Moderna

I had the vaccine on January 5 and I was fine the whole day. For the next two days my arm was sore from my elbow to my shoulder. the third day my whole upper right side was crippled were as my shoulder neck and arm was almost paralyzed and I couldn't really move without severe pain. A few hours later, my legs felt like noodles like I would fall over; I ended up leaving work early that day incase I couldn't get home. The next morning I went to work. the pain moved to my left side, same areas and creeped around my left rib cage. This has been going on since. I had off January 11 and 12 for my weekend. I haven't been back to work since January 13. I have had severe pain in my left neck, shoulder, rib cage, elbow, and now my left wrist and at times, my left hand feels numb. Also, the within the last 24-48 hours my breasts have been tender. I've been lethargic since yesterday and now my vision is blurry. My nurse keeps telling me to rotate between ibuprofen and tylenol, it's not helping at all, I am extremely uncomfortable and in pain. In fact, when I take the ibuprofen, it causes more pain. I've been trying to reach the on call doctor for pain medication and no one is calling me back. The only relief I have is when i hold my arm above my head. I am groggy and I am feeling emotional. I've missed a week of work and I'm nervous about getting my second vaccine, but I will get it. Oh, and I'm not sleeping well.

I received my second Moderna vaccine on 2/05/2021. Within 10 minutes of receiving the vaccine I got a real bad headache, was very dizzy and felt very hot all inside my body. I reported it to the nurse and she told me it was a normal reaction to the vaccine and to wait a little longer than the 15 minutes to see if it would go away. She gave me water and I did fell better and we left medical center. At around 5:30 pm that same day I started to get cold chills and body aches especially on my right side. my lower back and my right hip were hurting a lot and I was having trouble walking.at around 8:00 pm my husband notice my right foot was very swollen and I notice by breast, my arm and hand, my underarm and leg were extremely swollen and painful. I did take a Tylenol because that is what they told me to take. I was freezing cold by the time I went to bed during the night I was sweating a lot. As of that day my symptoms were: Swelling on my right side Body aches, Headaches Fever Difficulty breathing/Shortness of Breath Rapid heart rate ranging from 100-125 w/o doing anything My neck and throat were very swollen around my thyroid area Blurring vision Chills and hot flashes Fatigue/Malaise Big round red welt around my injection site about 4 inches wide and hot to the touch I finally called medical center on 2/18/21 because I still had right leg, hip pain and swelling. I had a tele-med appointment with one of their doctors and she told me I had to first get a Covid-19 test to see if I didn't have Covid. Which the test did come out negative. She also told me that maybe the vaccine triggered something in my body that was causing all the swelling. I do have an appointment for chest, hip spine x-ray and lab work for 3/22/21. I still have the hip pain but not as bad. The person who gave me my Covid test results said I should report my symptoms.

Approximately 5 hours after the shot these symptoms appeared: aches and pains, cramping, irritability, exhaustion, headache. Upon waking the next morning I was shocked to find I am menstruating, at age 60, for the first time since February 2016. It's six hours later and I'm still experiencing menstruation, cramping, irritability and exhaustion. What is going on? I feel younger and more energetic.

I bleed for just an hour then stopped( like menstrual bleeding) I also broke out with shingles.. I have shingles, but have not had an outbreak for over a year or more. This all happened right after the vaccine.

I got my first dose of the Modena vaccine on March 29th, only had local injection site pain for 3 days, then I did not have any other sides effects. Unfortunately 3 weeks later, my legs and back waist started growing rashes, total about 30 which were itchy, these rashes slowing faded in 3-4 days. Starting on the 19th, my waist and left hip are in pain and I can hardly move and can't bend. The pain changes place to place and from sometimes being very light and sometimes strong. It has been 6 days now, although pain is not getting worse. I am thinking that these symptoms are due to my body overacting in response to the vaccine, resulting in spine and hip joint inflammation inducing pain.

The adverse reaction was that I got a 5 day long menstrual period for the first time since 2012. I am 60 years old and past menopause since 2012, with no other menstrual bleeding, uterine problems or any gynecological issues during that intervening time. The period started about 2 hours after my 2nd dose of the COVID vaccine. It was a light period, not heavy, but more than just spotting...it did last 5 days, requiring a pad during all 5 of those days. I also had some fatigue and general achiness in my neck, back and joints, but that only lasted a day or 2. Unfortunately, I did not call my dr when this happened. For these reporting purposes, I guess that would have been helpful. I did call and make an appointment, but it will not occur until May 12, 2021. That is why I didn?t fill out the doctor and facility portions of this form. One last thing...I am not any kind of anti-vaxxer. I am a left-of-center suburban mom of 5 grown kids with a college education. (Not sure if that makes any difference here, but I offer it in the For-What-It?s Worth Dept.

2 episodes of postmenopausal spotting; This spontaneous case was reported by a patient and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0181321A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LISINOPRIL and RANITIDINE for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. There was no treatment for the event. Patient gave consent for Safety follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Postmenopausal light menstrual spotting 2 weeks after first vaccine and then 1.5 weeks after second vaccine. Resolved.

Started with flu like symptoms. Gradually got worse. Joints hurt. Migraines worse, hands shaking , head shaking, nausea, menstrual like cramps (menopause done for over 10 years), hot flashes so bad I vomited lower back hurt,, kidneys hurt. Started gaining weight. I have gained 30 pounds since being vaccinated. 4 days after 2nd shot I gained 19 pounds in one day. My blood test from obgyn says my ovaries are producing estrogen again therefore I will have to through menopause again. Once was bad enough

nauseous, vomited, faint, then ambulance went unconscious within 15 minutes of vaccine. Then one week later inverted T waves and hospitalized, recovered then about a week or two later Transient ischemic attack unable to speak recovered. then have been having abdominal pain/pelvic pain.

After the first dose I felt like a burning sensation. After the second one I kind of felt funky right away. For about 3-4 days I did not feel myself. It has gradually gotten worse in my joints and my left breast its still tender. I got a mammogram done in 06/23/2021 and they told me that sometimes the vaccine make your lymph nodes get swollen. They told me there was nothing wrong. They told me to report this. 2 weeks after the second dose I also had a respiratory problem and they did 2 Covid tests and they were both negative. They put me in antibiotics.

Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.

Itching, redness and swelling from injection site down to the elbow area. Also swelling under the arm to the left side of the left breast with tenderness upon pressing on the left breast. Skin is very tender to touch when I try to scratch it. There is a pink tint to the skin but not red. Am not running a fever.

Lymph nodes on right side armpit and side of breast swelled and were painful for about 24 hours. I took advil and used a heating pad to ease the pain.

Severe acute immune thrombocytopenia, now refractory to steroids and IVIG developed 10 days after second dose of vaccine. Patient developed spontaneous wet purpura, petechiae and vaginal bleeding on 3/19/2021. CBC showed undetectable platelet count. Normal hemoglobin and platelets. Did not respond to dexamethasone 40md daily x 4 or multiple IVIG doses. Started romiplostim on 3/25/21 and is currently on dose escalations with platelets persisting undetectable. On 3/28 developed acute anemia with a 2 to 3 g/dL hemoglobin drop and was found to have a spontaneous hemoperitoneum . Treated with tranexamic acid, multiple platelet transfusions and an additional dose of romiplostim. Bleeding has since resolved but platelets remain undetectable.

2 days of flu-like sx. She then developed sudden onset of bleeding of gums bruising and vaginal bleeding. High concern for thrombocytopenia. her Sx resolved at day 5 post-vaccine. Her platelets were slightly low 7 days post-vaccine. High clinical suspicion for low platelets

After years of being in menopause, I had vaginal bleeding for 7 days, it became very light after 4 days.

Immediately after I received the shot, I felt my whole left arm get very warm. Before going to bed Wednesday evening, my arm began to hurt. Beginning at approx. 1:00 am after receiving shot, I got a headache which kept me up most of the night. The headache continued until Friday morning with taking Tylenol every 4 hours. Thursday other than my head hurting, my body hurt and I had a loss of appetite. Thursday evening I got chills, and ran a temperature. I was still taking Tylenol. I was able to keep my temp at bay only getting to 100.5 at the highest. Thursday night with all my pain, I did not sleep well again. My left arm hurt so bad and I was having a hard time letting it rest at my side. I realized my left armpit was swollen and down my left side to my breast I was very sore and tender. I woke Friday morning without a headache. I worked out at a gym on Friday but was not able to keep up with my usual routine. I still did not have an appetite but ate just for the energy. Food did not taste good. I had Covid in early November and lost my taste and smell. It returned so I'm not sure why food is not tasting good. It almost has a bland, metal taste if that makes sense. I felt like I was on the road to recovery only to run a temp again Friday evening. I got chills and knew what what was coming. No temp on Saturday as of yet. I do not have a headache which I am glad. My left arm still hurts but I am getting better range of motion. It is still very tender under the armpit area.

INSTANT PAIN DOWN ARM TO WRIST. WITHIN HOUR S UPPER BODY PAIN , SWELLING LEFT UPPER ARM. UPPER BODY PAIN ARMS AND BACK DAY 2 PAIN IN MUSCLE AND BONES , MUSSEL FITUGE DAY 3 PAIN BAD UPPER BODY MUSCLE SHACKING FITUGE NITE SWEETS PELVIC PAIN NO FEVER MUSCLE AND BONE ARM BACK PAIN 2 WEEKS UNDER ARE SEEN SWELL TENDER TO TOUCH . CALLED AFTER DAY 4 TO REPORT . HOT BATH, ARITHUS TYLENOL. REST UN ABLE TO LIFT ARM SEVER PAIN

4/8 migraine, severe lower back pain, debilitating fatigue 4/11 &12 violent diarrhea 4/12 (eve) severe back pain returned, painful urination at times passing blood lower abdominal pain, pelvic pain back, pelvic pain, fatigue ongoing

I have been post menopausal for ~10 years. On the 2nd morning after the second dose, I was bleeding. I am not sure if the blood came from my vagina or bladder/kidneys

Pt. states received 2nd Moderna 04/16/2021 vaccine, and 06/03/2021 waiting with menstrual period symptoms (includes bleeding), lasting 3 days, experiencing another 07/06/2021 3 day period of discharge and discomfort. 06/13/2021 Primary visit and ordered monthly check-in/ 07/13/2021 appt. with physical exam (Ultrasound- Internal) no results noted. A1C down 6.5 Recommendation for an appt. with OBGYN (date unknown).

2/4/2021-Extreme rapid heart race 11:30pm until 4:00am . Skipping beats. Extreme heat sensation last all day. Shaking (not a chill feeling, body shaking so bad. Felt like Gallbadder inflamed and an Ovary had pain. No fever 2/5/2021_ Heart skipping. Extreme Heat/ Body Shaky (no chills) No Fever 2-6-2021- Heart racing. Extreme heat inside of body. Red blood dots on arms, chest and back. (not like rashes) Flat to feel. Extreme heat then shaking insides felt like it was being sucked out of body. Heart flutter. Muscle jumps. No Fever 2-7-2021- Body on fire again and shaking real bad all night. Feeling like insides were being sucked out. Heat fluttering. No fever. 2-8-2021- Heart Fluttering . Heat sensation. Went to doctor. EKG was performed. Doctor advised not to get the second dose. 2-9-2021 - Brain fog . Heart Flutter. I did not feel like myself until 3 weeks later. Kinda felt like my body was off or shutting down.

Upon awakening 2/27/2021 left arm was sore all the way to wrist. I noticed my left armpit was swollen all the way across and down to the top of left breast. The swelling is going down as of 3/3/2021 but not completely.

Slight vaginal bleeding, I haven't had my period in almost 15 years. Pain running through my left hip. Constant headache.

Nauseated, pounding headache; severe chest pain; trouble breathing; sharp quick repeated pain in my fingers, wrists, and feet; 100 degree temp; pelvic pain much more severe than I have ever had with Interstitial Cystitis = EIGHT HOURS

I had a lump in my right breast. Mamogram and Sonofgram showed no problem. I was told this is happening within 2 weeks of the vaccine.

5/12/21 felt sudden pain, burning sensation to Left side of left breast, swelling sensation of L breast, left under arm, below left collar bone area. Used icepacks, motrin, extra-strength tylenol for 4 days. Pain reduced slightly, but for 2 more weeks felt off & on left arm pit, and left arm swelling, sensation of fluid under skin near left chest, left upper back, left upper side. Minor relief by keeping left arm elevated, wearing a compression sleeve, wearing a sports bra all day and at night. Swelling is not going away. It increases and decreases but never feels normal. Its now 4 weeks. Inaddition to the above I had the expected side effects: bodyaches, left arm injection pain, tired, low grade temp, headache, foggy head for 10 days.

Approximately 5-6 days after 2nd vaccine I had tenderness in right arm pit, that progressed to swelling of Right breast and rib with discoloration and warm to the touch. On 4/28/21 my Radiation Oncologist believed it was an infection and prescribed Cephalexin 750mg 3xs daily for 10 days. No significant improvement took 10 more days of Cephalexin. Still not resolve and on 5/11/21 saw the Surgical Oncologist's Nurse Practitioner who gave me Cefadroxil 500mg 2x daily for 14 days and Mometasone 1x daily for 10 days. Still not resolved and Surgeon requested an ultrasound that showed no fluid but much inflammation in right breast. Now on Clindamycin 500mg 3xs daily for 15 days beginning 6/18/21. I believe it is Radiation Recall Phenomenon because timeline, symptoms fit the occurrence after my second Covid vaccine. Condition not resolved.

Within 7 days of the injection, my left breast begin to swell and feel uncomfortable. Days after this, left breast nipple inverted. This problem is only escalating in my opinion. Sporadic pain in breast - sharp deep pain. Within 10 days of the injection, large rash appeared at injection site, approx size of a softball. An additional rash also appeared below and to right (towards inner arm) of the injection site; it started small and proceeded to spread to approx several inches. Sporadic pain in upper arm continues. I reported all of this to my physician. I was told to take Tylenol and Bendadryl. I pushed for an appt to check on my breast, and that appt is scheduled for 3/12/21 with a PA.

feeling of pins and needles in their face; swollen and sore gums; swollen and sore gums; fever of 102F; heavy bleeding; A spontaneous report was received from consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heavy bleeding/ postmenopausal bleeding, and contained large blood clots/postmenopausal bleeding, fever of 102F/ pyrexia, swollen and sore gums/gum swelling, swollen and sore gums /gum pain. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided. On 14 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection. On 13 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection On 18 Feb 2021 four days after the first dose of vaccination, patient began to bleed as if the menstrual cycle began. Patient reported that she was at a menopausal phase in life to typically do not bleed or if they do there was a light pink blood excreted, the last time this had occurred was in November. Patient had a bleeding that was very heavy and contained large blood clots. The event heavy bleeding/ post menopausal bleeding was a medically significant event. Patient stated that this bleeding lasted 7 consecutive days until 25 Feb 2021. The bleeding then stopped 26 Feb 2021 for 2 days, and then heavy bleeding episode came back again on 28 Feb 2021 for 2 days lasting until 02 March 2021. On 03 March 2021 patient reported that she had a fever of 102F which lasted for 24 hours. Patient also reported that she had very very sore gums and swelling inside of mouth. Patient reported that she was not sure if these events were due to the vaccination. Treatment activities for event was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, experienced heavy bleeding, bleeding was very heavy, and contained large blood clots was resolved on 02-MAR-2021. The outcome of events, swollen and sore gums were unknown and fever of 102 F was resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

1. Metallic taste in my mouth. It started about 45 minutes after my vaccination and lasted all day. Resolved by the next day. 2.Extreme fatigue - all day of my vaccination. Resolved by the next day. 3.Fever of 100 degrees, chills, ached everywhere. Especially extreme ache in both of my hands. It all started about 11pm on the day after my vaccination. Lasted all night. Resolved in the morning. 4. Woke up Friday morning, 2 days after my vaccination, after feverish night to what felt like a busted lip. My lip upon inspection was fine, no abrasions, but felt tingly and like there was nerve damage upon waking. It has lasted 3 days, and began waning on the 4th day. There's just a bit of the sensation remaining. 5.Same time frame as #4. I awoke to left breast pain/ tenderness. I have a cyst with mild pain and tenderness that is monitored, and the vaccination made this area worse for the same time frame as above.

bleed heavily again; a feeling of pins and needles in their face/tingling sensation in face; A spontaneous report was received from a consumer who was also a 64-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heavy bleeding/ postmenopausal bleeding, a feeling of pins and needles that began on the left side of the face and radiated down to the bottom of the chin with sensitivity on the nose and lips/ paraesthesia oral. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided. The patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the left arm on 14 Feb 2021. On 13 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021 four days after the first dose of vaccination, patient began to bleed as if their menstrual cycle began. Patient reported that she was at a menopausal phase in life to typically do not bleed not or if they do there was a light pink blood excreted, the last time this had occurred was in November. Patient had a bleeding that was very heavy and contained large blood clots. The event heavy bleeding/ post menopausal bleeding was a medically significant event. Patient stated that this bleeding lasted 7 consecutive days until 25 Feb 2021. The bleeding then stopped 26 Feb 2021 for 2 days, and then heavy bleeding episode came back again on 28 Feb 2021 for 2 days lasting until 02 March 2021. On 03 March 2021, patient reported that she had a fever of 102F which lasted for 24 hours. Patient also reported that she had very sore gums and swelling inside of mouth. Patient reported that she was not sure if these evets were due to the vaccination. On 13 Mar 2021, after the 2nd dose patient had begun to bleed heavily again. Patient also reported that after the first and second dose immediately afterwards there was a feeling of pins and needles in their face. This tingling sensation began on the left side of face down to the bottom of the chin with the most sensitivity on the nose and lips. This tingling sensation was far more pronounced after the second dose than the feeling of the first dose. Patient reported that the heavy bleeding and feeling pins and needles in face were present on 15 March 2021. Treatment activities for event was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcome of events, heavy bleeding and tingling sensation that began on the left side of face down radiating to the bottom of the chin with the most sensitivity on the nose and lips were not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Ten days after injection, I experienced sudden onset of headache, upper back pain, fatigue and ? the most concerning and unanticipated? swelling, tenderness, and rash involving most of my left breast. The headache, fatigue, and pain resolved within one day. The breast symptoms gradually resolved over four days.

Notice redding in arm and as the day went on the red spot raised up and was hot. Applied ice pack off and on. I also discovered a lump in my left breast. I had a mamogram in Sept 2020 and nothing was detected. On October 01,2020 I had surgery on my left arm on my rotator cuff . On 02/22/2021 I saw my primary doctor regarding the lump he indicated that he didnt think it was caused by the injection. I saw him on 01/21/2021 for a physical and didnt notice any lump. I dont know how much of this is associated with the vaccine but wanted to make awareness.

Swelling, enlargement, pain in lymphnode(s) under my left arm beginning about 8pm 02/21/2021 until about 02/24/2021. On or about 02/22/2021, I felt dull pain, discomfort, swollen, full feeling in both breasts, in particular in areas under both breasts and on the outer sides of both breasts. This pain progressed each day, continues and has gotten worse.

I started bleeding vaginally about four days after the shot, plus was fairly dizzy for the first week. I haven't bled vaginally for nearly 13yrs and am very healthy. Tests were run and all came back normal. Medication solved the problem, but I bled for nearly two weeks.

Intense pain and cramping in lower abdomen/pelvic area with fever 100.7. I took Tylenol the first day then switched to ibuprofen (better results). Never any body aches, nausea , or diarrhea. Nurse thought a type of colitis. I have never had colitis. Today fever is gone but the pelvic area is very tender to touch. Cramps are very mild and now infrequent. My stools and urine were normal. Just weak from fever.

02/23/21, 7 pm - upset stomach and sore arm at injection site 02/24/21, 7 am to 11 pm - upset stomach, headache, body aches & chills and sore arm at injection site 02/25/21, 7 am to 02/27/21, 7 am - sore and swollen left underarm and breast, itchy rash extending down upper arm from injection site 02/27/21, 7 am to 02/28/21, 11 pm - swelling of left knee and left ankle 03/03/21, 7am to 03/06/21, 10 pm - back pain along bottom of right shoulder blade 03/08/21, 8 pm to 03/18/21, 10 pm - chest pain under right breast, especially with deep breathing, and highly elevated blood pressure

I started a menstrual cycle 3 weeks/2/20/21 after my first injection, lasted 8 days. 2nd injection on 2/27/21 and had another menstrual cycle on March 24th ended on March 30th and a 3rd cycle started on April 1, 2021 and ended 4/14/21. I'm 66 years old and my last regular menstrual cycle was when I was 51 yrs old.

36 hours post 1st shot: Immediate onset of severe neck pain, chills, body aches, headache 101 fever, red circle and knot at injection site, felt strange. The following day, I developed a severe rash on my upper abdomen, chest, back and face. On 04/10/21, my arm at injection site turned raised and red; freezing cold hand, tips of my fingers were numb for 45 minutes, itching, fast heart rate, extreme pain in left shoulder blade. On 4/26/21 I had a mammogram which showed 2 small masses (5 mm x 5 mm) and prominent lymph node left arm pit. Biopsies are scheduled on 5/6/21.

Patient developed Right breast tenderness over superior aspect of breast 5 days after 2nd Moderna vaccine. Also noted a 3cm x 5cm area of diffuse thickening at top of breast that came on with this. Was not present at monthly breast exam before 2nd moderna vaccine. Symptoms have now been present for 1 month without any improvement.

Large lump appeared in right breast suddenly, itching on right back, mess right side of breast area, itchy pimple rash right back atea

I have had heavy vaginal bleeding for 8 days ,now spot bleeding... Also bad cramps in feet?s and pains in legs on and off,besides headaches.

The evening I received the 2nd dose, I began having severe pelvic pain,bil. hip pain and stiffness, bil. hand pain and stiffness, right arm (deltoid) swelling, right axillary lymphadenopathy. I was unable to sleep for 36 hrs. The following day had fever, myalgia, severe epigastric pain, N/V. I felt awful for about 5 days (pains continued, fatigue and low grade fevers) and then had an acute renal calculi and ED visit on 03/3/2021.. To date, (6/7/21), I continue to have bil. hip pain and stiffness, pelvic pain. Left gastrocnemius is painful and stiff also.

Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Concomitant product use was not provided by the reporter.; 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

Itchiness at injection site on day 6 followed by 3 inch raised rash on days 7-9. Axillary tenderness and lateral breast tenderness from day 5 to present. At first did not associate the axillary tenderness with injection.

After vaccination I experienced very fatigue, nauseous, chills, fever, so cold, and sore, and today 48 hours it appears to have a menstrual cycle or vaginal bleeding that started today, I had a hysterotomy 20 years ago.

sore arm, left sided headache, chills, no fever, painful lump, sore throat 2/13 2/14 less intense headache, less pain in arm-2/15 dull red circle is itchy, no pain-hydrocortisone cream for 2 days 2/17-2/18 felt better, tender breasts 2/19 circle faded, bright pink and swollen 3x4 cm, panful to touch and itchy, 2/20-prominent red color, headache, 2/21 sore throat, burning pain couldn't swallow 2/22-2/25 intense soar throat, roof of mouth was irritated, ear pressure

Slight sore arm for two days, fatigue for 4 days, migraine headache for 5 days, extreme chills for 1.5 days, nausea for 4 days, fever 100.4 for 1 day, vaginal bleeding on day 3 for 1.5 days

I developed vaginal bleeding that resulted in a prescription of vaginal estrogen cream. Because I had already had a hysteroscopy and D&C done on 03/03/2021 from the reaction of the first dose. The bleeding lasted 3 days and stopped on it's own. I had a known fibroid on the uterus.

So about 4/4:30pm the evening of my vaccine I had a low fever, aches and chills that type of thing. Then around 6:30pm I started throwing up continually for several hours. I called someone and at 10:15pm they took me to the ER. They put me on an IV with anti-nausea medication and within 2-3 hours I was feeling better, and they sent me home. Then after that I just had the general not feeling well - the aches, chills, headache. The next day I was not feeling very good still and then the following morning after that I was pretty much back to normal. I don't know if this pertains or not but at the end of May I had a mammogram and I had a lump in my breast and then a couple weeks ago they did more tests and they saw I had an enlarged lymph node, and that is abnormal for me that has happened since my vaccination.

Next day after the shot, underarm pain that was unbearable. Then two days later, the lymph nodes in my breast were enlarged and my breast swelled to twice its size. I had redness and swollen glands that kept spreading until I was given antihistamines. Had to go to the ER twice and my primary doctor once. I am getting better after 8 days.

Two days after the second shot, April 2, 2021, my left armpit started to hurt and it was swollen the size of a lemon and the swelling lasted for 4 days. April 9th - 11th, 2021, my armpit was still in pain and April 11th - 13th, 2021, I had a mild headache and I never get headaches. On May 19th, 2021, I had a mammogram, and I can't remember the doctors name. I had to wait six week to get one and in the mammogram results it showed a lot of swelling in my lymph nodes under my left armpit and swelling in my breast. They said they think it's okay. Up until this date, the left arm is still week and I have pain in my left armpit down to my truck to my waist.

Pelvic joint and muscle pain; still persistent. At first I thought it was due to not walking owing to ice and snow but has intensified even though I am back to walking. I expected headaches or flu symptoms as I had from the first Shingrix shot. I have no history of adverse effects to flu vaccines.

On 2/22 I developed fever, fatigue, horrible muscle aches and general not feeling well. On Sat 3/28/21 I developed very large red hive like lesions all over my neck, under ears, and one very large one on my left side. These lasted for 4 days. They were very large welt line lesions but were nit itchy like hives. I also developed some vaginal spotting. I also became very flushed and very hot and fatigued with any excercise despite not having fever except for second day. I have pictures of these red hive like spots

Woke up next day with injection site and underarm pain that moved also to lymph node and breast swelling and pain. Early that evening chills, fever, body aches, headache, & dry cough that lasted most of the night. The following day fatigue, runny nose, body aches, headache, swollen lymph node/breast area & arm tenderness continued. The third day following the shot less fatigue, but still swollen area with pain and less headache. Today, (day 4) minor headache, injection area, under arm and side of breast is still quite tender and swollen. Research articles (U of MN, medRxiv services, etc.) indicate a 2nd shot may not be needed?????

Swollen hands; Heavy periods; chopped her hair since she sweats a lot in her scalp; Body aches; Headache; Fatigue; Bleeding started; Cannot think straight; Hot flashes; Back hurts; Itchy in eyes; Confused; Anxiety increased; Feels depressed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bleeding started) and MENTAL IMPAIRMENT (Cannot think straight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), LORAZEPAM, MELOXICAM, BLACK COHOSH [CIMICIFUGA RACEMOSA], ESTRADIOL, NORETHISTERONE ACETATE (ESTRADIOL AND NORETHINDRONE), CLOBETASOL PROPIONATE and ESTRADIOL for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding started) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Cannot think straight) (seriousness criterion medically significant), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). On 06-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen hands). At the time of the report, HAEMORRHAGE (Bleeding started), MENTAL IMPAIRMENT (Cannot think straight), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), PERIPHERAL SWELLING (Swollen hands), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. Patient stated that her OBGYN told her she is going thru menopause for which she was prescribed estrogen and she started getting a period. Treatment included Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. This case was linked to MOD-2021-110270 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: New concomitant drugs (Black Cohosh, Estradiol/norethindrone, Clobetasol propionate, Estradiol cream) were added, New events (Bleeding, back hurts, had period, itchy in eyes, cannot think straight, confused, body aches, heavy period, anxiety increased and feels depressed) were added and Suspect vaccine dosing details were updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.

Developed redness, pain and swelling at injection site approximately 2 days after injection. Swelling and pain started migrating into armpit and then into breast. She was experiencing breast vein distention, pain, generalized swelling to L armpit and breast, and a lump in her axilla. The redness, pain and swelling at injection site resolved after two weeks. She noticed the pain to the L breast lasted about 1 month, but she is still currently experiencing breast/axilla swelling and does not feel like this has resolved. She also noticed chest pain and tightness in the chest about 3 weeks after injection. She is not currently experiencing chest pain today.

Moderna COVID-a9 Vaccine EUA - Woke from sleep about 15-16 hours after vaccination with continuous sharp cutting sensations in arm pit of arm which received the vaccination. Upper portion of breast also was just tender to touch. The cutting sensation continued for about 24 hours with improvement continuing but 2.5 days later the upper portion of the breast presented bruising/bleeding signs. Picture was taken. Some tenderness.

Client called approximately 12:35 pm on 2/12/2021. Reports s/s: redness and warmth at the injection site; swelling under arm to under breast and up to neck area; mild discomfort. Recommended Benadryl and a ice pack to area periodically. Follow up phone call to client approximately 4:30 pm. Client reports improvement in s/s. Will continue to use Benadryl. Follow up phone call on 2/15/2021. Client is doing fine. Reports the swelling and redness are almost gone.

Began with stabbing pain in left shoulder that woke me up every 2 hours all night long. Progressed to massive migraine headache in a wide band across my forehead. Found fluid pooling in a channel from my armpit past my elbow; rubbed on it and raise arm until it went away. Muscles in left arm stopped working; couldn't move my arm; put left arm in a sling. Started feeling like I was burning up with fever, but body temperature was normal 98.8 degrees. Several hours later was having sudden chills and found body temperature had risen to 102 degrees F. Developed high blood pressure for me. The lymph node in my neck were swelling, armpit tender to touch, and left breast tender to touch too. Started icing the back of my neck to take down temp. Put ice on my shoulder to try to cool the pain. I was very frightened and worried that: (1) got sepsis bacterial infection from shot (2) got bad lot of Moderna or (3) Moderna vaccine sat out at room temperature too long and had gone bad. 48 hours after the 2nd dose and after icing, symptoms started to ease.

started vaginally bleeding Sunday Feb. 28th and has continued until present Saw Dr. and had blood work done and am going next week for Trans Vaginal ultrasound

I did not administer vaccine in my office, I was the provider she saw after seeing her PCP who wrote the adverse event off and was not worried about vaginal bleeding in a 68 woman.

Breasts starting feeling swollen over several weeks. Then I noticed some pain in both breasts. I had a mammogram on 05/11/2021 and it came back with some areas that required further testing. I am due for a diagnostic test on 05/24/2021.

Post menopausal heavy bleeding. Scheduled for an ultrasound but no previous GYN issues and physical exam normal.

Two weeks after the 1st vaccine I started having severe muscle and joint pain in my shoulder and pelvic Areas. Within 24 hours of my second vaccine I experienced four hours of chills and malaise. This lasted four hours. My second vaccine was on April 16, 2021 in my left arm. the Vaccine was Madonna, lot number 043 B21A. two days after my second vaccine, my left knee became swollen to the point of being unable to bear weight. The shoulder and pelvic area pain continued to worsen and I began experiencing profound fatigue. I felt as though I had full body inflammation. The acute pain then extended into my right-hand where I experienced a sudden and spontaneous rupture of my thumb tendon which required surgery to repair. The rapture occurred why was sitting quietly doing nothing strenuous. I am being followed by a rheumatologist with a new diagnosis of polymyalgia rheumatica. My symptoms have been going on for over two months and they're quite debilitating.

On February 23, 2021, exactly 5 days after my 2nd moderna vaccine, I experienced innapropriate bleeding from my vagina, extreme pain and stiffness in both of my hands and wrists and the heels of both hands became red. The bleeding came every 2 weeks for 3 months. The pain in my hands is still ongoing as are the red palms.

The next day after vaccine was given, I got vaginal spotting/breakthrough bleeding. I am postmenopausal and on HRT and have been for 14 years and have not had any spotting after menopause and HRT was started. This highly unusual. Today, I also got a little spotting in the afternoon, like yesterday. So this is the second day in a row. I do not have any discomfort. I contacted my doctor late today and left a message for her. I do hope she will contact me tomorrow. I have heard that there are some new symptoms reported in the UK regarding female gynecological side effects like changes in menstrual cycle, which would not apply directly to me, but maybe similar symptoms? I am hoping the spotting will stop soon. The question is, would a 2nd dose be advised or not?

Patient had MRI on 3/3/21 and a lung nodule and breast nodule was found on her right side which was the side she received the vaccine on. They do not know if malignant or not at this time. She has a follow up on 3/15/21 for a chest CT scan and will get a biopsy done soon.

Edema of lymph nodes in left armpit and left breast with pain and tenderness in breast lasting 4 days. Took Motrin 600 mg twice for discomfort twice on 03/22/2021. Discomfort abated gradually over time. As of today, 03/24/2021 pain remains occasional with overall tenderness in Left breast continuing.

Experienced loss of appetite. Weakness. Started with pelvic soreness and pain increased where patient couldn't walk. Admitted to Emergency Room and diagnosed with Acute Lymphoblastic leukemia.

After the initial side effects of chills, fever, and body aches subsided I had hot flashes and night sweats every night for 5 weeks. Then breast pain and swelling began and breast tissue changes were confirmed on May 28 via ultrasound. Two weeks later I developed a blood clot in my left calf as confirmed by an ultrasound on June 11, 2021. I believe this blood clot was provoked my the Moderna vaccine, as there were no other factors that could have provoked the blood clot.

After first vaccination on Jan. 11th, 2021 I had muscle weakness in legs lasting only about an hour. I just didn?t feel right. After one hour I was fine. Second vaccine was administered on Feb. 8th at noon. By 3:30 AM Feb 9th I could barely get out of bed because of severe joint pain and aching. I was nauseated, had a mild fever, mild headache and very tired. This lasted until February the 10th at which time I felt better. By Feb. 11th I had return of deep aching pain in my hips and pelvic bones. ( I have arthritis and know what joint pain is). This was much worse. I felt ill from about one week after receiving my 2nd dose of Moderna. I started feeling much better with the occasional return of mild symptoms. I go to physical therapy for arthritis pain and had taken a week off. I returned to physical therapy on Thursday. February 18th. I was unable to complete my usual workout due to weakness in my legs and joint pain. I returned on Feb. 22nd and the same thing happened I felt weak, diaphoretic, nauseated, after exercising a short time. This has never happened before.

Patient is a 70 year old female that is post-menopausal. Her first Moderna vaccine dose was given on 2/4/21. Exactly one week later on 2/9/21, the patient had vaginal bleeding that lasted one day. There were small clots in the blood that was discharged. The patient went to the doctor where a urinalysis was performed. The patient had a positive urinalysis and was started on antibiotics. The patient's second dose was on 3/4/21. Exactly one week later on 3/11/21, the patient had vaginal bleeding that lasted a day. Patient usually takes aspirin 81mg daily, however she stopped this medication prior to both doses being administered. She restarted the aspirin after each Moderna dose.

fever, chills, shakes, hallucinations, dizzy, light headed, headaches. arm pit and left breast were very tender, trouble negotiating from one room to another, loss of appetite and tired very easily.

Six weeks after my second Moderna shot, I had 10 days of a MenstruaL cycle, which I had not had for 22 years (since I was 48). Being 70 years old, I spoke to my doctor who was performing my colonoscopy when this occurred, and she and her nurses noted they had seen this in women over 60 recently who had the Moderna vaccine and I did bleed quite a bit from my vagina during the coloscopy; I also had bleeding hemorrhoid's which had re-engaged in bleeding about the same time. While I am fine now, it was concerning to have a full period at age 70, and I am scheduled to go to a gynecologist this Wednesday.

After the 1st vaccine, I had a lot of pain in my left arm. This pain lasted for at least a week. I felt well enough and went to get my 2nd dose 5/1/2021 ( lot 032B21A IMRA). I had the same symptom of arm pain that lasted about a week and I felt recovered. On 6/15/2021 at 5AM I had awoken with severe pelvic pain and lower back pain, chills and sweats. I called the ambulance and was taken the ER (Wilmington Hospital). At the hospital, they did an ultrasound and found a kidney stone. I was discharged to go home and rest and drink a lot of water. I made an appointment to see my doctor and saw him on 7/1/2021 and was prescribed Tamsulosin to help flush out my kidney stone. I still have my kidney stone which has not been flushed out yet. I am going to follow up with my urologist.

Fever, 100.8 for day and a half, chills, and bad headache. Three days later notice ache in left armpit. As days progress left breast was hurting and swelling on side of breast. Had a slight green color to skin in armpit and down side of chest. Also arm was sore from armpit to middle of arm on inside of arm. It has been two weeks now and my breast is still slightly swollen on left side near armpit and I am concerned. This is my first shot and what will happen if I get the second. The breast still bothers me. If I had to do it again I thing I might not of got the vaccine.

Lymph nodes swelling in right breast, lymph nodes swelling in right breast. Has a clear mammography 1 year prior. Was told to wait 2 months before doing mammography. Breasts felt like I was getting my period. I stopped wearing fitting bras. Some days are worse then others. I can feel the tender lymph nodes. It has been 4 months and no change. I also has an outbreak of Herpes, which I had not had in years. My thyroid medication has been increased 2x due to Hashimoto flare up and subsequent testing.

soreness and swelling from site to wrist then developed pain in pelvis and legs md told her to take aleve

Vaginal bleeding (Medium blood flow, Not Spotting); panicking; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:47 PM, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) (seriousness criterion medically significant) and PANIC REACTION (panicking). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) and PANIC REACTION (panicking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was not taking any blood thinners and had no Chronic Medical conditions. Concomitant medications and treatment information was not provided. The patient reported that it was not Hemorrhoids and was panicking because she heard someone died from bleeding after receiving the vaccine. This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. 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.

About 12 hours after my vaccine I got sick. I experienced nausea, headaches which progressed. My left arm was red, I felt feverish and I also had red rash radiating to my left breast and nipple. I placed a bandage under my left breast because I could not have anything brush my breast and nipple area since it was very sensitive. I talked to my doctor through telehealth and he prescribed antibiotics for ten days. My left breast was very sensitive and tender to the touch. I had tiny little red blotches under my breast, they kind of look like little warts. I will see a doctor next month to check the little red blotches I have under my left breast and nipple. Do not have lot number to provide.

pt states that she developed a ear ache in her left ear that lasted 2 days. A week after getting the vax her right arm was itchy, red, swollen at and below the injection site that lasted four days. She used ice pack which seemed to help. About 2 weeks later she had body aches and pain within her back, pelvis, shoulders, legs, and head. She had a pulsating pain that starts in the base of her neck and goes up the left side of her neck into her ear and then quits and starts again.

After Moderna Dose #1 Within one day of vaccination the person experienced extreme fatigue, muscle weakness, joint achiness, headache, and nausea. She felt feverish and chilled but had no fever. She noted nightmares , hard to focus, eye sensitivity, abdominal pain and about 10days after vaccination had an episode of thick saliva and drainage so that she had to sleep upright. These symptoms progressed for about a week and then slowly resolve completely by about 3 weeks post vaccination. After Moderna Dose #2 - RN spoke with client 1 week after dose #2. Within one day of vaccination she experiences intense fatigue, headache on day 2, light sensitivity, body aches in joints and muscles, her arm felt hot, swelling of her breasts, no appetite, and abdominal pain, She did NOT experience any rashes or itching or difficulty breathing. Her symptoms were so incapacitating that she could not do any of her ADL's and could only relieve her pain by lying down in bed all day. As soon as she tried to move around the intense joint pains returned and she had to lie down. Normally she treats her arthritis with Colchicine as needed but received no relief. After a few days she did try one dose of Allegra (antihistamine) with some relief. Resting by lying down in bed for a week has been her only relief. She did not indicate any allergies to PEG.

Patient states that she got a rash the size of a softball on her right arm below the injection site that lasted 3 weeks. She had heart palpitations and that would come and go for about 2 weeks. She had a headache that lasted about a week and a half. She has a itchy rash on her right knee that resembles psoriasis, which she has never had. About 3 days after the vax she started having a menstrual cycle that last 20 days. She went through menopause about 15 years ago. Pt went to her OB/GYN. They did a transvaginal sonogram and a endometrial biopsy to rule out cancer. Patient is waiting for test results. Pt is waiting on a CB from her PCP.

April 2. Chills fever body aches headache cough. April third extensive rash. April 7 right breast hot swollen painful

She got her vaccine, was really tired and her arm was hurting. Went to bed, and woke up in the morning at 4:00 AM with vaginal bleeding one episode. Then it stopped and then she had a reoccurrence on 4/26/21, 4/27/21 and again on 4/28/21 and then it stopped again. Had slight cramping. No problems from the vaccine site itself.

For days afterward - my arm was swollen, red , hot itchy and sore and that lasted that for about 5 days. I had a slight fever on Saturday night (the night after). It was gone the next day. Then vaginal bleeding started on the date marked on this report in April. I went to the Clinic. I was fine after taking the Nitro Furatoin. I had another bleeding episode - approximately a month later I went to ER at hospital - May 25, I think. Bleeding has stopped - it wasn't continuous. Have had several doctor visits.

Had mammogram May 11 told May 12 I had a 13mm mass Left breast. On May 27 after US of the left breast ,the m ass was a cyst caused by the Covid shot. it should go away on its own. I had both injections in the left arm.

Patient called covid hotline. Reports she got the vaccine 10 days ago. Since then she has had symptoms on and off. 2 days after the vaccine she had joint pains that resolved the next day. Now she is having fatigue on and off, but she is still able to do her usual activities including walking 1-1.5 miles/day. She also reports right sided breast tenderness and lymph node swelling. It occurred several days after the vaccine and has since resolved. She got the vaccine on the left deltoid. She denies any covid symptoms including headache, sore throat, cough, congestion, or fever. No known exposure.

Within 2 hours of the vaccine (2nd shot Moderna)- i started bleeding , not a lot but enough to stain my underwear, there was no bleeding the next day, but the next day - (48hours after shot) i was bleeding again - moderate bleeding, soaked thru underwear. but did not continue after that time. Summary - bleeding within 2 hours of shot, and no bleeding until 48 hours later, not a lot of bleeding but enough to scare me. I am 74 years old, had not had my period for over 20 years I had no side effects after the first shot, except sore arm, and no side effects except for the bleeding and sore arm after 2nd shot.

May 18 I received my first Covid Moderna Vaccination. 4 hours later when I went to urinate there was blood on the toilet paper. It only lasted about 3-4 minutes. 2 hours after that I went to the bathroom again to urinate and it burned really bad. I called my doctor and was able to see her the next morning ( May 19) She sent my urine in for a culture and it came back as a Urinary Tract Infection. She treated me with Cipro for 3 days. She felt that I should see my GYN regarding the bleeding and felt that it is Post Menopausal Bleeding. I saw my GYN on June 7. She did a Pap Smear and it came back normal but it showed that I have a Bacterial Vaginitis infection and treated me with Metronidazole Vaginal Gel for 5 days. Today June 14 is my last day for that. But when I went to the bathroom to urinate there was some blood again on the toilet paper. I don't know if all this is a coincidence or if this is a reaction to the vaccination. My doctor doesn't think it is a reaction but I want to make sure since I was fine till I was vaccinated. I am concerned because I had no sign of the bleeding or the burning before I got the vaccination. I am also concerned because my next vaccination is tomorrow June 15. If I don't get the second one then is the 1st one not going to be valid. If I do get the second one could I have a worse problem with bleeding and UTI? Due to the bleeding I have to have a vaginal ultrasound and depending on the results I might have to have an endometrial biopsy.

Following the vaccine she felt a little dizzy, a little achy. the 2nd day around noon felt really bad, was in the library and had to leave. She went home, laid down and took her temp which was 100.8, this was after taking Tylenol that morning. She went to bed early, got up to take Tylenol during the night. The next morning on 3/7/21 had soreness in the breast area, the lymph nodes in the arm were very sore to the point that she could not wear a bra. These symptoms also have gone and is still a little tired but otherwise doing better.

Vaccine given on 2/26/2021; 3/1/2021 noted enlarged lymph node under left armpit; 3/15/2021 sharp needlelike pain shooting in my left breast lasting 48 hours. Checked my left breast and noted breast quite enlarged. 3/25/ 2021 pain resume in left breast for 48 hours. 3/29/2021 had a previous appointment for checkup on right breast as a follow-up for breast cancer 7 years ago. had Dr check my left breast and he said I still have an enlarged node under my left armpit and my left breast definitely has lymphedema. Prior to this my bilateral breasts were more or less symmetrical.

Polyp 1.3 centimeter with blood clot beside polyp; Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago; Since then, she had spotting every day; 22 days gap; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anemia iron deficiency (because she is vegan), Attention deficit disorder, Cold sores, Migraine (menstrual related), Hypertension (mild) and Drug allergy (sensitive to some medication, as per patient; might not be significant). Concomitant products included IRON for Anemia iron deficiency, DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]) for Attention deficit disorder, LOSARTAN for Blood pressure high, ACICLOVIR (ACYCLOVIR ALPHARMA [ACICLOVIR]) from an unknown date to 09-Feb-2021 for Cold sore (herpetic), TROPICAMIDE (MIDRIN M) for Migraine, ESTROGENS CONJUGATED (PREMARIN) for Vaginal dryness, COLECALCIFEROL (VITAMIN D3), FISH OIL from an unknown date to 09-Feb-2021 and PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) from an unknown date to 09-Feb-2021 for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (22 days gap). On 16-May-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago) (seriousness criterion medically significant) and VAGINAL HAEMORRHAGE (Since then, she had spotting every day). On 27-May-2021, the patient experienced POLYP (Polyp 1.3 centimeter with blood clot beside polyp). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (22 days gap) had resolved. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Sudden gush of dark red blood - thick, like gel, more than water, last period (Menopause) 22 years ago) and POLYP (Polyp 1.3 centimeter with blood clot beside polyp) outcome was unknown and VAGINAL HAEMORRHAGE (Since then, she had spotting every day) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Gynaecological examination: normal (normal) Normal. On 27-May-2021, Ultrasound scan: abnormal (abnormal) found to have a polyp measuring 1.3 centimeters and a little blood clot was beside the polyp. Treatment included hysteroscopy, dilatation and curettage to remove polyp and clot, and specimens were sent to pathology, results not provided. She will be having a post-operation follow up consultation on 8 Jun 2021 with her gynecologist. 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.