine on 1/19/21, "got sick" on 1/20/21, and died in the early morning hours of 1/21/21. No further information was offered.

Anaphylactic reactions; Within 5 minutes could not breath; Heart was racing; A spontaneous report was received from a consumer concerning a 28-yearsold female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced within five minutes could not breath/ dyspnea, heart was racing/ palpitations, and anaphylactic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, five minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 16M20A0) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced within 5 minutes could not breathe, heart was racing, and anaphylactic reaction. The patient was seen in the emergency room for treatment. The event anaphylactic reactions was considered as Medically significant. Treatment for the event included oxygen, prednisone, cetirizine hydrochloride, diphenhydramine and two doses of epinephrine. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, could not breathe and heart racing, was resolved on 13 Feb 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Received Moderna COVID vaccine on 2/26/2021 and 3/26/2021. After initial dose she was fatigued. had also taken Plan B 3/1/2021. Fatigue lasted 1 month. 5-6 days after second dose she developed shortness of breath and chest pain. and 9-10 days lateraled noticed a prominent vein in the leg. Called physician office 4/8/2021 and sent to urgent care then ER, found to have superficial thrombosis in leg and multiple bilateral segmental and subsegmental pulmonary emboli.

Patient complained of dizziness, shakiness, and a tight chest. Vitals taken over several minutes and patient eventually complains of nausea. EMS is called at 3:57 pm. Complaints of chest pain 9/10. 4:03 pm EMS arrives and Epi pen administered (0.3 mg). Patient complains of itchy lips and eyes appear swollen. Transferred by ambulance to Hospital.

Pt received COVID 19 (Moderna) vaccine series on Dose 1: 3/18/21 & dose 2: 4/16/21. Pt is currently 8 weeks pregnant with expected delivery date of Nov 24, 2021. Pulmonary embolism diagnosed 4/20/21 treated with enoxaparin.

I was 19 weeks pregnant at the start of my 2nd dose. My due date is September 8, 2021. The morning after getting the shot I began to have vaginal bleeding. I went to my OBGYN to have the baby checked. I was referred to a specialist for a level 2 ultrasound. Everything was found to be normal with the baby. The cause of the bleeding is still unknown by the timing aligns perfectly with my vaccine. The bleeding increased and has now began to slow.

The day following the Moderna injection with severe headache and sensitivity to light which lasted for 3 days. then followed by low level confusion and forgetfulness, loosing words during conversation until 2/23/2021 when had grand mal seizure. I have a history of epilepsy since 13 yrs old and had been seizure free for 8+ years until 2/23/2021. Since that seizure with continued forgetfulness , foggy feeling in head, and eye fluttering. Seen by epilepsy specialist on 4/12 and was admitted to hospital for video EEG and MRI and found to have significant both focal and generalized seizure activity despite my usual anti-seizure medications that had been working for 14 years. My medications were changed and I was discharge home after 6 days.

1 day of moderate flow irregular vaginal bleeding 1 week before expected period, then exceptionally heavy and crampy period 7 days later

I've been vaginally bleeding for 2 weeks. Bleeding began hours after the vaccination and has not stopped since.

Patient developed extensive acute bilateral pulmonary emboli, R leg DVT, large LV thrombus, acute heart failure, hypertensive emergency with symptom onset 8 days after immunization. She presented to hospital 22 days after immunization for progressive sypmtoms including shortness of breath.

Patient got vaccinated at about 6-7 weeks gestation and 2-3 hours after vaccine had a napkin full of blood come out of her and then has been spotting since. Came in for appt 4/27 and was still spotting. Ultimately hcg levels kept increasing and as of 5/11 baby has HR 150 and is doing well.

Adverse Events: I went to the emergency room on 5/18 after experiencing major back pain, sharp pain in ribs, chest pains, difficulty breathing, shortness of breath and chronic coughing. Outcome: After x-rays, EKG, D-Dimer Test and a CT scan the doctor determined that I have Pulmonary Embolism (blood clots in my lungs). I've never had any symptoms prior to receiving the covid vaccine. Today is 5/24 and I am still experiencing most of the same symptoms despite taking my medications as prescribed. The worst symptoms are difficulty breathing and chronic coughing. Treatment: -No longer taking birth control (Azurette) since that can cause blood cots -Xarelto (to treat and prevent blood clots) -Gabapentin 100MG 3x Day (for pain) -Benzonatate 200MG 3x Day (for cough) -Tizanidine 2MG 1X day (for pain) -Albuterol Inhaler Every 4 hours

slight delirium; racing heart; tachycardia at 120 bpm; not hungry but very thirsty; not hungry but very thirsty; lot of trouble sleeping; low grade fever; EKG at home and she was catching Afib; tinnitus - ears ringing; could'nt talk; could'nt move; TIA with eyes fluttering; TIA with eyes fluttering, couldn't talk or move; chest pain; shortness of breath; extreme hypertension 200/115; forgot name for about 15 minutes; sterile diarrhea; lost 20 pounds; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (EKG at home and she was catching Afib), DELIRIUM (slight delirium) and TRANSIENT ISCHAEMIC ATTACK (TIA with eyes fluttering, couldn't talk or move) in a 28-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 COVID-19 (For about a month.) in March 2020. Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (COPPER IUD) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds). On 09-Apr-2021, the patient experienced DIARRHOEA (sterile diarrhea). On 10-Apr-2021, the patient experienced MEMORY IMPAIRMENT (forgot name for about 15 minutes). On 18-Apr-2021, the patient experienced CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and HYPERTENSION (extreme hypertension 200/115). On 19-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA with eyes fluttering, couldn't talk or move) (seriousness criterion medically significant), BLEPHAROSPASM (TIA with eyes fluttering), SPEECH DISORDER (could'nt talk) and HYPOKINESIA (could'nt move). On 20-Apr-2021, the patient experienced TINNITUS (tinnitus - ears ringing). On 27-Apr-2021, the patient experienced ATRIAL FIBRILLATION (EKG at home and she was catching Afib) (seriousness criterion medically significant). On an unknown date, the patient experienced DELIRIUM (slight delirium) (seriousness criterion medically significant), PALPITATIONS (racing heart), TACHYCARDIA (tachycardia at 120 bpm), DECREASED APPETITE (not hungry but very thirsty), THIRST (not hungry but very thirsty), INSOMNIA (lot of trouble sleeping) and PYREXIA (low grade fever). On 10-Apr-2021, MEMORY IMPAIRMENT (forgot name for about 15 minutes) had resolved. On 05-May-2021, PYREXIA (low grade fever) had resolved. At the time of the report, ATRIAL FIBRILLATION (EKG at home and she was catching Afib), DELIRIUM (slight delirium), TRANSIENT ISCHAEMIC ATTACK (TIA with eyes fluttering, couldn't talk or move), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), HYPERTENSION (extreme hypertension 200/115), BLEPHAROSPASM (TIA with eyes fluttering), PALPITATIONS (racing heart), TACHYCARDIA (tachycardia at 120 bpm), WEIGHT DECREASED (lost 20 pounds), DECREASED APPETITE (not hungry but very thirsty), THIRST (not hungry but very thirsty), TINNITUS (tinnitus - ears ringing), DIARRHOEA (sterile diarrhea), INSOMNIA (lot of trouble sleeping), SPEECH DISORDER (could'nt talk) and HYPOKINESIA (could'nt move) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Dehydroepiandrosterone test: increased (High) Elevated. On 18-Apr-2021, Blood pressure measurement: 200/115 (High) Extreme hypertension. On 18-Apr-2021, Urine analysis: increased (High) High leukocytes in urine. On 18-Apr-2021, White blood cell count: increased (High) Elevated.. On 19-Apr-2021, Body temperature: increased (High) Low grade fever. On 19-Apr-2021, Heart rate: 120 (High) 120 beats per minute. On 20-Apr-2021, Neutrophil count: increased (High) high. On 27-Apr-2021, Electrocardiogram: atrial fibrillation catching atrial fibrillation. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 09-Apr-2021, the patient reported that she consulted her primary care, followed by an OBGYN consult on On 13-Apr-2021, and unspecified blood work was done. The patient reported that she visited the ER (emergency room) on 18-Apr-2021, 19-Apr-2021 and 20-Apr-2021 with a follow-up visit with her primary care on 19-Apr-2021. The patient also reported that she started consulting her primary care physician since March 2020, for abnormal weight gain and blood tests were done for thyroid levels. It was reported that this whole period the patient lost 20 pounds. The Treatment medications included Tylenol (acetaminophen), hydroxyzine and propranolol. The patient reported that she had taken buspirone and quetiapine for insomnia, but stopped the medications on an unspecified date. On an unspecified date, Ativan (lorazepam) was discontinued. Company Comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded. Fever is consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded. Fever is consistent with the product known safety profile.

Fever, nausea, vomiting for 48 hours after, and an anaphylactic event two weeks after. Continued hives and allergic reactions ever since.

Participant was 5 weeks pregnant when she got the shot due date would have been December 9, 2021. April 17th around five o clock started to experience strange feeling so she just continued to rest, said she was spotting heavy and participant got an ultrasound 2 days later and later on during the day said she heavy bleeding still. On April the 22nd the doctor told her she had a miscarriage.

Bleeding from the vagina during and after intercourse. Intercourse and after was painless, I felt no discomfort at all but experienced large amount of bright red blood. I am not on my period and should not be for another few weeks. I have experienced bleeding after sex but never to this extreme.

Patient received first Moderna dose on June 8, 2021 and second dose on July 6, 2021. Patient started having flu-like symptoms such as, Fever (but doesn't know what temperature as she did not measure but she felt hot) and chills. After 1-2 days of flu-like symptoms she began to have painfulness around the left arm where she received both of her Moderna vaccines. This painfulness started 3-4 days after receiving the 2nd dose of Moderna vaccine. Patient was also having symptoms of pinching, aches, cramps on left arm along with light-headedness and dizziness. Patient visited the Emergency Department on July 12, 202 and confirmed by the Doctor that there is a blood clot on the left arm. The doctor at the Emergency Department wanted patient to reach out to the pharmacy and report the incident. Patient is currently prescribed for a blood thinner and will follow up with doctors tomorrow 07/15/2021 and another doctor in a week. Patient has allergies to Tree nuts and citrus seeds and was on a birth control Estarylla 0.25-0.035mg tablets until the day she found out that she has a blood clot (07/12/2021).

Following each vaccine, I felt fatigue, headaches, and body aches. I never had fever with either of the two vaccines. Potentially unrelated, on June 1, 2021, I was diagnosed with a deep vein thrombosis in the posterior tibial vein in my left leg. I have since seen a hematologist, and I am on anticoagulant therapy until a reassessment in September.

0820 Covid Vaccination given 0842 Pt honks horn in in distress 0843 Pt is extricated from her vehicle 0843 Medical Provider called 0844 Pt noted to have four separate tonic-clonic events without incontinence, oral injury or post ictal period 0854 ambulance arrives 0859 pt loaded into ambulance 0907 ambulance left for ER, the patient has a H/O of such events and did mention she was taken off anti-convuls. medications and had a possible diagnosis of pseudo-seizures. -

Anaphylaxis treated at Tufts Medical Center -Full body hives on 1/21- treated w Benadryl, Claritin, Famotidine -1/22 woke up with lip swelling, throat itching, lip tingling- came to ER on this date for evaluation, given epinephrine IM, Benadryl IV, fluids IV, prednisone PO

Symptoms reported: headache grand mal seizure. Was transferred to ER on 2/10/21. Per staff report ? I was sitting on the couch, and my partner noticed I have having a seizure, he lowered to me to the ground and called the ambulance. My seizure lasted for 1 minute. When I was in the ER, they gave me 2 bags of fluids, they did an X-ray, CT scan, blood work, and UA, they reported to me that all the result were normal. They did not send me home with any medications. However, they did not clear me to drive. They said that I need to get cleared by a neurologist before I can drive, so that?s why I have not been back to work?

I had just finished my cycle the day before. I woke up Mon morning to thick, clotted blood. I contacted my provider and I was instructed to take a pregnancy test, which was positive. I went in for an exam on the 12th and they confirmed that I was indeed pregnant. They tested my Beta Hcg twice. I didn't get my results immediately due to one site being closed due to COVID. I could've gone to the hospital and received the results immediately, but my doctor didn't want to take the chance due to the hospital having a lot of COVID. They confirmed that I was pregnant on the 19th or 20th. I bled for a few days after that. The final Beta Hcg was done and my level was 0.

Anaphylaxis 30 minutes after injection. Lasted 2 minutes. Came back 20 minutes later for 1 minute. Went away on it?s own both times. Currently pregnant, due November 10.

Mild cramping; spotting; and it started about 04:00 on Sunday. I called my physicians' office on Monday am and was seen on Monday afternoon. Symptoms continued until about Friday. And then they stopped. No treatment was needed. Pregnancy history: 3rd pregnancy - for first pregnancy was full term; and second pregnancy ended in miscarriage; October 4, 2021.

I was having intense chest pain, weakness/faintness feeling a few days after second dose of Moderna vaccine. I went into the ER after 4th day of pain. ER did a CT scan and found a couple blood clots in my right lung (pulmonary embolisms) along with tissue on lung. An ultrasound of my heart and legs were done to find the source of these blood clots and neither tests found blood clots or indicators that this is where they originated. I am currently in blood thinners in order to reduce the clots.

Patient received vaccine in left deltoid at 1000. Around 1015 patient notified pharmacist that she was having a hard time swallowing and felt slightly light headed. Pharmacist provided a chair to help elevate the patient's legs and provided patient with water. After 2 minutes pharmacist double check with patient and patient said she didn't feel worse but still felt like she was having a hard time swallowing, but did not complain of any shortness of breath. The pharmacist then called the medical team and after further assessment, the medical team transferred the patient to the Emergency Room for further review. Patient was treated in the ER for anaphylactic reaction and discharged.

Admitted 4/13/21at 39 weeks for planned primary low transverse Cesarean Section due to velamentous cord insertion. CS was uncomplicated. APGAARs 8 and 9, weight 6lbs, 10oz. On 4/14/21 patient got up to take a shower. After her shower she felt like her left leg felt ?tight? and was more red in appearance. She denied pain. She reports that leg got more swollen at one point in pregnancy as well. OBMD in to assess patient. Vascular US ordered and revealed extensive DVT from calf to groin on the left. Patient received her 2nd dose of Moderna 4/6/21.

Patient developed a cerebral venous sinus thrombosis diagnosed on 3/27/21 after receiving the moderna covid vaccine on 3/8/21

Pt called nurse triage stating that at approx. 1PM the day after her dose, she developed hives on her right breast, leg, and thigh that was very itchy. She also reported her face and ears feeling hot and flushed and that she felt hoarse and like she had phlegm in her throat and needed to keep clearing her throat. Pt went to ED and was diagnosed with anaphylaxis, was given benadryl, pepcid, methylprednisolone, and epinephrine. Pt was discharged from the ED upon resolution of symptoms and was instructed to follow-up with allergy.

A FEW MINUTES AFTER ADMIN, PATIENT STARTED FEELING BAD AND PASSED OUT 3 TIMES. I GAVE HER WATER WHICH SEEMED TO HELP BETWEEEN EACH EPISODE. HER EYES SEEMED TO ROLL BACK AND SHE TWICHED SLIGHTLY BUT CAME BACK. HER ARM DID BLEED A LITTLE SO I CLEANED AND PLACED ANOTHER BANDAGE ON HER ARM. PATIENT WAS FEELING BETTER AND SHE WENT HOME WITH HER SIGNIFICANT OTHER.

I got sick to my stomach almost instantaneously, I lost my taste for 3 days, I had fever and body aches for 3 days, my period became completely extreme I had blood clots which is not ordinary for me and it lasted an extra 4 days, my ears were pluged as well as not being able to move my arm for 3 days really at all, my throat was also sore and I had glands swell up

I have had an extremely heavy period for almost 6 weeks now. It has gotten worse this week with blood clots and bleeding through a tampon within 2 hours. I have severe cramps today. All things that are very unusual. My periods sometimes do not come at all and I never experience cramping due to birth control.

On 5/19/2021 patient woke up around 11 pm with a sharp pain in her upper abdomen, then had emesis and the pain subsided and she went back to bed. On 5/20/2021 at approximately 7:30 pm patient started bleeding vaginally. She called the on call doctor and an ultrasound and office visit was advised for the next day. On 5/21/21, patient presented in office for Ultrasound and office visit. The Ultrasound finding were diagnosed for a missed AB (miscarriage)/fetal death in utero. Patient's due date was 11/4/2021. This was her second pregnancy, with the first being a Missed AB (miscarriage) in 7/2020. Due to CRL and failed on Miso prior, patient scheduled for D&C 5/27/21

06/02/21 - Moderna vaccine administered at 3:30pm. Waited 15 mins at the HD without any reported side effects. When driving home, client states she felt dizzy. Developed fatigue around 5pm. At 8pm went to have a bowel movement and large amounts of red blood with small clots passed from rectum. Client states she had to flush 3 times d/ t the amount of blood. No stool passed. No other episodes reported. Client does state that around 2-3 am she was up to use the restroom and noted small amount of dried blood spots in her undergarment. Client states that she does have a h/o hemorrhoids since the birth of her baby but states this "definitely" was not related. Client reported feeling hot during the night with mild abdominal cramping but states she is to start her menstrual cycle soon. PHN questioned if she felt this was her menstrual cycle and client clearly states the blood was coming from her rectum. No further episodes of passing blood reported and states that she is feeling better today. Client states that she does not have a h/o of blood in stool except on occasion scant amounts from hemorrhoids. PHN encouraged client to report this finding to her PCP as well and that the PHN was going to report this to VAERS. No other s/s of bleeding reported to the PHN.

I went to the hospital due to shortness of breath and extreme pressure and pain in my chest, specifically surrounding my heart, diaphram, and radiating up to my collar bones and shoulders. After blood work and EKG, they found that my EKG was irregular and I had an elevated D-DIMER blood result at 1600. I was taken for a CAT scan of my upper abdomen and they found that I had a large (650ml) pericardial effusion causing cardiac tampenade. I underwent a procedure that inserted a needle into my pericardium, sucked out the fluid, and inserted a drain tube for 48 hours to drain excess fluid. Upon additional testing, it was determined that I had none of the usual causes for a pericardial effusion (no heart attack or trauma, no infection either viral or bacterial, no cancer, no autoimmune conditions.) My inflammation markers were extremely elevated and my lymph nodes in CAT scan were swollen. As a result, I now have constrictive pericarditis, scar like tissue surrounding my heart constricting its function.

cardiac tamponade, pericarditis, elevated pulse, pneumonia, aspiration. Began March 27th, has been hospitalized since then, discharged 3 times but never home more than 1 week

On the day of vaccine administration, I had severe body aches and my bones were hurting. I was very lethargic and blood pressure was continuing to drop. I drank about 3 bottles of energy drink to bring the blood pressure back up. I also had severe arm pain; the pain was so intense I could not lay on my left side for 3 nights. Miscarriage 4 weeks after receiving second dose of Moderna Covid-19 Vaccine. HcG beta and progesterone blood tests completed 48 hours apart to classify this as a miscarriage. Patient is having heavy vaginal bleeding and is feeling very lethargic.

A week before I was scheduled to have my 2nd dose, my symptoms included body chills, body aches and sweating. Found out I had high BP when I went to urgent care which they sent me to the ER, was taking different medications, did a CT scan and found fluid my heart which ended up with me getting admitted in June and got diagnosed with heart failure.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe

"history of multiple allergic type reactions in the past is presenting for itching and the feeling of hoarse voice after receiving the first Covid vaccine. Here, she is slightly tachycardic, but her oxygen level is good, her lungs are clear. She has no urticaria, she has no stridor or wheezing. She does not wish to receive epinephrine because she has had such bad effects from it in the past, and is agreeable to Solu-Medrol and Benadryl. She took Pepcid prior to having her injection. Her friend who is with her recommends that she has a history of severe events like this in the past, and she usually does better after breathing treatment. However, patient states that she often ends up on BIPAP" PER ED MD NOTE

Pt is G1P0. EDD was 8/15 by LMP. The patient had an ultrasound on 1/6 showing a live intrauterine pregnancy with crown rump length measuring 8 weeks 0 days. She had covid vaccine 1/7. Came in with vaginal bleeding 1/29 and found to have missed abortion on ultrasound (no heart tones, crown rump length measuring 8 weeks 3 days). Underwent D&C 2/1.

After receiving the first dose, experienced severe arm pain, shoulder pain, and hand numbness. Acute pain and numbness has worn off, but there is still moderate pain when using the arm. About a week post-dose, began spotting. Was not due to have menstrual period for 2-3 weeks according to birth control pill pack, and normally does not have any menstrual symptoms (no period) at all. Bleeding has increased daily, and is now fairly heavy. Accompanied by cramps.

vaginal spotting 3 days after injection, injection site delayed hypersensitivity reaction/RASH 8 days after injection

Pregnancy occurred within the 8 days following the vaccine. Pregnancy confirmed with positive urine pregnancy test on 03/01/2021. Some vaginal bleeding began 03/12/2021 but resolved quickly. Abdominal cramping and bleeding on 03/15/2021 and 03/16/2021. Blood work completed on 03/15/2021 and 03/17/2021 showed a decrease in pregnancy hormone and pregnancy was considered miscarried.

Dilated cardiomyopathy- patient with CHF symptoms starting on 3/12 and noted to have dilated cardiomyopathy with EF <20% on TTE on 3/26.

severe allergic reaction/anaphylaxis; hallucinations; accidentally given a 3 ml dose of the Moderna Covid-19 vaccine instead of 0.5 ml; nightly terrors; fear of dying; intermittent delusions that children were taken away; intermittent delusions that the vaccine was inside her and crawling through her skin; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of HALLUCINATION (hallucinations) and ANAPHYLACTIC REACTION (severe allergic reaction/anaphylaxis) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history was not provided). On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 3 milliliter. In March 2021, the patient experienced SLEEP TERROR (nightly terrors), FEAR OF DEATH (fear of dying), DELUSION (intermittent delusions that children were taken away) and FORMICATION (intermittent delusions that the vaccine was inside her and crawling through her skin). On 17-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (severe allergic reaction/anaphylaxis) (seriousness criterion hospitalization) and ACCIDENTAL OVERDOSE (accidentally given a 3 ml dose of the Moderna Covid-19 vaccine instead of 0.5 ml). On 24-Mar-2021, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant). The patient was hospitalized from 17-Mar-2021 to 18-Mar-2021 due to ANAPHYLACTIC REACTION. In March 2021, ANAPHYLACTIC REACTION (severe allergic reaction/anaphylaxis) had resolved. On 17-Mar-2021, ACCIDENTAL OVERDOSE (accidentally given a 3 ml dose of the Moderna Covid-19 vaccine instead of 0.5 ml) had resolved. At the time of the report, HALLUCINATION (hallucinations), SLEEP TERROR (nightly terrors), FEAR OF DEATH (fear of dying), DELUSION (intermittent delusions that children were taken away) and FORMICATION (intermittent delusions that the vaccine was inside her and crawling through her skin) 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 did not have any psychological history; this was the first time she experienced hallucinations. Treatment for the severe allergic reaction/anaphylaxis included intravenous steroids and hydrocortisone. Treatment for hallucinations included droperidol and lorazepam. Based on the current available information and temporal association between the use of the product and the start date of the event (anaphylactic reaction), a causal relationship cannot be excluded. Very limited information regarding the events (Hallucination, anaphylactic reaction, sleep terror, fear of death, delusion, and formication) has been provided at this time. This report refers to a case of (accidental overdose) for mRNA-1273, lot # 031A21A. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Significant Follow up appended; 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 (anaphylactic reaction), a causal relationship cannot be excluded. Very limited information regarding the events (Hallucination, anaphylactic reaction, sleep terror, fear of death, delusion, and formication) has been provided at this time. This report refers to a case of (accidental overdose) for mRNA-1273, lot # 031A21A. Further information has been requested.

Severe headaches began 3/19/21; Urgent Care treated with meds and did CT Scan; sent to ER on 3/25/21. Admitted to hospital. MRI and CT scans done; Lumbar Puncture done--no bacteria; diagnosed as Cerebral Vascular Sinus Thrombosis; treated with Lovonox for 5 days then switched to Pradaxa when released from hospital; given oxycodon, dilaudid, and tylenol for pain. Starting 4/1/21, numbness in right arm down to fingers. Sent to ER again on 4/8/21 as headaches and numbness worsened. MRI and CT done. Clot dissolving but pain continued at 10/10 level. Released and continues on Oxycodon, Tylenol, Elavil, without relief as of today, 4/13/21. Still incapacitated by pain and unable to walk at length, work, or any normal activities.

Idiopathic thrombocytopenic purpura; Itching; Rash on her chest; Cherry angioma; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 05-Apr-2021, the patient experienced HAEMANGIOMA OF SKIN (Cherry angioma). On 06-Apr-2021, the patient experienced PRURITUS (Itching) and RASH (Rash on her chest). On 07-Apr-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura), HAEMANGIOMA OF SKIN (Cherry angioma), PRURITUS (Itching) and RASH (Rash on her chest) 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. Her doctor thinks it an allergic reaction and an early stage ITP (idiopathic thrombocytopenic purpura). No concomitant medication reported by the reporter. No treatment medication reported 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.

blood clot on the left leg; blood clot on the right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot on the right leg) and THROMBOSIS (blood clot on the left leg) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038321A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history reported). On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced THROMBOSIS (blood clot on the right leg) (seriousness criterion medically significant). On 12-Apr-2021, the patient experienced THROMBOSIS (blood clot on the left leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot on the right leg) and THROMBOSIS (blood clot on the left leg) outcome was unknown. Not Provided The patient has not provided with any concomitant medication. No treatment medications are listed. Company Comment Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-043122 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2021-043122:1st dose

About two hours after my second shot, I started feeling tingling in my legs. Within half an hour, the tingling spread to my arms and face and my lips and tongue started to swell and my throat felt like it was closing. I called 911, and they gave me an epipen, shot of steroids, and a shot of benadryl and said I went into anaphylaxis shock. I was released from the hospital Friday night, but on Monday night I had another (milder) allergic reaction and the following day began to have shortness of breath. I went to my doctor's on Tuesday, who prescribed me steroids and histamine blockers. I began taking them but on Wednesday my difficulty breathing increased and it got to the point where I had difficultly swallowing and couldn't eat so I went to the ER again. I have had some sort of rash and hives every day since my second shot, which my doctor says is a continuing allergic reaction from the shot. I am going to see an allergist, but I have no history of allergies or allergic reactions to vaccines.

30yof received 1st dose of moderna covid vaccine on 3/19/21. She complained of headaches thereafter which did not subside for a few weeks. Subsequently diagnosed with ischemic stroke, transferred from Hospital to other Hospital. Patient did expire post-transfer (i do not know the date since the patient was not in our care). It is possible other hospital entered this into VAERS.

10 days after after my last period had ended, I had intense "spotting" (vaginal bleeding, about a tbsp of blood?) along with cramps, to the point where I thought I got my period again. Lasted only a few hours. I've never had this kind of thing happen to before, spotting is extremely abnormal for me.

patient received first dose of moderna covid vaccine in pregnancy at 19 wks gestation. she started to have bleeding 6 days later with subsequent abruption , fetal demise and delivery 2 wks later.

Immediate large welts and hives on arm then appeared on the entire body; confusion reported (and observed by me when she called me that afternoon on the phone) later, throat began to swell and constrict. She has Biphasic delayed protracted anaphylaxis as a result of multi drug allergy syndrome and her symptoms were consistent with that in this case as she has had this kind of on going response to other anaphylaxis events in the past. She had severe joint pain for more than 2 weeks and has ongoing recurrent hives on the injection site that have not completely subsided yet. She developed additional allergic responses and ultimately ended up in the ER after this and was seen by local allergist who advised DO NOT take next shot/vaccination.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination for STEMI.

Died; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) and HEART RATE IRREGULAR (irregular heartbeat) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Died) (seriousness criteria death and medically significant) and HEART RATE IRREGULAR (irregular heartbeat) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HEART RATE IRREGULAR (irregular heartbeat) outcome was unknown. Concomitant medication and treatment information were not reported. Action taken with mRNA-1273 in response to the event was Not Applicable. Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported.; Reported Cause(s) of Death: Died

Heavy menstrual bleeding (menorrhagia), massive clots followed by bleeding, ongoing 11 days. Abnormally high compared to any menstrual cycle in entire life.

On April 15th, the otherwise healthy 30 year old daughter of my cousin passed away in a hospital from a massive stroke and seizures related to encephalitis of unknown cause. She recovered easily from Covid19 back in November of 2020, along with several of her close friends and family members with no lingering effects. On March 30th, she was given a single dose of the Moderna vaccine along with her teaching colleagues at a local high school. She initially complained of mild nausea and vomiting but quickly developed a severe headache prompting her to visit the local ER where she received treatment for a migraine. She returned to the ER at least one more time after no relief from the headache. By April 3rd,Saturday, she no longer recognized her sister nor knew what a mask was for. Her family rushed her again to the same ER and she was subsequently transferred the following day to a Hospital. Due to dangerously high intracranial pressure, she suffered a stroke with paralysis of her left side and a seizure. Multiple lesions were noted on her brain via MRI. A shunt was inserted to relieve the pressure, she was intubated and placed into a deep coma from which she would never awaken. Despite these medical interventions and pharmacological interventions, the pressure did not subside. A craniotomy was performed the following Saturday as a last ditch effort to relieve the unrelenting pressure in her brain. The craniotomy was able to reduce the pressure but it was too late. There was no longer any brain activity and my cousin's daughter was removed from life support after they were able to say their goodbyes. The medical examiner will be examining her brain to attempt to find a cause but that report may take 6 months.

Anaphylaxis (difficulty swallowing, tingling tongue and throat, difficulty breathing, rash, increased heart rate) - transported to ER at Medical Center, treated with IV steroids/antihistamines, sent home with scripts for continued steroids/antihistamines

Per physician H&P notes; Patient states that she received her second Moderna vaccine in March and about 4 days later when she came out of the bathroom she felt her legs felt like Jell-O, she fell down, her patents were calling her but she was unable to respond, she heard them talking to her but she was unable to speak. She remembers EMS coming over to her home and the next thing she recalls that she woke up ICU 4 weeks later and her mother is telling her that she has paraplegia. According to notes for employee; Patient was admitted on March 20, 2021, discharged on April 16, 2021. She was admitted with seizures, DKA, aspiration pneumonia, septic shock, severe hypertriglyceridemia. She got intubated and during her MRI of the brain she had a brief cardiac arrest from 2 minutes. She developed pancreatitis also due to high triglyceride level. She received plasmapheresis for triglycerides above 5000. According to notes patients quadriparesis was worked up at Hospital. No definitive dx was found. She has been on chronic steroids. Continued physician notes; Patient comes with 24 hr hx of N/V, Chills. She has an indwelling Foley. She was discharged from this hospital on May 28, 21, see d/c summary. Patient is an unfortunate patient with paraplegia due to axonal neuropathy since March 2021. Patient does have indwelling Foley catheter and yesterday she started having severe nausea and she has been vomiting at least 5 times since then. She reports chills last night. She was brought to the emergency room where she was found to have abnormal urine suggesting UTI, then later she spiked temperature, 101.6 F. She does have the history of sinus tachycardia, currently her heart rate is 140/min. According to notes from employee; Quadriplegia due to axonal neuropathy. Started on plasmapheresis, 7/7 treatments completed. Received high-dose solu-medrol which transitioned to a taper of steroids 5mg qd; on 05/29 take 5mg qod for 3 doses, last dose on 06/02. On gabapentin 900 mg TID, nortriptyline 50 mg qhs. Has tried Topamax in the past and did note do well with it.

Patient requesting walk-in COVID-19 vaccine. Patient reported history of anaphylaxis to shellfish and iodine products during pre-vaccine screening and was told she would be observed for 30 minutes post vaccine, per protocol. Patient verbalized understanding. Vaccine administered. Patient observed for adverse reactions and verbally asked by nurse how she was feeling. Patient stated she was fine. Approximately 15 minutes after vaccine was administered, patient requested some water, which she was given. Nurse asked how she was feeling. Patient reported "It feels like I have something stuck in my throat." Sensation did not resolve with sips of water, nurse instructed clerk to call 911. Emergency cart was brought next to patient. Nurse drew up Epi. Patient was not in distress and continued to breathe unlabored. Nurse took patient's vital signs: heart beat was strong, steady, and a normal rate. BP was slightly elevated. Nurse uncertain whether clinical picture was consistent with anaphylaxis. Patient continued to breathe unlabored and stated throat felt the same: no better, no worse. Nurse called Clinic Nurse Supervisor by phone. Nurse Supervisor stated ?don?t give Epi unless you have to.? Nurse drew up IM Benadryl. Nurse used flashlight to look into patient?s throat and saw swelling. Nurse quickly explained to patient that this did appear to be mild anaphylaxis and that she did need the medications. Nurse administered Epi and then IM Benadryl, both to L thigh. EMS arrived shortly after and assessed patient. Vitals continued to be stable. Patient was transported to hospital. Nurse called patient today (2 days post event). Patient reports is now doing fine. Patient reports at hospital she developed "itchy rash" on her neck. Patient was given additional dose of Benadryl prior to being discharged.

Headache, visual disturbances, double vision, went to the ED and had MRI showing the cerebral venous clot and I was on a heparin drip for 5 days before transitioning to oral Coumadin; 3 weeks later changed to Eliquis for 6 months

On evening of 6-27-21 patient started with Nausea and Vomiting. Had approx 10 episodes of vomiting. Went to ER in Am on 6-28-21. Fluid noted in lower abdomen. Sepsis.

Post vaccine heavier menstrual periods. 6 months post vaccine absence of menstrual period for 2 months (May and June). Next menstrual period on July 19th with heavy bleeding and passing large blood clots no larger than a golf ball size.

Cerebral venous sinus thrombosis, intraventricular hemorrhage, subarachnoid hemorrhage: Headache beginning 2/1/21; diagnosis via CT 2/6/21

Patient presented to vaccine distribution site complaining of hard,red swollen injection site. Patient had systemic response to first dose of Moderna administered 12/29 (10 days prior). Advised patient to go to primary care or urgent care. Clinic contacted Vaccine distribution site: patient diagnosed with ?delayed allergic reaction?, topical medication and oral medication given.

At approximately 1:50 pm received her vaccination. A few minutes later she exhibited signs of allergic reaction. Pharmacist attended to her, and after some questioning she exhibited signs of Anaphylaxis. At 1:56 an Epipen 0.3 mg/0.3 ml dose was administered and 911 called. At 2:00 we checked her BP and it was 132/78 and pulse 95. A few minutes later, before a second check of BP was done, the EMT took over.

2nd pregnancy, at date of first dose (1/10/2021), 12 weeks 3 days gestation. on 2/2/2021 patient developed light vaginal bleeding. Ultrasound exam revealed no fetal heartbeat. Measurements showed gestational size 14 weeks 1 day (1/22/2021).

Patient received second dose of covid vaccine within 5 minutes of injection developed anaphylaxis reaction, 2 doses of epinephrine was administered on site. EMS was called and patient was transported to local emergency department for treatment.

Anaphylaxis; Hives; A spontaneous report was received from a healthcare professional concerning a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis and hives. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021 at 4:50 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 11 Jan 2021 at 4:50 pm, after receiving the vaccine, the patient experienced anaphylaxis and hives. She was given epinephrine and 50 mg of diphenhydramine. Emergency Medical Services (EMS) and the fire department were called. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, anaphylaxis and hives, were unknown.; Reporter's Comments: This case concerns a 31 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction, a non-serious unexpected event of urticaria. The event occurred 1 day (few min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Very early menstruation, occurring a couple of hours after the vaccine. It started as spotting that night, (I never spot) then a gradually heavier flow, working up to an unusually heavy & painful period over the course of the next 2 days. Also some very light clotting, which rarely happens for me. I was not due for my period for 2.5 weeks. My cycle is extremely regular and has never deviated from 28-31 days in the last 6+ years. I have a copper IUD (for 6 years), and have never been pregnant.

Anaphylaxis - chest pain, shortness of breath, tingling in throat, lightheadedness Responsive to Epipen x 2. Given IM solumerol EMS took her stable to ER

3/5: Had hematoma on the tongue, inside mouth, gums and over the body 3/6 am: platelets was 3, diagnosed as ITP, given steroids + platelets transfusion, platelets to 33 right after 3/7: platelets dropped to 8 in the morning, and then started steroids and 2nd platelets transfusion and IVIG, checked after, platelets 54, but random glucose 285, given 3 units insulin 3/8: platelets remained at 54, given steroids and 2nd IVIG 3/9 am checked platelets at 84, discharged

Vaccine Saturday evening. Noticed ball of left foot feeling numb Sunday morning. Numbness spread throughout left leg during the day. Some aching but mostly numbness in the subsequent days. No loss of function. Left arm went numb Wednesday. Right foot and right hand developed some tingling/numbness Wednesday night/Thursday morning (today). Right leg has progressively gotten more numb today (Thursday). Vaginal spotting started Tuesday 3/9, only 1.5 weeks into my current cycle and current pack of birth control pills (highly unusual).

Anaphylactic symptoms - paleness, dizziness, itchy lips, face, mouth, throat, hives, tachycardia, hypotension. Parametics called. Treatment - IV benadryl, famotidine, solu-medrol Improvement of symptoms, they did return later that evening, lessening in severity, and were treated with oral benadryl.

Patient had a tonic-clonic seizure approximately five minutes after receiving the first dose of the Moderna covid-19 vaccination. Post seizure the patient reported feeling a fever leading up to seizure. Patient had no history of seizure but has experienced fainting in the past. 911 was called immediately and paramedics cared for her.

breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included Hives. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (GIANVI) for an unknown indication. She had never had an allergic reaction to any vaccination on the past. She does have a skin condition so she gets hives easily and similar hives when taking some beers. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (breaking out on hives on her face, neck and chest. She saw a doctor and he told her it was anaphylactic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication reported Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Headache-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: Patient was given Moderna Covid Vaccine in Right Deltoid at 10:50. About 30 seconds later patient slid down from sitting possition and was shaking uncontrollably and reported difficulty in breathing. Patient was given Epi 0.3mg pen IM in right outer thigh and 911 was called.

Idiopathic thrombocytopenic purpura (ITP); This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Mar-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Full blood count: 238 (Inconclusive) 238. On 06-Mar-2021, Platelet count: 3 x 1000 (Inconclusive) 3 x 1000. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. She was first admitted to the ER on 06Mar2021. Indicator was that her platelet was 3x 1000. She received a platelet infusion and her platelet count went up and then down. Very limited information regarding this event/s has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: New information includes reporter email address, lot # of vaccine, treatment information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

patient reported that she had an anaphylactic reaction to sulfa drugs, advised to stay at pharmacy for a 30 minute wait post injection, patient called at 2pm stating that she had been having a severe headache, drowsiness, and weakness making it difficult to walk. Advised patient to call 911 and/or seek emergency medical care if they continued to feel this way.

Patient had nose bleed after first vaccination Jan 15, but 2 weeks after Feb 12 vaccination had unstoppable nosebleed and presented to ER with platelet of <6. Platelets were normal in 2019. Pt required platelet transfusion, high dose steroids, still on promacta and now hydroxychloroquine for her UCTD in case it was triggered by the vaccine to cause ITP.

5 weeks pregnant, due date December 29, 2021. Next day after the vaccine fever 102.2 for 24 hrs, chills, dizziness, heavy bleeding the day after. Confirmed miscarriage on May 1st.

Patient had miscarriage after 1st dose of COVID vaccine. Vaginal bleeding and cramping started after routine check at her OB clinic 4/22 showed fetal demise , Miscarriage complete 4/22/21. Seen by provider for pregnancy care per patient. Was around 16 weeks at time of 1st moderna vaccine- G4P1031. ER visit 4/22 reports she was supposed to be 17 weeks on that date but US confirmed fetal demise at 12w6 days. RH positive

31 yo F presented with gran mal seizure, bleeding tongue, bleeding forehead, and disorientation in a post-dictal state. Pt was combative while disoriented. Pt transported to treatment area and evaluated by EMS. Pt became cooperative over time. Has a history of seizures. Pt states that her doctor just changed her seizure medication last week. Pt care transferred to responding EMS unit and transported to local hospital emergency room for continued treatment.

Fever, fatigue, no appetite, chills, on 5/5/21 and 5/6/21. Rash developed under left armpit same arm as injection site 5/7 to 5/10. Right calf started to hurt on 5/12 and was diagnosed with a blood clot in right calf on 5/14. Chest felt heavy hard to breathe on 5/15 and went to ER. Bloodwork and EKG came back fine.

I had an reaction to the first dose of covid-19 vaccine. Within minutes I thought I was going to pass out. 3 days after the vaccine I noticed a lump with pain in my forearm. I suspected a blood clot in my forearm. I had a confirm ultrasound of a DVT in my right upper extremity brachial veins.

Patient had an injury to her foot several days prior to vaccination, with some pain to the area since. Received 2nd dose of vaccine on 1/26, several days after injury. Within a few days after vaccine, patient developed calf pain and some discoloration of foot. On 1/31, she presented to the ED for evaluation. Xrays and ultrasound ordered - ultrasound positive for DVT. Patient started on Xarelto and discharged with instructions for follow up with PCP and repeat ultrasound.

Patient presented with premature rupture of membranes and passed a clot at 20wks and 2 days approximately 18 days post vaccination for COVID19 (second dose). She is G2P1, no complications with current pregnancy and no history of preterm labor. 10/22/21

1st moderna covid vaccine 4/20 /21 4/23/21 period was 1 week early and "intense" which was unusual for her as she is always regular Conceived in between 1st and 2nd doses 2nd vaccine 5/18, First positive HPT on 5/21 and again on 5/22 and 5/23. 5/24 Started spotting lightly 5/25 Bleeding heavily and cramping badly

Received 2 doses of COVID19 (Moderna) vaccine - 1st dose: 5/6/2021; 2nd dose: 6/3/2021. Presented to hospital Emergency Dept on 6/22 with complaint of substernal non-radiating chest pain of 1 day duration. Patient reported she was asleep when chest pain began and severity wok her up. Reports the pain "pressure-like" in quality. Associated symptoms include nausea, vomiting, and palpitations. Laboratory tests were performed, including the following: Troponin-I - 6/22/21 09:05 = 1.05; 6/22/21 10:11 = 3.00; 6/22/21 14:09 = 8.00; 6/24/21 12:17 = 8.10; 6/25 06:39 = 7.90 (note: elevated) Coronavirus NAA - 6/22/21 12:15 = not detected Diagnostics tests performed during hospitalization: EKG - 6/22/21 08:59 = sinus bradycardia Echocardiogram - 6/22 11:23 = normal left ventricular systolic dysfunction, LVEF 55-60%; valves normal Pt underwent cardiac catheterization for NSTEMI. No lesions noted. Right coronary artery small and normal; left coronary artery dominant and normal. Pt diagnosed with myocarditis and discharged on 6/25 (3 day hospitalization) with MYOCARDITIS and NSTEMI.

I had an extremely high fever and illness that started 24hrs after the second vaccine that lasted up to 4 days. I was running 104F fever for 2 days that OTC medicine would not break the fever. On 04/20/21 I had my LMP while severely sick. I found out I was pregnant on 05/13/21 and had a miscarriage at around 10 weeks on 06/29/2021. I have 2 prior children with no history of miscarriage or fertility issues and was seen routinely and early on in my care. I wanted to report this in case anyone is studying these kinds of events and would want the information.

Patient vaccinated on 12/28. Approximately one day later, develops cough and on azithromycin x 1 week. On 1/3, patient develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory failure secondary to COVID - on H&P. Patient died on 1/4/21 at 7:20am.

Client complained of feeling flushed, hot, heart racing and tight throat and difficulty breathing. Vitals taken and placed in supine position with feet elevated but complained of hard to breathe so sat up. Started yelling she couldn't breathe, encouraged her to calm down take deep breaths, able to take drinks of water, and talk. BP 144/80 Pulse: 119 No swelling noted and no blueness of lips or fingers. Calmed down after drank water but then started yelling again in about 2 minutes she couldn't breathe and she wanted EPI would I please give her EPI. Gave 0.5cc Epinephrine, this immediately helped she said still wanted 911 called noted no breathing issues or swallowing issues drinking water, also called 911 . Ambulance here at 1:45 and checked o2 sat reported 98% Vitals taken by ambulance but not reported to us. Called the patient this morning 01/13/2021, she reported she had another episode in the ambulance she felt she couldn't breathe and they gave her Benadryl 0.5cc and she said she never had another episode after she got to the hospital, she reported the ER DR. diagnosed her with anaphylactic reaction to the vaccine. She returned to work this morning no issues she reported.

cellulitis at injection site. Diagnosed on 1/13. Bleeding and swelling and soreness immediately. Very sore arm and bruise got darker and darker. Started to feel better then began to get itchy on 1/11. Knot formed. Swollen raised. 1/13 raised. Red. Hot to touch. Low grade fever. Redness spread throughout the day. Grew approximately 4 inches around in size by 9pm at night.

Employee received the Covid 19 vaccine around 4pm on 1/15/21. Employee waited 15 minutes then returned to the floor her shift. Around 5:15 employee felt dizzy and has slight headache and stomachache. Employee passed out and hit head on floor and was not breathing. RN Charge at time called code blue and started compressions and gave employee O2. 911 was called, paramedics arrived and transferred via ambulance .

Client was pregnant at time of vaccination. She had consulted with 2 OBGYNS that are following her concerning if she should receive the covid vaccine. They both stated yes. She received her 1st covid vaccination to her left deltiod between 12pm - 1300 on 1/14/21. She did not experience any complications or feel any side effects immediately after vaccination. She was monitored by nursing staff for over 30 min to be prudent. On 1/16/21 the Sat following vaccination she began experiencing cramping in her stomach and began to bleed vaginally. She consulted w her OBGYN and was monitored. She miscarried on 1/19/21.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Anaphylaxis-Mild; symptoms lasted 8 days

Pt. with known allergic type reaction after first dose of vaccine, discussed getting the 2nd vaccine by intensivist and pulmonologist and was advised to go ahead and get second vaccine. 1st vaccine Reaction: Itchiness of entire body, fatigue, tongue "felt funny," stomach cramping. She was premedicated with Prednisone 40 mg po, Benadryl 25 mg po, Pepcid 20 mg morning of vaccine. Pt. was administered vaccine at 12:15 am and at 12:40, she started to have tongue and throat itching, swelling, voice change, H/A and abd. pain. Medical first response was called and Dr. (Anesthesia) and FNP was present on-site at 12:41 Epi 0.3 mg sq was given. Additional 50 mg IM of Benadryl was also administered. Pt. was transported to ED via wheelchair and found to have angioedema and dx of anaphylaxis. Pt. was administered Benadryl IV, Pepcid IV, Solu-Medrol IV, Epi IV was administered in the ED due to persistent angioedema. She was discharge home same day at 16:03 and asked to f/u with PCP in1-3 days. 2/2/21- Still on prednisone, pepcid and Zrytec. Tongue still feels itchy and a little swollen, but overall feeling well.

I was pregnant, embryo estimated 6 weeks gestation. I started having spotting approximately 34 hours after the 2nd dose. I went to my OB for heavy vaginal bleeding with an ultrasound completed 49 hours post vaccine with no concerns visually. Estimated miscarriage <72 hours after vaccine administration with confirmation via ultrasound 1 week and 2 days after vaccine.

Body aches, fever, fatigue, swollen lymph nodes, soreness red and inflamed at injection site. Anaphylaxis later that night and next day

I started bleeding on the 4th, doctor stated threaten miscarriage. I had blood clots and vomiting'. I was taking to emergency room. I was giving a DNC because I had a miscarriage.

positive at home pregnancy test 2/4/21 (same date as vaccine given). However, light bleeding/spotting started that night/next day but thought still normal. Heavier bleeding started 2/6/21 (Saturday) and continued through the weekend. Made appointment at hospital lab for Monday 2/8 to check HcG levels in blood. See below for details, but Dr. suggested repeat blood work on 2/10 as Hcg levels showed positive pregnancy, but very low. 2/10 Hcg levels slightly lower, which confirmed early miscarriage occurring.

I received my first dose of the Moderna COVIDI19 vaccine on 12/29/2020 not knowing I was pregnant. I took a home pregnancy test the week of 1/3/2021, which came back positive. On 1/17/2021, I started having some spotting and saw my OBGYN on 1/18/2021. My OBGYN did a transvaginal ultrasound and estimated I was about 5 weeks pregnant. I went for bloodwork prescribed by my OBGYN on 1/18 and 1/20 to measure my HcG levels. By 1/20-1/21 the bleeding became heavy and my HcG levels dropped. I had a follow up appointment with my OBGYN on 2/3/2021 where they performed another transvaginal ultrasound and more bloodwork to confirm that I had miscarried.

Other side effects; Anaphylaxis; Anaphylaxis; A spontaneous report was received from a nurse, concerning a 32-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2 episodes of anaphylaxis (onset: 28 Jan 2021 and 29 Jan 2021) and other unspecified side effects. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date patient took her first of two planned doses. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the event of anaphylaxis (life threatening), within 30minutes after the second dose of vaccine. Hence, she received epinephrine and her condition did not improve so received a second dose of the same, also was treated with diphenhydramine and oxygen and sent home. Next day, on 29 Jan 2021, the patient again went into anaphylaxis, hence, received another epinephrine and was also given with prednisone due to which patient got better and was stable today. But, however, she still having other side effects but not anaphylaxis. The patient's clinical history says that on Sunday night she continued to be symptomatic with vaccine side effects. The patient was confirmed to be not pregnant. Treatment for event other side effects were unknwon. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events anaphylaxis (onset: 28 Jan 2021) and anaphylaxis (onset date: 29 Jan 2021) was resolved on 29 Jan 2021. The outcome of event other side effects was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

5 day post vaccine - itchy hands 6 day post vaccine - itchy hands, neck 7 day post vaccine - itchy hands, neck, head - 25 mg Benadryl in afternoon / med wore off and symptoms came back 8 day post vaccine - itchy hands, neck, head, arms - 25 mg Benadryl in afternoon / med wore off and symptoms came back 9 day post vaccine - itchy hands, neck, head, arms, stomach, chest - 25 mg Benadryl in morning / med wore off and symptoms came back 10 day post vaccine - itchy hands, neck, head, arms, stomach, chest, legs - 25 mg Benadryl in morning / med wore off and symptoms came back and in evening went into anaphylaxis / transported to ER / albuterol treatment, solumedrol, Benadryl en route to hospital, pepcid and Benadryl at hospital 11 day post vaccine - med wore off from ER visit, woke up with hives and rash all over body, prednisone, epi on hand

Very heavy period with clotting. I was on day 3 of my period at the time of vaccination. Immediately upon receiving the vaccine I had uterine cramps and heavy bleeding with large clots continued throughout the day and into the next day. Had some dark bleeding/discharge about 4 days after my period ended for 2 days. This also happened during my first dose of Moderna, although my first dose was on the first day of my period so I didn?t quite register it since bleeding is normally heavy at the beginning of my period. First period was also substantially heavier with clots and had some dark bleeding/discharge 4 days after my period ended

On April 1,2021, patient experienced severe right arm pain up to right scapula & back, unable to move arm d/t pain & swelling, went to see provider, was sent & admitted to Hospital from 4/1-4/5/21. Diagnosed with RHABDOMYOSIS,

I had diarrhea about 20-40 minutes after receiving my first dose. I then got my period a few hours later. It was on time, however, it was extremely heavy. On the 3rd day, I began to have very large blood clots. I spoke to my gynecologist and she started me on birth control that sane day in order to stop the bleeding.

Within hours of receiving the vacine I began having vaginal bleeding spotting. By that evening it progressed to bleeding as if my menstrual cycle began. This was unusual because I just had my period. The last day of my previous cycle was 6 days earlier. This was accompanied by night swears and then a migrane that onset the following day along with usual symptoms of fatigue and a sore arm.

3/14/21 - took a dose of miralax, 30 minutes later became flushed, diaphoretic, developed a red/itchy rash on my head/neck/back/arms, 10 minutes later I had diarrhea, 10 minutes later intractable vomiting, EMS was called, BP 70/30 in ambulance, received 2L NS IVF and 60 mEq potassium (K 2.8 in ED), stayed in ED for 8 hours until BP 110s/70s. 3/19/21 - diagnosed with right occlusive thrombus in superficial cephalic vein large enough it was characterized as a DVT, started on therapeutic Eliquis. 3/22/21 - diagnosed with left occlusive thrombus in main branch of cephalic vein. Had to be out of work for 4 weeks until I was cleared by vascular surgery and hematology to return.

4/12/21 Patient presented to the emergency room with left side intermittent chest pain x1 week. Patient reports "feels like heart beating out of chest" yesterday. Workup was consistent with pulmonary embolism. Patient was admitted and Lovenox for pulmonary embolism treatment was started. Pain controlled, hypertension controlled.

Since getting the first vaccine I began spotting within two weeks of ending my regular period, which is very unusual since I have the implanon birth control. I have been spotting/ bleeding for over a week straight now, when I should even be having a period at all. I also developed a slight yeast infection during the time between my two doses.

Approximately one week after receiving the second dose of the vaccine my wife felt a pain in her left leg. The pain did not feel like a muscle pain and continued for a few days. She went to an urgent care and an MRI of her leg was conducted. She was diagnosed with a blood clot and has begun treatment. My wife is healthy, young and has no family history of blood clots prior to this incident.

On 03/22/2021 I started feeling a heavy sensation on my right side of my body it lasted about 3-4 hours. I went to the ER about 20-30 min after it started. They did an MRI & blood work and everything came back cleared. I got discharged. Then last week on 4/15/2021 they sent me with a stroke specialist and he diagnosed me and said I had a mini stroke. He prescribed me baby aspirin of 20mg.

Patient was admitted to the hospital due to chest pain and shortness of breath. Was found with right pulmonary arterial emboli on CT chest angiogram. Started therapeutic dose of Lovenox, and now switched to apixaban. Symptoms improved, still hospitalized today. No DVT was found in lower extremities. Echocardiogram showed no RV strain with normal LV function and size. EF 65%.

After waiting in the pharmacy for 15 minutes and not having any reaction the patient left and went home. About one hour after the vaccination she called the pharmacy stating that she thought she was having an allergic reaction and asked if she should use her Epi pen. After speaking with her about what her reaction was I told her to use her Epi pen and to call 911/go to the ER for further medical help. I called her back about 15 minutes later to check on her and she said she was doing better after the Epi pen, but did not go to the ER or call 911 yet. I reiterated to her that if she was having a reaction that required her to use her Epi pen she should seek medical help right away to be safe. She said okay.

Began vaginal spotting/bleeding that is outside of my regular menstrual cycle. Bleeding has been going on for over 3 days and is extremely heavy, soaking through a super pad every 1-2 hours. This is very abnormal for me.

NSTEMI with 99% occlusion of LAD, First ER visit 5/1/21 with reports of 2 days of throat tightness, Second ER visit 5/7/2021 NSTEMI via cardiac cath lab with stent placement. Had cardiac cath 10/2020 at hospital in with no abnormal findings

Outcome: unexpected/unexplained death Had first dose Moderna Vaccine 3/31/21. She described body aches and mild fever ? ?like I had COVID again for a day? ? lasting about 36 hours, and then felt fine. Had dose # 2 Moderna vaccine about 6:50 PM at Community vaccination site. She was driver, received left deltoid injection from Doctor. During observation period reported no symptoms, was happy and talkative with family and staff. Family reports later that evening she did not feel well ? ?just not hungry? and wanting to lie down. Slept well, then woke up feeling better except for left arm achiness at injection site. Did not report redness, rash, or any difficulty breathing. Was talkative, walking around, took a shower, and was planning to drive to the grocery store later that day. Mid morning ? maybe beginning about 11 AM, family said she went in and out of bathroom several times. She told them she had vomited three times and was feeling shaky. Her oral temperature was 101.3. About 1:30 PM, she was in her room and called out for her mother. When family went into the room, she was shaking ?like she was having a seizure? and then her eyes rolled back and she fell to her side and stopped breathing. Family called 911 and started CPR. CPR was continued by EMT?s once they arrived, but they were not able to resuscitate her.

Vaccine series in Dec/Jan. LMP Feb 11. Breast lump noticed March 2. Positive pregnancy test March 14. Bleeding April 10, miscarriage April 14. D/C April 16

Had 2 grand mal seizures 2 days after getting vaccine. Have had brain fogginess, right side numbness and pain in face, arm and leg, increased anxiety.

Beginning on day of dose one, tired, achy I had redness. Second dose was end of May. I was pregnant at the time. I started having a lot of bleeding and I went to ER.

The day after the second dose of the vaccine, I experienced breakthrough bleeding as if it was my period. It lasted 3 days and then abruptly stopped. I am currently breastfeeding so I have yet to get my period back since giving birth.

Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.

Anaphylactic shock. I was sent to the hospital. They weren?t able to get me stable at the clinic even after the epi pen injection.

Systemic: Anaphylaxis-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium; symptoms lasted 1 day

#Right parietal/temporal subarachnoid hemorrhage and right intra-axial hemorrhage CT brain (1/12/21): Right parietal intra-axial hemorrhage toward the convexity measuring 2.3 x 1.1 x 1.7 cm with decompression into the subarachnoid space, mild right predominantly temporal and parietal subarachnoid hemorrhage is seen with minimal associated hemorrhage along the tentorium. Mild diffuse right cerebral sulcal effacement with minimal leftward midline shift measuring 2.5 mm. #Dural sinus thrombosis CTA head (1/11/21): Increased density within the superior sagittal sinus, inferior sagittal sinus, and transverse sinuses on noncontrasted images with no flow seen on postcontrast sequences consistent with venous sinus thrombosis #Left sided weakness 2/2 above #Recent jaw alignment procedure

pt states that she did not know she pregnant when taking first dose of covid vax. On 2/3/2021 pt stated she started having vaginal bleeding and was transported to the ER by ambulance. She was given IV fluid and did US and blood work. She was told she was pregnant and that the baby was fine but she had a small hemorrhage. She has a repeat US on 2/12/2021 w/ OB/GYN doctor to get update on hemorrhage and to make sure baby is ok. Pt states this is her second pregnancy and due date is September 29, 2021.

Anaphylaxis happened within 12 minutes. I was administered epinephrine at the vaccine site, as well as in the ambulance. FURTHERMORE I was administered DiphenhydrAMINE, Famotidine, solu-MEDROL at the Emergency Department. Those are just a few of what I received. When I was finally discharged I was sent home with 2 epi-pens and a 4 day dosing of Prednisone.

Tachypnea, Tachycardia edema Narrative: hospitalized due to tachypnea, tachycardia, fluid retention and found to have pneumonia and pericardial fluid

received vaccine on 1/6; developed shortness of breath/respiratory failure on 1/10. Hospitalized for several weeks with end diagnosis of Multiple Sclerosis (new diagnosis)

Positive home pregnancy test on 02/24/21, followed by severe headaches starting on 2/27 and 2/28, abdominal cramping and spotting starting 2/28 at 7pm, and a negative home pregnancy test and bleeding on 3/1/21 in the AM

Patient immediately developed respirtory distress and wheezing concerning for anaphylaxis. Was given an IM injection of epinephrine alone with albuterol nebs which didn't improve her symptoms. She was not responsive to 4 albuterol nebs and an epinephrine drip and ultimately require intubation and mechanical ventilation. She stabilized on the ventilator but required a MEDEVAC to a civilian hospital for ongoing care.

Headache, nausea, and vomiting starting about 2 hours after vaccine and got worse overnight. Patient reported intractable vomiting the next morning an feeling week so she called EMS in the evening. She developed sudden onset of right lower extremity paralysis and numbness. In ED, stroke was called and Alteplase was given on 3/13/21

After the 2nd injection I waited 15min to make sure I am feeling ok. At that time I had no symptoms. As I was walking home walking home within 5min I had heavy bleeding, I wasn't suppose to get my period for another 2 weeks. The heavy bleeding lasted full 2 days, that day within 5hrs I had body aching and later had a fever. I had the fever and body aching for about 24hrs and my period for 2days. Since then I have been having random spotting of light or heavy bleeding. I had my period on 3-6-21 to 3-16-21 full days bleeding. Now I still have random spotting of blood cloth and heavy bleeding for few hours and it stops.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted 2-3 minutes after getting vaccinated with the first dose of moderna covid vaccine. She recovered immediately but had her front teeth bent from fallling forward. Pt was talking as usual after regaining consiousness and her bp was within normal range.

Pain in left calf began on April 2 during a long road trip. Pain continued for several days. On April 5, I visited Urgent Care for a suspected muscle strain. They referred me to the Hospital emergency care for an ultrasound. The ultrasound detected deep vein thrombosis (DVT) (blood clot) in the popliteal vein in my left leg, above and below my knee. I am currently taking anticoagulant (Eliquis) medication to treat the DVT.

I was diagnosed with placenta previa about 3 months ago. I had a bleeding event so I was hospitalized on the 27th. I was discharged on the 30th of March (3 days). I had another bleeding event on April 16 and I was discharged today (4 days). No medications added. Pregnancy history - I had a miscarriage in September 2020; this is my first full term pregnancy (getting there)- June 25th, 2021. I will still be on disability and not working for at least a few weeks.

Left calf pain. US completed. Blood clot in left great saphenous vein and branches. Patient is being treated with Lovenox 60 mg BID. Outcome is unknown at this time.

Unexpectedly long wait time at clinic; frightening and dehumanizing behavior from nurses and other staff; long drive in extreme heat in the middle of the afternoon. stroke, sunburn, and vomiting/migraine/nausea immediately after getting home. Extreme acute stress for weeks later. still waiting to see PCP.

mild anaphylactic reaction; Throat felt funny; Throat felt swollen; couldn't breath properly; coughing; wheezing; lip got swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (mild anaphylactic reaction) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergic to sulfa) and Asthma. On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (mild anaphylactic reaction) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen). At the time of the report, ANAPHYLACTIC REACTION (mild anaphylactic reaction), OROPHARYNGEAL DISCOMFORT (Throat felt funny), PHARYNGEAL SWELLING (Throat felt swollen), DYSPNOEA (couldn't breath properly), COUGH (coughing), WHEEZING (wheezing) and LIP SWELLING (lip got swollen) was resolving. No relevant concomitant medications were provided. She used inhalers and other at home treatment and thought her Asthma is acting up. She went to her Doctor who told her that she might had the mild anaphylactic reaction from the Vaccine. He gave her prednisone and diphenhydramine to use and she is feeling much better now. Action taken with mRNA in respect to the events was not applicable. This case was linked to MOD-2021-100620 (E2B Linked Report).; Sender's Comments: MOD-2021-100620:dose 1 case

thought she was suffering from a stroke; anemia; double vertigo; blood clots, thick blood; dissociated; liver spazzed; slurring words; could not speak; possible underlying autoimmune disorder where genetic composition may have triggered this; malabsorption; looked very pale; heart disease; blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension; severe vasculitis on the right side of brain; Thyroid calcification/thyroid had a lot of calcium build up; interstitial markings on lungs/doctor stated looked like COVID lungs; hands were so swollen that could not clench it; face was swollen; electrical shooting pain from the right brain stem of the neck; vision was blurry; stuttering; paranoid; confused; not able to recognize her daughter; hands were very stiff; stomach was bloated/looked 6 months pregnant; lethargic; bile dumps which then leads to inflammation of her intestines; clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red; stomach was inflamed; period started 10 days early, which is completely abnormal for her menstrual cycle; severe ovarian pain that was up very high; could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes; irritable; migraine; stabbing pain; kidney pain; period pain; lightheaded; pimple in the back of her head; headache; chills; fatigue, tired; fever of 102.6F/fever which lasted another 12 hours; nausea; body aches, muscles started to ache; diarrhea; significant abdominal pain from the cramping due to heaving from the nausea; cramping/lot of cramping in the groin and thigh area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke), HYPERTENSION (blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain), AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this), THROMBOSIS (blood clots, thick blood) and INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gallbladder removal. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MUSCLE SPASMS (cramping/lot of cramping in the groin and thigh area), ABDOMINAL PAIN (significant abdominal pain from the cramping due to heaving from the nausea), DIARRHOEA (diarrhea), PYREXIA (fever of 102.6F/fever which lasted another 12 hours), NAUSEA (nausea), MYALGIA (body aches, muscles started to ache), CHILLS (chills) and FATIGUE (fatigue, tired). On 10-Apr-2021, the patient experienced HEADACHE (headache). On 12-Apr-2021, the patient experienced ACNE (pimple in the back of her head). On 13-Apr-2021, the patient experienced MENSTRUAL DISORDER (period started 10 days early, which is completely abnormal for her menstrual cycle), ADNEXA UTERI PAIN (severe ovarian pain that was up very high), FEELING ABNORMAL (could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes), IRRITABILITY (irritable), MIGRAINE (migraine), PAIN (stabbing pain), RENAL PAIN (kidney pain), DYSMENORRHOEA (period pain), DIZZINESS (lightheaded), GASTRITIS (stomach was inflamed), GASTROINTESTINAL INFLAMMATION (bile dumps which then leads to inflammation of her intestines) and HEAVY MENSTRUAL BLEEDING (clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red). On 14-Apr-2021, the patient experienced LETHARGY (lethargic). On 15-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (hands were very stiff), ABDOMINAL DISTENSION (stomach was bloated/looked 6 months pregnant), PERIPHERAL SWELLING (hands were so swollen that could not clench it), SWELLING FACE (face was swollen), NECK PAIN (electrical shooting pain from the right brain stem of the neck), VISION BLURRED (vision was blurry), DYSPHEMIA (stuttering), PARANOIA (paranoid), CONFUSIONAL STATE (confused) and MEMORY IMPAIRMENT (not able to recognize her daughter). On 16-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke) (seriousness criterion hospitalization), HYPERTENSION (blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension) (seriousness criterion hospitalization prolonged), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain) (seriousness criterion medically significant), INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs) (seriousness criterion medically significant), PALLOR (looked very pale), CARDIAC DISORDER (heart disease) and THYROID CALCIFICATION (Thyroid calcification/thyroid had a lot of calcium build up). On 19-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this) (seriousness criterion medically significant) and MALABSORPTION (malabsorption). On an unknown date, the patient experienced THROMBOSIS (blood clots, thick blood) (seriousness criteria disability and medically significant), ANAEMIA (anemia), VERTIGO (double vertigo), DISSOCIATION (dissociated), LIVER DISORDER (liver spazzed), DYSARTHRIA (slurring words) and APHASIA (could not speak). The patient was hospitalized from 16-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT and HYPERTENSION. On 10-Apr-2021, PYREXIA (fever of 102.6F/fever which lasted another 12 hours) and CHILLS (chills) had resolved. On 12-Apr-2021, MUSCLE SPASMS (cramping/lot of cramping in the groin and thigh area), MYALGIA (body aches, muscles started to ache) and FATIGUE (fatigue, tired) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain), AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this), THROMBOSIS (blood clots, thick blood), INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs), IRRITABILITY (irritable), PAIN (stabbing pain), DIZZINESS (lightheaded), MUSCULOSKELETAL STIFFNESS (hands were very stiff), ABDOMINAL DISTENSION (stomach was bloated/looked 6 months pregnant), GASTRITIS (stomach was inflamed), PERIPHERAL SWELLING (hands were so swollen that could not clench it), SWELLING FACE (face was swollen), NECK PAIN (electrical shooting pain from the right brain stem of the neck), VISION BLURRED (vision was blurry), DYSPHEMIA (stuttering), PARANOIA (paranoid), CONFUSIONAL STATE (confused), MEMORY IMPAIRMENT (not able to recognize her daughter), PALLOR (looked very pale), CARDIAC DISORDER (heart disease), MALABSORPTION (malabsorption), ANAEMIA (anemia), VERTIGO (double vertigo), THYROID CALCIFICATION (Thyroid calcification/thyroid had a lot of calcium build up), GASTROINTESTINAL INFLAMMATION (bile dumps which then leads to inflammation of her intestines), LETHARGY (lethargic), ACNE (pimple in the back of her head), DIARRHOEA (diarrhea), DISSOCIATION (dissociated), LIVER DISORDER (liver spazzed), DYSARTHRIA (slurring words), APHASIA (could not speak), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown, HYPERTENSION (blood pressure was elevated, blood pressure was 190/130, uncontrolled and unspecified hypertension) and FEELING ABNORMAL (could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes) had not resolved, MENSTRUAL DISORDER (period started 10 days early, which is completely abnormal for her menstrual cycle), ADNEXA UTERI PAIN (severe ovarian pain that was up very high), RENAL PAIN (kidney pain), DYSMENORRHOEA (period pain), HEAVY MENSTRUAL BLEEDING (clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red) and ABDOMINAL PAIN (significant abdominal pain from the cramping due to heaving from the nausea) had resolved and MIGRAINE (migraine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.6 (High) fever of 102.6F. In April 2021, Neurological examination: abnormal (abnormal) neurological damage to the hippocampus of the central cranial. On 16-Apr-2021, Blood pressure measurement: 190/130 (abnormal) 190/130 and 175/99 (abnormal) 175/99 after treatment with Metoprolol. On 16-Apr-2021, Chest X-ray: interstitial markings of her lungs (abnormal) interstitial markings of her lungs. On 16-Apr-2021, Computerised tomogram: interstitial markings of her lungs (abnormal) interstitial markings of her lungs. On 16-Apr-2021, Magnetic resonance imaging: severe vasculitis on the right side of her brain (abnormal) severe vasculitis on the right side of her brain. On 16-Apr-2021, Neurological examination: 3/5 tests failed (abnormal) 3/5 tests failed. On 19-Apr-2021, Stool analysis: abnormal (abnormal) showed she was putting out too much potassium, magnesium. On 28-Apr-2021, Blood pressure measurement: 145/90 (abnormal) 145/90. On 28-Apr-2021, Heart rate: 90 (High) was not coming under 90 bpm. On 28-Apr-2021, Magnetic resonance imaging: blood clots, thick blood, anemia (abnormal) blood clots, thick blood, anemia. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-095842 (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 have been on the DEPO shot for 4 years and have had no menstral cycle or symptoms. A month after I got the first vaccine and a week after, I started having light bleeding and cramps. It has been 4 years since I had experienced this. Now on today, May 15 - 2 months after my first dose of Moderna, I am having period symptoms again but with some stabbing pain in my uterus. I am very frustrated because these were NOT listed as side effects in the information given and I would not have gotten this vaccine had I known this would happen.

Facial swelling, chest tightness, and diffuse hives all over body within minutes of 1st dose on 5/11/2021. Patient received Covid vaccine at immunization site. During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness Gave 50 mg Benadryl PO 945 am Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over Has a history of Behcet's Disease, Ehlers-Danlos Syndrome, and self-reported history of intubations due to anaphylactic reactions from numerous medications/vaccines. Patient presented to the ED via EMS on 5/11/21 after receiving her first Moderna COVID-19 vaccine. Shortly after receiving the dose, the patient developed chest tightness, lip swelling, and diffuse hives. She immediately received 0.3mg EPI (@9:50am) and 50mg Benadryl PO with no symptom relief. Paramedics were called, and upon arrival to the field, administered 0.5mg EPI (@10:10am), 50mg Benadryl IV, and 10mg Decadron. The patient presented to the ED at 10:25am, and at that time, the patient reported that her symptoms mostly resolved, however with lingering abnormal sensations in her chest and lips. She notes that in her past allergic reactions, she had required two EPI doses, Decadron, Benadryl, and a prednisone taper. Of note, the patient was given Zofran by EMS for nausea en route to BWMC. The patient states to being allergic to the medication, but believes it to be from the aspartame found in Zofran's ODT formulation. The patient was noted to have urticarial-like rashes (mouth and chin area) without uvulitis, tongue swelling, lip swellling, strides, wheezes/rales/rhonci, or respiratory distress. The patient was tachycardic, talking in full sentences, and is A/O x4. Roughly 10 to 15 minutes later, the patient started to experience refractory allergy symptoms - throat tightness or return of facial hives. Her airways were noted to be patent and her lungs were noted to be clear. She was given Ativan 1mg and placed on EPI gtt (rate: 0.05mcg/min). Thereafter, the patient states to improving symptoms. Transferred to the ICU for further management respiratory distress in the setting of anaphylactic reaction.

possibility of a blood clot; Legs were numb; Rash on arm; Whole arm was totally swollen; whole arm Itchy; Fell down; weakness post-vaccination; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (possibility of a blood clot), HYPOAESTHESIA (Legs were numb), RASH (Rash on arm) and PERIPHERAL SWELLING (Whole arm was totally swollen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3020B1A and 044BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (possibility of a blood clot) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Legs were numb) (seriousness criterion hospitalization), RASH (Rash on arm) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Whole arm was totally swollen) (seriousness criterion hospitalization), PRURITUS (whole arm Itchy), ASTHENIA (weakness post-vaccination) and PYREXIA (fever). 30-Apr-2021, the patient experienced FALL (Fell down). The patient was hospitalized on 30-Apr-2021 due to HYPOAESTHESIA and PERIPHERAL SWELLING. At the time of the report, THROMBOSIS (possibility of a blood clot), HYPOAESTHESIA (Legs were numb), RASH (Rash on arm), PERIPHERAL SWELLING (Whole arm was totally swollen), PRURITUS (whole arm Itchy), FALL (Fell down), ASTHENIA (weakness post-vaccination) and PYREXIA (fever) outcome was unknown. No concomitant medications were reported. Treatment for the events included IV antibiotics, medication to stop itching, oral cephalexin, and Tylenol. Based on the current 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-2021-121103 (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.

Extreme depression after vaccine Delayed period, spotty dark blood, very large blood clots and heavy cramping for over 3 days

After first Moderna vaccine had spotting and hotflashes. Three days after second moderna vaccine had vaginal bleeding for 21 days

Head ache, arm was sore and felt fatigue the first day, March 9, did not feel had a COVID test prior to second dose and it was negative. When on second dose on March 12, 2021 second dose got really sick fever, breathing issues, had congestion and head aches and was in bed for a few days. Had to get pregnazone and ex-rays show phnemonia and was having issues Cardiovascular and still having appointment. Two months of having issues with breathing and activation of Asthma. hands for rash, and swelling and Fatigue.

The morning before my second Moderna vaccine I took a pregnancy test and it was inconclusive so I figured I wasn't pregnant and got my second vaccine (1/26/21). I missed my period and took another pregnancy test on 1/30/21 and it was positive. I went to my first ultrasound on 3/2/21 when I should have been around 8 or 9 weeks and the baby was measuring small but it had a heart beat that was in a normal range. A week later on 3/9/21 I started spotting and I called my doctor and they told me to let them know if it got worse. I went to work but by the end of my shift the bleeding had got worse and my doctor made me go to the ER so I could have another ultrasound. The ultra sound showed the baby still had a heart rate but it was low. I stayed home from work the next day to take it easy and I ended up having a miscarrage that night 3/10/21. I had a follow up ultrasound on 3/11/21 that proved it. I wasn't planning on reporting this because really anything could have caused it but I signed up for the vaccine app when I got my vaccines and answered the follow up questions. Someone called me because of how I answered my question and she recommended that I report it.

Non-stop flow of period bleeding like peeing Blood after second vaccine; Thrombocytopenia Diagnosis after second vaccine; Bruised all over the body after second vaccine; Platelet level was 5on blood test after second vaccine; Nose Bleeding; Oral Purpura on the Lip after second vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) and THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced EPISTAXIS (Nose Bleeding) and ORAL PURPURA (Oral Purpura on the Lip after second vaccine). On 19-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) (seriousness criteria hospitalization, medically significant and life threatening). On 27-May-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) (seriousness criteria medically significant and life threatening), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine). The patient was hospitalized from 27-May-2021 to 28-May-2021 due to HEAVY MENSTRUAL BLEEDING. At the time of the report, HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine), THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine), EPISTAXIS (Nose Bleeding), ORAL PURPURA (Oral Purpura on the Lip after second vaccine), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 5 (Low) 5. No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient received the Covid-19 vaccine. She reports symptoms of Anaphylaxis - chest discomfort, palpitations, tachycardia, shortness of breath, feeling of tightness in the throat. I have observed patient was mildy anxious, with shallow rapid respirations. Patient then disclosed having similar reaction after previous covid vaccination. Per the vaccinator patient had stated having an "issue" with her first vaccination, but that she had spoke with her primary and was told it would be ok to proceed" . No report of allergic reaction was reported at this vaccination. Patient described previous reaction as tightness in the chest "menthol feeling" with some shortness of approximately 40 minutes post initial vaccination lasting 7 hours. This reaction remained mild initially. Approximately 20 minutes into observation time patient reported having increased s/sx - chest tightness and rapid heart rate, some shortness of breath and throat/tongue swelling. Patient then reported having hx of anaphylaxis to bee stings. Patient reported this reaction was consistent with previous allergic reactions. Patient advised epi would be best choice - patient refused. MED TEAM called. Patient agreed to PO benadryl, however, as medication was prepped did agree to IM benadryl and 50mg was given to patient in the R deltoid as team arrived on scene. Patient transferred to ED via wheelchair.

Had vaginal bleeding with clots after first dose of vaccine and for the month in between the 1st and 2nd doses of COVID vaccine, had irregular menstrual bleeding

Heart failure (myopathy). Began with fluid accumulation in lungs, eventually led to hospitalization within weeks. Ejection fraction was at 18%. Treated with hospitalization, medication, cardiac rehabilitation therapy, defibrillator vest.

1st shot was on 6/2/21-was in bed sick for 3 days. 2nd shot was on 6/30/21-in bed sick for two days Then on 7/ 8 she start feeling severe pain in left leg along with swelling. She couldnt put any weight on leg. She was taken to ER on 7/14. She was diagnosed with a blood clot in her left leg and discharged on 7/15. On 7/21 she saw her primary doctor and was admitted back to hospital for 7 days to be monitored and to be given heparin.

On the evening of the vaccination, 01/29/2021 I started feeling pain on my left arm which was not the arm I received my vaccination at and chest pain and heart palpitations and that's what ultimately took me to the Emergency Department. On 04/08/2021 I went to the Emergency Department. They did a D-dimer test which came out positive. On 04/12/2021 I was diagnosed with Pulmonary Embolism in both my right and left lungs. They did a CT scan which found the blood clots visually. They prescribed the Lovenox -an injection - blood thinner, I took from 04/08-04/12. Then I started on the Eliquis 5 mg, twice daily, on 04/12 and I am currently still on it.

The employer called and stated that she had a grand mal seizure 1 hour after having her vaccine. Her employer stated that she has a history of seizures and that her neurologist had told her she could receive the vaccine but that it could trigger a seizure. Patient was taken by ambulance to the hospital.

on Wed 1/6/21 I had an allergic reaction and am unsure what set it off. My eyes became itchy, watery and my corneas swelled. I was sneezing and coughing. I had a runny nose. on Sun 1/10/21 I had an allergic reaction; I think it was set off by a type of sunblock I've never used before. But I've never had a reaction to any type of sunblock before. I went into anaphylactic shock: eyes swollen shut, flushed face, tight throat, rapid heart beat, shortness of breath, severe abdominal cramping. I had to go to the ER.

Day 1-3 after the dose flu like symptoms Day 3-7 swelling in lymph nodes on left side of body (baseball sized) took ibuprofen and Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red rash all over body and face still going on Day 16- present: severe joint pain and fever, unable to obtain any relief

Anaphylaxis; A spontaneous report was received from a consumer concerning a 34-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for COVID-19 infection prophylaxis. On 09 Jan 2021, 15 minutes after receiving the mRNA-1273 vaccination, the patient was taken to the hospital for anaphylaxis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, anaphylaxis, was unknown.; Reporter's Comments: This case concerns a patient who experienced a serious unexpected event of Anaphylaxis. The event occurred 1 day after first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Approx 10 days after vaccine a red, raised rash appeared around injection site. Area was swollen, painful, warm, and itching. The rash continued to spread and almost completely wrapped around the entire arm. She also experienced heavy vaginal bleeding, and was not due to begin cycle. Last cycle ended 1/5 and bleeding began on 1/23, and she also experienced abdominal pain on 1/25. When rash was at its worst, she was extremely fatigued.

called to report to her supervisor/employer that while she was at the gym working out she started to not feel well, she felt she was hyperventilating and then her left arm went numb and although she was awake, she not able to respond. The paramedics was contacted and came. She reported that once she was in the emergency department all her tests were clear, including her CT scan. The MD felt it was most likely a "mini TIA". She has fully recovered and denies any other symptoms at this time, but was instructed by her MD to contact the facility that administered her MODERNA covid vaccine.

I got the covid-19 vaccine on January 4th, 2021 at 8:00a.m. after 5 or 10 min later my right side of my lips up and down started getting numb for around 5 min. The same day around 1:30pm. all my mouth and tongue started getting numb again, my throat dried to the point that made me vomit. This time numbness was for around 50min. to an hour.

I have the Nexplanon birth control implant in my left upper inner arm. I rarely get my monthly period and since I received the vaccine I have had vaginal bleeding for the past 17 days. My entire left arm is still very painful and very weak.

02/08 @ 1700 Sore throat. @2300 with fever of 102.5, chills, sweating, body aches, nausea, nasal congestion. 02/09/21: Fever continues, chills, sweating, body aches, nausea, nasal congestion and dry heaving. Fever broke at 1300, body aches subsided, continued with chills and sweating, nasal congestions, sore throat and dry heaving. 02/10/21: Chills and sweats GONE, body aches GONE,. Sore throat still, with nasal congestion and NEW SYMPTOM: COUGH with phlegm. 2/11/21: Nasal congestion continues and cough feels like pneumonia or bronchitis. All other symptoms are gone.

Patient saw blood, complained immediately of feeling dizzy, sweaty and nauseous. States that she wanted "to curl up." Borout via wheelchair to cot, took vital signs, all within normal limits. Reports no breakfast, gave some water. Vitals rechecked 15 minutes later, normal remained stable. Discharged to home with husband.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe

Background 1: Anaphylaxis (previously reported) - within 30m of administration of vaccine I experienced a severe anaphylactic reaction impacting multiple body systems - diagnosed by PCP and allergy specialist Background 2 (not reported previously): Side effects from insert -The day after vaccine I developed a fever (>100f) which persisted for 8 days (>99.5) in addition to substantial mental fog, aches and pain, diarrhea and vomiting, severe nausea, food aversions and altered sense of taste, 5lb weight loss, and general feeling of unwellness. Adverse event (not reported previously): Anemia symptoms became so severe that my physician recommended that I avoid driving and either seek emergency treatment or schedule iron infusion within 3 days. I became extremely dizzy and short of breath with visual disturbances. My doctor hypothesized that my reaction to the vaccine had caused this rapid deterioration in my health.

Had seizure symptoms at 2:30 am the following day. Husband woke to our dog whining. I was very disoriented before it happened, I was freezing cold, aching, shooting pains, could hardly move or speak but got out the words, ?im not ok, I?m having a sever reaction? My husband said I then went into what he saw as a seizure. Head throat, neck, back tensed- unconscious, unable to arrouse. Lasted about a minute. Where I lied unconscious and he didn?t think I was breathing. 30 seconds later I opened my eyes, but then had a similar but shorter episode 30 seconds and then was able to get me to come to. He called 911, and they took me to hospital. All vitals came back normal. Blood pressure was on the low side. I have no history of seizures.

1 week of left sided chest pain/tightness, pleuritic in nature, some dyspnea with exertion, symptoms started 3/31, diagnosed with bilateral pulmonary emboli

I have a history of heavy periods which resulted in the need for an ablation in October 2018. Since the ablation my periods have been much more manageable. I got my period 13 days after receiving the shot and it started out much heavier than normal, by the second day I was bleeding extremely heavily, soaking an overnight pad in less than 2 hours with bright red blood and passing clots the size of dimes and pennies. Day 3 has started out the same as day 2. Prior to my period starting my back hurt and I had much worse than normal abdominal cramps. Nothing in my life has changed besides the vaccine, I am certain there is a connection between the two. I am not sure how long this will last, I was instructed to go ahead an report the adverse event.

One week after the first dose of the vaccine I had breakthrough bleeding. It was enough to soak a sanitary pad. I went to the ER and they could not identify the reason for the vaginal bleeding. I was discharged the same night. It reoccurred three days after when I had been on a walk. It did not happen again and I did not have any problems after the second shot. The baby seems to be fine. Due Date -09/17/2021 Pregnancy-First

Spotting (light bleeding) for 3 days turned into shedding huge blood clots vaginally from 4/3 - 4/5. I bled though pads in just 5-10 minutes. Clots ranged from the size of a quarter to the size of the palm of my hand. They were very large, very frequent, and very painful. I never experienced this before in my life. The bleeding lasted 12 days total.

She got her vaccine, initially she had bruising on her forearm that was blue/yellow with a swollen vein connected running down to her hand. She had tingling and numbness in her fingers in a select few on the left hand. She also had drooping of her left eye for a short period and a sensation on her left leg, swelling and pain. She went to the urgent care on 4/15/21, they told her to go home and monitor it. She knew that somewhat was not right and called a nurse at Hospital and went to the ER shortly thereafter and confirmed that she had a blood clot in her jugular vein IJ-DVT. In the ER they gave her a shot of Lovenox in the ER into her stomach and run several tests. They also gave her an anti-inflammatory in her right arm. She was sent home with Eliquis for the next 3 months. She has extreme exhaustion, and in addition to that she has had a lot of swelling on the left side of her leg, and visited the ER again on 4/17/21. Her left foot became blue, very swollen, so they ran a number of tests which all came back negative. She thinks these are side effects in relation to the previous. She is still continuing with stiffness in her neck as well. She also has a severe headache, fever of about 100, and severe achiness. She has not been able to work due to these symptoms since 4/15/21. The ER told her to have a lot of rest, no heavy listing/straining due to the clot.

Patient experienced a headache that lasted for a few days prior to admission, relieved with ibuprofen. On 4/17/21, patient had two seizures at home and subsequently brought to the ER, started on levetiracetam. CT brain on admission showed dural venous sinus thrombosis, heparin drip initiated. Hypercoagulable workup was negative.

On 3/18 I began having shortness of breath upon exertion. On 3/24 I realized that when I felt that shortness of breath my heart rate was also going very high. On 3/26 I was diagnosed with extensive bilateral pulmonary embolisms. I have started on blood thinners. As of today I am still unwell.

Thirst, itchy/tingly sensation throat, numbness and tingly sensation in left side of body (including face, arm, leg). Symptoms started 20-30min after vaccine, while I was driving. 3-4hours later numbness was gone; left side still feels "weird". Went to clinic, EMS to the ER and admitted to hospital, discharged the following day in the afternoon. Discharge Diagnosis: TIA secondary to adverse effect of Moderna vaccine Microangiopathic changes on MRI brain 4/15/2021

Pt develop heavy vaginal bleeding with clots 5 days after receiving the shot. Bleeding was heavy enough to drop her hemoglobin and require an emergency D&C.

On 4/30/21, I spoke to a physician I work closely with. I was concerned about the excessive/easy bruising I had been having over the past several weeks. I had a very large, excessive bruise on my R inner thigh from my dog running and jumping on me. The doctor was concerned as well and sent me for blood work on 4/30/21. It was noted that my platelet count was low on 5/2/21 and was diagnosed with thrombocytopenia and recommended to f/u with PCP to continue monitoring. I had blood work taken a week after my first COVID 19 vaccine and it was unremarkable. My platelet count at that time was 212. On 4/30/21, my platelet count was 144, which is lower than the normative value which is likely the cause of excessive/easy bruising.

Vaginal blood hemorrhaging started at 4am. Admitted to ER. Severe bleeding and passing of large blood clots. Required an emergency D&C and a blood transfusion, plus fluids.

Patient developed spotting within 3-4 hours of vaccine administration, and miscarried approximately 24 hours later. Patient was about 7 weeks pregnant at the time of vaccination.

As patient walked out pharmacy after her 1st moderna vaccine, she felt light-headed and dizzy. She temporarily lost consciousness and felt on the street. She hit her head on something that she can not recall and got injured on her knees causing some bleeding. A random person walking by called 911 for the patient so she got transported to ER immediately.

Miscarriage Got my first Moderna shot on 04/03/2021, second Moderna shot on 05/05/2021. Cramping on April 26, 2021 as I was 5 weeks pregnant, bleeding on 05/06/2021 confirming miscarriage. Last period was 03/25/2021, due date was planned 12/30/2021.

I received my 2nd vaccine and My period came 5 days early and I am bleeding heavy and clotting quarter size clots. Started about 8:30pm on 5/13/2021.

Patient received the vaccine Thursday 4/8/21 and on the Friday went to Hospital in complaining of not being able to breathe. A chest x-ray was done to rule out a PE. None was found. The following day the patient was called back and found to have a blood clot in her left calf muscle. She was treated and is now ok. I do not know specific test and dates. Hospital was the treatment facility. Patient did not know the name of the Doctor who treated her. We only found out about this adverse effect when we called her to schedule her 2nd dose.

Vaginal bleeding, cramps and headaches as of 5/13/2021 to present day. Period cycle was prior to vaccination and only last 3 days.

Menstrual cycle started after the first dose of Moderna. Continued through the entire next month (daily). Received the second dose and the cycle continued daily with heavy bleeding and enormous blood clots. Lasted 10 weeks. Stopped for 3 weeks. Started again and currently on day 16 of continuous menstrual cycle. Blood clots were as large as my palm with excessive cramping occurring. Using tampons made the clot presence and intensity worse too. Fainted twice in my bathroom after passing blood clots. Sometimes the blood clots fall into the toilet and sound like marbles hitting the water. The largest blood clot had smooth borders, could not be pulled apart, and was the size of my palm.

One week after the first shot I started having abnormal vaginal spotting. I have not had a period since before getting the first dose. I noticed extreme thirst hours after getting both doses that lasted about 24 hours.

I believe I was very early on in my pregnancy (as in, implantation or first week after conception) when I received the second dose of the vaccine. EDD was January 9th, 2022. I had brown spotting every day for the duration of my pregnancy, obviously concerning and something I paid attention to (though not altogether unusual in early pregnancy). I ended up miscarrying naturally at 6 weeks. I am strongly in favor and appreciative of this vaccine and would be surprised if there was a direct link, but I do know there is a growing conversation about its impact on women's menstrual cycles. I wanted to submit my experience just in case it was in fact a trend for other trying-to-conceive or early pregnant females.

Extremely tight and sore arm/ shoulder and neck up to occipital ridge. Hospitalized at later date for Rhabdomyolysis in same problem areas.

Red rash on both legs with purple pin point rash all over body with bruising. Low platelet count, low red blood cell count Diagnosed with Vasculitis, Thrombocytopenia

shortness of breath with exertion, syncopal episode. Patient found to have significant pulmonary clot burden and CT evidence of heart strain. O2 sats = 95% on room air. No family or personal history of thromboembolic events. Patient BMI = 47.6 kg/m2 and is sedentary. Vascular is consulted who treats with EKOS. Patient also has occlusive thrombus of the right distal femoral vein. Xarelto started at day of d/c.

Deep Femoral DVT diagnosed w/ Ultrasound on 6/11/21. Pregnancy's approximately 6 weeks at time of vaccine

The patient is an associate at this store. Per front end associate the patient called the store a few minutes after leaving and stated that she was calling from her car and couldn't see (blacking out) and she was shaking. Associate says she was incoherent and not making sense. She said she was on her way back to the store and her hands were going stiff and she was sweating a lot. Management came to the pharmacy at approximately 6pm to ask me to come outside to take care of an associate having an anapylactic reaction. I grabbed the Epipen and closed the pharmacy. As we were walking to the parking lot I was informed that the patient has just received a vaccine at the pharmacy. When we arrived to the patient, paramedics had already arrived on scene and they were preparing to take her to the hospital. I could see her shaking and her arms sticking rigidly out of the car door. The patient received her vaccine at 3:16pm on 6/15/2021, this was her second dose of the Moderna vaccine. She reported some side effects from the first vaccine including muscle aches, feeling "out of it" and having to leave work early.

Episode of atrial fibrillation/atrial tachycardia- responded to propranolol-had blood work which showed elevated d-dimer-had a neg cta-had an echocardiogram which showed elevated right sided heart pressures-follow-up right heart cath showed elevated pulmonary artery pressures with exercise- 2 points away from being dx with exercise induced pulmonary htn-6 min walk test oxygen dropped to 93 and heart rate was elevated-awaiting PFTs Since early april have been have significant SOB with mild acitivity along with episodes of tachycardia and bradycardia-also days with significant fatigue

5 days afterwards i had a grandmal seizure for unknown cause. No history of seizures. No symptoms prior to this event.

fluid around my heart again; Moderate swelling all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (fluid around my heart again) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Fibromyalgia, Bipolar affective disorder and Allergy to antibiotic. On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced PERICARDIAL EFFUSION (fluid around my heart again) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Moderate swelling all over my body). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERICARDIAL EFFUSION (fluid around my heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) had not resolved. The action taken with mRNA-1273 in response to the event was not applicable. The patient had right arm, leg back and left leg are all swollen and starting to get fluid around heart again. Treating with ibuprofen right now did the same after first vaccine. No concomitant medication information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

mild anaphylaxis, long term side effects too: brain fog, dropping things, hyper/hypoglycemia postprandial and nighttime, paresthesias, palpitations

Fluid around heart again; Moderate swelling all over my body; This case was initially received via another Manufacturer (Reference number: PVIUS2021001073) on 19-Jun-2021. The most recent information was received on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. The license partner had received the report from VAERS (Reference number: 1435708). This regulatory authority case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (Fluid around heart again) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Fibromyalgia, Bipolar affective disorder and Allergy to antibiotic (Ceflosporin). On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDIAL EFFUSION (Fluid around heart again) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Moderate swelling all over my body). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERICARDIAL EFFUSION (Fluid around heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERICARDIAL EFFUSION (Fluid around heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) to be possibly related. The patient had right arm, leg back and left leg are all swollen and starting to get fluid around heart again. Treating with ibuprofen right now did the same after first vaccine. No concomitant medication information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document received on 13 Jul 2021 updated report type as Regulatory authority case. Secondary reporter details added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Breast tenderness and vaginal bleeding. Bleeding was light and lasted about two weeks. I didn?t think much of it until I got my second shot and I started bleeding again the same day. The breast tenderness was worse after the second shot than the first, I will file a separate report for the second shot.

I was vaccinated for my 2nd dose of Moderna Vaccine on 5/4/21. We have been trying to get pregnant for months and I found out on 5/14/21 that I was pregnant. Confirmed with a hcg blood test at the urgent care on 5/15/21. Monday 5/17/21 at around noon, I just started spotting and went to MD right away. He ordered bedrest for the whole week but my bleeding didnt stopped and led to miscarriage.

Bilateral PE with significant clot burden, DVT in right lower extremity. Vascular is consulted. Catheter directed lysis of PE is performed. Rivaroxaban is initiated. At discharge, patient is instructed to stop birth control pills and follow up with vascular.

Anaphylactic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Misoprostol on 01-Jan-2016 and Amoxicillin on 01-Jan-2019. Past adverse reactions to the above products included Anaphylaxis with Amoxicillin and Misoprostol. Concurrent medical conditions included Cystitis interstitial since 01-Jan-2004. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 13-Apr-2021 to 20-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form. On 13-Apr-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Heart rate: high (High) Fast heart rate. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient had allergic side effect ongoing after vaccination for 1-2 weeks. In addition, the patient had allergic side effects to the Vitamin D3 supplement (SOB and tachycardia) and the Macrobid (anaphylaxis) which was after the moderna vaccine Based on the current 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 13-Jul-2021: Follow up information was received from initial reporter: Patient demographics, medical history, and treatment medications were added. Events dyspnea, palpitations, dizziness, tremor, Blood Pressure fluctuation were deleted and subsumed under anaphylactic reaction. This case was upgraded from non-serious to serious due to the addition of new anaphylactic reaction.; 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 am of child bearing age. The vaccine brochure did not state that I could get spotting but I started getting spotting after 3 days. Other than that I am fine. Just had minor achy arm at the injection site. I just wonder if other woman are experience this? And if this will affect my fertility?

Patient received first Moderna vaccine. While in observation period, patient stated she felt like she had "cotton" in her throat and her face was tingling. VS were taken. She was laying on the litter. Patient kept stating she was not able to breath. She stated she had anaphylactic reaction prior but does not carry an Epi pen as it is to other medications. Patient asked to take her mask off and lay on her side as her breathing felt worse. Code was called. Patient was administered Epi pen. She was taken via litter to ED for assessment. Patient monitored in ED and discharged.

Seizure occurred about 22 hours after vaccine. Unclear if related to the vaccine or recent changes in medications. Patient does not typically have generalized clonic-tonic seizures but had a 2.5 minute GTC seizure the day after vaccination.

Headache and chills about 12 hrs after the shot, L arm soreness about 3 hrs after, HA and chills resolved within 36 hrs. Vaginal bleeding/spotting occurring about 48 hrs after and is currently still happening. Menstrual cycle is not due for another 1.5 weeks.

Within a minute, there was a different taste in my mouth. Shortly after, began to feel incredibly hot, flushed, burning, and tingling throughout body. Throat and tongue also became tingly. It was like a wave that moved through my body. After waiting it for a few minutes to see if there was improvement, there was a strong ?wave? that came with all of the above, but my heart started racing with palpitations. HR was 120. The heat feeling became worse. Would describe the feeling as a CT contrast feeling, including the feeling of voiding or heat/burning of the bladder. Tongue and throat more tingly. A few minutes later the feeling all became stronger and this is what became the strongest ?wave? of the feeling with my heart beating incredibly fast. The heat/burning/tingling (including the mouth and tongue) were severe. HR 148. Nauseated and lightheaded/dizzy. Transferred to ED. In the ER, epi was administered due to the persisting flushing/burning of the skin/and tingling of the throat and tongue with tachycardia. IV fluid bolus, Benadryl, and zofran were also administered. Tryptase was obtained approximately 35 - 45 minutes after injection. Tryptase 10.8. Improvement in all symptoms following epi/benadryl. Was monitored in the ER and within approximately 1.5 hours, the burning feeling returned, but was centralized in my core (felt internal versus skin). Abdomen/chest area with intermittent burning. At approximately 2-3 hours, the tingling began to return. Slight tingling of the tongue, lip. The burning feeling continued to worsen, now back to the skin as well as the core, and additional benadryl was administered in addition to solu-medrol. Prior to this, the attending physician was concerned that my heart rate remained elevated into the 110/120s 3 hours after the epi administration and she recommended transfer to an adult facility for further evaluation. Due to the burning in my chest, EKG was obtained. Sinus tachycardia. Slight chest tightness, duoneb provided. Had not taken inhalers throughout the day and felt similar to tight chest/difficulty getting deep breath in relation to asthma. Relief after the second dose of benadryl and duoneb. BP remains elevated from shortly after vaccine administration. Transferred to MVH at 4-5 hours post vaccine. En route to facility, HR 130s and BP lower (90s/60 and 90s/50s) - Medic did not think was accurate BP. At MVH, cardiac rule out completed with additional EKG due to development of some chest pains and return of core burning sensation as well as ongoing tachycardia. EKG remains sinus tach, troponins normal. Requested anxiety medication to see if that would help with heart rate. Low dose ativan given. Minimal change to resting heart rate, still elevated. Also received 4 baby aspirin and tylenol for extreme headache. Oxygen saturations were 97-100%. Oxygen saturation at MVH was 90-93%. Attending physician not concerned with going home and saturation still being low 90s as long as there was no shortness of breath. Discharged home with methylprednisone 4 mg 6 day pack and pepcid prescriptions. Resting HR was low 100s at time of discharge. Instructed to continue with antihistamines every 6 hours. DX anaphylactic reaction. Husband checking on me while sleeping, oxygen saturation in sleep 89-91%. After awakening, saturation improved to 94-95%. At home, burning skin and core feelings persisted. Tingling of the throat/tongue/lips continued to be intermittent. Antihistamines helped to relieve symptoms. 26-28 hours after vaccine, symptoms were very strong, was suffering from extreme burning and tingling of the mouth/lips. Considered return to ER but oxygen saturation was okay. HR elevated. 125 at rest. MVH attending physician encouraged me to try to not use the prednisone packet unless necessary/return of symptoms. Started prednisone with the return of symptoms. Continued on routine Benadryl until myoclonic jerking became too pronounced, discontinued on 12/25/2020 and changed to hydroxyzine. Jerking remained but improved and was less bothersome. Continued taking daily dose of Claritin, daily pepcid, daily aspirin. Hives developed 12/25/2020. Return to ER on 12/29/2020 as the jerking was intense and felt to be in chest along with palpitations. EKG and troponin was good, only notable thing physician reported on labs was an elevated WBC count. Did not discuss jerking. To PCP on 1/4/2020 - discussed adverse reaction. Continued problems after vaccine include: intermittent tachycardia (low 100s at rest occasionally vs norm of 70s/ low 80s), higher heart rate when active, burning skin (feels similar to bad sunburn feeling), random pains and occasional brief numbness/tingling/tremoring in muscles/extremities, jerking (continues to improve - recommended change off of benadryl/hydroxyzine to zyrtec), increased need for inhaler, bubbling sensation in left lower abdomen. It does feel as if it comes in waves. Burning sensation, internal tremors of left upper thigh, and intermittent tachycardia continue, 1 month post vax. Antihistamines do help, but discontinued due to jerking. Continue on daily claritin.

Anaphylactic Shock. 10 minutes after injection - vomiting, shortness of breath, throat swelling, chest pain. Self-administered EpiPen and went to the ER, given multiple doses of epinephrine, solumedrol, Benadryl, Pepcid. was monitored overnight and sent prednisone and Pepcid.

Unusual amount of blood dropped down my arm immediately after the injection (seemed strange for an injection in the upper arm). Redness and swelling at injection site that progressed over night and the next days becoming a hard red lump. Very itchy on the same day of the injection and following days.

Sweating, low-grade fever, chills, body aches, exhaustion, headache. I took Tylenol for 24 hours starting when I woke up at 6am to help with symptoms. It took about 36 hours for my symptoms to be gone after they started. I was also on my period when I received the vaccine. My period seemed to slow down almost completely while my symptoms were happening, and then my period resumed with abnormal cramping and clotting after my symptoms were gone.

Started bleeding the 17th, went to the doctor OB/GYN office and had an Ultrasound - I was supposed to be measuring at 8 weeks and I was measuring at 6 weeks. Miscarried. My due date 9/26/2021 would have been due date; That was my fifth pregnancy. That was my 3rd miscarriage. I have had two full term vaginal deliveries.

Chronology of Events: March 19th 2021-One day post vaccine, severe headache developed along with flu like symptoms and pronounced malaise March 20th 2021-Continued symptoms from previous day and additionally bleeding vaginally (had cycle end over a week prior to vaccine dose 1) March 21st 2021-Severe hemorrhaging vaginally with large amounts of clots developed. Completely saturated overnight pads at a rate of about 1 per hour. Began at 7pm. Had never had bleeding like this before with other cycles. Unable to control so went to local Emergency Department in the where we are stationed. Unable to determine a cause for the bleeding, was put on TXA to help control. Discharged at 0400 March 22nd. March 22nd 2021-Continued to have excessive bleeding, and continued TXA treatment during day at home with Rx. Follow up made with GYN doctor for Wednesday March 24th. Headache has continued this entire time.

Delayed Anaplyactic Shock. Patient awoke with swollen face and trouble breathing. She went to Urgent Care. She was given an IV steroid that helped. Further details of treatment are unknown to me. She was still experiencing swelling of the lips the day after (03/24/21) that was self treated at home with oral Benadryl.

I started to feel pain in both knees going down both legs around 4/1/21. An ultrasound was performed and a blood clot was found in my left lower leg.

Due date 4/18/2021. Pt presented in labor on 4/10/21. Her labor was uncomplicated and progressing appropriately. She had sudden onset of coughing following by loss of consciousness. Code blue was called. Emergency bedside C/S was performed. Despite resuscitative efforts of 1 hour and 15 minutes, the patient expired.

Five days after. My second Moderna vaccine, my period came weeks early and was heavier than usual. Then I had another period about one week later. Now I am having cramping and spotting/irregular bleeding.

I have endometriosis and my periods are heavy with painful cramps first 2 days and my period is done by the 4th day. I take aleve a day before my period which helps with my cramps. My last period started April 9th and I am still on my period today April 15th. I had heavy bleeding and blood clots the size of quarters for the first 5 days. The aleve didn?t seem to help and my pain level was at a 10, I would pass out from the pain. My period usually last 4 days and I am on day 7 and still bleeding, but not experiencing any cramps. I?ve read that Covid effects the blood clotting process and also read other women are experiencing heavier menstrual cycles after their covid shot. I also read that moderna didn?t study any side effects related to the menstrual cycle. I have an appointment today (April 15th) to get my second shot. I am not sure if I should get the second shot, due to the amount of clots I had.

Stroke in pregnancy. 4/8/21 35YF, 29 weeks pregnancy with stroke about 2-3 weeks after second vaccine dose. Past medical history significant for migraine headache with visual aura. She also has a history of kidney stones. 4/8 She presents to the emergency department for acute onset of right sided weakness. This occurred while she was cooking French toast for her kids and she noticed that she had a sudden onset of right arm weakness. She says it was "floppy". She was unable to lift it. A few minutes later, she noticed that her tongue felt "fat" and she was unable to speak properly. Her words sounded very "thick." She did not notice any drooping of her face. About 5 minutes later, she noticed that her arm weakness resolved and the sensation in her tongue resolved. 4/8 with some paresthesias of her right face and right arm. 4/9 Subjective; no weakness, Discharged home 4/9/21 on Aspirin

35 y/o with asthma (on alvesco and singulair), GERD, morbid obesity (BMI 45) and RA (on prednisone and MTX, SZA.) Vaccinated for COVID 2.12. and 3.10 Recent lab 3/17- normal, including negative CRP. Code continued for 50 minutes, no shock advised. PEA, gave Epi X 4. Normal BS. Considered narcan. Over the weekend- 4/17 Chest pain that started with eating. Labile blood pressure. EKG showed NSR rate 64. Treated with ASA 325, clear liquid diet and rest. Treated with toradol and Zofran. Improved. At f/u on Monday, discussed chronic knee pain was overall better. Normal for her exam. BP 136/79. Felt dizzy and then passed out, hitting her head, became pulseless an apneic and was coded for over an hour.

Weakness, fatigue, muscle aches, starting 3 days after first COVID Moderna vaccine, then worsened to fatigue causing her to stay in bed. Some bleeding gums on brushing, no other bleeding or ecchymosis noted. She went to hospital 2 weeks after vaccine. Myocarditis diagnosed in hospital with elevated troponins, also thrombocytopenia and elevated D Dimer.

2 days after the vaccine (on 2 May), I woke with an accelerated heart rate, chest pain, tightness of chest and shortness of breath. I presented to MD where they took my vitals and an EKG. The doctor called an ambulance for me as she assessed I was potentially displaying signs of pulmonary embolism. The ambulance took me to the emergency department. I ultimately stayed there two nights, and following many tests was diagnosed with acute pericarditis versus myopericarditis. My admitting doctor and the cardiologist both advised that while they could not be 100% certain, the pericarditis could very well be an adverse reaction to the Moderna COVID-19 vaccine. The admitting doctor told me she would report it as an adverse reaction. I am now on colchacine anti-inflammatory medication for 3 months and have one follow-up with the cardiologist to come.

I was 7 weeks pregnant at the time of receiving Dose 1 of the Moderna Covid vaccine. I began experiencing vaginal bleeding on Wednesday April 28. The bleeding continued and began heavier so I went to Urgent Care on Friday April 30. May 1 I experienced a miscarriage and lost the pregnancy.

This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (felt out of it) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker and Detergent sensitivity (Thirteen years ago, contact allergies with Woolite and Tide laundry detergent) since 2008. Concomitant products included AMFETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 30-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (felt out of it) (seriousness criteria medically significant), ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DIZZINESS (felt dizzy), FEEDING DISORDER (unable to eat until 4pm) and DYSPNOEA (hard time breathing). On 30-Apr-2021 at 1:00 PM, the patient experienced OROPHARYNGEAL DISCOMFORT (throat started to clamp up). On 01-May-2021, the patient experienced PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat). On 30-Apr-2021 at 4:00 PM, FEEDING DISORDER (unable to eat until 4pm) had resolved. At the time of the report, ALTERED STATE OF CONSCIOUSNESS (felt out of it), ANAPHYLACTIC REACTION (anaphylactic reaction), DIZZINESS (felt dizzy) and OROPHARYNGEAL DISCOMFORT (throat started to clamp up) was resolving and DYSPNOEA (hard time breathing), PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient has never had a reaction to vaccines or latex. After waiting in the vaccinating provider's observation area, she felt fine. On the drive home she felt dizzy and a little out of it. Her Epi-Pen had expired. She took Claritin and laid down to see if the reaction would get better or worse. The symptoms got better 2.5-3 hours (3:30-4pm) later. Things were better and she felt fine. She took Claritin for a total of 4 days following the injection. She did contact her healthcare professional, who referred her to an allergist and her appointment with the allergist is pending. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile.

Anaphylaxis: 1:45pm- Immediately upon receiving vaccine noted dry mouth 1:45-2:15pm- Waited at facility to monitor for reactions. Dry mouth sx increased and noted increased sweating from under arms. Cleared to go home as no other sx noted. 3:00-5:00pm- intermittent dry cough started 5:00-6:30pm- interior mouth, cheeks, lips and tongue started to feel like they were swelling, took 2 Benadryl 6:30pm-7:00pm- tongue, lips. and cheeks swelling increased. Lisp when speaking. 7:23pm Took 1st Epi-pen and headed to ER. On route to ER chest developed rash and voice became hoarse with episodes of nausea. In ER hands and forearms showed rash. Received IV Benadryl, Epi, and Pepcid. Discharged after 3 hours observation.

This is a 35-year-old female, G2, P1 Ab0, 23 weeks pregnant, who presents to the emergency department for chest pain. Patient reports receiving her second Madura COVID-19 vaccine yesterday at around noon. She states that later that evening, she reports onset of fatigue, and pleuritic chest discomfort. She reports increasing in discomfort into this afternoon, with shortness of breath. She also reports body aches, and bilateral lower extremity calf pain. No fevers, or chills. No nausea, or vomiting. Patient is currently being followed by doctor of OB/GYN, with whom she had a conversation with this morning. Doctor already recommended she come in for evaluation. Otherwise patient denies any vaginal bleeding, discharge. No urinary symptoms. No prior history of a cardiac or pulmonary disease. No lightheadedness, dizziness, or syncope. No prior history of DVTs, pulmonary embolisms.

Can?t say if it?s related or not but I?ve been sick for almost a month now so I?m really starting to wonder. Developed cellulitis on my lower right leg on Thursday, was put on Keflex on Friday, then switched to Bactrum on Saturday. By Sunday, the abscess was large and my leg was swollen double the size, red and hot to the touch. I spiked a fever and felt very ill. I went to the ER Sunday night. Was told I was septic and was admitted. Transferred to another hospital on Tuesday. On Thursday, I had surgery to cut out the abscess (I&D). The following Sunday, my right foot and ankle became so swollen and red, another surgery was considered. Miraculously the swelling and redness went down through the night. I was sent home with a PICC line and IV antibiotics - Vancomycin. My Vanco trough kept showing low levels and I?m now on a dose of 1500mg 2x day. I am fatigued, nauseous, constant headache, spiking fevers 1-2 times a day for the last 7 days, my WBC and RBC is very low, I?m considered anemic now, waking up with night sweats when I do finally fall asleep...feels like no end in sight.

Immediate burning in my arm as the vaccine was injected. Soreness in my arm there after. In the next 24 hours I had trouble concentrating and remembering anything. I felt like I had pregnancy brain. This lasted for almost 5 days. I woke up and found my ear had started bleeding at some point. Sever headache and nauseous for the next 2 days.

Borderline septic; Small bowel obstruction; Post surgery ileus; Stomach still hurt; Was not able to use the restroom; Severe abdominal pain; Back pain; Vomiting; Soreness at the injection site; Fatigue; Loss of appetite; Flu-like symptoms.; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (Small bowel obstruction), SEPSIS (Borderline septic) and POSTOPERATIVE ILEUS (Post surgery ileus) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20a and 013m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse reaction with Flu shot. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), INFLUENZA LIKE ILLNESS (Flu-like symptoms.), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (Fatigue). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach still hurt), CONSTIPATION (Was not able to use the restroom), ABDOMINAL PAIN (Severe abdominal pain), BACK PAIN (Back pain) and VOMITING (Vomiting). On 08-Feb-2021, the patient experienced SMALL INTESTINAL OBSTRUCTION (Small bowel obstruction) (seriousness criteria hospitalization and medically significant) and SEPSIS (Borderline septic) (seriousness criteria hospitalization and medically significant). On 12-Feb-2021, the patient experienced POSTOPERATIVE ILEUS (Post surgery ileus) (seriousness criterion medically significant). The patient was hospitalized from 08-Feb-2021 to 11-Feb-2021 due to SMALL INTESTINAL OBSTRUCTION. The patient was treated with MAGNESIUM CITRATE on 12-Feb-2021 for Postoperative ileus, at a dose of UNK dosage form and Surgery for Small intestinal obstruction. On 14-Feb-2021, POSTOPERATIVE ILEUS (Post surgery ileus) had resolved. In February 2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms.), ABDOMINAL PAIN UPPER (Stomach still hurt), CONSTIPATION (Was not able to use the restroom), ABDOMINAL PAIN (Severe abdominal pain), BACK PAIN (Back pain), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Fatigue) and VOMITING (Vomiting) had resolved. At the time of the report, SMALL INTESTINAL OBSTRUCTION (Small bowel obstruction), SEPSIS (Borderline septic) and DECREASED APPETITE (Loss of appetite) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Computerised tomogram: abnormal (abnormal) Showed a small bowel obstruction and was borderline septic.. In February 2021, Pathology test: normal (normal) Part of the removed intestine was sent to pathology, nothing was found.. In 2021, X-ray: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. On 08 Feb 2021, due to severe abdominal pain and back pain patient went to emergency room. Patient was diagnosed with small bowel obstruction with borderline septic during the emergency room visit. Patient had surgery in which 10 inches of small intestines was removed and had resectioning. On 12 Feb 2021, patient experienced post surgery ileus and NG tube was placed, patient's stomach pumped, and magnesium citrate was given via the NG tube to clear. Patient stayed in the hospital and was released on 14 Feb 2021. Patient had bloodwork done to rule out blood disorders or clotting disorders and the results were pending at the time of this report. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0. Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth. Based on the current 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-2021-011644, MOD-2021-011644 (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.

R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction N17.9 - Acute kidney failure, unspecified

Around 10 pm chills, fever (102°F around 1am) and migraine exacerbated to pain level 10, chest pain with every breath at around 11 am day after shot. Feeling faint. Chest pain worsened the next day after ER visit, pain with every breath, accelerated heart rate, shortness of breath with mild activity, feeling weak and faint.

Patient presented to ER with headache and cough. Patient was admitted on 06/28/2021 for pneumonia and respiratory failure. Patient discharged 07/06/2021

After the 2nd dose vaccine, I am pregnant and go every week for check up since I am high risk. On 4/7/2021, protein was found in my urine which is a indicator for preeclampsia /high blood pressure. I would go in for doctor's visit weekly to check my bp reading. My bp readings were 150/90 range and I had to be induced at 37 weeks. The baby is healthy but had a little jaundice at birth. I was put on bp medication labetatol for 3 weeks. After the deliver, I had 4 episodes of bleeding and hemorrhage. I was found to have retained placenta and had surgery on 5/2021 for that and was hospitalized for 3 days (Hospital).

Sick day of shot, bad cough within 5 days, misdiagnosed with bronchitis, started passing out, x-ray shows blood clots.

On May 21, 2021 I had a positive pregnancy test. We were preventing conception and were very surprised. On 5/27/21 at 12:30 pm I started having vaginal bleeding and went to Hospital ER where I was told I was having a miscarriage. I have had two pregnancies and 2 lives births, no previous miscarriage

Had Chest pain 7/19/2021 went to er and was diagnosed with pulmonary embolism. Started on rivaroxaban/ xarelto. Was discharged from ER same day. Stable. Would not say she is "recovered" as we are early out from PE. Stopped combination oral contraception.

Trouble breathing. Chest tightness, hives, redness, started at 10:08 and it was called as a code at 10:15 and they administered epi

Nausea, hives, anaphylactic shock, throat swelling, hypotension, headache, dizziness, weakness . The symptoms returned at 1:25pm the best day as well. I?ve now had two anaphylactic reactions

Patient presented with diffuse petechiae, easy bruising and oral bruises. She has a history of stable ITP with her last required infusion of IVIG 12 years prior during pregnancy and monitors her CBC every 6 months. Her baseline platelet count is ~50-60k. She received treatment with dexamethasone 40 mg IVPB x 3 doses and IVIG 95 grams (1 gram/kg) IVPB x 2 doses.

Full anaphylactic shock; Hives; Low blood pressure; Dizziness; Stuffy nose; Bad headache; Nausea; A spontaneous report was received from a healthcare facility staff member who was a 36-year-old, female patient who received Moderna's COVID-19 Vaccine, and who developed full anaphylactic shock, nausea, hives, low blood pressure, dizziness, bad headache, and stuffy nose. The patient's medical history included a latex allergy and pregnancy. Concomitant product use was not provided by the reporter. On 06-Jan-2021, approximately 30 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 01122019) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received her Moderna vaccine on 06 Jan 2021 at noon. She reported that approximately 30 minutes after receiving the vaccine, she went into full anaphylactic shock. She stated that the reaction began with nausea. She then developed hives, got low blood pressure, and was dizzy. She was taken to the hospital. There, she received two rounds of epinephrine along with diphenhydramine and famotidine. She was released that same day from the hospital once she stabilized. On 07-Jan-2021, a full 24 hours after receiving her vaccine, she experienced another anaphylactic reaction. She stated that the reaction happened exactly like it did on 06 Jan 2021 and presented with all the same symptoms. Patient injected herself with the epinephrine pen that she had at home as soon as the symptoms started. In addition to the anaphylactic reactions she experienced, patient reported that she had a bad headache since receiving the vaccine as well as a stuffy nose that comes and goes and coincides with hives. As of 10 Jan 2021, she stated that the flare ups had finally subsided, however, she continued taking diphenhydramine and famotidine as prophylaxis for anaphylactic reaction. Treatment for the event included epinephrine, diphenhydramine, and famotidine. Action taken with mRNA-1273 in response to the events, full anaphylactic shock, nausea, hives, low blood pressure, dizziness, bad headache, and stuffy nose, was not provided. The events, full anaphylactic shock and low blood pressure were considered resolved on 07 Jan 2021. The events, nausea, hives, and dizziness were considered recovered/resolved on 10 Jan 2021. The outcome of the events, bad headache and stuffy nose, were not reported.; Reporter's Comments: This case concerns a 36-year-old female patient with medical history of latex allergy, who received their first of two planned doses of mRNA-1273 (Lot 01122019), and who experienced the serious unlisted event of Anaphylactic shock, the non-serious listed events of Headache and Nausea, and the non-serious unlisted events of Urticaria, Hypotension, Dizziness, and Nasal congestion. Based on the current available information and temporal associon between the use of the product and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Received vaccine on 1/4. Started menstrual cycle on 1/16 which was 1 week early. 3 days into the cycle, heavy vaginal bleeding with large blot clots (golf ball size) starting on 1/20/201 and continuing until now 1/31, bleeding still going on.

6 minutes after receiving vaccine patient reported that her tongue was starting to swell and that her heart was racing. Staff called 911 immediately. Pulse was 166-169, BP 125/88, O2 sat 97%. No wheezing, and the patient was moving air and talking. I had an epi-pen on hand but waited since patient was moving air and had such a high HR. After a few minutes patient reported she felt better and that her tongue was still swollen but not any more so; HR 120s, O2 sat 97%. EMTs arrived 10:39 a.m., got the same VS, and they decided not to give epinephrine. Patient was initially reluctant to be transported by ambulance and intended to have sister drive her to ED. However she reported her tongue was overlapping her teeth all the way around, and was persuaded to go by ambulance. She walked out of public health clinic into ambulance. She was treated with IV Benadryl and steroids. The ED doctor diagnosed anaphylactic reaction but also did not give epinephrine due to tachycardia. She felt better, but 4 hours afterward she did have a rebound reaction and was treated with more Benadryl and again felt better. She was discharged from the ED with 2 epi-pens. She currently feels well. States that they are having her take PO Benadryl q 4 hours x 48 hours. She was treated in the emergency department.

Anaphylaxis While driving home: difficulty breathing, tightness in chest, swelling of tongue and lips, difficulty swallowing, tingling in left arm

2/6 I had the 2nd Moderna vaccine. On 2/7-2/8 I had body aches, chills, and 99.4F temp. On 2/9 those symptoms subsided, but I started to get right-sided flank pain with pain on inhalation. I took acetaminophen and ibuprofen around the clock, used a heating pad on 2/9 and 2/10, but pain progressed. Mid-day on 2/10 the pain was so severe, I went to urgent care. They said it was gastritis and released me. I went back 2 hours later and saw a different doctor. He diagnosed me with a pulmonary embolism, pulmonary infarction, and pleural effusion. I was sent by ambulance to the hospital and admitted. I was treated for pain and started on Eliquis. I was discharged the evening of 2/12. The morning of 2/13, I woke up with 100.6 F Temp and 85% O2 at. I went to urgent care again, they thought I had pneumonia and referred me to the hospital. I was admitted to a different hospital on 2/12 and continue to antibiotic s and a heparin drip

Had a slight rash on the front of my chest and one big round rash on my back. I also started to have vaginal bleeding when I wasn?t due to have a period. The rash got progressively worse, to spread all over torso back and front. Vaginal bleeding also continued to worsen. Went to ER to have labs checked, was told it looked like Pityriasis rosea- and that all lab values and clotting factors were normal. Sent home with prescription for Atarax if needed. Was told it would be self limiting but if worsened to come back.

Anaphalaxis: hives, flushing/redness, itchiness, tongue swelling/tightness in chest. Self-administered Auvi-q epinephrine, went to the Hospital, received prednisone, pepcid, benedryl. Prednisone taper for 4 days after

Allergic reaction; Syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe; Syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe; Administered another new dose; A spontaneous report was received on 12 FEB 2021 from a pharmacist concerning a 36-years-old, female patient who received second dose of Moderna's COVID-19 vaccine and had syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe developed allergic reaction, heart racing, arm was on fire and throat was itchy and was administered another new dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 on 28 Jan 2021 (LOT number: unknown) for COVID-19 infection prophylaxis. On 28 JAN 2021, patients received second dose of mRNA-1273(BATCH/LOT number: 025J20-2A) in the right upper arm for the prophylaxis of COVID-19 infection. On 28 JAN 2021, when patient received the vaccine, the syringe was "malfunctioned", and the vaccine ran down patient's arm. Vaccine administrator noticed there was still some vaccine left in the syringe and thought the patient did not receive that dose because it was leaked down patients arm. The patient received another new dose. After receiving vaccine, patient had an allergic reaction, heart racing, arm was on fire and throat was itchy. Treatment for the events provided was diphenhydramine. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event's allergic reaction, heart racing, arm was on fire and throat was were unknown. The outcome of the events syringe malfunctioned, and the vaccine ran down patients arm noticed there was still some vaccine left in the syringe developed and administered another new dose were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Large red rash appearance around injection site. Began to get bigger. Then part of it disappeared and reappeared further down my arm with pain upon touch or movement. Woke in the morning with a bad nose bleed (took about 20 minutes to control it) On birth control, yet I have been having ?spotting? for the past few days and period is not due for another 2 weeks.

2/22: RLE started to swell, attempted to elevate overnight but no improvement 2/23: 2+ pitting edema in RLE warm to touch 2/24: 2+ pitting edema in RLE warm to touch, painful and SOB 2/24: went to er: dopper on Right leg and CT with contrast of chest 2/24: admitted to hospital for bilateral PE and DVT in RLE

Passed out approximately an hour after vaccine administration after waiting in the facility for over 30 mins, while driving. Stopped breathing, broke bones in 8 different places in my face requiring surgery. Still recovering.

On the following day after receiving my first dose of the vaccination, my arm was throbbing, completely swollen, decreased ROM and skin was RED and severely tender to the touch. Took OTC Tylenol (2) po and had no signs of relief. Pain , swelling, and skin redness lasted for 3 days. On February 10th, 2021 I had a positive pregnancy test (confirmed by bloodwork and urine) which indicated I was 6-7 weeks pregnant and had a miscarriage on March 2021, after giving live births 3 prior times. The cause of the miscarriage is unknown. I also developed a blood clot on the arm that was inserted for an IV. I have no family history or personal history of needing blood thinners.

pt received her first covid vaccine on Thursday. Friday had some soreness of the right arm, fatigue. sunday march 14th evening she noted some axillary pain, by Monday had more severe pain and noted swelling and discoloration of her right arm and hand. she went to the ER and had labs and ultrasound confirming dvt of right upper extremity.

Following her vaccination after she got home she experienced muscle aches and pain, also at sites different than the administration site. Feelings of faintness for about two days, blurred vision for a couple days. Hairloss. Vasculits in the arms and legs. Atrial Fibrilation which lasted only the night of the vaccine. Vaccine administration arm coldness and temperature drop. Patient reported the symptoms to her doctors and they recommended she get the second shot

Severe headache and abdominal cramping the day after on 3/19. Followed by worsening cramps and vaginal spotting from Saturday 3/20, Sunday 3/21, Monday 3/22 and Tuesday 3/23. Ultrasound was done on 3/23/21 at 14 weeks 1 day pregnant and no fetal heartbeat was found. EDD was 9/20/21

Working full time during this post injecting time but 2days later sarted with nausea and vomiting and then itching and then next day asthma started to flare up and by the next day it developed into full blown exacerbation. As everything worsened and couldn't control anymore with inhaler and even tried nebulizer, I went to hospital. I went to ER that day on 2/17. They did breathing treatments, several Blood tests, chest xrays, Epi injection, IV steroids and several other meds, oxygen, and was admitted. As it worsened I had to be intubated 3 different times, where I would get to point they thought could be weaned off and for a day or two and would be a little better and then would worsen again requiring me to be reintubated for a total of about 10 days on the ventilator. During this time on vent second time I developed pneumonia, staph/MRSA, UTI. After being put on vent 3rd time I had to be life flighted to bigger hospital ICU. Then after a few days they were able to wean of ventilator but during which time I developed laryngospasms. I continued to improve with breathing but mentioned I had leg pain and the said probably due to low sodium and lack of mobility. I was finally released on 3/5 and discharged home with home health but sent home in supplemental oxygen due to says dropping and poore tolerance without sitting O2 stay at hospital prior to DC home. After getting home the next day or two right leg pain worsened along with breathing worsenining and HH sent me to PCP who discovered blood clots and sent me to local er, that day which was 3/8. That hospital evaluated breathing issues and took blood work and chest xrays, started me on heparin drip and sepsis protocol and then called in life flight to send me to bigger ICU hospital within a few hours after arrival which they debated on ventilator or bipap but ended up on bipap and flown to hospital. There I was treated for breathing issues, infection, clot, vocal cord dysfunction from the multiple intubations then sent home when stable again with home health RN, PT, PT and ST. Also during all this hospital stay I was treated 4x for covid and all negative. Then after coming home this last time on 3/13 i had 15-20lb with gain in a little over a week and in 3 of those last days almost 9lbs with abdominal distension and chest pain/ nausea/ dizziness/low BP but fluctuating high at times / high Hr, so referred back to PCP 3/23 who sent me to ER that day concerned of abd blessed, kidney and or liver issues/sepsis/etc. PCP sent to ER. They did blood work and Abd CT and xray not showing anything and blood levels of liver slightly elevated, with blood in urine and so they said nothing of concern even though I went from looking normal to 6/7 months pregnant in less than a week. Followed up with pulmonologist who said bases of lungs hypoventilated, PFT very poor, wheezing and tight and WBC still up and gave me more steroids and asthma meds. Went to urologist due to blood in urine and also having urinary retention. They advised me to self cath and I will follow up in 1 month to determine if they need to do more tests to look into it more. PCP still concerned about these new abd. And other symptoms, and referring to specialists (cardiologist, Gastrointerologist, and Nephrologist) along with others already seeing too find the root of what are causing these new problems and if other organs are being affected with this whole immune response. I work full time, had 3 kids and works out with no limitations in my daily activities or ability to function, however since all this and being the hospital for pretty much most of laar month, the ongoing breathing issues (which I'm still requiring O2 at home) and all the other medical issues and the physical weakness/ lack of cardiopulmonary endurance I am unable to work (on short term disability/FMLA) and limited to home with ability to do much at all. Now I'm left with decreased income and tons of medical bills to come which is very concerning in itself how I will even pay since i can't work right now, but the most concerning is I'm still in this waiting game to figure out why things are not improving that much and why these other symptoms are arising. I have worked my whole life and love my work and my life and was trying to protect from this horrible virus by doing my part and getting vaccinated. But it seems that my life went from nothing wrong to one crazy medical reaction to another after this 2nd covid-19 19 moderna injection.

At the time of my first vaccine on 1/14/21 I was 9 weeks pregnant and on lovenox for DVT and progesterone for pregnancy maintenance. On 2/5/21 I miscarried the baby and ended up hemmoraging thus requiring a blood transfusion. The fetus was sent to pathology and I was informed that at 12 weeks when I miscarried that the baby had termed at 9 weeks which was the time of my first vaccine injection.

My right arm was swollen and in a lot of pain, my stomach hurt, and I started to get very itchy. I was lethargic and had no energy. I went to the Urgent Care listed above, and I was given a steroid shot. However, I was diagnosed with a double ear infection and pneumonia after complaining of chest pain. I made a Teledoc appointment, and they couldn't decipher if I had Covid or a reaction from the vaccine.

Initially I had arm soreness at the area of the shot. Saturday evening following the vaccine I had pain in my left side of the neck. Sunday the pain went from the left side of my neck down to the base of my ribs and then progressed to include the back and chest almost constantly instead of just on inhalation. I went to the ER on Sunday evening, assuming very bad costochondritis; however, was diagnosed with multiple pulmonary embolisms in the left lung, areas of possible infarction, and pleurisy. I had a CT scan at a Medical Center prior to receiving the Moderna vaccine for a suspected PE and it was negative.

Menstrual cycle started 9 days early and pretty heavy. Usually on schedule and not as heavy bleeding or clotting/spotting.

Participant had mild systems after her first dose, mild generalize pain. About 5 min after her second dose, developed generalize rash, numbness of tongue, audible wheezing and stated was getting difficult to breath. Administered 0.3 mg of epi in opposite deltoid. Responded well to epi, improved respiratory status. BP taken after epi administration was 215/140 and came back quickly to normal limits for her. EMT came started an IV and administered Benadryl. Taken to hospital. O2 sats were < 80 but came up quickly in the ER. In the ER received Solumedrol, another dose of Benadryl and Pepcid. She was released about 2 hours after arrival. She has called her provider to report the incident and waiting for a call back. Is also going to see an alergist.

Got the vaccine on 14th (14th days after getting Tdap - I was 27 weeks pregnant when I got that vaccine) - 29 weeks pregnant when I received this COVID vaccine; on the 18th - mild placenta obruptions; bleeding and cramps for a couple of days. They did a stand rule out of pre-term delivery. I had a course of Steroids (beta methasone) and Magnesium Sulfate - within 36 hours I was doing much better. No new bleeding, contractions have gone away. I may be able to go home from hospital soon. I entered the hospital the 20th at midday. Another doctor who has been treating me at this same Medical center This is my 3rd pregnancy - hopefully it will be my second child. June 30, 2021 - estimated date of delivery.

This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2001, 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 an unknown date, the patient experienced ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was unknown. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Hands began itching, later led to anaphylaxis Itching, loss of consciousness, red, hives, difficulty breathing, face, hands, mouth, tongue, throat swollen, face and mouth numb, nausea, stomach distress, drop in blood pressure, increased heart rate, sweating

Chills, muscle pain, headache, fatigue, dizziness, weakness 8 minutes after shot, anaphylaxis 1.5 hours after shot.

I got my period when I should not have. I was on Day 12 of my cycle, which is very regular, and got my period again for the second time in two weeks. I started spotting the morning after getting ym vaccine and was bleeding heavily by the next day. My period lasted five full days and was heavy on each day. When I received my second shot I also got my period right away, however, this was 28 days after the first shot so it as not as alarming.

brain hemorrhage; Can not Walk; Can not speak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not Walk) and SPEECH DISORDER (Can not speak) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. 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 19-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (brain hemorrhage) (seriousness criterion hospitalization). On 30-Apr-2021, the patient experienced WALKING DISABILITY (Can not Walk) (seriousness criterion intervention required) and SPEECH DISORDER (Can not speak) (seriousness criterion intervention required). The patient was hospitalized on sometime in April 2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (brain hemorrhage), WALKING DISABILITY (Can not Walk) and SPEECH DISORDER (Can not speak) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient ended up going to Hospital by ambulance and underwent t emergency surgery. She stayed in ICU and in at the time of report, she was still hospitalized.; 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.

5 mins after receiving COVID-19 Moderna vaccine, patient started vomiting every 15 mins. MD called to examine. audible wheezing. patient complained of very dry throat progressing to tight throat States that she's had vomiting after receiving an asthma IM med. Vital Signs Height 58.75 in, BP Left Arm:142/94, Heart rate 113 /min, O2 saturation 100.

Almost instantaneous ovary pains, blood clots passing vaginally, abnormal vaginal bleeding for two weeks

Patient took ibuprofen on sat 5/15/21 4am and around 1pm due to fever from vaccination. Patient first noticed petechiae on left wrist/hand area when she woke up on sun 5/16/21 6am. Patient stopped by the pharmacy and rph referred her to visit urgent care if PCP closed around 11am since petechiae is associated with ITP ( immune thrombocytopenia) and may require further attention.

7 weeks pregnant at the time of 2nd vaccine. The morning after, I had a headache, fever, and nausea. In the afternoon, I had some some spotting and by evening I was bleeding. Bleeding continued over night and the next few days.

About 2 weeks after first vaccine symptoms of lung dysfunction and possible infection developed nightly fever; after 2nd vaccine high fever developed within hours, lethargy, body aches and headache. All of these symptoms subsided by 5/13/2021and left joint pain and inflammation in it's wake.

I had a sudden onset of racing heart, shortness of breath, and a crackling sound when I would exhale starting on 4/19/21. I went to the doctor on 4/22/21 where they did a COVID swab (negative), a chest x-ray, and a d-dimer blood test. My d-dimer value was 4520, so the clinic immediately sent me to the ER. At the ER, they did another COVID swab (negative), a chest x-ray, a CT scan with contrast dye, and an EKG. The CT scan found multiple pulmonary emboli in my lungs, including a large one near my heart. I was admitted to the hospital from 4/22/21-4/24/21. They started me on blood thinners (Xarelto) and did an ultrasound of my heart, in which they determined my heart has not sustained damage. The shortness of breath subsided in about a week post-hospitalization. I am still on daily blood thinners.

Patient is a 36 yo female with history of IVDU, Hep C, fibromyalgia who presents with left leg pain and swelling found to have significant left leg DVT now s/p femoropopliteal vein thrombectomy. HPI: Patient is a 36 y.o. female with history of IVDU, Hep C, fibromyalgia who presents with left leg pain and swelling. Patient woke up this morning with her entire left leg being painful, swollen, "tight", and "achy" throughout. She had been experiencing 1 week of left leg pain, followed by an acute worsening in the last 2 days. She denies any recent travel or leg trauma. She denied any fevers, chills, SOB, or chest pain. She denies any new tattoos, recent malignancies, or blood clotting disorders. Of note, she is currently undergoing evaluation for lupus due to fatigue and rashes. Per her IVDU, she injects heroin in her arm (last use 1 month ago after 4 years of sobriety), and is currently on methadone. This pain is different from her fibromyalgia. Of note, she got her first Moderna COVID vaccine last week. Highlights of ED course: Pertinent exam findings: tachycardia, marked LLE swelling (mid thigh 70 cm vs 64 cm on RLE) Warm bilateral LE, palpable pulses Important data gathered: LENI: left deep vein thrombosis extending from common femoral vein to distal posterior tibial veins, ESR 47, CRP 58, elevated d-dimer > 4000 Key treatments administered: heparin gtt, oxyodone 5 mg for pain, vascular medicine, cardiology consult Patient was subsequently evaluated by vascular medicine, who brought her to cath lab for venography and endovenous intervention. She went to the cath lab. U/s guided access to L popliteal vein with micropuncture. J-wire into L CIV, serial dilation and placement of 12F sheath. Multiple passess with Penumbra lightning aspiration catheter. Femoropopliteal vein with restored patency, continued organized clot in iliac vein, infusion of 6mg TPA with 10 min dwell time. Further passages of aspiration catheter. Decision to leave 30 cm infusion cath. When seen on the floor, patient was hemodynamically stable. Still with pain in lower extremities and back. No chest pain or SOB. #DVT, s/p vascular surgery thrombectomy 2 days of acute left leg pain and swelling. Initial exam notable for purplish LLE in ED. LENIs notable for left DVT extending from CF vein to distal PT veins. Vascular evaluated and performed femoropopliteal vein thrombectomy with restored patency, continued organized clot in iliac vein, infusion of 6mg TPA with 10 min dwell time. Further passages of aspiration catheter. Decision to leave 30 cm infusion cath. On OCPs but no known other risk factors (quit smoking), suggesting unprovoked DVT. Other potential etiology includes venous congestion. Hypercoaguable w/u pending. Notably, Moderna vaccine 1 week ago, although limited evidence suggesting relation between mRNA vaccine and increased thrombosis risk. Hypercoagulability workup was sent. Patient transitioned from heparin to apixaban for discharge with vascular medicine and vascular surgery followup

Anaphylaxis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. Event outcome was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: This follow-up was received on 20-MAY-2021 with updated route of administration and contact details.

Patient received COVID vaccine on 4/22/21 and diagnosed with brachial vein DVT in her right arm on 4/25/21 via doppler. Patient started on Eliquis to treat. Patient does have a history of PE in the past. Hypercoagulable workup showed prolonged dilute Russell viper venom time at 49.8. Cardiolipin antibodies are negative. Patient needs further eval as outpatient. Patient was discharged to home on Eliquis.

Body temperature decreased; Myalgia; Atrial fibrillation; Alopecia; Nasopharyngitis; Vision blurred; Vasculitis; Dizziness; This case was received via FDA VAERS (Reference number: 1124402) on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Codeine, hydrocodone and tramadol.) and Autoimmune disorder. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness) and MYALGIA (Myalgia). On an unknown date, the patient experienced BODY TEMPERATURE DECREASED (Body temperature decreased). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) had resolved and ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness), BODY TEMPERATURE DECREASED (Body temperature decreased) and MYALGIA (Myalgia) 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. Concomitant product was not provided by the reporter. Patient vaccine administration arm coldness and temperature drop. Patient reported the symptoms to her doctors and they recommended she get the second shot. Treatment information was not provided. Company comment: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.

Soreness at injection site One week later, my doctor discovered a subchronic hematoma in my uterus after I had spotting at home

On the 26th of January I had pain all over my body, vomitting, and diarrhea.I went septic. I went to the hospital on the morning of the 27th and they thought maybe I had a UTI that had went down to my kidneys.

Patient called to report that she believes the second dose of her Moderna Covid shot has delayed her menstrual cycle. According to the patient, her menstrual cycle is very precise and she should have started on Saturday, June 6/12/2021. She has only spotted the last three days and that is very unusual for her. She also reports she is sexual active and not on any birth control. She was planning on calling her OB, after speaking with me because she was concerned that she may also be pregnant. Unknown the result of that conversation.

started with SOB, then got terrible pain in left leg, had called 911 taken to hospital and was Diagnosed with 2 Pulmonary Embolism and 2 deep vein thrombosis in the right leg and foot drop of the left foot, numbness of the left leg and foot.

Death: 5/7/2021 Causes of death listed on death certificate: 1) COVID-19 2) Sepsis 3) Sarcoidosis 4) End stage renal disease Other: Hypertension, Congestive heart failure

06/25/2021 - noticed swelling in arm 06/26/2021 - went to urgent care for swelling and was diagnosed with a blood clot.

Period came 2 weeks early. EXTREMELY painful period cramps, leg pain, back pain, and nausea. Excessive bleeding with significant clots. No relief from OTC ibuprofin. This is not normal!

Fever, pain in thigh, vomiting, diarrhea, sepsis, eventually died two weeks later. Time of death 6-11-21 1am

Patient was 15w0d G1P0 presented to Emergency Room on 6/28/21 with complaint of mid abdominal pain and low back pain for several hours. Noted some vaginal spotting which occurred the night prior to ER and continued. Ultrasound performed. Confirmed Spontaneous abortion. blood type of B-, patient received dose of RhoGam. Labs: evaluated and unremarkable except for low potassium (3.0) Removal of products of conception at ER.

Site: Pain at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Additional Details: Pt indicated that had such severe pain for several days after the Moderna vaccine that was unable to get up to use restroom. 2 days later when symptoms did not ease, pt went to ER and was given benedryl and steroids.

I had my second dose of the Covid19 vaccine on March 24, 2021. I didn't know at the time that I was pregnant, it was very early. Received a positive confirmation on April 14, 2021. At this time I was about 6 weeks along. Due date was estimated for the beginning to mid- December. On May 7th I had my first appointment with an OB, at that time she was unable to find a heartbeat. HCG quants were checked and I was sent for a more extensive ultrasound on May 11. Miscarriage was confirmed that day. Scheduled a D&C for May 24th, on the 21st I spiked a fever and was exhibiting signs on sepsis. That evening an emergent D&C was performed. Seemed to be on the mend the next morning and was sent home with oral antibiotics. On the 25th I spiked another fever and was advised by my physician to get to the emergency room. Spent the next three nights in the hospital with IV antibiotics. Came home with a couple different oral antibiotics (Flagyl and Clindamycin) for the next 2 weeks. This seemed to cover the infection.

Low platelet count; Fatigue; Body ache; Bad headache; Fever; Chills; Shaking; Soreness in the arm but little bit worse than 1st time; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (Low platelet count) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus nephritis (Platelet count has dropped significantly since receiving the vaccine; I have been put on a course of Prednisone) since January 2004 and Allergy to antibiotic (Amoxicillin). Concomitant products included LISINOPRIL from January 2021 to an unknown date for Nephritis, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 2020 to an unknown date for Prevention, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 2021 to an unknown date for Vitamin supplementation, VITAMIN D3 for an unknown indication. On 22-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 7:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced TREMOR (Shaking). 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm but little bit worse than 1st time). On 19-Feb-2021 at 4:30 PM, the patient experienced CHILLS (Chills). On 20-Feb-2021, the patient experienced HEADACHE (Bad headache). On 20-Feb-2021 at 12:00 PM, the patient experienced FATIGUE (Fatigue) and MYALGIA (Body ache). In April 2021, the patient experienced THROMBOCYTOPENIA (Low platelet count) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL EXTRA-STRENGTH) on 19-Feb-2021 for Adverse event, at a dose of 1 tablet and PARACETAMOL (TYLENOL EXTRA-STRENGTH) on 20-Feb-2021 for Adverse event, at a dose of 2 tablets. On 21-Feb-2021, TREMOR (Shaking), VACCINATION SITE PAIN (Soreness in the arm but little bit worse than 1st time), CHILLS (Chills), HEADACHE (Bad headache), FATIGUE (Fatigue) and MYALGIA (Body ache) had resolved. At the time of the report, THROMBOCYTOPENIA (Low platelet count) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 99.6 (Inconclusive) First a low grade fever with 99.6. Around 8 or 9 pm, fever rose up to 102. In middle of the night, the temperature was 100.7.. On 20-Feb-2021, Body temperature: 104.4 (Inconclusive) high. In April 2021, Platelet count: decreased (Low) Decreased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered TREMOR (Shaking), VACCINATION SITE PAIN (Soreness in the arm but little bit worse than 1st time), CHILLS (Chills), HEADACHE (Bad headache), FATIGUE (Fatigue) and MYALGIA (Body ache) to be possibly related. No further causality assessment was provided for THROMBOCYTOPENIA (Low platelet count). The patient was treated with unspecified IV steroids. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. For the event Thrombocytopenia, current condition Lupus might be co-suspect/confounder This case was linked to MOD-2021-041453. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-jun-2021 contains information regarding the reporter, the patient demographics (height, weight, and ethnicity), allergic conditions, start date and batch number of first dose of Moderna vaccine, additional event of platelet count low and the case was upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. For the event Thrombocytopenia, current condition Lupus might be co-suspect/confounder

Chest pain, leg pain, blood clots, pulmonary embolism, thrombectomy, hypotension shock, life saving measures. Heparin and Eliquis are the medications needed to thin my blood.

she was diagnosed by sonogram for DVT in her right femoral vein; Pulmonary embolism; Chest pain; Could not move around normally, sharp pain in her right left when she put weight on it; Couldnot breath normally ,having difficulty breathing and had to pause in the middle of sentences to catch her breath; Discovered a sharp pain in her right leg,when she put weight on it that felt like a string being pulled tight; Uncomfortable; Inappropriate schedule of vaccine administered; The patient was discharged with no further complications for her or the; after second vaccine, began feeling progressively tired and uncomfortable; Feverish; Anxious; could not sleep; Began feeling very unwell; body's response to the vaccine caused enough stress to cause the emergent crisis; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (she was diagnosed by sonogram for DVT in her right femoral vein) and PULMONARY EMBOLISM (Pulmonary embolism) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), EXPOSURE DURING PREGNANCY (The patient was discharged with no further complications for her or the), DISCOMFORT (Uncomfortable) and FATIGUE (after second vaccine, began feeling progressively tired and uncomfortable). On 03-May-2021, the patient experienced DEEP VEIN THROMBOSIS (she was diagnosed by sonogram for DVT in her right femoral vein) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain), HYPOKINESIA (Could not move around normally, sharp pain in her right left when she put weight on it), DYSPNOEA (Couldnot breath normally ,having difficulty breathing and had to pause in the middle of sentences to catch her breath) and PAIN IN EXTREMITY (Discovered a sharp pain in her right leg,when she put weight on it that felt like a string being pulled tight). 03-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced ANXIETY (Anxious). May 2021, the patient experienced INSOMNIA (could not sleep), MALAISE (Began feeling very unwell), STRESS (body's response to the vaccine caused enough stress to cause the emergent crisis) and PYREXIA (Feverish). The patient was treated with LOW MOLECULAR WEIGHT HEPARIN (subdermal) ongoing from 03-May-2021 for DVT, at a dose of 1 dosage form every twelve hours. On 02-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (The patient was discharged with no further complications for her or the), DEEP VEIN THROMBOSIS (she was diagnosed by sonogram for DVT in her right femoral vein), PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain), DISCOMFORT (Uncomfortable), ANXIETY (Anxious), INSOMNIA (could not sleep), MALAISE (Began feeling very unwell), HYPOKINESIA (Could not move around normally, sharp pain in her right left when she put weight on it), DYSPNOEA (Couldnot breath normally ,having difficulty breathing and had to pause in the middle of sentences to catch her breath), PAIN IN EXTREMITY (Discovered a sharp pain in her right leg,when she put weight on it that felt like a string being pulled tight), STRESS (body's response to the vaccine caused enough stress to cause the emergent crisis), FATIGUE (after second vaccine, began feeling progressively tired and uncomfortable) and PYREXIA (Feverish) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Chest X-ray: abnormal (abnormal) Pulmonary embolism. On 03-May-2021, Ultrasound scan: abnormal (abnormal) DVT in right femoral vein. No concomitant medications were reported. After one night in the ICU, the patient was discharged with no further complications for her or the fetus to date. Based on the current 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-2021-251077 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: No new information added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Acute Pulmonary Embolism; bronchitis; Blood clot; Passed out 5 times that night; Couldn't breathe; Heart pain; Cough; Fever; Muscle sore; Super sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Acute Pulmonary Embolism), LOSS OF CONSCIOUSNESS (Passed out 5 times that night) and THROMBOSIS (Blood clot) in a 36-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 Emergency care (got X-ray and was told she possibly had bronchitis.) on 06-Jun-2021 and Emergency care (was hospitalized for 2 days with a diagnosis of Acute Pulmonary Embolism.) on 08-Jul-2021. Concurrent medical conditions included Drug allergy (Allergy to Hydrocodone) and Drug allergy (Allergy to Codeine). Concomitant products included VIT D [VITAMIN D NOS] for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced SOMNOLENCE (Super sleepy), PYREXIA (Fever) and MYALGIA (Muscle sore). On 15-May-2021, the patient experienced COUGH (Cough). On 06-Jun-2021, the patient experienced DYSPNOEA (Couldn't breathe) and CHEST PAIN (Heart pain). On 06-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out 5 times that night) (seriousness criterion medically significant). On 08-Jul-2021, the patient experienced PULMONARY EMBOLISM (Acute Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). 08-Jul-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced BRONCHITIS (bronchitis). The patient was treated with RIVAROXABAN (XARELTO VASCULAR) at a dose of 15mg. On 16-May-2021, SOMNOLENCE (Super sleepy), PYREXIA (Fever) and MYALGIA (Muscle sore) had resolved. On 10-Jul-2021, PULMONARY EMBOLISM (Acute Pulmonary Embolism) and THROMBOSIS (Blood clot) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out 5 times that night), DYSPNOEA (Couldn't breathe), CHEST PAIN (Heart pain), BRONCHITIS (bronchitis) and COUGH (Cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, X-ray: inconclusive (Inconclusive) possibly had bronchitis as reported by patient. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

inferred pulmonary embolism; deep vein thrombosis in right femoral vein; It was the second trimester in her pregnancy /Pregnant; Chest pain (non-cardiac); Shortness of breath; Feeling unwell; Insomnia; Feeling anxious; sore upper arm after first vaccine; Fever; Vaccination site pain; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (inferred pulmonary embolism) and DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PULMONARY EMBOLISM (inferred pulmonary embolism) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (It was the second trimester in her pregnancy /Pregnant), NON-CARDIAC CHEST PAIN (Chest pain (non-cardiac)), DYSPNOEA (Shortness of breath), MALAISE (Feeling unwell), INSOMNIA (Insomnia), ANXIETY (Feeling anxious), MYALGIA (sore upper arm after first vaccine), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). The delivery occurred on an unknown date. For neonate 1, patient was 25 weeks pregnant during the vaccination. The patient was treated with HEPARIN for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (inferred pulmonary embolism), DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein), NON-CARDIAC CHEST PAIN (Chest pain (non-cardiac)), DYSPNOEA (Shortness of breath), MALAISE (Feeling unwell), INSOMNIA (Insomnia), ANXIETY (Feeling anxious), MYALGIA (sore upper arm after first vaccine), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) outcome was unknown and EXPOSURE DURING PREGNANCY (It was the second trimester in her pregnancy /Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) DVT in right femoral vein. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not reported. Concomitant was not reported. In the emergency room, patient was diagnosed by sonogram for DVT in her right femoral vein. A chest x-ray was taken and due to the patient's symptoms a pulmonary embolism was inferred to be the cause without further need of investigation by CT scan due to the increased risk for pregnant females. patient was treated with a shot of low molecular weight heparin (LMWH) and continues to get a LMWH subdermal shot every twelve hours for the duration of her pregnancy. After one night in the ICU, the patient was discharged with no further complications for pregnant patient or the fetus to date. The blue-sky scenario is this patient developed a blood clot prior to vaccination, and the body's response to the vaccine caused enough stress to cause the emergent crisis. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-251142 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received contains No New Information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

After being given the Moderna vaccine on March 6th I began vaginally bleeding on March 8th. I had 6 days of what seemed like a period of bleeding even though it wasn't the time I should have had a period. I'm very regular and never had an issue with my period. I began bleed on all the following dates as well April 2nd-8th, April 21st-29th, May 16th-June 13th. I saw my doctor and begin oral birth control on June 13, 2021. I have since had a rash outbreak all over my legs since July 12th. I stopped taking the birth control June 20th as the doctors have believed now a side effect of possibly the birth control/vaccine is Erythema Nodosum. A biospy was taken on June 21st & the results will take 10-14 days. Additionally, as soon as I stopped taking the oral birth control I began bleeding immediately and hopefully it won't be never ending again.

1/6/21 Pt received vaccine and complained of difficulty swallowing and rapid heart rate. Pt received methylprednisolone 125mg IVP, diphenhydramine 25mg IVP, & famotidine 20mg IVP. Pt reported improvement and was discharged. Sent home on diphenhydramine and oral prednisone. 1/7/21 Pt unable to swallow her own secretions and experienced eyelid swelling. Pt vomitted. Pt received epinephrine and Benadryl X 1 dose each. Pt then transported to hospital via ambulance. Reason for admission - acute respiratory failure secondary to anaphylactic reaction. Decision was made to emergently intubate the patient for airway protection despite aggressive intervention. Pt successfully extubated 1/8/21. Plan to discharge home and start Medrol Dose Pack 1/9/21.

Anaphylaxis severe anaphylaxis; SOB, stridor Narrative: Patient has multiple allergies including severe anaphylaxis to peanuts and a reaction to a previous flu vaccine. Patient desired COVID vaccination and was cleared by private PC to receive vaccine from Employee Health. Patient had with her her own Epi-pen and albuterol inhaler. Patient was administered vaccine and observed in the observation area. Approximately 14 minutes after vaccination physician in observation area responded to patient with stridor and code white was called. Code team responded to vaccination testing site. Upon arrival, patient seated and alert sitting using albuterol inhaler. BP 160/93, HR 97, 99% room air. She was tachypneic and in respiratory distress following the first dose of her COVID 19 vaccine. Patient gave herself OT of EPI, and then our on call team arrived. Upon arrival as noted above, she was using her albuterol inhaler, 12.5mg benadryl attempted to be given however patient with difficulty swallowing. She was taken to ED and on way 2nd dose of epinephrine given. Patient was stabilized. Follow-up: Take Prednisone for 3-5 days. Take an antihistamine like Benadryl or Zyrtec for the next 3-5 days. Also take Pepcid 20 mg 2 times daily for the next 3-5 days. Return for worsening reaction. Timeline of event: Situation: 1001 Pt was given her first Covid vaccine, staff was watching her time and at 1014 it was noticed that she was not breathing well. 1015 Code white called. 1015 Pt gave herself and dose of Epi, 1018 pt took own inhaler,1019 Benadryl 12.5 given. 1021 pt to ED for evaluation, on the way 2nd dose of Epi given- 1025 1030=pt was acode white from the area from where getting covid vaccine shots, pt states received shot at 1001 this am and with in 30 min she began to feel SOB, when pt arrived to ER respirations of stridor. pt spo2 at 99% on room air. 1045-pt has had a 20g placed by Rn in lt ac with blood draw, pt has been placed on monitor. VS WN. 1055- pt has received pepcid 20mg IV in 50ml to run over 30 min. sol-medrol 125ng ivp benadryl 50mg ivp 1100- pt now resting with warm blanket pt no longer having stridor. upper resp clear. pt spo2 at 99% ON ROOM AIR. will continue to monitor. 1120- pt states she feels much better. 1200-pt still sleeping in room. 1225- pt has been D/c to home with instructions from provider.

LEFT FACIAL SWELLING WITH LARGE AMOUNT OF NASAL BLEEDING AND CLOTTING. SHE SAW HER PCP AND HAD LAB TESTING AND GIVEN BENEDRYL. SHE WILL F/U WITH PCP AGAIN TODAY.

I am not completely convinced that this is related to the vaccine but thought I should report it just in case. I thought I had a spider bite on my left foot, and then I thought it was shingles and then cellulitis. I was then diagnosed with a blood clot today. I have never had blood clots before.

Patient calls 911 w/ anaphylactic reaction 45 MiNs s/p Moderna Covid-19 vaccine. x 4 0.3 mg Epi peNs given prior to ED arrival. Airway patent but difficulty speaky. Further ED treatments included IV MedicatioNs & breathy treatment.

When this individual received her Moderna Covid-19 vaccine (Dose #1) on 12-29-2020 she did not know her pregnancy status. She did not think she was pregnant. On Thursday 1-7-2021 around 4 AM she started experiencing severe abdominal pain. She did not go to work that day but did go in on Friday 1-8-2021. On Saturday 1-9-2021 she woke up with significant vaginal bleeding. On Monday 1-11-2021 she went to the OB/GYN and there she had a positive pregnancy test. The diagnosis of miscarriage was made at that time. A couple of days later, a repeat pregnancy test resulted in a negative reading.

Patient experienced an anaphylactic reaction. During 15 minutes waiting period post-vaccination, patient started experiencing systemic itching and hives. 25mg oral diphenydramine was given. Symptoms persisted and progressed to more severe itching, cough, flushing, and rhinorrhea. 125mg IM solu-medrol and 50mg IM diphenhydramine were administered into left deltoid. Patient progressed to a persistent cough and throat closure. Epinephrine auto-injector was administered into right outer thigh. Patient was transported to Local emergency department by spouse for further treatment and evaluation. Symptoms began to improve post injection of epinephrine, but still required further medical treatment.

On 1/20/20 I was 5 weeks 6 days pregnant and had the second dose of the Covid-19 vaccine. My expected due date 9/17/21. In the evening my arm started to get extremely sore at the injection site followed by body aches and a severe headache that last 48 hours. By Friday evening around b 7 pm I ended up throwing up and started to feel relief. Waking Saturday morning I had cramping and vaginal bleeding. After a trip to the er at 2 pm I had a ULTRASOUND which did not show a fetal heart tone. As of today Thursday 1/28/21 I am still bleeding. The headache has come and gone since the severity let up on friday

Pain at injection site started the day after vaccination (1/23). On 2/1, she noticed a bullseye rash to injection site along with intense pain and itching. She then noticed elevated heart rate and began to feel light headed. She was instructed to go to the emergency department at our local hospital . Her heart rate was 107 and blood pressure was 162/112. An IV was started and IV Solumedrol and Benadryl were administered. Chest X-Ray revealed pneumonia. Bloodwork is pending.

Shortness of breath, abnormal ECGs, lack of oxygen to the heart, numbness of legs and arms, tachycardia (130-160) for over 12 hours, difficulty breathing, bilateral pin point pain in legs, dizzy, syncopal convusions, fainting, hyperventilation, vomiting, chills, headache, heart pain, fever, kidney pain

Pulmonary Embolism, hospitalized from 2/2/2021-2/3/2021. Received anti-coagulants and will remain on anti-coagulants for at least 3 months.

2/9/21 0800 Pt called regarding delayed rxn to vaccine moderna. Pt rcv'd moderna 2nd dose on 2/5/21 and developed sx's 2/6/21 around 1700-1800. Pt contacted PCP. PCP stated it was a delayed rxn to vaccine. PCP informed pt to tx with tylenol, ibuprofen, benadryl and cold compress. PCP also informed pt to go to ED for anaphylaxis sx's. Pt reports hx of rxn to previous vaccination. Pt stated 1st vaccination of moderna was not severe. Pt sx's verbally reported following 2nd moderna dose: -swollen lymph nodes in neck and axillary region -streaking on arm of injection -rash on arm of injection -fevers 101-102 -chills -diarrhea -H/A -Muscle pain -ear pain and swelling

Pt is a 37y F with previous history of pericarditis diagnosed after an initial COVID infection SEP20 with a second occurrence NOV20. Pt subsequently received her first COVID Vaccine shot on 22JAN21 and reported to medical on 3FEB21 with mild chest pain and an EKG with changes demonstrating pericarditis and a US demonstrating trace effusion. Pt was minimally symptomatic but given her previous episodes was sent to the Role 3 for further evaluation. Her work up on 10FEB21 demonstrated resolution of EKG changes and effusion with normal cardiopulmonary work up. Given her history it has been recommended that she does not receive the second dose of the vaccination.

Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation.

Fever (max 105F), generalized tonic clonic seizure lasting >60minutes resulting in rhabdomyolysis , leukocytosis (16k) s/p ceftriaxone x 1 with COVID-19, Flu A/B, RSV all PCR negative followed by transfer to hospital (2/25/2021) with ongoing high fever (Tmax 104F), Admission labs found rhabdomyolysis (CK >100,000 on day 2), elevated lactate (4.4), acute liver injury (AST/ALT >5000), elevated Cr (3.8) requiring CVVHD, DIC, shock, and respiratory failure requiring urgent intubation.

anaphylactic reaction; Sweating; Slow hands movement; nausea; Body aches; A spontaneous report was received from a consumer who was a 37-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, sweating, body aches and anaphylactic reaction. The patient's medical history included a previous anaphylactic reaction to her first Moderna Covid-19 vaccine. .Concomitant medications were not reported. On 30-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) and on 27-JAN-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 27-JAN-2021, after receiving the second dose of mRNA-1273, the patient reported that she experienced nausea, sweating, body aches, and an anaphylactic reaction that was characterized by slow hand movements and facial swelling. The patient reported that she would see her doctor on 18-Feb-2021. Treatment for the events were not reported. The patient received both doses of mRNA-1273, therefore, action taken with the drug was not applicable. The outcomes of the events, nausea, sweating, body aches and anaphylactic reaction, 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.

anaphylactic reaction , -- shortness of breath, cough, sore throat, swelling, itching. Treatment Epi pen injection and 2 rounds or benadryl outcome : resolved

Tachycardia for couple of days after the vaccination. Shortness of breath since the moment of the first dose. Pain on both legs after first dose. Severe Migraines on the second dose of the vaccine that lasted for 3 weeks. Hematoma on the leg without pain, with swelling. Leg pain with warmth sensation.

Patient passed out after getting the injection. Per RN, patient with Stridor. 37yo female presented to the UC and was pale with complaints of tightness in chest. Heart rate up to 160s. BP 114/83. EKG shows sinus tachycardia at 116. s/p anaphylactic versus vasovagal reaction to vaccine. Support the later consider vitals stable, no signs of angioedema/rash notes on examination. Possibly stridor at the tent, but patient notes she does recall starting to breathing heavy before loosing cautiousness. Patient was s/p epi pen x 2 (investigating if the pens fired properly) when presented to the UC. She was tachy and pale, but otherwise clinically was stable.

Patient described having lightheadedness, the began to experience dyspnea saying her breathing felt strange. This began approximately 5 minutes after her dose was administered. We had her sit down in our injection room and began to monitor her symptoms. I immediately got out our protocol for Treatment of an Allergic Reaction as part of our vaccination program protocol. the patient remained conscious and responsive throughout the encounter. A pulse oximeter was placed on her left pointer finger. Her heart rate fluctuated in the 110s to 130s during the encounter. Her pulse ox remained 97% throughout the encounter. Patient reported having a history of hypertension treated with lisinopril. We placed a blood pressure monitor on her left wrist to take her blood pressure. Her initial blood pressure was 164/105, which she reported was "just a little bit over normal" for her. After taking the initial blood pressure, she described that her symptoms were beginning to subside a bit. We discussed the signs/symptoms that we would be looking for in an anaphylaxis type reaction, some of which were present (i.e. tachycardia, dyspnea) and some of which were not (i.e. hives, swelling of the face/lips, throat, etc.). We then began to take her blood pressure again. The second blood pressure measurement was 156/104. Shortly after taking the second blood pressure, she described having feelings of dyspnea again. At that time, I notified another staff member to contact EMS/call 911 and let them know we potentially had an allergic reaction to the second dose of Moderna COVID-19 vaccine. When the symptoms came back for the second time, I got out the Epipen Two Pack in the case that we would need to administer a dose. We continued to monitor her symptoms and kept her responsive over the next few minutes, until the first set of EMS arrived from the local fire department. The EMS staff began taking her vitals and took over care of that patient at that point. Patient was still responsive and describing only dyspnea and having clinical symptoms of tachycardia and hypertension. Patient got nauseated around 10 minutes after the first set of EMS arrived, and experienced a bit of vomiting. About 10-15 minutes after the first set of EMS arrived and took over care of the patient, the ambulance and second set of EMS arrived and took over care. They began monitoring the patients symptoms and placed an IV line. The patient was then transported to the local Emergency Department. At around 5PM, the patient called the pharmacy to report that the physicians at the emergency department had ruled that she had experienced an allergic, non-anaphylactic reaction to the dose of Moderna COVID-19 vaccine.

Strong Atrial Fibrillation/ pressure in chest (2/27/2021 at 10:00 PM) event followed by shorter intermittent for a few days, shortness of breath, fatigue, chills, cold extremities and overall body temp feeling throughout the day for the same time-line (3-4 days following the injection). 7 days after the injection 3/4/2021 Deep pressure under left under arm and injection site inflamed into a hard mass which dissipated into a spherical rash 3 cm below the injection site. Pain under arm dissipated within 24 hours. Rash took a few days.

Patient presented with anaphylactic symptoms 5 minutes after vaccine. Patient stated she had tingling in her face, lips and throat. She stated she was becoming short of breath and her voice was changing and becoming raspy. I administered an epipen and recorded the time at 11:27AM. I called 911 at 11:30AM. The patient said she felt much better after the epipen. The emergency medical team arrived quickly and took over treatment.

Began symptoms of a period the next day after previously finishing my period 4 days prior to shot: spotting, cramping and flow enough for a tampon.

I had vaginal spotting and bleeding after BOTH doses. After my first shot I had one day of bleeding, and after this 2nd shot, I am on day 4 of vaginal spotting and bleeding. This is concerning because I just had a baby in January, I am currently breastfeeding, and due to my PCOS, I rarely have periods in general.

This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TOPIRAMATE (TOPAMAX) for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (Severe Tachycardia/ Still very tachycardia) and FEELING ABNORMAL (Felt a little weird). On 03-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Could not get up), ASTHMA (Asthma) and ASTHENIA (Could not get up). On 04-Feb-2021, the patient experienced CONTUSION (Bruise on her right and left leg) and VACCINATION COMPLICATION (Had a reaction to the vaccine). On 01-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low). At the time of the report, DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg), TACHYCARDIA (Severe Tachycardia/ Still very tachycardia), DYSPNOEA (Difficulty breathing), FEELING ABNORMAL (Felt a little weird), FATIGUE (Could not get up), ASTHMA (Asthma), CONTUSION (Bruise on her right and left leg), ASTHENIA (Could not get up), VACCINATION COMPLICATION (Had a reaction to the vaccine), HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemoglobin: low gram per litre (Low) LOW. In March 2021, Red blood cell count: low cells per microlitre (Low) LOW. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment informations reported were Levalbuterol tartrate and Rivaroxaba 20 mg This case was linked to MOD-2021-059897 (Patient Link).

37 y/o female with known hx of epilepsy c/o 2 episodes of witnessed grand mal seizure over a 2 minute period s/p receiving 1st dose of Moderna. Time of Moderna dose unknown. 1st witnessed seizure while sitting in chair in observation room @ 15:34, lasted approximately 30 seconds. Assisted patient to wheelchair and placed on cardiac monitor in med bay bed. Turned patient on side and @15:35 had second witnessed grand mal seizure. Lasted approximately 50 seconds, 911 called during this time and patient placed on oxygen. Pt post-ictal until 15:42, not alert or oriented to person place or time. Pt slowly became A & O x 4, states curently on Keppra and Diltiazem, no skipped doses. Informed pt 911 was called and on their way, pt stated that she did not want to go to ER. EMS arrived at this time @ 15:52 and took over evaluation of patient. Per EMS, long discussion with patient and is signing out AMA. Pt informed EMS she will go by private transport, husband will drive her to nearest ER. Upon dc, pt alert and oriented x 4. EMS transported patient to outside of the center to join husband. Vital Signs: Time: 15:34 BP: 124/56 P: 98 O2 Sats: 100% on 3L Time: 15:52pm BP: 127/62 P: 98 O2 Sats: 100% on no oxygen Labs/tests done: none Medications given: none Outcome of the adverse event (if paramedic please list hospital taken to): EMS arrived on scene at 15:52 and took over care of patient. Informed pt EMS their rec is to transport to ER for further evaluation however pt refusing. Pts husband contacted and states will drive patient to nearest ER at the hospital.

After the first Dose I exp tingling on right side of my face. I woke up next day exp headache and fatigue realized right eye lid wasn't closing same time as left eyelid. I went to walk in clinic next morning confirmed Bell's Palsy started Prednisone. I do have a genetic blood clotting disorder for 18 years.Since the vaccine on 3/31 I woke up with pain in my foot on lower right leg applied ice and took Tylenol. I scheduled a doppler at the Imaging center on 2/7 confirmed blood clots and prescribed Xarelto.

Sudden onset atrial fibrillation, started at 1200 hours did not convert to normal sinus rhythm until 2200 hours. Tachycardia (140-170s), dizziness, palpitations, shortness of breath,

I got the vaccine on Tuesday. I had terrible headaches Wednesday, Thursday and the start of a migraine Friday. Friday night I suffered a stroke.

Extremely heavy period bleeding started on February 20th out of no where. Bleeding contained big clots and was very heavy. Went to my GYN on March 15th who prescribed a five day supply of Tranexamic acid. On March 20th, my bleeding finally stopped.

I completed my Moderna vaccine series on 2/5/21 to protect myself against COVID-19. I also tested positive for COVID-19 in mid-December. This past week I had a menstrual cycle, and I discharged a high volume of blood blots. I am taking an oral contraceptive and my periods are are normal frequency, length and flow, until this last period. The clots could fill an entire maxi pad that needed to be changed every 2 hours, for about 48 hours. After that single clots were discharged every 2 hours for another 2 days (and still occurring as I write this). I sent my PCP (an OBGYN) a direct message in patient portal also reporting symptoms.

Vaginal bleeding 2 days after shot , very dark red, and had just finished period 5 days prior. Swollen lymph nodes under left arm pit

Presented with anemia (hemoglobin 7.2), thrombocytopenia (platelets 9) on 4/29/21, antiplatelet antibody positive, consistent with ITP, perhaps exacerbated by mRNA COVID vaccine. Platelets are stable after transfusion and improving with steroids.

I had very heavy bleeding approximately 2 weeks after I got the second dose of the vaccine. It was not a miscarriage, because I had my period right on time before and after the bleeding event.

On May 7, 2 Days after receiving the Moderna shot, I started to get breast tenderness, indicating an upcoming menstruel cycle, despite not being due until May 17. It is important for me to note here that my period is always on time (within a day or 2). On May 9, I began to have some cramping. When I got out of the shower on the morning of May 10, I had begun bleeding. At this point, the cramps began to worsen. Often leaving me doubled over in pain (while common for some women, this is completely abnormal for me. I normally don't have any cramping at all.) The bleeding itself is heavier than usual. I'm also extremely exhausted compared to usual.

LMP: 4/23/2021. Vaginal bleeding appeared mid-cycle on the day mentioned in item 5, accompanied with cramping. It appeared like spotting in the beginning and increased to an amount similar to first day of period. Cramps stopped after two days but bleeding has been persistent, with next period occurring early on 5/18 (expected was 5/22).

My joint pain the first night was debilitatingly severe and I spiked a fever which finally broke overnight that Saturday. I was drinking lots of fluids, so when I started peeing more than usual on Saturday I didn't think much of it. It got worse on Sunday, but there was no pain. The pain finally started today, along with a little blood. I went to the doctor and the test confirmed I have a UTI. There are red and white blood cells in my urine, and the hyaline casts were high enough that it flagged them too. Normally, I would not have reported this but the timing was very strange and based on the severity of my joint pain the night of, it is not just a weird coincidence. I was not experiencing any urinary symptoms before the vaccine. I found that there have been others during the study who experienced UTI's following vaccination with the Moderna and Pfizer vaccines and although the study determined no correlation, I thought it important to report it. With me, for reasons no one seems to understand, my kidneys react to my allergens before anything else does. I'm assuming that is why I am having the UTI issue right now, although no bacteria got flagged in my sample.

A few days after the first vaccine I had chest tightness, especially on the left side and middle of my chest that came out of nowhere (no runny nose or anything). It felt like my lungs were irritated and I was short of breath, very tired. Worried it might be covid I went to get tested and it came back negative. Monocytes were high and the doctor suspected early pneumonia. Chest x ray came back without signs of pneumonia (but I continued the antibiotics for 10 days just in case it had been too early to show on the X-ray). Chest discomfort especially on left side, especially with deep inhale and when moving or laying on my side persisted. Lungs felt better but still left side chest discomfort. Followed up with a chest CT after three weeks and it showed pericardial effusion and splenomegaly in addition to micro nodules in left lung. Pulmonologist cleared me for lung issues, infectious disease tested many things all came back negative. The source of the random chest pain especially on inhaling, shortness of breathe, etc has not been solidly determined and all symptoms started after getting the first moderna shot. After the second shot I felt extremely unwell with high fever for many days. Chest CT was done after the second shot so it is hard to know if the pericardial effusion and splenomegaly came from both shots.

Started heavy vaginal bleeding and severe abdominal pain within 6 hours of receiving vaccine. Bleeding continued for 6 days. Abdominal pain at time of report has not fully resolved.

1st - severe body aches, severe headaches, lethargic, congestion, coughing and couldn?t sleep much. - medicine given was a z-pak, cough medicine and an inhaler. 2nd - severe body aches, vomiting, diarrhea, severe migraines, severe headaches, blood clots coming out of my nose without nose bleeds. Stomach pains behind my chest. So incredibly tired, - medicine given anti nausea Med, cough Med and pain Med. Went to Urgent Care then ER.

Per report from patient's husband, the patient developed a fever to 103 on the evening of 6/21/21. She awoke in the morning and was "not herself". He describes her as having difficulty breathing and not being lucid. He took her to the hospital where she was hospitalized and then he got a call from the hospital in the evening reporting that she had walked to the restroom and then collapsed. Per his report, she had CPR performed for 30 minutes prior to being declared deceased. His phone number is the one included in this report.

patient complained of intermittent fevers since the first administration of the Moderna vaccine on 4/7/21. fevers continued intermittently until second moderna dose on 5/5/21. Patient developed lymphadenopathy and eventually was hospitalized on 6/6/21 for sepsis symptoms. Patient was intubated and found to have an acute lymphoproliferative disorder that caused cardiac arrest and the patient expired on 6/8/21. She has no lab abnormalities suggesting a lymphoproliferative disorder prior to these events.

One week after my vaccination I was diagnosed with Covid-19 and I was treated with prednisone. I had a COVID-19 test and it was positive. I had respiratory symptoms like wheezing shortness of breath, cough, muscle aches, and headaches. A week and 1/2 after the vaccination I went to the ER because I had respiratory symptoms and I passed out in the ER. I was diagnosed with pneumonia.

Anaphylaxis effect during first 15 minutes. After that, I went an urgent care with high blood pressure, tachycardia, breath shortness and stomach discomfort

Anaphylaxis; Swelling of the face; Facial flushing; Nausea; Facial flushing; Facial swelling; Cough; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis (treated with Ocrevus has polysorbate as an ingredient.). Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis, AMITRIPTYLINE and BACLOFEN for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of FLUSHING (Facial flushing), SWELLING FACE (Facial swelling), COUGH (Cough) and NAUSEA (Nausea). On 13-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant), SWELLING FACE (Swelling of the face) and the second episode of FLUSHING (Facial flushing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Facial flushing, Swelling, Cough and Nausea, at a dose of 1 dosage form and EPINEPHRINE for Anaphylaxis, at a dose of 1 dosage form. On 12-Mar-2021, SWELLING FACE (Facial swelling), COUGH (Cough) and NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis), SWELLING FACE (Swelling of the face) and the last episode of FLUSHING (Facial flushing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was treated with for Multiple sclerosis that has polysorbate as an ingredient. She had a theory that there was some sort of cross-reactivity between the polysorbate in the Ocreubus and the PEG in the Moderna COVID-19 vaccine that caused this reaction. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-Significant Follow-Up Appended; Sender's Comments: This case concerns a 37-year-old female with a serious expected event of anaphylactic reaction, and nonserious swelling face, cough, nausea, and flushing. Event onset 2 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.

24 hrs after my second shot I got a fever that lasted through the night. Two days after receiving my second shot I began getting chest pains (pressure, fluttering, sharp pain that radiated from my heart up my neck). They became more severe and I was worried that I was having a heart attack. Went to my regular doctor. Had an EKG that looked normal, was sent for a chest x-ray, and blood work. As well as prescribed a ZioPatch heart monitor for 2 weeks. Lab work came back normal and ZioPatch recorded one instance of Ventricular Tachycardia so I was referred to a cardiologist. Symptoms continued for about 3 weeks slowly becoming less intense but including lightheadedness and constant feeling of pressure with occasional (daily) pains that felt like a side ache in my heart. Strong Symptoms reappeared in the beginning of June. Cadiologist ordered a stress echo. This came back normal as well. I was given a Clinical Diagnosis of Pericarditis and told to take Ibuprofen. Symptoms continued through the second week of July and then diminished again.

Chest pain with NSTEMI - troponin elevated to 6, downtrended. No EKG changes. TTE without reduced EF or wall motion abnormalities. Left heart cath did not show any significant CAD. Therefore, we believe this was a case of mRNA myocarditis from the 2ns Moderna dose 48 hours prior

Dx: Myocarditis S/S: Lethargy/Fatigue, Dyspnea on exertion, onset 02/13/2021 Possible alternative diagnosis: Prolonged number of visits for PVCs, etc. Patient seen in ED 3 times 3/2/21, 3/11/21 and 3/18/21 for palpitations. Discharged each time without dx of myo or pericarditis. Seen outpt cardiology 3/15. More extensive workup planned but diagnosis of PVCs and QT prolongation by ECG. Troponin negative. ECHO 3/17 1. Left ventricular ejection fraction, by visual estimation, is 45% with diffuse hypokinesis and frequent PVCs. 2. Mild mitral valve prolapse. 3. Mild mitral valve regurgitation. Seen again in Cardiology 3/25. Had CMRI 3/24. CMRI in abstract above diagnosis made Add Hx: She reports that she had forgotten that she was very sick with a viral infection in the end of January 2021. She had got Covid tested at that time twice the results of both were negative. Moderna 1.8 and 2.4 had "viral infection " late Jan but dx myocarditis March after presenting with palpitations

Blood clot in right left, pulmonary embolism and pulmonary infarction. Results stated ?excessive? in lungs.

38 year old female - healthy with no significant past medical history. Morning of 1/15/21, pt woke up with difficulty speaking (would be talking and then unable to articulate words which were replaced by grunting sounds) and tingling to her face. No changes to breathing, no numbness/tingling to extremities, equal facial symmetry. Slow onset of symptoms. Pt went to the ED, where she received a CT, MRI (inconclusive reading), lab work reported as normal per pt, EKG and chest x-ray. Symptoms self resolved while in the ED, however MD staff wanted to admit patient for 24 hours of observation and to complete an echocardiogram. Pt left AMA the evening of 1/15/21 due to resolution of symptoms and wanting to follow up with her cardiologist for the echocardiogram. Pt told by MD staff symptoms were likely caused by either TIA, possible reaction to vaccine or migraine presentation (no report of headaches/auras). Plan was to have patient on blood thinners x 30 days then baby Aspirin thereafter. Pt still needing to follow up with PCP and cardiologist for further work up.

Right after I received the vaccine I went into to 15 minute observation area. Once I sat down I felt a tingling sensation go from my head to my feet. At that point it started radiating in different areas. The lady next me was also having the same sensation. The nurses brought us both back behind the desk. They got my bp which was 158/88. It was on the higher side. Then a third lady complained of the same sensation and also was taken back behind the desk. The tingling would not stop and was I was advised to walk around at that point. When I did that the tingling became much worse again. I was given an Allegra and started to feel pressure in my chest. Not pain just a weird sensation. They called a Code Blue on me. Which is what they do when you?re in the outpatient part of the hospital. I was placed on a simple oxygen mask and taken to the ER. When I arrived to the ER I was taken off the oxygen and placed on HR monitor lead and a pulse ox. Both the doctor that arrived first to my code and the ER doctor did a neuro assessment. They did an ekg on me which was normal, but was not done right away. The doctor came in to assess me again. At that time I was having more feeling on my left side. He sent me for a head CT which was read as normal. I was observed and discharged at around 930pm. I do also have anxiety but what I was feeling was not right. I can?t describe but just a weird tingling all over. It would always get worse when ai would get up and walk. That did not stop until around 9pm. I was also concerned with the fact that two other people were having the same symptoms as me. I have not been to work for two days. I had awful pain in my arm, I?ve had a horrible headache, nauseous, dry mouth, and I?m extremely fatigued.

Itching, chest tightness, SOB, tingling lips, loss of voice. Administered 100mg of benadryl within 5 min of symptom onset followed by Epi Pen with call to 911. Paramedics transported to ED. Patient was admitted with anaphylaxis. Used Adverse Event Emergency Policy.

ANAPHYLAXIS, EPI, BenADRL TRANSPORT To ER Pt initially complained about feeling hot and then complained about weakness. Pt later developed a slight rash on the neck and complained about difficulty swallowing.

Received second COVID vaccine Moderna on Wednesday evening at 6pm. Later that night, I was a little light-headed and achey, but went to bed. On thursday, my legs and arms were extremely achy. I took Tylenol and Motrin in the morning. It seemed to help some, but continued to feel very achy in my legs. I left work early (I am a pediatrician) on Thursday and went home and just sat and rested. I felt terrible, but had talked to other colleagues who felt very bad that first day after the shot. Friday morning, I woke up still achy but feeling better overall. I took motrin and Tylenol again on Friday morning. I worked the whole day seeing patients. Was tired, but got thru the workday. At around 6pm, I noticed petechiae rash on my lower legs. The rash started spreading thru the night- up my legs and to my arms. I went to ER. They did order CBC, CMP. Platelets were undetectable- 1 platelet was seen under microscope. CMP was normal. I was told to go to bigger hospital. I went, My platelets read as 4. I was admitted for two nights. Two doses of IVIG were given and I was put on Decadron 40mg PO daily for 4 days. I had tylenol, benadryl, zofran before the IVIG and after. I will see Hematology next week for follow up. Platelets yesterday at discharge were 60. Will be checked frequently for the next few months. ITP= diagnosis. COVID shot was trigger.

I am 38 years old with no history of medical problems. I do NOT have a history of miscarriages and have one healthy child who is 22 months old. On 1/13/21, I took a home pregnancy test which came back positive. At that time, I had a missed period but also had several common pregnancy symptoms such as bloating, acne, fatigue and tender breast. later that week, I called OB/Gyn and spoke to an RN to schedule my 8/9 week ultrasound and to inquiry about the vaccine during pregnancy since I had no clue whether it was recommended/safe or not. the RN, very confident and without any disclaimer, stated that hospital is recommending all of their pregnant patients to receive the vaccine. Obviously, I decided to trust this medical professional who was so confident in her response. My normal pregnancy symptoms continued. On 1/19/21, I was 5 weeks pregnant and received my first dosage of the vaccine. felt fine other than a sore left arm. on 1/20/21, I woke up with a lot of abdominal cramping and pain. It was new to me but assumed it was normal. My cramping and pain continued until 1/21/21. On 1/21/21, I woke up without the cramping and pain. But, I also noticed that my breast were no longer tender and my skin had completely cleared up. I became concerned but prayed everything was fine since my home pregnancy test was still positive. On 1/22/21, by cramps continued once again but more mild. My pregnancy symptoms seemed as if they were no longer present but remained hopeful. On 1/23/21, I woke up with light spotting that only lasted through the morning. Soon after, I started having extreme abdominal pains. I prayed everything was fine. The pain continued and became worse. That night, the pain was so bad that I just went to bed. Right before going to bed, I noticed I had started spotting again. A little heavier than in the morning. I made sure to lay on my left side, hoping it was normal in pregnancy. On 1/24/21, I woke up with heavy bleeding and clotting. I went to the doctor and got an ultrasound and blood test. I was told by the doctor at Hospital that I had a miscarriage.

Day after (2/8/21): Severe chills, tiredness, body aches, headache, loss of appetite, fever (101.4), bloody nose w/blood clots (left nostril only). 2 days after (2/9/21): Intermittent headache, aches in joints, bloody nose w/blood clots (left nostril only), hive around injection site.

- Headache: starting about 12 hours after the vaccine and continuing for 2 days - Fatigue: starting about 12 hours after the vaccine and continuing for about 2 days - Chills: starting about 16 hours after the vaccine and intensifying until 24 hours after the vaccine administration - Fever: starting about 16 hours after the vaccine and intensifying until 24 hours after the vaccine administration - Blood clots: expulsion of clots during the same period as the fever and chills. Had completed menstruation 2 weeks prior, so not related to that.

atrial flutter pain in right arm , pain kept going up arm but only if you touched it, got on xartorl ( blood thinner) . right forearm was really swollen , tingling and turned blue, went to hospital they did a ultrasound to check pressure in veins. if she had hand at 90 degree angel it wouldnt turn blue but if I drop it it would turn blue. next day ran more test. MRI on arm. taped vitamin c to spot where pain was in arm. developed blood clot. told her to put heat on arm and take pain meds. felt better until she stopped blood thinner feb22, 2021. two days later had more blood clots on arms, veins were showing huge in breast and foot, pants got tighter. feb 27veins in lower leg and neck started appearing more. feb28 my left hand was cold and the veins were showing more and u could see veins. right back veins started appearing , got period but after 12 hours it stopped. march 3 veins started appearing again. march 4 right arm swelled and tingling in fingers and right right arm was so painful. Nerve pain. put back on blood thinner. march 4 in evening was put on new meds. I'm still dealing with pain and different issues. march 9 had a Val moment but had tingling from butt to brain . next morning felt miserable, nauseous , throwing up and couldnt control it. 3/11 neck is swollen. referring her to university because no doctor can figure out what it is.

Started abdominal pain and heavy vaginal bleeding at the night of the first vaccine shot on 2/12/2021. That day was my 5th day of my period and there were very few brown spot during the day time as normal. After dinner, I started feel abdominal cramp and suddenly a lot of blood came out. The bleeding lasted about 1 hour and soaked 5-6 pads. The next few days had small amount of blood. This situation never happened in my past 20 years period experience before. I had very normal period always lasted about 5-6 days.

7pm fever 103.4° chills, tremors, vomiting. Fever remained for 2 days, low back and abdominal pain became increasingly worse. Finally went to ER 2/26 was septic hospitalized for 13 days

Headache, redness and swelling at the injection site followed by large bruises, skin rash/hives all over body, fever, body aches and joint pain, vaginal bleeding while not menstruating

Unprovoked Pulmonary Embolism - symptom onset week of 1/18, hospitalized 1/30-1/31 - treated with oral anticoagulants

I was trying for a pregnancy and was likely pregnant but not detectable at vaccine number 1. Found out about pregnancy a week or so before vaccine 2. (I was likely about 5 weeks pregnant then based on LMP of dec 22 with avg cycles of 35 days. Decided to get vaccine due to general advice that it is okay during pregnancy. (No known adverse effects). After dose 2, had about 10-12 hours of chills without fever and general fatigue. Shortly afterwards experienced mild cramps. This is my 5th pregnancy and I have no history of complications of any sort. Cramps are not usual for my pregnancies but I know it can be normal so I did not think anything of it. Mild spotting occurred but again did not think anything of it as I know it can be normal. I was scheduled for a first OB visit Mar 3 where I should have been 10 weeks. (Initial positive pregnancy test was Jan 29). Ultrasound showed empty 5.6 week gestational sac with a yolk sac and subchorionic hemorrhage. OB suspected pregnancy failure. We followed pregnancy with ultrasound of better quality 10 days later which showed a possible fetal pole and yolk sac but no heart beat and gestational sac measured at 6.0 weeks. Today March 18 awaiting repeat ultrasound tomorrow but started bleeding and cramping. Consistent with the start of the miscarriage. With no histories of abnormal pregnancies and with the gestational sac consistently measure at 6 weeks (matching to about the time of shot#2), I am inclined to believe that the second covid shot stopped the progression of my pregnancy. I am a huge pro vaccine health care provider but would recommend now an investigation into first trimester covid vaccinations and possibly not recommend this during that time period.

3/13- First shot of Moderna vaccine received. 3/14- Sore arm, chills and a headache. 3/15- Shortness of breath and rapid heartbeat. 3/16- Went to ER because of more severe shortness of breath and rapid heartbeat. 3/17- COVID test with negative result. 3/19- Patient messaged her PCP explaining persisted symptoms. 3/23- Chest pain and shortness of breath developed and she died at ER in PEA. 3/25- Autopsy showed pulmonary embolism with no evidence of peripheral vascular disease. Double check COVID test with negative result.

5 hours after immunization developed head ache and stroke like symptoms with left facial droop, ataxia and left arm and leg weakness. she was given tpa for stroke and transferred to Hospital.

Copied from MD discharge note - Patient is a 38 y.o. female with PMH significant for asthma and lupus not on any treatment admitted on 3/27/2021 with progressive shortness of breath and cough for months, found to have hypoxia, bilateral multifocal infiltrate without pulmonary embolism on CTA, leukocytosis, elevated troponin, elevated BNP, normal EF on echocardiogram. COVID- 19 tests were negative 4 times in the last 1 week. Blood cultures were negative. Urine and strep antigens are negative. HIV-1 also negative. Rheum consulted for hx of lupus. They did not feel this was lupus pneumonitis. Negative anti-dsDNA/SSA/SSB and RF. Pts resp status continued to decline. She was intubated on 4/3 and transferred to the ICU. Bronch washings were also neg for COVID. Despite neg cultures pt was given multiple rounds of abx including vanc, merrem, azithromycin, cefepime, without benefit. IV steroids added for possible reactive pneumonitis. Pt with shock, likely multifactorial including septic and cardiogenic. Multiple pressors maximized and BP remained low. Nephro following for worsening renal function. CRRT initiated to attempt to correct electrolyte and acidosis. Pt did not tolerate CRRT after several adjustments by neprho, pts electrolytes continued to drift from normal. Hgb dropped and CRRT held. Pt went into cardiac arrest at 1329 on 4/8/21. After several rounds of epinephrine and optimized ACLS, no pulse was recovered and ROSC was not achieved. Family notified of death at 1344 on 4/8/21

Suspected anaphylaxis: Client vaccinated at 10:48am. Sat in wait room area for brief time, then out to car in parking lot. Client experienced dry mouth, raspy voice, cough & continued clearing of through. Sat and drank water in car for 40 minutes. Came back into clinic at 11:35 to report symptoms. No SOB noted; regular respirations; mild anxiety noted. VS @ 1143am: BP 138/98, P 68, R 16. Client continually observed. No improvement in dry mouth, raspy voice, cough & continued clearing of throat. Client continually observed. EMS called at 1210p for further assessment of possible anaphylaxis. VS @ 1215p: BP 150/100, P 70, R 18. EMS arrived and recommended transport to local ED for further assessment. Client transported at 1225pm from clinic.

Vaccine triggered ITP platelet drop: purpura observed in right armpit. This is common for me when platelets drop below 75k. Since the purpura began on a Sunday, I decided to wait until Monday to see my doctor; however, by Monday morning the purpura were gone and no other symptoms presented.

Same day:Tingly arm. Metal taste in mouth. That night: very sore arm. Nausea started and dizzy spell at night. Nausea lasted 2 days 3 weeks after shot: spotting about 6 days before period. Heavy period with clots that came a few days early.

3 days after receiving my 2nd Moderna vaccine I went into anaphylaxis. My throat felt like it was closing, tongue swelled up and could barely speak. My hands swelled and very extremely itchy. I developed hives all over my upper body including my head. This has Never happened before.

8 days after 1st dose I had a heart attack. Cardiologist intervened with catheter. No blockages or problems found. Can't figure out what triggered heart attack. No stress at time or prior too heart attack. No heart issues in past ever.

Increased heart rate within 2 hours of injection Body aches by 12 hours Headache and cough by 24 hours Cough and trouble breathing increased daily Went to urgent care on day 15 as cough worsened and was diagnosed with pneumonia. Put on antibiotics and steroids

Within 30 hours, Platelets dropped to zero. Admitted for ITP for 3 days. 4 week after IVIG and steroids, numbness and tingling started in legs. Cervical spinal cord lesion found now C2-C4. Lost ability to walk and sit up. Admitted to Medical Center for the past 3 weeks receiving treatment for transverse myelitis vs. MOG. Physicians believe trigger was COVID shot. Begging CDC to investigate since I have had both ITP and now transverse myelitis after second covid shot. Now out of work and will be in rehab for months. Please investigate. I was very healthy, marathon runner. I hope to eventually gain back my ability to run but the neurologists have no idea.

Death. Approximately 12 hours after administering the vaccination shot, patient experienced a medical emergency and lost her pulse. Paramedics attempted to resuscitate her for about 80 minutes. Her heart was unable to be restarted. She was declared deceased at 3:00 AM locally.

Blood clot in left arm confirmed by ultrasound. Additional swelling and pain in left leg but no identifiable blood clots. Swollen lymph nodes and pain since injection (Left arm = in arm, across breast, under armpit and Right = under armpit), rash for 2 days, tingling in fingers for 4 weeks, and injection site pain for 4 weeks,

On 5/7/2021 Patient was admitted into the ER then later the ICU for a Cerebral Edema. Patient was also hospitalized for Acute Respiratory Failure and Hyponatremia. Sodium Level was 105. She was unconscious and intubated for 36 hours with massive swelling to her Brain. All the symptoms that took us to the hospital on the morning of 5/07/21 started on 04/30/21.

anaphylaxis. 8 days in ICU on Epi due to rebounding anaphylaxis. then 2 weeks on a critical care floor before d/c. still regaining my full strength .

Right after injection, I got really hot and flushed. I thought I am not a fan of needles - so I thought it was anxiety. My throat got really dry. They gave me a Dixie cup of water and I asked for more. After I had finished the one cup, I was clearing my throat and it felt like I couldn't swallow and my tongue had swollen up and I couldn't swallow any water from next Dixie cup. I couldn't swallow - it felt like it would get stuck at the back of my throat. The nurse said she was going to stab me with the epi-pen but had me lay down first and my face started to feel slightly numb and I told her that and she stabbed me in right hip with the epi-pen. They called the ambulance to take me to hospital and after the epi-pen was given they had me sit up and put a mask on my face and I was in a state of panic. I wore an oxygen full face mask and was breathing into it. The paramedics came in and put me on stretcher - monitored for six hours. Because of the adrenaline from the epi- pen - I had high blood pressure and heart rates - everything was really high. After a few hours, she told me that my tongue was looking better and there was better color in my tongue. I was sitting there every six hours - I was monitoring as how to I was doing. They gave me Benadryl and I think they gave me something else but I can't remember what it was. I came home and it was late at night - 11:00 or 11:30 and from there until February 1st, I was extremely sick. I went back to ER on 23rd; and did telehealth visits - with my doctor (right after ER visit from Injection was first one; and then I went to the hospital on the 23rd; Telehealth on 24th or 25th and I - I was running fevers of 104, 103 and went up to 105 almost- on 23rd of January - 3 days after injection - I'm weak, I can't move - everything hurt. From head to toe. I couldn't sleep or do anything. I was so weak, I couldn't even move. It was difficult just to use the bathroom. I had the fevers that was causing my chills and my body aches were bad. I had been trying to alternate Tylenol and Ibuprofen; I was finally prescribed Hydro Codone just to sleep. I was told to take this during the day and the Tylenol and Ibuprofen combo at night. Shoulder surgery was about a month after the vaccine - 18th of February - And on the 22nd of February I went to the hospital again for left side chest pains. - I couldn't breathe - I was discharged February 25th - I was on blood thinners for three months. - the surgeon said that I developed clots and I developed these shortly after surgery and ended up in the hospital for three days. The clots are unknown - blood clots started in the legs and then developed the fluid/clot issue in the lungs - I had a pulmonary embolism in my left lung. Surgeon said it could have been caused by vaccine as he did not work on the lower part of my body.

THROMBOCYTOPENIA (LOW BLOOD PLATELETS)-Primary; ECCHYMOSIS; PETECHIAE; treatment: prednisone (ORASONE) 20 mg Oral Tab (Taking) Take 4 tablets by mouth every morning with a meal as directed

I am a nurse practitioner, so as a healthcare worker, I received a very early vaccine. I have had little time to report what happened to me but not that it remains an issue I think I need to do so. I had a very serious initial reaction and am now having chronic problems likely related to my vaccine. I received my first dose of Moderna 12/27/20 at POD lot# 025J20A and my second dose 1/24/21 at POD lot#029L20A. After the first vaccine within a few hours I had significant injection site and arm pain. By the time I went to bed that night I could barely lift my arm over my head it was so stiff and warm. The arm was very painful, and I required Ibuprofen 800 mg TID for 3 days to control the pain. I did not have systemic symptoms from the first vaccine. After the second vaccine, within hours I had systemic symptoms of fatigue, generalized aches in my muscles and severe arm pain in the injection arm. I received the vaccine in the afternoon. I went to bed that night and woke up suddenly at 3 am, about 14 hours later. I had severe myalgias and rigors. I was barely able to move. I was not able to walk or perform fine or gross motor tasks without difficulty. I was unable to dress myself or get up to go to the bathroom. I required almost fulltime care from my husband for three days. On day 4 I developed severe headaches nausea and vomiting. The muscles still ached but I was able to walk and move again. My fine motor was still impaired for a total of 7 days. I was out of work for 8 days and did not feel 100% well for 12-14 days after the vaccine. As the symptoms started to resolve on day 5, I believe I had a mild case of Rhabdomyolysis as my urine was very dark almost brown and there was sediment in the toilet. There was no blood in my urine and no dysuria. I did a urine dip at work and it had protein and ketones but no bacteria. The specific gravity was very concentrated. I did not check my renal function at that time. My renal function a few weeks later was normal Cr 0.88. GFR 85. The dark urine and sediment lasted for about 2-3 days. I was drinking lots of water through this time-period and during then I was very ill. I was not seen at a hospital and rather I treated myself at home. During the above week was the first time I ever had neck or back pain. It did subside but I still had a dull aching in my neck after all of this. I had two episodes, one in late January and one in mid-February of left neck being very sensitive to touch, felt warm, and my ear was very hypersensitive to touch as well. It felt almost like shingles but there was never a rash and I took Acyclovir 800 mg TID for 3-5 days without relief. It subsided each time after about 7 days. This was on the same side of my body on the left as the vaccine was. In the end of March 2021 I began with left trapezoid pain in the same side of the body. I had some numbness in that arm as well so I saw orthopedics and received an MRI of my left brachial plexus which showed C3-4, C4-5, and C6-7 disc herniations that had not been present before. If the herniations were present in the past they were acutely inflamed by the inflammatory process the vaccine caused in my body. The MRI also showed significant and specifically left cervical and left axillary adenopathy this being the side of my vaccine. The pain spread beyond my trapezoid and become progressively worse into my neck and upper back only on the left side. The entire left side of my spine both cervical and thoracic was painful but the right side unaffected. It was very sharp nerve like pain shooting and running up into my head and anterior neck. Another MRI was done of the full cervical spine this time confirming these same herniations, but the discs appear to be pulling to the left with isolated left inflammatory process. The nerve pain became so severe that last week I began having numbness in that left arm and numbness into the left side of my face. A stat MRI of my brain only shows T2 flare pattern consistent with sequela of an inflammatory process of unknown origin. The foraminal stenosis at these spinal levels are very mild and do not explain my symptoms very well. Spine specialist reports that there can be symptoms of this nature but usually not with this mild of a pathology. The facial numbness has been identified as a trigeminal neuropathy of cervical origin but is rarely documented in medical journals and not seen by these spine specialists. There is a very significant amount of left sided nerve over stimulation, inflammation and adenopathy that is not explained. I have never had any spine or neck pain in my life before this and I have no history of traumatic events to explain this sudden change in my condition. I truly feel that ever since I received the Moderna vaccine and had that very severe reaction, my body has been in a constant inflammatory phase and there has been nerve pain in and around only the left upper side of my body where the vaccine was placed. I am scheduled on Monday for epidural spinal injections as I have been unable to find pain relief with any other therapies including dry needling, physical therapy, traction, tramadol, muscle relaxers, oral steroid bursts, etc. I know this may be a very strange and unique case, but I can say confidently that I believe the vaccine stimulated this entire cascade of events. If someone could please contact me related to this, I would appreciate it.

Heart attack, angiogram, overnight stay and transfer, 5 meds daily now, cost of medical care over $20,000, whole life change, currently still have swollen lymph nodes since 2 injection, diabetes, HTN, random body itching, within 12 hours of the shots I had chills and cold and hot sweats, whole body ache, couldn't sleep, low grade fever of 100.8, headache this resolved within about 48 hours. In less than 72 of receiving the vaccine I was having a heart attack and was in the emergency room. I'm sure I'm forgetting something with so much unexpected life changes and great.

Patient found unresponsive due to unknown cause on 5/26 (6 days post-vaccination). Transferred, noted to be COVID + by NP swab with high cycle threshold on admission, tracheal aspirate was COVID neg. Patient had prior COIVD infection in Nov. 2020. Workup for encephalopathy included MRI (5/27) which revealed thrombosis of left transverse/sigmoid sinuses and proximal jugular vein. However, platelets were normal 245 x 10^9/L (5/26).

Anaphylactic reaction, immediately after receiving vaccine. Got Epi-Pen, then went to emergency room for 6 hours. Was told to see an allergist, have not found one yet. Took off 2 days of work, 2 more days where felt somewhat sick, then fine after that

First vaccine was given 05/12/2021 and later that day I started menstrual bleeding and have already had my menstrual cycle a week prior. But I thought it was just my menstrual cycle being funny. During t next 7 days my menstrual bleeding was extremely heavy.btoday I received my 2nd dose and approximately 2 hours after I started to have vaginal bleeding and this time I also have an extremely painful migraine on the left side of my head.

Per family, patient reported to have been experiencing fatigue for several days after receiving Covid vaccine. On 6/15/21, patient's significant other discovered patient in bed, not breathing, with ashen appearance, uncertain how long it had been since patient was last breathing. EMS was contacted, CPR was given and patient was transferred to Emergency Department at the hospital. Diagnosis of Cardiologist is cardiac arrest, NSTEMI (suspects type 2). Per cardiologist, patient appears to exhibit cardiomyopathy, etiology difficult to ascertain (patient's family/acquaintances have endorsed periodic use by patient of anabolic steroids in the past, making it more difficult to rule out source of cardiomyopathy. ). Physicians involved are reporting this case in the event that this may be a case of vaccine-induced myocarditis, although no diagnosis as such has been made.

Anaphylactic reaction; Heartbeat fast; Hands were shaking; Dizzy and lightheaded; Could not swallow; Flushed; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 38-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 Rhinitis (She did have severe sinusitis 2 years ago) and Sinuplasty (This responded well to sinuplasty). Concomitant products included BIOTIN, KERATIN (BIOTIN PLUS KERATIN), COLLAGEN BOVINE and LINACLOTIDE (LINZESS) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed). The patient was treated with EPINEPHRINE 14-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 14-Jan-2021 at a dose of 1 dosage form. On 14-Jan-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 106/71 (normal) 106/71. On 14-Jan-2021, Body temperature: 36.6 (normal) 36.6. On 14-Jan-2021, Heart rate: 87 (normal) Temporal pulse 87. On 14-Jan-2021, Oxygen saturation: 98 (normal) 98%. On 14-Jan-2021, Respiratory rate: 18 (Inconclusive) 18 bpm. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was taken to ER, treated with IV fluid and also IV steroid. Patient was observed for 4 hours, improved completely and discharged form the ER. She was recommended to take epi-pen, vitamin D, vitamin C and zinc. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Added medical history, lab data, concomitant medications and new event; updated patient demography and event stop date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient had just recovered from COVID and ended quarantine on 1/1/21. On 1/4/21, she received the first COVID vaccination. While driving home on 1/6/21, she experienced an MI diagnosed in the emergency room 30 minutes later. She was admitted to the hospital and underwent a heart catheterization and received a STENT. She had previous cardiogenic shock in 2003.

Received at 12:15pm. Other than a slightly sore arm nothing until 6pm. Started at 6pm with the injection site being very warm and the whole right arm began to heat and swell all joints from knuckles to my neck began aching at a 7 on a 1-10 pain scale. At 6pm the rest of the joints in my body began aching but not as bad as the injection arm. By 10pm I was extremely nauseous and had a steady throbbing headache and was only able to sit as any movement was painful and nauseating. I vomited twice that night. By 6am the next day I was unable to grip or lift anything with the injection arm as moving it all caused intense pressure and pain in that arm a 8.5-9 on the 1-10 scale. By this time my entire body was a steady and constant 8 pain wise. Especially my lower back and hips my joints felt like they were being crushed and pulled apart. I was unable to get out of bed except 3 times to pee for the entire second day. The pain in the lower back, hips and injection arm increased to the point where I would just cry and yell as it was the worst joint and back pain I have ever had in my life. I tried sleeping most of the day and would wake from the pain. I have not had a period in about 4 years and had vaginal bleeding like a period that night with abdominal cramping as well. There was nothing that relieved the pain but time. By 10pm the pain finally subsided some and today 1/24 two days post injection the pain is now a constant dull joint ache like a normal flu ache. I am still very sore in the injection arm but can move it today, still causes too much pain and pressure to lift or pull with it. If I sit or stand up for more than 30 minutes my arm begins to throb and the headache and nausea come back.

1/22 started with chills, low fever, pain, burning sensation and swelling in both arms. 1/27 - pain and swelling continued, numbness of left hand. Evaluated in ER. Stated she received an anticoagulant, CK 2,500, liver enzymes elevated. 1/28 under the care of Dr. 180 Engle st Englewood. Dx. Rhabdomyolysis. treatment with aspirin, Cold compresses, fluids, and antibiotics if symptoms do not improve. 1/29 pain levels are improving, no antibiotics. Employee expects to return to work on Sunday, 1/31.

Approximately five days after the injection, I had my first period since 2013. Due to a combination of pregnancy (delivered 2/2014) and subsequently two Morena IUDs, I have not even had spotting since 2013. For three days, I had period-like blood and cramping. I reported this during my routine rheumatologist appointment who told me to report it here. Additionally, I had pain in the arm for three days as expected from the literature about side effects from the trials. I am scheduled to have my second dose on 2/4/21 and will report any other side effects.

Moderna COVID-19 Vaccine EUA: Vaccine recipient reported 2/6/2021 that she received 1st dose of Moderna on 12/29/2020. Within 24 hours she developed a fever (T max 102) and body aches. She reported that the fever would not break. On 1/1/2021 she went to the ED and was prescribed azithromycin for left lower lobe pneumonia. COVID-19 test was negative on 1/1/21. On 1/6/2021 she went back to the ED for worsening symptoms and was subsequently admitted. Her COVID tests were negative. From 1/6/2021 to 1/11/2021 she was hospitalized at Medical Center for pneumonia. She was ordered antibiotics and steroids. Her COVID-19 test was negative on 1/11/2021. She was discharged on 1/11/21 to home.

Pt has h/o HTN (not on medication) and occasional asthma(no hospitalizations), and allergies to Penicillin (tongue swelling), tree nuts (throat swelling), and Bees (local swelling); Pt notes she only takes benadryl for these reactions; she has never been prescribed or used epinephrine. Pt denies heart disease, strokes, diabetes, increased bleeding tendency. No early heart disease in family. LMP in the last week. Pt notes she was supposed to see allergist in past, but has not. Pt was feeling well this morning before she came to COVID vaccine clinic. Pt had received first Moderna Vaccine shortly before 0918am here. At 0938 Pt noted feeling "heaviness" in head and "lump in throat." Pt denied itching/swelling to mouth, itching/hives to body, dyspnea, chest pain, nausea. No lightheadedness/dizziness. Pt walked to stretcher. BP at right forearm was 223/151 and then 221/132 on repeat. Heartrate in 90s. Sao2 on RA 100%. RR 18. Pt notes having high BPs at times, but not often as high here. Pt speaking is slightly hoarse voice. No strider. Pt speaking in full sentences. No oropharyngeal edema. No urticaria. No tachypnea or wheeze. HRT RRR. 2+ left rad pulse. A/P: given Pt's h/o severe allergies and now new Globus sensation and change to voice I discussed with Pt that she was likely having allergic reaction. Given involvement of airway I recommended epi administration to neutralize reaction and transfer to ED for observation. I advised Pt that epi would increase heartrate and blood pressure. I determined benefit of treating anaphylaxis outweighed risk of elevating BP, even though she has hypertensive urgency BP values. Pt has some headache; she could be bordering on hypertensive emergency. I asked pharmacist to call 911 indicating early anaphylaxis and request of paramedic. ~5 minutes after Epi (given at 0942) Pt notes lump sensation and voice improved. I had RN place IV to left AC and gave verbal order for benadryl 25mg IV. Pt notes some nausea and dizziness. Lump sensation continues to improve. EMS arrived ~0950. I gave report to paramedic. I discussed with Pt that I would place referral to Allergy and Immunology; they will determine if and when Pt could receive second moderna vaccine.

She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl.

Patient got the vaccine and within minutes she became gray in color, limp, and her head went down. she then started to take deep breathes and her body stiffened right up and she stopped breathing for a second. we called 911 as soon as we noticed something was off with her. When she came to a few minutes later she knew she passed out but that was it. she did not go with the EMS, another staff member took her to the ER.

throat and tongue swelling 5 minutes after vaccine. Hard time swallowing. Sat at the facility for 1 hour under observation, then went to the ER. by the time I got to ER, I was short on breath. Doctors immediately gave epi and steroids. Was diagnosed with anaphylaxis.

pt complained of dry mouth and difficulty swallowing. pt observed for over an hour with no signs of distress, pt. provided water and gum. pt said symptoms resolved. Medics notified that pt went to ER one hour later.

Pt was admitted for right lower extremity swelling. has had DVT and pulmonary embolism. Pt found to have thrombosis of right popliteal vein. pt following up with hematologist.

On Thu, Mar 11, 2021, 6:18 PM patient wrote: I have had an allergic reaction to this vaccine. I felt like crap afterwards and stayed the full 30 minutes too. I had thought maybe it was anxiety, but I've broken out all over in hives and I can barely talk now due to how hoarse my throat is. I felt off very quickly post vax and like I was drunk or something after my injection. I have had a high pulse, palpitations, bad headache, jitters, lightheaded/ dizziness, nausea, vomiting, feeling like I have to constantly swallow (and do), and other post vax issues. I have felt very out of it and overall very cruddy. I hope you'll respond to this email so that I know it gets reported. I have taken a lot benadryl and have an EpiPen handy if I ended up needing it. My mouth has been fine, but not my throat.. but it isn't closing up so I think it's okay for it to just be swollen. I have had so much going on post vax that I've literally just been laying in bed hoping I'll feel better. 03/12/2021 The hives have come back and the itching hasn't ever stopped, my tongue is still super swollen and sore from me constantly accidentally biting it, my throat is still red, swollen, and sore, and I generally feel like crap. I'm taking a ton of antihistamines to combat this and they're not touching it. I am probably going to need more steroids and a visit to urgent care tomorrow. :( 03/13/2021 The email is too large with the new pics and it got kicked back...trying again minus the body hive pics. The hives just keep spreading :( . I know you can't see them all because the lighting isn't great, but you can make out the outlines of the welts like on my forehead. I have hives all over my face, throat, neck, chest, arms, and more every day. My whole body is very itchy even in areas without hives. I am still dealing with: hives/ itchiness, stomach issues, tongue, throat, headache, etc. I am taking zyrtec twice a day, 50 mg benadryl every 8 hours, a prednisone pack, and a pepcid twice a day. I have my h1, h2, and h3 categories covered along with steroids onboard which is my allergic reaction regimen protocol from my allergist. I also have my asthma meds which helps with allergies. Unfortunately it isn't working to keep it from spreading/ continuing or to even keep it at bay. I am trying to hang out until Monday morning for my allergist's office to open and see if I can get an appt or help via meds called in. I've never had this before in my life! One big bad reaction and then it goes away, not this long dragged out big reaction. This is crazy! I figure you probably need this info for the CDC VAERS report, I'm sorry if you didn't! Show quoted text 03/14/2021 The hives are even on my feet now ( my whole body either has hives or is itchy). I feel like absolute hell and I am completely regretting this.???? Here I thought the moderna would of been safe for allergic people. I have all of these allergy meds too and nothing is helping, but I'm going to call my doctors first thing when they open and try to get seen tomorrow or at least Tuesday with my allergist. This is all just so crazy to me! I have had all of my vaccines with no problems too, last one was my tetanus shot and that was within the last 2 years... not one single problem with the exception of injection site soreness for a day. 03/15/2021 I am still going strong with the hives and now I have pneumonia, which I have never had before in my life. :( The doctor gave me a Z pack, but I can't take it until after I see the allergist tomorrow and that's if he says it is safe for me to do so. She is worried it would cause another anaphylactic reaction. We are also worried about the 1 week delayed allergic reaction that people are having now and what that will mean for me when I'm already bad off. Allergist appt is tomorrow at 245pm. 03/17/2021 I'm sorry I didn't update. I'm still dealing with hives, but they're getting better. I am still dealing with the heart arrhythmias pretty hard. They are not pleasant to say the least and I am still feeling really wiped out. I am dealing with PVCs for the most part today and some others that I'm not sure what they're called (like I don't know if it's a PAC, PVT, but I do know I've had V-tach and PVCs going on). Hopefully it will get better soon, I'm so over all of this and have things I need to get done LOL! 03/20/21 I am on a 2 week heart monitor now due to the heart issues I've been having post vax. I just saw a fb post from a friend and she's having the same problems after hers. I never posted about the heart issues with mine either and correlation doesnt equal causation of course, but this is interesting and may be of concern so I'm passing it along. The hives are finally gone minus the "moderna arm." 03/21/20 Dude... this rash started up a tiny bit friday, a little more then went away Saturday, and now it's coming back in full force! I'm still taking allergy meds too! This is just crazy!

Early onset of menstrual period-14 days early-lasted 11 days versus normal 5 and heavy bleeding including large clots for 10 days.

Bleeding right after the first shot; Pregnant; A spontaneous report was received from consumer, concerning herself, a 39-year-old, pregnant female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a bleeding right after the 1st shot, pregnant. The patient's medical history include 3 miscarriages on Dec 2013 , Feb 2013, Apr 2013 (all not more 2months). Products known to have been used by the patient, included Progesterone 300mg indicated for after 3miscarriages, Tylenol, Folic acid 1mg . On 18JAN 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 FEB 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She experienced bleeding right after the 1ST shot. She would like to be enrolled into the pregnancy registry. On 15JAN2021, the patient received a positive pregnancy test. Her last menstrual period was on 07 DEC 2020 and conception date was unknown. The patient's estimated due date is 12SEP2021. No treatment information was provided. Relevant laboratory test on 22 Feb 2021 last Ultrasound were done and the Result were normal. Action taken with mRNA-1273 in response to events were not provided. The outcome of the event bleeding right after the 1st shot was unknown and pregnant is ongoing.; Reporter's Comments: This is a case of product exposure on a 39-year-old pregnant of unknown gestation (LMP 07 DEC 2020) and experienced PV bleed right after the first shot. Very limited information regarding this event has been provided at this time. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

I am 9weeks pregnant. My Dr. wanted me to get the Covid Vaccine because I am high risk (Diabetes and high blood pressure). The day after the shot, I started having hard cramping. By supper time I started to have bleeding. I went to the er and the next day to the Dr. The baby is ok. But I'm still spotting a bit.

39 y.o. female with history of asthma but no previous anaphylaxis to vaccines received covid-19 vaccine (Moderna) at 4:15pm today and within a few minutes developed tachycardia, nausea and vomiting No shortness of breath, no wheezing, speaking in full sentences No chest pain She has a history of asthma and hives to terbutaline, and anxiety reaction to gabepentin. No history of intubation or serious reaction from asthma Transferred to the procedure room by RN with my assistance Blood pressure 132/82 pulse of 135, 02 sat 100% on RA, speaking full sentences, stating she had some chills lungs clear, tachycardic, and moving air well, no wheezing. Patient stated said she had to the bathroom right away, was going to have diarrhea. Said she could walk, and was walked across hall with assistance to bathroom, where I stayed with patient. I accompanied patient to bathroom, she had one episode of diarrhea, and dry heaving, returned to procedure room, lied supine, IV started, NS bag hung. RN present, additional ARNP present, staff aware, anaphylaxis kit present. Patient tachycardic and continued with normal 02 sat and good air movement, EMS with request for ALS activated due to reaction to vaccine. I made decision to give epinephrine with her tachycardia and continued nausea with diagnosis of anaphylaxis, and as preparing epinephrine, patient stated she started to feel tight in chest, epinephrine given 0.3mg of 1:1000 IM. Lungs notable for reduced air movement lung bases. Patient denied throat tightening, rash, lip swelling, but she continued to have dry heaves, and stated she had a "sore throat". EMS had already been activated before first epinephrine dose. Awaiting medics, patient given Solumedrol 125mg IV, benadryl 50mg IV, and zofran 4mg IV Patient also given four puffs of albuterol MDI with spacer. Medics arrived, patient still feeling tight in chest, blood pressure 125/70, 02 sat 100%, lungs still tight with reduced air movement Patient given second dose of epinephrine 0.3mg, 1:1000 IM, approximately 7-8 min after the first dose. EMS transferred patient to gurney with transport to PEMC Patient alert during entire reaction. PEMC notified. To ED via ALS PEMC notified Timeline of anaphylactic reaction: 1615: Covid Moderna 2nd injection given RN notified of patient feeling rapid heart rate and nausea. Patient pulled back to procedure room. 1631: Vitals: BP 132/82, HR 135, Temp 97.1, O2 sat 100% 1637: IV start in LAC, NS running 1645: 0.3 mg IM Epi - administered by RN 1648: 4 mg IV Zofran - administered by ARNP 1650: 4 puff Albuterol sulfate 90 mgc given via spacer - administered by MD 1651: 50 mg IV Benadryl - administered by ARNP 1652: 125 mg IV Solumedrol - administered by ARNP 1653: 0.3 mg IM Epi - administered by RN

needed kidney and/or bladder transplant; within 30 hs after second shot, she died; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (within 30 hs after second shot, she died) and TRANSPLANT (needed kidney and/or bladder transplant) in a 39-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 reported medical history). 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 DEATH (within 30 hs after second shot, she died) (seriousness criterion death) and TRANSPLANT (needed kidney and/or bladder transplant) (seriousness criteria death, hospitalization and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. The reporter does not remember if this was from Pfizer or Moderna. Concomitant product us e was not provided. Treatment information was unknown. This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine. Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Reporter did not allow further contact; Reporter's Comments: Th; Sender's Comments: This case concerns death of a 30 year old female 30 minutes after the administration of the mRNA-1273 vaccine. Patient is reported to have no underlying issue. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death

Started feeling shortness of breath on 4/13/2021, got worse everyday. Went to clinic on 4/19/2021 and was diagnosed with pneumonia.

Patient was here for her second dose of COVID vaccine (Moderna), patient c/o itchiness and developed some 2 small hives on the right side of her arm shortly after receving the vaccine. Vaccine clinic physician assessed patient at bedside and ordered 50mg Diphenhydramine PO x1 dose. Patient took the PO Diphenhydramine at 1626 and tolerated medication well. Symptoms improved initially but then developed new symptoms of chest tightness and difficulty breathing 8 minutes after PO Diphenhydramine. Symptoms are consistent with anaphylactic reaction, Epi-Pen 0.3mg administered by RN on patient's right outer thigh x1 at 1635. EMS arrived at 1645. Patient is sent to hospital with EMS at 1700.

Patient felt initially well, but later in that afternoon her arm started hurting and she felt increasingly nauseous and started vomiting at 10:49pm, two hours later she was pronounced dead at approximately 12:30am.

Patient began experiencing pain and difficulty walking on Tuesday, March 23. Later that afternoon she was taken to an Urgent care, who sent her to the ER for evaluation. She was diagnosed with a very large blood clot in her leg, spanning from just above the knee to her groin area. They admitted her and began treating her with blood thinners. While undergoing that treatment, her heart stopped 3 times and she had to be resuscitated. They discovered a pulmonary embolism. While removing a large clot from her lungs, the doctor found that her lungs were riddled with hundreds of tiny blood clots. They also said that she was bleeding internally, very heavily, from an unknown location. In all, they gave her 20 units of blood, and none of it stayed in her veins. The doctor said it seemed to just disintegrate. At that point, her brain and organs had begun shutting down and family made the decision to remove her from life support. She passed away Thursday evening, March 25, 2021.

Fever and chills with myoclonic seizure (jerks in head,neck, arms and legs) for the duration of the fever: about 6 hours. At least one tonic clonic full body seizure.

Immediate facial flushing, minor difficulty breathing that lasted approximately 48 hours. Injection site pain, small (quarter-sized) rash right next to injection site. 1 week after injection, I developed lymph node pain, mostly in both underarms. I had spotting the week prior to my menstrual cycle for (so far) two cycles. Fatigue began about 2 days after the injection, and continues to linger.

Patient developed severe leg pain and presented to the emergency room. She was diagnosed with a deep vein thrombosis

Within 12 hours of 2nd injection woke up at 4:30 am feeling nauceious, diarharra, body aches terrible in back. (Advil taken after piece of peanut butter toast ingested) By Noon: headaching was beginning to set in. Body aches still terrible in back. (took Advil at noon for headache and body aches, ate small bowl of chicken noodle soup with ginger ale) By 4:00 pm: vominting every hour on the hour til 10:00pm. Headached is dilibating: have to be laying in bed with arm over head and eyes closed. Got to sleep that night after 10:00 vomiting spell. Slept through night. Monday morning dull headache behind right temple. Toast and Advil taken. Body aches in back still present but less severe. Took Advil every 4 hours for the day to keep headache under control and rested a bit from fatigue. Monday, April 26 notice bumps forming on my right side under my arm pit. Notice about 2 -4 bumps at that time. Stomach is growly, loud, rolls, random waves of nausesousness. Loose bowl at aprox 4:00pm daily for the week (not normal/typcial), right leg begins to have noticalbe times when it tingles like my leg is falling asleep while sstanding at work or walking. Approx. 4-6 spells of that throughout the day. Tuesday & Wednesday, April 27th and 28th, expericce break through bleeding (spotting, never had this occur before and on birthcontrol pill.) During this time, the bumps are multiplying down right side of back. Approx, 15, then 25, then by Friday when visted doctor approxiamtely 35-50 bumps/rash on side/back. mostly on the right side, but a few are scattered on left side. Dull headache was expereicned each morning during this week. Advil was taken with morning pill/vitamins to treat headache. Throughout all of this NEVER expereiced a fever.

Initially developed normal immune response sx about 12 hours after injection, however has had 2 weeks of persistent fatigue, vaginal bleeding/spotting, body aches.

Began to feel discomfort on left hand side starting on 4/22, progressively worsening until pain woke me up from sleep on 4/29 resulting in a trip to the ER where I was diagnosed with Bilateral Pulmonary Embolism.

I received my second shot on March 28 I had typical flu like symptoms fever 104.3°, body aches, chills, shortness of breath, by Wednesday March 31 my over all symptoms had resolved. On Thursday I had an intense calf pain that would not go away, seen primary care provider on 4/5/21, had ultrasound done DVT was ruled out. On Tuesday 4/6/21 I had left sided chest pain with residual left sided arm pain, and shortness of breath. Went to the ER, where they had done labs and ruled out heart attack. They had me follow up with PCP, whom referred me to cardiologist. Cardiologist was seen tests have been ordered but not completed yet. Feelings of shortness of breath have been on going since I had completed the second shot.

Wheezing in my chest and bad cough started on 5/5. Pain in my left calf began on 5/14. I went to the Emergency Room on 5/16 and was diagnosed pulmonary embolism in both lungs and deep vein thrombosis in my left leg.

stroke; feeling exhausted; problems with her eye after the stroke; threw up everything/ vomiting; fever; diarrhea; no energy; dizzy; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 39-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 Osteoporosis and Common variable immunodeficiency. Concomitant products included ZOLEDRONIC ACID (RECLAST) for Osteoporosis, LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication. On 02-May-2021 at 10:20 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On 03-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DIARRHOEA (diarrhea), ASTHENIA (no energy), VOMITING (threw up everything/ vomiting) and PYREXIA (fever). On 04-May-2021, the patient experienced EYE DISORDER (problems with her eye after the stroke). On 07-May-2021, the patient experienced FATIGUE (feeling exhausted). The patient was hospitalized from 03-May-2021 to 04-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DIARRHOEA (diarrhea), ASTHENIA (no energy) and VOMITING (threw up everything/ vomiting) outcome was unknown and DIZZINESS (dizzy), EYE DISORDER (problems with her eye after the stroke), NAUSEA (nauseous), PYREXIA (fever) and FATIGUE (feeling exhausted) had not resolved. Patient gets Immunoglobin infusion for autoimmune disease Common variable immunodeficiency (CVID). At the hospital patient was treated with intravenous medication, blood thinners and she took Ibuprofen. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-106750 (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.

Anaphlaxis Saturday, April 17th Day of Vaccination: under 5 minutes - lips tingle, injection site incredibly itchy within 10 minutes, itching spread across back, hives/rash appeared, face became beet red, confusion, throat began to swell Alerted EMT at 5 minute mark, taken to triage, Transported to Hospital by ambulance, treated for anaphylaxis- given steroid injection (left thigh) and benedryl (right arm) Post-ER treatment - benedryl Continued Allergic Reaction Rash continued and got worse, returned to primary care doctor on April 27th Red rash protruded down arm and across back, throat swelled, thought to lymph-nodes swelling Primary care physician proscribed prednisone - 7 day course to stop allergic reaction ER doctor and primary care doctor recommended no second dose

Blood pressure had risen it got really high around 150/70 or 150/80; Felt electric shocks in the head area; She forgets often; Only had first dose of vaccine from the vaccination series; Watched for a stroke; Tingling first on her chin, then her lips, all over head, and went into left arm; Numbness first on her chin, then her lips, all over head, and went into left arm; Speech was slurred; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Watched for a stroke) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Watched for a stroke) (seriousness criterion medically significant), PARAESTHESIA (Tingling first on her chin, then her lips, all over head, and went into left arm), HYPOAESTHESIA (Numbness first on her chin, then her lips, all over head, and went into left arm) and DYSARTHRIA (Speech was slurred). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure had risen it got really high around 150/70 or 150/80), ELECTRIC SHOCK SENSATION (Felt electric shocks in the head area), MEMORY IMPAIRMENT (She forgets often) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only had first dose of vaccine from the vaccination series). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Watched for a stroke) outcome was unknown and PARAESTHESIA (Tingling first on her chin, then her lips, all over head, and went into left arm), HYPOAESTHESIA (Numbness first on her chin, then her lips, all over head, and went into left arm), DYSARTHRIA (Speech was slurred), BLOOD PRESSURE INCREASED (Blood pressure had risen it got really high around 150/70 or 150/80), ELECTRIC SHOCK SENSATION (Felt electric shocks in the head area), MEMORY IMPAIRMENT (She forgets often) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only had first dose of vaccine from the vaccination series) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) The blood pressure had risen during this time- "It got really high- around 150/70 or 150/80, don't remember exactly. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the event of Cerebrovascular accident is not supported in the source documents, is invalid and should be deleted and the case downgrade to non-serious.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the event of Cerebrovascular accident is not supported in the source documents, is invalid and should be deleted and the case downgrade to non-serious.

Internal Bleeding; Anaphylactic reaction; bad allergies; sinus migraine; acne on face/ back; nausea; vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Internal Bleeding) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 39-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 product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis. Concurrent medical conditions included Latex allergy (latex allergy), Gluten intolerance (Gluten allergy) and Drug allergy (Tylenol). Concomitant products included MAGNESIUM CITRATE, MOMETASONE FUROATE (NASONEX), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D3, MULTIVITAMIN AND MINERAL and FISH OIL for an unknown indication. On 10-Sep-2020, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERNAL HAEMORRHAGE (Internal Bleeding) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, INTERNAL HAEMORRHAGE (Internal Bleeding), ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERSENSITIVITY (bad allergies), MIGRAINE (sinus migraine), ACNE (acne on face/ back), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications and treatment medications were reported. Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product known safety profile.

Fever; Headache; FLU; Suffocating; Almost had a heart attack; High blood pressure/pressure rose; Breathing is not well/the breath is short; Feels a pressure in the chest; Lost the desire to eat/doesn't get hungry; Heart was beating fast; Does not sleep well; Very dry mouth; Very thirsty; Has been unable to work; Lost about 8 pounds; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Almost had a heart attack), ASPHYXIA (Suffocating), DYSPNOEA (Breathing is not well/the breath is short), CHEST DISCOMFORT (Feels a pressure in the chest), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry), PALPITATIONS (Heart was beating fast), INSOMNIA (Does not sleep well), DRY MOUTH (Very dry mouth), THIRST (Very thirsty), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work), WEIGHT DECREASED (Lost about 8 pounds), PYREXIA (Fever), HEADACHE (Headache), INFLUENZA (FLU) and HYPERTENSION (High blood pressure/pressure rose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced DYSPNOEA (Breathing is not well/the breath is short) (seriousness criterion hospitalization prolonged), CHEST DISCOMFORT (Feels a pressure in the chest) (seriousness criterion hospitalization prolonged), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry) (seriousness criterion hospitalization prolonged), PALPITATIONS (Heart was beating fast) (seriousness criterion hospitalization prolonged), INSOMNIA (Does not sleep well) (seriousness criterion hospitalization), DRY MOUTH (Very dry mouth) (seriousness criterion hospitalization prolonged), THIRST (Very thirsty) (seriousness criterion hospitalization prolonged), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work) (seriousness criterion hospitalization prolonged), WEIGHT DECREASED (Lost about 8 pounds) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), INFLUENZA (FLU) (seriousness criterion hospitalization) and HYPERTENSION (High blood pressure/pressure rose) (seriousness criterion hospitalization prolonged). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Almost had a heart attack) (seriousness criteria hospitalization prolonged and medically significant). On 08-Jun-2021, the patient experienced ASPHYXIA (Suffocating) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 19-May-2021 to 22-May-2021 due to HYPERTENSION, MYOCARDIAL INFARCTION and PALPITATIONS. On 22-May-2021, MYOCARDIAL INFARCTION (Almost had a heart attack) and HYPERTENSION (High blood pressure/pressure rose) had resolved. At the time of the report, ASPHYXIA (Suffocating), DYSPNOEA (Breathing is not well/the breath is short), CHEST DISCOMFORT (Feels a pressure in the chest), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry), PALPITATIONS (Heart was beating fast), INSOMNIA (Does not sleep well), DRY MOUTH (Very dry mouth), THIRST (Very thirsty), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work), WEIGHT DECREASED (Lost about 8 pounds), PYREXIA (Fever), HEADACHE (Headache) and INFLUENZA (FLU) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Blood pressure measurement: high (High) Blood pressure rose. On 19-May-2021, Blood pressure measurement: high (High) Blood pressure rose. Concomitants medications 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 events, a causal relationship cannot be excluded. This case was linked to MOD-2021-214924 (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 received her 2nd moderna covid 19 vaccine on 4/6/21. she was hospitalized on 5/30 with c diff infection. she was treated with vancomycin po and discharged on 6/1/21. She reports no recent exposure to antibiotics and takes probiotics every day. She denies any prior hx of c diff infection in the past. She also has a recent hx of sudden vaginal bleeding and was seen in our ER on 5/7/21 for this. She reports she has not had a menstrual cycle since 2018 after she underwent an endometrial ablation and dx hysteroscopy In 5/18 with no further problem or bleeding and has been on medroxyprogesterone and suddenly started bleeding recently which concerned her. She reports she is now scheduled for a diagnostic hysteroscopy/d and c rollerball button and endometrial lining ablation on 6/2/21 which revealed a stenotic cervix and it was not dilated due to risk of uterin perforation. the cause for the Menorrhagia. Dysmenorrhea is unclear

Patient started feeling bad due to fever, nausea, vomiting, and blood in urine. Was transported to emergency room and was diagnosed with sepsis. Was admitted overnight and given iv fluids and antibiotics. Discharged following day and given more antibiotics

pneumonia; upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). At the time of the report, PNEUMONIA (pneumonia) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) outcome was unknown. Treatment medication used as Steroids and Antibiotics. Concomitant medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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 contacted my primary care office after experiencing a tender knot on my calf for a couple of days that also became reddened on the skin surface. It was determined by ultrasound that I had a small, superficial blood clot in my lower right calf on June 3rd. We treated the blood clot at home with a compression stocking, elevation and heat, and I had a follow-up ultrasound on June 10th that indicated no change in clot location or size. I continued with home treatment and did not have any further complications. The pain and redness have resolved since that time. Prior to this pregnancy I have had two healthy pregnancies and one miscarriage at 8 weeks between those two. I delivered my third child on June 14, 2021 via C-section without complications. Baby weight was 6 lbs 15.5 oz.

Estimated delivery date of August 5th, 2021. Currently 35 weeks. Development of preeclampsia, gestational diabetes at 34 weeks. 2 episodes of heavy vaginal bleeding during pregnancy, one at 30 weeks (just after 2nd dose of moderna vaccine) and one at 34 weeks. Currently being monitored for worsening preeclampsia with plans to deliver at 37 weeks (July 15, 2021) if stable. Gestational diabetes managed with diet and exercise at this time. Bleeding resolved within 2 or 3 days. Developed anemia after second bleeding episode.

Excessive, heavy menstrual bleeding from March to June without stop (bled daily for the better part of 4 months). Presence of clots discharging from my body when I used toilet or showered. Heavy cramping and pain. Stopped my period mid June and then started around July 4 with heavy cramps, bleeding and clots which then lasted 5 days and stopped. Prior to this, I did not hardly have a period because I have an IUD with hormones. (Morena)

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe